[This Transcript is Unedited]
NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS
SUBCOMMITTEE ON PRIVACY AND CONFIDENTIALITY
October 4, 2007
Hubert H. Humphrey Building 200
Independence Avenue, SW
Washington, D.C. 20201
CASET Associates, Ltd.
10201 Lee Highway, Suite 180
Fairfax, Virginia 22030
- Mark A. Rothstein, J.D. Chairman
- Simon P. Cohn, M.D.
- Leslie P. Francis, J.D., Ph.D.
- Harry Reynolds
- Paul C. Tang, M.D.
- Larry Green, M.D.
- Marc Overhage, M.D.
- Marjorie Greenberg
- Gail Horlick, M.S.W., J.D., CDC
- Sarah Wattenberg, SAMHSA
- Maya Bernstein, J.D.
P R O C E E D I N G S [1:00 p.m.]
MR. ROTHSTEIN: Good afternoon, everyone. This meeting is being recorded and transcribed, and there is one person who has called in, and I have a guess who that might be, but could you say hi.
MS. HORLICK: Hi, this is Gail Horlick, CDC.
MR. ROTHSTEIN: Hi, Gail.
MS. HORLICK: Hi, Mark.
MR. ROTHSTEIN: Good to hear from you. And just for the record, I’d like to begin by going around the room and having people identify themselves as members of the Committee or staff or whatever. Paul?
DR. TANG: Paul Tang, Palo Alto Medical Foundation, Member of the Subcommittee, no conflict.
DR. OVERHAGE: Marc Overhage, Regenstrief Institute, member of the Committee.
MS. KHAN: Hetty Khan, CDC, NCHS staff to the Committee.
DR. COHN: Simon Cohn, Associate Executive Director for Kaiser Permanente, member and Chair of the Committee.
MR. REYNOLDS: Harry Reynolds, Blue Cross Blue Shield North Carolina, member of the Committee, no conflicts.
MS. WATTENBERG: Sarah Wattenberg, SAMHSA, staff to the Committee.
DR. GREEN: Larry Green, member of the NCVHS Committee, not a member of this Committee, no conflicts.
MR. DICARLO: Mike DiCarlo of the Blue Cross Blue Shield Association. I’m an observer.
MS. JACKSON: Debbie Jackson as a Center for Health Statistics Committee staff.
DR. GABLE: Paul Gable, SSH.
MR. ROTHSTEIN: Thank you and welcome and especially thanks to Marc Overhage and Larry Green for joining us today. Maya is on personal business, and she will be here within an hour or so, but I will endeavor to take any notes that she might use.
Let me just take a minute to tell you sort of where we are and what I’d like to do this afternoon.
You should have in front of you a copy that’s labeled Draft No. 8, and I hope you’ve had a chance to read it. And let me see if I can tell you the background for where the draft comes from. You may recall that at our last meeting which was at a break out session at the September Full Committee meeting, we discussed some of the overall issues where there were concerns raised about the other letter. We didn’t actually talk about Draft No. 7 itself at that meeting. But after that meeting, I took Draft Seven and then added some things to get to Draft 8, and let me tell you how Draft No. 8 differs from 7 and its predecessors.
So what I did to do Draft 8, Maya was out of the country and unavailable to do it. Number one, I included general comments that were made at our last discussion meeting, and for example, it was suggested then that some of the sections be reordered which I did, and the comment was made by a couple people that the letter’s getting too long. In particular, the sections where we said what we’re not doing and which approaches we didn’t follow. So I did those things.
Number two, in Draft No. 7, you may recall that Maya added some questions in the text of Draft 7 such as don’t you think we should define what we mean by these various categories. So I attempted to do that just as a starting point.
And third, this Draft No. 8 attempts to include Paul’s comments as relayed to me by Leslie. Oh, also I hear that laugh. Did you join us?
DR. FRANCIS: I’m here.
MR. ROTHSTEIN: Okay. Especially in two areas, number one, in terminology where I understand that Paul requested that we use the word sequester instead of mask, which I did, and also in the section on electronic decision support. But if I misinterpreted, we can clean up that intent.
DR. FRANCIS: I mistranslated.
MR. ROTHSTEIN: Yeah. Well, or if anybody wants to do anything by way of modification. So if you haven’t had a chance to redraft number eight, it pretty much tracks earlier drafts. I do want to point out that what the areas in which it’s different. On page two, where you see what is sensitive information, as a starting point we can tinker with this if you want. I attempted to add some definitions for what we mean by genetic information, mental health, domestic violence, et cetera.
Let’s see what else I did. On page four, where we – actually, it starts at the bottom of three, options for letting the disclosure. I moved restriction by categories to be first. It was in Draft 7 last. And then I shortened some of the other four discussions.
And the other thing that I did in this draft is on page six under clinical decision support. I attempted to make it clear that we don’t believe that clinical decisions support or anything is ready off the shelf, and we’re recommending research and development.
So the recommendation should be electronic clinical decision support developed by NHIN should explore whether it will be beneficial to search sequestered information or report all information of clinical significance. So that’s slightly different wording of the recommendation.
So let me ask anyone if they have any general comments, or Paul to see if I have been responsive at all to your concerns, or do you have additional suggestions.
DR. TANG: Okay, thanks, Mark. Let me try to summarize the things that Leslie and I talked about, and some of it is here like the use of the word sequester, and some isn’t.
So the major thing is that for the types of information, there’s some that are routine because they’re coded in federal law and providers know how to behave and know what may be missing. That is, for example, mental health and substance abuse, and that’s relatively straightforward.
I don’t know whether domestic violence information is protected by federal law. So I’m not sure, is it?
MS. WATTENBERG: No. The current federal law only protects substance abuse information that originates in a program. So actually primary care physicians and everybody else will not understand this at all in terms of – so they will not have sort of a history of understanding how to protect this except they do have more familiarity with mental health and tend to group substance abuse with mental health. So what they do know is that they have to do something.
DR. TANG: So I mean I can jump up to the general principle then at least either the concern or the principle I was trying to raise is that where, so that would fall under social and family history which is very pertinent to most of the medical encounters in that it would be a disservice to exclude that in selected pieces from consideration for most of the encounters. And the fact that it’s not something people are used which is the distinction I was trying to draw makes it hard for people to rely on information in this repository now in electronic form.
Once you sort of disable or impede the routine use of information, then we’ve done a disservice to our primary goal which is to make sure that the information needed to make decisions on that patient that day, you end up, I mean, that value goes down and hence in the extreme. Just like you say that people will stop even telling their physician something the same thing as people stop using the information, and that would be the wrong thing for us to do.
MR. ROTHSTEIN: Well, let me ask you, do you want us to do them one at a time, or do you want to go through your whole list, and then we’ll go back to them.
DR. TANG: I might as well go through this whole list because you said you were trying to reflect the –
MR. ROTHSTEIN: Okay, that’s all right. All right, I just wanted to make sure – okay, so the first one would be the, I’m sorry.
MS. GREENBERG: I’d kind of like to ask Paul a question because I saw that Maya had asked regarding social and family history whether you meant social and non-medical family history because history of disease, I mean, is just a common thing asked that I think it’s quite important to know whether somebody has, the mother had breast cancer, their father had heart disease. Either it’s important or they have been asking me this for years, and it didn’t really make any difference. But from everything I know, these – is that what was intended by family history of disease or some other family disease?
MR. ROTHSTEIN: Well, we’re going to talk about this. But basically what I mean to include or allow people to exclude is under the following rationale. If we adopt this format and allow people to sort of hide, mask questions or whatever you want to call it certain categories, we’re going to be allowing patients to not disclose certain kinds of information like mental health history or substance abuse information that is arguably highly relevant to their care but under the theory that it’s so sensitive that there are other things. Here, what I’m suggesting is, well, should they be able to mask that their father was an alcoholic and their mother was a drug abuser and all these other things which might be just as sensitive and of less clinical value.
DR. TANG: It’s not less clinical.
MR. ROTHSTEIN: Okay, well –
MS. GREENBERG: Let’s get into the details.
DR. TANG: The point, well, Marjorie’s point is a good one because if it is sort of bears on the earlier discussion. It’s – you weren’t here when we were talking about is this something that’s a disclosure that would be unexpected by the patient and deemed undesirable or harmful. And we had trouble defining, well, which one of the, how do we classify each one of thousand uses.
It’s probably easier to say, you know what, I’ll bet you if I put you at risk in terms of liability, you pretty much know which one’s worth shading and which ones weren’t. So same thing here —
MS. GREENBERG: This was this morning’s conversation?
DR. TANG: This was this morning’s conversation. So same thing here, if there’s going to be a lack of clarity about what may be sequestered versus not, then I think it’s harmful to the care process. So if I have to guess what you consider sensitive family history and what you, then it’s destroying the value of the record itself as an information source. And that’s what I’m trying to avoid by this thing.
And so the words “specific content” in our six and our seven again go to that same problem where in masking actually describes that which is why I think that concept, I don’t think, is a good one. It interferes with care.
The second piece was –
MR. ROTHSTEIN: Okay, so your first concern is it was the social information.
DR. TANG: Yes. Things that are other than in routine practice – like routinely we understand mental health’s literally sequestered.
MS. GREENBERG: Is it all mental health, or just the notes?
DR. FRANCIS: Paul, can I interrupt you for a minute? This is Leslie. I just want to be sure kind of backing up that we agreed that it’s okay to try to define some categories.
DR. TANG: Right, that are commonly understood.
DR. FRANCIS: And that the starting point should be categories that are commonly understood.
DR. TANG: Right.
DR. FRANCIS: So we should start with and say that substance abuse or mental health might be examples of those categories.
DR. TANG: Right.
DR. FRANCIS: Right, okay. So there’s no dispute about that. And so we could say that really clearly upfront, and then the next question would be I suppose in some ways we could think about it as whether we want to define any other categories, and we need to talk about that, how they might be defined, whether they – I mean, it could turn out to be that as electronic records get developed, new categories might emerge that would be recognized in practice. I mean, it currently recognized in practice categories aren’t set in stone; they just happen to be in some cases actually for legal reasons like the substance abuse ones, they happen to be ones that have become very familiar. So we start with the familiar, and then the question would be what the benefits and risks and so on would be additional categories.
DR. TANG: Or, like this morning’s conversation, you find a way to penalize folks who abuse the information they have access to. So this morning you could either enumerate each of the thousand good and bad uses, or you decide that people are going to be held accountable for all the gray areas which the hostel is you can pretty much figure out what’s good and bad, even though you can’t define it.
MR. ROTHSTEIN: Okay, let’s move on to number two. We’ll come back and – oh, I’m sorry. Simon, did you want to – he’s going to set out his list, and then if anyone wants to add topics to the list, we’ll get those. And then we’ll just go through them in order, if that’s okay. Oh, yes, for the record, Leslie, could you introduce yourself.
DR. FRANCIS: Oh, I’m sorry. I’m Leslie Francis. I’m in Law School, University of Utah. To the best of my knowledge, I have no conflicts, and I’m on the telephone.
MR. ROTHSTEIN: Okay. Oh, yes, and Marjorie.
MS. GREENBERG: I’m Marjorie Greenberg, National Center for Health Statistics and executive secretary to the Committee.
MR. ROTHSTEIN: Okay, thank you. Paul?
DR. TANG: Okay, so the second point was the granularity with which patients can “mask data.” And I was hoping that we had backed away from masking individual data elements, but I think it’s come back into some of the verbiage in the recommendations.
MR. ROTHSTEIN: Well, that wasn’t our intent, but we can look at it. And so, all right, I’ll just put as number two the granularity of –
DR. TANG: Right. And the third is the whole nature of clinical decision support and what had been, and I think – well, I haven’t read this particular version. But the notion that the computer would act on information that is not visible to the human professional. I have an objection on two counts. One is it sort of violates a principle that the human end of the computer should be operating on the same data when they are trying to make decisions. That’s one piece.
The second piece is the limitation of “decision support.” And an example I give is drug interaction. So drug interactions, the majority meaning, you know, at a partner study like 87 percent are ignored as the wrong, they’re not acted upon in a way that would change the order. So that means there’s a high false positive rate. So if this computer system were to constant 87 percent of the time say, oop, there’s something I know that you don’t know, and it could be interfering with, then what have we done. We have practically destroyed again both the concept of the record and the concept of masking.
So I feel it’s untenable on those two pieces, one on a theoretical sort of principle of how decision support, computer decision support should interact with the human professional, and, two, the limitations and it causes really a disarming both of what you’re trying to do and what the record’s there for.
MR. ROTHSTEIN: OkaY, that’s number three. We’re going through them all.
DR. TANG: And I have a fourth, but it will come back.
MR. ROTHSTEIN: Okay.
DR. TANG: I forgot.
MR. ROTHSTEIN: So our list has three on it, and does anyone want to add something? Simon?
DR. COHN: Well, you know, actually I just had a couple of comments, and I’m not trying to adding so much. But first I wanted to compliment you because I think this is a much better document than the one I’ve seen, and I actually just had the opportunity while Paul was talking of read it. So it actually addresses, I think, some of Paul’s concerns.
You know, I do, and this is just sort of, maybe it’s getting to the answers or whatever. I mean, I guess I share all these with at – this issue around social and family history, and I would agree with everyone that there’s, I think, concerns about possible aspects of it that – I mean, the issue is that there could be things there that are very sensitive and a person would not willingly want to have disclosed.
The problem is that it’s such a broad area and so vaguely defined that it almost feels like it’s a research agenda to figure out how to approach that in a way that is meaningful. And I would just suggest, I mean, the other ones I’m actually supportive of. Now I do have sort of just two other questions here or whatever.
One is recommendation four, what is the recommendation. There seems to be either a lack of verb or something.
MR. ROTHSTEIN: I think there was one where the word “should’ was left out.
DR. COHN: Oh, is that what it is?
MR. ROTHSTEIN: Yes.
DR. COHN: Recommendation four.
MR. ROTHSTEIN: Yes, recommendation four, I think it’s electronic decision support should be developed. Oh, wait, I’m sorry. Electronic decision support for the NHIN should explore – I knew there was a “should” somewhere.
DR. COHN: Okay, so this becomes more, okay, thank you.
MR. ROTHSTEIN: It should explore what would be beneficial.
DR. COHN: That certainly answers my other question there. Thank you.
MR. ROTHSTEIN: Okay, Harry.
MR. REYNOLDS: Yes, on the one Paul used the example of ePrescribing. So Paul, what you’re saying is that ePrescribing should not be allowed to see the medications if the physician’s not.
DR. TANG: I’m saying computer clinical decision support not be acting on different information than what the human professional’s looking at.
DR. FRANCIS: Well, Paul, what I understood you to say is that the strategy of masking, say, a prescription for a psychotropic drug as part of mental health but letting a decision support take that into account in warning a physician about drug interaction when the physician him or herself is masked from the SSR, whatever it is, drug. That’s what’s problematic.
DR. TANG: Right.
DR. FRANCIS: And I’m still puzzled about why because all that goes on is the physician gets a flag from the decision support. So the physician gets information that the decision support has identified something. Now so what is the physician to do? Well, the physician –
DR. TANG: So Leslie, that would happen in probably in excess of 80 percent of all encounters for all patients, and therefore what have you accomplished by masking anything.
DR. FRANCIS: That would happen where a patient is on a psychotropic drug or –
DR. TANG: Or has any other lab test that I can’t see like a lithium level. So you basically, it’s a liability for the patient. We’re already in a nebulous area in terms of how are people supposed to react to decision support. The worse world would be to react on decision support on data that I can’t see. Then I’m absolutely obligated to say, okay, look, give me your pin. I got to see because I just have to because otherwise I don’t even know what trouble I’m in.
So it’s completely –
DR. FRANCIS: So basically what’s going to happen, your contention is that what’s going to happen is physicians are going to have to say in 80 percent of the cases to patients I can’t treat you unless I break the glass.
MR. ROTHSTEIN: Okay, Harry wants to finish the question and then –
DR. FRANCIS: Yes, I just wanted to be sure I understood it.
MR. REYNOLDS: You know, our Full Committee helped move along ePrescribing, and this was not a subject that was brought forward in the final rule probably being worked on right now. So and all that data is owned back to our earlier discussion today. It’s available to covered entities. It’s available, considered part of it as part of treatment quality. I mean, so I think this particular one, I mean, I’m weighing in on all of them. But this particular one concerns me because the plusses, there are very few, you know, we talk about all this electronic stuff going on, and I know that I’m getting the watch. EPrescribing will make a huge difference.
And so this particular one to me may move which one of our better plusses of using information the right way at the point of care, letting the doctor-patient relationship stay the same, let them be able to do this, this and this and make sure that as in our cases there are numbers of doctors actually changing medications once they realize these things go, and we’ve got statistics on all of it.
I struggle a lot with this one because all the best that we’ve all been trying to get to comes to bear, in my opinion, under ePrescribing. And now, if we go where we’re going, then you may take that asunder on some of the situations that may be the ones that if that particular patient ended up in the emergency room because it was shut down basically, you know, the information was kept out, that’s a problem. I really struggle to go there. I truly struggle to go that far.
So I understand from a doctor’s standpoint, but I also understand from everything we’ve all been meeting on here a long time. That’s kind of they call perfect storm. That’s kind of perfect day. EPrescribing sometimes can be the perfect day because all the right things come to bear at the right time, it’s not a storm. So I want to make sure–
DR. TANG: You’re supporting that, I think.
MR. REYNOLDS: I’m supporting what? No, I’m not supporting it.
DR. TANG: You’re supportive of masking.
MR. REYNOLDS: No.
DR. TANG: So you’re saying –
MR. REYNOLDS: No, you’re right. Here was your position. If it’s masked, it can’t be used by decision support. I’m not sure that masking shuts it out of ePrescribing which is part of treatment payment health care operations.
DR. FRANCIS: Wait, I don’t understand now what you’re saying here.
MR. REYNOLDS: Well, no, this is the NHIN guys. This is the NHIN.
DR. TANG: Whatever that is.
MR. REYNOLDS: Whatever that is, ePrescribing is not the NHIN, okay. The data’s available. It’s not going to be masked. If we say it’s masked over the NHIN but it’s not masked in ePrescribing, then what the heck is it.
DR. OVERHAGE: No, it is, though.
DR. FRANCIS: Yes.
MR. REYNOLDS: It can’t get where?
DR. OVERHAGE: So I send a patient to the laboratory to have variant coagulation testing done, and the patient said – and one of the things that is now recommended by the FDA is that you have a genetic test done to determine the dosing of Coumadin. So the patient said I don’t want my genetic information shared. So that lab, thorough initial health information network cannot if the patient said they want their genetic information masked, deliver that result to me.
MR. REYNOLDS: Through the Nationwide Health Information Network.
DR. OVERHAGE: Yes.
MR. REYNOLDS: No, no, no, that’s where I’m going. I’m a member. EPrescribing to me is not part of the Nationwide Health Information Network.
DR. OVERHAGE: Well, I agree. It’s just an application at the end.
MR. REYNOLDS: Okay, and remember, the data goes to all the players.
DR. OVERHAGE: No, it doesn’t.
MR. REYNOLDS: But let me finish. You’re the expert. I’m throwing it to. We go back and forth. I’m just going to put it in. Every prescription goes to the PBM.
DR. OVERHAGE: Very few, very few.
MR. REYNOLDS: Okay, fine.
DR. OVERHAGE: I mean, because that’s the underlying drug benefit.
MR. REYNOLDS: Okay, well, fine. I’ll adjust it then for those that do. Okay, we’ll go there. We’ll center the argument. For those that do, if they want paid to their insurance, and I’ll make sure I – I’ll go specifically, I do the use case, and they want paid by their insurance. It is submitted, and it goes to a PBM. And if that group and if that area has part of the country or whatever has ePrescribing, that data is available to that decision support for ePrescribing.
DR. OVERHAGE: I don’t understand that.
DR. TANG: They’re proposing that you mask.
MS. WATTENBERG: Right, so that data may go in. But it’s not available to the end user.
DR. TANG: What we’re trying to figure out is and do you support masking or the not masking.
MR. REYNOLDS: I have no further comment on it.
MS. GREENBERG: Do you think that information should be available or decision support that is not available to the clinician?
MR. REYNOLDS: Yes, I do.
MR. ROTHSTEIN: Okay, I just want to take a second to allow Maya to introduce herself.
MR. ROTHSTEIN: So if there’s no objection, what I’d like to do, we were going to discuss each of them in detail. And the last thing we were on was electronic decisions where I’d like to continue that discussion and maybe go in reverse order, if that’s okay.
If you haven’t read the new version on page six of the section on electronic decision support, one of the things that I specifically tried to do was to make this less sort of prescriptive than the last versions, and I’d like to give you just a second to re-read that and see if it increases your discomfort level.
DR. FRANCIS: And only recommend pilot.
MR. ROTHSTEIN: Yes. Especially the last sentence.
DR. TANG: But if you think that this is a – it’s like saying we’re only piloting whether somebody should be allowed to commit murder, we’re not committing ourselves yet until we assess the societal good. What the two pieces of, the two concerns I raised are first principle concerns.
DR. FRANCIS: Paul, once again, would it make sense to, because it’s actually an empirical question, how frequently this would turn out to be a problem. It might turn out to be a problem for some kinds of prescriptions but not for others, for example, and it’s also a question of whether, I mean, how practice would evolve and so on in response to this possibility.
So what about if that section were crafted so that it pointed out both what this could do and pointed out what are your absolutely legitimate concerns. That is, it might get triggered too often so that the information might turn out to be meaningless. It might turn out to be the kind of situation in which physicians really can’t function without getting the information. So that if we made both sides of the concern clear and then said with these concerns in mind, we recommend that because, of course, it would be ideal if we could avoid your concerns and mask the information.
DR. TANG: Well, the good news is that we can make it evidence based because this data already exists. The data on the interactions between psychotropic drugs and the community of prevalent drugs that are used already exists. So we can assess that and certainly I was quoting from partners. So there’s quantitative data to back up the fact that there’s going to be a high prevalence of false positives interactions among drug –
DR. FRANCIS: And the question is what, how physicians will deal with that, whether it’s possible to figure out how to deal with that and so on. So we could, we could even cite the data. I mean, if you provide the, you know, we can cite things in letters.
What seems to me to make sense to do is to say that, you know, the privacy case is a strong case. There are these really serious practice concerns. What we recommend isn’t giving up, but what we recommend is trying to figure out through some pilot studies whether there’s a way to meet both concerns.
MR. ROTHSTEIN: Can I ask you a question, Paul, about this? We’re all, I think, in favor of electronic decisions as a concept, right, in the abstract, right.
DR. TANG: Yes.
MR. ROTHSTEIN: And I think we’re all in support of the notion of sequestering information, maybe.
DR. TANG: In very limited context.
MR. ROTHSTEIN: Well, I mean in certain categories that we talked about.
DR. TANG: Mental health.
MR. ROTHSTEIN: Okay, that’s fine, okay. So now the question is, would you be better off not, I mean, your position is that doctors would be better off receiving less information, right, than information that would be potentially misleading or confusing or would make matters worse?
DR. TANG: No, there’s no way to practice medicine in this country saying that there’s something lurking in there that you don’t know about. You’ve got to go discover it. And I’m saying that we can provide you numbers that say the majority of cases will have one of these records. So all you’ve done is added to the time burden, the administrative hassle, taken away from the relationship between the patient and doctor and increased the legal liability of the physician for the majority of cases in dealing with people with mental disorders.
MR. ROTHSTEIN: Well, suppose you’ve got a patient who also has a diagnosis of mental illness, and you’re seeing them for some other problem, okay. If we’re allowing them to mask or sequester the mental illness information and now you’re treating them for the flu, the question that I have is would you be better off not knowing that they had any mental illness because we’re agreeing, I think, that they can sequester that, and when you write your prescription for antibiotics, let’s say, now you don’t know whether they have any other health problem. So you – would you then automatically ask every patient whether they have any condition that might interact with the antibiotic?
DR. TANG: You have to.
MR. ROTHSTEIN: Okay, so —
DR. TANG: The thing that’s protected by – let me sure I get this right while I’m – is psychotherapy notes. So – not the diagnosis and not the drugs.
MS. BERNSTEIN: Psychotherapy notes, just to be clear, are able to be withheld from the patient if the patient requests his or her own record if the records have been separated. But it doesn’t automatically protect them. It just permits the physician to withhold them if the physician wants to.
DR. TANG: No, I’m talking about sharing information.
MR. ROTHSTEIN: So basically there are – if you buy the concept that patients can separate their mental health information, okay, now the question is are you better off, I mean, your argument, I think, is as a clinician I’m better off not getting any information about possible drug interaction than I am getting information because there are false positives, it’s not specific, it could be problems with it. And then you as the treating doc are invariably going to be making the same inquiries, or you’d have to make the same inquiries of the patient that automatically is now being done electronically. Am I right? I mean, I’m trying to understand what you’re —
DR. OVERHAGE: Well, I generally agree with what Paul said. But could you clarify – we were talking about these terms in a vague way. So mental health information is one discussion which I understand about psychotherapy notes.
MR. ROTHSTEIN: We are in this letter proposing that it be extended because the psychotherapy notes exception is very narrow. It only applies to the records maintained by a “mental health provider,” et cetera, et cetera. Okay. So if we broaden it and allow individuals to isolate, however we call it, their mental illness information, now the question is should decision support probe that, or to give you more information, or is it counterproductive to do that because of false positives, because it’s confusing, inaccurate or any other reason that’s going to lower the quality of care. But you said, I think, that the kind of thing that the decision support is going to do in terms of interactions, a reasonable physician would want to do anyhow to check for the interactions. So is that a fair description of the problem, Marc?
DR. OVERHAGE: I think that’s a fair description of the problem and the root of the problem. I mean, the whole notion of sequestering any significant amount of record, I think, is absolutely impossible and still practice medicine because anything you want to pick on here, reproductive history, if you take the number of, I mean, half – well, not half but 38 percent or whatever it is of the people in this country are potentially going to get pregnant, and there are hundreds of drugs and dozens of treatments that I need to know that, for example. I mean, it’s over and over, and I can’t imagine taking care of a patient with knowing, as Paul said, that there’s something I can’t touch because I may have to go find it out.
DR. FRANCIS: Well, let’s maybe back up. This is Leslie. So we have several different possibilities, and this is why I wanted to back up and say are we going to talk about sequestering by type of information et al because, so here, I think, in the real world, here are the kinds of things that could happen.
If we have the knowledge that there’s a very powerful interoperative electronic health records system, patients will either not go to providers at all if they don’t want records in the system, or they will go to providers and specifically request somehow either they don’t pay, they pay personally or they try to figure out some way to get it siloed.
So you’re not facing an ideal world of practice because the information won’t get there one way or another. It might not get to you – so which would you rather have, people never go in to see a mental health provider, or you never know that they’ve seen it because they essentially do it off budget because they never want it to get in the record.
Or, would you rather have a case in which it’s in the record, you get a notice that there’s something sequestered in the record. I guess that doesn’t happen very often because most people aren’t going to sequester stuff. But when it does, when they sequester the record and then you ask.
MR. ROTHSTEIN: Okay, we’ve got Harry, then Sarah, then Marco.
MR. REYNOLDS: I will defer my time to the gentleman from Indiana, and I’ll go third.
MR. ROTHSTEIN: Okay, Marc. Okay, Sarah.
MS. WATTENBERG: Okay. So I want to echo something that Leslie was saying which is one of the things that this paragraph on clinical support doesn’t say – is that in protecting sensitive health information should not unduly interfere with optimal clinical care. But it also needs to promote having patients participate in care. And I think that we really lose sight of the fact when we have all these conversations, we sort of get so not in the weeds in the sense that we shouldn’t be talking about it, but we keep forgetting what, you know, all sources of data tell you, survey, whatever it is, if people with mental health and substance abuse disorders don’t feel that their information is protected due to the ongoing serious harms, due to stigma and discrimination, they will not go to treatment. And there’s already a pretty significant underground substance abuse treatment phenomenon that goes on now because of that.
So it’s just to say that that’s part of the balance that really needs to be brought in here. The other thing –
MR. ROTHSTEIN: Excuse me, Sarah, let me just point out that on page three under the importance of individual control, I think that argument is made. But maybe it needs to be brought forward.
MS. WATTENBERG: Yes. But I think if you’re going to put it under the decision support thing that it can’t interfere with clinical care, you also have to stick in that other piece just to frame the argument.
The other thing is that I am not sure why you think that 80 percent of your clinical encounters would show up with these false positives. That seems pretty high to me. But the other thing I’ll say is that my understanding of some of the California Health Care Foundation surveys is that if you engage your clients in a conversation about sharing information at specific encounters, they are more inclined, not less inclined, to offer you permission to access that information or will give it to you. So when you talk about all sorts of, you know, gymnastics that a physician might have to go through, I think that’s an overestimation of what would really happen. I think typically when you ask the patient, you know, I’m seeing here that there’s some kind of medication interactions, I’m not receiving information, what are the medications you’re taking, but let me tell you that if you’re on some psychotropic drugs or if you’re on Buprenorphine or something like this, it could potentially have serious effects, and I need to know that to adequately prescribe, chances are that’s all you need to do.
Now that could be wrong. But I’m just saying that’s my understanding at least with the population that I saw in this survey.
DR. FRANCIS: And in that way members of that population know they’re being respected.
MS. WATTENBERG: Yes. Now the other thing I would just say is if you don’t want all of this, then essentially what you’re saying is those categories of information are not entitled to extra privacy protections, and then the whole conversation is ridiculous because that’s what we’re talking about, you know. Not ridiculous, but sort of misleading because, you know.
MR. ROTHSTEIN: Okay, we’ve got Marc, then Harry, and then Bob.
DR. OVERHAGE: A couple of things. I think some of the categories that we described, well, first of all, let’s have at the slippery slope. I mean, you’re talking about a category where there’s a category. So we talk about substance abuse treatment or mental health treatment. So what’s the most commonly prescribed drug in the country or top two or three? I mean, it is, and you know 30 percent of the people that walk in a primary care physician’s office are there for a mental health issue. Depression, far and away the most common mental health thing in the country and far and away the most common diagnosis from primary care.
DR. TANG: And far and away, the most commonly prescribed drug.
DR. OVERHAGE: Yes. So when you say mental health, for example, I think partly people sometimes have this, you know, it’s the schizophrenic or it’s the you know, whatever. It’s most of us and across the lifetime of a population. I forget the lifetime risk, but it’s huge for all of us to have a mental illness. So when we say that, we’re talking about a huge swath of the population.
But the other part of it that gets very tricky, extremely tricky to me. So Amitriptyline, common drug used to treat depression and for pain therapy and used for dozens of things. So the edges are very tricky to this thing. Say a category, psychotherapy notes, that’s easy, and you can find them and manage them and understand them. But as soon as you go beyond that, the drug levels of the drugs, I mean, these commonly used drugs, I think in every one of these categories, reproductive health falls into the same bucket.
You know, the fact that somebody had a hysterectomy ten years ago could have tremendous implications. We have somebody could decide that’s part of reproductive health and therefore shouldn’t be available. And on top of that, to even practically begin to sort those things out is almost impossible because that hysterectomy is mentioned in the past medical history and some note, and the same with mental illness and things like that.
So on a practical standpoint, drawing a circle around these buckets is extremely challenging. One more thing, and that is you made the point about how many people does this affect. I think you can make a pretty good argument about the large number of people that it affects. I want to turn around for just a minute and think about the burden that you potentially impose on the entire health care delivery system and then ask yourself the question how many people, and maybe the percentage, I mean, I think you talk about numbers of people in the country would (a) care to exercise that right or privilege and (b) would be knowledgeable enough to exercise it in a rational way, and I think that number is vanishingly small.
MR. ROTHSTEIN: Okay, Harry, you’ve been very patient.
MR. REYNOLDS: Okay, I agree with Marc. I just gave a presentation on this to the IM Information Management People for the Blues about this exact subject using some more categories.
But I need a couple clarifications. So we’re recommending that data, if it’s masked or sequestered, whatever term we’re using, that a note be sent to the physician saying that when it came up on the NHIN. That’s what this is saying. I’m not saying what everybody’s agreeing on around the table. I’m saying what this says.
MS. GREENBERG: It’s just saying something to that effect.
MR. REYNOLDS: Okay, okay. Now so when you look at ePrescribing and you get the alert, it’s kind of saying the same thing because you’re going to have – we get a little focused on NHIN which we struggled with in the previous meeting this morning, and we will struggle with forever until it becomes something that then you can actually put it up on the wall and throw darts at it as to what it means.
And so – and knowing that the Department and others are moving some of these things along, I’m trying, this NHI – what’s in the NHI and what’s not in the NHIN and whether this is okay, this isn’t okay. But help me understand. Maybe, Paul, you can help me understand why isn’t that a good message to the doctor because if the patient comes in and says here’s what I have and you’re about to give a drug, and then when you put the drug in, it comes back and says there’s a drug interaction, you’re going wait a minute, the two drugs you told me and the drug I got, that’s not a problem. And the numbers we’re getting right now off of ePrescribing are 23 percent of the drugs that are putting in are drug interaction and 2 percent on drug allergy.
So but –
MS. GREENBERG: But how many are overwritten?
MR. REYNOLDS: About 25 percent of the drug and 54 percent of the drug allergy on what we’re seeing right now, a thousand docs. But so all I’m saying in general is if you wanted to –
DR. TANG: Twenty-three are overwritten?
MR. REYNOLDS: No, 23 percent of the 23 percent.
MS. GREENBERG: Twenty-five percent of the 23 percent.
MR. REYNOLDS: Yes. Well, let’s forget my numbers. Let’s stay with this. So if you want the alert, if this goes forward, if you want the alert that there’s data being withheld, then isn’t that the same thing you’re getting. And then I got a follow on question. But I need you to help me with that.
DR. TANG: I’m not sure I know how to respond to that exactly. So let me try, but there is a relevant point that combines what you and Sarah have said. So you gave actually a very eloquent message when faced with what you just proposed meaning, okay, I’ve got a verb about something. Then you gave a 30 second eloquent response. Most docs could not do it that precisely now definitely, that’s point one.
But the bigger point is that that would generate a minutes long conversation. Now in the ten minutes that we’re talking big percent. The other point is and I could have gleaned the information and dismissed, disposed of it meaning make disposition, not throw away in 20 seconds. So that’s both the value and the efficiency I get by letting me know what decision, what information I need to know, and I’ve also looked a whole lot smarter to the patient instead of I’ve made an informed decision, not I’m fishing around.
So there’s all kinds of stuff that’s going into that interaction, efficiency, effectiveness, relationship. And so another anecdote then is so we’re talking about minutes here. Our docs will complain bitterly for one extra tick if they get an extra tick or an upgrade. So we’re talking about three orders of magnitude in time, and so the point is how much that seemingly innocuous conversation like this costs the doctor in actual practice.
DR. FRANCIS: Paul?
DR. TANG: Well, let me just finish.
DR. FRANCIS: Yes, finish. I can’t see when you finish.
MR. REYNOLDS: And then I get to finish, Leslie, and then you can talk.
DR. TANG: Amitriptyline was another great app because it treats so many things medical and mental health and unfortunately it interacts with a whole lot of things including things related to your heart, and that’s just rampid in this community and in depression.
And actually on the depression issue, we are probably prosecuted more for not recognizing and treating depression than for trying to ignore it which from the doctor point of view is what’s the affect of this masking stuff.
And so finally my practical out. Practically speaking, psychotherapy is all done in text. The computer doesn’t understand one iota of text. So it will not either trigger or reveal anything like that. And there are ways that are fairly straightforward to say, okay, let’s isolate this conversation. We’re going to talk about something sensitive. Many EHR systems will allow you to make that encounter, that particular document sensitive only to me. Yet, there’s nothing that is, I mean, that’s sort of a compromise between what Marc was saying. So this text material which does not include the coded information about the diagnosis or the med or the allergy can be “sequestered.”
But that’s different because the health care profession has been party to saying I’m going to label this as something that I understand is sensitive to you, but I also in my judgment feel that is not deleterious to sequestering it, and I’ve coded the information that is useful diagnosis, problems, allergies.
That’s an important interchange versus what the recommendation says which is a patient who is not maliciously but without being informed saying I want that sequestered from this person, this sequestered to that person because they’re making an uninformed decision, not because they’re either, they’re just not informed. They’re not expected to be, and replacing that burden of selecting on the wrong party.
So maybe what I’ve sort of actually said as I was thinking out loud, this partnership by saying, okay, I understand you’re suggesting this, and I will as a health care professional also help inform you and decide with you what we’re actually “sequester.”
MR. ROTHSTEIN: Okay, let me just remind everybody the order of questioners. So Harry is next, followed by Marjorie, Leslie and then Sarah, and then I want to reserve my spot because –
MR. REYNOLDS: Okay, the one thing that’s not mentioned in here is liability. So –
MR. ROTHSTEIN: Oh, I did.
MR. REYNOLDS: Oh, okay, but I’m going to say it again. Obviously, the doctor has certain liabilities that if the person withholds data but there is also another significant chain. The whole health industry has a liability because if the person withholds information and ends up in the ER and ends up somewhere else, employers may pay for it. Others may pay for it.
And so, you know, I don’t think we’re taking that into consideration. In other words, to me because again I’m still worried about this NHIN and regular operate – because we still play in that nebulous land. But at some point, there’s a whole lot of other people in that doctor’s office with that doctor and patient or in that decision support system with that doctor and patient that seem to be getting dramatically shortchanged in this process from a standpoint that the person is not taking any liability necessarily. It’s all being transferred over here, and then where I get concerned about going back to where I was, let’s take an employer who pays for that employee’s health insurance who also would like to see things like ePrescribing and other things out there to help the doctor and the patient is basically, it’s taken away from them as a way of keeping their employee out of the hospital.
And you know that’s where I start getting a little freaked out because we’ve got data that’s supposed to improve. We spent all morning talking about quality. Well, I can tell you right now things like ePrescribing adds to the quality. So I’m struggling that we keep, we don’t even mention those other things.
MS. GREENBERG: I just want to verify what that is about because I hear him saying the same things we are.
MR. REYNOLDS: It’s not in this letter.
MS. GREENBERG: I think, yes, what are you freaked out about? I just want to make sure –
MR. REYNOLDS: That I don’t see any liability belonging to the patient.
MS. WATTENBERG: You just said liability’s discussed in the letter.
MR. REYNOLDS: It’s not discussed in the letter.
DR. TANG: It’s a responsibility to society, is that what you’re saying?
MR. REYNOLDS: There you go. I’ll go with that. It’s not, you know —
MS. GREENBERG: Not to sequester information?
MR. REYNOLDS: No, I’m saying if somebody does sequester it or it’s taken out of decision support, then that person, so for example, if I was an employer and I found out that my employer, right, wrong, indifferent, I know that’s a fear, but it’s reality, too. If I found out employees are going to the doctor getting drugs and not telling them what else is going on, and they end up in the emergency room and end up in intensive care for three weeks, I got a problem.
I got a huge problem because you –
MS. GREENBERG: It’s not happing right now.
MR. REYNOLDS: I’m not saying it isn’t. But now that we get these better tools which we’re all trying to build to make it better, then there’s got to be a –
DR. TANG: You’re arguing for what I’m asking, then.
MR. REYNOLDS: Okay, we’ve got an order, and I’ll just stick to it.
MR. ROTHSTEIN: Marjorie? Marjorie, then Leslie, Sarah and then me.
MS. GREENBERG: This is difficult because – no, it really is, and one solution is to describe the problem and have no recommendations whatsoever. But I’m at this particular area. I mean, I always come back to that if we can’t agree on a recommendation, cannot even describe the problem is doing an injustice to the policymakers because they don’t have the information, the benefit of the thinking of different members of the Committee.
But putting that aside, it seems to me and in some ways we’re looking for a solution, we’re recommending potentially a solution to the wrong problem in a way. Right now, you’ve got – well, you don’t have electronic records, or you don’t have sharing of information in any kind of systematic way.
You know, a person goes into the doctor’s office, he or she asks, you get something write down what medications you’re taking. You tell them what you want. I mean, that’s the way it is, okay. So that’s the current situation, right.
So when you see what the person wrote down, do you believe that completely? Probably not. So, you know, is there anything else or I’m going to prescribe this. It interacts with these things. Is there anything, you know, I see you’re not taking any of those drugs. So I can maybe just make a statement. I can feel comfortable then prescribing it. They say, oh, well, as a matter of fact, you know, you may be giving them some information. But the fact is you have incomplete information because you’re just relying on what the patient told you.
So I mean, I think what I hear you saying about the decision support and so what we would like, I mean, to take an app to its conclusion this thought, we would like electronic health records and even the NHIN to improve this situation because we know we have quality of care problems in this country and probably in every country. But you know, we know we do.
And so we’re no better off than we were with the paper records or maybe worse off because we have this belief that we got better information, and we really don’t. Then that’s just kind of a, you know, putting a lot of money into something that isn’t getting us any better off. So that’s a problem, okay.
But what I’m hearing about decision support is that it’s a very imprecise tool. And I think that those of us who are not in the medical field other than we’ve been around it for so long we think we are, but even people as well informed as we are compared to your average probably person who doesn’t deal in this field thinks that decision support is better than it is. We think that if you’re told there’s an interaction, then that was to my benefit that you found that out, and then you won’t prescribe it. But it isn’t like that. And the fact is that for every time you’re told there might be an interaction, maybe half of the time, maybe a quarter of the time, I don’t know, maybe three-quarters of the time, all right. But when you’re told there’s an interaction, you’re saying it’s okay because what they – it isn’t a problem. If you’ve got the information, you can reject the alert because you have the information. You say, well, it might have been a problem for this person if he’d been 105 years old and also had this condition, but those don’t apply.
So I think that is something that we have to keep in mind. So one of the problems we’re dealing with is that decision support is a very rough tool. It’s helpful today, today. Over time, it could be better. It could get a lot better as we get a lot more population based information. Then we’ll know that certain things are important and certain things aren’t, and that’s what the NHIN, I think, might offer us, better data for research.
But right now, decision support is not what we might think it would be. So that’s a problem, and that’s a problem that we’re not talking about or we’re sort of talking around. But it requires a different solution than masking or not masking data or including data in decision support that is masked. You know, I mean these are all – what the problem I see is that decision support is marginally useful in its current state, it appears, at least regarding medications.
Well, if you could get information that told you there’s an interaction here and you could rely on the fact that you don’t have to know anything more, then it wouldn’t matter that you didn’t have the information.
MS. WATTENBERG: Paul, you need to get a microphone. We cannot hear you.
DR. TANG: But that’s not saying that – it’s not that decision support even in its current form is marginal. It’s just that –
MS. GREENBERG: All right. But it’s not sufficient.
DR. TANG: It doesn’t have a high positive particular value.
MS. GREENBERG: If the alerts were adequate in and of themselves, this wouldn’t be a problem that you don’t’ have all the data.
DR. TANG: That’s a fair statement, but it’s not fair to say decision support is marginally useful.
MS. GREENBERG: Okay, but if decision support were a higher level of reliability, then it maybe is in the drug interaction. It wouldn’t be a problem. Anyway, that to me it seems like a problem. Then we’ve got the issue of employers. I mean, no, we don’t want employers to get information. And people who want to withhold their information maybe are not that worried. Some are. Some just feel strongly nobody has to know anything that they don’t want them to but are not so worried so much that this particular clinician will know it, but that once it gets into somebody’s records, it could get to other people like employers, and that’s a problem with the current HIPAA and with our privacy legislation.
Then we’ve got educational issues that patients don’t understand a lot of this, and that also maybe there are clinicians who do discriminate against somebody in some ways once they find out that they’ve got a mental health problem. They say, oh, it’s probably in their head, and they really don’t have a problem and they don’t do certain tests, correct. It happens all the time.
So we have huge educational problems here and problems with our technology and everything that are making this not work. And I just think that in a way we should go after those problems. We should have some recommendations or recognize those problems as being the source of this problem.
MR. ROTHSTEIN: Everybody wants to jump in. The order is Leslie, then Sarah.
DR. FRANCIS: Okay. So what I wanted to say is that I hear everybody raising questions either about why it’s really important to try to figure out some way to further patient trust and protect privacy because if we don’t, that’s going to really mess up the whole moving forward of any kind of electronic record system or it’s going to create worlds in which many people opt out, and we all agree that’s a bad world.
I’ve also been hearing and it’s a wonderful list that’s everything from how decision support tools will work, what about liability considerations, how physicians will react if it takes a minute longer in their practice, how they’re – of course, it may take much less because they’ve got electronic records. So they’re not flipping through papers, who knows. But there’s all kinds of things.
But these are a huge number of unknowns. And I really appreciated the way Marjorie started out a minute ago because when she said that, you know, these are what people were doing was outlining a whole lot of issues that need to be on the table. And it seems to me that what’s going on in the discussion is people are either saying why it’s important to try, or people are saying what the roadblocks are. And I think the way for us to move forward is to acknowledge both and to have our recommendations be that there be some piloting and suggest the kinds of health data where piloting would be most important.
And I think we can all agree on what those areas are, and I think we can even point out where it’s likely to be hardest but where piloting might be most important and make that recommendation because if people don’t start to think about what the costs would be of not doing this as well as to try to work in a really serious work on what the implementation problems are, you know, and all the problems that people have been bringing up, I mean I see a huge problem.
But I think that we can’t just say, oh, these are huge problems, so forget it because if we do that, the horse is out of the barn.
MR. ROTHSTEIN: Okay, thank you, Leslie. Sarah?
MS. WATTENBERG: I think to move forward, there are a couple of things. One is it’s not true in the letter, so I would not sort of support this in the letter that there is no technology for sequestering information.
There is technology, the Canadian paper that we distributed earlier talks about it. They’ve done it for ten years. So part of what I would suggest is that, you know, we actually explore some of these systems that have been doing different combinations of sequestering and masking and really trying to find out what the implication is on the quality of the clinical experience and to see, I mean, it actually may sacrifice quality, and it may not. We have a whole group out there of people who have been doing this for a while, and they have some very interesting lessons that can really inform and maybe shift some of the ambivalence that’s going on here.
The other thing is just to speak to what Marjorie is talking about which is if you really get down to the root cause of what the problem is around sharing information, it’s not typically about sharing it with the primary physician or the doctor. It’s about all the other stigma and discriminatory practices that happen around that information just floating around.
And so I’m not sure that you can even write a letter like this without putting it in some kind of context to explain that we’re really trying to solve a problem that is not actually being correctly defined, that what you’re trying to do is resolve a problem with a solution that isn’t even attached to the original problem. And I think that’s part of why it is very difficult for people to sort of come up with specific ways of addressing this because we’re not really addressing what the root cause is. And I think that may be harder to address. No, exactly, so I think that’s really an important piece. But if we write a letter, it has to be clearly explicated if that’s a word.
MR. ROTHSTEIN: Okay, thank you. I’m next on the list, but I want to call on Larry first because he hasn’t spoken yet, and then I’m going to see if we can get our arms around this. Larry.
DR. GREEN: I wanted to ask two questions. One is page two, the first full paragraph on page two, the opening sentence. “We have concluded that individuals should be given limited control over access of their health information disclosed by NHIN.” Could you tell me what the next sentence would say so that we would understand what health information we’re talking about.
MR. ROTHSTEIN: Can you help me a little bit more with that —
DR. GREEN: The sentence implies that the Committee believes that there is at least two types of health information that is disclosed by the NHIN versus that which is not disclosed by the NHIN. What is it?
This is an absolutely crucial sentence in the letter. This is the scope of the letter. This is the answer to the question what does these recommendations apply to, and the letter presently says it applies to health information disclosed by the NHIN. What does that mean?
MR. ROTHSTEIN: Well, I’d be happy to describe that. It refers to another issue. You think this is a point of contention? You should have been around for the last 18 months before June of 2006.
The question that we considered as a subcommittee and then ultimately as a full committee was when we made recommendations two years ago whether we were talking about all health information including that which is at rest or within a single entity, or only that information as it travels via whatever that mechanism is that we’re calling the NHIN.
And the Committee decided on the latter. In other words, that the recommendations were only pertaining to information that traveled and not to the information at rest. That was, as I described, a point of somewhat strong difference of opinion at the time, but the latter view was adopted. Does that help at all?
DR. GREEN: No. Let me ask the question in the converse. Can you give me an example of personal health information that would reasonably be expected to exist which would not either be transmitted over the NHIN or be at risk to be transmitted over the NHIN, any information where an individual, presumably individuals will have some sort of choice in the matter either by opting in or opting out or some other mechanism which we —
MR. ROTHSTEIN: Recommend. I’m going to answer your question. And therefore, if I for some reason, don’t want my information traveling around, I can opt out of an NHIN and my information will not be transmitted in electronic form beyond my individual health care provider.
Now if I’m in an integrated delivery system or whatever we say in the letter that the healthcare provider has the right to determine in what form they want to keep the records. But I as a consumer, according to our letter, should have a right to say you’re not sending it to California to my specialist that I want to see out there.
DR. GREEN: Well, just a quick comment, and then I’d like to ask my second question.
MR. ROTHSTEIN: Okay.
DR. GREEN: The comment is it’s really not knowable when you’re taking care of patients where the information is going to go any more. To know that in advance is probably sort of pretending that we know stuff that we don’t know. At the time of the transaction, you may think that this information is not going to go to a laboratory or it’s not going to go to Bangladore, but it’s going to go to Bangladore after they get the x-ray done.
And so I want to just really call attention to that sentence unencumbered by all of the pain and agony that has preceded this version eight, I believe that sentence is absolutely crucial to this letter being able to make sense to the rest of the world, and that it is not clear enough.
MR. ROTHSTEIN: Actually, this sentence is not one that I personally subscribe to. It was a compromise in the subcommittee, and this is a verbatim quote from the June 2006 letter.
DR. TANG: That is taken out of context, and that’s not the question Larry’s asking actually.
MR. ROTHSTEIN: Well, what is the question?
DR. GREEN: My question is to what data does this recommendation apply?
MS. BERNSTEIN: Well, your question seems to really be to what does it not apply?
DR. GREEN: I’ll take either one. Tell me something it does not apply to.
MS. BERNSTEIN: Paper records.
DR. GREEN: What?
MS. BERNSTEIN: Paper records that are walked around speaker net.
DR. TANG: I think Larry is –
DR. GREEN: There really is no such thing any more as a paper record that doesn’t go anywhere unless you absolutely do —
MS. BERNSTEIN: I didn’t say it didn’t go anywhere. I said it didn’t get transferred by this facility by this method.
DR. GREEN: So if this is about a method of data transfer, that’s what the letter should be talking about. And if that’s the case, it’s really pretty much a silly letter in my view. What they’re really talking about is a much more important issue.
DR. TANG: I think he is asking, he is basically positing that there’s only one way to “control access.” It’s either opt in or opt out fully. That’s what he’s asking, and that is – I think it’s not the manner you’re talking about, Marc. I think it’s challenging whether you can have control over pieces of your health record. Am I right?
DR. GREEN: Well, let me just – I’ve certainly explained that as best I can, and I don’t think I did a very good job. But I’d like to ask my second one – what is the thinking of the Committee about what would happen if physicians just said I won’t take care of you if you do this. What would be the consequences?
MR. ROTHSTEIN: I think, I mean we did not specifically address that issue. But we talked about the idea that it would be reasonable, I think, for a physician to say unless you disclose information that is relevant, I mean, there’s something that’s blocked here, and you’re seeking treatment for a very complicated condition. And unless you authorize me to see everything, then I can’t treat you. And maybe we ought to say that expressly in here, but I think one of the things that perhaps we didn’t explore is that the assumption that all docs needs to see the same level of information, and that’s not true.
And your dermatologist or your dentist or your podiatrist doesn’t need to see the same level of information. We didn’t choose to block it by time period, and really that was one of the things on the agenda at some point so that you didn’t have to report your ten-year-old abortion that had no complications. We did it by category. So if you wanted to block your reproductive history, you blocked all of your reproductive history which might include more recent things where if you’re going to go see an endocrinologist, the endocrinologist could say, listen, this is related, I need to see your reproductive history. So that was the thinking, Larry.
DR. GREEN: Well, that makes sense.
MS. BERNSTEIN: Can I just add another possibility is that the patients rise up and say I’m not going to go to a physician that doesn’t protect my privacy, and physicians as a business matter decide that they’re going to offer privacy protection as a marketing tool. I mean, it’s another – I don’t think it’s realistic, but I think that’s a possibility.
DR. GREEN: Absolutely. So this tension between personal privacy and the ability to take good care of people is really what is on the table. And my question wasn’t to argue one way or another, but it was just to understand if the Committee is thinking that there might be some sort of consequences that are associated with this. And the decision to not – it’s interesting, Mark, in your comments, you went back to the rejected idea that you wouldn’t sequester this by source or by type of provider. It’s better to do it by type of information and by category.
Yet, in your example, you point out that there’s a different set of issues pertinent to different types of provider. So, really a little quantitative compassion here. We know that this month, October 2007, that approximately 113 of every thousand people in this country are going to go face to face with a general internist, a general pediatrician or a family physician. I would predict that when this letter is vetted that if you make sure it goes through those professional societies that you should anticipate that those doctors who, by the way, will account for 54 percent of all the visits made to doctors this month, is going to be a majority of all visits and 113 Americans per month that they’re going to tell you if this becomes the expectation as a standard of practice or a requirement, I won’t see you.
And the reason they will do it, the reason they will do it is they will have a very strong evidence-based case that they cannot practice medicine under these circumstances.
There’s a myth. The myth is that there is such a thing as a simple human being. There are no patients but one category – complex. All patients are complex, and we delude ourselves if we think we can make rules for information management in medicine that assumes that some of the patients don’t really need to know this, that or the other. You don’t know in the practice of medicine what you need to know until you start taking care of the patient.
So this is a very problematic area. I’m not – I don’t want to be – I want to be constructive here, and I just think the point I would make is let’s be sure we vet this letter in advance and give various professions an opportunity to react to this so we find out what they’re really thinking.
MR. ROTHSTEIN: Okay. I was on the list before Larry, and so I gave him my spot. I’ll never do that again. Okay, I’ll get you, Marjorie. I just have two quick comments.
One is that I think there’s a lot of mythology surrounding the quality of current medical records. There, you know, whether paper or electronic, they contain misstatements, fabrications, faulty memory, erroneous, all sorts of junk, and physicians learn that they don’t trust stuff in medical records that they didn’t put in there themselves and/or that they can’t vouch for. If the patient says I’ve been diagnosed with X, if you don’t have a letter from the diagnosing doctor, you can’t often just rely on the patient.
The other thing I would say is that I think I actually have more confidence in physicians than my three physician colleagues here because in 1972, when there were three court decisions in the United States that established the requirement of informed consent, the doctors in this country rose up and said that is going to destroy medical practice. We can’t tell patients all of the options and all the alternatives to treatment. They need medical school training to do this. We’re the only ones who are qualified to do this, and we can’t possibly work with patients and tell them all that information.
And in fact, the only way that this would possibly work is if we maintained a therapeutic privilege which means that we’re not going to tell you stuff that we in our best judgment determine would not be good for you. In other words, stuff that will upset you and make you anxious and complicate your case.
The fact of the matter is that last year in August of 2006, the AMA finally unanimously voted to reject the therapeutic privilege saying that it was inconsistent with patient autonomy and the ability of physicians to work collaboratively with patients.
So the field of medicine is changing, and I have every confidence that my colleagues will be able to adjust to a new era in which patients have some additional rights to withhold some information.
I would hope that in the normal course of events, patients would have so much trust in their docs that they wouldn’t mask information, that they wouldn’t sequester information. And if they did, they certainly wouldn’t keep it hidden from their primary care docs and their internists. They might say, well, I have this thing in my past that I don’t want my new dentist and my new chiropractor to be looking at. But giving people that right, I don’t think is going to be problematic.
Okay, that’s just sort of water under the bridge. What we need to be thinking of, we all recognize that this is, you know, an issue on which many people have very strong views, and I’m talking about the decision support. We haven’t even reached the other issues yet.
What I attempted to do in page 6 was recognize that there is no current decision support capability that would do effectively what even its most ardent proponents would like it to do, and that there may in fact be serious problems in undermining optimum clinical care.
DR. GREEN: I don’t understand that statement.
MR. ROTHSTEIN: Well, what I tried to put in six is that there’s no off the shelf technology that would serve to be effective decision support even under the most optimistic scenario.
DR. GREEN: What’s the basis for that statement?
MR. ROTHSTEIN: Do you think there is off the shelf decision support that’s going to do all this stuff?
DR. GREEN: When you say something like all this stuff, something as simple as reducing the number of ambulatory first drug events by 50 percent alone is sufficient. I don’t need anything else.
MR. ROTHSTEIN: No. All right, let me rephrase this statement. We have no evidence base that electronic decision support in the contest of sequestered information would have on balance a positive or negative impact on the quality of clinical care. Would you agree with that?
DR. GREEN: But I could model the answer to that question.
MR. ROTHSTEIN: No, you could speculate on that question.
DR. GREEN: I could model it because I can run it. We run millions of decision support decisions every day, and I can tell you how many would be impacted.
MR. ROTHSTEIN: That’s not the question.
DR. GREEN: By sequestering any particular subset of data.
MR. ROTHSTEIN: No, the question is would it undermine the ability of physicians to provide what they consider to be the optimum standard of care. Now you can run the data, but what I – so all that this paragraph and the recommendation is attempting to do is to say clinical decision support is likely to be an important part of the NHIN as it’s developed, and with regard to the overall strategy in this letter of suggesting that patients have a right to isolate certain parts of the information, there ought to be some pilots done to see what that effect would be of putting together these two elements. The decision support with the masking, and that’s the extent of the recommendation.
DR. FRANCIS: The question is whether we know, you know.
MR. ROTHSTEIN: Okay, Paul and then Harry and then Sarah. Well, everybody wants to respond to something Larry said. So we’ll take Paul and then Simon, Marjorie, and then Marc.
DR. TANG: You stated correctly that the three docs because Simon was out of the room now probably the four docs have a special reaction to this. Larry’s was the strongest like we would stop practicing medicine or not take care of those patients.
So what’s in common? And so the only thing I can think of is how can I help these other folks understand what we’re feeling. And when you try to do that with any, right, because we’re all the same. You’ve found some commonality.
What if we had lawyers, not to pick on any, and what if you had access to some portion of case law. I want you to work your heart off, work your tail off for the next three months on this case, but I’m only going to show you some of the case law. Now I may say there’s other hidden pieces, it’s up to you to go find out the rest.
MS. BERNSTEIN: But that’s not the right analogy. The analogy is your client doesn’t tell you something. Your client hides information. You have all the case law and al the training that you have as a lawyer, but your client withholds information from you, and that’s what happens all the time in medicine and in law.
DR. TANG: No, but I had this computerized case search tool, and it’s going to say there’s some case out there you don’t know about, and it’s up to you to – pardon me?
DR. GREEN: It’s actually compared analogy to facts. There are facts that are –
DR. TANG: That’s right. There are facts about you, and there’s also –
MS. BERNSTEIN: There are facts you don’t know, and there’s law.
DR. TANG: No, but the decision support thing is the quote law. So no, it’s law that’s relevant to this thing. Okay, so I’m holding two things, facts and law. Facts and basically to us we don’t know how to operate without deliberate –
MS. BERNSTEIN: Do not say –
DR. TANG: No, but there’s certain things that patients – it is not as random as what you’re proposing to practicing physicians. What you’re proposing is far more random than what we’re exposed to today. So just leave it at that. Just go back to the case law business.
Same thing with your financial – you are just reading thing, you’re talking to the patient, and you’re sort of – well, let me try to get past it, and I’ll give you –
MS. BERNSTEIN: There’s an assumption that you’re not involved with the patient, that no physician is involved with the patient when they’re making the decision as to what do –
DR. TANG: You’re creating a hypothetical scenario that we face all day long and making our life much worse and much more falling through the cracks and much more at risk from a legal point of view. And so to us, the example you’re trying to propose us to do this experiment, and the difference between saying, well, there’s pros and cons of something is there’s some of us that are saying but one of them is actually a first principles wrong. And you’re asking us to say, well, all we’re doing is saying we’re not saying to do it, but try it. So that’s the same thing as saying, well, you know, I don’t know whether allergies are all that accurate in records. Why don’t you try some with allergies and some without allergies. And we would say I don’t think you can do that. It is professionally wrong, even though we know that the allergies are not completely accurate or that the med list or the problem list.
So that’s the difference between saying there’s controversy, there’s things that you could do research on versus there’s things that it would be unethical to do research on in our opinion. That’s all I’m trying to say. And then go back to what’s the real root cause. The real root problem is what we’re afraid of is you’re getting, we’ve spent all this time talking about secondary use and how all this stuff should be primary, it’s all useful, and we’re ripping apart the very reason that you’re afraid for us to disclose in the first place, the one-to-one care.
When in fact the problem is we’re trying to avoid the bad guys, the nefarious uses. And we should go and attack the nefarious uses and hold those people accountable rather than permanently maim all the good uses of the data, and I think that’s as close to what Larry said as I could get.
MR. ROTHSTEIN: Okay.
DR. TANG: I see a lot of unhappy faces. So I’ll take that –
MR. ROTHSTEIN: Okay, we’ve got Harry and then Simon on the list. Sorry, we’ve got Simon who hasn’t spoken yet.
DR. COHN: Well, now I was gone for an hour. I feel like I –
MR. ROTHSTEIN: You haven’t missed very much.
DR. COHN: I’ve really during the break I’ll have to find out what you said that got everybody going. That’s fine. Now let’s try to bring the tempo down hill and calm things down a little bit.
Now I thought this letter had gotten dramatically better than what we started with. I guess I would make the supposition. One is that some data somehow is going to be whatever we call it sequestered, masked, using Marc’s parlance, not sent to the Indianapolis Reel because people don’t want it to be sent around, or the patient’s not going to show it because they don’t have trust that the information will be sequestered or masked. I mean, that’s albeit drug abuse data or something that happened to me when I was 18 or 16 or 23. I mean, we live in a world of dealing with incomplete data, and we can decide what it is that we’re going to be masking or not. But effectively there’s going to be likely some masking because of the federal law going on.
So that’s drug abuse data, for example, by providers and probably psychiatric records, just an example. Very narrow, okay, but we can talk about what the narrow pieces are. Now, but I think that’s sort of the concept, and we can talk about what fields ought to be masked or not, and whether they are provider basis which is the current world, or on a subject basis which is what I think we were talking about or contemplating here. But that’s one set of issues and how wide and how deep that is. But there will always be something.
Now the question in number four is not that doing clinical decision – I mean, we all think for recommendation four, clinical decision support is a good day. Now the question is, is there any value, and to me it’s a really speculative question. I don’t know the answer to it. Is there any value in terms of as it relates to masked data, or is there not? Is there usability? I can certainly argue and at some set agree with Paul that getting queries to come back telling me things that I can’t figure out what the heck they’re all about like it’s a big ding, and I’m going like, well, kid go get me information is a real conundrum.
On the other hand, remember, I’m an emergency physician, and I don’t get sued – the reason I get sued is for bad results. Now the reason I may get convicted or whatever or whatever is that I did something wrong. But I’ll tell you that’s a whole other two years down the line, and I’ll tell you nobody wants to get sued.
So the real question here is, is there any value, which I don’t know the answer to about doing any sort of decision support that relates to masking, and I think that that’s all that this is, I think, proposing that, geez, that there be some research to look at it and maybe this involves funding Marc to look at some of his data. Maybe there’s some environment —
MR. ROTHSTEIN: That’s missing in here, funding Marc.
DR. COHN: No, no, but what I’m saying is I don’t know what the evaluation is. But the other question is, will patient outcomes be better, can people tolerate it, do we have data. I mean, and that’s all we’re talking about here. We’re not saying that this is a principle for moving forward with the NHIN or anything like that. We’re saying that this is sort of interesting and deserves some research. So anyway, that’s all and I’ll stop there.
MR. ROTHSTEIN: All right, I want to interrupt, and I will propose something else, that we take a break until three o’clock, and then we let the electronic decision support issue slide for a minute. We’re just going to put it aside for a second.
PARTICIPANT: Wasn’t he on the list?
MR. ROTHSTEIN: So is about ten other people on the list, okay, and then we’ll take it back –
PARTICIPANT: That’s only three. So we can go for ten more minutes –
MR. ROTHSTEIN: Okay, then, sure. Okay, we have Marjorie, then Marc, then Sarah. But let me just say what my strategy was because it would be very nice for our Subcommittee to find something on which we could agree on the list. And I think your number two item of granularity of information is a non-issue that we can resolve because I think it’s just a wording issue, and that would – I’d like to take a step forward after making 50 batteries.
Oh, the list has number one, the social information issue. The second is Paul had some issue dealing with granularity we’re going to talk about right now, and then the electronic decision support. Okay, so can we jump ahead to the granularity while you’re here?
DR. TANG: It sounds like you think we can finish. I think we can get closer. We’re not in the projectory right now. We really have very disparate views, and there’s a way we can get
MR. ROTHSTEIN: Well, that’s what I’d like to do. I’d like to recognize anybody who’s going to get us out of this thicket.
MS. GREENBERG: I thought I had a way, but maybe not.
MR. ROTHSTEIN: Sarah?
MS. BERNSTEIN: My question, Paul, is I don’t want to put you on record as having said that it would only take 40 extra seconds, right. It was 60 seconds minus 20 to really resolve this whole issue, and this is my question.
Can this issue be resolved just by physicians spending a little more time asking questions. I mean, because part of what you were saying is that would take extra time to sort of give that explanation and to really ask the question. And if that’s really true, then I think that is worth the balance that it would provide in terms of a public trust with this new sort of healthcare order.
DR. TANG: So this is – I mean, it really is a culture kind of thing. And I wish I could come up with the precise analogy in the world to say would you rather glean the information quickly from, let’s say, a table, I’ll just try to – versus asking Marjorie and Harry and Simon which would only take you 60 more seconds to ask the question. It may be very hard to get the response and digest which is exactly what happens in the game room. You could say it’s easy to say, well, you know, do you have any blood in your stools. It’s actually a long discussion, okay. But if I have a record that said, you know, melano or blood prorectamin –
MS. BERNSTEIN: But that’s not the kind of information we’re talking about. We’re talking about something has shown up in your masked decision support that tells me you have some medication related to the five areas of mental health, substance abuse, HIV or something.
DR. TANG: That’s took a long time –
MS. BERNSTEIN: No, but what I’m saying is that it may take longer. But the physicians – and I do really understand the physician point of view on this. I mean, I have a tremendous commitment to the quality. We understand all the comorbid problems.
But the physicians, I think, really cannot take the position that they’re not going to have to change how they practice because with the expectation that consumers have of having more control and a little more involvement, you necessarily are going to have to change how you do practice.
And so the question is really just about do you have a mental health condition for which you’re being treated with psychotropic or other kinds of medication, that’s easier than blood in the stools to ask a patient.
DR. TANG: I just have to qualitatively say no. So basically in the 20 seconds you’re digesting not just the answer, you’re assessing the whole context of whether this is right or wrong or we should proceed. And you’ve just got to believe just like I respect your professional judgment in your field that there’s a big context that you’re weighing these facts in, and the time it takes to get additional facts versus me being able to do a better job with whole context is central to any profession.
And I now you attempted to blow it down to a matter of seconds. It’s not at all a fair comparison. It would be just like saying, well, don’t you want to spend more time with your clients. That’s close to beating your wife analogy.
MR. ROTHSTEIN: We have three minutes left before he leaves. Marjorie and you still want to be on the list? To be on the list, you must pledge your way out of this thicket. Okay.
MS. GREENBERG: I thought I had, too. I started with saying.
MR. ROTHSTEIN: Okay, Leslie, you’re on the list after Marc.
MS. GREENBERG: Well, first of all I thought that Simon made a very reasonable observation or summation of the situation which means that I think each of us should leave the room for an hour and then we’ll be able to continue something.
But I think what I reacted to Larry was you said, well, we wouldn’t take care of patients under these circumstances, and these are the circumstances now under which you are now taking care of patients. That’s where I think we keep missing, and several of us have tried to say that.
But I don’t think there’s anyone in this room who wouldn’t agree that having full information is the best situation. I don’t think there’s anyone saying having full information is not important or that wouldn’t be the best situation.
But we’re talking about a reality in which, as Simon said, people one way or another, some people find a way either because it’s legally allowed or because they don’t say something, to not provide certain information. So you’ve got to take that as a given that certain people will not provide certain information. And if they’re not allowed to keep it and if they do provide it in the one situation where they’re getting care there and then they’re not allowed to keep it from going to other clinicians, they will then not get the care or they will go and try to find a way to pay for the care so it won’t get into the information. That is going to happen.
So this is what we’re weighing. We’re not arguing with you – with the clinicians that they would do a better job with more and complete information. Of course, you would. But you have to deal with this reality that there is – and until we can get all the anti-discrimination laws out there and we can provide and we can prevent data from going to people we don’t want it to go to like employers, what have you, until we can get all of that done, there are going to be people who will do something that will perhaps be injurious to their health to not provide information widely about certain conditions. I think you have to take that as a given.
So then we say, okay, how should we deal with that? You know, it’s not the same as case law because we’re talking about some other kind of principle here of people feeling that they have autonomy and that they have trust and that they have a right to not have to share all of their information with everybody right off the bat until they develop maybe some level of trust. And you can’t just make that go away.
So we’ve got to take that as a given. We also have to take as a given that every clinician will provide better care if he or she has as much relevant information as possible. We’ve got those as two givens.
DR. FRANCIS: So why isn’t the compromise that would enable us to move forward and to outline the reasons for, to outline as we set up the letter what the clinicians’ concerns are and then to say that the balance, to say what we know about what technology there is and what technology there isn’t, and then to say that we recommend that there be work on these fronts including the kinds of pilots to see how difficult it is to do the protection, to see because we all grant there’d be something lost if you can’t do the protection.
How difficult it is to incorporate the clinician’s concerns or to mitigate them, we don’t know the answers to those questions. And it seems to me that a recommendation that says this is a really huge issue. It’s an issue that I think could be a stopping point for any kind of development of an electronic records system that’s any good. So let’s say we really need to know the answers to these things.
MR. ROTHSTEI: Larry, I’m sorry, Marc and then Larry are going to help us out.
DR. OVERHAGE: The window, maybe.
MS. GREENBERG: I didn’t answer his question. He said how does this relate to decision support. Well, I think Leslie said, I mean, given these realities, are you better off or worse off, and we don’t know by allowing this. And so there needs to be research.
DR. GREEN: And this nicely segues into some of the other discussion. But I think one of the ways that people have tried to solve this and Harry, of course, in his brilliance came up with this before me, is you make it all or not, and that solves the clinician’s dilemma because you know that you know nothing, and you can have the dialogue, I mean, just as Simon described.
So you know you know everything there is to know, and you can drill out. You know what is available – I understand what you’re saying, Maya, but it is a way that lets you just in the clinical decision support part of this, you’re not going to get any decision support because there’s nothing to base it on if the individual has opted out, if you will. It’s a predictable doubt, exactly.
Or you know you’ve got as much as is going to be available, and you’ve got to go from there.
MR. ROTHSTEIN: Are you finished?
DR. GREEN: Yes.
MR. ROTHSTEIN: Okay, Larry.
DR. GREEN: Well, I want to build on what Leslie was saying because I really think she was providing great leadership there. Our dog in the fight, it seems to me, is that we really recognize how we can take such a giant step forward in the quality of care that people in this country get through the application of information technologies, and that we’re running into some serious problems. And one of them is the resurrection of some old unresolved privacy issues that have been dealt with in inadequate ways that are not going to work for the NHIN, and we’re agreed about that. We have all of us are passionate about this because we recognize that promise, and I heard Leslie saying we just need to stay focused and begin to identify what a big issue this privacy piece is right here. There’s no way to do this.
My suggestion – what I’d like to add to that is I think we could get further if we adjusted the paragraph that starts out with what is sensitive information. And the best way I can think of to make this –
MS. BERNSTEIN: Where are you, what page?
DR. GREEN: Page two. My point is that while each of these categories has a quite defensible rationale for why it should be included, they remain too broad and taken together are almost devastating to the ability to actually take care of patients if you’re a personal physician.
Now there could be types of professional services provided by the health care system where you don’t need to know this. But let me illustrate this. Just imagine with me for a minute that pretend that you’re a 23-year-old woman, you’re Hispanic, and you come and say, hey, doc, I’m here because I’ve got headaches. And then just imagine that I know the following or make yourself the physician that she’s seeing, and you know that she is a single parent who lost her job last month, who is living with a partner that’s an illegal immigrant from Mexico who’s building houses in your neighborhood, who has no insurance. You also know that when she was 14 she tried to commit suicide, and she has a three-year-old at home that is driving her nuts and may have ADD.
Now according to our standards of categorizations, if she has told someone at any point that she wants to sequester her sensitive information, she wants to mask her sensitive information, none of that is available in her medical record. We must rely on our memories which we have good evidence is lousy. But if that is knowable, then as I understand what we’re talking about moving toward, there’d be a little mark in her medical record that says she has masked information. And that’s what you as a physician would then be faced with.
Now she’s got a headache. What are you going to do? Well, let’s do a CT Scan. Let’s start thinking about what you might think would make sense. But once you know the masked information and you can contextualize this 23-year-old woman’s headachy, you do things completely differently.
We can all agree that what we want her to get is great care that’s the right care at the right time, and to say, well, she’s got some other things that need help and all of which in my little scenario here is now masked and unavailable.
But if I break the glass, if I break the glass, then I can go see it. Now was that an emergency? I mean, it’s a 23-year-old woman walking into a primary care doctor’s office and said I have a headache. Is that an emergency? No. So I can’t break the glass.
MS. BERNSTEIN: You’re going to do a CT scan? So you’re not going to do it because you know she’s got an illegal immigrant husband.
DR. GREEN: I’m not going to do the CT scan because its posterior predictive value is zero. That’s why I’m not going to do it.
MS. BERNSTEIN: But you suggested that you might do that if you had no evidence about her.
MR. ROTHSTEIN: Okay, Larry, you promised a way out here.
DR. GREEN: Yeah, the way out is if this goes forward with this section about what is sensitive information, where we are in our understanding of the problem at this point in time, this list needs to be narrowed substantially if we’re going to have any chance of a serious discussion of this proposition. That’s my key best effort at helping us get out of this.
A narrower focus on this. When you throw in the word reproductive, you have genital urinary health, my God, what is that. So if we could narrow the focus, we could raise the need for the research and the information on this. We could also maybe put a damper on all these concerns about doctors being reactionary, doctors being traditional, doctors not wanting to change, doctors being afraid of being used, doctors not wanting to spend more time with their patients.
If we can minimize the bait for getting into that discussion, we could maximize the chance to figure out how to help a person not have published on the internet that they’re bipolar when they don’t want that information out there. That’s what we’re really after. If we could hone in on a couple or three really important tragic things that are out there at stake and figure those out, then we could enlarge that and build privacy and there are other things like that we might work our way into a solution.
MR. ROTHSTEIN: Let me respond to that comment which I think is actually helpful. I mean, what I attempted to do with these definitions was just put sort of out there the broad fields that we’re talking about, and this is never intended to be sort of the final anything. And we can sort of qualify that and say here is a broad list of subject areas and further refinement after consultation with the medical professionals in the fields would be required and so on and so forth. Would that make it a little more palatable? What do you think, Marjorie?
MS. GREENBERG: I absolutely agree that these are too broad. I mean, they assume this real dichotomy between the medical model and the social model. If you don’t have an integrated medical/social model of care, then you’re going to have inadequate care, and it perpetuates this dichotomy between the medical model and the social model. So I object to that.
I also feel that, I mean, I know and I’ve mentioned this before, but in NCHS surveys it’s more sensitive to tell somebody your income, we’ve found, than your sexual behavior. So I think what’s sensitive to one person is not sensitive to another. I think we start – I think what categories actually get extra protection, I think, has to be resolved in the political process, and that’s what happens now and by state laws.
I don’t think it’s great to have laws different from this state to that state. But this is a political process deals with that now. Maybe it’s not a very good way to do it, and also that’s why we’ve never gotten privacy legislation out of Congress. But it is a political issue. It’s what – because what one person thinks is sensitive, another person doesn’t. I think we start with those things that are currently protected because that’s reality that currently have extra protection.
And then I think the only option – there are only a few options. One is either you completely opt in, or you completely opt out. Or that any person can decide what’s sensitive and what isn’t. And I mean I realize that may be chaos, but that’s the only way to do it because I don’t think that this Committee can tell people this is sensitive and that isn’t. To some people, the fact that they have diabetes is very sensitive, and they think nobody will marry them if they have diabetes. Saunders had diabetes since he was eight. That was the first thing he said to me at age eight. So you know, but then hopefully he gets educated – a person gets educated that I have a much better chance of being healthy if I tell people and they know. And so then I can get the right care, and people can respond to me properly.
So I don’t think we can decide what is sensitive and what isn’t, and I think these categories are way too broad.
DR. FRANCIS: Marjorie, it is Leslie. I think it’s really going to be awfully hard if patients just get to do whatever. I mean, we could delineate some and we can delineate them in a narrower way and say based on our knowledge of patient preferences because there are some pretty clear categories.
MS. GREENBERG: Well, start with what is state law.
DR. FRANCIS: These are the ones that we think should be started with.
MS. GREENBERG: We’ve got the HIVSC has categorized all of these laws. Let’s do an analysis of that.
MR. ROTHSTEIN: We are backing up even more. The Subcommittee considered this issue and rejected the idea of giving patients line item control on deciding – I’m sorry?
DR. TANG: That’s at least one option. So you’re correct that we decided not to do individual item by item control.
MR. ROTHSTEIN: Right.
DR. TANG: So I’m not sure whether we –
MS. GREENBERG: Well, you might have to revisit that. I don’t know.
DR. TANG: That it be opt in and opt out. It was raised because we had –
MS. BERNSTEIN: I thought we decided that. We vetted that and decided that in a June 2006 letter.
MR. ROTHSTEIN: Correct. In that letter, we said that we recognized the fact or imagined the result being that if it was all opt in or all opt out, people with sensitive information would opt out, and the result would be that we would have so many people opt out that it would undermine the futility of the NHIN. So that’s why in June 2006 we said that there should – we left open the issue of how to limit it which is what we’re taking up now, but then we left out —
DR. TANG: But then in our testimony, we heard from the international group. In the same day we heard from the international, we heard from Regenstrief. They both, remember I said, well, ironically, you both came up with the exact same number, .03 percent would opt out.
So that is new information we had since our June ’06 letter. So one might say from that that when you give people that option, they choose not to opt out which we did not have in June ’06.
MS. BERNSTEIN: Well, 0.3 percent of them choose to opt out, and the rest don’t. A large majority understand that.
DR. TANG: Yes.
MR. ROTHSTEIN: Okay, we haven’t heard from Harry in a while.
MR. REYNOLDS: Marc, do you have a question?
DR. OVERHAGE: Well, it really comes to and maybe part of the tension I’m feeling is the quantitative thing that we’re just touching on is so critical because when you talk about having a process, whether it’s line by line or category or category, for patients to decide what they are comfortable sharing or not, you’re spending a lot of money, a huge amount of money, and there’s an opportunity cost. So the question that I think that those – and I don’t know what the right number is, but you know, I’m worried that we’re spending a lot of time chasing down a hole that at the end of the day we’re talking about, and I come back to my question, so how many patients in the country are we talking about. Yes, there are risks. Yes, there are trade offs, and we’ve got to make those at both an individual level and a societal level, and I haven’t seen any quantificaton.
MR. ROTHSTEIN: How many patients in what sense?
DR. OVERHAGE: Well, for example, we bandy about patients won’t seek care. How many?
MR. ROTHSTEIN: One-sixth according to the –
DR. OVERHAGE: Okay, of how many?
MR. ROTHSTEIN: One-sixth of all patients, according to the California Health Foundation have engaged in —
DR. TANG: Methodologically, the way that question was asked was have you or anyone of your family members or friends, you have to divide one-sixth by all those folks.
DR. OVERHAGE: Twenty or whatever it is.
DR. TANG: So that’s a very, very important point, actually.
MR. ROTHSTEIN: Well, you know, you can argue it either way. The statistics will support any – so that, I mean, you can make the argument that it’s not that great a burden to clinicians because very few are going to do that, or you can make the argument that it’s really not needed. So I mean the numbers will say whatever they want.
DR. OVERHAGE: Speaking of clinicians for the moment, what does it take to put in place nationally a framework so that every patient has the opportunity to decide by category, by line item, whatever you want to choose, what they would like to share or not, to have that dialogue with somebody and then to have somebody report and enter and update that information and maintain it. And we’ll make a recommendation that is billions of dollars.
MR. ROTHSTEIN: Well, I think there are countries all over the world who are considering the same issue. It’s not like we’re going –
MS. BERNSTEIN: I think it’s the same issue. Well, the other issue is what you can measure how many people may opt out. But what you haven’t measured is what happens if you institute a national health information network and you don’t provide this option for people. What happens then? What is the other cost of patients withdrawing or withholding information.
DR. OVERHAGE: And the experience is people don’t withdraw, that they do it. Over 99 percent in Massachusetts and in Indianapolis.
MS. BERNSTEIN: That’s not what I’m asking. What I’m saying is if you don’t give them the choice.
DR. OVERHAGE: Yes.
MS. BERNSTEIN: What are the other consequences? What are you not seeing? What patients pay cash, what patients avoid the network all together or avoid care? How does that cost the system?
DR. OVERHAGE: That’s my question. And I’ve never seen any estimate of that, and I think it’s very small.
MS. WATTENBERG: But you don’t know that.
MS. BERNSTEIN: Right, but then you’re assuming it’s small.
DR. OVERHAGE: Well, that’s fine. But let’s do the estimate then. Let’s not guess.
MR. ROTHSTEIN: Well, you agree people should be able to opt out generally, I mean just opt out.
DR. OVERHAGE: Some way or fashion.
MR. ROTHSTEIN: What we tried to do in this letter is not be proscriptive and say you have to do A, B, C and D. What we said was in order to maximize privacy but also maintain high quality of care, these were some of the directions that we think should be explored.
And I mean this is our preferred model. In other words —
DR. OVERHAGE: The designation of “should” doesn’t sound like explore.
MR. ROTHSTEIN: Should what? We –
DR. OVERHAGE: In this case, permit patients to sequester specific sections of their record.
MR. ROTHSTEIN: That was our preference as opposed to the line by line or opt in/opt out.
DR. OVERHAGE: When you say our preference, was out –
MR. ROTHSTEIN: Well, that was the Committee.
DR. OVERHAGE: Well, and then NCVHS as doctors need to evolve.
DR. GREEN: The way out of this is to just do a little bit of framing, don’t you think that says, based on testimony and estimates from inside and outside the United States, we have reasons to believe that there’s a very small but important portion of the population that will have a need to mask medical information. We think that might be as little as .3 percent.
However, the impact of not having that option may actually influence millions of people in how they are willing to obtain and use health care in the United States, and we find ourselves in a bit of a conundum at this point is that we don’t have estimates about this. This is another reason why we really very urgently need to sort this problem out a little bit better.
If this is that important, the NHIN’s going to be held up until we get a strategy for this. Holding the NHIN up is a big, big problem that we don’t want to have. We want this to move, and that becomes a different type of letter in terms of its content and recommendations than the way I read this one cold.
MS. BERNSTEIN: I just want to make two quick points. One is I think what we do know is that when they’re given the choice, they choose to share. So you have to provide that choice for that to take place. The other thing is to just point out to people from a public policy point of view your option, then they can leave treatment and pay on their own is that you’re unduly burdening the vulnerable people. And so essentially you’re creating a bifurcated tiered healthcare structure through your national policy.
And so I think you really need to weigh your social opportunity cost against that.
DR. OVERHAGE: Well, what I’m still looking for some language, some compromise. I mean, we included, I mean, the language that Larry just suggested really tracks language we already have on page three that we can supplement, and I quote, “Even if you really like to put restrictions on disclosure sensitive health information, most people would value having the right and the ability to do so. There’s a strong public interest in encouraging individuals to seek prompt treatment for sensitive conditions,” et cetera, et cetera, et cetera.
Maybe it’s not said as artfully as it could or needs to include other things. I’m certainly open to the idea of having the letter be even sort of less directive, more as options, research, et cetera. But we in after literally a year and a half of debate, we debated the issue of whether it should be only opt in or opt out or line item control, and full NCVHS voted 18-0 to have a recommendation that said individuals should have a limited ability to control information.
DR. TANG: And it’s the limited that we –
DR. OVERHAGE: Exactly. So what we’re trying to do is explore what that means, and I’m just sort of at a loss here. Marjorie?
MS. GREENBERG: Hello. How about thinking outside of the box here and saying okay, again I do feel that these categories are much too broad and I’ve said what I had to say about that.
But I think this is a partnership if it works between a patient and a healthcare system, a non-healthcare system. But okay. So if a patient wants certain information only to be known by this particular clinician because they want this clinician to treat them for this condition and they have the confidence in his ability, but they just don’t want it just going out there to everybody, then maybe there’s some onus – and first of all, I think you’ve got your, as I said, your legislative areas. So those we got to argue with because those are there, and we may not agree with them, but the political system has resulted in these.
And maybe education will eventually overcome some of those. But right now, that’s what we have, and you could keep it to that. But if you want to give the real person autonomy, then you could require this person because Marc said, well, somebody’s got to mark – they are going to have to enter this information into a computer. They are going to have to go through a tutorial maybe which will explain to them what the costs of their health, et cetera. And I mean, I don’t see, you could come up with – this could be an experiment. But I mean – no, but I mean the burden doesn’t all have to be on the healthcare system. If a person wants to take these risks, maybe you could use it as an educational opportunity.
MR. ROTHSTEIN: Well, the way it’s currently couched is that the patient would have to elect to —
MS. GREENBERG: It would burden the system.
MR. ROTHSTEIN: So the default is there would be no information sequestered. It would not automatically do that. The burden would be on the individual to request doing that. I don’t know what the least onerous method of that would be.
I am going to ask that we take a ten minute break, and we will resume this and sign off on the letter.
MR. ROTHSTEIN: And Leslie, are you still there? Well, maybe she’ll back on. Okay, so here’s where we are, and it’s a very important stage of our discussion.
There is clearly some very sincerely held fundamental disagreements among the Subcommittee members and full Committee members. I think that’s probably the only statement made today that has not been contested. And the question is a very serious one, and that is what do we do now.
And the way I see it, there are a couple of options, and I want to see what people think. We can slug ahead, although it’s not clear to me that it’s going to be that productive because there are sort of somewhat widely differently views. We can on the other hand, we can pull the letter and just say that we can’t reach agreement and do something else, or we can come up with something different on this topic that’s totally different.
I just want to add my views about what would happen if we pulled the letter, and that is that we are not the only people in town studying this issue. There are many other people working on this, and I guess you could argue that, well, they don’t need us. On the other hand, we would be, I think, giving up our seat at the table when these issues are decided, and therefore if we don’t choose to go forward or we choose not to go forward, then it’s not as if somebody isn’t going to decide the issue.
Now whether that somebody is Congress or the Department or some other agencies or advisory groups or whatever, I have no idea. But clearly this is an important issue because it’s really integral to the NHIN and going forward, that is, the issue of – maybe not this narrow issue that we’ve been talking about, but the issue of, well, what role do patients have in controlling their information.
So I’ve always been of the view that NCVHS is highly respected, that we do good work, that we have in the past come up with some excellent recommendations including on the issues involved privacy and confidentiality. So my view would be ideally we could get something out. But I really don’t want to burden the Subcommittee members and then the full Committee members to, you know, step into the ring on a weekly basis when there’s just quite a perhaps unresolvable difference of opinion.
So I would be interested in hearing from the other members of the Subcommittee about what your advice would be going forward. Should we just say, well, we’re not going anywhere and hang up or is there some other approach that you want to take. I think frankly in some respects we moved backwards at this meeting because we had some issues where there were clear divisions, but now we’re increasingly being asked to sort of revisit things that we’d already decided either as a full committee or as a subcommittee.
So if everything’s on the table and we can’t reach agreement, then maybe our energies would be better used in other areas. Simon, do you have any advice for us? Well, if you want to pass, somebody else might. But I mean you’re our leader.
DR. COHN: Well, let me just make a comment. I did have to struggle a little bit because I agree with you. I had thought that we were moving closer and closer, though, and if we were all together, we wouldn’t have needed to have this meeting.
I do think the issue’s an important one. I guess I’m sort of – and let me say that I think there are many good things about the letter. I mean, I think the concept of breaking the glass is a very important, very useful concept.
I think the recognition that there is a lot of things in this area that are R&D and need to be sort of figured out if they add value, if so, how do they add value. I think as Marc and Paul had commented, if they have value, how you can do it in a way that doesn’t over burden all of us in the healthcare system. So I think there is actually an important R&D agenda here which I do think we want to bring forward.
Now I guess as I’m listening and once again going back to sort of the basics and I’m just trying to think of where the basics are here. The basics may be more basic than our letter of 2006 in terms of the reality here. The reality, of course, is that there is data that exists in what we would determine to be most people’s optimal view of electronic health information, personal health information, that is sort of by definition masked because of federal rules, and Marc is right that there aren’t a lot of them, but there are some.
There are also things that obviously vary from state to state but then are also subject to masking, and I will tell you California is not exactly the same as Indiana which is not the same as North Carolina. But, as Marjorie has commented, that in the real world there is data that’s already effectively being masked. And so maybe the piece here is that we start by acknowledging that there are sort of by definition is masked data. The question then becomes is it to be totally excluded from the NHIN, or you know this is obviously combinates between the internist and the emergency physician, is there some way to begin to get access to it under appropriate circumstances.
And then there’s also a research agenda. I mean, we need to figure out how even to do that. And Marc would agree as we were talking, he was sort of looking and going, you know, our systems don’t do that. We don’t know how to do this, which I would sort of agree.
But then there’s the other question of, well, from there, are there more subject matter related areas which is, I think, a more desirable end point though, you know, we can somehow work on. But that’s once again a research and evaluation. I mean, how do we do this, and I think Larry made the point that you don’t want to throw the baby out with the bath water. You don’t want to mask so much information you don’t know what to do, you don’t know how to care for the patient.
But clearly I think, you know, in our testimony both here and in secondary uses of data, we heard about a lot of interest and a lot of plans by people talking about consent management, control of the data be it in personal health records, be it in health data banks, be it you name it. So getting people looking at this one as well as grappling with even the current regulatory here and now as unglamorous as it is might be a valuable thing to put on the Secretary’s radar.
And then I’m sort of speaking once again, I mean, I can’t think of anything much more basic than current regulation, current law. That’s why I’m starting there.
MR. ROTHSTEIN: Harry?
MR. REYNOLDS: Yes, as a co-chair of a committee that pulls waters back regularly because we enter the world of here we go again, too. So I can feel your pain a little bit. But we have always done that because it was the good thing to do.
But as you think about and you think about anything, there’s good debate. Then sometimes it gets to passion, and sometimes it gets to emotion. And the toughest subjects a lot of time end up in emotion, and I think if you just sat back and that’s why I started being quiet here. You sit back, it got into who was going to win or lose, and who was right and who was wrong and who understood and who didn’t, and I think we’ve got to go back to good debate.
And I think the other thing is, though, the one things I love about NCVHS, people don’t have these discussions. We’re willing to have the discussion and we’re willing to do it even when it gets emotional, nobody ends up hitting each other or walking away from each other. I mean, we don’t – well, I mean, maybe there will be a fight.
DR. FRANCIS: Not on my watch.
MR. REYNOLDS: Thank you. Yes, Mother wouldn’t let that happen. But the point is our courage needs to be that we take on difficult subjects, and our courage needs to be that at times that we agree to disagree which is not a bad thing either, that we figure out how we can still help others in the industry move forward because that’s the pleasure of being on this Committee is nobody will have this serious a discussion. But on the other hand, we have to make sure that when we get to where people who have agreed on many, many difficult things and this Committee has agreed on some real serious difficult things, it starts to get this – you can almost term it aberrant behavior where you know the doctors don’t know what they’re doing or they don’t want, I mean, you realize that that’s because we got hold of a tough one. No, I’m just saying that’s because we got hold of a tough one.
DR. FRANCIS: Oh, yes. It’s the toughest.
MR. REYNOLDS: What’s that?
DR. FRANCIS: I said, this is Leslie back again. I’m just saying, Harry, it’s the toughest.
MR. REYNOLDS: Yes. So the point is how do we move whatever rhetoric by whom, including ourselves, forward to make sure that the things that really need to get some attention get the attention, and the issues, I mean, we agreed to disagree on the opt in, opt out. But it still doesn’t make it any less of a subject.
And so as we decide what we’re going to do, let us make a difference and continue it because personally if others are working on it, I don’t think they’re as good at it as we are. So they might be working on it, and we might lose a seat at the table. But that table is not going to be any easier to get four people sitting in the four chairs to agree to go anywhere any more than we are.
So I want to make sure that we stay, we keep the courage to understand the issue that are placed and put them down even if we don’t say do this or do this. And that’s what I – so I’m signing up for that, and I’m planning on being –
MR. ROTHSTEIN: So Harry, is it your recommendation that we keep at it?
MR. REYNOLDS: Well, I think we keep at the subjects. We may not go as far as to say so the recommendation is, you know, that you mask exactly, and I’ll play off Marjorie and Larry and everybody. You don’t mask exactly this field. But because the basic subject in the end is and Simon was making a few comments on it, if we really believe in masking, what’s really good about that or what’s really bad about that, and what does it do – not just get down to the details. I’m an implementer. I’m not sure we want to implement it yet. So I don’t want to say any more. But that’s what I hope we do because that’s what makes us different because we have people around the room that know what they’re doing, and we want to make a difference.
MR. ROTHSTEIN: See, if I thought we had agreement on what you just said, then I think we could work out the rest. But I’m not sure that there even is a consensus in support of the concept any more of masking or sequestering or –
MR. REYNOLDS: Well, then that may be fine, too, because again as soon as – and the other thing I guess I would add one thing to it. A lot of us are working on a lot of subjects that interrelate. For example, when I was talking about ePrescribing a little bit ago, I was talking about ePrescribing because it wasn’t part of NHIN. Well, Marc’s alerted me that if it’s involved with RX Hub, it’s part of the NHIN. Well, but it’s not an NHIN function as I would assume it. And then we spent all morning and we spent forever number of hours working on the secondary uses or whatever we’re working on now, and the point is I’m Vice-Chair now with the crap we’re calling it.
No, but the point is we are learning every day’s like a month compared to most people that are in this space because we get a lot of input from people, and we share with each other and we’re having debates. So I don’t want us to lose the passion. I don’t want the emotion involved. I don’t want us to lose the passion or the good debate for the purposes of going to the emotion and somebody wins and somebody loses, and somebody has the best idea and somebody doesn’t. So I’m willing to play in that.
MR. ROTHSTEIN: Well, let me just say that in this letter I’m willing to – and it’s just my personal view, compromise, modify sort of anything in the letter except for one thing, and that is the concept that patients should have some control over their records. And what I’m not able to do is to say that they should, you know, that’s it sort of a take it or leave it thing because we rejected that a year and a half ago, and I think the NCVHS was right to do so, to say that it shouldn’t be an opt in or opt out. You’re all in or you’re all out. We all agreed on that.
Not only do I feel philosophically that it would be wrong to make patients make that choice, but I think that strategically it would be wrong to do so. Politically, it would be a real mistake to take that position, and that would never fly politically.
But all the other stuff, I mean, I’m willing to personally – this is my personal view, the decision support, the categories, the this, the that, I’m certainly willing to consider changing, modifying, pulling stuff and so on just to get the concept out.
But I’m not convinced any more that the basic, from our discussion this afternoon, that the basic concept would get through the Committee, and I could be wrong, and I don’t know whether the basic concept of —
MS. WATTENBERG: Can you make explicit when you say that what you mean.
MR. ROTHSTEIN: Allowing patients to elect to somehow not disclose some part of their record that they thought was sensitive, whether we have pre-existing categories that they can choose from or whatever. I’m not sure that the concept of patient control would be the unanimous view of the Subcommittee or certainly the full Committee. And without that, I don’t know that we can go – I don’t know what’s left to bring forward. Larry?
DR. GREEN: I accept that, and I would again while we’re expressing personal opinions, I would support that position.
MR. ROTHSTEIN: Which position is that?
DR. GREEN: What you just said. You said what for you was the really non-negotiable part of this is that an individual should be able to have some control over the disclosure of their medical history. I think that’s a fair point, and I think I would agree with you. And in Full Committee, I would be a guy that would support that.
MR. ROTHSTEIN: Thank you. Well, I got a vote.
MR. REYNOLDS: You have a vote for a subject. No, I’m not being ugly. I’m talking about good debate. So good as a subject, it’s good. It’s how many levels down does where it start becoming emotional. It goes from good debate to passion to emotion, and that’s where we’ve got to figure it out.
MR. ROTHSTEIN: But Marc, I want to ask – it’s not to put you on the spot, but I know your views are very strongly held. Would you be sort of opposed to that sort of basic principle?
DR. OVERHAGE: I think I am not opposed to the concept. I worry a great deal about what it means. So let me take that just a little bit further.
For example, Sarah’s come back a number of times to data of a nature around, and I’ll use an undefined term of severe mental illness and drug abuse, that might lead patients, for example, not to seek treatment. Well, I think having the patients having ability to control disclosure of that information if it was that important to them, if that’s the trade off of no care versus and especially, although I think it’s an interesting question, whether they can, if they understand the consequences of that choice, the trade offs that they’re making.
Where I struggle is when we go much beyond those, and I guess I’m like Harry said, I’m a pragmatist trying to do things on the ground for real. And I just –
DR. TANG: For real or for real?
DR. OVERHAGE: Both. Actually, we don’t use that word. But I just don’t know how you do it realistically, and I think that we have to think hard about the recommendations that we make in terms of priorities, you know, what else this might preempt in terms of energy, time, debate, money.
We have to think about impracticalities of – and I know you’ll think I’m a pessimist. But I don’t think most patients (a) want to nor can understand the trade off they’re making once they get beyond the very few things, and I don’t think most physicians know what the trade off the patient would be making in any way that would be helpful to explain to the patient.
So, for example, you say genetic data. Everybody goes, well, that’s okay. But, well, that’s means genetic testing data which is increasingly important. So the principle, I agree with. And the question it’s always the devil’s in the details and how you make it work in a practical way.
MR. REYNOLDS: I just want to let Sarah know the point is that, yes, you can do it. But how do you really make it work and really make it meaningful and really make it have it to be embraced. And so there’s no question, I mean, I guess I just gave a speech on it and Marc will do the same thing tomorrow morning.
Tell me the business requirements, I can mask anything. Tell me the business requirements – I can move it from here to there. Tell me the business requirements – I can move the record around. I can technically move it around. But through the many disparate groups as we all struggle with the philosophy of the NHIN and as soon as you stick that tag on it, now you kind of add some clouds out there that you don’t know if it’s going to rain or sun or you don’t know exactly what it is.
And I think that’s just a great example of the emotion. It can be done. It can be done technically. But as we struggle with all the things as we’ve messed with ePrescribing, as we do everything that we do, but making it improve our health system and in a pragmatic way be delivered so it’s delivered every day all day to every patient in the right way making a difference, it’s those layers when it goes down that it starts to come apart.
So we’re all agreeing up there. But as you start down is where we also have to all stay together so that as you go down that second level, the discussion stays the same because those are real, real, real issues. They’re not roadblocks to say we can do any of this. Denmark on one hand makes everybody in, and as it was mentioned, no, no, and then there’s a mention that Canada doesn’t. So all I’m saying is everybody can come up with a piece of data that either moves one forward or moves it back. And so we got to really stay together on it, I think.
MR. ROTHSTEIN: Leslie?
DR. FRANCIS: Yes?
MR. ROTHSTEIN: Did you have something to say?
DR. FRANCIS: No, I wanted to just apologize because something interrupted me, and my phone crashed. Anyway, but I’m back.
MR. ROTHSTEIN: Okay, thank you. Okay, so let’s assume that we’ve got agreement on this very narrow starting point. At what I would need now, I mean, as I’m mentally thinking, okay, I can rewrite, I can totally rewrite this letter. But where do I lose my support, you know, in the second sentence, in the third sentence. I mean, where is it for you – I mean, it would be very helpful if I knew where you got off the bus. I mean, I think it’s very – because we can’t go forward unless we know that, and unless there is maybe some sort of secondary principles that we could agree on, we’re not really advancing the discussion very much.
So Larry or Marc or Simon or anybody, if you could give me a sense of, okay, we’ll start out, we agree with this principle that patients should have some right to control some aspects of their health record, but don’t go there, and I want to know where there is.
MS. BERNSTEIN: Can I just – I haven’t talked much, and I’m kind of listening to this and trying to absorb all of it. The technology is developing a lot faster than the policy, and that’s the usual case. And one of the things we’re talking about earlier is what’s going to happen if we didn’t this, and you know, the technologists are going to develop what they’re going to develop, and if they’re not required to give patients control, they’re not going to get it, and pretty much that’s what happening now. Unless there’s some law that requires them or some other policy that requires them to incorporate these things of things, it’s not happening. So we’re already getting systems that don’t have these kinds of policies that we’re discussing incorporated into them because the technologists don’t have to do it, and they’re not being asked to do it.
But the other thing I was thinking of is that as we are trying to reap all the benefits of NHIN, a great variety of benefits, better quality, speed, whatever, I think we not only need to consider all the costs and Marc and asking us to do this, to consider all the costs. But I think maybe it was Sarah, maybe it was Marjorie who said we have this incredibly useful new tool. We expect that it’s going to change medicine in a variety of ways. But somehow I get the feeling that the physicians are not willing to change the way they practice or not be open – it’s sort of broad about the types of ways that the practices might change.
So that the assumption seems to be that it’s the physician that’s going to have to spend all the time with the patient explaining this rather than some person they hire in their office, a nurse who gets extra training about privacy and whose job it is to explain to the patient on intake at the very beginning of the relationship this is how things work now, your record’s going to be electronic, I want you to understand at the beginning of our relationship what your choices are and what that means.
And so that this conversation with the physician may still happen but might be shorter or more abbreviated, or maybe there’s some people who go into business to, you know, train people, help people understand all their choices if they want them explained to them. Most – some people, say, publish my information on the Internet because I had the experience of being on vacation in some odd place and I had to go to emergency and I wanted the doctor to know everything, and my view now is publish everything, I don’t care. And some people’s views not that because their experience is different.
But I think, you know, there are lots of different ways that practice could change. We’re going to reap some benefits because of electronic records that will reduce cost, reduce time and improve quality. And there are going to be other things that will be cost that may increase those things. Hopefully, on balance, there’ll be more benefits than cost. That’s what we generally are presuming that this system will increase benefits and, you know, that the benefits will be more than the cost. But we’re planning on making a big investment in this thing. So we are already planning on spending a lot on it, and maybe we ought to be thinking about in a broad minded way what the costs are or what the burdens are and how we might lessen them on physicians, the creative ways that we could make this work in order to reap the benefits that NHIN is supposed to bring us. But I don’t – that’s enough.
DR. OVERHAGE: Just for the record, Marc, to demonstrate that physicians will change, it just takes them 30 years.
MR. ROTHSTEIN: Paul, are you still there? No. Larry?
DR. GREEN: I basically agree with the last comments. I’d like to go back and focus more tightly on your question of where do you lose this and try to answer that.
My best short at it this afternoon is you start losing me when you make – we have declarative sentences that says, we recommend the following six categories be eligible for special privacy protection at the discretion of the patient. That is one hell of a mouthful. And I am uncomfortable deciding that those are the right six categories, and I’m not sure that that’s a good idea.
So where I get out of sync with you, with the letter is when the areas are presented as if those are the right ones, given that I had spoken eloquently early afternoon again is that what’s sensitive to one person is not to another. And so this is a limitation of trying to do it by category.
And then it’s the scope –
MR. ROTHSTEIN: Can I interrupt you for just a second?
DR. FRANCIS: Larry, yes, could I offer –
DR. GREEN: If we could just narrow that for –
MR. ROTHSTEIN: I have a question for you. Is it that it’s over stated? In other words, suppose it said something like we believe that the best to do this would be categorical and examples of possible categories might be things like the following which the testimony indicated were sensitive to many patients.
DR. GREEN: Yes.
DR. FRANCIS: That’s exactly what I would –
MR. ROTHSTEIN: At least one – I didn’t hear you.
DR. FRANCIS: What I was going to suggest was –
MR. REYNOLDS: Well, we’re categorizing many. We’ve heard certain testimony. Marc came back and said two percent of the people opt out. So we just got conflicted. Those are the kinds of things we have to – the testifiers, yes, but whether or not, as we heard other things, if given a chance, only two percent would opt out, that’s 98 that will say I’ll take it all and two out. So that’s all I’m saying.
MR. ROTHSTEIN: Okay. Leslie?
DR. FRANCIS: What Marc was saying, which I think is a really sensible way to do it, would be to say something like these are categories that through testimony and published work and so on –
MR. ROTHSTEIN: Or existing legal requirements.
DR. FRANCIS: That seem to be that first line ones to investigate or something like that. We propose that these are the ones –
MR ROTHSTEIN: That should be considered.
DR. FRANCIS: That should be considered. That’s not the same as saying we recommend that these be sequestered. That’s a look, we think you need to start considering this problem in a very serious way, and here are the first starts in. And I also think we could say that the kind of point that Paul was making which is that with some of them, there’s a real track history. Doctors are more used to them. With others, there isn’t. And it may be far more technically difficult to figure out how to even do it. But on the other hand the stakes may be higher for patients with them. We just don’t know yet. But these are the categories we propose for investigation.
MR. ROTHSTEIN: Initially.
DR. FRANCIS: Yes, for initial investigation. Does that make sense?
MR. ROTHSTEIN: Well, I think Larry’s okay with that. Marc?
DR. OVERHAGE: I think – Maya, you’re not doing your job. Actually, I’m sure you are. I’m okay with that, although I’d like to add to it that I think it’s important that we describe some of the challenges with categories. I mean, genetic information, I think, is a great example because when people hear genetic information, they think my genome, my diseases that are going to put me at that insurance risk, and Harry’s not going to insure me, and my employer’s not going to want me, and my wife is going to divorce me, especially as we go –
DR. TANG: You’ll be all right otherwise.
DR. OVERHAGE: Yes. But as we go forward, there are a lot of snippets of genetic information that are critically important, and I don’t think the patient would want to. So we create these broad labels and substance abuse information or psychiatric information. It’s a very broad bucket, and I think we need to at least underscore for people that if they’re not careful as they think about the buckets, they may end up getting what they ask for, and the patient maybe what they think may be a sensible trade off may take on more risk than they would anticipate.
And I guess it reflects a fundamental pessimism, but it comes from years of trying to educate patients. It’s very hard to get people to understand those trade offs and risks, and privacy is an even harder one. I mean, you can stand in front of the 35-year-old guy with a cancerous lung and say this is what you’re doing to yourself with your smoking, and they’re like, yeah, I know, it’s okay, I mean literally, and you know, now I’m going to say to somebody, you know, if you elect this, you might not get good care or you don’t elect this, you might lose your privacy. I mean, it’s a very subtle thing.
And frankly, I think any attempt to broadly educate the public about that is doomed to failure, not because they’re too stupid. It’s just not a big enough part of their life and not important enough to them to spend energy on other than a minority.
MR. ROTHSTEIN: Okay, I interrupted Larry. He said you had another thing you would say.
DR. GREEN: I’d really be interested in you pushing back about this, but it might be that if you were to recraft this letter to where it had a section that really emphasized that this is another policy issue that needs to be carefully evaluated for its unintended consequences and its costs. That is not really apparent to me in reading the letter, and we know quite a bit about that. We learned quite a bit about that. And enough to know that there’s a lot here we don’t know.
MR. ROTHSTEIN: Larry, you get no push back from me on that. I think that’s studying stuff always meets with my approval.
DR. GREEN: Well, that sets up holding on to what I think is an important insight to put into play, and that’s the breaking the glass recommendation in emergency situations. I mean that’s a way forward. That, I believe, is an idea whose time has come, you know. I don’t know that there’s a rule that we can’t put something in this letter that we think is a really good idea to do. And I think that’s an excellent idea. It just shouldn’t be assumed to solve problems for which it’s not a solution.
MR. ROTHSTEIN: Marjorie, and then Harry.
MS. GREENBERG: I was wondering if Paul was still on the line — which apparently he isn’t. And you asked what’s a deal breaker, and what I wanted to ask him was when he said, he just was adamant against doing research in certain areas. And if that’s a deal breaker for him, then I do question the ability to get this letter out except maybe with a minority opinion because I think if there are areas, there’s some agreement here. I’m hearing a little bit of agreement in that maybe things have to be phased in some different ways instead of, you know, recognizing that these if you want to recognize these areas, they’re ones that you’ve heard about, that there are state laws, some state laws that people are, whatever, you know, couch it in that language.
But if there are things that you can’t all agree on, then it seems that they would be candidates for study or research.
MR. ROTHSTEIN: Marjorie, not to speak for Paul, but I think what he was opposed to was the research on the electronic decision support.
MS. GREENBERG: Yes.
MR. ROTHSTEIN: Under the theory that you can’t study something that’s a total loser to begin with.
MS. GREENBERG: That’s right.
MR. ROTHSTEIN: Is that, I mean –
MS. GREENBERG: He did say that. I don’t know whether he felt that way about any of the other things.
MR. ROTHSTEIN: Well, I didn’t hear that.
MS. GREENBERG: But that would mean that you’d have a really hard time having a recommendation on that topic.
MR. ROTHSTEIN: I agree. Well, we’ll worry about that one later. Harry. You were next.
MR. REYNOLDS: And to play off of Larry’s comment, also if you talk about things that I like in the letter, recommendation five, six and seven not only does five allow the breaking of the glass, it also starts to put a stewardship which we’ve been talking about stewardship in everything we’re doing, a stewardship around the management of that not at a draconian level, but basically at a level that says then break the glass is not as it was discussed in other cases. Anybody that walks by is going to pop the glass open, take the data and run. It says that once it happens, an institution – and then we go back to this whole idea we’ve been dealing with in the other things, covered entities, and you’ve got the whole thing where, so that starts to build not just an answer. It starts to build a whole mechanism around making sure that that answer does take whoever uses it in mind as well as whoever’s data is being used, and I think that’s a nice approach to make that more of a complete recommendation and more of a complete picture of thinking it through rather than just throwing out break the glass, and then we have all these other issues that come up. So I like the way five, six and seven play off of exactly what Larry said. That, and if we could take each of the things we talk about and build it out the same way because on some of them we just want to say go, and then everybody says, no, I don’t like the second stuff.
So this worked out good because this has good – it kind of steps down. Here’s a decision, here’s what would happen, and here’s what it means.
MR. ROTHSTEIN: I want to back up and see if Maya got that. Did you, I know you’re out of compute – you’re going to be able to recapture that, I assume maybe.
MS. BERNSTEIN: It will be in the transcript.
MR. ROTHSTEIN: All right. So I was going to ask Larry to make sure that you had his second point because he had the first one about the – he cautioned us not to be too proscriptive on the categories and not to be too specific.
MS. BERNSTEIN: Yes.
MR. ROTHSTEIN: And we added to tie that into the fact that the list that we are putting forward are things that are either in state law or federal law or physicians have some familiarity with already. But this is not written in stone, that sort of thing. Okay?
MS. BERNSTEIN: So that’s where you want our starting place or –
MR. ROTHSTEIN: No, no, no. I asked him and everybody else help us out, you know, go off in a direction that you can’t support. And so show us the problem areas. So that was the first one.
And the second one, to make sure, and Larry, correct me if I mischaracterize what you said, make sure there is in place some way that we would be on to researching and evaluating and studying to make sure that none of these recommendations would lead to unintended negative consequences for individuals, for physicians, for patient care, for whatever. Is that fair?
MS. BERNSTEIN: Well, there could be some negative consequences, but they won’t be intended. But they will be known.
DR. GREEN: The point wasn’t to be sure you’re not going to screw up before you get started. The point was to put into the letter what we learned about where the risk lies and moving in this direction and understand what the potential – that we can see some places where there could be trouble here.
And I wanted to tack into that what I thought – I think Marc made this point strongest of anyone in the discussion today is that we’re making some recommendations here that haven’t been costed out, and the economic implications of some of these apparent trivial sentences should be considered.
MR. REYNOLDS: Mark, and I want to add one other thing.
MR. ROTHSTEIN: Harry?
MR. REYNOLDS: As part of that research, at what point do the numbers of categories or the depths of the categories make it – in other words, at some point as you’re doing research, you say you do this, you do this, and at some point you get down there where the doctors, the caregivers would throw their hands up, go not worth it. And Larry’s example earlier was an excellent example whether it’s an individual example, or it’s an example of what happens 100,000 times a day. So those are the kinds of words that need to be in there, too, because if we just say look at the categories and then –- so we’re going to come out with an answer in every category or whatever the categories are, we also have to equally have the research done. At what point do the caregivers walk away.
MR. ROTHSTEIN: Well, I think that maybe we should consider adding a statement in there that physicians would have no obligation to treat a patient who refused to provide them with information that they considered necessary for the patient’s care. I think that’s – I’m sorry?
MS. BERNSTEIN: That they know about. If the patient tells them they’re withholding information, then they have that choice.
MR. ROTHSTEIN: Right.
MS. BERNSTEIN: But patients withhold information all the time.
MR. ROTHSTEIN: Of course, they do that.
MS. BERNSTEIN: Okay.
MR. ROTHSTEIN: But today, if I go see a doc, and the doc asks me a bunch of questions, and I say I don’t want to answer them, then my doctor is free to say, look, I can’t treat you unless I know this stuff, and you’ll have to see somebody else. I can’t prescribe you these pain killers unless I know what other pain killers you’re on.
MS. BERNSTEIN: Sure.
MS. WATTENBERG: Can I just ask a question? Marc, do you have any sense of sort of what physician threshold there is, like at what point do you think, just based on your experience, do you think a doc would just say can’t help you.
DR. OVERHAGE: Well, I think that the kinds of things that would create a lot of angst were any lab results, any drugs, any diagnoses.
MS. WATTENBERG: That they would walk away from the patient and say I can’t help you?
DR. OVERHAGE: Yes.
DR. FRANCIS: The other thing is don’t you think that it’s also just hard to walk away.
DR. OVERHAGE: With the patient or the doc?
DR. FRANCIS: For the doc, and that needs to be acknowledged, too. I mean, docs don’t like to say, well, bye.
MS. WATTENBERG: But that’s what I’m asking. I mean, it sounds like what you’re saying is that it’s not that hard, that I mean, maybe emotionally it would be hard, but that you’re fairly clear that –
DR. OVERHAGE: But there’s a difference between what they would do and what they have a right to do.
MS. WATTENBERG: No, no. I’m saying –
DR. OVERHAGE: Okay, and that’s different because one of the things we talk about with – I talk about with my medical students is what to do with a non-compliant patient. I mean, do you say, well, I advise you to stop smoking for the last five years. Every six months, you come in with a new respiratory problem. And unless you stop smoking, I’m not going to treat you any more. And initially, the students say, well, that’s what you ought to do. But if you gave up on all your non-compliant patients, you wouldn’t have anybody to treat.
MS. WATTENBERG: No, working in mental health and substance abuse. Mark, do you disagree with Dr. Overhage?
DR. GREEN: I think the key point for me about the categories is really to (1) is the Committee heard people raise issues in these categories that were important to people where they might want to restrict access. That’s a very good point that I think should be made.
Key point number two is as stated presently in the letter there, too broad, too far reaching, subject to an interpretation that, in just one person’s opinion at the table, are sufficiently ambiguous that, if taken literally, would make it virtually impossible to practice medicine. And, therefore, I think you would go too far and would lose support for the recommendation.
MR. ROTHSTEIN: Could you explain that? Is that what you were going to ask him?
MS. BERNSTEIN: No, that’s not what I was asking. But if you need to ask him that, you should.
MR. ROTHSTEIN: Could you give us a little more guidance on that?
DR. GREEN: Yes. So substance abuse is on the list, right?
MR. ROTHSTEIN: Yes.
DR. GREEN: The number one reason you die before you had to and the number one reason you suffer when you didn’t have to is the use of tobacco in the United States. If you tell me that my patients can keep that information from me, it makes it very difficult for me to accomplish my mission as a primary care physician.
We know that the obesity epidemic is the overwhelming explanation for the diabetes epidemic, which is going to bankrupt Social Security and the entire federal treasury. And if you tell me that I cannot know about personal behaviors related to obesity in some way or another because of family history, this is the way our family eats. You have to see your patients behind a screen and you can only see their head.
MR. ROTHSTEIN: You need to know why are they obese?
DR. GREEN: We’ve really got a cultural gap here. The examples I’m using are just the normal routine aspects of trying to do a decent job with who comes to the doctor.
MR. ROTHSTEIN: I think we should use those as examples.
DR. GREEN: So the category of family history. I man, the NIH is on primary care’s case you must do a much better job at getting family history collected so that we can reap the rewards of the genetic revolution. And then you turn around and say, oh, yeah, but you can’t see it because it’s on the list, and I don’t want you to know this, that or the other.
So it is the scope. Marjorie said this twice. It is the range and scope of these categories that has to be narrowed. And I believe that the Committee should stay focused on our fundamental conclusion is that NHIN is going to be held back until there is the opportunity for individuals to control the disclosure of what they consider to be sensitive information, and we really care about that. We want to get that going. But we shouldn’t present it out there in a way that’s going to generate a fire storm and five years of argument if it’s done in a way that makes it virtually impossible to take care of the folks. That’s all I’m – thank you. That’s my point.
MR. ROTHSTEIN: That was a helpful clarification, and we got some stuff to add in the letter. Maya, you had a question you wanted to ask.
MS. BERNSTEIN: Sort of, yes, I mean, I’m not sure what you meant when you just said the NHIN will be held back until we have an opportunity to –
DR. GREEN: That was our first starting premise –
MS. BERNSTEIN: That’s not going to happen. I mean, the NHIN is not a governmental thing. We can’t, even if we recommended and the Secretary took up our recommendation, it’s a private sector matter that’s being developed essentially. In fact, we have no way to have it held back.
DR. GREEN: Well, that’s different from the viewpoint that was expressed here in the room about 20 minutes ago.
MR. ROTHSTEIN: We talked about the government role in the NHIN.
MS. BERNSTEIN: Right. But the NHIN is not a governmental entity. It might be government sponsored, you know, it might be funding, promotion, whatever, but it’s going to happen with or without –
DR. GREEN: Well, but Maya, I mean holding back takes many forms. There’s usability and acceptance by people, and that’s another form of holding things back.
MS. BERNSTEIN: Sure, okay, okay. If that’s what you mean, then I understand it. But my other point was that in trying to be more granular, I don’t know if this is the same granularity as you were saying before about what the categories might be or what the types of subject matters are, I think, I mean I predict, I guess, we can try to have that discussion and try to get it to be more granular. But we’re either going to run into everybody has their own version of what’s sensitive, so at another time we sort of jokingly courted our friend and colleague, Bob Gellman(?) who points out that mental health history isn’t that sensitive. How does he know? Because he knows plenty of people in therapy. How does he know that? Because they tell him, right.
And he says he doesn’t know anyone who’s ever been to a proctologist. So, right. So we don’t call them that any more, right. But the point is what’s sensitive to one person not sensitive to another. We’ve heard testimony on that as well that trying to pick those categories is difficult. And when we get more granular about the type of information, I think we may end up moving from categories to those item-by-item things that we’ve already kind of rejected.
So I just think that’s – I’m just pointing out it’s very challenging to get more granular, and that’s one of the reasons we didn’t do it. But maybe the caveat language at the beginning that we talked about solves that problem, and we don’t have to get there. But I also think that if we don’t try, this group has a particular expertise, you know, sort of funding gets together and talks. And as Harry was saying, really has a way of grappling with these issues that others who try either don’t do or don’t do as successfully. And if we punt on the hard questions, I mean, look, I’m just the staff. But I’d like to see this group because I think it’s well constituted and there are thoughtful efforts –
DR. COHN: Well, we’ve decided to go ahead. That’s the plan.
MS. BERNSTEIN: Yeah, but you need to not punt.
DR. ROTHSTEIN: So we’ve got Simon and then Marc.
DR. COHN: Maya, I was just responding to Maya because actually I’m sort of liking how the letter’s beginning to look. I guess, Maya, there’s a –
DR. COHN: I’m an optimist.
MS. BERNSTEIN: Simon’s so agreeable.
DR. COHN: But remember I had talked about the things that I had liked about this letter is it being a lot about research and evaluation and all of this. And I think what we’re doing is admitting that we have gotten to a certain level of specificity in terms of sort of what Rob described as gross chunky of areas that need probably some pilots and evaluations.
MS. BERNSTEIN: Chunking?
DR. COHN: Chunking, chunking, yeah with some pilots and evaluations for sort of really what in there is doable and sensitive and all of this stuff.
MR. ROTHSTEIN: Well, Simon, can I ask you –
DR. COHN: And so I think it’s good.
MR. ROTHSTEIN: And everyone to turn to page seven which includes recommendation nine. It’s over here on research and see if there’s something there that would raise a red flag. Marc?
DR. OVERHAGE: This isn’t quite a red flag. But the things I read I’d like to see thought through a little bit more on nine is the question of this describes technology research. This is not a technology challenger issue. It’s psychology, it’s people, it’s policy, it’s process, it’s law. I hate to admit that.
MR. ROTHSTEIN: It’s recommendation number nine. So we need to broaden what we do there. Do you see in recommendation nine. It says, “Piloting, testing, technologies and tools.”
MS. GREENBERG: They may want behavioral research.
MR. ROTHSTEIN: Yes, Marc’s point is that it needs to be much more broad. Social science could be factors. Professional relations, et cetera, et cetera. And so we will do that. What I’ve been doing as we’ve talked is kind of gone through this and figured where the problems are. I skipped over clinical decision support. We’ll worry about that later.
I have a question on five I’d like to ask you to – page five, yes, which includes recommendation number three, and that is the flagging concept. We haven’t really talked about that too much today. But this is the idea that if somebody elects to sequester information from any of the approved fields, that the physician or any provider accessing will get a standard message that says at the patient’s request, certain information has been withheld. And I’d like to see whether you think, I mean, assuming that we’re allowing them to withhold some information, do you think that the flag is appropriate. I’m at the bottom of page five where it says when patients to providers. I think you’re on a different version of this, yeah. I’m sorry, recommendation three on page five. There you go.
MR. REYNOLDS: I’ll let Marc go first, and then I’d like to comment.
MR. ROTHSTEIN: Okay, thanks, Harry.
DR. OVERHAGE: Again, a mild thought, and that is I think what you were headed towards here is that the provider should be able to be aware that there’s sequestered information.
MR. ROTHSTEIN: Correct.
DR. OVERHAGE: I think that makes sense. I don’t know if in the recommendation we want to go so far as to say how they should be made aware. I want to back off a little bit and sensing that there’s a flag or whatever that we would just say that when a healthcare provider accesses health information with one or more categories sequestered, they will be notified, made aware, I don’t know what the right word is. But we’re proscribing a particular solution that tomorrow may be a lousy solution.
MR. ROTHSTEIN: Okay, Harry and then Sarah.
MR. REYNOLDS: I know you wanted to stay away from this whole decision support. But again we’re looking out into the future, and there’s going to be types of decision support. You know, we’re talking about whether or not the actual record that comes across has it, there’s going to be systems built around systems and everything else. And so I would at least like to have a note in here that any other appropriate decision support that would work on the same data or other data about that person. It could even be your own internal system. In other words, if you think about the data coming about a person, so let’s say that they’re under Marc’s organization, but they’ve also seen two other clinics. The data that’s coming from the two other clinics is what is under these auspices. The data in his current environment is not under those auspices. So all I’m saying that all appropriate systems, and I don’t even want to wordsmith it, but we got to be careful that we’re thinking about it. It’s only coming from somewhere, but a lot of this data is going to be somewhere because that person’s getting care there.
So when we talk about decision support, your decision support that you use internally may not be the same thing or the same issue that’s going to come across the NHIN. So we need to be careful as we do this.
MR. ROTHSTEIN: Okay, Harry, can I raise an objection for my friend John Houston who’s not here because I know what he would say. He’s on vacation, so he’s not Poor John. He’s just absent John.
MS. BERNSTEIN: He’s definitely not poor.
MR. ROTHSTEIN: He would say that you have to keep it to the NHIN because I don’t want anybody telling me what I’m using at UPMC, and that’s what he says all the time, right. I mean, it’s not something I necessarily believe, but I’m making his argument for him, probably poorly. But that the scope of our letter is only for what goes out over this mythical NHIN, and it’s not within my institution.
So how would you respond to that?
MS. BERNSTEIN: Because it’s an organization’s prerogative to choose how to manage their records.
MR. REYNOLDS: Okay now I’m the patient. I’m going to be a patient, and we may never get this transmitted. I know we are, and I agree with Marc. There’s a lot of trend. So you’re telling me that in two of the three cases, I’m using my example, in two to three cases my data is masked, and in the other one it isn’t.
MR. ROTHSTEIN: Right.
MR. REYNOLDS: I’m not agreeing or disagreeing with that. But how in the heck do you explain that.
MR. ROTHSTEIN: Well, if you’ve given information to someone who’s treating you, by definition you haven’t masked it. But then the question of where it goes from there.
MR. REYNOLDS: Good example. I’m just saying –
MR. ROTHSTEIN: Well, I mean, personally I think it’s hard to defend. But he’s made the point, and he’s actually in fact prevailed, as you know, because Paul supported that in 2006.
MR. REYNOLDS: I’m not pushing the subject. But, again, let’s continue to not think about – every time somebody says the NHIN and gives an example, it’s like that’s it.
MR. ROTHSTEIN: Right. No, I understand.
MR. REYNOLDS: And that’s the only way it’s going to be, and that’s the only system going to be involved in, and that’s all said. We just need to keep that in mind.
MR. ROTHSTEIN: Maybe we can say, we can make that point without making that the subject of our recommendation.
MR. REYNOLDS: And I’m just fine with that. I was building it onto this as another thought.
MR. ROTHSTEIN: I know that John would react to that because he’s very predictable on that point.
MS. WATTENBERG: Yeah, but isn’t it true that, all right, HIPAA doesn’t require consent for treatment and care given by an institution or a healthcare system or whatever, isn’t that treatment, yes. So I don’t know that it’s just John who has this view. It seems, you know, even though I remember a discussion maybe in this very room – it wasn’t the one where we were writing on the wall, that was a different discussion. But I do remember a discussion in this room where, and I think John was here, where we said, you know, because the extent to which we don’t know what the NHIN is that it’s small providers or even big providers or whatever, all of their electronic exchange may be through the NHIN is a network of networks, right. So let’s say all of their exchange of information, even to the person whose providing treatment? The physician next door to them, is going through this RIO or this regional network, which is part of the NHIN. So in that case, the distinction doesn’t really make sense.
But since we can, I mean, since it’s not been completely clear as to what the NHIN is, I guess we can just keep with that distinction. But we are talking about something other than the treatment, or are we trying to rewrite the HIPAA law, too here.
MR. ROTHSTEIN: No. We can’t get to first base. So –
MS. WATTENBERG: Okay. So in that sense if he’s just in an organization that’s providing treatment, this doesn’t really apply to that.
MS. BERNSTEIN: But we also shouldn’t assume that HIPAA will never change just because we aren’t going to change.
MR. ROTHSTEIN: Right. But we’re not taking on the world in this letter.
MS. WATTENBERG: Okay.
MR. ROTHSTEIN: Uh, I think –
MR. REYNOLDS: One last comment on it.
MR. ROTHSTEIN: Please, Harry.
MR. REYNOLDS: One last comment on it. So what John seems to be saying, and if you come to his institution, then any doctor you see in that institution, this whole bag doesn’t apply to. So I’ll quote you from a couple other times. If I go see this psychiatrist at John’s area and then I go see the dermatologist, and I have said through the NHIN I don’t want my psychiatric stuff going to other doctors, you’re saying that John, even though the patient went to the first psychiatrist, you’re telling me they went to John’s whole organization which –
MR. ROTHSTEIN: What’s what he said?
MR. REYNOLDS: Okay. I don’t want an answer to that.
MS. BERNSTEIN: I don’t think that’s exactly what he would say because under HIPAA you can’t transfer the – the second physician, whoever it is, inside that network is not permitted to look at that record unless it’s for treatment. They can’t just go into the record. If it goes to that other physician for treatment –
MR. ROTHSTEIN: He sees the psychiatrist. Now he’s sees another doctor. The second doctor gets everything, and it’s not sequestered in any way. And, therefore, John’s view is the whole limit on what we’re talking about here is stuff that’s going out outside the –
MR. REYNOLDS: Well, then we’re kidding people that there’s hold back.
MR. ROTHSTEIN: That’s my view. But call your buddy. Simon?
DR. COHN: Yes I think you actually have to put plural on the “buddy”.
MR. ROTHSTEIN: Buddies.
DR. COHN: You know, I think this is actually an issue that probably is the subject of another letter of another time.
MS. GREENBERG: After you reach out to the Committee.
DR. COHN: No, no. So I think this is actually a multi-dimensional issue because, you know, at the beginning of this letter, we talked about health care. We say, geez, this doesn’t apply to payment issues, showing data with payers, or what payers may do with data. I mean, and this has really multiple, it just gets into that issue of, well, what really is in NHIN, is it us, is it something out there. I mean, I think it’s an important issue, and I think we’ve been skirting it.
I do think, however, if we build this into this letter, I know it’s not going to be a November letter.
MR. ROTHSTEI: Okay, I have one more specific question that I’d like to ask Marc and Larry for some guidance on, and that is on page five, recommendation two.
MS. BERNSTEIN: Have we left recommendation three as it is for now, the one we’re doing in here?
MR. ROTHSTEIN: Well, we made the change that Marc suggested, not saying flag and just say you should be notified.
DR. OVERHAGE: Something like that.
MS. BERNSTEIN: It says a standard message should note. You didn’t like that?
MR. ROTHSTEIN: Yeah, well –
DR. OVERHAGE: It sort of feels like a box should pop up and say in red letters –
MR. ROTHSTEIN: It just sort of de-specifies that.
DR. OVERHAGE: Yes.
MR. ROTHSTEIN: And we can worry about that. Okay, so I just want to explain recommendation two, and this is where I elect to have my psychiatric history masked, but I’d like to have my psychiatrist be able to look at it. And what we’re saying in recommendation two is there has to be some mechanism, and we didn’t say how –
MS. WATTENBERG: Something other than break the glass.
MR. ROTHSTEIN: Correct, to authorize any particular physician that may be a specialist in that field, for example, to gain access to the complete record. So comments?
DR. OVERHAGE: Conceptually, of course, it makes perfect sense. The problem is how in the heck you do that. What I mean by that is so the patient presumably is sitting there or somewhere at some computer application or some form trying to say who they want to see their record.
MS. BERNSTEIN: Yes.
DR. OVERHAGE: So they pick Clement J. McDonald in Indianapolis, right.
MS. BERNSTEIN: Yes.
DR. OVERHAGE: Well, they just sent it to the wrong guy. Instead of the EMT that they were trying to disclose it to, they just sent it to the general internist medical information.
MR. ROTHSTEIN: There are two of them that –
DR. OVERHAGE: Yes, and in fact there’s a Siddartha Merkilawirtha(?), there are three in Indianapolis and two of them are internists.
MR. ROTHSTEIN: So from what –
MS. BERNSTEIN: But he knows that that’s an ambiguous designation, right? When I suggest and I email to my secretary whose name is Christina Williams, it pops up and says which one do you mean? There’s one at FDA, and there’s one at ASP. Which one do you mean?
DR. OVERHAGE: Well, just my point is that I think the concept if very reasonable. The risk of getting it wrong is significant. And the evidence I would cite for that is Medicaid PCP selection by patients which in many states is 30 percent erroneous.
MR. ROTHSTEIN: Well, as a strategy matter, let me ask you this, okay. We to avoid those problems and other kinds of problems, we didn’t say how that should be done. So is it your recommendation that we should leave it sort of vague like this or put some additional language that would improve it?
DR. OVERHAGE: I think leaving it vague is okay. But I struggle on any recommendations when we maybe can’t see all the way to how they can be implemented.
MS. BERNSTEIN: Could I say –
DR. OVERHAGE: Not to figure out how, but the how sort of –
MS. GREENBERG: When you’re in that doctor’s office, you could trigger something.
MS. BERNSTEIN: In terms of identifying doctors, we have the same problem with identifying patients, John Smith, John Smith, whose record. We have record locator issues. For patients, we probably have the same issue you’re pointing out with doctors. We’re working on solutions to that problem. I don’t think we have to solve it. But the ambiguity issue is not just an issue for picking doctors. It’s for choosing from a list of patients as well.
DR. OVERHAGE: Right. I’m just pointing out that this seemingly innocuous idea that you should be able to specify who (a) exposes the patient to additional risk by giving the wrong person.
MS. BERNSTEIN: But how is that additional risk than the risk today or of, you know, when I ask for my record to go to my internist whose name is Lisa Kaufman and not the dermatologist Lisa Kaufman across town whom I happy to know.
DR. OVERHAGE: Well, exactly.
MS. BERNSTEIN: How do I do it? They ask for her address and phone number. I know it. I put it down. I mean, there’s a way to identify them unless they both work in the same office, which is probably unusual, right.
MR. ROTHSTEIN: Marc, my reactions are I’d like to conceptualize. I think we should bring very carefully in our mind that recommendations one, two and three are a package deal. And one says that patients have rights. Two says we develop systems. When they exercise these rights, once they know which information they want to sequester, they should also have the opportunity to open that information up to people they want to have it, right, that’s what it says.
And then the third one says and when that process is in place, there needs to be a reliable way where that can be known to people throughout the healthcare delivery system. So taken together as a trio, I think that’s just fine conceptually.
However, I want to now loop back to our fundamental conclusion which is that the evolution and use of the NHIN vendors producing the products that are needed to make it so and people being willing to use it is at risk here because of the urgency in getting this resolved. That’s our key cornerstone of this letter, it seems to me. Every design constraint that we recommend delays implementation, and we need to come clean about that. So now we’ve got three, then we have four, then we have five.
This starts being something that the system – the electronic health record vendors, people designing the data standards, they’re saying come on, now where’s this going to stop. I mean, I’ve already got $185 million sunk into this design, and now you’re telling me I have to go back to the very beginning of the registration data set, I’ve got to now put two things in it, which means I’ve got to reprogram the whole thing. When do you guys ever get off? We’ve got to be realistic about that. If we keep putting more constraints on it, our fundamental objective of getting it to happen moves further away. That’s my point. So we want to be very judicious about how many of these things we put into the letter.
We are out of time almost and out of quorum. And the question I have for Maya is when can we see a new draft.
MS. BERNSTEIN: You’re kidding, right? Of what?
MR. ROTHSTEIN: Of the newly word letter. Seriously, I mean, we’re still shooting for November.
MS. BERNSTEIN: No, I know. But the Subcommittee has discussed all manner of policy. It’s not – it hasn’t told me exactly what they want to say since, well, you sort of have in some places. For the parts that we espoused in the last hour, I suppose. But –
DR. GREEN: Well, the two of you need to talk about it. You were indicating, I mean, it was nice to know who was going to be rewriting it.
DR. OVERHAGE: I’ll rewrite it.
MS. GREENBERG: It would be really helpful to have the transcript. We can try to put a rush on this part using this part of the transcript.
MS. BERNSTEIN: Well, we can talk about it together.
DR. GREEN: I’d like to just make one other comment. I mentioned this to Marc earlier, but after seeing some of the prior versions, I went back and looked at the quality series at the IOM and looking at all the reports trying to think through the implications of this issue for working the quality issue, and I got stuck at the mental health report.
And what really continues to be a problem for me is that in that report –
MS. BERNSTEIN: What?
DR. GREEN: The IOM report, part of the quality series in the IOM, the one about mental health. Here we are identifying mental health information being sensitive and something that should be sequesterable, maskable, that sort of stuff. They point out that in the United States today a person with a major mental health disorder dies 25 years earlier than everyone else, and they point out that the main explanation known for that is their lack of access to routine medical care.
Now what I’m stuck on is that moving toward policy that does anything to further segregate medical care for people with mental conditions. So I’ve reached the mark up. I’ve really got a new comfort zone with this letter. We’re doing great here as far as I’m concerned. But just for the good of the order, that is sitting in the front, not the back, the front of my mind where I say just what the hell are we accomplishing here.
MR. ROTHSTEIN: Well, I think our hope would be that this letter and a system that we could put in place would give people with mental illness greater confidence and comfort in seeking treatment because they would know that they have some level of protection for their privacy. But on the other hand, there are many other societal problems it causes. I mean, you’ve got unemployment and homelessness and all the other things that trouble people with mental health.
DR. GREEN: Which will be in their social history.
MR. ROTHSTEIN: Right. So we have no sort of timetable for when we’re going to distribute this. Maya and I will get together.
MS. BERNSTEIN: Okay, when is the next Full Committee meeting, the end of November, right?
MR. ROTHSTEIN: It’s after Thanksgiving.
MS. BERNSTEIN: So we have like six weeks?
MR. ROTHSTEIN: It’s the 27th, I think. So we’ve got a lot of work, and it’s not clear that we’re going to be able to do it in time. But we ought to try. And I want to thank all of you for a very productive meeting today, especially the second half. I mean not that the first half wasn’t interesting, and it was important to get those things out on table. I mean, people have strong views, and I let them express them.
But I think the second half where we got down to, okay, what would you be willing to live with even if it’s not your first choice, I think it was very helpful. And we will try as best we can to be faithful to the discussion in this second session. And to the extent that it differs, it’s not intentional. It’s just an oversight that you guys will help us correct.
DR. FRANCIS: Mark?
MR. ROTHSTEIN: Yes.
DR. FRANCIS: One thing. Anything I can do to help, drafting or whatever, just let me know. Just let me know.
MS. BERNSTEIN: The only thing, I mean, I think it’s important – sorry, Harry.
MR. REYNOLDS: Can the minutes reflect that this afternoon we figured out ways to move the industry forward, not what we could live with?
MS. BERNSTEIN: You know, as we go onto next month, I mean I think it’s important to just keep in your mind, you know, what am I willing to live with and not as what is my ideal situation, but if it’s my second choice because I think that’s what’s really going to get this letter forward.
DR. FRANCIS: Right. I mean, I think that’s so right. The thing is we have to get something forward. I think we all agree on that.
MR. ROTHSTEIN: Thank you, Leslie. Maya will be in touch immediately.
DR. FRANCIS: I’m heading away now, having been in judicial. Bye-bye, guys.
MR. ROTHSTEIN: Thank you all. Thank you for our AV support and staff for organizing things, and the meeting is adjourned.
[Whereupon, at 5:03 p.m., the meeting was adjourned.]