[This Transcript is Unedited]
Department of Health and Human Services
National Committee on Vital and Health Statistics
Subcommittee on Privacy and Confidentiality
February 21, 2006
Hubert H. Humphrey Building
200 Independence Avenue, S.W.
Washington, DC 20001
CASET Associates, Ltd.
10201 Lee Highway, suite 180
Fairfax, Virginia 22030
TABLE OF CONTENTS
- Welcome and Introductions – Mark Rothstein, J.D., Chair
- Discussion of Letter/Report to the Secretary on Privacy and the NHIN Subcommittee
P R O C E E D I N G S [12:15 p.m.]
Agenda Item: Welcome and Introductions – Mr. Rothstein, Chair
MR. ROTHSTEIN: The meeting of the Subcommittee on Privacy and Confidentiality is called to order and we are not on the internet but we are being recorded so for the record we need introduce ourselves. I’m Mark Rothstein from the University of Louisville, chair of the subcommittee.
MS. BERNSTEIN: Maya Bernstein from the Office of the Assistant Secretary for Planning and Evaluation, I’m lead staff to the subcommittee.
MR. HOUSTON: I’m John Houston, I’m a member of the NCVHS as well as the subcommittee, I’m with the University of Pittsburgh Medical Center.
MR. REYNOLDS: Harry Reynolds, Blue Cross and Blue Shield of North Carolina, member of the full committee, member of the subcommittee.
MS. HORLICK: Gail Horlick, Centers for Disease Control and Prevention and staff to the subcommittee.
MS. GREENBERG: I’m Marjorie Greenberg from the National Center for Health Statistics and as I once introduced myself I’m the executive subcommittee to the committee, I’m the executive secretary to the committee.
MS. MCANDREW: Sue McAndrew, Office for Civil Rights, privacy liaison to the subcommittee.
MS. CHAPPER: Amy Chapper, Centers for Medicare and Medicaid Services, staff to the subcommittee.
DR. COHN: Simon Cohn, chair of the committee and member of the subcommittee.
MR. RODE: Dan Rode, American Health Information Management Association.
PARTICIPANT: [Comment off microphone.]
MS. FRANKLIN(?): Angela Franklin, Blue Cross Blue Shield Association.
Agenda Item: Discussion of Letter/Report to the Secretary on Privacy and the NHIN
MR. ROTHSTEIN: Thank you all. A great task still remains in front of us, we’ve got all afternoon to work on it, and let me at the outset tell you where we need to be going, the kinds of things we need to get done today.
In the cover memo that Maya forwarded to you she noted the status of each of the sections, so just to run through those five and then I’ll give you to two other things we need to consider. The cover letter, the introductory section which isn’t even noted and Section A has not been considered. The rest of Section B, that’s the cover letter, the opening paragraphs and then Section A, we haven’t considered that yet. We’re about two thirds of the way through Section B. C through F we’ve completed except I noted that there’s part of the enforcement principles that we need to clean up. And all the recommendations, we haven’t actually considered any of the recommendations yet. In advance of this meeting I put together that list of draft recommendations and keyed it to the text that had been approved just so that we could follow along but that has not been approved at all.
The other things that we need to do on our list are first we need to decide how best to use our time at the full NCVHS committee meeting tomorrow, we have from 1:00 to 2:00 devoted to our Privacy and Confidentiality report and there are as many different sort of views on what we should do with that time as there are members of the committee, or the subcommittee, so we need to work that out at some point today.
And finally to add to our schedule we’re now getting to the home stretch and we are committed to bringing the final letter to the full committee for a vote in June, and so we have to back up, assuming that we’re ready of course, we need to back up from there and try to work out a timeline or timeframe for each of the steps so it has to be, a final version has to be approved by the subcommittee, it has to go to the executive committee and so forth, to make sure that we can get that on the agenda and voted on at the June meeting. So that unless I’ve left out something else covers what we need to finish.
I have not prepared an agenda because I want to leave it up to the committee members because there are different ways that we can proceed and that was mentioned on our last call, somebody wanted to see recommendations, I drafted recommendations. Somebody wanted to see the entire document rather then work on a section so I redrafted the entire document. There’s also some thought to well let’s at least finish B first before we take other things on, other people I think suggested that we start at the beginning with the introduction and then go through A to B. So rather then being prescriptive I want to proceed in the way that the members think would be most efficient. John?
MR. HOUSTON: We have some open sections that we really haven’t discussed yet, my preference personally would be we finish our discussion on the sections that are open, I don’t think there’s a lot of work to be done there —
MR. ROTHSTEIN: So are you suggesting finish B first, then —
MR. HOUSTON: B, A, and then get the recommendations from what was it, E, whatever they are on page 12, and I think the document, a thorough first draft is done and from that I think we can —
MR. ROTHSTEIN: Well that would be my inclination but I just want to give everyone a chance to —
MR. HOUSTON: But from that I think the next step would be to go through the recommendations because I think those I think should get before the committee this time.
MR. ROTHSTEIN: You mean as in tomorrow?
MR. HOUSTON: As in tomorrow for discussion.
MR. ROTHSTEIN: Well, that’s —
DR. COHN: Depending on where we come to on this.
MR. HOUSTON: Yeah, right, but you know how we talked before on the committee about on these difficult complex documents get recommendations together for the committee to discuss without getting into the body of document because if we want to try to bring it to closure at our next committee meeting or so I think we do need to try to make sure we’re all on the same page philosophically with the committee. So I think finish up the first pass, go to the recommendations, see if the recommendations, we all agree upon, to make sure they’re from the committee, and then from the feedback we get from the committee we then can clean the main document up.
MR. ROTHSTEIN: So I’m taking that as a motion to commit to an hour on finishing Section B, if we finish it in less time then we can figure out where we’re going to next but rather then figuring out what we’re going to do three and four jumps from now, we’ve got until 5:00 so can we commit up to an hour to finish B?
DR. COHN: Sure, sure.
MR. ROTHSTEIN: Is that all right with you, Harry?
MR. REYNOLDS: I’m willing to go along, I do want to spend the majority of the time on the recommendations because I think the thing that this does, I’m happy to finish B but I think even after we finish it stepping back to the recommendations, then I think we’re all agreeing on what we’re agreeing on. And then if we have to go back after that and work on a section then I can go there but I really appreciated you putting these together this way because now at least I have a sense of what we’re saying in the end, we can get lost in these, these are some pretty serious sections and some of the discussion back and forth, you can lose stepping up from it, so I thought this was an excellent way to do it. So I’m happy to go through B but I really want to make sure we spend the time here.
DR. COHN: I actually am fine with the process we have for I think going through the day, I did want to insert I think an additional piece, it’s called between now and June or whatever, and I guess as I looked through this document, and I want to thank Maya and Mark for putting it all back together so we could actually look at it, what I was struck with was of course a lot has changed over the last year since we stopped holding hearings on all of this and it might make some sense as we begin to think about, I mean as we begin to sort of try to finalize the document we actually want to hear from some people outside of our group, there’s people involved with the NHIN projects or whatever, to find out what they’re thinking about, I mean as we talk about B there’s obviously, B depends a lot on architecture and it might be useful to hear some of that.
MS. BERNSTEIN: You mean the contracts that are going on that have been let out of —
DR. COHN: Yeah, yeah, as well as maybe hearing from states about their perceptions on some of this because it might help us tighten some of these things up. It’s just sort of a next step item which once again doesn’t have to do with the agenda today.
MR. ROTHSTEIN: Well one of the things that Simon and I talked about is we have not really drafted this as a document, it’s a collection of sections at the moment so it’s uneven in various ways. Once we get a general consensus on sort of the substance then we can step back and say okay what are the assumptions on which part A or B or C are written and we have to make sure that they’re all consistent but I think we can get to that. So let’s pick up on page seven —
MR. HOUSTON: I’m not sure what the intent is of getting feedback at this point in time because I thought some of the intent here was to try to get out in front of the process because of the fact before the process got too far along. Because I think this is trying to shape, I thought the purpose of the document was to try to shape policy with regards to discussions on privacy before people went too far down the road of discussing and coming to conclusions about how privacy is going to get integrated into the NHIN and the like and part of my concern is it’s already starting to happen, I was just talking to Mark before this meeting and getting invited to attend something that Paul is involved in with one of these contractors who was in fact one of the awards for doing one of the pilots, is that what they are? What is —
MS. BERNSTEIN: They’re called contracts —
MR. HOUSTON: They’re already marching down the road of putting a form together for privacy and I’m just telling you I think we can —
MS. BERNSTEIN: One of the contractors you’re talking about or are you talking about —
MR. HOUSTON: No, one of the contractors, and so my point being —
MS. BERNSTEIN: But there’s a contract for privacy as well, right?
MR. HOUSTON: Yes but that’s separate, that’s the 50 state or 48 state analysis —
MS. MCANDREW: There are these four areas that are going to model the architecture —
MR. HOUSTON: Right, the four areas, right, and one of those groups is already doing a privacy form and my concern is is we can either be out front or we can, they can already be fairly far along in their discussions before we ever —
DR. COHN: I agree with what you’re saying though I can’t think of any particular value given that we can’t do this letter before June anyway, of keeping everything secret and then sort of springing it on everybody at the end of June as opposed to having conversations with these people at a time where they’re still probably thinking through things.
MS. MCANDREW: Which people are we —
DR. COHN: The NHIN contractors, I mean that was sort of the question, I’m not seeking to turn this into another year process from now —
MR. ROTHSTEIN: I think that if we, I think we would have to discuss with Dr. Brailer and others whether we want to go forward in some way to have an advisory relationship with the contractors because I can see us for example coming out with a letter to the Secretary and this report in June and then possibly in July say calling in the contractors and say all right we’ve recommended A, B, and C, are you working on any of those issues? Do you have any plans to work on those? Is that an approach that you’re taking? Is it feasible to do A, B, or C within the general architecture that you have? On the other hand I don’t know how that would affect the relationship between ONC and the contractors, we can’t, it’s not our role to sort of manage the contractors.
DR. COHN: Agreed, but I think we’re advising the Secretary and the Secretary is in charge of the contracts.
MR. HOUSTON: It’s dangerous, we can either be, again, in front of the process or behind it, and if we’re behind it a lot of what we’ve taken a lot of time to put together can frankly be for naught simply because of timing. I’m just concerned about, we were concerned getting it out too fast, now I think frankly they’re starting to get some momentum here that might indicate that we can miss the boat.
MR. REYNOLDS: The possibility of hearing from someone else, the only way it helps me is as we are writing a lot of this we are philosophically presupposing what the NHIN might look like, where’s the data, how might the data flow, where might it flow, what’s this and what’s that and nobody knows. We stand two possibilities, let’s leave the June timeframe right where it is, I’m not talking about touching the June timeframe. In the middle if you hear from these contractors to make sure that the four of them are not heading in a direction that blows up half of our recommendations, so by the time we put the letter up they’re already being paid by the government to do it and coming back with a completely different recommendation. We know that they sit there, it’s been touted, it’s visible, everybody thinks it’s going to be a direction and it would just, it just might be one last check off because if they were taking another direction we don’t agree with we may bolster a section, we may add this, we may add that, we may, that’s all I’m saying. Because we’re all dealing with this philosophy of NHIN because right now we’re just nothing more then a philosophy, I mean it could be the internet or it could be PKI messages where everybody is, we know everything is secured, it could go that far both ways, and that would be the only thing that would be helpful.
MS. HORLICK: I was just going to say I don’t even think it was a month ago we had a presentation at CDC, I can’t remember the contractor but one that Jared Adair was associated with, Jared Adair from CMS —
MS. GREENBERG: She has one of the architecture contracts —
MS. HORLICK: Right, Jared Adair that used to be with CMS is now with another, I can’t remember the name, I want to say like CRS or something, I don’t remember, but anyway the point is they did, it was a two and a half hours they had allotted and I have handouts at home, the short answer in terms of what they presented, they didn’t answer any of the, they didn’t even go into the choice opt out, any of that was not presented, they talked more about the architecture and in their particular situation they talked about three different ways this could be implemented and I think they were trying them differently, centrally stored, access from here, so it sounded very open and not, that might not totally address all of your concerns but what they presented was very much trying these different —
MS. BERNSTEIN: In response to your concern, my sense is, I don’t know if Sue, you guys have the same sense, that the four contracts are not sort of all driving toward the same thing, they’re sort of four competing ideas essentially about what the architecture might be, they’re models of possibilities and so even if one of them goes down a path where they create a particular response or particular idea about what the privacy model should look like you could have three totally different ones and the other three architectures, right, even within the one, and so —
MR. HOUSTON: I agree with you but that all goes back to my point is that what is the role of NCVHS here and I would think that in this particular case with regards to privacy and the NHIN we are intended to be a think tank or a thought leader on this and I think we should not be compelled to change our perspectives is some one of these contracts decides they want to do it a certain way. We have to think about, and I think without a lot of bias as to what we think needs to be in place and what the considerations need to be so that people can focus on them, or the department can come out and say yes, taking these recommendations, some of them require action of HHS, other ones are simply recommendations. But I think that, I think that should translate into something that then these contracts can look to and say okay.
MR. ROTHSTEIN: John, I agree with you, I think we’ve actually tried to do that over our meetings and maybe we need to clean some stuff up but I think what we tried to get in the text and certainly in the recommendations is the principles, so we believe that information should not be over disclosed, that individuals should have options where appropriate, etc., but so I think we need to have a report that would work with any kind of system that they come up with but some ideas of what they need to include in the system.
MR. REYNOLDS: I would just play with one of your words, I was not even alluding to being compelled once we heard something that would change, I am more into awareness and right now there are four major players out there about doing something and it’s very visible. And so I like the word awareness, if I’m going to submit something and I know there’s something going on big, I’d like to at least be aware of what it is, I’d like to at least understand the framework of which it is, and then I know that as soon as whatever I do hits the table I at least understand where the noise might come from, what the issues might be, what are the other things. That’s all I’m talking, I’m not compelled to change anything, I’m not even recommending we change anything, but that one more awareness might be, like I said one last check in the box that says nope, no surprises.
MS. BERNSTEIN: I don’t know if we can be so aware of what they’re doing until they come out with their results, are their interim reports from these contractors or is what they’re doing until they come out with their result, it’s not proprietary exactly because they’re on contract —
MR. REYNOLDS: I’ll give you an example, I met with IBM in North Carolina, extensively, interesting is the word I’ll use. No, that is the appropriate word to use, in other words I’m not going any further then that. I mean everybody’s approach is going to be different, it’s going to be interesting, they’re where they are in the thing and gain I don’t want to talk about process —
MR. ROTHSTEIN: Harry, I have a question for you related to that and maybe Gail could answer as well, I am concerned about getting some input from these contractors but I’m more concerned about our getting input into them, so I mean do they know that we exist, that we’re going to be preparing a document for the Secretary?
MR. HOUSTON: They don’t know that we are preparing a document as far as I can tell, at least the one that contacted me, they’re planning on doing their own privacy forum and starting to vet these issues separately.
MS. GREENBERG: Who’s going to do the privacy forum?
MR. HOUSTON: It’s related to the IBM initiative and it’s happening March 6th and I’ve been getting emails all day long about attending it all of a sudden.
MS. GREENBERG: Because you’ve also got the other contract with the 50 states and all of that.
MR. HOUSTON: I think the privacy stuff that they’re talking about doing is related to the types of discussions we’re having here with regards to philosophically what has to be in place.
MR. REYNOLDS: Mark, I would tend to say that some of the other work is much less far along even in infrastructure, forget the privacy, forget the other things that wrap around it, that some of the other initiatives may not even get as close, get even close to privacy.
MS. HORLICK: One thing I can do is I might be able to get the handouts of the facts tomorrow, I mean you can take a look at them, I mean I just really when I heard it I didn’t —
MS. BERNSTEIN: Could I just interrupt for just one minute? I have to go for an hour and a half or a couple hours and I’ll be back but either Gail or Amy, if somebody could take over and we talked about it, I don’t know if you guys want to switch off, compare typing skills or something and I’ll just show you what I did here, what I set up.
MS. GREENBERG: On the one hand I really agree with Mark that the kind of thoughtful process that this subcommittee has gone through with the hearings and now preparing this document in a sense needs to come to its conclusion regardless of what all these other people are thinking about and doing, etc., because it is at a level that isn’t really, and as I look at these draft recommendations, isn’t really recommending an approach that would just be dead on arrival because it’s more fundamental then that, it lays out the issues and then says these are questions that have to be resolved and these are concerns that people have, etc.
At the same time if there are other people thinking of doing the same thing, like this privacy forum or whatever, I think it’s important that everybody knows that this is coming, that the national committee has this process and that this is coming. And one thing I’m wondering is, let’s see, the next meeting of the community is what, March 7th, and I’m sure everybody who has a contract will have at least one person there, I mean they were all on the agenda at the January meeting, I don’t know if they are on this agenda but they’ll probably be represented. And I wonder if there’s any way to give a little heads up from the national committee that this has been, we’ve been working on this, that we’re coming to closure on it, that these are the broad areas we’re addressing, and I do think we have to do it in June, I don’t think it’s an option not to have this done by June even the executive secretary has to lock the key and throw it away, lock the door and throw away the key. I mean just realistically I think it’s still timely in June but then you really start creating a timeliness.
So you could either write a one page, or a half a page letter to Brailer and ask him to include it in their materials or ask that Simon could speak for five minutes since he’s going to be there, and offer to provide what you can but you wouldn’t have obviously anything from the committee because it wouldn’t have been provided. But there are transcripts of last meeting and this meeting if people are interested in knowing what you’re talking about, and then say if people are doing similar things, you’d like to coordinate with them or whatever. But I do think some type of a heads up at this community meeting in March would be a good idea.
MR. ROTHSTEIN: I think that would be fine or even in sort of a less formal way because everyone in this room knows every time that David appears before NCVHS or talks about this issue he says how much he’s look forward to receiving our recommendations and how important what we have to say is, blah, blah, blah, blah, so I would assume that naturally he would, or someone in ONC would tell the four groups —
MS. GREENBERG: Don’t assume anything.
MR. ROTHSTEIN: I’m being kind, I would hope that someone would have communication with the four groups and say as you go forward with the architecture work you should know that the NCVHS has been working for a year and a half on the privacy and confidentiality issues and their report will be out in June, blah, blah, blah —
MS. GREENBERG: I have no confidence that that’s happening but just because of the way things take on lives of their own, I’m not saying that, a neutral statement on my part —
MR. ROTHSTEIN: Well maybe the chair of NCVHS could —
DR. COHN: Send a letter to the NHIN contractors?
MR. ROTHSTEIN: No, talk to David and find out if they know that we exist and how we’re going to have —
DR. COHN: Can I ask a question? I guess I’m having a major disconnect, I had sort of said geez, we ought to have them come so we can talk to them directly and let’s invite them, hold a hearing where they’re talking, where we’re talking, we’re sharing ideas and sort of hearing where they are, this is somehow morphed into well geez we ought to send them a letter or otherwise communicate with them that we exist and we’re writing a letter. And I guess I’m trying to think of if what we want to do is to communicate with them or make an impact it would seem to me to be talking with them and making them know that we’re here by inviting them to one of our hearings is a very powerful way to A, get their attention, and B, get them involved in the conversation.
Now I agree with Harry that hearing from them does not necessarily mean that we change the document but I would sure like to be informed as well as if we produce this thing not have it appear like it came out a bolt out of lighting —
MR. ROTHSTEIN: That would be fine but I think we can’t do that before June because we’ve got nothing to tell them because we have no agreement on our position on anything, I mean the only way it would be would be unidirectional, we could find out what they’re doing to the extent that they wanted to tell us but we couldn’t, we have nothing to present. I would think that if we scheduled hearings in July, let them react to what we recommend to the Secretary.
DR. COHN: Can I make a comment? I guess this idea of sort of this black box way of handling things where we’re keeping it under wraps and then unveil it I think is generally not a real wise move, I actually think we have, I mean once again I haven’t been that close to these conversations but I see a lot more in here then you think, I know you’ve been all focused on B but there’s actually some very good things here that we could ask, the questions that we ask them we could begin to hear about what it is they’re talking about. A lot of cases we don’t have conclusions but I think the fact that we’ve identified areas to focus that are important I think is very helpful to the conversation. But you’re right, I don’t think we’d be presenting them with the final answer at that meeting.
MR. HOUSTON: My concern is it sort of goes back to the issue of being timely, first of all I don’t think this is black box, I mean the fact that these meetings are open, I mean you see Dan here and others here, I don’t think anybody is trying to be secretive about what’s being discussed here. I think that we’ve held a lot of open meetings and there have been a lot of discussions about this document and so I don’t think there’s an intention to be that way.
I think though to try to between now and June try to go through another round of hearings and the like I think simply delays trying to get something out the door and my fear is, again, because of the fact that these groups are already, these contractors are already going out and developing privacy forums themselves I think there’s a real fear that I have that what could be very timely information, that could be very useful in setting the tone and the dialogue will simply be too late in coming and that people will have already gone down the road and have tried to establish their privacy framework and this will simply be okay, fine —
MR. ROTHSTEIN: I’m going to ask Simon to take the last word on this and then to move the agenda.
DR. COHN: I guess we need to move the agenda. John Paul, you’ve gone back to that a number of times, I don’t think anybody is arguing for moving beyond June, I’m actually talking about putting this in between now and June and I guess I’m struggling with why this wouldn’t move us back as to opposed to move us forward and maybe get some of this information publicized and out onto the street earlier then we might already have done it.
MR. HOUSTON: My only fear I guess is twofold, is do we have time before June to insert something in in a way that if we did find something of great value that came out of the hearing how do we, I guess we just simply have to be very diligent about trying to incorporate it. That’s my only thought is I think we’ve really tried to have an informed dialogue and get testimony to come up with something, to come up with the questions and the recommendations and make them meaningful. I guess I’m just sort of overlaying my, not bias but my opinion as to what’s going to come out of all of this.
MR. ROTHSTEIN: Okay, thank you, to be continued.
If I may I’d like to ask you to turn to page seven and I want to give you a little bit of background before we get into the actual language, just so everyone is brought up to where we are because we starting in the middle of Section B. The paragraph that begins there are various we have not approved, we have approved the language prior to that. Now let me just run through, not the text of B but the recommendations that track Section B, so we have said if you look in the draft recommendations, the method by which personal health information is stored should be left to health care providers. We said that individuals should have the right to decide whether they want to have their records accessible via the NHIN.
I don’t want to debate the language of the draft recommendations but when I wrote this I didn’t want to put NCVHS takes no position on the following issue, I put it in the way that HHS should decide blah, blah, blah, I’m now on number three. So we’re saying HHS should decide whether to have an opt in or opt out. Then we say under either opt in or opt out HHS should require that individuals are given enough information to make the decision. And number five we say that HHS should decide whether the same rules regarding privacy and confidentiality should also apply to EHRs. We also say then that HHS should decide whether individuals should have the right to control content such as by deleting or blocking. We further say in the letter number seven, if individuals are given a right to control their records the rights should be limited such as by being based on the age of the information, blah, blah, blah.
Okay, that is the flow of Section B thus far. Now when we get to the paragraph that begins on seven there are various ways in which patient rights to revise health records could be limited. So we are not saying that this is what we think they ought to be, we are saying first of all that HHS has to decide whether to limit them, an issue over which we’ve had much discussion as you all know, but if they do then these are some of the ways to do that. So by agreeing with this language you’re not buying necessarily the result, okay, so that’s my little bit of background to the there are various.
DR. TANG: Is this helpful to them?
MR. ROTHSTEIN: What?
DR. TANG: Is this helpful?
MR. ROTHSTEIN: To the Secretary? Well, I’m guess you think that it might not be helpful.
DR. TANG: Well, if you say you should make a bunch of decisions, like all the hard questions, opt in, opt out, control, is this advice or not? I don’t know —
MR. ROTHSTEIN: Well, let me give you an example of the kind of thing that I think would be valuable, let me go to, I’m blocking on the number but I’m saying, I’ll find it. You’ve got two choices, whether you want to allow people to have some control over their records, you could say yes or you could say no, okay, and we’re saying in the letter but if you go for yes we don’t think you should be able, patients should be able to control anything. If they have control it should be limited and for reasons that we’ve put in the letter, I think on page six, giving them too much control would undermine effective care, etc., etc., etc., and that it should be limited to certain things like really old things or maybe psychiatric records or some other classification. And that is what there are various ways paragraph is supposed to indicate. The last sentence in the preceding paragraph, for these reasons if patients are given the right to control their records the rights should be limited. So we’re trying to in the there are various put some meat on that and give some illustrations of how that might be done. And you don’t think that’s helpful?
DR. TANG: Well, see if you’ve got all these conditions, if you then do the math, so what you’re saying is they should either have no, I suggested a word alter instead of control, I’m still trying to get really concrete, we said they should have no rights to alter their record, I mean don’t go yes or no but if yes then do this, just go from here to here, you see what I’m saying? Instead of saying you could go to, what we’re actually saying never go in this part then just tell them —
MR. ROTHSTEIN: Well the reason I think —
DR. TANG: They should have either no or limited versus saying no or yes and then if yes then no. It’s just trying to parse what you’re proposing a little —
MS. HORLICK: So you’re not saying that we should actually make the decision about whether or not they should have any control but you’re just saying —
DR. TANG: Tell the range instead of offering the big range and then saying but you can offer the big range because actually we were saving it, give them this range that you’re actually trying —
MR. ROTHSTEIN: See but I think we are not doing as effective a job if we did that because someone is going to say well you only gave them, you didn’t make the case for why people shouldn’t have absolute total control of their, or the rights to alter their records to use your term, in any way they want, it’s their records and I think we need to, I think making that bridge we’re really going to come out in the same place because the option that we’re presenting is the patient has no ability to do that or they have a limited ability, but I think first we have to say why we don’t think the right should be total.
DR. TANG: I’m just thinking that the recommendations would look a little bit more processed if we had a position and then justified the position —
MR. ROTHSTEIN: Well we don’t have a position.
DR. TANG: We have strongly recommended against this part, the unlimited, right?
MR. ROTHSTEIN: Well we say that.
DR. TANG: I know but —
MS. HORLICK: But we still don’t have a position on whether there should be no control or limited control, the only thing we’re really —
MR. ROTHSTEIN: That’s because we don’t have any agreement.
MR. HOUSTON: But we can do opt in versus opt out.
MR. ROTHSTEIN: That’s the same way we handled that.
MR. HOUSTON: And I’m not sure, I don’t personally have a problem with not having a position, I think what we’ve done is developed sort of a process by which to get to whatever the answer is. And I think frankly, again, if this is NHIN I guess there might be one answer but I know the different RHIOs in the different parts of the country are probably going to have different opinions as to certain issues such as opt in versus opt out, and the question is is what level of control should they have versus NHIN having a set position that has to be adhered to. I don’t have an opinion on that, I’m just throwing out the argument.
DR. TANG: I’m trying to think is there a different way to present, it’s possibly the same body but a different way to present recommendations, so how do you show that we’ve digested a lot of things and have come up either with an approach, that’s another way to present what we come up with is an approach, a way of thinking, control over what is access versus not, I’m not thinking this through, but an approach rather then you need to decide A or B, then you decide D and C, and then you decide, see what I’m saying? It looks like we’ve just drawn the map rather then given any kind of highlighted, given them a compass as well.
MR. ROTHSTEIN: I think we are highlighting the decision points that any regulator would have to reach, it would be nice if we had agreement, we don’t have agreement, and so the only thing that we actually do have agreement on is that last line in the first paragraph, if patients are given control or alteration rights it should be limited. We have agreement on that but we don’t have an agreement on whether they should have any rights.
DR. TANG: Is there a way that if you agree that they should have limited rights the following just all fall into line? So I only have to make one general strategic approach decision rather then all these bifurcations —
MS. HORLICK: You mean no rights or limited rights?
DR. TANG: Yeah, it’s either, I had to describe it as no rights but making it not alterable versus giving some limited control, and then the path is clear, it’d be nice to have a bifurcation where after you make a major approach decision you have a clear path, you don’t think it’s possible —
MR. ROTHSTEIN: No, and not just for semantic or logical reasons but also for political reasons because we are the Subcommittee on Privacy and Confidentiality and if we are going to reject or not endorse what some privacy advocates would say is the most privacy favoring position, which is it’s the patient’s record, they should, an EHR is basically a PHR, we need to I think make the case why we’re not, why we’re saying we don’t endorse that. And also make the case as to what we have in mind if a limited right is given to patients. So I would not like to restrict the range of options that we’re giving the Secretary even though I think we’re not actually disagreeing about the merits. Simon?
DR. COHN: I guess I’m sort of hearing what Paul is asking and I think it almost may be handled by us putting appropriate sub-headers to begin to clarify decisions points and lines of thinking, well, this doesn’t make any sense separately so I think it’s useful for us to look at, but having this out like this you’re right, I mean I’m convinced looking at this that it somehow likely will need to be put into various sections or various parts —
MR. ROTHSTEIN: We have not decided that issue and the cover memo notes that, right?
DR. COHN: But I think this is part of the problem and I guess even as I look at the document it needs ways to help guide that.
MR. REYNOLDS: This paragraph sitting where it is, if you moved this paragraph two paragraphs down, there are various, where we started, if you’re reading the flow you’re kind of giving a story about what we heard and the next paragraph after the one we’re talking about says it’s complicated and the next one says you’d have to flag it if you did it, this one to me is almost a summary paragraph where if we’re going to take a stand we ought to take a stand, this there are various ways. In other words, so the other thing talk about it’s complicated, talk about everything else, if that was moved down and then we decided if we’re going to say, so if the recommendation is, back to playing off Paul’s thing, we said in our recommendation HHS is going to have to pick whether you’re going to let, but once you pick it you’re going to have to make it very clear using such things as this and you’re going to have to then, then we say in this one, we talk about flag, whether or not if you’re going to let it then we think it should be flagged. So that paragraph moved down to me let’s you tell the whole story and then maybe hit it a little harder.
MR. ROTHSTEIN: Does that help you, Paul?
DR. TANG: Well here’s an introductory sentence, I think we’re feeling the same thing, so I’d introduce this paragraph with a compromise option would grant patients limited control over the release of their information on the NHIN, there are various ways. And what that stating is what he said which is we’re now ready to give you sort of a recommendation but you need to hear this compromise —
MR. REYNOLDS: I think we need to let them hear these two paragraphs then start saying it.
MS. GREENBERG: I see where you’re going but I question whether this really works in the sense that, what you’re talking about is control over the content of their records, right?
MR. ROTHSTEIN: Right.
MS. GREENBERG: So I think you’ve got to be clear about that because there are other types of control like control over who has access and so I think this is, it’s not even exactly clear what you’re talking about here so I think what you’re really talking about is control over the content of the record that, what, that goes anywhere or if it even stays in —
DR. TANG: The way I phrase it was limited control over the release of their information on the NHIN.
MS. GREENBERG: Whether it’s in the record on the NHIN or whether it’s released from the record on the NHIN —
MR. ROTHSTEIN: That’s actually an issue that we’ve already agreed on and the agreement was reflected in draft recommendation five HHS should decide whether the same rules regarding privacy and confidentiality of health information applicable to disclosure by the NHIN should also apply —
DR. TANG: We decided not to decide?
MR. ROTHSTEIN: That’s correct, we did not have agreement on that.
DR. TANG: John and I did.
MR. ROTHSTEIN: Well, yes, and Harry and I, so it was —
MS. GREENBERG: So we’re talking here about content and release?
MR. ROTHSTEIN: Let me go back to, see we’re picking up the idea in the middle and that I think has hurt us —
DR. COHN: Could I just stop on that last, I just am confused, can you explain to me what the decision was on five and the fact that we, I mean what the various, I mean you and Harry supported what versus you and John supported, I’m sorry, because I made a notion here about access, too.
MR. ROTHSTEIN: The issue was whether the rules that we are developing and the recommendations in this report should be exclusively concerned with information moving, anything, in the NHIN. Or, whether it should include both stuff that’s in the NHIN moving from place to place and in what we call the EHR, maybe I’m describing, I’m trying to do the best —
— [Multiple speakers.] —
MR. HOUSTON: The provider based EHR —
MR. ROTHSTEIN: And whether individuals should have rights vis-à-vis stuff that even doesn’t move in the NHIN, that just resides, I mean they could opt out of the NHIN.
DR. COHN: I’m just talking about access —
DR. TANG: If there is, if you want to propose that you either delete or block access to something across the NHIN should the patient also be able to block or delete access within the provider’s EHR? That was the question, is that correct?
MR. HOUSTON: The varying positions are, I think Paul and I believe absolutely not, I mean the provider EHR is very direct and related to specific care to the patient and we cannot afford from a liability and a patient care perspective say patients should be able to go in there and remove information or block information or in any way limit information because again, this is within the facility —
DR. COHN: How did that ever get to be a conversation with this —
MS. HORLICK: I’m confused about what we were talking about as we went through all these issues, were we talking about the NHIN or on the provider’s record, and we kept going back and forth.
DR. COHN: And I apologize, I must have either zoned out or probably been at another meeting, so basically there was, I guess I have always perceived of this, we were talking about the NHIN, we weren’t talking about local provider’s personal health records and that wasn’t even part of the conversation. Then I thought what we were just now talking about was access through the NHIN to a provider’s PHR that, and then the question gets to be gee, does the patient have the opportunity at that distant space to block some of the information going, and it appears there was a whole different conversation in response —
MR. ROTHSTEIN: Okay, but the other view is that we don’t know what the NHIN is and distinctions between the EHR and the NHIN may go away somehow but the privacy issues are the same and what we are talking about in many respect in this document is a new federal privacy initiative and it would be I think, not to rehash the same arguments, it would be inadequate protection of privacy and confidentiality to only focus on health information as its moving and not as it is on either side.
MR. HOUSTON: That’s the counter —
MR. REYNOLDS: I think John you took a little bit of license on what we were talking about because I think when you said remove, now, blocking and then we talk about whether —
MR. HOUSTON: You’re right.
MR. REYNOLDS: So if you pull removing out of your discussion that’s where I was in that discussion —
DR. COHN: As opposed to blocking.
MR. REYNOLDS: Blocking is a whole separate situation because the current privacy, I know I have never stood up for somebody being able to go into a doctor’s record, which is your EHR and remove something —
MR. ROTHSTEIN: So there are lots of different views and that’s why we didn’t take a position on it. Marjorie?
MS. GREENBERG: Here on page six you start off there are three main arguments raised to support the view that patients should have no right to control the content of their health records.
MR. ROTHSTEIN: Right.
MS. GREENBERG: Next paragraph. The NCVHS heard two main arguments in favor of giving patients the right to control access to the contents of their health records, so have you left the subject of content now and are you only talking about access to the content? Or are we still on the same subject here?
MR. ROTHSTEIN: We’re controlling, this is not worded ideally, I would be in favor of, there was a version of this that did not have the word access in it and then access was put in but I think —
MS. GREENBERG: I mean I think you have to deal clearly with content and then with access.
MR. ROTHSTEIN: We are talking about content.
MS. GREENBERG: Okay, so this access doesn’t really belong here —
MR. ROTHSTEIN: That’s correct.
MS. GREENBERG: Which is what had me confused, then you talk about supporters of patient control, again, I think you need to say over the content here of the health records, also —
MR. ROTHSTEIN: Right.
MS. GREENBERG: So that was one of my problems.
MR. ROTHSTEIN: Yes, okay, I’m with you.
MS. GREENBERG: And then for these reasons if patients are given the right to control their records, so again now you’re talking about the content of their records, the rights should be limited.
MR. ROTHSTEIN: Correct.
MS. GREENBERG: Well, how does it really work if the right is limited? I can see that if it’s only like for time limited that could be a limit but when you start talking about on the nature of the condition or treatment what are you going to say, we’re only going to give you each one treatment? One nature of condition? Or everything has to do with the nature of your condition or your treatment, so I mean really think about it —
MR. ROTHSTEIN: What we meant by this was alcohol and drug abuse —
MS. GREENBERG: Only certain conditions.
MR. ROTHSTEIN: Psychiatric, certain delineated conditions.
MS. GREENBERG: For everybody it will only be certain conditions.
MR. ROTHSTEIN: Correct. That’s one way of doing it, this is only —
MS. GREENBERG: But we know that what’s sensitive to one person is maybe not to someone else.
MR. HOUSTON: Can we go back now to the paragraph that we started on because I think it’s meaningful? The very last sentence here, there are various ways, the last sentence, in developing a strategy for deciding what types of information patients should be permitted to control it is important to consult with, you said patient advocates, I would add health care providers and patient advocates, including those representing culturally diverse populations. I think the point of this, that closure on that paragraph sort of says there’s got to be an informed discussion, if there’s going to be some patient control there’s got to be a process to decide what that is.
MR. ROTHSTEIN: That was the thinking that —
MS. GREENBERG: You would have to have consensus that these are the conditions or these are the treatments that you can control and you can’t control any others. Right?
MR. ROTHSTEIN: Yes, I think that is the compromise position.
DR. COHN: Can I ask a question? And I guess I’m taking of the, we’re talking about the issue of revision to information now as opposed to access, revising information, altering, okay. And I guess I’m confused about we’re talking about access or control —
MR. ROTHSTEIN: No it wouldn’t, some people are uncomfortable with altering —
DR. COHN: Can I make a comment then? And this is based on, I’d have you sort of maybe go back and review the PHR report that we spent so much time working on and we actually went over the sort of issue of well in what space does this area of people being able to alter their provider’s record live, and at least my memory from that report was that we said remember there’s dimensions in this NHIN of data, it isn’t just the personal, it isn’t just the provider health record, it’s also potentially the personal health record. And I think we all said in the personal health record that patients had considerable latitude to be able to revise. Now all of that may exist on the NHIN and so the issue of deleting and modifying and revising content, I mean if what you think about is if you’re thinking about the provider can make, the patient could make available things that were on the personal health record, they could block access to things from their provider health record, it would become clear to the person getting the information exactly what was done but this doesn’t get into the issue of revising information from the provider health record which is illegal, at least as I last heard —
— [Multiple speakers.] —
MR. HOUSTON: Let me suggest this, I agree with you, Simon, as we walked through this process honestly I really hadn’t even thought about the personal health record dimension of this and I think it’s probably important as part of this letter to describe the bounds of what we’re talking here because I don’t think there was a lot of thought about including the personal health record as a part of this discussion. Either we’ve got to say as part of this letter I think based upon what you just said either that our consideration of this discussion of the medical record that is created and established by providers, we can say that the personal health record, one which is developed by the patient individual, that’s out of scope of our discussions and that the provider side stuff is in scope and then refers to what you said which was our recommendations on the PHR. I think that helps scope it because I don’t think anybody ever intended that this encompass the patient developed component of a record.
MS. GREENBERG: This is an interesting option actually, that what the person could put on the NHIN would be their personal health record as they have amended, it would be their personal health record. They have taken into it everything that their provider would give them and then they’ve edited it. I don’t know whether any clinician really wants to see something like this.
MR. ROTHSTEIN: Let’s think of the value of that, okay? So if I have a, and we discuss this in this letter, if I have a PHR that I’ve massaged into any shape that I want and that’s the only thing that’s disclosed to a physician they’re going to consider that garbage and they’re going to start from scratch to develop their own health record and that totally undermines the whole purpose of the NHIN and we make that statement in this letter.
MR. HOUSTON: I don’t disagree, I’m responding to what I think Simon discussed which is a reasonable, a good comment, which is we really never scoped though our discussion here, we really don’t talk about the fact that there is this concept of the PHR that we’ve already made, we’ve already made recommendations regarding, and that really is intended to be —
MR. ROTHSTEIN: I’m happy to add that, I’m not happy to add that, Harry?
MR. REYNOLDS: No, I’m not happy. There is still no clear definition in this country of where these things start and where they stop, and I will tell you it’s subtle. Let’s take a large university health system, the patient may live within there, more and more of them will be offering a personal health record as part of what they’re doing, so there is no definition. And so clearly some people call something an EHR, some people call something an EMR, somebody calls it a PHR, somebody calls it an NHIN record. I mean so all I’m saying is that I have a problem, if we’re not real focused, we’re talking about moving this data around, some the patient has got complete control over, some it belongs, Paul has said this, I totally agree with Paul, the doctor’s record belongs to the doctor. Now I continue to hear around the table that some of us are in agreement that they should never change that record, they should never delete from that record, if they are given the right to block from that record it is clearly sent with the record that they blocked something. So I know we keep going back, there has not, Mark, I don’t think you have either, we have not discussed letting somebody go into a doctor’s record and change it —
— [Multiple speakers.] —
DR. COHN: Well I guess I was reading this paragraph as content, am I wrong about that?
MR. ROTHSTEIN: I’m sorry?
DR. COHN: I was reading this paragraph on page seven as issues revising content, there are various ways in which patient rights to revise health records could be limited.
MR. ROTHSTEIN: Well, you’re reading the word revised as to sort of scratch out and write new stuff in, we are using it in the sense of to block or otherwise control —
DR. COHN: Because Marjorie was going off on revising content —
MS. HORLICK: We had this discussion at the last meeting and actually I raised, on the last paragraph on five we have a sentence, the last paragraph on page five I said are we talking about access or content and we had this discussion last time because we did talk about control based access and all of those things, can the patient control who has access to the record but we also talked about content, assuming this isn’t the personal record now but just let’s say I have all these records can I, if I have some choice about electing to participate in the NHIN can I say okay I don’t want any of my psychiatric records on there or whatever. So that’s control —
DR. COHN: That’s access.
MS. HORLICK: Well, it’s not a block if they’re not on there to begin with, I picture a block that people, if they’re there but people can’t access them but if I elect not to have that provider put them there, if that’s a possibility, then that to me is not a block, it’s controlling the content because —
MR. ROTHSTEIN: See the reason it gets so confusing is because we also talk about controlling access, so in other words my psychiatric information might be available to my psychiatrist but not to other, so is that content or is that access?
MS. HORLICK: Well if everything is there then it appears to be access control, if the only way to be in the NHIN is everything is there then it’s access control, only my psychiatrist can get it or something like that. But if there’s a choice before that point about anything older then ten years or 20 years or anything psychiatric or I have some choice then to me it’s not really an access issue because that content, it’s a content issue.
MR. ROTHSTEIN: Right, I mean it is both. Harry?
MR. REYNOLDS: Let me play off Gail’s word there, the whole argument, discussion we were having earlier, I would say to you, we’ll use Paul’s institution’s records. Paul’s institution’s records are not going to be moved there to reside somewhere else, they’re going to remain in your environment. If I want my record, if I come and see you and I want people to be able to get my information on the NHIN yours stays there, they come there. So it’s not like I’m moving your record and changing it. However, so access says they can come to you —
MS. GREENBERG: Aren’t there some models where they might be —
MR. REYNOLDS: Yeah, but the whole point, that’s part of what Simon and I were talking about earlier, until we get a sense of what, we’re writing a privacy against something that we’re using as the word there but there isn’t clear. So back to my earlier point, so one, I want to control access to who can go get that record from Paul, and second the discussion is whether or not I want to be able to block pieces of that from moving and have it clearly stated, so that’s the deal here. The problem with, and so I agree with you, so the word there immediately throws us 14 ways because there is not clear. If you told me that this was a central database and everybody had access my mind immediately clicks into a box —
MS. HORLICK: And actually the presentation I saw had permutations of —
DR. COHN: And the problem is it exists, I mean Part B talks about that but the comment I made last night to you well geez, maybe it’s a different architecture, maybe it’s the dialogue that you’re describing, and so we probably need, I mean there’s probably permutations but the issue has become a little different depending on the —
MR. REYNOLDS: But I think in every permutation that I know, I have been dealing with, I am not in favor of anybody being able to change that data at rest that belongs to that institution, whether or not they send a block line, an example I used was I told you the system that was set up in North Carolina by the doctor that if you brought the information it showed that a section of your record was blocked or if somebody touched it you got an email saying they touched it, those kind of things. So I want to go on record that I am not, I mean you and I have agreed on things but it’s not been that somebody goes in and changes those records —
MR. ROTHSTEIN: Correct, and I’ve never advocated that —
MR. REYNOLDS: No, I’m saying, but the way it’s being kind of drawn up here, that’s not where we are, we’re talking about —
MR. ROTHSTEIN: You and I don’t agree entirely but we’re certainly not the position that we’ve been alleged to have.
MR. REYNOLDS: We do agree that we’re not going —
— [Laughter.] —
DR. TANG: Well, I certainly have heard that message and that’s where John and I think really, I mean on the call, if I hear you correctly I think what you’re suggesting is illegal at least in the State of California, I looked it up on the web —
MR. HOUSTON: You’re right.
DR. TANG: And so we clearly had that message —
MR. ROTHSTEIN: As I pointed out on the call I don’t care what California law is because we are trying to make recommendations regarding federal law that may well have preemptive effect on California law. So that is one of the options that we have a right to consider, so we are not being, I think it’s ill advised to consider the law in any state as sort of restricting the range of things we want to think about.
DR. TANG: But then I went and looked, I quoted from AHIMA, the medical records professionals, and it is clear in their code of conduct they do not allow that, you can strike out, in fact it says, strike out initial, never delete, the word was —
MR. ROTHSTEIN: But these wonderful people could change that tomorrow on the basis of some, I mean —
MS. HORLICK: And even with the example that you gave of, let’s say I go to your institution for ten years now so either somebody has, depending on how the architecture is could that all be involved with the NHIN and yet my psychiatric records from ten years before that in another state could still not be involved, I mean there’s still some patient, could be some patient control that wouldn’t interfere with what you’re saying —
DR. TANG: Yeah, that’s access.
MS. HORLICK: So I think it’s just, we’re having a hard time spelling it out and making it —
DR. COHN: Can I ask a question? And this is, let me start with recommendation six to make sure I understand it because I had read it, recommendation six, in the same way that I read that paragraph. So what we’re really talking about is HHS should decide whether individuals should have the right to control access to the contents of their health record —
MR. ROTHSTEIN: No, because —
DR. COHN: Oh, we’re talking about content now —
MR. ROTHSTEIN: Because some people would say you have a right to, should have a right to delete certain things.
MS. HORLICK: Well not include them, not delete. If you’re talking about the model where the records are all at Paul’s institution then I think it is should they have a right to control access to the contents because they’re all there, but if you’re talking about maybe not deleting but if I in fact have records elsewhere that were before I got to Paul’s institution do I have the right to not include those and what is accessible through the NHIN, has nothing —
DR. COHN: So we’re not talking about access then, I just wanted to keep access and modifying content to be, to my mind they’re sort of separate things.
MS. HORLICK: The way where I see it’s content is if I have most of my records at Paul’s and some records somewhere else and I decide whatever way not to include or not to provide —
DR. COHN: You’re not modifying the content of those records.
MS. HORLICK: Of either one of them but I might be modifying what is available to someone through —
DR. COHN: That’s access, that’s access, so am I taking that to understand that most of the conversation here is around access issues? Am I mistaken about that one?
MR. REYNOLDS: No, I don’t think it is.
MS. HORLICK: I think it is about access in the way we’ve defined it but I also would see that in terms of if I were the patient having some control over the content because even though my psychiatrist would have, I wouldn’t be picking and choosing from that, I would be in some way controlling the content of what is available to anyone through —
DR. COHN: I keep hearing it being an access issue because you aren’t deleting the psychiatrist record at their home site, you’re basically just limiting access to another physician.
MS. GREENBERG: Or you’re not putting it at all on the NHIN.
DR. COHN: But let’s try to make, I guess I’m having —
— [Multiple speakers.] —
MR. ROTHSTEIN: We’ve done this already 100 times, it gets so complicated we decided not to include it.
MS. WATTENBERG: We heard testimony from people saying they wanted to be able to strike things from the record —
MR. HOUSTON: Well hold on, let me just say this, and again, I probably sound like a broken record, but the privacy rule today discusses a mechanism by which a patient can go and request an amendment to the record which may include the provider deciding that the information was wrong and that it should be removed from the record. I think, going back to Simon’s point, I think that the integrity of the record when it’s in the provider’s hands should be fully within the provider’s responsibility and if there’s something wrong HIPAA says you got to change it. But I think that really the issue then comes down to access, how does information, how should, what type of control should be in place that govern the control of information as it leaves the door of the provider. I think before that time the provider, I feel very strongly the provider has got to have absolute rights over that data, it’s the custodian of that data, within his walls, and the only time that that should be changed should be when, again, pursuant to HIPAA, if there’s something wrong in that record —
MR. REYNOLDS: I agree, nobody disagrees.
— [Multiple speakers.] —
DR. COHN: That’s what John Paul just said.
MS. WATTENBERG: The only point I was making is that we go back and forth between this issue of are we just giving what we think or are we also trying to capture the testimony that we heard.
DR. COHN: I think we’re making recommendations.-
MR. REYNOLDS: I think we’re trying to do both.
MS. WATTENBERG: Right, so that was my only point about this —
MR. ROTHSTEIN: Can I ask you what you’re driving at?
MS. WATTENBERG: This issue of when they were talking about —
DR. COHN: Revised health records?
MS. WATTENBERG: Yeah, right, is that we’re going back and forth between what we think is right and sentences in here which are just trying to capture what people had testified on, so that was my only —
DR. COHN: And what I’m trying to do is to actually see if there’s more consensus then I thought walking in that may exist, so Mark, do you mind if I just ask a couple of questions, because I mean I’m hearing that we’re all talking past each other and we’re still trying to figure out what the words mean that we’re using, so what we’ve all said is I think that within a boundary to whatever, Mark would argue that what an EHR is and whether a provider, it’s a little bit vague, but I think we’re all saying that within that, whatever that space is, I can’t legally define it, the record exists, there are HIPAA rules for amending or clarifying, nobody is talking about deleting or making unavailable within that provider space, that record. So the real question becomes that issue of now as we move into the role of the NHIN, you’re someplace else, you’re requesting a record or requesting access, and the access issue, and the question is is are we saying by definition that everything that all providers have needs to be on the web, unblocked, unflagged, un whatever, fully accessible to anybody who wants it or whatever, or do patients have a right to block either at, where their chart was generated or —
MR. ROTHSTEIN: We’re not taking a position on that.
DR. COHN: Well, let me just, I’m just pushing it, I mean either at where the chart was generated, saying geez, I don’t want this accessible to anybody else, or on the other side where you’re dealing with the other physician and they’re saying geez, can I go on the NHIN and get information from you, presuming we’re allowing them to ask the patient or whatever, and them saying well yes you can get this and this but I don’t want you to get that and that. Or are we saying that by definition going onto that you have to have absolutely everything available? Now is there a consensus on whether the patient has some right to block at one side or the other what is being given to the physician?
MR. ROTHSTEIN: I don’t know.
MR. REYNOLDS: There’s not consensus, there are two different opinions.
MR. HOUSTON: No, I think there is one level of consensus I thought we achieved to is that we thought there is, I thought there was consensus that we believe that the right to block information was a limited right, that was all we spoke to and I think that’s really where we’re at which is that we think some blocking maybe reasonable but that it’d have to be limited and it would have to be decided in a very informed fashion as to what could be blocked.
MR. ROTHSTEIN: Which is I think reflected on page seven —
MS. HORLICK: Where you talk about either the time or the subject matter.
MR. ROTHSTEIN: Well, for these reasons the patients are given the right to control their records and whatever that means, the right should be limited. And then we made some attempts to give examples on what the limits would be.
DR. COHN: Okay, and I guess I was asking the more basic question is is that, I mean this is still left as if and whether HHS, whether individuals should have control of the access, was there any consensus that patients do have the right to do any sort of blocking on any, knowing that psychiatric records I understand under HIPAA need to be handled different, isn’t that correct? And drug abuse records?
— [Multiple speakers.] —
DR. COHN: I’m sorry, psychotherapy records, which are notes, and drug abuse records need to be handled separately, federal law, okay. I guess I’m just trying to figure out —
MR. HOUSTON: The thought was again was at the patient level that any rights to block, limit information would be limited and there was going, I think what we all agreed on that there is a core set of data for which we don’t believe should ever, if the patient is going to be in NHIN this data needs to be available because it is central to the treatment of the patient.
MR. ROTHSTEIN: Let me also set out for you a place where you may not feel comfortable going in terms of privacy but this is what is certainly in my mind, we’re all thinking about sharing of medical information among providers, okay, part of this document and a lot of what I am worried about is that a third party with economic leverage over you can make you sign an authorization to disclose everything in the files and if it’s not blocked or somehow deleted, restricted, whatever, at the home site then everything goes out. And it’s not, it doesn’t necessarily even involve the NHIN, okay, we have that problem today with paper records that where everything goes out. And I’m not asking you to agree with whatever I’m saying, all I’m saying is this other dimension of the use of the records is driving a lot of my concern about not drawing distinctions between what’s within the four walls of an institution versus what’s accessible via this unknown NHIN, and that’s, I mean I’m just giving you background, you don’t have to sign on to that.
MR. REYNOLDS: But part of the reason for going there is not knowing anything about the structure of what we’re about to enter into, what is NHIN, what does it look like, who gets it, who doesn’t get it, can you just sign on, can you sign up somewhere, let’s take an example I used the other day, life insurance company, life insurance company when you sign up for life insurance right now you say you can get my doctor’s records. Well, as you just see IBM and National Geographic are going together and doing a lot of genetic testing and this genetic testing is going all over the place right now with everything that’s going on. Would I want that life insurance company to have access to my genetics test? I mean we talked about the things that are under the HIPAA law but there are other things out there that are like hand grenades, that are sitting out there. So is that something that maybe HHS ought to decide that if somebody, if genetic testing is sitting out there somewhere that’s not something that, that’s routinely blocked when it goes out over the NHIN. So until we have a much better, clearer look, that’s why we’re having this discussion on the fact that this blocking is being discussed. And where I was kind of shaking my head a few times, access is a big word, access says do I get the door and then what can I see, so access has multi-layers, so where I was hesitating to go all the way with you guys on access, access says to me when I get home I can sign on to my system, but then I got another password to get into certain points of it. So those are both access but the second one is content because I’m getting into certain things, I’m able to access Blue Cross but I’m only able to get into certain things and within there there’s certain information, so the only way to do that as to what we’re talking about is possibly this idea of being to block some information. That’s why I can’t go all the way to just call it an access situation, it’s a concept situation, that’s where I was going.
DR. COHN: And maybe I’m sort of following along with you and I guess once again I’m maybe, I don’t know whether I’m being simple minded or whatever but, and once again obviously this issue of the great database in the sky is, I mean that’s really what Part B is about, I mean if we’re talking about a networked environment where Paul has his data and there’s a request for the data, request to see the data, are we positing that the patient, and once again I apologize, I get a little confused because the opt in and opt out doesn’t really apply very well in this circumstance because you would assume that Paul would have the capability to network in and wouldn’t really be asking the patient whether they’re on the network or not, I mean God knows if I’m Paul’s patient and I’m in the emergency room somewhere a thousand miles away I would not want to have to make the decision to be on or off the net before that happens, I’d want to in those circumstances authorize that emergency room to get needed data from Paul’s shop. But as I say that are we, is there anyplace in here that talks about, I mean I don’t know whether that’s consent or are we perceiving a, well, I guess I didn’t see that in D very well, I couldn’t figure out where it was, I mean is that sort of something else we agree with that in the world of the NHIN when you move beyond the provider boundaries if you’re grabbing other data from other providers the patient has to sort of authorize it at either forever or saying yes or whatever?
MR. HOUSTON: My understanding was that that was sort of part of the whole concept, either opt in versus opt out, there was a decision out of the patient at some point in time as to participate in the NHIN, it was not an episodic participation authorization but it was more of a global yeah I want to be part of this or I don’t want to be part of this —
DR. COHN: So once you opt in suddenly you’re in, everything is available —
MS. GREENBERG: But would you opt in by provider?
MR. REYNOLDS: Everything is where we’re stopping short.
DR. COHN: Okay, everything but things that you may want to block, I’m just sort of asking because I guess I’d always thought at the early days of this thing that you would be asking —
MR. ROTHSTEIN: On page five, the first full paragraph discusses that.
DR. COHN: Is this under opt in/opt out?
MR. ROTHSTEIN: No, it’s before you get to opt in/opt out.
DR. COHN: This is about the participation?
MR. ROTHSTEIN: Yeah.
DR. COHN: Okay, which I guess is to my mind if you’re talking about my being in Paul’s shop and Paul being wired into the NHIN, that no data residing out there —
MS. HORLICK: But we hadn’t really gotten to that that was a given.
DR. COHN: Well, I don’t know, I’m just sort of asking, then how does the term participation of the concept —
MR. REYNOLDS: Most of the time when you are recommended something you have something to recommend it against. There is no NHIN, we don’t know how, you’re laying in an emergency room somewhere, we don’t know what it is so we don’t know how you would give authorization and we don’t know how somebody would get on and what that means or doesn’t mean or what the limitations are or aren’t, so that’s the hard part, is when go try to say okay Paul is your doctor in California and you’re in the emergency room here, what do you do to say yes, then do some set up some password and does he have to put, does he have to know, how does it work —
DR. TANG: I’m not sure I understand why we need to know that, I think the word is do you want to make your data available via the NHIN and that’s all we have to know.
MS. HORLICK: Is this really written from the patient perspective of patient opting in or out or limiting their data, not the provider electing to go —
MS. GREENBERG: Unless the patient is getting all of his or her care through an organized system, which you could just either opt in or opt out, it does seem like this opt in or opt out option would have to be by provider in a sense. I mean otherwise how would they know?
DR. TANG: Then you would have, today’s situation is you sign an ROI, release of information, so if you go to Gail you say I want to pick up, you may access Harry’s records, and you sign that, Harry gets a copy of that and boom, the records go over, so in a sense that’s the default standard which is you opt in every time you want information —
MR. ROTHSTEIN: But that’s not the HIPAA rule —
MS. GREENBERG: I’m not talking about access really, I’m saying all right, you go to your dermatologist and you opt in, you say all of these records, I don’t want you to put any of them on or you can put them on. You go to this, and a lot of people that’s the way they see to have medical care now, they’re not in an organized system, they’re going to this one and that one, etc., so I’m not each time you give access to this person or not that person, you just say I opt in to this part of the NHIN or I opt out. Then there is another aspect of it that you got all these providers you’ve opted in or you didn’t opt out, however it works, then the question is even in that environment can you then also block certain information.
MR. ROTHSTEIN: And I think that’s the way we attempted to structure the letter, you’re in or you’re out and then if you’re in what controls do you have downstream. Harry was next and then Simon.
MR. REYNOLDS: I want to go back to something Sarah said earlier, we heard a lot of testimony and that testimony I thought was actually excellent and it went in lots of different directions. And the things that I always keep filtering everything I hear from is trust, adoption, what belongs to who, how can it work, the opt in/opt out, what does it mean, so I guess, some one of your earlier points is what are we really recommending and I think in some of these it is polarized in many ways, the reason that I’m comfortable putting down the two options in a lot of cases and not getting hysterically specific is you don’t have anything to match it against right now but on the other hand I think we have heard good honorable, what I think personally I’ve actually had to almost eliminate because we really, I mean this gets down to a real personal thing for a lot of people that are going to be in and out of this and dealing with a lot of elderly people, man, they ain’t going to have a clue whether they’re in, out, upside down or whatever, even if somebody tells them.
So I think a lot of what we’re doing is I’m comfortable personally what I would make as a recommendation but with the breadth of the testimony we heard and the breadth of the disparity in people’s beliefs I think, so I’m trying to frame everything, I’m framing around some specific beliefs like the EHR belongs to the provider and this and this and this is the way I’m looking at it. So as we make these recommendations I am trying to keep all that in mind and boy, it’s not an easy final answer.
DR. COHN: Well I guess once again this does get back to the architecture because I can buy a lot of the ways that this is structured in B if what we’re talking about is submitting data to a single database that exists, some sort of an uber database somewhere. The example that Marjorie just gave is not access to the NHIN, it has to do with given approval for access and it’s a one to one sort of connection where, I mean if you think about it it’s what exists today, it’s sort of like she goes to a doctor, he asks her for approval to go and get records from X, Y, and Z, they get it and they send it to them. And the same way that if Paul, if you’re talking about one of these networked environments where Paul potentially could have the data, the patient would come to me and I would get approval from the patient or he would get approval from the patient and the information electronically would be made accessible to me. And once again it’s a different way of thinking about it but none of that is opting in or opting out to the NHIN, it’s agreeing to a transaction.
MS. GREENBERG: No, I was talking about all of your records could be on, I’m not just —
DR. COHN: I heard what you’re saying but what I’m saying is is that, I mean we’re talking about different paradigms, I mean if something comes into a central database where it exists there forever and people can have access to it then the opt in/opt out makes perfect sense. But if it’s all being basically residented on Paul’s stuff except that he sends it using the NHIN to Marjorie’s doctor —
PARTICIPANT: That’s what we’re talking about —
DR. COHN: I’m not sure what we’re talking about here, I think it’s a very different paradigm.
MS. HORLICK: I think like from the presentation I saw they talked a lot about that like the master patient indicator, I think that’s where it’s a little different then I go to one doctor and say would you get the records from that doctor, whether or not this goes, they talked about go to this place and it pulls the record from all, I don’t think many people are talking about all the records, everybody’s being in this —
MR. ROTHSTEIN: May I just add something of a general note? We’ve been on this now for an hour and 45 minutes, we’ve spent many previous hours debating I think largely the same issues, and we all recognize that there is widespread consensus on some things but widespread disagreement on other things. And I think we have to recognize that we are never going to get a letter that is to everyone’s liking as to every word, paragraph and recommendation. And keep in mind we’re just talking about the subcommittee, we haven’t even thought about what’s going to sell to the whole committee. So I think as an approach I would really suggest that we not make the perfect the enemy of the good, we’ve got a lot of good stuff in here that we all agree to in C, D, E, and F, and we all know that B is very contentious, we’re not making any positive, you must do this, we’re trying to give a range of options, some decision points for the architecture folks, for ONC, for the Secretary, for whomever. So my request, plea, would be that to try to work with us to get, if there’s something in there that you think is just totally wrong, you can’t live with, it is just missing the point, hey, that’s why we’re meeting. But we’re not going to get anywhere by revisiting all these issues that we’ve been talking about for months. Paul?
DR. TANG: I agree with your point about we’re rehashing from the same principle, so I guess I’m still stuck with how would I, in whatever roles we have if somebody came up and said I have 44 decisions for you to make, I’ve done my homework and here are the 44 decisions you have to make, I don’t feel well served. As an alternative instead of going at it with the same way the breakthrough I would look for is a different way of actually looking at the problem and really striving to search for that breakthrough. So one example, John used a phrase, provider created and maintained, or patient created and maintained, that was very descriptive to me. So what if we were to consider instead of 44 decisions four buckets and try to make policy decisions on four buckets, let me just throw something out. So we have things that are sourced, created and maintained by the patient, and things that are sourced, or created and maintained by the provider, those are two buckets. Now there’s two states for those two data, two types of data, one is it has been read and used in decision making and one is it hasn’t. So as a thing that’s on the table, if a provider creates something and uses it to make a decision he can’t touch it, there ain’t no way to touch it. If a patient creates it and the provider has not used it for a decision the patient can do anything he or she wants to do —
MR. HOUSTON: Absolute control.
DR. TANG: Absolute control. If the patient has created it and the provider has used it I’m afraid this has to look different, if they’re going to change anything it’s going to have to look different —
MR. HOUSTON: Well, no, it has to be if the patient has created it and the provider has relied on specific information to deliver care, that portion of the information for which the provider relied on falls in the bucket of —
DR. TANG: Correct, correct —
MS. GREENBERG: — into the provider’s record if the patient allowed that.
DR. TANG: So let me, for right now those are four cells and I’ve got four colors, and as long as you tell me what color that data point is then let’s make a policy decision on that color. I’m just looking for a breakthrough —
MR. ROTHSTEIN: Well, I don’t buy your premise. I don’t buy the premise that, first of all I don’t really care about patient generated records, okay? Because they have limited utility in clinical setting because you don’t know what’s in them, who created them, their value is just for doctors, so I only care about the records that were created and maintained or used, however you phrased it, in the health care institutions —
DR. TANG: By?
MR. ROTHSTEIN: By doctors. I’m not willing to agree to your premise that if a doctor created some information and used some information that means that automatically the patient, I don’t even know what you mean by this term, can’t touch it —
DR. TANG: That’s what my taxonomy up there is, on the left is EHR content and that is the doctor stuff, the operations that, let’s use those, here’s a proposal, that’s what those three words mean. Add, you sit up, pick up your pen, write another added word, add something to the record. Amend means you pick up your pen and you strike out something, authenticate it, and put whatever else you want. Delete means it disappears off the face of the planet. So when I say not touch the patient is allowed to request the top two, add or amend, and the doctor may or may not, because it’s the doctor’s EHR content, honor that request.
MR. ROTHSTEIN: Okay that’s something that I do not agree with. I wouldn’t, there are certain things in people’s medical records that are 25 years old that have no current or future clinical relevance and that should not be disclosable to every employer, future insurer or any third party who can require that you sign an authorization as a condition of getting a mortgage or a job or insurance or anything else.
DR. TANG: Let me just bring up an example just from last night, you’re reviewing a chart, there’s calcified nodules in the right lower lung of this patient. The thing I needed to know is where she lived, has she ever worked in a sanitarium, has she ever had TB, I mean there are lots of things that would be very relevant from over 25 years ago —
MR. ROTHSTEIN: I didn’t say 25 years you have that, I’m saying that might be an example of the kind of, and we heard several examples discussed in our hearings such as a domestic violence incident in which there was a minor abrasion and yet there is —
MR. HOUSTON: How do you decide?
MR. ROTHSTEIN: The point is that I think if an individual is truly autonomous they ought to have a right to control within certain parameters information that they are willing to not disclose to anyone else.
MR. HOUSTON: Let me just say this and I heard your argument about the minor abrasion and the domestic issue. I hear Paul talking about a totally different set of circumstances, that patient may not even remember or may not remember something from 25 years ago that if Paul is able to simply call it up and say oh, here’s the missing piece of the puzzle that I didn’t know about. And again, I’m just concerned that we don’t —
— [Multiple speakers.] —
MR. HOUSTON: Let me make one closing statement here and I think it’s important, my position on privacy always is I would much rather explain to a patient why we provided too much access to information then to have to explain to the patient’s family why the patient died because we didn’t have access to something that was actually relevant and meaningful that had we had it we would have had a better outcome.
MR. ROTHSTEIN: Okay, my point is simply this is not the magic bucket, we’re back where we were before.
DR. COHN: Let me make first a comment, I mean like Mark I’m sure you’re really frustrated —
MR. ROTHSTEIN: Trying not to show it.
— [Laughter.] —
DR. COHN: First of all, let me move up a step here. There are many good things, Mark, as you commented that are very good in this document and I think as you move to the next page and as I look at recommendations eight and down I would hate to see this whole thing being held hostage to B because we’re arguing about B. Similarly I think what we’ve, and so I want to just make that comment, I think our context based and role based discussion is I think a brilliant addition and something that really needs to be brought forward as well as education and all that, so we just need to keep this in mind as we argue about this. Now having said that I have lived, I mean I’ve been on this committee not quite as long as Marjorie but my observation usually is that when you get into discussions, and I’m speaking of other committees, subcommittees that I’ve been on, where there’s been this much conflict about things that it needs to be brought up a notch —
MR. ROTHSTEIN: The level of abstraction.
DR. COHN: The level of abstraction needs to be brought up a notch and what I think we’ve come upon, and let me just describe this a little differently maybe then Mark has, we’ve come upon a variety of sort of very problematic public policy issues and that’s what these are and we are arguing among ourselves almost even how to conceptualize them though in good faith and we are basically arguing among ourselves even really how to describe these issues, though it is important that we come to some sort of agreement about even what the issues are since we seem to be going like this but we need to focus on that. But having said that we have not come up with the public policy solution which is why we have four or five things here where we don’t have really any particular advice to give HHS.
Now when I see that I see that there are eight public policy issues and at least as we’ve described it we don’t have the answer. So I would say is is that somehow between now and June and maybe even now we need to look not at HHS should decide but more along the lines of well if we can’t decide what should we think that HHS can decide, and so let’s recommend something that they can do to move them closer to a decision or at least have data upon which, it may be research, it may be demonstration projects, it may be pilot projects, it may be evaluations of X, Y, and Z, but let’s think about the things that we can recommend to HHS that sounds like an action agenda, so it actually isn’t well I knew I had to decide this before —
MR. ROTHSTEIN: Simon, let me just respond to that and then, I think, no you make a very good point in terms of if we can get, we’ve talked about this, more action items or we need to research this or whatever, whatever, fine. But I think by saying that we are not really giving the Secretary very much —
DR. COHN: In these first items.
MR. ROTHSTEIN: No, no, in the ones where we don’t take a position, I think you’re overestimating the quality of analysis that people out there are using when they look at privacy within the NHIN or anything else, I think many of the people who are looking at these issues, and I don’t want to sort of slander a whole group of people, but just from my experience from the people that I’ve talked to, they don’t even understand what the decision points are and so to the extent that we can raise issues I think is very valuable. I mean when the HIPAA privacy rule was adopted and revised, should it be notice or should there be consent and we’re still fighting about those issues but at least here we’re maybe to some degree serving a function by framing the question even if we don’t have the answer because there’s disagreement. So we’ve got Marjorie and John and then Gail.
MS. GREENBERG: I agree with both of you. I think to the extent that you can recommend things that will advance the discussion that’s all to the good but I’m skeptical actually whether research or projects will do it. But I do come back to what Sarah said and that is that, I mean we can’t agree in this room but we’re actually in a relatively small area of disagreement compared to some of the testimony that was heard. There are people who representing organizations and advocacy groups, etc., who I think Mark is sort of trying to keep some of those concerns before the group but at the same time bringing a lot of realism into how things actually operate. But this is a narrow area of disagreement here compared to I think what some of the positions are which could bring down the whole house.
So I think it’s really important that the committee report faithfully that there are groups advocating A, B, C, and then say we have looked at these in these A or B area and we do not feel that these, we feel that by going with these positions you would cause these problems which would essentially undermine what you’re trying to accomplish here. So you’re I think a pretty respected group but you’ve got to not gloss around that because this is partly what you heard in testimony, that you heard these positions, they support this line of thinking which has some merit but you’re not going that far for these other reasons and that’s where I think you do have agreement, exactly where you draw the line is where there isn’t agreement.
And I think that is useful but beyond that I don’t think you’re going to get much more agreement in this area and I thought what Simon was saying was, I mean I came up with a policy I think when we were talking about the PHR letter at NCHS I remember saying if after an hour we still can’t agree how this should be worded let’s strike it because there’s a point at which you’re not, so I think you may have to scale back in this area because to what you heard, how you assessed what you heard, and where this leaves you, and then be more concrete in the other areas. But otherwise, I mean it’s either we’re going to be here a few years from now as well.
Is that going to be helpful? Well, the fact that you looked at the more what I would call kind of extreme positions and have articulated what you can agree and probably can get the whole committee to agree are the deficits in those positions and what the problems are with them, that could be useful I think. But beyond that I just, I think that you’re just not going to reach agreement on some of these things and so you have to maybe scale back as to what you’re going to address beyond saying this is what we heard and this is how we see it.
MR. ROTHSTEIN: We’re going to hear from John and Gail, okay, John and Paul, did you want to comment? And then we’re going to take a break and we’re going to come back with a whole new outlook on life.
MR. HOUSTON: As a backdrop to this, it’s funny, when I read this section I said this is, I was all in agreement coming into this room and I think I still sort of like the original text and frankly don’t have a lot of concerns. But now having listened to everybody around the room I would say this, that I sort of have a different, I sort of disagree with Marjorie what you just said, in a way I sort of think that we almost because of how fast things are going and people in these groups starting to put together the recommendations on privacy it really behooves us I think to have to answer the hard questions and I’m almost thinking that the opposite tack maybe because this seems to me, and by the way I think the difference of opinion on this particular issue, if people have good faith bonifide differences of opinion that frankly are, I understand them, I can listen to what people are saying and say I okay I don’t agree with it but I absolutely understand why they had that position. And I’m almost of the opinion or I am of the opinion that maybe what we need to do is spend our time tomorrow and focus on —
MR. ROTHSTEIN: You mean in the main committee meeting?
MR. HOUSTON: In the main committee meeting tomorrow and say okay we’ve got a couple real seminal issues here that really require us as a committee to have some thoughtful discussion on them because they are that important. This might be one of these which frankly really is one which requires the committee to sit down, we can describe as best as we can in a very succinct way what the issue is and allow the committee members to discuss what their opinions are —
MR. ROTHSTEIN: But John we did that at the last meeting —
MS. GREENBERG: We tried that at the last meeting.
MR. ROTHSTEIN: And all that I was convinced of is that the same disagreement that we have here we have there.
MR. HOUSTON: Can we try to broker a position statement? I think what’s going to happen here, and I do agree with Marjorie in one sense, that I think that this isn’t the type of issue we can punt it to HHS and they can try to do projects and things to try to evaluate this and evaluations, I don’t think we’re going to come to a conclusion. This is almost a public policy, a public policy issue for which there is absolutely going to be disagreement in good faith from one segment of the population, another segment of the population is going to another opinion, and another segment is going to say yeah I agree with this. And I don’t know —
MS. GREENBERG: There is an out though, so you say, and I think this is an important thing for you to say, that you’ve got to let people just opt out completely, can’t be mandatory. So for those who have —
MR. HOUSTON: And we’ve already agreed upon that.
MS. GREENBERG: So you’ve said that and at that point, that’s important because the people who testified and had what I call the more extreme views, they’ll just opt out completely.
MR. HOUSTON: By the way you may have resolved the issue just in that statement because if somebody says well I want to be able to pick and choose you say you have the ability to completely opt out and leave it —
MS. GREENBERG: I’m not saying necessarily that that’s enough but we have said that.
MR. ROTHSTEIN: But John, we’ve debated that because if we don’t, if we say you’re in or you’re out but impose what many people consider to be onerous conditions on being in they’re going to opt out and we won’t want too many people opting out or we’re going to screw things up.
MR. HOUSTON: Well I think we already have some agreement as to the fact that there should be certain types of information, limited ability of individuals to say no, I don’t want this included, I think we’ve already made that compromise. So we’re not being onerous, I don’t think, I agree with you, Marjorie —
MR. ROTHSTEIN: I must have misinterpreted, I thought what you were suggesting is just say opt in or opt out and then don’t go into this detail.
MR. HOUSTON: No, no, no, if you’re opting in you still, I think one of our recommendations is still that there is some ability on a limited basis to be able to exclude information, we just have to be very careful that we’re not excluding —
MS. GREENBERG: But it’s hard to know —
DR. TANG: I really do like what Marjorie and John have said, what John said or I think he said, I just think that it’s our job to consciously come up with a recommendation for a policy, we have debated, we have listened, that may be more then HHS gets to do. They knocked out HIPAA, and I think it overall did a good job for the country, so they stood up to that, even though it was really hard they were up to that task and they did it. I think you need to do the same —
MR. ROTHSTEIN: But we don’t have the same structure, there is a boss who says this is the way it’s going to be, we’re a committee and we all have one vote.
DR. TANG: Right, and so I would say that I think we should strive to get to a place where we do vote, and if it’s four to three that’s not what I would consider, so in the committee let’s say if it’s ten to two I think we should go with that especially given what, I thought that was a really nice out because we could do our best job, it will be a compromise and there’s always the ultimate opt out. But I just can’t, it would be worse, let’s put it this way, it will be worse in my opinion for the country if we leave it hanging and nothing gets done just as I think if we didn’t have HIPAA we would have less privacy.
MR. ROTHSTEIN: Okay, let me just respond to your point then we’re going to take a break. I don’t think that it’s a great idea for us to have a series of ten to eight or 15 to three or however they come out votes because we’ve consistently over the years had statements that everybody could live with, this is very controversial stuff and I think that if we came up with something that would be much to your dislike that you would feel compelled to maybe write a dissent or I might —
DR. TANG: That would be better then —
MR. ROTHSTEIN: Oh, I just think that would be terrible.
DR. COHN: Mark, I agree with you.
MR. ROTHSTEIN: I mean that’s been done in the past and that’s something to be avoided if possible —
MS. GREENBERG: I would say if the Secretary had said to you you must provide me a recommendation on X, that’s the boss model, then you really would have no choice probably but to maybe take a vote and then let there be minority opinions. But you’re not actually, you are more in control over what you’re doing then that and I don’t know —
MR. HOUSTON: I would prefer not to punt if we could avoid punting, I just think this committee, we’ve had a lot —
MR. ROTHSTEIN: It’s 4th and 39 —
MR. HOUSTON: Come on, Mark, I disagree, I think there’s a lot of good faith disagreement here, difference of opinion, but I think we’re really, I agree with Marjorie, we’re close on a lot of stuff here and I really think that if we frame this is in an informed way, there’s a lot of thought, maturity of thought here, and frankly it’s going to take a long time for other people to get to the point where we’ve gotten to over the space of all this time working on this.
DR. TANG: Can I point out just one addition to what Marjorie said which is you can opt out and you all have all the mechanisms you have today to get information that you want from one place to another, that exists today, the opt out exists in the electronic pre-authorized transmission, so there’s you will be denied in the new world that you don’t have today, you may decide to opt out of a very fast efficient way of getting things but there is nothing we’re leaving behind but we have given perhaps the gross majority of folks another option.
MS. HORLICK: Paul, I wanted to ask, was part of what you were saying besides that we didn’t have specific recommendations that it’s sort of like you read through this and you go wait a minute, what do they want me to do?
DR. TANG: Right.
MS. HORLICK: So I was almost thinking of that, the decision tree for am I a covered entity, I mean I wonder if it would be at some, I know this is a formal letter but that’s what I’m almost thinking like what are the real decisions. I think part of what the problem is is that it’s sort of not clear about all that —
MR. ROTHSTEIN: Maya and I have been working on this for months but I started doing one to try to clarify things and it got so complicated that we decided it wasn’t worth it, it was going to make things worse —
MS. HORLICK: That whole opt in or opt out, I didn’t realize that because —
MR. ROTHSTEIN: Oh yeah, feel free to look at that. Let’s take a break until 2:30.
MR. ROTHSTEIN: Okay, we need to, not that that wasn’t thoroughly illuminating but I’d like to change the focus of our discussion for just a minute now because this is something of immediate concern and that is what we’re going to do from 1:00 to 2:00 tomorrow. We are on the agenda at the full NCVHS Committee meeting to discuss our NHIN report and so the question is how can we best use our time and there are various options and let me see if I can run through them as I see them.
One option is, John mentioned that we should raise the issues that have consumed us and look for some confirmation, insight, opinions from the full committee. Weighing against that is the fact that that’s what we did at the February meeting, or whenever the last meeting was, and so we focused on B and it really takes a long time until you get into it because all the parts are interrelated and it’s not clear how much we’re going to get out of that.
Another option is, and this was suggested by other people, is that we need to start preparing the full committee for our recommendations and that we distribute to the committee members just for discussion purposes the draft recommendations that we have here. Now cutting against that is the following, I think it’s hard to appreciate the draft recommendations unless you’ve seen the body of the letter and the body of the letter is not ready for prime time for a variety of reasons. We haven’t approved all of it and even in the sections that we’ve approved it’s really, it’s not a sort of a seamless document, it was written in stages and different parts and blah, blah, blah, and tomorrow is a public meeting. And even though this is as well —
MS. GREENBERG: This is a public meeting too but —
MR. ROTHSTEIN: It’s being broadcast live —
MS. BERNSTEIN: And people are calling about it by the way, I’ve gotten several messages just today about this meeting, a couple people who couldn’t find the room or whatever and also people who, one from the press, from the trade press, who are interested in this meeting and asking for transcripts and so forth, just so you know that it’s happening.
— [Multiple speakers.] —
MR. ROTHSTEIN: And so that would sort of cut against doing that, I’d frankly be uncomfortable, I don’t think we’re ready yet.
Another option is to go over parts of the letter that we haven’t previously discussed with the committee members before, we could highlight things from C, D, E and F, we could talk to them about overall philosophy, we could talk to them about strategy, we could describe for example that we are divided on key issues and should we, what should we do about that. So there are many ways to go, I would not like to waste that time because it’s our last sort of informal session with the full committee before we have a completed document.
MR. HOUSTON: Can I ask a question? Are we divided based upon that last discussion point?
MR. ROTHSTEIN: Are you serious?
MR. HOUSTON: No, I mean we sort of left the room with sort of Marjorie’s proposal and we sort of broke, and how much difference at that, I mean philosophically we have sort of a different perspective but does that proposal bridge the gap?
MR. ROTHSTEIN: What proposal are you —
MS. GREENBERG: The one you disagreed with?
MR. HOUSTON: The discussion about how if somebody really had a concern against their record being included in the NHIN they have the ability to opt out.
PARTICIPANT: But it doesn’t really solve what —
MR. HOUSTON: And we also talked about if they opt in there was at least some limited rights to block information I think is what we were proposing.
MR. ROTHSTEIN: We’ve agreed to that.
MS. GREENBERG: Well if we’ve all agreed that there should be some limited rights to block information —
MR. ROTHSTEIN: We’ve agreed to that.
MR. HOUSTON: And people can opt out, it sounds like we may have consensus —
MR. ROTHSTEIN: We have that, that’s in the letter —
MR. HOUSTON: I agree but we were arguing, what we were arguing, what there was a difference of opinion was is that I think everybody got out of context but when Marjorie said hey but you can opt out if you really are offended by this or really don’t want to have it happen then it was sort of, I don’t know, I sort of say okay, that’s a great way to bridge our difference of opinion as to the rights of patients and it does in my mind, if I’m of your position it does in my mind, I think it would say yeah, you’re right in context it does make sense, it does give the patient rights if they really don’t want to have their information, because they can decide to opt out —
MS. WATTENBERG: But it doesn’t give them subtle rights, I mean it gives them an all or nothing.
MS. GREENBERG: You’re not saying in lieu of also maybe having some limited blocking.
MR. HOUSTON: No, it would not be in lieu of, it would be in addition to.
MS. GREENBERG: In addition to, but you still want to have, you still think if there is agreement of this limited blocking though I think it’s ambiguous what that means, because obviously it’s going to be limited, if you opt, I mean because if it were total you’d be opting out, so by definition it’s limited, right, it’s just how you limit it, the ultimate control is you opt out in the first place. So once you’ve opted in then it wouldn’t make sense to have an option where you could say I’m opting in but all of this is being blocked, so that makes no sense. But if you actually agree that, if you agree that you could not, I don’t think you agree on this though, you could not in any way really alter what’s there once you’ve opted in, and again it’s not clear whether you’re opting in by provider, because I don’t think it’s right to say because I tell my dermatologist yes, I’m opting in to the NHIN, I’ve also told my psychiatrist and my OB-GYN, that makes no sense. But you could have, if I were a Kaiser patient and all my stuff was through Kaiser I could do a complete opt in with Kaiser or work out something with them and maybe that would be the limited part, I’d say I have Kaiser, I’m going to be a part of the NHIN.
MR. HOUSTON: Without getting into that detail, again I’m going to call you to the one sentence that I said before, the last sentence of the paragraph there are various ways, there are various ways in which patient rights may —
MS. GREENBERG: I’d say forget the various ways.
MR. HOUSTON: Okay, but the last sentence I think is meaningful because I thought we had sort of, Mark wrote it and I kind of agree with it, is the one area that I think we could leave it up to another group is to say to the extent that the strategy for the type of information that patients should be limited to control would be as a result of health care providers and patient advocates making that decision —
MR. ROTHSTEIN: We amended that pretty much.
MR. HOUSTON: I think that is reasonable to say, it is up to HHS to decide what, if you used a strategy of health care provides and patient advocates to decide what was appropriate to say can be limited.
MS. HORLICK: But I actually like this information in here, I mean that’s what the hearings —
MR. HOUSTON: Gail, I’m just trying to get to a conclusion, I think we all agree in large measure as to the strategy here for this.
MS. GREENBERG: But that we’re talking about an access thing, we’re talking about a blocking thing, what about the issue of whether you can actually have, amend the records? That’s the one where I heard there wasn’t agreement.
DR. TANG: You can always amend, HIPAA gives you that right.
MS. GREENBERG: No, HIPAA gives you the right to request and the provider can just ignore you.
DR. COHN: Are we talking about the first sentence now?
MS. HEIDE: The provider can decide not to amend the records if for example he or she disagrees, believes what’s in the record is correct.
MS. BERNSTEIN: But there are providers who just as a flat matter refuse to ever amend and always take —
MR. HOUSTON: They’re not permitted —
MS. GREENBERG: Well what about —
MS. BERNSTEIN: They always allow their patient to write their letter or whatever it is and add to the record and that’s the way they deal with it, they never change anything.
MS. HEIDE: And they have to allow individuals to request an amendment and they can deny that request, but they can deny that request if they disagree —
MS. GREENBERG: But can they deny the request to append something to the record?
DR. TANG: They must accept the patient, so you get denied you can say well okay that’s fine but include this —
MR. HOUSTON: And they’re required upon disclosure to include —
DR. TANG: In a sense they cannot deny your statement, they can deny amending —
MR. HOUSTON: And HIPAA says they’re required to make that patient statement available, disagreement available anytime that record is then released.
MS. GREENBERG: That’s fine.
MR. HOUSTON: I think we have agreement, I really do.
MS. GREENBERG: So where are we disagreeing?
MR. ROTHSTEIN: What John has said is I think he’s prepared to support the language on page seven —
MR. HOUSTON: I did before —
MR. ROTHSTEIN: Okay, so that’s where we started. I’m prepared to support the language, I wrote the language on page seven. But Paul is not happy with the language on page seven —
DR. TANG: Which language?
MR. ROTHSTEIN: Well pretty much anything —
MS. HORLICK: I thought Paul’s initial comment when we started the discussion was that there was a lot of still decisions left for HHS to make and that maybe we weren’t giving, I don’t think anyone was disagreeing with that statement and so then I thought Paul was moving in the direction of are we going to come up with making these decisions or are we still going to lay all this out in the letter. And I think even if we’re all in agreement with that statement there’s still an awful lot of unresolved issues like —
MR. ROTHSTEIN: What I would love to have happen in terms of our process is let’s hypothetically say we agree to approve the rest of B in terms of the framework and we agree to A and the introduction, now we put on the table okay, how can we make this letter really work as something that is a good recommendation and now we can add Simon’s suggestions in terms of what needs more research, what is appropriate for demonstration projects, we can have subheads, we can make the writing more consistent, we can decide on how to draft the recommendations to be a little zippier and reach the issue of whether they should be sort of slotted in in the right places and so on.
MR. HOUSTON: And one point, because Maya was not in the room at the time, we discussed making sure it was clear in this letter that we are not talking about PHRs, that was a separate set of recommendations and I think that’s very important.
MR. ROTHSTEIN: Which will go in sort of one of the introductory things. Marjorie and then Simon —
MS. GREENBERG: You also have to agree I think that you’re not really talking about controlling the content of the records —
DR. TANG: Correct, so when you said we agree with the rest of B I don’t think we got beyond the various, very first paragraph —
MR. ROTHSTEIN: We approved everything up to there are various —
MS. GREENBERG: Is it practical when a person opts in to a particular provider to say, do feel it’s practical to allow people to say okay, I want you to include my records in this NHIN but don’t include this information, that’s content. The alternative is to say but don’t give anyone except this particular provider or something access to this information. That is a difference, whether it even gets into the system or whether people have access to it, that’s where I thought there wasn’t agreement.
MR. HOUSTON: You have a architectural bias there which I don’t, I think we have to be very careful about, because you’re assuming there is a repository, I would argue the opposite that there’s a federated model where you go out and ask for available information —
MS. GREENBERG: Yes, but when you ask can you limit who —
MR. HOUSTON: And personally I think that’s an architectural issue that has to be adjudicated at whatever the —
DR. TANG: The donating site, the providing site.
MR. HOUSTON: I’m thinking of the core, the hub —
MS. BERNSTEIN: She’s just talking about what’s available theoretically to whom, not how it gets available or where it goes. I don’t think Marjorie is making that point at all, she’s just —
MR. HOUSTON: I understand what Marjorie is saying, I’m saying I don’t think it’s the individual, we shouldn’t assume it’s individual institutions that are responsible for deciding or maintaining what the patient decides they want to contribute, it very well could be as part of the RHIO function the RHIO maintains information on whether the patient decides site data from any provider should be provided.
MS. BERNSTEIN: But I don’t think Marjorie is making that distinction, I think she’s just saying who collects the decision of the patient and if they forward it onto somebody else who actually implements the decisions of the patient, I don’t think that Marjorie has an issue with that.
MR. HOUSTON: I don’t think that’s what —
MS. BERNSTEIN: You’re just talking about who can get what not who implements that decision, right?
MS. GREENBERG: But it is a question of whether, because it could be a model, we have to be open to all models, there could be a RHIO model where there was some kind of a repository of records, like east Indianapolis —
DR. TANG: Indianapolis does have that model.
MS. GREENBERG: Yes, they do, I think all of Indianapolis, so that could be one model and then it does have to do with whether the stuff even goes there. Another model is where it’s pulled from a record that never went anywhere and then it’s a question of access —
MR. ROTHSTEIN: And it’s possible that we are going to have ten different models, the model that we’ll come up with is just a patchwork of different models as long as they’re interoperable —
— [Multiple speakers.] —
MS. BERNSTEIN: — trustee where I’m going to put all my information —
MS. GREENBERG: — have a policy for the model where they do, something does leave the provider’s office and goes somewhere else, how far I don’t know. And that’s where I don’t know if you have agreement.
MR. ROTHSTEIN: I’m lost.
DR. TANG: Are you referring to the paragraph after the various ways paragraph? This is where, if you’re saying we’re accepting the rest of B I guess —
MR. ROTHSTEIN: No, no, no, I wasn’t saying that at all.
DR. TANG: I thought that’s what you just said.
MR. ROTHSTEIN: I said hypothetically if, no I was not moving B forward, I was suggesting a plan of where we’re going to go with this.
I want to get back what I started this session with and that is tomorrow at 1:00 and the question is what should we present to the committee. Marjorie?
MS. GREENBERG: Well first of all how about B1 and B2? I think you’ve got, even though they’re related you’ve got to plainly talk about this idea of content and then you’ve got to plainly talk about the idea of access, because it’s just, they’re too mixed up here. And I think, I’m almost sure that you’ve got agreement about the access issues but in some limited way, you could all agree that in some limited way people should have the right to block certain information.
PARTICIPANT: That’s not access.
MS. GREENBERG: Yeah, that is access, that’s access, you’re blocking it from somebody, but it’s not removed, it got there. Isn’t the option where like the Indianapolis model the whole record went, maybe, but then you’re blocking some of the information unless the patient actively releases it. It seems to me that everyone agrees about that, that in some limited way there should be the right for the patient to block access to some part of the information. But the other issue is should they be able to specify that some part of a record not go at all, should they be able to partially opt out, that’s a content information.
MR. ROTHSTEIN: Well the other way of looking at it is what is the scope of the blocking, so I mean it’s another descriptor so instead of viewing blocking as this blocking might be that and then —
MS. GREENBERG: But you’re already saying blocking should be limited, shouldn’t be this.
MR. HOUSTON: Right, that’s a whole other issue.
MR. ROTHSTEIN: No, it can’t be everything, the question is how big the block is, right?
MR. HOUSTON: You’ve already said here in that paragraph though that we’re talking on a limited basis.
MR. ROTHSTEIN: I agree.
MS. GREENBERG: But the prior question is whether once they opt in they should be able to say I opt in but don’t send this, this and this, to a model where you’re sending some data somewhere.
DR. COHN: As opposed to blocking that data.
MS. WATTENBERG: Which means you send it but don’t want people to look at it, it’s more of a convenience —
MS. GREENBERG: But it might be some could look at it but others couldn’t.
MR. ROTHSTEIN: I’m having trouble with the level of specificity that we’re getting to because there’s another model, I mean just to make things sort of really complicated, you can send my records to any doctor who wants them except my former colleagues and my ex-wife.
MS. GREENBERG: That’s an access issue.
MR. ROTHSTEIN: I don’t care how you describe it it’s another layer of complexity.
MR. HOUSTON: I’m a little concerned about, I understand where you’re going, Mark, in a perfect world I think you’d want to be able to provide a patient with all sorts of ways to put a block, by provider, by this or by that, my question is is how prepared are we going, is anybody going to be able to develop this infrastructure initially to do that?
MR. ROTHSTEIN: I don’t know, that’s why I don’t want to get to that level of specificity.
MR. HOUSTON: And I agree with you in that regard, I think in a perfect world I can think of a lot of things we could put in place —
MR. ROTHSTEIN: And that’s why that first full paragraph on seven tries to say here are some examples of the kinds of things that might be considered, I didn’t include the provider blocks but just by diagnosis block or age, or type of provider I meant —
MS. GREENBERG: Provider name you said.
MR. ROTHSTEIN: Did I put that in there? It slipped in there —
MS. GREENBERG: I’m not communicating well but all this issue about blocking is still not getting at content, do you want to say anything about content and do you have consensus on that?
DR. TANG: Can I try at least diagramming so we can at least talk about, I can only do three, so four is stretching it, so content, access, block, access, so there’s access and there’s content and there’s EHR that’s used by the doc and the NHIN, which is let’s say for this moment by the doc. So we cannot prevent or alter the content of what’s in the EHR or the access by the doc of information in the EHR —
MS. WATTENBERG: The treating physician, the main treating physician —
DR. TANG: The source, EHR is at the source. Just so we can at least cubbyhole our arguments, and then the NHIN we still, I mean that’s what this X means but it may not be right, cannot touch the content in that EHR, in the source EHR, but there are some information that you can block, that you allow access by a physician to the content and there’s some where you do not, you block access. And the size of this is what we’re talking about, but is that at least the right cubbyholes?
MS. WATTENBERG: But then there’s a third in that one that you’ve divided which is information exists but it doesn’t even get into the NHIN.
MS. GREENBERG: Well that’s more the bottom one, that would be dividing the content one —
DR. TANG: Right, right, the content is there, you can’t remove that content, you cannot delete without a trace, but you can prevent access.
MS. GREENBERG: I don’t know if there’s agreement on the lower right hand box.
MR. HOUSTON: I think that in part depends upon the architecture that’s established because going back to a repository based system then you would say it’s going to be in, but if it’s going to be a federal model where it’s drawn at time of request then you can say it can be, the access can be denied based upon data type.
DR. TANG: So there’s —
MR. REYNOLDS: I think there’s a yes and no right there.
DR. TANG: The no is the source EHR, you can’t do anything about it, right?
MS. GREENBERG: Well, except what’s already allowed under HIPAA.
DR. COHN: I thought we were going towards a consensus here —
DR. TANG: Well, I’m trying, that’s what we’re looking for, and the yes is the centralized, is the regional database —
DR. COHN: Can I ask a question? Because I’m getting confused between content and access now, I had thought originally when we talked about content we meant changing the content as opposed to the access to the content, and now we seem to be having some sort of a discussion of well, if the content isn’t there that’s a content question as opposed to an access question. I just think it’s a deeper access question and there’s two levels of blocking —
MS. BERNSTEIN: I just think there’s more then one way to divide how you might block things, you could block it by content, you could block it by what provider, you could block it by age of the record, and those are just different ways of blocking access.
DR. COHN: Within the NHIN you can block it —
— [Multiple speakers.] —
MR. ROTHSTEIN: Let me praise all the attempts by the subcommittee members to reach consensus, I don’t, I think there is, I think we’re stuck a little bit —
— [Multiple speakers.] —
DR. COHN: Mark, I think that people are agreeing, they’re just using different words —
MS. GREENBERG: Mark, do you think that people should, who’ve opted in, be able to say but I don’t want you to send this information?
MR. ROTHSTEIN: Yes.
MS. GREENBERG: Okay, assuming that you have a model where stuff is sent somewhere as opposed to just the model where you go to the source —
DR. TANG: Why do you think that is logically different? It’s physically different but why do you think it’s logically different?
MS. GREENBERG: Because that affects the opt in I think or the opt out, this stuff never is even available to anyone else.
DR. TANG: In fact, so this upper right is the only thing affected by opt in and opt out, that’s the other, maybe that’s something we can come to agreement on, this is the only opt in, in versus out, that is the only cell that is affected.
MR. HOUSTON: Can I make one statement too about that? I think what we’re finding and what you’re going to continue to find is that the model for RHIOs are going to differ, I think small rural areas are going to develop RHIOs that have a repository because it’s the only economic way for them to develop this, I think what you’re also going to find is that other areas that are more urban are going to find that they’re going to develop RHIOs which are developed around a federated model which is we’re going to grab information when we need it and that providers themselves are going to maintain the information. And then the reason why I think this isn’t going to happen is exact opposite, I think what’s going to happen is is these RHIOs, to develop a repository in a large urban area is going to become so expensive because of the storage requirements and things like that that what you’re going to find is that yours could be this federated model, the hospital across town wants to see your CT scan, they’re going to make a request through a RHIO and it’s going to get pulled from where it was done at and sent over in real time. So I think because of the fact that there’s those two different models there and I think they’re going to exist in the United States I think you’re all left with what Paul said which is that upper right hand column which is at some level based upon patient preference that information is either going to be given to the recipient upon request or it’s not —
MS. GREENBERG: But if it isn’t there it can’t be given.
MR. HOUSTON: I understand that but does it matter, the reason why I make this differentiation is I think the difference in small rural areas is between them having any EHR is going to be the development of a regional repository which all providers in that area are going to draw upon. I don’t there’s going to be any capacity —
MS. GREENBERG: There will not be a source record you’re saying.
MR. HOUSTON: The source record will end up in the repository because that’s —
MS. GREENBERG: It won’t be a separate source record.
MR. HOUSTON: Exactly, so I think we have to continue to think in terms of access.
MS. GREENBERG: So the only option you have is what Paul mentioned in San Francisco, Dr. Tang, please don’t put this in my record.
MR. HOUSTON: No, no, no, what you’re going to have is, actually I think what’s going to happen is —
MS. GREENBERG: Once he puts it in it’s there.
MR. HOUSTON: I think the data may be there but like a hospital’s own E HR, what’s really going to be at play here is a patient is going to say I don’t want to have my psych information available, it’s still in part of the repository because that repository maybe the only place where it’s at but Dr. Tang doesn’t need to see it, or doesn’t have the right to see it, so it’s simply going to be not made available to him.
MS. GREENBERG: So it’d just be blocked.
MR. HOUSTON: And that becomes an access issue and I think that really at the end of the day is the only way to think about this while trying to take into consideration all the different models that may establish themselves within this country and I think that’s where the patient probably, and that’s what the patient is really concerned about is not necessarily how their information is stored I think —
MS. GREENBERG: No, I don’t —
MR. HOUSTON: No, no, hear me out, but rather how it’s made, where it’s made available.
MS. GREENBERG: Because there is the philosophy that once it’s electronic —
MS. WATTENBERG: And I think consumers have a very different perception of that, I think consumers feel like they have a measure of control when they can just say I want to participate in the RHIO but I don’t want my shrink sending in any records to it or listing any of it on a master patient index.
MR. HOUSTON: My concern is going to be, again, I’ve heard it loud and clear in Pennsylvania, there is a bunch of rural providers who the only way they’re ever going even to get to an EHR is by going together into some type of community based records environment where the only instance of that record I think will ultimately be in that —
MS. GREENBERG: And that make sense to me, I mean I can see that —
MR. HOUSTON: And in that model I think you’re going to have a problem restricting —
MR. REYNOLDS: And must of that will be driven probably by hospital systems —
MR. HOUSTON: Well, no, I think you’re going to end up with hospital systems —
MS. GREENBERG: I think you should just talk about access then because you can agree on access and I don’t think you should talk about content. Access to content obviously but I mean content per se.
MS. BERNSTEIN: And in a situation that John describes in the rural area, I’m going to do what Sarah’s model patient is doing which is I’m going to go to a shrink who writes their records on paper, handwritten, and I’m going to pay cash, you’re never going to see my record —
MS. WATTENBERG: And here’s the problem with that is that you’re creating an underground health care system and it already exists in substance abuse and it’s very dangerous to not be able to provide differential access to people and let me just say because I have the floor that I think a very different message has gone out to consumer groups that the message they’ve heard for right or for wrong in terms of the linguistics is that there will be no central database. This sounds to a consumer, regardless of whether or not it’s just in this RHIO or just in Pennsylvania or just rural providers, that sounds like a central depository and the message that has gone out has been that for everything that it will be it’s not going to be that.
DR. TANG: Well, to be a little bit more precise they said there would not be a central database in the sky nationally —
MS. WATTENBERG: Right, but I’m telling you what consumers are hearing, they don’t hear that —
MR. HOUSTON: Right now RHIO formations that I’ve heard of, a lot of them are already pretty well advanced, are all going with the repository model.
DR. TANG: You know why? Because if you want decision support it’s the only way you can do it.
MS. WATTENBERG: That’s not true, that’s completely not true —
DR. TANG: No, you need to standardize —
MS. WATTENBERG: You can get decision support by connecting to a web, I mean that’s not —
DR. TANG: No, no, decision support, the machine has to understand, in other to process the rules it has to understand every data element that comes in. There’s two main reasons that Indianapolis when with the central repository, one, on the way in it gets translated into their centralized nomenclature and everything gets coded hence the rules cannot —
MS. GREENBERG: What is it, it’s not SNOMED is it?
DR. TANG: It’s LOINC, it’s probably ICD, it may or may not be SNOMED, I don’t know whether that’s in there. But all the things that Indianapolis pioneered in terms of their nomenclature they’ve coded everything else so that their rules can fire. And the second reason is what John was talking about, basically now they can guarantee their up time, their accessibility, all the other things you’d want that nobody else wants to see, for the good of everybody I’m going to have this kind of support, they just offload that basically, and for security reasons too, they don’t want people coming in, you manage that and that turns out to be a decent model. So it actually tends to be in a more efficient centralized way —
MS. GREENBERG: But at a community level.
MR. HOUSTON: Again, I understand all these different concerns, all I’m trying to do is because of the various architectures that are going to be established and I’m hearing about being established, we just can’t be predisposed to sort of a solution or thinking about a solution that may not fit all the different models that are being established, I’m just really concerned —
MR. ROTHSTEIN: We have to be very careful of that, I think that’s a good point.
MR. HOUSTON: And again, that’s the only reason why I’m sort of trying to, if we work back to this upper right hand corner of the access issue I understand all the patient concerns, don’t get me wrong, it’s just I just think there are going to be cases where it’s just going to be, if we get too specific in the way we’re looking at it —
MS. WATTENBERG: So then what’s the role for what we talked about earlier which is that you could selectively opt in according to providers?
MR. HOUSTON: Selectively opting in for providers, I think the point again —
MS. GREENBERG: That becomes meaningless because we said in that model because we said patients shouldn’t be able to say I don’t want my data to be electronic.
MR. HOUSTON: Now hold on, but again there, think of this as three different models, I’m going to do the Paul Tang, bear with me for two minutes. There’s three models which I think at a high level are going to be established —
MS. WATTENBERG: But my only point is that I think that the letter is internally inconsistent, that if you’re saying you can do that —
MR. HOUSTON: But hear me out, hold on, hear me out. There are three models and I’ll do it real fast here, there’s a central repository model where every hospital that has its own EHRs and has its own data and it’s contributing, okay, that’s one model. The second model is you have this cloud in the sky which is the RHIO that doesn’t hold any data and anytime a request is made from one provider to another it goes out there and pulls her data and sends the data to whomever needs it. The third model is all of these providers, especially I think in the rural areas, are going to say hey, I don’t have the wherewithal, my facility does not have the wherewithal, the money, to create an EHR, I can’t do it, I just cannot do it. So all these providers are going to be out there and say you know something, the only way I can get to an EHR is if we develop a community based system. And the reason I’m so concerned about this is that in this environment here especially what we’re talking about, the data that all the providers are going to store that is going to be necessary for them to deliver care is going to be stored in some community based repository —
MS. WATTENBERG: And how is that one different from the first one?
MS. GREENBERG: The first one there are separate EHRs —
MR. HOUSTON: Let’s just say the hospital here can say here’s all of my data, I may only contribute a subset of it to here, here by default everything is going to have to make its way in there because that’s the only way that the community has determined that it can support an EHR is by saying it’s everything, CTs, lab results, everything is in here because that’s the only way they can get, economically it’s feasible for them to put something together. And the reason why I point this out is I just want to make sure that as we’re developing these recommendations we don’t say you say something, we didn’t really think about this one, we have the mindset of these two —
MS. GREENBERG: But that one you have to admit then makes the opt in/opt out, no, not opt in/opt out, it makes, it does, because we already said patients shouldn’t be able to say I don’t want my data electronic —
MR. HOUSTON: But it’s not going to be a choice though.
MR. ROTHSTEIN: Okay, Harry has been waiting.
MR. REYNOLDS: I agree with that and the one think I would change, Paul, on your block, if you went to the lower right hand block, because I’m not buying into everybody’s use of access in such a dramatic way —
MS. GREENBERG: You’re what?
MR. REYNOLDS: I’m not buying into everybody’s use of the word access in such a far reaching way, because if you went to that lower right hand corner and you put an F for full and a / and a B for blocked, or subset, okay, so what you’re saying is, full record, and an S for subset, we could use blocked or let’s use a subset. So to me what it’s saying is in the access I’m either agreeing to be in or out, the doctor gets to do what they want to with their own records and the person gets to get in or out of NHIN.
Now I go down to the actual record itself —
DR. TANG: The EHR record?
MR. REYNOLDS: The actual EHR record, it can’t be changed except under the HIPAA laws and everything else, but when you go to the lower right if I opt in and say just send all my records, that’s full. If I want to use whatever methodology is set up to decide what I get to block, we talk in this category about X amount of years old or this or that, then I have that selection. Now I buy into that —
DR. TANG: Okay, so that only makes a difference here —
MR. REYNOLDS: No, it does not. Let me tell you why. I think it fits all three of the models —
MS. GREENBERG: How does it fit the left model?
MR. REYNOLDS: No, it fits every one of them, let me tell you why it fits all of them. Information coming into that one it doesn’t fit, we are talking about information after it is put out there, how it gets to someone, gets back again —
MS. GREENBERG: Isn’t that blocking then?
MR. REYNOLDS: What I’m saying is, let’s take this one, all of the EHRs are stored here, this doctor doesn’t know this doctor doesn’t know this doctor, they don’t know, but it’s kept here. But if I’m seeing this doctor and this doctor wants to get my record I should be able, my blocking and whether or not I’m sharing that record with this doctor comes into play right there. It’s not going in, it’s coming back out. Now remember, because we’re agreeing at the top there —
MS. GREENBERG: That’s an access, although you could say that the same record exists in two forms. I mean it’s the same record but conceptually it exists as the source clinician’s EHR but it also exists the RHIO EHR and when it’s in that manifestation it has some content limitations.
MR. REYNOLDS: It has this characteristics, when it resides as the RHIO it has these characteristics, I think that takes everything we’ve been arguing about, I think that takes everything we have argued about and discussed and it now puts it up there so that everybody that said had what they say —
DR. TANG: So the hedge will be how small and big those by section is, and that’s easier to say.
MR. REYNOLDS: That is correct.
DR. TANG: Now we’re getting to —
MR. ROTHSTEIN: Now we’re back where we started.
MR. REYNOLDS: No, I think that supports this letter.
DR. TANG: And then we talk about —
MS. GREENBERG: You’ve said something then about content and you’ve said something about —
MR. REYNOLDS: That’s right, and that’s the reason, see I couldn’t go before because nobody wanted to differentiate in that lower right hand column, so now I’m saying if it’s differentiated down there now I’m okay.
MS. GREENBERG: So if John agrees, because we’ve given Mark —
MR. REYNOLDS: I’m going to answer his question. And I can tell you right now this is most of the large university hospitals right now in the United States, and this is UNC is the same way, and now that the discussion has been about STARK(?) to where these universities can go out there and start picking up a whole lot of doctors, in my opinion in the smaller places, the big university hospital is going to be the RHIO for that particular area of the state or whatever. I see this doctor, this is my doctor, now right now I’d say to you I don’t know where those records are right now electronically, whether they’re in their database or whether they’re somewhere else. But I’m seeing this doctor and this doctor can store it anywhere he or she wants to, so I’m in. The minute they decide that they are going to give rights to somebody else, it’s no different, this model to me once it comes in here and sits at rest looks exactly like the other ones, looks exactly like that or anything else because, it does philosophically, this doctor’s record is right here, so once its there if somebody else wants to have access to it I can decide if any of the rest of these people can have access to it just like it’s any of these models. And secondly I can say by the way when you send this, if this person wants this record I want to be able to block this information because this guy’s a dermatologist and this one is a psychiatrist, it shouldn’t be any different.
MS. BERNSTEIN: I have a question. If this, in this model if everybody is going, as I understand everybody is going in together and storing their electronic health records there and not at their home office, right? Because that model is they don’t have the money to do it —
MR. REYNOLDS: It becomes their home office.
MS. BERNSTEIN: Doctor over there, your primary care physician over there, has the record, they’re storing the record there, when they need to get access to that record they get access to that record, right?
MR. REYNOLDS: Because it’s their record.
MS. BERNSTEIN: Now in between Dr. B over here on the right, your shrink, is storing records over there, is it the same record?
MR. REYNOLDS: No.
MS. BERNSTEIN: So I have as many providers as I have I have a different record?
MR. REYNOLDS: That is correct.
MS. BERNSTEIN: And they’re all stored there.
MR. HOUSTON: I don’t agree with that —
MS. BERNSTEIN: That’s not what your model is, right?
MR. HOUSTON: Let me just say this. In Harry’s example of a large organization, my organization has an EHR which is just like that for all the hospitals, when you walk into any physician practice or hospital, when you sign a consent it says we are going to use your information throughout our organization for purposes of your care as well as payment and other purposes. And you sign a consent form, it says that record, that consolidated record about you, is available as necessary for treatment. Now we will, we do things to segment psych data, HIV data, things like that. But the record itself, your record in our system, is one record.
MR. RODE: But it doesn’t have to be.
MR. HOUSTON: No, it doesn’t have to be, but Harry is assuming it isn’t, Harry is assuming that it isn’t, that it is separate, I’m saying that a lot of environments it is one record —
MR. REYNOLDS: But then I would say to you is that is one organization, that’s one doctor’s office, because what I’m saying is you are inflicting the rules of a single doctor’s office on all the doctors.
MR. HOUSTON: I’m just going to tell you that if you came into UPMC tomorrow and said hey, I don’t like that, I don’t want you to do that, we’re going to say you need to go somewhere else for treatment.
MR. REYNOLDS: I gotcha, but that’s what I’m saying —
MR. HOUSTON: If the person is medically stable we will say no, this is —
MR. REYNOLDS: You are one doctor’s office and that’s my point, I don’t care if you have 5,000 of them.
DR. TANG: We just need antitrust to get into Pittsburgh, that’s all.
Can I draw, let me check this one out with Harry, this is this, okay? And you have multiple business entities which may not be true, multiple entities, the data, your CBC is stored in one place only, you may see two docs, when you’re here I remove this filter, when you go here you say, I removed this filter and you both are looking at the same data elements in the same database. So in that, with that reasoning I would say the content is always there.
Now when you want to send it, when you’ve gone off to Washington you say may we get your information and you say yes, across the NHIN, I will remove this filter. And that I would call access, this is content.
MR. HOUSTON: I agree with that, yeah.
DR. TANG: So in that way I can distill the argument down to still the upper right hand corner, how does that fit, critique it and tell me how if —
MR. ROTHSTEIN: Are we getting anywhere?
DR. TANG: I’m trying to.
MS. GREENBERG: We were, we’ve backtracked.
MR. ROTHSTEIN: I’d like to call a halt to this, just sort of going over stuff again. I do have, the discussion was helpful to me in one respect because it reminded me of an issue that we might want to consider for a recommendation that comes right out of this discussion and that is, and I’d be interested in John’s view based on a comment that he said, that providers should not be able to condition treatment on the individual being in the NHIN.
MR. HOUSTON: I agree with the provider should not be able to condition treatment, what I was speaking to was my own organization —
MR. ROTHSTEIN: Are you okay with that?
MR. HOUSTON: Absolutely.
MR. ROTHSTEIN: Because we have not, we said that sort of indirectly by saying you have a right to do that but we haven’t said, and there’s a comparable HIPAA provision and I think it would be —
MS. GREENBERG: What’s the provision?
MR. ROTHSTEIN: That a provider should not be able to condition treatment on the patient being within the NHIN, either not opting out or specifically opting in.
MS. GREENBERG: But a provider, if the patient came and said I don’t want you to keep my record electronically, that’s the only way I can keep my record.
MR. ROTHSTEIN: That’s right, that’s okay —
MS. GREENBERG: That’s okay —
MR. ROTHSTEIN: Yeah, that’s okay but should not be able to condition treatment on your agreeing to be in the NHIN. Is that agreed to? Okay, so I will —
MS. WATTENBERG: What happened though if somebody, if you have these providers who can’t keep their own EHRs —
MR. ROTHSTEIN: Then what you’re going to have to do is get a separate, either I would say you’re going to have to get a separate authorization —
MR. HOUSTON: Let me say this too, we’re talking about two different animals here and maybe we’re blurring this or maybe I’m blurring this, I looked at the RHIOs in a community as being a little bit different then NHIN which I think is, NHIN as being the overarching infrastructure to support this. I think a RHIO that’s created on the left hand side very well may say as part of their individual authorizations that this is a reality, this is what we say to our patients, it’s a reality, it’s not like you can opt out because we by default have one large repository, everything is in there, it’s where it goes. So when you come here it all goes here and if somebody says well I don’t want that, I want it to be left off, we say we can’t do it because our record, our patient record is an enterprise record. And I think that in that left hand wall it very well could be the discussion with the patient is is that it is a regional record because of economics or I don’t know but I just, I don’t know how —
MR. REYNOLDS: And after the meeting, I don’t want to focus on it now, I will show you why I believe you fall into a totally different category on Paul’s chart then you think you do with that model.
MR. ROTHSTEIN: Okay, as long as we have a shift now, I want to go back to 1:00 tomorrow and when Simon calls on me I don’t want to say we’re disagreeing about what we’re doing in this one hour period. So what would be most helpful to us as a subcommittee and also to the full NCVHS to get them sort of geared up to consider our consider weighing the various interests that we have of not prematurely spilling our work product, on the other hand not rehashing other stuff? Paul?
DR. TANG: The core division of thoughts, Marjorie brought it up, is content and access, and to the extent that we can come up, just a personal opinion, a way of framing the discussion of what box, framing the discussion, I think that would be useful pre-work to presenting our later recommendations in that framework.
MR. ROTHSTEIN: Here’s my reservation about that, and that is it might take an hour to get people to the position where they could understand your box. I’m being serious, that is, that’s a diagram that helps conceptualize for people who’ve been working on this a lot and people, that may be just too difficult for them —
MS. BERNSTEIN: And we’re having trouble with it.
MR. REYNOLDS: You want recommendations about what we should do tomorrow? If this is our last time with the committee —
MR. ROTHSTEIN: Pre-June, yeah.
MR. REYNOLDS: Pre-June, if you took these draft, in other words if I was sitting in the audience, I’m trying to think about I’m sitting in the audience and then all of a sudden I’m going to get this letter and then I got to act on it in June, so I might see it end of May, I might see it end of June, and I got to read it and I’ve got to go well I’m in or I’m not. Just looking through some of these first, I feel that if you could use the right words, and I just picked on this, let’s take first, I’ll say first of all if you went down and categorized the types of recommendations, the far reaching nature of what we’re about to do, and you took them through and as you discussed each one of them you did not say what the recommendation is, you said what it relates to, so I’ll just pick the first one. We have to decide how —
MR. ROTHSTEIN: Whether individuals should have the right —
MR. REYNOLDS: Yeah, how is record going to be stored, the next one would be do people have the right to whether they’re going to be in or out, are we opting in or are we opting out. In other words if you went through a succession of those to show them the breadth of the issue based on what we’ve defined it, this is what we really defined the issues to be because that’s why we’re making our recommendations on them, and you kept it generic enough so that if I was sitting there as the press I wouldn’t preempt what you’ve already decided or I wouldn’t be immediately asking you what you decided because we’re just showing them how we have parsed this incredibly difficult subject into the things that really are going to make a difference in the answer, I mean all this body is a warm up to that.
MR. ROTHSTEIN: So you’re Russ Localio or some other member of the committee and is it going to help you very much to have that kind of framework?
MR. REYNOLDS: Well, if we don’t, I mean for example if we don’t then reading them one or two sections out of context it’s a great example, last night I was very happy to have this because we’ve spent so much time going through the wording of this, I was able to sit there just unencumbered basically in my hotel room and go through this and go yeah, that’s what we’re talking about, that’s the breadth of what we’re dealing with. And so now everything, every comment I’ve been making today is based on the body of work, it’s not based on am I in paragraph three section two and how the heck did that relate to everything else I already said —
MR. ROTHSTEIN: So you think it would be valuable to not present the recommendations but just to present the subject matters on which the recommendations deal. In other words we’re dealing with the issue of access, we’re dealing with the issue of —
MR. REYNOLDS: As sound bites rather then actual recommendations or really diving into them too deep.
MS. HORLICK: But there are areas where we don’t have a recommendation and haven’t taken a position and I wonder whether that’s something we need to address.
MR. HOUSTON: Well, I think that’s even in the recommendation —
MR. REYNOLDS: It’s in the recommendations, it’s we’re not satisfied with them.
MR. HOUSTON: — we don’t have an opinion, we recommend that the HHS do something which might mean —
MR. REYNOLDS: We didn’t go far enough —
MS. HORLICK: Maybe that’s some whole issue of how complex they all, the lack of consensus, clearly there needs to be consensus on some narrow —
MR. REYNOLDS: We don’t know where they’re going to trip up, we don’t know who’s going to grab what, you got a lot of people around the room, we don’t know who’s going to get upset with what so if we pick a subset to talk about, everybody is nodding their head and they’re the ones that are going to blow up the next time we get into the next subject.
MS. BERNSTEIN: I think that’s similar to what we did last time and we got a pretty good sense of who is going to blow up where last time and so while I think that is, I mean I’m sort of a mixed mind because I think what Harry is suggesting is right and in fact it’s something similar to what we did last time for the reasons that you say, that we wanted to give them a sense of the complexity of the issues and which direction we could possibly go and they sort of grabbed on to the possible actual recommendations and kind of went off with it. But I thought that discussion was kind of useful for figuring out who’s going to likely stand where I mean because they were pretty clear about where they stood, they haven’t read the whole report, they haven’t had the opportunity of all of our discussions or the arguments as they got onto paper and maybe that would persuade some of them but I’m guessing some of them will not be persuaded from where they originally started. But I found the discussion useful for that reason and frankly I thought it was sort of lively and fun and interesting and that’s sort of one of the things that they were looking for is to have a way of engaging on these issues and to get drawn on. And I think they’re less likely to have that, I mean they may just go off on their own anyway if we present it like that but the question is is that, if we do that again is going to be helpful to us or are we going to get a similar, I mean what’s your goal for coming out at the end of that hour?
MR. ROTHSTEIN: Well, I think it would be valuable, I’m trying to think what would help us get to June in the best shape and I think we’re going to stumble at B whenever we get to those issues because there were people at the meeting who were very vehement about their positions and we’ll just have to work with them somehow to show them that we have flexibility built in and so forth.
One possibility might be to go through C through F and if we could get some sort of, I don’t want a straw boat or anything like that but just sort of a nodding okay we’re sort of on the same page as the subcommittee then maybe when we get to June and get to those issues we’ll get like, they’ll cut us some slack at least on that section and we’ll just have to worry about B. If we had to go every section by section and just, it would just be awful. John?
MR. HOUSTON: First of all, again I’m going to go back, I think we really in large measure have consensus on B and I think present it at a high level as to what we do have consensus on, I think we can present it in a way that satisfies people’s concerns and I think we can look at each one of those sections, pick what out we think are the really the seminal recommendations in each section and try to focus on them, what our recommendation is and how it meets —
MR. ROTHSTEIN: Are you talking about tomorrow?
MR. HOUSTON: Yes, I think if we were to pick one or two key issues from each section and say hey here’s what it is, here’s where we think we’ve arrived at it as what needs to be done —
MR. ROTHSTEIN: We could say something like the report is, the way it’s structured we’ve got six sections and we don’t have the time to burden you with all the stuff, you’re going to get a report and so forth, but here are a couple of representative recommendations from each of the sections. Now is that what you’re —
MR. HOUSTON: Absolutely, yes, and by example you would say with regards to patient control, you could say we recognize this is a significant issue and a barrier and there are a lot of differences of opinion but what we think at a high level is, a couple different key concepts, the first concept is is that that the patient needs to have the right to opt in or opt out, so if a patient was so concerned about access through the NHIN they’ll always have the right to opt out. But, assuming that the patient opts in we believe that there should be some limited control over the information that the patient could have excluded, not be accesses or however we want to say it, from the NHIN, we believe that’s another fundamental principle. And between those two principles we believe that that does address at a high level individual’s concerns over the privacy of their data within NHIN.
MS. BERNSTEIN: The provider’s concerns that the EHR is available to them.
MS. HORLICK: And I think you could mention maybe also the recognition that there are certain core elements or something that would need to address the providers of the group that are concerned.
MR. HOUSTON: But you go back to them, but to the extent —
MS. BERNSTEIN: The most dissent we had was from the providers in that —
MR. HOUSTON: But I think what we’ve come upon is that there is a core set of elements that we do need to have access to but the point being at the end of the day, going back to Marjorie’s comment, we could say end of the day we’re advocating that there be an opt in or an opt out which does provide the patient at the end of the day the ability if they are so offended by or concerned about the access of their information within the NHIN they can always decide to take themselves out of it and that leaves them in no worse position then they have today with regards to their providers having access to their information.
If you present it that way I think that we can get consensus from the committee on B. Now if you look at each one of those other areas I think you can similarly pick out the one recommendation that may have some concern, present it in a way that I think we’ll achieve it, or maybe punt it to HHS if that’s the recommendation.
MR. ROTHSTEIN: Would you raise the issue, or should we raise the issue tomorrow about the fact that there are a number of areas where the subcommittee has not reached agreement and we’re not going to have recommendations, just finesse that until June?
MR. REYNOLDS: We’re coming in with a letter in June.
MR. HOUSTON: Yeah, I think we have to take that tack, and again, back to B, I think we have a lot more common ground then I think we think, I think we have a lot more people on the same page then we think. So I’m not sure whether we’re going to necessarily end up with areas where we have fundamental disagreement at the end of the day.
MS. GREENBERG: Two things, I mean there’s no hiding that obviously these are contentious issues and there isn’t all unanimity, but it may be kind of the way you spin it that there won’t appear to be as much lack of consensus as there may be at the detail level because there’s more consensus at the more general level.
I was thinking that if at the end of the day there are some areas where you just cannot agree but you feel you can’t just delete it, you’ve got to say something, it could be useful to ask them what they thought would be a more helpful approach, whether it should be a minority and a majority position, which we kind of don’t think so, but I mean don’t ask them to agree to things that I guess nobody thinks are real options, or punting as it were to the department, giving three options, I mean I don’t know, that could be an interesting discussion to see whether the other members feel there’s a good way to handle this.
The other thing I was going to say is that I think you could also in your letter ultimately kind of give yourselves the out to say at this point really we don’t know what the architectures are going to be, there are a variety of scenarios we have discussed, there could be other scenarios, these principles that we’ve laid out here may well play out differently in different scenarios. And when there are more concrete architectures to respond to we’ll come back, we’d like to come back —
MR. ROTHSTEIN: Right, I think that’s in the introductory page.
MS. GREENBERG: It might be there, but I think that’s really important because there will be I’d say in the next, by the end of the year there will be some more concrete architectures actually being recommended and then it won’t be so hypothetical and then you could come back to the principles and say, because I still think there’s, when there’s only one record and it’s invisible whether it’s Dr. Jones’ record or the whole institution’s records or the whole health plan’s record, some of this stuff doesn’t work.
MS. BERNSTEIN: Just in terms of how much lack of consensus you want to describe or show to the committee, I’m thinking none —
MS. GREENBERG: Not too much at this point.
MS. BERNSTEIN: I mean in order to be, my sense is as a sense of strategy that in order to be successful at getting a letter through the committee the subcommittee has to present itself as a unified group and once it is presented in front of the committee then whoever is making the presentation that’s it, the chair or whoever can respond to questions or whatever —
MS. GREENBERG: The areas where we’ve agreed to disagree —
MR. ROTHSTEIN: Yeah, but I mean there are several of them that we’re going to, everybody is going to be on board —
MS. GREENBERG: But everyone will be —
MS. BERNSTEIN: That’s what I’m saying, this isn’t agreement now and the way we’ve decided to resolve it is to punt, ask for research, or a study, that’s an agreement at that point, it’s not any longer a disagreement.
MS. GREENBERG: I mean the worst —
MS. BERNSTEIN: But your point about spin is exactly right, agreeing to disagreement, that’s agreement.
MS. GREENBERG: No, I mean the worst thing I ever sat through from the point of view of presenting a report is when the chair was not there and so another member presented the report, none of you may have been on the committee at the time, and started disagreeing with the report. And I’m like get me out of here, it was painful, I mean there was no prayer.
MS. BERNSTEIN: The PHR letter there was more, as I recall there was more then one meeting of the full committee in which they discussed it, right, and if they’re only going to see the actual text before one meeting and you expect action on it in June it’s even more important I think to have a kind of a unified front before the committee and have within the subcommittee even though it’s on the record have our disagreements aired here which we are clearly able to do.
MR. ROTHSTEIN: Let me, I think you’re exactly right on that. I want to suggest what we’re going to do tomorrow, a strategy for the hour. If you would be willing to support this we’ve got six parts to present and I’d like to assign different people to present the A, B, C, D and so forth —
MS. BERNSTEIN: You want to present all six.
MR. ROTHSTEIN: Well, I don’t want to present all six, I want somebody —
MS. BERNSTEIN: You want somebody to present all six.
MR. ROTHSTEIN: Yes, I want the whole to be presented, I think that was the consensus, but I’d like to not allow questions until we’re done because we’ll only get through A if we allow questions and comments. So we’ll all take three to five minutes to make some points about A, B, C, D, E, and F, and then the floor will be open and people can discuss any aspect that we mentioned. Harry?
MR. REYNOLDS: I would like to see you present it and let me tell you why I say that, just have Mark present, I believe tomorrow we’re telling a story about what we’ve seen. Last time we did it I thought it was excellent to split it up, total agreement, and I can tell you what, it’s got nothing to do with wanting to do it or not, I’d be happy to do it if that’s what comes out of here. But I think tomorrow especially since it’s the last time we’re going to see them before June we got to start weaving a consistent story and I’m very comfortable that you more then anyone have put the time and effort into have that consistent story. I also am very comfortable that you can position this in the right way based on what we’ve tall talked about because again, chairing Standards and Security Jeff and I can usually talk dramatically different about something then one of the committee members who comes into the meeting or out of the meeting and is not working on it all the time in between, which most of us do. So I would actually vote exactly the same way if it my committee that I’m chairing with Jeff. So I think it’s time to now pull it back together, give them the picture, and then obviously as discussion comes up you can defer to anyone you might want to deal with that but I think if, now, if we had a couple more times where we’re going to see them before June I would have just said fine, I’ll be happy to present whatever, but I think that that one picture now says this is what you’re going to see, here’s who we are and what we are, what we’ve done, what we think, and that’s how it’s going to come back in once piece when it comes back to you so that would be my recommendation.
MR. ROTHSTEIN: Well I would happy to do it, the reason that I suggested everyone to do it was so that it shows everyone’s part of the process but I would do it. I would request the following, I will do my very best to present it, not all of this but highlights of this in a way that reflects all of our views and not to try to spin it in my direction —
MR. REYNOLDS: You don’t even have to say that, we accept that.
MR. ROTHSTEIN: No, but what I would like you to do is if I slip up somewhere in a minor way don’t chime in Mark didn’t get it quite right, correct me later, we’ll work it out, but to have the committee members starting to disagree even on emphasis, I think it’s a bad time to start doing that.
MR. REYNOLDS: When I recommended that what I’m recommending is that we unanimously agree with whatever you’re going to say tomorrow, period.
MR. HOUSTON: Let’s state that a little bit differently, we as a committee should not be asking questions and voicing concerns about this document tomorrow, I think we have to be —
MS. GREENBERG: Or about his presentation.
MR. REYNOLDS: That is my point, that’s exactly right.
MR. HOUSTON: We need to have a consolidated front, I think we’ve had a dialogue in here, we have good faith difference of opinions, I think less then we think, but I think once we start, if we start picking our own stuff apart at any point it’s just opening a door for more dialogue.
MR. REYNOLDS: That’s what I’m saying is we are voting you to represent the committee and the rest of us have nothing to say tomorrow unless you call on us, and we got to make sure we talk to Simon. I didn’t say that for any reason other then he’s not here voting unanimously —
MS. BERNSTEIN: Well if you look at his notes, too, I mean I think given that he hasn’t participated as fully, hasn’t been able to participate as fully as everyone else I think he will defer for now to that and he sort of says in his email, he puts his comments on paper given where he is right now, I don’t want to put words in his mouth but there they are.
MR. ROTHSTEIN: Okay, so we’ve taken of what we’re going to do tomorrow. How are we going to proceed between tomorrow and June? We’re going to need probably another at least conference call or more to take care of lots of the details, so we’re going to have to send around some schedules —
MR. HOUSTON: Can I suggest, because I think it’s best if we have Simon and Paul at the table rather then on the end of the phone, if they’re going to be here for other meetings that we might try to take advantage of their being here in D.C. if possible —
DR. TANG: You want to have it face to face is that what you’re saying?
MR. HOUSTON: My preference would be, I think we do better face to face. If you were going to say I’m going to be D.C. in April that we look at those dates to preference to pull it together.
MR. ROTHSTEIN: Can we go off the record please?
— [Brief off record.] —
MS. BERNSTEIN: We’re going to move on with section —
MR. ROTHSTEIN: No, we’re going to finish up the introduction and Section A —
DR. TANG: So the first time you use NCVHS needs to be written out, at the bottom of paragraph one, so write that one out and so you don’t have to write it out —
And may I just do a little wordsmithing of the first sentence of the third paragraph, because you said some people have suggested that there’s a fundamental conflict and again that brings up conflict, how about the NHIN, there is tension between individual interests and privacy and confidentiality —
MS. GREENBERG: But maybe what you’re saying is that people have suggested there’s an irreconcilable conflict —
MR. ROTHSTEIN: Well people have said that but I go on to say but that’s a false dichotomy —
DR. TANG: But why set ourselves up in your opening paragraphs, why get them into battle —
MS. GREENBERG: Why don’t you make it positive, say the national committee does not believe that there is a fundamental conflict —
DR. TANG: Good, NCVHS recognizes the difficulty of balancing the interests, start with that sentence, forget about the people —
MR. ROTHSTEIN: So drop the first sentence?
DR. TANG: Dropt the first sentence and just start out NCVHS recognizes the difficulty in balancing the interests of privacy and confidentiality against health care economic and societal benefits —
— [Multiple speakers.] —
MR. HOUSTON: On the paragraph before, the first sentence, the report uses some other terms with defining, I’m thinking that’s sort of, I’m not sure how to restate it other then, but that was my only comment —
MR. ROTHSTEIN: Okay, delete that sentence. So is there anything else in the introduction, everybody okay?
MR. HOUSTON: No, I have a couple more comments.
MR. ROTHSTEIN: In the introduction, okay.
MR. HOUSTON: Bottom of page two, paragraph starting throughout our hearings, there’s a point where you say as availability of information increases, and I’m not sure whether it’s worth clarifying what we mean by availability of information, is that type, is that quantity? When I read it I kept thinking okay what are we talking about and I’m not sure, I just raise that as a comment. And also when you talk about availability aren’t we really, since we’ve already defined personal health information shouldn’t we say availability of personal health information increases?
MR. ROTHSTEIN: As availability of personal health information increases?
DR. TANG: Or as more personal health information becomes available online, isn’t that what we’re saying?
MR. HOUSTON: Yes, available broadly online or widely online. My thought it is —
MS. GREENBERG: Online sounds like anyone can get it —
MR. HOUSTON: When I read availability of information I think that there’s, I’m not sure in what context we’ve, it’s more broadly available —
MR. ROTHSTEIN: Electronic health information?
DR. TANG: As more personal health information becomes available electronically —
MR. ROTHSTEIN: As more health information becomes available in electronic form —
MR. HOUSTON: Personal health information becomes, because we’ve defined personal health information.
MS. BERNSTEIN: As more personal health information becomes available in electronic form —
DR. TANG: — electronically, we must be careful to protect it’s confidentiality.
MS. GREENBERG: Why can’t you keep what’s there? It may have greater utility but it also poses a greater threat to privacy —
MR. HOUSTON: Then in the next sentence, similarly giving patient choices, rather then saying means, results in a more complicated health information system, and I’m going to say put or architecture at the end, or something, because it’s the framework that becomes more —
MS. BERNSTEIN: Architecture is too technical for that though, you mean the system, not just the architecture we mean the management, the human capital, we mean the whole —
MR. ROTHSTEIN: It puts greater demands on providers, on patients —
MR. HOUSTON: Okay, I just want to write complicated health information system, something is dangling.
MR. ROTHSTEIN: We could say makes health care more complicated —
MR. HOUSTON: The more requirements you put in place for this system the more complicated the system —
MR. ROTHSTEIN: No, that’s actually not what I meant, what I meant is the following, we want to give people choices and the word choices replaced autonomy in an earlier version, remember. To give people greater autonomy means you have to have a more complicated system to allow them to exercise all these various choices that they’re making. So you can’t just, you’re not going to be able to give them autonomy as an absolute, we’re going to have to trade it off because we’re interested in not making the system so complicated.
DR. TANG: So is it possible you could, I don’t remember whether you discussed this in more detail somewhere else but the single sentence doesn’t do it justice and I think the longer one doesn’t belong in an introductory paragraph, explaining the whole thing I think would be too complex to put in your opening section, if you explain it somewhere else —
MR. ROTHSTEIN: I’m talking about the tradeoffs —
MR. HOUSTON: Can we change system to environment maybe? Because that I think more captures what you’re talking about, when I see system I think of the architecture, the technical system, maybe environment, I think that’s what he’s talking about —
DR. TANG: No, he’s talking about the application.
MS. BERNSTEIN: Paul is talking about more then that, he’s talking about organizational structure, he’s talking about management, he’s talking about —
MR. ROTHSTEIN: I’m not getting this point across too well —
DR. TANG: Are we sure we shouldn’t use the Marjorie rule? Because if we can’t clarify it —
MR. ROTHSTEIN: Oh, I’m going to clarify it, I think it’s an important point because we’re saying that this whole area involves tradeoffs and two of them are more information is good because it allows us to do better things and have more efficient health care and better health care and all this other stuff, but it also threatens privacy, and also giving people more choices is good to an extent but a system with lots of choices built in gets very complicated which is not so good. Choices, opt in, opt out, block this, those sort —
MR. REYNOLDS: I understand what they are, you put them in this paragraph and you tell people they got choices, I’m reading this, I don’t know what you’re talking about.
MR. ROTHSTEIN: All right, so let’s go back to the question, is it worth making the long version here or should we just drop it?
MR. REYNOLDS: I thought if you just stop before you got to choices, I like the paragraph.
DR. TANG: That’s exactly right. It’s all about use of information and the protection of it, yes, I understand this is what we’re setting up.
MS. BERNSTEIN: So end after a greater threat to privacy and confidentiality?
MR. REYNOLDS: Because we spend plenty of other time in the document talking about —
MS. HORLICK: You might be able to insert this sentence later when you’re actually discussing the issue, just move it.
DR. TANG: And you can actually, short paragraph, you can add the next paragraph, the next paragraph can be brought into this one.
MS. GREENBERG: Yes, well you can say this, so you could have that sort of general statement as availability of, well, as information becomes more available in electronic form or whatever you were saying, it may have greater utility but it also poses a greater threat to privacy and confidentiality. And then you could say this report or something addresses the issues and the tradeoffs as, are you ever saying or was that only in the opening, because sometimes this gets separated from the letter so you might want to say something about openings, this reflects discussions about these, testimony we received, the national committee received during 2005 about these issues in the following six areas or something like that, because otherwise you haven’t said anything except in the little letter about the hearings.
MS. BERNSTEIN: Where would you like to put that in?
MR. ROTHSTEIN: In this paragraph —
MS. GREENBERG: And then bring in that and then it’s a reasonable paragraph.
MS. BERNSTEIN: The report addresses, mine now says addresses the issues and the tradeoffs inherent in resolving these policy choices, contains the following, you want to put in discussion about our procedural approach —
MR. ROTHSTEIN: You could just put this report based on a series of hearings in 2005 from the various parties and stakeholders —
MS. GREENBERG: I think you do have to give yourself some legitimacy here, that you heard from people and then you adjusted it —
MS. BERNSTEIN: There probably needs to be a procedural thing that explains in the report more fully exactly what we did.
MR. REYNOLDS: You might want to also mention in there that we did leave Washington.
MR. ROTHSTEIN: Oh yes, that’s right, including in Chicago —
MR. REYNOLDS: I think that’s a real good point to make right there.
MR. ROTHSTEIN: John, did you have anything else in the introduction?
MR. HOUSTON: No.
MR. ROTHSTEIN: Okay, we’re now to A.
DR. TANG: Just have a couple minor, I only had a couple, I thought it was very well done. At the bottom of three, last paragraph in the middle because you talk about how when everything was on paper it was protected and I don’t think that’s quite, I know what you mean but you might modify that so, precisely because it was access, the second sentence —
MR. ROTHSTEIN: You mean are thereby inaccessible is what you mean, right, instead of protected, last paragraph on three —
DR. TANG: Precisely, okay, so you’re saying confidentiality are thereby protected or modify it, comma, albeit in an arbitrary fashion or something.
MS. BERNSTEIN: Precisely because comprehensive health information is difficult to access, compile, use and disclose, is that where you are?
MR. HOUSTON: I had the same comment, I thought the word achieved may be better then protected —
DR. TANG: But you didn’t achieve it deliberately, my point of the arbitrarily got theirs because it wasn’t by design is just you couldn’t get, it was inaccessible.
MR. HOUSTON: I think a bunch of HIM people would probably tell you that it’s also purposeful that they achieved privacy through their manual processes.
DR. TANG: His point is that you can’t do anything with the paper, I don’t think that was deliberate.
MR. ROTHSTEIN: Okay, so we’re going to do something to the end of this —
MS. BERNSTEIN: Thereby protecting you don’t like —
MR. ROTHSTEIN: It’s not protected, it’s not available, but Paul wants to get in that it’s not, it’s the result.
MR. HOUSTON: That’s why I used the word achieve because it happens but it doesn’t necessarily mean, protection is a byproduct, or occurs, maybe occurs.
MR. ROTHSTEIN: Okay, Gail, you had some stuff.
MS. HORLICK: Well going back to the first paragraph, the sentence that begins with many individuals, I thought or at all including with friends, I thought that was a little awkward, I’m not even sure you need the word including, many individuals believe, there are things they don’t want to share widely or at all, comma, with friends, family members, or even their physicians —
DR. TANG: How about even with friends, family members or physicians?
MR. ROTHSTEIN: Even with friends, family members or their physicians?
MS. HORLICK: Right, I think the including is not necessary.
MR. ROTHSTEIN: We’re going to take out including —
MS. HORLICK: And in the next sentence, similarly many people are quite concerned, I inserted about the potential ramifications —
MS. BERNSTEIN: Even with friends, family members or their physicians, similarly many people are quite concerned about the potential ramifications if employers, insurers, and other third parties —
MR. HOUSTON: Have access to their personal information and I put in parens including personal health information closed paren period. Because we talk about personal health records, or personal health information definitionally then we use their health record, so I just want to be consistent, I think there’s a lot of discussion about a variety of types of information, we heard people are concerned about their employers and others, maybe not employers but others knowing about their financial information and so I think the point I’m trying to make here is that their concerns include personal health information —
MS. BERNSTEIN: We’re talking very generally in this paragraph, public opinion surveys, we’re sort of starting from the general and getting to the more specific.
MR. HOUSTON: Now can I go back to that second sentence, public confidence surveys? It’s actually consistently confirm the value of privacy to the public, I thought that was better then important —
MS. BERNSTEIN: Well value applies —
MR. HOUSTON: Again, when I read through it I thought value sounded better but you can decide.
MR. ROTHSTEIN: Anything else? Okay, second paragraph —
MS. BERNSTEIN: Does anybody else have anything on this paragraph?
MR. ROTHSTEIN: Do it one paragraph at a time, I’m sorry. Okay, second paragraph? As a practical matter? John?
MR. HOUSTON: First sentence, as a practical matter, the ability to disclose sensitive potentially embarrassing information to health care providers is I would say often essential to obtaining appropriate treatment, period.
MR. ROTHSTEIN: Okay. Gail?
MS. HORLICK: And then in the next sentence, allows, and then, confidence in the rules allows individuals to share information, and limits on disclosure, I wrote are designed to protect individuals because I don’t know that we can absolutely say that they always protect.
MR. HOUSTON: I have questions about that sentence, I don’t like the word allows, I was thinking, and I don’t know of a good word other then I thought of facilitate but I’m not sure that’s even a good word, confidence and health, privacy —
MR. ROTHSTEIN: Encourages?
MR. HOUSTON: Encourages individuals, there’s you go, thank you. And then at the end of that sentence you say personal information, I think you should say personal health information.
MS. BERNSTEIN: Encourages individuals to share information and at the end —
MR. HOUSTON: Personal health information.
MS. HORLICK: And in the next sentence privacy and confidentiality —
MS. BERNSTEIN: Before we go there, personal health information, what do we use in HIPAA? We use personally identifiable, we took out the technical term from HIPAA, right?
— [Multiple speakers.] —
MR. HOUSTON: We defined personal health information in the second paragraph of the introduction, so I’m just trying to use the defined term —
MS. BERNSTEIN: I remember we did something to that on purpose —
MR. HOUSTON: I just want to use the defined term since we are talking about health.
MR. ROTHSTEIN: Harry, we’re in Section A —
MS. BERNSTEIN: Paragraph two, unless you have something on paragraph one, in that case we’ll go back for a moment.
MR. ROTHSTEIN: Then are we done with two?
MS. HORLICK: I just have one more thing on two, privacy and confidentiality, I thought it was missing a word like safeguards or protections or something —
MR. ROTHSTEIN: Protections?
MS. HORLICK: Yeah, I mean it’s not the confidentiality, it’s the safeguards —
MS. BERNSTEIN: I would say in fact it is —
MS. HORLICK: You think we don’t need it?
MR. HOUSTON: It’s a confidence, towards that last sentence we say confidences in health privacy and confidentiality, same thing, it’s the confidences in privacy and confidentiality that promote —
MS. HORLICK: It seems like it’s just not privacy and confidentiality —
MR. ROTHSTEIN: All right, we’ll put that in, privacy and confidentiality, what was the word we wanted then?
MS. HORLICK: I had suggested maybe safeguards or protections —
MS. GREENBERG: Can you talk about privacy safeguards?
MS. BERNSTEIN: It’s not, see I disagree with that, I think, it’s not the safeguards that protect it, it’s the fact of having confidentiality and being able to be candid with your providers that actually promotes the public health, it’s not the fact that we have technical, managerial or administrative safeguards it’s that we have confidentiality.
MR. HOUSTON: But, but, I think the concept here is that when you deal with confidences if the patient’s perception is that it’s not confidential no matter how confidential it is they will have misgivings about wanting it to be available. So really the trust issue —
MS. BERNSTEIN: Safeguards are more important whether or not they work is what you’re saying.
MR. HOUSTON: No, safeguards are more important —
— [Multiple speakers.] —
MS. HORLICK: Well maybe it doesn’t fit with privacy but I think, I understand what you’re saying and I don’t have hugely strongly feelings about it but I do think that it is a perception —
MS. GREENBERG: Assurances of confidentiality or something but I mean it’s confidentiality that promotes public health I think.
MR. HOUSTON: Again, we could have confidentiality but if there is no, if the public is not, what’s the word, if they don’t feel it’s confidential even if it is there are going to be concerns about availability of information. I think that’s a lot of —
MS. HORLICK: Yeah, it’s not all the technical safeguards —
MS. BERNSTEIN: I think it’s both things though, right, so maybe we need to add that, you want actual working privacy and confidentiality rules and you want people to know that they’re in place and that they work. So it’s all those other things, education, public information, a feeling of confidence, maybe that’s not the right word —
MR. HOUSTON: Can we merge the last sentence with it? Confidence, health care, privacy, health privacy and confidentiality rules, what’s the word we decided here? Mark, was the word we used —
MR. ROTHSTEIN: Protects, safeguard, encourages.
MR. HOUSTON: Encourages individuals to share information that they would not want publicly known, limits —
MS. BERNSTEIN: Limits on disclosure, that’s another, it’s an independent clause —
MR. HOUSTON: Oh, I’m sorry, I was just trying to think of where to merge, by sort of making public health be another category —
DR. TANG: Can I make a simpler sentence like confidential reporting is an essential tool for promoting public health —
MR. ROTHSTEIN: It’s confidentiality because you get, the decision whether to seek treatment, when you’re potentially contagious with a communicable disease —
MS. HORLICK: I think you guys could probably read it over later.
MS. GREENBERG: I think you could delete that and say, just say the risk to other members of the public also is reduced when individuals with potentially contagious or communicable disease are not inhibited from seeking treatment.
MR. ROTHSTEIN: Okay.
MS. BERNSTEIN: I need Marjorie to repeat that —
MS. GREENBERG: The risk to other members of the public —
MS. BERNSTEIN: Where do you want to put this?
MS. GREENBERG: For the risk to public health or something, risk to public health, or the health of the public, the risk to the public’s health also is reduced when individuals with potentially contagious, and that kind of gets in the idea of public health, or communicable disease are not inhibited from seeking treatment. So it just, the risk to the public’s health also is reduced when —
MR. ROTHSTEIN: And a period after the word treatment.
MS. GREENBERG: And just get rid of that other sentence. Then it’s the same, when individuals through treatment.
MR. ROTHSTEIN: Okay, Gail, you had something in the third paragraph?
MS. HORLICK: No.
MR. HOUSTON: It says people differ widely in their views regarding privacy and confidentiality, comma, and individual opinions may be influenced by —
MR. ROTHSTEIN: How about and their opinions —
MR. HOUSTON: And their opinions may be influenced by, and I think we need to insert here something like the individual’s health condition or as a result of cultural, religious or other beliefs.
MS. GREENBERG: Now when people really, I don’t want to be picky here but if you’re saying that there’s something different between privacy and confidentiality then to complete, to always use them as if they’re synonymous is sort of problematic. I mean I wonder if what people really differ widely is in their views regarding privacy.
MS. BERNSTEIN: I already lost that argument, Marjorie, about a month ago.
MS. GREENBERG: But I mean do people really differ as to the obligations of those who receive information to respect the privacy interests of those which the data —
MS. BERNSTEIN: They disagree in this room, sure. They certainly disagree among the committee members. People differ widely in their views regarding —
MR. HOUSTON: Privacy and confidentiality, comma —
MS. BERNSTEIN: And individual opinions, you want to take out the possessive —
MR. ROTHSTEIN: That’s fine.
MR. HOUSTON: Individual opinions may be influenced by, this is where I added the individual’s health condition, or as the result of cultural, religious or other beliefs. The only reason I put as a result of is because there were two or’s there, there was an or before cultural and then there was an or before other beliefs, so I thought that it —
MR. ROTHSTEIN: How about as well as?
MR. HOUSTON: That’s fine, I just, either way, but the point that I think is important here is if health care conditionals are often why people decide, make decisions about privacy and confidentiality, not just cultural. That’s all I had in the that paragraph.
MR. ROTHSTEIN: Anyone else? Paragraph three? Okay, paragraph four?
— [Multiple speakers.] —
MR. ROTHSTEIN: We’re trying to get the discrimination issue —
DR. TANG: Can we state it more directly?
MR. ROTHSTEIN: I suppose. This is a paragraph that originally failed the Jeff test because it had autonomy, beneficence, non-malfeasance, justice and all these other terms —
MS. BERNSTEIN: He didn’t like any of them.
DR. TANG: The quality of opportunity may not be discrimination —
MR. ROTHSTEIN: Well, that’s justice.
MR. HOUSTON: Should be equal access is advanced, access to health care?
MR. ROTHSTEIN: No, it’s not just, this employment, insurance, mortgages, how about furthermore limiting excessive and unnecessary disclosure of health information helps to prevent health based discrimination.
MR. HOUSTON: Yes.
MR. ROTHSTEIN: Limiting excessive and unnecessary disclosure of health information —
MS. BERNSTEIN: Can result in health based discrimination, just like that?
MR. ROTHSTEIN: No, no, it’s backwards, helps to prevent, limiting unnecessary, helps prevent health based discrimination.
Now in the fourth paragraph I have a sentence I’d like to add, okay in the fourth paragraph I have a sentence I want to add at the end —
MR. HOUSTON: Can I do number four? Absolute I thought should be plural, privacy and confidential are neither new concepts nor absolutes, I just thought it, that was my only comment there.
MR. ROTHSTEIN: Okay, and the sentence I want to add at the end is we talked about the Hippocratic Oath, blah, blah, blah, and now I say, now I want to add comparable provisions are now contained in the codes of ethics of virtually all health professionals, the slow version is comparable provisions, referring back to the Hippocratic, are now contained in the codes of ethics of virtually all health professionals.
MS. GREENBERG: Going beyond physicians you’re saying.
MR. ROTHSTEIN: Yes. I’ve got nurses, dentists, physical therapists, they all have, last paragraph on three —
MS. BERNSTEIN: Does anybody else have anything on that paragraph?
MR. HOUSTON: I have a comment on the last paragraph on three, again wordsmithing, the third sentence —
MS. BERNSTEIN: Is that the one that begins one of the major weaknesses? It’s no longer, it’s no longer on page three for me because we’ve added things —
MR. HOUSTON: The third sentence is precisely, because public health information is difficult to access, compile, use and disclose, health information, privacy and confidentiality are thereby, I don’t want to say protect —
MS. BERNSTEIN: Now it says occurs by default.
MR. HOUSTON: Never mind, never mind.
MR. ROTHSTEIN: Next? Do you have anything else in that paragraph?
MR. HOUSTON: I do, end of the paragraph, end of the very last sentence, in place, I would just think of a better word in place, a phrase, I’d maybe sure ensure, adopted, mandated, in place —
MR. ROTHSTEIN: It’s a little slang I think. Established, maintained —
MR. HOUSTON: Right, or something that’s —
MS. BERNSTEIN: I got it, I’ll work on it.
MR. ROTHSTEIN: Anything else in that paragraph? Next paragraph, in an age?
MR. HOUSTON: Here’s a case where we actually ourselves mixing terms, in the first sentence you used the phrase safe and secure, EHR systems depend on public confidence and trust that their information, should we simply say is kept confidential? Because we’re not, we’ve already said we’re not talking about security —
MR. ROTHSTEIN: Are you talking about the first —
MR. HOUSTON: First sentence, third line, safe and secure, it’s kept confidential.
MS. BERNSTEIN: Security lapse is only one part of that is what you’re saying, right?
MR. ROTHSTEIN: Okay, here’s what I’m trying to say, even though we’re not talking about security in this report much of the public equates security with privacy and that the lapses in security in banking and other areas that are widely reported undermines public trust sort of across the board. Now I may not have said that well but, I mean expressed that, but that’s the thought I’m trying to get it.
MS. BERNSTEIN: And it’s also not confidential.
MR. HOUSTON: If you say their information is safe and secure and just replace that with is kept confidential —
MR. ROTHSTEIN: That’s narrow, that deals with their disclosing to the right people —
MS. GREENBERG: How about just saying is protected?
MR. HOUSTON: Protected is good, okay, that’s fine.
MR. ROTHSTEIN: Sold.
MS. BERNSTEIN: What are we sold on?
MR. ROTHSTEIN: Instead of safe and secure we’re going to make that projected.
MS. BERNSTEIN: The information is protected —
MR. ROTHSTEIN: So that’s safe from hackers and safe from wrongful disclosure and everything. Anything else in A?
DR. TANG: Right before that part of the sentence, public support for a comprehensive, you have EHR system, sounds like the big EHR system in the sky and might suggest comprehensive network of interconnected EHRs —
MS. BERNSTEIN: That sounds worse if you’re a consumer, everything is connected to everything else.
MR. HOUSTON: Well this is a report about the National Health Information Network, why don’t we say public support for the National Health Information Network depends on public confidence?
MR. ROTHSTEIN: That’s the way it was originally.
MS. HORLICK: I heard on an ASTO call that they changed, they said that someone else changed the terminology to nationwide, I don’t know if that was true. Do you have any idea what the politics on that was?
MR. RODE: Because nationwide doesn’t make you think federal.
MS. GREENBERG: But it sounds like an insurance company.
MR. ROTHSTEIN: So we’re going to have to change our report, it’s now on the nationwide, is that official?
MS. HORLICK: It sounded like it was official.
MR. HOUSTON: We need to completely go through testimony all over again and see if people can comment on that.
MR. REYNOLDS: One thing I want to make sure that we do in the entire document based on this particular question is we use personal health information, just to right near the end read it one more time to make sure that people don’t get EHRs, PHRs, I mean really read it, maybe even have somebody that’s not part just look it over one more time and make sure that we don’t confuse people. Because the whole thing with personal health information versus a personal health record versus EHR versus, just to filter it one more time once we get it all together.
MR. HOUSTON: Unfortunately we’re running out of descriptive phrases —
MR. REYNOLDS: No, I know, but some of them are becoming terms of art and as soon as they do it pops somebody into a whole different thought process.
MR. ROTHSTEIN: I have a couple of other things to ask you about.
MS. HORLICK: Are you still on that paragraph?
MR. ROTHSTEIN: I think we’re done unless you’ve got something.
MS. HORLICK: Well, I had the same question where it says incorporating privacy and confidentiality, I didn’t know if we needed the word protections but maybe you don’t want it there.
MS. BERNSTEIN: Where are you?
MS. HORLICK: The very last —
MR. ROTHSTEIN: The health care industry must commit —
MS. BERNSTEIN: To incorporating privacy and confidentiality practices —
MS. GREENBERG: It does need —
MR. ROTHSTEIN: Measures?
MS. BERNSTEIN: Measures? What word do you like?
MS. GREENBERG: Measures is too weak.
MS. HORLICK: I think protections.
MS. GREENBERG: Protections is okay, it ties in with the thing before about being protected.
MR. ROTHSTEIN: If it doesn’t sound right we’ll change it later.
MS. BERNSTEIN: Safety, safe and secure, we changed that —
MR. ROTHSTEIN: Safe and secure we changed to protected.
MS. BERNSTEIN: Protected, we like that word. So now it says, but right after that it says will not be disclosed without their consent so we were discussing whether the right word is confidence and trust that their information is protected, does that mean something different then won’t be disclosed without their consent?
MR. ROTHSTEIN: Well maybe we ought to put a period after protected. See we wanted to get security and confidentiality —
MS. BERNSTEIN: That’s why we put it there, do you want to re-look at it in light of the whole sentence?
MR. ROTHSTEIN: In the in an age paragraph it says that it depends on public confidence and trust that their information, the way it was originally was is safe and secure, hence the security satisfied, and will not be disclosed without their consent, meaning confidentiality is protected. When we changed it we made it is protected and will not be disclosed without their consent, so we lost the security aspect and now we’ve got two sort of confidentiality words.
MR. HOUSTON: Protected doesn’t necessarily mean, I think it’s also security —
MS. GREENBERG: I would just say is protected because frankly some of their information is going to be disclosed without their consent, we know it, I mean it’s HIPAA.
MR. REYNOLDS: I had said after you got through these I wanted to make a recommendation. The one thing that still worries me about us finishing for June is Paul’s chart, the chart that’s up there, and I would like to spend at least ten or 15 more minutes either agreeing or disagreeing with that chart because that again is the basis for us being able to agree —
DR. TANG: Do you think the chart stands in the way or facilitates?
MR. REYNOLDS: I am comfortable with the chart, I want to understand if everybody else is comfortable —
MR. ROTHSTEIN: I want to walk through the chart —
MR. REYNOLDS: That’s what I’m saying because I think, again, if we’re not going to see each other and we’re not, and we’re going to be on the phone, we’re not going to see that on the phone and we’re not going to be able to really agree or disagree with what we’re saying as a philosophy and that’s the only thing that worries me about finishing.
MR. ROTHSTEIN: Let me run through a few more things and then we’ll spend the rest of the time doing that.
MS. BERNSTEIN: What else do we have to do —
MR. ROTHSTEIN: Well, here’s what I want to do, I want to see if I can get agreement from the subcommittee members that the next version of the draft that you see will have the recommendations interspersed in the text where they appear. Second, the next version that you will see will take the enforcement principles on page 12 and turn that into text, because they’re just like bullets now and that was sort of an add on and it was never made into text so we will do that and you’ll have an opportunity to —
MR. HOUSTON: Can I make a comment about a couple of these? Just in reading through it —
DR. TANG: More then a couple?
MR. ROTHSTEIN: The principles?
DR. TANG: I’m not sure I was after that, you think was approved on the call?
MS. BERNSTEIN: No, this came up, we came up with this during a meeting in which, it was right here in this room and we were having a discussion about the enforcement provisions and every time the group came up with something that I thought was one I stuck it on a list and then I refined the list —
MR. ROTHSTEIN: There are a lot of things here that I don’t agree with either.
MS. BERNSTEIN: These are all possible, not things we agreed on but possible things that either should be discussed, reviewed, whatever, but that are in the nature of enforcement, that’s all that is. Please tell me what page you’re on.
MR. ROTHSTEIN: Used to be 12, at the bottom. There are a couple of things I would like —
MS. BERNSTEIN: These are only potential ideas, they’re not anything that we necessarily agree on.
MR. ROTHSTEIN: I would like to start at the bottom and work my way up crossing off stuff, does that sound okay?
DR. TANG: I chair call five, is that —
MS. BERNSTEIN: Do you have a place for that call set up already?
DR. TANG: No, can I stay here or move —
MR. ROTHSTEIN: We’ll get you an office. Let’s start at the bottom and work our way up. Is there anyone who wants to defend the last one?
MR. HOUSTON: No.
DR. TANG: No.
MR. ROTHSTEIN: Okay, so that’s gone. Is there anyone who wants to defend the next, do you know where we are Marjorie? We’re on 12, enforcement principles from October 21st discussion —
MS. BERNSTEIN: Pooled compensation, anyone?
MS. GREENBERG: Who didn’t defend what?
MR. ROTHSTEIN: We are starting at the bottom and working our way up because they seem to be sort of farther out the farther along we go. So we’ve deleted the last two. Anyone want to defend the third one up? You want arbitration?
MR. HOUSTON: I think arbitration is actually a good concept, but I think it’s not just commercial users, NHIN should make provisions to be part of the system, I just think that there should be a, generally speaking there should be some system of arbitration available —
DR. TANG: Where are we basing this off of?
MR. HOUSTON: These are recommendations, doesn’t have to be a hearing for it, we decided this relates, generally the concept of enforcement and I think these were just concepts we’re trying to —
MS. BERNSTEIN: We did hear from people who were. at least one patient advocacy group complained that they have these arbitration clauses that require them to have binding arbitration, they are prevented from getting into court and so forth. Did we hear, am I mixing it up with something else?
MR. HOUSTON: And by the way, we don’t have to require this either —
MS. BERNSTEIN: Right, if it’s available it’s not the same.
MR. HOUSTON: Like in our health system patients have available to them the right of arbitration, or mediation, it’s not mandatory, it’s something that they can choose to go through —
MR. ROTHSTEIN: Well, I have a proposal, how about this? We can debate the merits of this stuff individually if you want but I would recommend that we keep the first two and that —
MR. HOUSTON: I think we should merge the first two.
MR. ROTHSTEIN: Well, or merge the first two, and that we merge the rest as options to consider —
MS. BERNSTEIN: Remedy? Any kind of remedy?
MR. ROTHSTEIN: In other words individuals should be entitled to some remedy for disclosures and among those possible remedies are the following, just set that out, because we’re never going to get agreement on that.
MR. HOUSTON: I’m not in agreement of, we did talk about compensation didn’t we?
DR. TANG: Should be compensated for actual harms, how is that different from remedy?
MS. BERNSTEIN: A remedy could be an apology, a remedy could be, it doesn’t have to be compensation —
DR. TANG: Which may include compensation for actual harm.
MR. HOUSTON: Yeah, I know where this came from, I did agree with this, if there is actual documented harm —
MR. ROTHSTEIN: Somebody lost their job, their insurance, their whatever —
MR. HOUSTON: That we agreed that that was something that should be considered.
MR. ROTHSTEIN: But what I’m saying is rather then, I don’t want to, I have some problems with arbitration but I don’t want to rule it out, I don’t want to endorse it but I don’t want to rule it out either so I’m happy to say that there are —
MS. BERNSTEIN: This just says commercial users should be part of a system that’s available, it doesn’t say we should use it or not it just says on the commercial side if somebody —
MR. HOUSTON: I don’t even think it should be commercial, but I like Maya’s point, mediation, non-mandatory mediation should be available as a means to, I really think that there’s a value to that and I just think —
MR. ROTHSTEIN: I think politically that’s raising a red flag that we don’t need to.
MR. HOUSTON: Why?
MR. ROTHSTEIN: Because I think whenever you say that you have to have any form of alternative dispute resolution it implies that it’s in place of your other legal rights —
MS. BERNSTEIN: Mediation is not.
MR. HOUSTON: We could say offer, we should say that providers should be encouraged to offer mediation, or a system of mediation to discuss disputes regarding privacy and confidentiality or something like that because I can —
MR. ROTHSTEIN: Well, I think we can say that alternative dispute resolution should be encouraged, I have no problem with that.
MR. HOUSTON: Or mediation should be encouraged or a system of mediation.
MR. ROTHSTEIN: Okay, but we’re going to scratch the last two and work with the others to put it into some form of text.
Now there are two things hanging, one is Paul’s concern about the last —
MR. HOUSTON: Well we have recommendations here that are already sort of speak to some of this stuff, I think if we just clean them a little bit —
MR. ROTHSTEIN: Aside from your table, which we’re going to talk about, is there something about, like the flag paragraph that is bothering you? It used to be the bottom of seven, it’s maybe the top of eight for you, it’s the paragraph that begins another issue to consider —
DR. TANG: Well, actually the one before it, both of those. So it says information as removed from the accessible record is to be either deleted or blocked, if deleted is removed without a trace, which I thought we went back and forth on, John and I, in saying we think that is really against the code of ethics for AHIMA, and actually AHIMA maybe can speak for themselves —
MR. ROTHSTEIN: We’re not advocating it, we’re just describing what it is.
MS. BERNSTEIN: You have to read this in the whole context of all the paragraphs that go around it too because this is not saying this is a possibility, it’s describing what would be meant by that.
DR. TANG: I don’t understand why did it describe something that we don’t —
MS. BERNSTEIN: Because people are out there talking about it and we are either going to accept, reject, or discuss it, we don’t want to ignore the fact that people have presented this to us in our hearings.
MS. GREENBERG: What is the issue?
DR. TANG: Well I guess the question I have is why describe this action of deleted and removing something without a trace, why even bring it up?
MS. BERNSTEIN: Because some people advocated it, we need to —
MR. HOUSTON: The issue is is that from an NHIN perspective nothing is ever deleted from the record, it will struck through, it will be noted —
MS. GREENBERG: But something could be blocked.
MR. HOUSTON: But purely from a records perspective things don’t get deleted from the record.
MR. ROTHSTEIN: That’s the way it is today, you could do it if you wanted to. I’m not saying that we ought to but you could —
MR. HOUSTON: And there are good reasons why it doesn’t occur.
MR. ROTHSTEIN: That may be true —
MS. BERNSTEIN: We understand that.
MS. HORLICK: Maybe we need to say something in this sentence that indicates that we heard testimony about it —
MS. GREENBERG: Where does it say that something has been deleted?
MS. HORLICK: It says if it is deleted it is removed without a trace, and maybe we ought to just say something like we heard that there should be an option to delete information without a trace —
MR. ROTHSTEIN: Meaning that it would be —
MS. HORLICK: Meaning that, right, but not so much like we’re considering that.
MR. ROTHSTEIN: I think personally you should have a right to delete certain stuff.
MR. HOUSTON: No.
MR. ROTHSTEIN: Well, I knew you’d disagree —
MR. REYNOLDS: Should be allowed to delete certain stuff?
MS. HORLICK: Well delete it or just not opt it in, I mean that’s the thing, if I don’t put my psychiatrist records in the NHIN I’m not deleting them from my psychiatrist’s office —
MR. ROTHSTEIN: Right, and you would have to disclose them if they were subpoenaed.
MR. HOUSTON: But the reason why information is not deleted from the record is if it was actually relied upon for purposes of clinical care and then later deleted because it was inaccurate or was the wrong patient, a physician might come back and say geez, I treated this person because of this lab test and if a lab test is no longer part of the record because it was in error the physician has nothing to point back to and say what his basis was for a clinical decision —
MS. BERNSTEIN: We’re back to square one, we’re not arguing the merits of the case —
MR. HOUSTON: I agree —
DR. TANG: It has to at least set a context because —
MR. ROTHSTEIN: I don’t want to give the impression that we are advocating this —
DR. TANG: But it does give that impression so all we’re saying is take Gail’s suggestion and say that we’re describing what’s been —
MR. HOUSTON: We’re simply reiterating what has been described to us.
MR. ROTHSTEIN: I want to be able to, after a tryst a teenager with someone who was known to have a sexually transmitted disease, now I go to my doctor and say I had a relationship with someone who has gonorrhea and I want to undergo testing to make sure I have it, and the test is negative, okay? Now why am I being forced to keep that in my record? That I have to disclose to every future employer, every graduate school —
MS. HORLICK: If I’m understanding you correctly you don’t have, you could have a way of limiting that information being accessed by other people but your doc that you went to the test for or your original doc that you saw, that would still remain —
MS. BERNSTEIN: Wait a minute, we’re getting into the substance of this argument which we do not need to get into for the purpose of this paragraph —
MS. GREENBERG: It’d be better to go to the public health —
MS. BERNSTEIN: All we are doing is defining, if you read in the context of the previous paragraph which starts there are various ways in which we might like to revise our records, they could be based on age or provider or whatever, and then it says affording the control would be complicated, if information is removed it could be either deleted or blocked. What I want to say is to block a record means it would be removed without a trace, I’m sorry, to delete a record means that it would be removed without a trace. Blocking means the information would still exist but, it’s just defining terms, that’s all we’re doing —
MR. ROTHSTEIN: I think that would be better —
MS. BERNSTEIN: That is all we’re doing, we go on to say —
MS. GREENBERG: Well then should we say that deletion is not accepted practice —
DR. TANG: That’s exactly what I would say.
MR. ROTHSTEIN: Currently not accepted —
DR. TANG: Currently not accepted practice according to AHIMA and in many states it would be illegal.
MS. HORLICK: Maybe the people that were advocating it didn’t know it was illegal —
MR. ROTHSTEIN: Or maybe they thought the law and the professional standards would be advancing in the 21st century.
MS. BERNSTEIN: Mark, don’t egg him on, we only have 15 minutes. You’re arguing the merits of the case, we do not need to, we know what everybody’s position is. Deleting information would mean it is removed for the accessible record, if information, it could be deleted or blocked.
MR. ROTHSTEIN: Okay, so we’re going to change that. Tell me what your next issue is.
DR. TANG: And then the next thing is the whole blocking thing, transparency works for computer programs just as well as it works for human policies, the doc has to, just like you talked about trust and the network, the doc has to trust the rules that are written in clinical decision support, you cannot have a computer knowing something that the doc doesn’t and then making recommendations that are unverifiable, that’s just not good practice, just like trust in the —
MR. ROTHSTEIN: Well, we heard testimony that that works.
DR. TANG: No, I would like to, I read the transcript, it does not say, it may imply some things but I think you got to get to the details to figure out exactly what did happen in Denmark because I would really like to know the details because I suspect it is hiding a particular encounter, not hiding a data element, those things can happen. I assume what the perception of what was said may be true but it seems to me it’s certainly not commonplace at all if it even exists in this one country. So I wouldn’t rely on the interpretation of what was stated, at least the words that were in the transcription, as an indication that it is saying exactly what you mean which is you can block individual items and have the decision —
MR. ROTHSTEIN: You’ll recall in the transcript I specifically asked him, looking ahead to this, if there were approved elements in advance that you could only block, in other words could you only block STDs and so forth, and his response was they can block anything they want.
MS. BERNSTEIN: But it happens rarely, that’s what he said.
DR. TANG: He is, I don’t remember what his position was but it’s quite possible that someone in his position does not know the technical details and could be not exactly representing how it’s coded in the application because I find it fairly unlikely that the way it’s being interpreted is what’s going on.
MR. ROTHSTEIN: Okay, let me ask you this question, is it your view that it’s a bad idea to do that or is it your view that it’s impossible to do that?
DR. TANG: it is a bad idea, nothing is impossible, so I feel it is clinically, it would be, it’s the same thing as this whole deletion thing —
MR. ROTHSTEIN: Okay, but we’re not endorsing that, we’re just saying that’s an option, one that you’re not agreeing with but we’re just saying that it’s an option.
DR. TANG: Well, we’re spending a lot of paragraph time on things that we do not think is either legal or ethical or clinically defensible and then I have an issue with that, yes, we could talk about a lot of things in our report but to spend half a page on things that are —
MR. HOUSTON: Hearing Paul I think the issue is, and I saw this another place, where there’s an argument or discussion to one side and there really isn’t any counterbalancing argument as to why it is either impractical or inappropriate, and I just think that we, by stating something without any discussion to the opposite may imply or at least give the read —
DR. TANG: That it’s even valid.
MS. GREENBERG: Are you saying that a responsible clinician can’t go with a black box decision support?
DR. TANG: No, you can’t.
MS. GREENBERG: So you can’t just be told you shouldn’t prescribe this —
DR. TANG: Because of something I know but you can’t.
MS. GREENBERG: — this drug because it interacts with something else they’re taking, you’re saying you have to know what the other thing is they’re taking.
DR. TANG: That’s the only way to be responsible —
MR. ROTHSTEIN: And you couldn’t ask your patient —
DR. TANG: What don’t I know?
MR. ROTHSTEIN: Yeah, it says here that I’m not supposed to prescribe this because there is a drug interaction warning —
DR. TANG: Most patients don’t know the drug’s interactions —
MR. ROTHSTEIN: Are you taking anything else now?
DR. TANG: How would I know what to actually fess up to? It’s an —
MR. HOUSTON: Let me make another argument here, I mean if the patient is obviously, if they’re incapacitated that’s an issue but let me just say these, all these vendors that sell, First Data Bank, have these massive disclaimers in there that say that this is not a substitute for medical judgment and that we take no responsibility for the accurate or completeness of our information, the implication in the contract is that you’re also responsible for validating the results of the data that they’re providing to you. So if there’s a drug/drug interaction it’s actually up to the clinician or physician to confirm, to review the PDR or whatever and to confirm the fact that that interactions exists, so it really is, I agree with Paul that there is a lot of liability —
MS. BERNSTEIN: And if you get an odd lab result that’s unexplained don’t you go back to the patient in an iterative process and say I’m getting this lab result —
DR. TANG: It’s that I don’t even know what the lab result, what the test was even, so basically I’m saying, I would prescribe this drug in a patient with some lab test that’s not being shown. How would I do with that information, it’s just not good, it’s not detectable —
MR. ROTHSTEIN: You understand that privacy is not free and it costs and one of the costs is that it interferes with optimum clinical care and so if you want to respect the privacy of individuals they are willing to in effect take the risk that you’re not going to have all the information that you need. We are trying as a matter of public policy to try to limit, and we’re not recommend you understand that we go this route, but if we go the route of allowing patients to have some degree of limiting, blocking ability, we are recommending in the last line of the first paragraph on seven that it be narrow. And so I’m saying how narrow that is but they shouldn’t be allowed to block just anything and there may be five categories or ten categories or two categories of things that they can block, they can block STDs, they can block drug abuse or whatever, and now you’ve got your clues.
MS. GREENBERG: The issue is whether, I mean there’s a cost to them too so if they block something do they just have to accept that it doesn’t go into decision support?
DR. TANG: It would be better for it not to be included in decision support and I don’t get to see what the basis of it —
MR. ROTHSTEIN: Well how about, would you think this is one of the areas for research to see whether decision support, whether decision support for blocked information works?
DR. TANG: To me it’s just, if you believe in transparency you cannot take advice from someone where you cannot verify —
MR. HOUSTON: Paul, let me just make a statement. I think what Paul is really trying to say is if something is that important that it shows up in some type of decision support role, if it’s that important to clinical care then the physician has the right to know what it is.
MS. GREENBERG: Well, no, I mean you can’t force the patient to tell them.
MR. HOUSTON: it’s a basic tenet in here, throughout this letter we’re trying to say we don’t want to block health care, we’re trying to only exclude information for which there’s really no relationship to a certain care that has to be provided —
MS. BERNSTEIN: No, we’re not saying that —
MS. GREENBERG: That’s one thing but that’s not everything.
MS. BERNSTEIN: We’re excluding whatever, the patient can exclude pretty much whatever they want and there’s a risk to that, privacy puts inefficiencies in place on purpose to get some other value —
MR. HOUSTON: Not just inefficiency, I think there’s potential —
MS. BERNSTEIN: Damage, harm, that’s inefficient, it costs money and harm.
MR. ROTHSTEIN: Anytime a doctor takes a history patients are coloring, shading, in denial, lying, forgetting —
DR. TANG: Decisions are made on the record and the recorded history and data elements, but what’s proposed is that we have something in the database, the computer uses a rule, and you don’t tell the physician that, I don’t know how —
MS. GREENBERG: To me it’s like an added protection, I mean I think obviously it’s not everything but if you can accept that patients should have some limited right to block information then you’ve already accepted that you’re not going to have everything like you’d like to. But it’s not as dangerous if in fact it could still be included in decision support, say he was taking a psychiatric drug, you just prefer not to share that information, but it turns out, it’s still in the decision support and so it shows that there’s a conflict so then you can probe further or you could just say well I’ll have to find another medication I guess or tell the patient I’m in a bad situation here because this is the medication I want you to take and I don’t know what it’s conflicting with. It’s not that bad.
MR. ROTHSTEIN: Paul, isn’t it better then nothing? I mean you’re arguing you’d rather have nothing. So you have a woman patient who had an abortion and she had an adverse reaction to the anesthetic that was given to her and she wants to block the abortion incident from, the encounter, and now you are getting ready to schedule her for surgery, wouldn’t you like a warning, and you say we’re going to use X anesthesia, wouldn’t you like a warning to come up that interaction with that anesthesia, or history of adverse event —
DR. TANG: So the alert would tell me everything?
MR. ROTHSTEIN: The alert would tell you don’t prescribe this, she had a bad reaction to it. Now I don’t know what your options are at that point but at least you’re not going to kill her.
MR. HOUSTON: That’s a little different then Paul’s example, I agree in that particular case you could avoid the episode while still saying that she reacted poorly to that anesthetic. I think it’s entirely different when you’ve got a drug to drug interaction issue, or a cocktail of medications that result in an issue. And Paul is only given, he gets an indication that there’s a drug to drug interaction yet it may be because of the cocktail —
MR. ROTHSTEIN: Okay, but now you’re getting to the specifics which we haven’t done, all I’m saying is I think as a concept if you, as Marjorie said, if you agree that patients should have some ability to block some information the question is is it better then nothing, if it’s feasible, to have some decision support running beneath that which we heard about in Australia, as well as Denmark, and I think UK although I have to read it over, they were thinking about doing this, so the question is if we could do it is it better then having nothing because we’re saying that one of the options, if they went that route, to block stuff, wouldn’t you like to know some information that might be very valuable?
MS. GREENBERG: Maybe you could just say clinical decision support however potentially could be programmed and then say but further research would need to be done as to the feasibility and utility of this approach, the risks associated with such an approach. I mean I don’t think, if we heard that testimony I don’t see any reason to hide to but you could put a cautionary note in.
MR. ROTHSTEIN: And we’re not endorsing it, we’re not saying that’s the way —
MS. GREENBERG: I think it may sound like you’re endorsing it if you don’t put a cautionary note in.
MR. ROTHSTEIN: Okay, did you get that? Maybe Marjorie could come back with that language, I think it was good.
MS. GREENBERG: I said something and then John said something, further research is needed to determine the feasibility and the utility and the risks associated with such an approach. So that way you’re putting in a cautionary note —
MS. BERNSTEIN: But further research is necessary sounds like we recommend further research.
MR. ROTHSTEIN: Well how about say before adoption, if this options were to be pursued —
MS. GREENBERG: Further research would be needed.
MR. ROTHSTEIN: John, would that be okay? Paul, any objections? Hearing none —
MR. REYNOLDS: Why would we want to put the recommendation in the body of this when we’re putting the other recommendations as part of recommendations?
MS. GREENBERG: It’s not really a recommendation, I think it’s just a cautionary note.
MR. REYNOLDS: If you say that you recommend research it’s a recommendation. I’m not agreeing with any of you —
MR. ROTHSTEIN: It’s a good point, I’m happy the way it is but I’m trying to save the thought —
MS. GREENBERG: Well I think we should be sensitive to Paul’s concern that without a cautionary note that it sounds like the committee might be recommending that —
MR. HOUSTON: He’s the clinician in the room, physician in the room, and I think he’s —
MR. ROTHSTEIN: So he should be disqualified I think —
MR. HOUSTON: No, I think he has the ability to represent a position very directly on this issue —
MS. GREENBERG: Well he feels uncomfortable having an implication that we’re kind of suggesting this is a good idea and that’s his professional sensibility which I think we should respect —
MR. ROTHSTEIN: Well, if he has that view there are going to be six other people in the full committee —
MS. GREENBERG: And I think it’s responsible on his part, I mean I don’t think he’s being irrational or anything so I think a cautionary note allows you to keep it in —
MR. ROTHSTEIN: Well try to save it without recommending anything.
MS. GREENBERG: Because I’m sort of intrigued by it myself so I kind of hate to have you have to eliminate it so I think a cautionary note might be a compromise.
MR. ROTHSTEIN: And this is the kind of thing I’d love to explore with the architecture developers, I mean this is what they would do and so forth.
Okay, we lost the opportunity and I’m sorry, Harry, to review Paul’s diagram, and we are out of time, we can’t because we only have the transcription until 5:00, so we are —
MS. GREENBERG: You can tell Simon how you plan to deal with tomorrow.
MR. ROTHSTEIN: So we will circulate calendars tomorrow for a conference call, well for as many conference calls as we can work out, but we’re actually in the last hour we did more then, tomorrow I’m going to report in general terms on the areas in which we have recommendations that will be coming to the committee and I’m going to ask not, to have questions held until I get through it all and then we can have a wide ranging discussion on the issues but I’m not going to go point by point, I’m going to selectively pick out a couple from each of the areas.
DR. COHN: Okay, were you planning on having a face to face meeting between now and June?
MR. ROTHSTEIN: No, we don’t have the money.
MS. GREENBERG: Well, that’s not the only issue —
MR. ROTHSTEIN: There’s a personal issue as well.
DR. COHN: Let’s talk about that offline because I think I mentioned something to you, we were being asked to do, and I guess we’ll have to tell them we can’t do it.
MR. ROTHSTEIN: We can talk about it.
MS. GREENBERG: And the committee members are not going to challenge anything in the public meeting, the subcommittee members are not going to challenge anything that Mark says, of course afterwards everything, just tomorrow —
MS. BERNSTEIN: If I were to edit everything we did today, and I had a clean document by tomorrow morning, you still would or would not like to show it to the committee?
MR. REYNOLDS: The letter? I don’t think we agree —
MR. HOUSTON: Well, hold on, but any committee member is permitted to come here to these meetings, so they would otherwise be able to see that letter —
MS. GREENBERG: If you pass out a letter —
MR. HOUSTON: My point is why wouldn’t we give, if the committee is already entitled to see it if somebody asks for it why wouldn’t we provide it to them simply as a courtesy for them to look at?
DR. COHN: Have we voted on it yet? Is it agreed to by people?
MR. ROTHSTEIN: Well we approved in a general sense each of the sections, we have not voted on the entire thing, we have not gone over the specific wording of the recommendations —
MR. HOUSTON: This is simply a courtesy I’m just thinking, I don’t know. Either way —
MR. ROTHSTEIN: I think it’s premature, given the fact that —
MS. HORLICK: They could maybe get it before the June meeting, I mean I know we always send it before the meeting but I mean even like after our next conference call at that point the edits —
MR. ROTHSTEIN: We might send them a draft version.
MS. GREENBERG: That would be a good idea.
MR. ROTHSTEIN: Send them an FYI draft version so they can follow what’s going on.
MS. BERNSTEIN: Do you want to request comments at that time? Can we do that legally, Marjorie, do you know? I’m not asking you a legal question, but legally can we within advisory committee send out a draft for email or other comments before the meeting?
MR. ROTHSTEIN: To committee members? Sure.
MS. BERNSTEIN: Before the meeting?
MS. GREENBERG: Sure, why not? I mean you’re not voting on it, you’re not asking them to vote on it, you’re asking them for comments.
MS. BERNSTEIN: Well, we’ll get a sense of what’s going to happen at the meeting.
[Whereupon at 5:08 p.m. the meeting was adjourned.]