[This Transcript is Unedited]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS
SUBCOMMITTEE ON PRIVACY AND CONFIDENTIALITY
June 19, 2007
Hubert H. Humphrey Building
200 Independence Avenue, SW
CASET Associates, Ltd.
10201 Lee Highway
Fairfax, Virginia 22030
Table of Contents:
- Welcome – Mark Rothstein
- Follow Up Discussion of April 17th Hearing On “Consumer Controls for Sensitive Health Records”
P R O C E E D I N G S (9:30 a.m.)
Agenda Item: Welcome
MR. ROTHSTEIN: I am Mark Rothstein, Chair of the Subcommittee on Privacy and Confidentiality of the National Committee on Vital and Health Statistics. This is our Subcommittee working session to discuss matters that are currently pending or will be pending before the Committee. We will have brief introductions now.
Agenda item: Follow Up Discussion of April 17th Hearing on “Consumer Controls for Sensitive Health Records”
MR. ROTHSTEIN: Today I want to do two main things. First of all let me say that our FERPA letters are in your briefing books so we will take those up tomorrow. The main purpose of today’s discussion is to talk about the issue of consumer controls for sensitive health records. When we finish that I am going to talk about our fall hearing schedule and get a sense of what issues we should tackle next.
My hope is, depending on how we resolve here today, that maybe we can have a letter issued for September. Who knows?
MR. REYNOLDS: I think it is also going to be very important that the Committee have some position to help the other committee we are involved in which is the “Secondary Uses” because obviously this whole idea of where the person stands – the whole word “secondary” says that the person has to have some idea of what that means. I think it will be great input.
MR. ROTHSTEIN: This is stuff as everybody knows, is so closely related.
MR. REYNOLDS: There is no separation.
DR. TANG: It is interesting that there is one solution for our work, secondary use work, CPS work, the AHIC-CE work, and that is the thing that we have all been saying – now they just said in the AHIC hearing – if we just treat all the people who have access to it as accountable and responsible, that would almost end this discussion.
MR. REYNOLDS: I think it ends half of it.
MR. ROTHSTEIN: I think it ends part of it.
DR. TANG: Speak more.
MR. ROTHSTEIN: What it ends is what we talked about in our covered entity letter, but it still doesn’t deal with the issue that there is some information in health records that patients view as very sensitive and they don’t want disclosed basically at anybody.
MR. REYNOLDS: Where I would go is obviously if you make everybody a philosophically covered entity. That says if they have it they will protect it but you still have the other discussion of do I concur that they have it as a person. Do I want – in other words, if you said that that was the only answer then everybody could get all the data because they are covered and they are suppose to protect it.
DR. TANG: No. There is the minimum necessary provision as a covered entity. So it is not as if as a covered entity I need your consent to do virtually everything except treat you.
MR. REYNOLDS: A treatment payment healthcare operation.
DR. TANG: Web MD is not part of TPO. So if they have some request for your data I am going to have to ask you.
MR. REYNOLDS: That is what we were saying. Just listening to your words you basically said, all we do it make these people covered entities and it is fine.
DR. TANG: Which is possible.
MR. REYNOLDS: You still added some kind of consent.
DR. TANG: Which covered entities need to have except for TPO.
MR. ROTHSTEIN: But I am concerned about the “T”.
DR. TANG: The “T”. The treatment. Why?
DR. FRANCIS: It may even be that people don’t want information sharing those ways. If they don’t want information shared from those ways then they ought to be able to say that.
DR. TANG: Let me just test it. What is an example of something where you do not want an information –
MR. ROTHSTEIN: Okay. I sprain my ankle today or brake my ankle and I am being seen by an orthopedics and that orthopedics does not need to see my mental health records.
DR. TANG: Did your orthopedics ask for your mental health record?
MR. ROTHSTEIN: No, but he asked for my medical records and under current treatment categories everything could go.
DR. TANG: They could go but they don’t have to go. There is nothing in HIPAA that says – and this does follow state law — we could not release your mental health records to an orthopod who asked for –
MR. ROTHSTEIN: No, the orthopod would ask for my medical records because maybe the orthopod wants to know if I have allergies or if I am hypertensive, whatever, and asks for my medical records and unless we figure out some way to isolate certain sensitive information; STD’s, mental health, substance abuse, et cetera, then the stuff that customarily goes –
DR. TANG: Okay. What customarily goes in your example does not include mental health records.
MR. ROTHSTEIN: I disagree with that Paul. You are making an assumption that all mental health stuff is as a result of psychiatric or psychology visits – I would say that the majority of that comes from primary care docs who patients say, doc, I am really nervous now because of blah, blah, blah,. The doctor writes a prescription for Valium or something. There is no way now of isolating that information.
DR. TANG: Okay. Let us continue with this. If the covered entity orthopod has that information how can that cause you harm if they are governed and they comply –
MR. ROTHSTEIN: Because I don’t want them to get it. He has no reason to see that.
DR. TANG: But he can’t do anything with it outside of treating your –
MR. ROTHSTEIN: There is an element of, I would argue, intrinsic harm quite apart from whether I am going to lose my insurance or my job or whether I have any sort of tangible thing that happens to me. Patients, in my judgment, have a right to certainly as to not medically relevant sensitive information, make a call as to whether they think everybody ought to get it or anyone who is treating somebody. Keep in mind the example that we are talking about deals with my current health status. But with the NHIN and the ability to aggregate historical stuff as well, now we are talking about things that could go back many years – I was treated for STD, I was treated for substance abuse, whatever, if that is not somehow filtered by whatever means we decide on then that is part of my medical record that is going to go out.
MS. BERNSTEIN: I Am Maya Bernstein. I am lead staff to the Subcommittee.
MS. MC ANDREW: Sue McAndrew, Office for Civil Rights, liaison to the Subcommittee.
MR. REYNOLDS: I try to think of things as an implementer. That is my day job. I think there is a couple of things. I don’t think covered entities is going to fly for everybody because it has restrictions that a lot of people are not going to be able to follow. It is a term of art that people absolutely run from – I mean hysterical. Whatever comes out we will say that you have got to protect it and you have got to some other things but I don’t think you are going to be called a “covered entity”. So now you have got this other group of people.
The other thing that you have. Everybody knows I have had a number of surgeries recently. I was signing something at Duke before I had my knee done and I went all the way down this thing and then on number ten it says that they could use the material from the surgery for this and that for research and further tests. I said what if I crossed of that last one. I personally did not care but what if I did cross off that last one? The person dealing with me was just mortified that I had that question.
MS. BERNSTEIN: Because they did not know how to answer it – right?
MR. REYNOLDS: Right. So if I would say that I am fine with everything that we are talking about – moving my stuff around and everything else – and I am actually fine not necessarily parson things out of mine. But if I want to say that I don’t want it sent to a research company that I don’t know who they are who what they do – I don’t care if you say that they are protected, I want to have some idea that is going on.
As I sent as an implementer of systems in hospitals and at Blue Cross, I am sitting here going wow, what kind of crap are you pulling off. I am more interested in the pragmatic approach to whatever we decide. I can actually debate both sides of this equally hard but when you actually said, okay, good. Everybody has done the rhetoric – how do we actually do this because the NHIN is going a thousand miles an hour, the HIE’s are going a thousand miles an hour, and the problem with technology – we look at it everyday we turn on the news – the problem with technology is that it is there.
Let’s go back to Mark’s comment – a lot of what happens now is somebody doesn’t copy the whole medical record cause wow, you might not want to copy the whole medical record and send it to somebody. If it is there electronically the last thing you would want to do is go look at it and parse something out to send it to someone else. You just hit the button and there goes the data.
I am in to it from a standpoint of somebody needs to help me figure out how it works and what is a description of how it works is what we are not getting to because if we don’t get to that at some point then it is going to be left in the eye of the beholder and some of the beholder’s are not necessarily of equal stature and thought process and money to protect it and everything else that we all have going on to do that.
That is why I am still pushing. That is the same thing on the Quality – the new workgroup that we have. What can your data be used for from a quality standpoint? What I have read as a layman now, quality is anything somebody wants to decide that it is. It is different than covered entity — it is not a term of art. It is not a term of art that you can say I understand the definition. That is why we have kind of come up with this idea of uses of data – forget “secondary” because secondary kind of says – if I were a researcher then what is my primary use? Research. To the patient it is not secondary it is still use so that is why we started playing with those words so that we have the real debate because I know we are going to look at quality but it is the same for every piece of data you got whether it is quality or not. Whether it is some other research or some other this and being I technology there are so many switches out there that this data is going through that even if you call them “covered entity” or “somebody special”, this is a bunch of techies. Just like the internet – this is a bunch of techies shooting your stuff around and so that is where I am coming from.
If we get to a point where we talk about the real “how” – then that kind of is to me the bottom line where I am willing to sign off. If you can’t tell me “how” then you did not understand it. If you can’t tell me how you would want me to make it less then you have not really thought the whole thing through. That is where I was going with your thing.
I think part of it no question, is everybody has to be covered. We have said that how many times in letters and everything else. Everybody who touches your data has got to have some kind of stake in the game but then these business arrangements that are going on right now are pretty scary because anybody can hook to anybody electronically now because of the internet. The internet has basically upped the ante to me, not because I am afraid or not afraid of the internet but because technology used to be a speed bump.
I have made a number of speeches – five years ago you did not have to worry about anything changing because technology was enough of a speed bump and in some cases a wall, that you could not get past it. Now – it is like driving in the soft flats – it is wide open, you can go as fast as you want to, you can drive as recklessly as you want to and you can not care where you are going. You can head in any direction going full speed.
That is where I a trying to go, Paul, what I think is going to be really helpful to me and a lot of people is to really have that debate because if we buy at some point that you should parse it and we say that people should be covered – how does that work? If you don’t get the degree of parsing in because everybody that is going to build the system – we all know – if you don’t build the parsing in it doesn’t get parsed. It is sent as a whole package. I am coming from a little different world than a lot of you, so I am looking at it from the standpoint of somebody gives me that requirement of the NHIN – let’s just say that – Jeff and I talk a lot because he is now heading up that HIE so we talk a lot – so somebody sends me that requirement – I am going to ask them those same questions.
The country is handing us this thing called “NHIN” and it is handing us this thing called “Quality” and it is handing us this thing called “Privacy” – they are no longer separate subjects. It is still how in the end how does it work. Once you tell me how it works then I will tell you whether you debated it enough because if I can ask you five more questions and you can’t answer them then how is it going to work and how are you as an individual regardless of what you believe, and again everybody around the rooms believes differently, regardless of how you believe how are we going to explain it?
I got a letter the other day. One of the Blue’s is offering personal health records. They sent a letter to their members. I thought it was an incredibly well written letter. So I am trying to get a lot of these things to say, what are you really saying. In the end it is what do we say to the people and how do we allow parsing because as soon as we fix the other – I think we are probably in a little better shape.
MR. ROTHSTEIN: I just want to add one thing Paul to my sense of the reason why we need to segregate some information – it is not just this abstraction that we are fostering privacy. I think there is a real public health issue here and there is lots of literature in the public health world that people will forego, delay, abandon treatment for mental illness, STD’s, anything that has a stigma attached to it if they have no confidence that they can control that information.
In the paper world, the unconnected world, I could go to a STD clinic or maybe went to my college health service or something to be treated for an STD. Now the electronic interconnected world – doesn’t matter where I go because presumably all of that stuff is going to be connected. Unless there is some sort of way that patients can have confidence that treatment for their most sensitive sort of conditions, drug problems or what have you, is not going to be routinely disclosed to every subsequent requester – then I worry about people saying – you wanted a tangible – I think that is the tangible side.
MR. REYNOLDS: One other thing that we have experienced. We had gotten away from being a government contractor now we are back doing some government business – if the government, for example, through any of the government programs required the reporting of things then that means that almost anything that entity does will have that same kind of reporting involved. You are not going to have two systems. You are not going to have two totally different approaches; one where I report to the government and one where I don’t necessarily. As more and more business becomes government related and the government may require some of this reporting –
MS. BERNSTEIN: Can you give an example, Harry, of the kind of reporting you are talking about?
MR. REYNOLDS: Let’s use Marks as an example. If that clinic also sees government patients that are covered by Medicare and so on and has to report certain things –
MS. BERNSTEIN: — to the government.
MR. REYNOLDS: As part of the program –
MS. BERNSTEIN: — government employees.
MR. REYOLDS: Philosophically but remember that a lot of these little places that we are talking about don’t have two systems and sixteen ways of doing business, Medicare, Medicaid, — they don’t necessarily have six different reporting staff. All I am saying is as we talk about bio-surveillance, as we get more and more about what is normal, what has to be there in place – I am not saying it is real but these are the things that you have to keep in mind because once somebody has to report it for somebody – I sat in for 15 minutes – the chart that showed up there a little bit ago was this is all the stuff – this is all the quality stuff that they have to report from one place to all the different entities that they deal with. Some are asking different questions.
We are all sitting here and remember I am co-chairing Standards, if we are trying to figure out a way that each of you that are in institutions could one way send a record so that it had all the right data in it – whether you are sending it to anybody in this room, that is a good administrative way to go and it is a good savings but it also starts to break down the delineation between private and government and on and on, especially as we bring smaller and smaller entities that aren’t all the big players who are used to parsing, into the mix and then electronic is electronic and a record is a record and quality information is quality information and it starts to lose it’s sensitivity for the spirit of standards – again, I am not trying to argue one way or the other, it is just a reality of working with these smaller entities. We work with a lot of single doctor offices that have a software – I gave a speech not too long ago and I listed the first three pages of software vendors that our physicians use in North Carolina and I told the people in the room to put your hand up when you recognize one – when there is a name that I say that you recognize put your hand up — fourth page, single spaced.
So as we talk about this becoming electronic and little vendor A and little vendor B doing something – boy, data is data and it sure isn’t going to be parsed like all of us sitting in our big conference rooms and say we are really going to look at this differently. The electronics allow everybody to play and all the data to play. That is a filter I am trying to put on it as I think about it because the actual real implementation of what we say is going to decide whether or not that person actually has any rights that are actually executed and not defended later, but whether or not people actually implement systems that can work.
MR. ROTHSTEIN: Let me see if I can summarize the question we have on the table. From the e-mails that have been exchanged and you probably should have received all of these. If you need copies we will get them for you. There is an e-mail from me, there is one from Leslie — our differences are not relevant at the moment – in which we support the idea of consumer control to some degree.
Harry, I think, is orally on the record as supporting that in principle. Paul’s e mail, which John has basically signed onto, proposes to adopt the Indiana model that we heard from in April where you are basically in or you are out. There is no degree of consumer control over what is in the record.
The question arises as to whether there is any way to reconcile these two different positions. I think—John is not here and I don’t know whether this is the case but it may be the case knowing John’s concern and even the one he put in the letter – that he is concerned with emergencies. He mentioned in his letter ICU, AD access, I think if we have a break the glass feature where you can get access to that information in emergency – a more complete record – that might bring him on board. I don’t know because he is not here. I am just mentioning that but I don’t – of course I don’t know what Simon’s view is – but I don’t know Paul, whether there is some area where we could bridge the gap between your view, the everything view –
DR. TANG: If you read my letter I don’t think that is what it says.
MR. ROTHSTEIN: I am sorry then. I mischaracterized it.
DR. TANG: Just reread it.
(Subcommittee reads Dr. Tang’s letter).
MR. ROTHSTEIN: Even though you say earlier – in point number two, it would be good to find a way to mask the data from universal access – the recommendation that you have at the end says, adopt the IMPC privacy policies as a baseline and then just sort of monitor what is going on.
DR. TANG: Where are you reading that?
MR. ROTHSTEIN: I am on page two under your recommendation. So I went by your recommendation as opposed to your discussion.
DR. TANG: What I heard Terry say is there is the policy level and then there is the implementation level. That is what I heard his two halves were. I agree with that. If it were affordable to have the magic of all worlds I think we could do that but with the second part with what is practical and affordable, I would suggest it is something like number two which is you mask sections because it is relatively easy for the physician to deal with that.
I can as your orthopod, for example, I can deal with that I am not getting either the sexual history or the mental history when I am fixing your ankle. I can deal with that even as an internist. I think with regard to number three – where I think I had the flags – as an internist I do have to have an awareness that if I do want to get more information that may be relevant I should ask you today.
I can’t deal with its some – it can be different every single person – I can’t deal with that.
MR. ROTHSTEIN: Paul, in my e mail I say basically that. I am not advocating sort of line item veto for patients – I’m advocating certain areas that –
DR. TANG: Do you agree with number two?
MR. ROTHSTEIN: Yes.
DR. TANG: I would say, at baseline – I used the word baseline – I think their baseline is probably a good thing to start with.
MR. ROTHSTEIN: But their baseline means everything.
DR. FRANCIS: I sort of think there are different roles here. You are starting with an implementation baseline which is that everything is in. I start back a level and I want to ask what the goals are that design on me. It seems to me that one goal is clearly what you have here in one, the need for reliable – actually I would not say complete – I would say reliable and relevant information. We could bracket what complete is. I think we could agree on that goal. I think we could also agree that patient’s needs for privacy should be respected. Then the question is to figure out what implementation strategy best realizes those goals. Whether it is setting the default position as everything goes in. Whether it is structuring – you pull certain elements of data and that is what everybody gets. Where it is something with a break the glass feature – those are different ways to try to do it.
As I see it I think people are pretty well agreed on some of the special areas but then what gets really tricky is you can’t separate that out by providers. You can’t just put all the psychiatrist records in one place because people don’t go to psychiatrist for mental health treatment in so many cases.
MS. BERNSTEIN: The other thing I remember they said in their testimony – the Indiana folks, was there is whole kinds of data that they don’t put in because they can’t figure out how to – so they don’t even have a lot of psychiatric records or mental health records. On the one hand has advantages maybe, if you can think of it that way for privacy, but has disadvantages in terms of health care of an individual and their ability to take advantage of all – if you think there are lots of advantages to these systems that there is a whole class of people who don’t get those advantages because that group has not figured out how to deal with the issue that we are talking about so they just leave those records out.
MR. REYNOLDS: Right but the model already excludes them. We originally said it is all in or all out. Well, they exclude certain things that are all in. We are using a lot of words and I think we are not necessarily disagreeing but we have got to come up with some idea as to what is the general agreement as to what things are okay and then what categories are not okay? Mark, I have heard you use the term several times, there are some things. As soon as we start debating a list of some things then I think you move off –
MR. ROTHSTEIN: I am ready to –
MR. REYNOLDS: What I am saying is once you pick it, if you can’t sit and explain it to your grandmother then I don’t think we implement the NHIN across the country in some kind of a reasonable way that people are get it, understand it, and we really did what we need to do. On the other hand, if you have multiple categories and Paul sitting there as a doctor says, data has not been given to me – then you have got the right to either break the glass if you have an emergency situation or you ask the question and if they won’t answer the question then you may not treat them. But if we don’t make it simple, again, I really go back to if we don’t make it simple what do we really do?
DR. TANG: Can I just put up a straw proposal based on this? I am agreeing with what Leslie said by saying point one. That is the philosophy – this is what we need to do in order to take care of patients and respect their privacy. From the implementation point of view I pointed out number four, which is how Indiana did it with the proviso that Maya just said. My proposal would be that it would be for that more explicit – which fits your diagram which is number two, and that we mask certain sections and we enumerate those sections so I can explain it to your grandmother and even you, Harry, and that those be mental health, substance abuse and sexual activity – which were explicitly discussed at the testimony in a very compelling way.
Let me just put as one of those three boxes underneath that you drew, those three sections and then here other people’s suggestion for more than that. We could say, domestic violence – no, those are the three sections that I heard about so let’s put those there and then see if there are any that need to be added or edited and see if we can find the compromise.
MR. REYNOLDS: That is what Mark putting up there. If we don’t put this up on the board then we are philosophy disagreeing but we sure not getting any closer to discussing it.
MS. BERNSTEIN: Should we read what is on the board for the record?
MR. ROTHSTEIN: Yes. For the record our five possibilities for separate information; mental health, substance abuse, reproductive health, domestic violence and sensitive social history. Which for example would include misattributed paternity – you go and see a generic counselor and you mention that my social father is really not my biological father because my mother had an affair with the milkman.
DR. TANG: My hesitation, as I started to articulate your number four, domestic violence, is I think not knowing is potentially harmful to the victim. I am open to hearing other ways but one of our biggest problems is not enough people know what is going on in the home so your orthopod that is fixing your bones of this person that has been beaten needs to know this so he or she can alert the authorities. That is the kind of thing that is going through my mind. I think that is one of the most sensitive but under-reported and under-treated and under-recognized and under-dealt with.
DR. FRANCIS: Sure and if you included – I’m assuming you are including domestic violence, elder abuse, child abuse, and abuse of people with disabilities. I want to say yes and no to what you said because let us take elder abuse. It can easily be the case that an older person has seen a physician who1makes a note about worries that the person is being abused. One of the primary reasons that older people don’t end up getting all kinds of social services, and I would include health care services, is precisely that they are worried that reports of abuse will end up not related to saving homes.
So I would have Mark’s kind of worry about if there were a worry about elder abuse, an important assay might be –
DR. TANG: Who is worried about that?
DR. FRANCIS: Older people are often worried that because of concerns that they can no longer care for themselves or a relative is abusing them, they won’t be able to stay in the homes. SO it is not at all improbable that they will shut the door to social services workers, they won’t go see doctors, they would rather stay in their home and be abused.
DR. TANG: I’m not sure that we all agree that that is a good thing.
DR. FRANCIS: I don’t think it is a good thing at all. But the worse thing is to have them stay in their home, be abused and see no one. The next best thing is to see them stay in their home and access the kinds of social services that can help reduce or protect them against abuse and that is certainly a possibility. If they are afraid that any time there is a suspicion of abuse the record gets passed along, there are risks that elder people will not go see health care providers. You can talk to folks in aging services. I don’t know where I would put it, questions about competence, which are medically relevant, but which might –
MS. BERNSTEIN: Have legal consequences.
DR. FRANCIS: Yes.
DR. TANG: I guess we have to figure out what –
DR. FRANCIS: I just wasn’t sure, but I think the domestic violence area is – some states you have to report a gunshot would and things like that. Some states require reporting on domestic violence. Other states don’t. It is more common that they would require a report of elder abuse.
[Dr. Houston arrives.]
DR. HOUSTON: I am John Houston, University of Pittsburgh Medical Center, member of the Subcommittee.
DR. FRANCIS: I just single that out as something if you are dealing with somebody who is losing capacity and there is a lot of suspicion, it could be just disastrous.
MS. BERNSTEIN: Before we go on, could I just remind folks about the issue that we have talked about with respect to domestic violence, which may be different from other types of abuse that you arte talking about. The concern of many domestic violence victims is not that the abuse itself will be discovered, but that their location, their address or where they are staying, will be discovered by their abuser, by its being recorded in the record. Then the abuser would be able to find them if they flee. SO the fact that you have demographic information in the record – name, address, age, that sort of thing – it is not the treatment record that the person is usually concerned about in terms of spousal abuse or a boyfriend or whatever, that sort of thing, but just the fact that somebody could discover where they are, where they are being treated and so forth. Abusers come in every sort of form, so they could be law enforcement officers, they can work in hospitals, they can work in social services and so forth, and people are concerned about location information. Information on elder abuse of child abuse or whatever, the content of the information might be an issue more than in spousal abuse.
DR. TANG: I can see how it cuts both ways. I am trying to make sure that the social worker does find out this information, instead of its being sequestered from the record, and perhaps the compromise is that when there is information that is being masked that there is a flag. Then that causes a break-the-glass. So I know which hospital workers, social worker, whatever broke the glass to know that at least that leaves a trail if we are going to find some mischief going on and have that information.
MS. BERNSTEIN: What about Mark’s proposal from the meeting that you don’t get a notice that there is psychiatric data missing. You get a general notice that says there might be psychiatric data —
MR. ROTHSTEIN: Sensitive information missing which means it is one of these five categories.
MS. BERNSTEIN: — reproductive health data missing. Just be aware that you might not be getting something in one of those categories so be diligent. You don’t know which category it is. It could be nothing. Every patient you have the same notice. Some information of the following types might be missing from your record. And when you go to break the glass there might be nothing there.
MR. ROTHSTEIN: No, what I suggested was like a check box on some people’s record, a flag, if you will, that say at patient request certain information has been withheld. The physician doesn’t know in what category it is, so you would never sort of break the glass and find nothing. You might break the glass and find nothing that is relevant, that is going to help you, but only certain people who elected to opt some of their material into the sensitive file would have a flag.
DR. TANG: SO the flag means there is information present in some sensitive area, so that if you do break the glass you will find something.
MS. BERNSTEIN: That is right. I misstated – and it might not be relevant.
DR. FRANCIS: There is another way to do it, which is to have the default position be that for everyone certain categories are present and certain categories of information are absent.
MR. REYNOLDS:: Absent or masked?
DR. FRANCIS: Masked. You only get it if it is an emergency situation and there is a need to know. Otherwise, if there is a red flag for ten percent of the records, I worry that glass-breaking would become routine in most cases. I don’t know. A different way to do it – and if you routinely mask those and then you don’t mask out of those, however, the fact that a prescription – there is a way to know what the prescription is but know that if somebody puts in a prescription then –
MR. ROTHSTEIN: You would still have decision support.
DR. FRANCIS: Yes, and people are protected against medication interactions with that. Then it would simply be part of good medical practice as it is today, I think, when physicians think there is reason for concern that some of this might be relevant –
MR. ROTHSTEIN: Harry was next.
MR. REYNOLDS: I think we have the provider who did the service, who got the drugs, you have lab results, you have other things. SO you can say that you have it broken down and you have blocked it. But you can have a random lab test or a random prescription or anything else that many of them would not be masked under some of this – let’s go with the –
MR. ROTHSTEIN: HMV.
MR. REYNOLDS: Any of it – the domestic violence, any of it. In other words, the point is this. Once somebody goes to see somebody, tests and everything are being done by disparate organizations. Let’s use your example of demographics. Making sure that demographics don’t get there when a lab is doing the billing or somebody is doing the billing – they are going to have to have something – so all of a sudden when somebody goes in for care it goes like that, pow, these days. It is being sent to the labs, it is being sent out to this and that, so the data is flowing around. But when we talk about the record, let’s be careful not to talk about that one person controls the record, they don’t. You have the centralizing, you have the federated models, and the federated model is going to say my data is going to be wherever it is and when you want to get my data you are pulling it to go. SO I ask us all to be very careful as we do this.
This is great. If I were sitting here talking about the VA – great lists, very different model where you get someone seeing six doctors, that are using six different labs, that are using this for this, and you have a pharmacy PVM and you have everything else going on. O all I’m saying to you, as you think about it, make sure that we keep that in mind because the federated model makes the idea of your health record a dramatically different chap than if I am only seeing a certain entity, like if I am in the VA or I am in somewhere else. That is a whole different deal because it is a single system, single sets of data, single this and single that and some other things.
So as we do this let’s make sure that we add that one more filter to the debate. Does it work in a federated model and what would be the restrictions in a federated model and how does that really work?
MR. ROTHSTEIN: May I ask a different question that will govern this? That is, at what level of specificity should we make our recommendation to the Secretary? I think this is very important. It seems to me that our discussion about, for example, domestic violence, is very interesting, but it seems to me that the Secretary would not want to design or make recommendations about a system for the entire country dealing with that issue without hearing from social workers, without hearing from AARP, without having a whole big thing.
So why should we, on the basis of incomplete information, sort of lock in a position of recommending or not recommending, for example, domestic violence? Would it be better, and we might achieve more consensus not only in the subcommittee but thinking to the full committee, if we just agreed on a framework and we agreed – there are certain issues we are going to have to deal with. One is whether everyone’s stuff is masked or only people who elect to have it masked, and what is more complicated and so on and practical to do? But I am questioning whether we need to get into the nitty gritty of what we mean by all these things when we might just say, for example, we believe there are certain sensitive areas that for public health and privacy reasons need to be treated separately in the following way. And these areas may include the following and blah, blah, blah.
MR. REYNOLDS: So you don’t misunderstand, the only reason I am forcing these two things is that it forces a discussion. In no way should we go to that level of a recommendation. But it forces the discussion about the reality of what is going to happen and the reality of what it is, because right now we are agreeing to disagree on words. This gives you a different context as another filter to look at it. Not necessarily that we would go there, stay there, or even list those factors. I am just trying to force some real discussion, not a philosophical agreement or disagreement, a real discussion and then you can go back to write the letter that says, okay, we can all go there because we know how we got there.
DR. FRANCIS: I think unless we could actually work out what a model for one of those would look like – something that says while we need to protect patient privacy on these things, and we also need to have good medical records for doctors on these things, we might as well say nothing.
MR. ROTHSTEIN: I am not suggesting that. What I am suggesting is that suppose we adopted for discussion purposes the model that the patient can elect to mask certain things. We recommend that patients be allowed to mask certain things and the masking should not be line item. It is categorical. And we think a starting point would be to consider the following five categories ro six categories or maybe more, maybe less. But that approach.
MR. REYNOLDS: And I would say a structured set of things. You have a reason to go there, because it has to be something —
MR. HOUSTON: The machine can do.
MR. REYNOLDS: It can’t be something. It has to be a structured set. So we may not list it, but there has got to be a clear list.
MR. ROTHSTEIN: We are going to recommend that the ultimate decision include a clear list but maybe we are not going to make that list.
DR. FRANCIS: I think we should have some starter categories.
MR. REYNOLDS: Yes, here are some categories.
DR. FRANCIS: I think we should add – I don’t know what you really mean by reproductive health. I don’t know whetehr rape has anything to do with reproductive health.
MR. ROTHSTEIN: Social history?
DR. FRANCIS: Maybe.
MR. ROTHSTEIN: We can put another list of some of the things that we think should be specially treated.
DR. FRANCIS: It is a diagnosis of dementia that I’m concerned about.
MR. ROTHSTEIN: Sue, you looked like you were having some heartburn earlier?
MS. MC ANDREW: In terms of your structure?
MR. ROTHSTEIN: In terms of the suggestion of what we might out in the recommendation to the Secretary.
MS. MC ANDREW: I was just trying to tease out some of the operational issues related to this structure, and to the extent – are you conceiving of individual – you have these sensitive buckets and they all have a label, and the individual gets to mask the bucket and it is their election to mask or not?
MR. ROTHSETIN: Right.
MS. MC ANDREW: But their choice is because you don’t want o go to a line item – it’s an all or nothing.
DR. TANG: Or nothing masked.
MR. ROTHSTEIN: With a category.
MS. MC ANDREW: SO they cannot say my treating team needs this data to treat me, but if I release it to my treating team then I have to release it to my dentist.
MR. ROTHSTEIN: Speaking for myself, what I would say is there are some providers you would want to release sensitive information to, but releasing or unmasking certain things with regard to one provider does not unmask to all providers.
MS. MC ANDREW: So now I not only get to mask the data but I get to identify as to whom it is masked. It is not all or nothing.
MR. ROTHSTEIN: Right.
MS. MC AMDREW: And how do I know those people?
MR. ROTHSTEIN: We might have, as the default, that your reproductive history is masked, but when you see your ob-gyn you give them some sort of code or consent and that is unmasked for them, but it is not unmasked for your dentist.
MS. MC ANDREW: But it is an unmasking that I can affirmatively grant to somebody else that is different and more limited than a breaking the glass, emergency access.
MS. BERNSTEIN: That is not breaking the glass; that is giving consent.
MS. MC ANDREW: I am just trying to figure out what you are conceiving as the rules of the road with respect to consumer control over their sensitive data. And do they have – who they can grant access to other than nobody except in an emergency.
DR. TANG: It is easier to just pick up on what you said, reacting to her break the glass, that is an easier way to implement it than to prospectively say, well, I am going to change dentists and I had better tell the central agency – instead she goes to the dentist and say I’d like you to have this information and here is the way you can get it. And that dentist breaks the glass, gives the reason, whatever. Then there is no central authority.
MS. BERNSTEIN: Now I think we are mixing metaphors. When we say breaking the glass, the way I conceive of what you are talking about as break the glass is that the patient is unavailable to give consent in any way. The patient is incompetent, the patient is unconscious, whatever reason the patient cannot give consent.
This is the way I think of it. There are other ways you might get to the record. You can get there with the patient’s consent. What Sue is describing, in my view, is that the patient consents by giving you the code or by whatever it is that enables the physician or telling the physician what the history its – any of those thing that the patient can do is not breaking the glass. Breaking the glass is doing something on the part of the physician without consent.
MR. REYNOLDS: Only for purposes of discussion.
MS. BERNSTEIN: Yes, I just don’t want to mix up the possible models.
MR. REYNOLDS: In Sue’s case, if I went in and I was going to see a doctor and I could give them a PIN that would allow them to get all my information, I can change that PIN whenever I want to. SO if I gave it to them today and I decided they don’t get to keep it, I change the PIN, just like you do with your ATM cards.
Second, the idea of break the glass is, if somebody needs to do that, if they put their doctor number in and they put a PIN in that is given to the doctors, that breaks the glass. So to me, if you look it that way you have a little more structure. So you are allowed to break the glass as a physician in a life-saving situation and you basically put your number on the line there. You basically say I’m in, I’m busting the glass, just like if you walked in this building and hit the fire alarm and you stay there you had better have a good reason. There had better be some smoke somewhere.
MS. BERNSTEIN: Or you might have two PINs, the one that indicates that the patient consented and gave it to them, and one that opens the file.
MR. REYNOLDS: I guess that is what I am saying. Those would be examples of how using – if I need money and I couldn’t get out of this building I could give you my ATM card and a PIN and you could go get it. Then I may call, knowing it’s you, I may call right away and change the PIN. In other words, use philosophies and theories of the way we tend to do our lives.
MR. HOUSTON: There is a lot of design and a lot of consideration that needs to be considered. I mean, there are a lot of things to be considered here. I will give you an example of one of the considerations I think really people are forgetting. You say I can give you a PIN and take it away. You can ook at it once. But the reality is, once a provider provides care, they sure as heck want to build a document that has the information they use for the basis of their decisions. SO yes, you are giving access – that person is giving access to their record so the person breaking the glass can get to their record – but the reality is if I am a provider, once I provide that care I want an historic record of all the information I had access to because I don’t want somebody coming back later. I think we have to be very careful about the ramifications of this because I was hearing discussion about having a one-time PIN and you can give it and take it away. Those are things that scare me. And I think we need to be very conscious of those types of considerations.
DR. FRANCIS: And the question or one of the question that raises is if the physician has the PIN, is that access on a read-only basis or is that download capacity? Because once it’s downloaded the genie is out of the bottle.
MR. HOUSTON: That is my point. If I am a physician providing care I darn well want to be able to download it and frankly update it or at least make my records current so if somebody downloads my records in the future on a break-the-glass that is contains the treatment I just provided, because it very well could be meaningful in other situations.
MR. ROTHSTEIN: And just to follow up on that, there are all these liability issues, if what they did is not in the record somewhere. But it could be in a masked record, right? So in other words, I am the gynecologist and my patient gives me access to reproductive health history. The stuff that I do is now added to that masked record and I am thinking if she releases it to a second gynecologist for a second opinion, they are going to get the record and what I have done as well. Right?
MR. HOUSTON: I would think so, yes.
MS. BRNSTEIN: And it would also be – when electronic records are created you have a history of when they were changed, too. SO it should not be at all difficult, if the physician has provided it on a re-open basis, it would not be at all difficult in a malpractice suit to print out exactly what the physician saw –
MR. HOUSTON: I will tell you right now it is not that easy. Let’s assume you have a record retention law that only requires somebody to keep records for a certain period of time and they decide to discard at the end of that time, and then a suit comes up afterwards.
MS. BERNSTEIN: But that is not different with paper or electronic records.
MR. HOUSTON: I disagree, because if it is a paper record and there is an issue, you fax those paper records to me –
MS. BERNSTEIN: If I am not required to keep them after fifteen years and I destroy them –
MR. HOUSTON: But different providers keep them different periods of time and there might be reasons why you keep a record longer or someone rely more or less, state laws may different. I am just saying every provider, most providers would say that they want to have control of the data they use in order to deliver care. Not to say they cannot get it form somewhere else, but once they have delivered care and they have relied on data, they want to have that as part of their permanent record in the event there are questions or in the event there is a peer review or whatever might happen.
MR. ROTHSTEIN: Are you saying we cannot do that within this broad framework we are talking about?
MR. HOUSTON: I have heard on a number of occasions this morning, and I don’t mean to get into design, but people talk about a read-only, downloadable, this or that and I am just concerned about that as a concept because I think there are a lot of pitfalls to that. AS we are making broad recommendations, and I think we should stay in the broad recommendations rather than drilling down –
MR. REYNOLDS: We are making a discussion; we are not making recommendations.
MR. HOUSTON: But I am just saying that if we do make recommendations that are broad recommendations, my point is that we have to be thoughtful about these types of things.
MR. REYNOLDS: That was our whole discussion before you got here.
DR. FRANCIS: Another goal, when we were thinking about physicians delivering care, another goal might be protecting them against litigation.
DR. TANG: Just to put my vote out on the floor, I would agree with this at the conceptual level – masking certain sections, and those are fine sections for me if you end up with sections in parentheses, examples.
MS. BERNSTEIN: Is there anything missing, do you think?
DR. TANG: I don’t have anything right now.
MR. HOUSTON: I believe there needs to be a category for genetic information.
DR. TANG: That is a very good category. So at the patient’s election a way to mask certain sensitive information such as those in those categories and that when the patient elects to do so, I think is what Mark said, a flag would be put up so the physician knows there is something there. The physician may break the glass – the counter example is, let’s say I don’t have any of those things that I want hidden, it will be unmasked if there is no flag, because I have not decided to opt out.
I understand this is probably not the way most people would think of it, but the three implications of break-the-glass from our point of view – one is that it is a reminder to the user who is about to look at that information, hey, remember this is sort of sensitive information, so make a deliberate decision to look or not to look. The second one is that it does give emergency access because you may need it and that is your situation you described. And the third implication is that automatically the privacy officer will be notified. So when we say break the glass, which is why I think Sue’s example could fit those three very nicely, that is what it means to me. That is part of the implementation part.
MR. ROTHSTEIN: Before you leave I have one more question for you.
DR. TANG: One more thing, you said John signed on to my e-mail. I am going to give John my proxy in my absence.
MR. ROTHSETIN: Good. But I have a question for you. Structurally, if you cannot come back –
DR. TANG: I am coming back at two.
MR. ROTHSTEIN: Then I will hold the question.
The question was, assuming we have this agreement at this general level, do we need to hear from any more witnesses and have ore hearings before we try to put something together in terms of a letter? We can think about that and where we go with this.
MR. REYNOLDS: I would add one other thing to what you said – and play off John’s comment. Once a physician receives that information, then they are allowed to do business as they would normally do business. I am playing off your comment, John. In other words, if you tell me, as a doctor, if you come to me to get treatment, and you give me the record, then I am allowed to use the record in my normal business process to protect myself – I am a covered entity so I have to protect you – you gave it to me. Remember, as this changes and there are laws and everything else and there is data retention and everything else that goes on, we have to, at some point, allow the physician who we have trusted to give the care to be able to do what they have to do.
MR. ROTHSTEIN: My question for you, Harry, on that is the information you have added to this protected category, that is still protected, though. So you are my psychiatrist and I release my mental health stuff. But the fact that it is now a course of business record, that doesn’t mean that what you add or the whole file will now we automatically released to my dentist.
MR. REYNOLDS: No, which is one of the reasons if we have the two different categories – in other words, if our normal thought process is, again not designing, just talking, if our normal process is the base record goes minus those things, then that should be the practice we all buy into under the NHIN. SO John is in a hospital and they are referring patients –
MR. ROTHSTEIN: But the information you add would then be treated as additional masked information.
MR. REYNOLDS: Which everything they are already doing is going to be treated that way because they are already sending stuff to the NHIN and if I am up here in Washington, and I have been to John’s hospital recently, and now their federated model goes to find me, it is going to find me in John’s institution and it is going to send the top record. Unless I said send everything it is going to send only the stuff that is not masked. Then I would have to say wheterh they could have more. All I am saying is that, at some point, we have to allow the physicians and hospitals to do what they do.
MS. BERNSTEIN: In the kind of thing that Jon or Harry or whatever was talking about, could that be satisfied with access that I would call read and append? You can’t change anything that is already there. You can add to the end, which is a very typical geeky computer thing. If you are a physician you add to the end of the record. That is what you normaly do. You don’t change anything that is already there and you can read whatever has been there n the day you saw it. So what Leslie was talking about, that you have a growing log of everything that happened in that record with chronological dates. On any date I can recreate the record as it was on that day and I can see who appended what.
MR. HOUSTON: Within the facility or in NHIN? My thought is this –
MS. BERNSTEIN: It can be recreated.
MR. HOUSTON: The NHIN is always read only. Every facility participating would contribute, in the federated model, to a record that is established about a patient, or would serve uip records that would be available by the patient. So if I am a provider and there are ten other providers out there who are part of the NHIN or whatever, when I went out and made a call for records, everybody could respond back about with the records they have about a particular patient that meet certain criteria. But those records would then come to me an my records that I generate because of that encounter could also be served up and accessible if that patient went somewhere else. SO it si always a matter of your creating your own record for the encounters you have provided care for, but then you are also taking records from other providers to supplement the records to supplement the care that you have provided. SO I never see the NHIN as being something that you modify records for the NHIN. You simply have your own records that will be available by the NHIN.
MR. REYNOLDS: But you’re saying read. You are still going to create a record in your name that has all the data that came in.
MS. BERNSTEIN: But in the Indiana model that is not what they do. IN the Indiana model they are keeping the records for everybody who is in there.
MR. HOUSTON: Typical medical records process in a hospital would say that you have the part of the record you generated at the facility itself, and then you have the portion of the record that is retrieved from other sources. It is faxed, records that were brought in, images created somewhere else. They are treated differently. They are all part of the record, but those records that are in some way from a third party source are I want to call them almost reference material. They are part of the patient record. They are referred to, they explain things, but they would never be modified. They would be there for reference or for evidence of the fact that somebody may have relied on them.
MS. BERNSTEIN: According to Paul your own record would never be modified either.
MR. HOUSTON: Sure it would be. When you come into our facility and you get treated, your record grows.
MS. BERNSTEIN: Yes, grows, but it doesn’t change.
MR. HOUSTON: Yes, you never delete – Paul is talking about an error in the record. Somebody does not go in and delete the fact that medication was given. If they realize the medication was a different dosage than what they give, some kind of notation is made in the record saying there was an error in the documentation of the medication that was given.
MS. BERNSTEIN: Right and it is added to the bottom.
Whatever it is there is a notation made that is later made and it is clear that it is later made.
MR. HOUSTON: But documents coming in from third party sources are treated differently.
MS. BERNSTEIN: In what way?
MR. HOUSTON: You would never modify or append a record form a third party source. What you do is when you provide treatment, the treatment you provide is documented in your own record.
MR. ROTHSTEIN: I am confused. I was okay until about90 seconds ago. SO I come into your hospital –
MR. HOUSTON: You walk in with records in your hand from your physician.
MR. ROTHSTEIN: Okay, and your people are going to do certain things, maybe in reliance on the MRI I had yesterday. And they will be treated differently somehow?
MR. HOUSTON: We would bring those records in, we would import them into our record. We are electronic so we would scan them into our record, but they would always be considered to be third party records.
MS< BERNSTEIN: What is the import then? What does it mean to treat them as third party records? How is that different than your own records? What would you do with them?
MR. HOUSTON: First of all, there are two important reasons. There is a trust level when you are dealing with internal versus external records. It just happens. You may ask for a test to be rerun because you don’t quite trust the result or because you are suspicious of something or you don’t believe they looked at the right thing. But w always recognize that as being a record from another source other than a UPMC facility. It is documented separately. It is identified as being a separate part of the record. It is referenced within our electronic record, but you won’t see a lab value within a table of lab values. You won’t see a physician order a note or something within a panel of one of the screens. You will see it as a document that is scanned in and is simply appended or noted.
MR. REYNOLDS: It is a static document.
MR. HOUSTON: And they are treated differently. I can tell you right now, gee, I reran that test because I just didn’t trust it coming from this other hospital. I didn’t like the fidelity of the image. I didn’t like the reading. A great example is radiology reports. If you get the report and not the image, they will go run the image.
DR. FRANCIS: What I don’t understand is what the significance is of what you are saying. You are just pointing out that electronic records can do this.
MR. HOUSTON: My point all along has been that – all I was trying to make the point all along is when you rely upon a record you want to make sure that you have that data – providers always want to have that data within their –
MS. BERNSTEIN: We are just talking about storage now, really. You are just talking about where it is stored.
MR. HOUSTON: My point is, I don’t think providers are going to be willing to look at a federated model and go back an recreate a document years later because what happens to the data is the data still there, is there some issue?
MR. ROTHSTEIN: I have a question. Before you came in, I interpreted your e-mail as stating that your primary concern in this area was emergency departments, ICUs getting access to the complete record in an emergency.
MR. HOUSTON: Absolutely.
MR. ROTHSTEIN: Okay, from our discussion of the break-the-glass feature which we had earlier, would that satisfy your concerns? Or do you still have some other concerns that were not addressed by that?
MR. HOUSTON: I believe that emergency situations are the case where there is the most compelling argument to have break the glass. Whatever you need to have you need to have. I think we heard that from emergency room physicians who testified. We are talking even on the mental health side.
MR. ROTHSTEIN: I understand that. What I am saying is if we made a recommendation to go to this system that Paul described before he left, and it has a break-the-glass feature, would that satisfy your concerns. Or was there something else that we haven’t done? Your concern was emergency access to the complete record. I think we have satisfied that. Tell me if there is something that we haven’t done?
MR. HOUSTON: We were on another tangent here, I think. I think the break the glass meets by concern about care in emergent situations.
MR. ROTHSTEIN: Are there other issues that we haven’t gotten to that you have concerns about under what Paul described before he left as what he thought our consensus was?
MR. HOUSTON: I am not sure I understand.
MR. ROTHSTEIN: DO you want me to go through those points?
MR. HOUSTON: I am trying to come up to speed.
MR. ROTHSTEIN: I think he said the fault is that the record is comprehensive unless the patient identifies certain pre-selected areas, such as the six that we have there, in which case all of the information from that area would be blocked.
MR. REYNOLDS: Block says you may never get it. Masked says you don’t see it but if somebody says oyu can see it, it comes right back.
MR. ROTHSTEIN: People in Denmark use block –
MR. REYNOLDS: That is an aggressive statement.
MR. ROTHSTEIN: SO this stuff, at the patient’s election, would be masked. In the event that the patient opted to mask one or more areas there would be a flag and the flag indicates that the patient has elected to mask certain information. Then the doc could ask the patient more questions or would you release whatever.
MR. HOUSTON: What happens if they are incapacitated?
MS. BERNSTEIN: That is what we are talking about.
MR. HOUSTON: SO as long as the patient has their mental faculties and they saw there was a masking of something, they would have to ask the patient for the information. I think that is reasonable.
Then if something was there that was relevant and the patient said no, then the physician, as a defense, if there is an issue regarding quality of care or inappropriate treatment or whatever –
MR. ROTHSTEIN: Not to make my task any more difficult, but just thinking about unusual situations, suppose you have a patient who elects that they don’t want any more treatment. They may have some terminal diagnosis, right? And they say I don’t want any more treatment and they refuse medical care, maybe they have a bracelet or whatever. That would include, maybe from their perspective, don’t look at my masked information because I don’t want you to use it anyhow. In other words, could you have a sign, in effect a do not unmask directive, to docs?
MR. HOUSTON: There is a moral issue there.
DR. FRANCIS: There are a couple of tough questions there, I think. One is, I take it that when we talk about consent, we intend to include appropriate surrogate consent. But then there is the question about the directives. I actually think you described the situation of a patient who is refusing aggressive care is not refusing all care.
MR. REYNOLDS: Not necessarily.
DR. FRANCIS: Typically, the patient would continue to have –
MR. ROTHSTEIN: But suppose they bring somebody in who is unconscious –
MS. BERNSTEIN: With DNR tattooed on their chest.
MR. ROTHSTEIN: Yes, they don’t want any care and they don’t want you to unmask the record.
DR. FRANCIS: That would be a question about whether you could do it by advance directive. Here would be an example that I don’t think is totally farfetched. Someone who is no hospice is refusing aggressive chemotherapy, but who is continuing to get oxycotin and has a relative who diverts the oxycotin prescription. That is abuse. It seems to me that knowledge of that – I might very easily not consent to further treatment, but it could be very important to have the oxycotin prescription known to providers, or a history that my relative has been ripping them off.
MR. ROTHSTEIN: But that would have to be reported anyhow under some state law.
DR. FRANCIS: But still the abuse question would be reportable, but the question about whether that is going to be included in the medical record is a different question. Those are real cases. I know lots of cases of oxycotin diversion.
MR. REYNOLDS: I guess my feeling would be I am not sure that is an issue. The reason I say that is if a person comes in and it is life-threatening, that would be the only break-the-glass theory. SO if it is not life-threatening, then the mask –
MR. HOUSTON: The person is incapacitated. Does that mean it is life-threatening?
MS. BERNSTEIN: Someone could be incompetent mentally and other wise be generally healthy and come in for something where the person’s variance(?) is not available or whatever.
MR. HOUSTON: But in that particular case, it is not life threatening, I would argue the break the glass also applies. In an emergent situation – it does not have to be life-threatening, but it can be something that necessitates immediate attention.
MR. REYNOLDS: A person is thrust upon a health cre professional, then back to my earlier point, the health cre professional needs to do his job. If the person is incapacitated, nobody with them, or anything else, they are going to do their job.
MS. BERNSTEIN: But if it is a broken arm that needs immediate treatment, and the person is not competent, that is one thing.
MR. REYNOLDS: I think we are going way too far to the dark side. Of the discussion, earlier you were trying to talk to us about not being overly specific.
MR. ROTHSTEIN: I would never include that.
MR. REYNOLDS: But the reason I am challenging back is, like anything we try to do that is this complicated, there are five ro ten or fifteen things over here that we cannot do, but that is not going to move us forward. Then what it does is elevate the emotion and then we have a harder time coming back together. That is all I am saying. It is all thrown out on the table here – there are real things on both sides and I think if we start bringing them back in again that is when we start separating again.
MR. ROTHSTEIN: I certainly don’t want to undo what seems to be agreed on. Another question is we haven’t discussed at all today the CCR/CCD and whether that has any role in what we are recommending.
MR. HOUSTON: What is CCR?
MR. ROTHSTEIN: Continuity of care – we talked about that to some degree –
MR. REYNOLDS: My feeling is you basically, whatever one of those is picked, we just discussed how you are going to have to have things set up in whatever record that is so that you can parse categories, whatever those categories end up being, whether it is one, two, three, four, five or ten. So as those things go, our recommendation is whichever record is established, whatever one is selected for the NHIN, which HITSB and others are probably gong to be the ones to pick that, it would need to have that capability.
MR. HOUSTON: The CCR has medications and stuff like that in it, correct? So in theory there is a bunch of things in there that would still show up as being –
DR. FRANCIS: They don’t have to because they can be masked if they are mental health.
MR. REYNOLDS: That is my point.
DR. FRANCIS: They are masked but they show up on when thee are actions or decision support screens.
MR. HOUSTON: That is where I am going with this. What I thought Mark saying was the CCR – is it implicated by what we are talking about. The point being just that, that there are going to be things on the CCR that would fall into those six categories and they would be relevant. If they are not there they are going to be missing from something else.
MR. ROTHSTEIN: Do we need, in our letter, to expressly discuss that issue? Or should we just leave it out?
MR. REYNOLDS: We need to say there are possible candidates for a standard record out there. This needs to be laid over top of them to make sure that this capability can be adhered to o whatever is picked by HITSB or anyone else. IN other words, we are saying that this is a requirement. To me the CCR, the CCD is a package of data. Whether you pick one or the other, it is a package of data. Now whether or not that package of data can be parsed in any way will be decided at the end, not necessarily what the data elements are. That is where I think we are going.
MR. HOUSTON: You say a package that can be parsed. Does that mean that the CCR is this monolithic thing that comes as one package and there is no ability to differentiate elements within the package?
MR. REYNOLDS: I am sure there is. It is seventeen different categories and I think the top five or six categories are the ones that are predominantly used, but I haven’t mapped those categories and exactly what is in those categories and data pieces to this.
MR. HOUSTON: My point is more basic. When I get a CCR – I ask for the CCR and I get the CCR or is it –
MS. BERNSTEIN: It looks like this. There is an example in your folder.
MR. HOUSTON: But my point again, when I ask for the CCR, is there a CCR or are there components of CCR which would then, to Marks’ point, have the ability to say that is a drug associated or a test associated with metal health or substance abuse or whatever. It is not part of the CCR unless expressly authorized or called out for. Do you see where I am going? Is that what you are asking, Mark?
MR. ROTHSTEIN: I am trying to get the relationship between the two so we can make a sound recommendation that is integrated.
MR. REYNOLDS: In the first place, you won’t get one. You’ll get it from every provider. You will get a federated model. You will get that same data from everybody. If you set that up as your package to move things, you will get it from — if you send a message out onto the NHIN, you get it from everybody.
But your question, John, if you look at these in your blue folder, it breaks them down into things like the patient and who is the patient seen by and what is the subjective information and what is the objective exam and what are the vital signs. In other words, these are what I call indexes. That is how you can go into a record, by these categories.
So what I am saying, Mark, back to your point, whatever they select, if you can’t go into that record with these categories, it won’t work.
MR. HOUSTON: When you say it doesn’t work, —
MR. REYNOLDS: If you just have a whole list of — let’s just go with drugs or primary care doctor’s notes, and those are not identified in a way that you could mask — if you got a list of drugs and there are 40 drugs that somebody has been taking, and this is not unfiltered, it is laid over top of them, so that number three is not shown anymore and number nine is not shown anymore and number 15 is not shown anymore, then guess what? You won’t have any of this, you will have the whole record.
So that is why this is so important. What we are doing right now is really important, because people are out picking standards. The problem with the standard, if a standard doesn’t have the rules and everything that you have got to think about how you are going to do the data, then I promise you, the standards are going to be hard to work with. You are going to have to go in and add things to it, and you are going to have to add things to it and you are going to tear it apart in different ways.
So it is almost like if whatever they had aligned a little more to that thinking and took these other elements and fit it under that thinking, possibly. I’m not recommending that; I’m just talking from a designer standpoint.
MR. ROTHSTEIN: In other words, the way I look at the CCR, CCD, it is sort of like the executive summary of a medical record. Anything that we operate like a system that we place over the full file, we are also placing over the subset of file, that is, the CCR, CCD.
MR. REYNOLDS: I don’t think it is an executive summary.
MR. ROTHSTEIN: Isn’t it information distilled from the full record?
MR. HOUSTON: CCR, sure, it has to be.
MR. REYNOLDS: But again, remember, if you are seeing six doctors, you are getting six different ones.
MR. HOUSTON: Each provider provides their own —
MR. REYNOLDS: Yes, so when we say executive summary, that is usually brought together in one place. Remember, the federated model says, everybody that’s got a record, I am going to get a record from them, and if it is in the format of a CCR, if it is in a format of the CCD or whatever you want to call it, —
MR. ROTHSTEIN: So there really isn’t a CCR; there are CCRs.
MR. HOUSTON: Each provider has a CCR.
DR. FRANCIS: If you look at the summary, it is over in additional comments. There was a discussion of something sensitive, the patient is exposed when a victim of rape.
MR. REYNOLDS: It appears his child was beat up.
DR. FRANCIS: Yes, right. Then unless there is a way to filter this, if this just blanks those into the record, and there is a whole list of these that go that are completely searchable, then what you have got there is —
MR. REYNOLDS: That is why this is so important. This is why the whole discussion has all of a sudden gotten a lot more rhetoric about it. If you don’t have that to start from, if you don’t start from what you are thinking about as the ways you want the patient to decide what does or doesn’t happen, or everybody to see what does or doesn’t happen, then everything you build after that actually will be going in 180 degree opposite of what we need to do.
So that is why this is like paramount now, because standards are flying out like crazy. They are setting up standards committees to do things and so on.
Sue, you haven’t commented much. This is a new world, too. What do you think?
MS. MC ANDREW: I think you need to be clear in your head that your whole context of conversation here is treatment, and you are not debating any other type of use of this information, which is going to raise a whole other set of parameters and concerns and balances.
MR. ROTHSTEIN: In our June 2006 letter we actually did refer to that. But that is a good point, too.
MS. MC ANDREW: I think it is going to be much trickier than you believe, than this conversation reflects, about what information you are going to be putting into these sensitive masked buckets, particularly on subsequent treatment encounters, where provider two is given access to the unmasked data that was given to provider one.
MR. HOUSTON: Can I make a statement about that real quick? Going back to medical records, typically when a medical record is forwarded to another institution, you don’t forward another institution’s medical records to them. So they would forward information that was generated at their institution. They may reference the fact that they relied on other materials from other institutions, but they would not forward materials, medical records information, that they were provided either by the patient or by the institution.
MR. REYNOLDS: That is the way you guys do business.
MR. HOUSTON: Yes, that is what most providers do. I don’t know if that affects what you are saying about the fact that you were getting information that was given to one provider that is sensitive that is now going to another provider. I don’t know if that affects — or we have to make a provision for that type of a process.
MS. MC ANDREW: Well, it seems to me one may wind up basically thinking how that process works now in an NHIN; does it essentially replicate that process, because whoever is asking you for the information is also asking the people that gave you the information that you relied on.
MR. HOUSTON: That is more reason, by the way, why we shouldn’t be giving that information out, but you should be relying on the source materials from somewhere else.
MS. MC ANDREW: And why everyone is responding the same way, although you may have information from another network.
MR. HOUSTON: That should be part of the rules of the road, though.
MS. MC ANDREW: Again, it is important to talk about this in terms of treatment and access issues, where you would come out differently on that, because the individual has the right to that information.
The other thing is, it is going to be very tricky, particularly when you get into drugs and things like that, certainly when you get into genetic information about trying to come up with a reasonable bucket to allow the masking, because genetic information, the way it is currently being defined, you are talking about family history.
MR. ROTHSTEIN: I would have a narrow definition of genetic information such as genetic test results.
MS. MC ANDREW: But you need to be aware
MS. BERNSTEIN: Are you saying tricky because it falls into more than one category, or for some other reason?
MS. MC ANDREW: It is going to be tricky because we are probably on the cusp at least in HIPAA of getting the GINA bill definition of what genetic information is.
MR. ROTHSTEIN: The civil rights definition may be too broad for a medication definition.
MS. MC ANDREW: But it is going to be our medical definition.
MR. HOUSTON: When is that supposed to arrive?
MR. ROTHSTEIN: As soon as Congress votes on it.
MS. BERNSTEIN: According to the wisdom of the Congress.
MS. MC ANDREW: Through the House, staff is cobbling out compromises in the Senate. If we get it, we get it. But it has a very broad definition of what genetic information is, and that will become the HIPAA definition of genetic information.
MR. ROTHSTEIN: That’s all right, that doesn’t bother me, because a lot of what GINA calls genetic information, we are going to have here under sensitive social — father died of Huntington’s disease, that would be genetic information under GINA, but we would still capture it here.
MR. HOUSTON: Why would that be considered genetic information?
MR. ROTHSTEIN: Because it is information about genetic risks.
MR. HOUSTON: I would argue that almost any disease, many diseases, some of whom were stigmatizing others, there is a genetic marker for, or will potentially be a genetic marker for. It can be anything from skin cancer to lung cancer to this cancer, that cancer.
MS. BERNSTEIN: Right, and if your father is not the father you thought he was —
MR. HOUSTON: You are talking about a diagnosis there, which is different, or a cause of death which is different.
MS. MC ANDREW: The current definition is any medical condition of a family member that is being used to diagnose you. The medical conditions attached to family members are not conditioned on there being a genetic marker.
MS. BERNSTEIN: Right. The fact that my mother has high cholesterol and my father had heart disease puts me at high risk, that is genetic information, whether or not there is a gene test associated with it.
MR. HOUSTON: It is dangerous to sit around and try to differentiate genetic information.
MS. MC ANDREW: If you are trying to identify and mask genetic information as a category, you are masking almost the entire medical record.
MR. HOUSTON: Your medical history now becomes —
MS. BERNSTEIN: Just because they call it genetic doesn’t mean it is still not family history like we have always thought of it.
MR. HOUSTON: My point is that if you define what is the family history as being genetic information by law, you are going to —
MS. BERNSTEIN: It depends on what the law does with the genetic information.
MR. ROTHSTEIN: It makes certain uses of family history.
MR. REYNOLDS: We referenced earlier — Paul referenced the Indiana model. Either you are all in or you are all out. If you look at the real heart of these discussions and everything we are getting to, unless we are really clear on what everybody is going to do across the board, it is either all in or all out. I’m telling you, it gets real difficult as you go, and the definitions are changing.
Again, we are trying to look at this stuff ten years out or 15 years out. We are not looking at tomorrow morning. So that is why this is a tough deal. We have got to have the courage to stay with it.
DR. FRANCIS: Part of the appeal to me is that you start with a framework of certain types of information that are in and certain types that are in but masked, is exactly that problem. I don’t fully know the basis of continuity of care records. If they are simply reports of visits, then it doesn’t work that way. But if what is in the record are things like, every time there is a blood pressure reading it goes in, every time there are vital signs it goes in, every time there is a lab result it goes in, every time there is a prescription it goes in. So you have a list of data elements that just automatically get in.
Then the random, father was questioned about bruises, never goes in because it is not in one of those fields. I could be talked out of it, but I have become pretty well convinced that that is the only initial structure that could work in a way that you don’t get all the random stuff.
The other way would be, you simply decide that certain visits do not get included. That again is very mechanical. But that has the disadvantage that you are going to have to increase the primary care visits, and you are also going to have to include medication if you go to see a mental health professional.
MR. ROTHSTEIN: I think we need to take a break for all sorts of reasons. We will break for 15 minutes.
MR. ROTHSTEIN: The next thing we need to think about is going forward in drafting this letter. I think we have got enough information to come up with a draft.
MS. BERNSTEIN: To determine that we do not need any further hearings and so forth?
MR. ROTHSTEIN: I think that is right. But my question is about the timing. From what you know, Harry, Sue, anybody, is a September letter — would that be considered timely enough to get these ideas into the pipeline? We are not missing the train, are we?
MS. MC ANDREW: I don’t think you are missing the AHIC train. The group is doing — I think they are still on the entity question.
MR. ROTHSTEIN: Right.
MS. MC ANDREW: So we may assume their next set of recommendations will be going to the AHIC in general.
MR. REYNOLDS: And you say October because that is when we are going forward, we are trying to get ready with the secondary issues, so they can go into AHIC in October.
MS. BERNSTEIN: But they meet every two months, right?
MS. MC ANDREW: Every quarter, I think.
DR. FRANCIS: They just met, right?
MS. MC ANDREW: Right.
MR. ROTHSTEIN: But it is vapor ware.
MS. BERNSTEIN: Well, framework has another meaning, too. My view of that is that it originated with the CPS work group as a starting point for the work group to look into issues and somehow, I’m not sure exactly how, morphed into an announcement at the May meeting. It characterized it in a funny way, actually. We were on a pretty good track, and then they went off into cyberspace and God help them, they got atomized.
MS. MC ANDREW: The next AHIC meeting is at the end of August.
MS. BERNSTEIN: Really? At the end of August?
MS. MC ANDREW: August 31 I have on my calendar. I’m sorry, July 31.
MR. ROTHSTEIN: So Sue, would you like to go off the record for your answer? Seriously.
MS. MC ANDREW: No. I don’t control their calendar.
MR. ROTHSTEIN: When you say the AHIC train, are you saying there is an ONC train?
MS. BERNSTEIN: An OCR train?
MR. REYNOLDS: There are RFIs on the street right now for health information exchanges.
MS. MC ANDREW: But there are lots of people in this little pile-up. The AHIC is pressing to maintain their — gateway role to this whole thing. ONC however and AHRQ within the Department, they are blossoming through contracts a lot of piloting and testing and prototyping. Much of that is going on its own track. They are supposed to be flexible in their prototyping to accommodate future policy calls. So in theory, this is not too late even for that prototyping test.
But in terms of the track, there is a Departmental track for this to have an impact in terms of what ONC, AHRQ and others want to see in the testing and the piloting that goes on as well as the official recommendations that are coming up through the AHIC.
DR. FRANCIS: What is the structure of the piloting? What I am asking actually is, when you talk about piloting, are the structures that are being piloted ones that would make it harder or easier to do something like that?
MS. MC ANDREW: They are supposed to be open ended enough to accommodate something like that.
DR. FRANCIS: That is what they are supposed to be.
MS. BERNSTEIN: But they just put them on the street, so we have no idea what they are going to do.
MS. BERNSTEIN: To the extent anyone paid attention to the demos that were put out in the fall, it was then going through those, selecting some and then taking them to the next stage of actual operational level architect language. They are still just prototypes of repeating models. They are just proving theories, or disproving.
One would like to think, but I don’t think it is true, that there are all these RIOs and networks that are blossoming out there. You get competing stories in terms of, all of this is taking off in the private sector and we are too late to influence it, versus, the adoption rate is still pathetically low.
MR. REYNOLDS: There is no business model.
MS. BERNSTEIN: The world isn’t going to be done in three months.
MR. REYNOLDS: I would like to go off the record.
MR. ROTHSTEIN: Could we go off the record, please?
(Comments off the record.)
MR. HOUSTON: I know in Pennsylvania substance abuse and mental health specifically require additional restrictions already. So I can imagine some of these forming around what state laws currently require now.
But having said that, I agree with Harry. I don’t think there is a business model yet. I think it is true that there is not the traction that people would like you to believe.
MR. ROTHSTEIN: Do we know whether our proposal for masking substance abuse records would satisfy the substance abuse treatment regs?
MS. BERNSTEIN: I do not know the answer to that. Sara would, but she is not with us.
MR. ROTHSTEIN: It says separate, but this is not separate.
MR. ROTHSTEIN: It could be.
MS. BERNSTEIN: There are other requirements besides separate, though.
MS. MC ANDREW: I think the only question would be whether — I don’t think they have like a break the glass emergency access permission.
MR. ROTHSTEIN: Right. Would you run that past Sara?
MS. BERNSTEIN: Yes.
MS. MC ANDREW: So there might be a whole different set of controls in how they operate that would be different than one would assume.
MR. ROTHSTEIN: Right, so we are going to have to also build in not just federal law, but also state law. Suppose there is a state law that makes HIV information absolutely not disclosable and so forth. Then the break the glass feature still couldn’t reveal that, right?
DR. FRANCIS: How does the substance abuse work with the prescription information?
MS. BERNSTEIN: I don’t know the answer to that.
DR. FRANCIS: Would it be in the notion of decision support?
MR. HOUSTON: I suspect that the substance abuse issues that we are talking about are peoples’ treatment for or diagnosis of or something other than simply the fact that they have been prescribed a bunch of medications.
DR. FRANCIS: I was interested in a substance abuse treatment record that involved a prescription, e.g., methadone.
MS. BERNSTEIN: But what about that? A substance abuse treatment record that is covered has to be in a specialty practice, a substance abuse treatment specialty, and separated.
DR. FRANCIS: Yes. Suppose you had something like that and it included a prescription for methadone?
MR. HOUSTON: But methadone is not only used for substance abuse.
MS. BERNSTEIN: But there is a good chance it is.
DR. FRANCIS: What I was just questioning was, another part of the proposal was that there would be decision support with respect to prescription interactions. I just wanted to know how that would work with substance abuse records.
MR. REYNOLDS: That’s a good point.
MS. BERNSTEIN: I don’t know how the decision support part would work, but what I do know is, if the methadone prescription, if there is a notation of it in the internist’s record, it is not protected.
DR. FRANCIS: Right, I know that. I am just simply pointing out that one of the things that — if we wanted good decision tools for prescriptions, that is an issue.
MS. MC ANDREW: In a way, I think the SAMHSA issues become more concerns of those facilities that are covered, and whether or not because of the SAMHSA rules would they be able to part of the network. Or do they have to remain out because the network can’t accommodate their confidentiality.
MS. BERNSTEIN: One of the issues that we talked about the day of the hearing and even before that when we were planning the hearing was whether — for example, in the HIPAA rule there is a similar provision; you have to be a mental health provider and you have to have the record segregated somehow. It is a similar, although it is a more narrow record that is covered. Whether that makes sense to have the protection be that narrow in sensitive records or whether a record of mental health treatment or substance abuse treatment in an internist’s record should also be protected. So that is how the discussion was originally —
MR. ROTHSTEIN: I want to focus on the committee’s plan for this. Let’s suppose that three weeks from now, we have a draft for you. Suppose we got something out by early or mid July. Do you think the best approach would be to schedule a series of conference calls?
DR. FRANCIS: In theory it has to go then to the full committee, right?
MR. ROTHSTEIN: Of course, yes, by September.
DR. FRANCIS: And the full committee meeting is September 27-28? Do I have that right?
MR. REYNOLDS: Mark, again, whatever we start putting together will be useful, with everything else that we are doing.
MR. ROTHSTEIN: The meeting is — I have the NCVHS meeting the 25th and 26th, Tuesday and Wednesday, September.
So in thinking about setting up our fall schedule, we could do one of two things. We could take on other topics, or we could say this is so important, what we would like to do is have a hearing and focus on substance abuse, and get people talking about the regs and how it might affect them, and have mental health people, have domestic violence people, get the AARP people, the social workers, the geriatricians and so forth. That is another option.
If we did that, I think it would be helpful to the ultimate decision makings, because we maybe then will have a followup letter, here is some further detail on what we recommended, sort of like what we are doing now. We started with a framework last year.
MR. REYNOLDS: Could I add some others?
MR. ROTHSTEIN: Yes, please.
MR. REYNOLDS: I think we would definitely want to hear from some of the HIEs. We are focusing on these five, but we have got to focus on whether or not people could ever pull this off.
MS. BERNSTEIN: It is frustrating to me that if we focus on whether the technologists can do what we want the policy to do instead of what the policy is, we will never get to the policy. My sense is that eventually the technologists will be able to do it, eventually.
MR. REYNOLDS: That would be an opinion.
MR. ROTHSTEIN: The people I talked to said, we can do anything we want, as long as you have got enough money.
MR. REYNOLDS: Wait, I’m not relinquishing the floor yet. I defer to a number of you in your day jobs. I have a day job also. That day job is doing this, and been doing it for 30 years. So I have designed every kind of system that you can think of that has to do with health care.
The problem is that if you don’t keep that as a filter, we are playing games. When we talk about a federated model, we can’t group this industry up to do NPI. We can’t just pick numbers and implement them, and not do them in five year periods.
MR. ROTHSTEIN: The question here then, is it still logical in your recommendation that we move ahead with the September letter even before bringing in the —
MR. REYNOLDS: No, I’m not stopping you. The reason I am putting it in is, part of trying to drive policy is understanding the practical limitations so that they don’t trip you up after you send the policy in. I’m just as comfortable in policy as the other, but if we just focus on what substance abuse we want out there, — I’ll tell you, one thing that is moving quickly, different than my earlier statement, HITSPE and other people like that are looking to pick standards very quickly. If we don’t have this discussion on some of these things so that we can help drive some of that discussion, if the wrong records get picked, if the wrong packages get picked, there is no technology that can fix it.
Back to John’s earlier statement about a static document. He gets a lot of stuff. We all scan stuff. You get it in, if it becomes a static document you can’t do a lot with it. But these other things are not static documents, these other standards that are going on out there.
I guess where I am going, and I am on all the different committees, standards, secondary use, privacy, fine, I’m seeing the whole picture. Some of you are better at each one, but I am living the whole picture. The point is, if we don’t get this right and we don’t get this holistically then the rest of it really starts to fall apart. Or being a technologist, it goes back very simply to all in or all out, have a nice day.
MR. HOUSTON: I have a concern. I think we can’t be naive as to how we look at making the recommendations. I think it is naive to think that we are going to get a quick change in state laws. I think it is naive to think that we are going to get a quick change in federal law, if ever, which means that whether the technology on the surface would seem to be able to support the things that we want to do, we can’t allow that to govern.
First of all, it is amazing what technology can do if people decide they need to do it. I am always amazed by what people end up doing that they said was not doable. I think this is a lot of programming, but this is infinitely doable, setting these things in place that we are talking about.
MR. REYNOLDS: Setting these types of things in place.
MR. HOUSTON: Absolutely. It could become a fairly exotic infrastructure, but it is one for which you deal with in other issues like banking that are much more involved.
So the point being, I think we need to be driven by what — if we try to set a standard that is consistent with state and federal laws, knowing that there is a variation in state laws, I think we are going to find out it is going to be more demanding than what we had ever envisioned, and we will probably need the criteria that this subcommittee would probably put in place — you can imagine what some of these state laws require in some of these areas.
So my point being is, it might be good to take a step back and try to understand the federal and state law framework and try to understand whether somebody has done a highest common denominator assessment of these different types of information demand, and see whether from that we could maybe try to come up with a consensus as to an approach.
DR. FRANCIS: Probably the one where you are going to find state law will be the genetic information.
MR. HOUSTON: I think there have been studies done of all of the — the AHIC stuff, I just saw that all come out.
MR. ROTHSTEIN: You mean the RTI?
DR. FRANCIS: That is actually not a list of what the state laws are. That put people together to look to see whether they incorporated that in their decision making on the test cases.
MS. BERNSTEIN: I was with John until you got to the last point about going back to state and federal law. Earlier you said state and federal law is very complicated. We can’t be naive about it, but we can’t get to a place where we promulgate all of it because it is too complicated.
MR. HOUSTON: No, that isn’t what I said. I apologize. What I was saying is, don’t think we will ever displace it. My point is that there is a lot of variation, but I suspect at some point if we picked a fairly high standard to encompass everything in all these areas, would that satisfy the committee’s variation in opinion as to how to treat this information.
If we look at all the state laws, if we wanted to have commonality because we were having this Nationwide Health Information Network, here is what we would be required to do, if we were to try to set a standard that is high enough for everybody to participate without changes in laws. We may find that —
MS. BERNSTEIN: A high enough standard or a low enough standard?
MR. HOUSTON: A high enough standard. Some states are probably silent as to these things. In other cases they may address all of them. It would be interesting to find out whether anybody has looked to see what the highest standard is in these different areas. The reason why I say that is, we are not going to get these state laws changed.
MR. ROTHSTEIN: But if we put together a system that is flexible enough to let the states that may have some special law go forward, as long as it doesn’t conflict with the state law, and the is will enable the providers to comply with that, I think that is good.
MR. HOUSTON: My concern though is that we have an interstate movement of records issue.
MS. BERNSTEIN: In what way?
MR. HOUSTON: In what way? I have got a cancer center in Steubenville. My main cancer center is in Pennsylvania. Ohio and Pennsylvania have different laws. Now, where is the site of that patient’s care?
MS. BERNSTEIN: It is a conflict of laws issue.
MR. HOUSTON: It is not even a — it is a conflict of laws issue. By the way, that patient has also been seen in my Pittsburgh facility and my Steubenville facility. Their treatment is being done at both facilities. They might come to my Pittsburgh facility to get diagnosed. We may develop a treatment plan in Pittsburgh.
MS. BERNSTEIN: All you are saying is that the state laws are different and you have to accommodate that in the record.
DR. FRANCIS: You must made a very interesting argument that I can see showing up on radar screens very soon about the question of federal pre-emption, putting together a federal statutory scheme that would pre-empt, and with respect to health records is going to make it a whole lot harder for states to have more stringent standards.
MR. ROTHSTEIN: I want to wrap up this discussion.
MS. BERNSTEIN: I wanted to make a point about what John was saying, which is, the analysis you are asking for is a multi-million dollar long term analysis. It is incredibly complicated to find out what each state is doing. Every state is doing something different. I tried one small piece of it once with Bob Gelman on a contract when I wasn’t in the government, and it was incredibly complicated. Some of the law firms are spending a lot of money doing it.
MR. HOUSTON: Wasn’t there a law firm that did it once?
MR. ROTHSTEIN: Yes, I remember.
MS. BERNSTEIN: They did a piece of that kind of thing, but you are talking about a pre-emption analysis, which is incredibly complicated. They are all orthogonal.
MR. HOUSTON: I think your point is, we are never going to have federal pre-emptions. That is the hot potato nobody wants to touch.
DR. FRANCIS: I’ll be very shocked, if it is really a health information network and state standards are —
MR. HOUSTON: I’d love to see it. I advocate it, but I’m not sure how practical that is going to be.
DR. FRANCIS: I just think it is on the horizon.
MS. BERNSTEIN: I don’t want to express any comment about education that, but I do want to respond to what Harry was saying before about policy versus figuring out a technologist can do, what we ask them to do.
Right now, we have a bunch of health information exchanges that are cropping up that don’t have — either like Indiana or other types of exchanges or business models that are coming up that are not including all this kind of stuff that we are thinking about all the time, because they are not being asked to. There is no reason for them to do it.
But to me, if you don’t get a policy in place, nobody is going to start thinking about doing that. Policy is hard and squishy and a lot of gray, and nobody wants to touch it because it is hard and squishy and has a lot of gray. But without trying to nail down the policy, which I think this group is spending a lot of time ruminating over it, which is great, if we don’t get a policy, we are never going to get anybody to try the technology.
MR. HOUSTON: Then to Mark’s point and everybody else’s point about timing, we might as well do the full monte and say we should be pushing a letter out for September, because it is going to take a lot of time to try to get it right.
MS. BERNSTEIN: We can get a preliminary letter the same way and then build on it.
DR. FRANCIS: That is what I think we should do.
MR. HOUSTON: But the point being, if it is that hard nobody is ready to have something fast anyway.
MS. BERNSTEIN: I agree with that. That is why I think you can take it on in that sense. Nothing is going to be a done deal by September.
MR. HOUSTON: Individual hospitals, substance abuse, we have gone through great pains to deal with how to segment our record substance abuse information, our electronic medical record, to satisfy our state laws. We are in our results a de facto RIO, because we have got 19 hospitals and we have got an electronic medical record system, probably about two-thirds of that.
We have actually gone through the evaluation in setting up the deal with a lot of different sensitive data types. There are people thinking a about them. I think part of the problem is that that there has to be sophistication of thought. As you get more systems that start to deal with it, I think there has to be —
MR. ROTHSTEIN: We are going to resume this discussion at two. But I just want to say that I think there are two different elements. I appreciate the discussion reinforcing this. One is the policy, the conceptual level. I think that we can get that out and ought to get that out in September.
Keep in mind, we have been working on this for two and a half years, these sorts of issues. It is astonishing to me, the amount of progress that we have made on this in terms of having —
MS. BERNSTEIN: We?
MR. ROTHSTEIN: The subcommittee and to a lesser extent the full committee, in having a real convergence of views. I think we need to recognize that there are going to be people who have philosophical issues with what we are presenting, but they are also going to have practical issues. To the extent that we can drill down at further hearings and make more detailed recommendations to the Secretary about each one of these, —
MR. HOUSTON: Can I ask a question? You are wanting to put together — I hate to use the word philosophical letter, but put together a benchmark letter that says, here is a benchmark for the way these things should be handled.
MR. ROTHSTEIN: Here are the concerns that we have. We want doctors to get as much information as they need to treat, but we are also concerned about not dissuading people from seeking treatment because of privacy issues. Here is how in general we have attempted to strike the balance. Then put this at this framework.
MR. HOUSTON: That sounds good.
(The meeting recessed for lunch at 12:10 p.m., to reconvene at 2:10 p.m.)
A F T E R N O O N S E S S I O N (2:10 p.m.)
MR. ROTHSTEIN: I think there are two things that we have left to do today, and they shouldn’t take that long. This morning we agreed to draft a letter to the Secretary on the issue of patient control of sensitive information. It will be circulated by mid July, and we are going to have lots of work to do on it after that.
But what we need to do is try to figure out when we should arrange our next batch of conference calls to discuss the letter, so that is one thing. The other thing that we need to do is to plan our fall hearings where we are going to go into some of the issues in more depth.
So Simon, what we decided in addition to the letter, which we hope to get to the full committee for the September 25 meeting, we are going to be setting out in that letter our recommendations in a conceptual sense.
What we want to do after that is follow up by going into more detail. So for example, we are going to recommend that there be special treatment of substance abuse information. But that raises all sorts of issues in terms of the operational stage about the interworkings with the SAMHSA regs and all sorts of particular things. We agreed that the more information we could obtain on the specifics of each of these areas and other things that we are working on, the more useful it would be to the Secretary.
So that is the plan for the fall. At the moment, I think it is probably premature to come up with any schedule for letter writing, because we don’t know where this is going to take us yet. How many hearings do you think we would need? Maybe a half a day on each topic?
DR. COHN: Mark, could I ask an odd question?
MR. ROTHSTEIN: Yes.
DR. COHN: I realize you are jumping into the problem areas here, but I just wanted to make sure, I wasn’t clear what is the conceptual agreement that you are going to be proposing for September? Just give it to me at a very high level.
MR. ROTHSTEIN: I will be happy to give it to you at a high level. A patient can elect to have certain areas, not items, but areas of his or her health record masked. These are the areas that we are currently working with. The result would be that the information would not be accessible to providers without additional consent from the individual, except with the following two exceptions.
One, there is a break the glass feature for emergency situations when you can’t get consent. Number two, if the individual has elected to mask a certain field or more than one field, there will be a flag on the file that says, patient has masked certain information, but not identify what category the information is from. However, there would still be decision support that would go through the masked information for drug interactions, for prescribing, stuff like that.
So that is basically the approach that we are recommending. But we want to in the hearings try to learn as much as we can about the specific areas. I think that would be very helpful.
DR. COHN: Thank you for clarifying that.
MR. ROTHSTEIN: If you remember, two and a half years ago when we first started down this path, we were like six different — there was just total disagreement about where we ought to be going and why and how and everything. Over this period of time, I am just extraordinarily pleased and grateful that the subcommittee at least and hopefully the committee as well, has reached a pretty strong consensus on what we need to be doing.
It is not going to be easy. It is going to be difficult, contentious, complicated. There are lots of problems, but I think they are problems that are worth trying to solve.
DR. COHN: Just to make sure I understand, basically the high level agreement is that for some certain set of specific issues, people can mask that information. We haven’t exactly figured out what those issues are, but there is a starter set you have up there, right? But this is not meant to be open ended, you can mask everything.
MR. ROTHSTEIN: No.
MR. REYNOLDS: We call it structured.
MR. ROTHSTEIN: You only have those choices, because that is what we identified as sensitive information. We can’t say I want my cataract surgery masked. That is not going to happen.
MR. REYNOLDS: We are clearly trying to identify the granularity, not let granularity be in the eye of the beholder.
DR. COHN: I just wanted to make sure that this wasn’t the beginning of a hundred topics.
MR. REYNOLDS: No, no.
MR. ROTHSTEIN: The other thing that we need to do is schedule hearings. The question would be, can we get to some level of specifics on that, such as what hearings on what topics and who do you want to hear from. We are not going to be meeting in person again until September. We are going to have to have those hearings in the works.
It seems to me that with any luck, we will have the draft out by mid July. I would like to schedule initially two two-hour conference calls for us to revise and thrash out the particulars on the draft letter. That probably should take us until Labor Day to resolve. Then we can start planning a couple of hearings, maybe two hearings in September and two in October.
MS. BERNSTEIN: That is unlikely.
MR. ROTHSTEIN: Unlikely?
MS. BERNSTEIN: The Jewish holidays are in the middle of all that. And there is a full committee hearing.
(Discussion of the record regarding future meeting arrangements.)
MR. ROTHSTEIN: What I would like to do in the last 45 minutes or so is to go through the major principles that we talked about and see whether we think we need any more input and so on.
One question I had for Harry. Harry made the point before lunch about the need to run this framework past the IT experts, the technical people, like how would you do this, and what is the most practical framework. At what stage, Harry, do you think we ought to do this? In other words, should we do these subject areas and then have the IT guys come in last? Should we have them come in first? Should we have them at each of these hearings? What is your suggestion?
MR. REYNOLDS: I wasn’t necessarily talking about the IT guys. I was talking about the HIE people. In other words, for some reason Indiana chose not to do this.
DR. COHN: I think their view is, if you don’t want it to go through, don’t put it in.
MR. REYNOLDS: I agree.
MS. BERNSTEIN: Their technology is 20 years old.
MR. REYNOLDS: Yes, but if you are going to change it, you’re going to change 20 years worth of work.
DR. COHN: I think you do need to hear from people, I don’t know whether it is HIE or software developers or a combination of A, B and C.
The devil was in the detail on all of this stuff. I guess it is a question of how much detail we want to get. I am reminded that when you look at HIPAA, don’t say you can’t put mental health in. It is more like, all mental health has extra protections. What they say is, X note, there is a civic note, there is identifiable that you can put your arms around that is protected. Others enjoy the regular HIPAA protections. Am I saying that correctly?
MR. REYNOLDS: Yes.
DR. COHN: On that you can probably put your arms around. It gets a little harder when these 12 ICD codes and these 13 procedures and these 25 medications —
MR. ROTHSTEIN: That’s right. For example, under —
MS. BERNSTEIN: If there are codes for them, it is easy. You know which ones they are and can identify them.
MR. ROTHSTEIN: I’m not prejudging how we are going to come down on this, but I would say that we should not be wed to the psychotherapy notes exception under HIPAA, because I think it is overly restrictive. It has to be developed by a mental health professional under the psychotherapy exemption, where I think we want to have more general coverage and so forth. But that is the kind of issue we need to pursue.
MR. REYNOLDS: Somebody like WebMD, somebody like some of the HIEs, anybody else that has got —
DR. COHN: The first question is, can a software vendor who is selling electronic health records or quasi-health records or whatever screen this stuff out from going to the HIE. The second question is, can the HIE even manage and screen this stuff.
MR. ROTHSTEIN: Should we hear from the prototype developers?
MR. REYNOLDS: No.
DR. COHN: Which prototypes?
MR. ROTHSTEIN: The prototype developers.
MR. REYNOLDS: You mean the consortia?
MR. ROTHSTEIN: Yes.
MR. REYNOLDS: I don’t think they want anywhere near this.
DR. COHN: The new contracts they might.
MR. REYNOLDS: The new contracts. You said before initial.
MR. ROTHSTEIN: Right.
MR. REYNOLDS: No. That would be my feeling. We heard a lot from them, and I don’t think we got anywhere near this kind of level.
MR. ROTHSTEIN: They do have a degree of expertise.
MR. REYNOLDS: I don’t have a problem with them as entities.
MR. ROTHSTEIN: Right, not talking about what they did.
MR. REYNOLDS: Then I’m okay with that.
MR. ROTHSTEIN: I don’t want to talk about their framework.
MR. REYNOLDS: The other thing you talked about this morning, which would be another group that fits in with this, you have got CCR out there, you have got CCD out there, you have got some of those other ones. As people are looking at setting standards and trying to figure out how this data is going to flow, how well do those kind of things adapt to this kind of an idea.
We have a copy in our packet of the top five or six areas of the CCR. If you look at that and how it is structured, and then you start thinking about what we drew on the board, if those records aren’t set up in a way that you can parse this kind of stuff out, then basically you have got a package that you are delivering all this data back and forth, whatever one you pick, it doesn’t matter. But can you parse it out that way or not?
DR. COHN: This is a reasonable area to explore, but certainly dealing with this on a provider basis rather than on a field basis, record in, record out, that sort of thing, as opposed to this sentence in, this sentence out.
MR. ROTHSTEIN: We rejected the line item approach.
DR. FRANCIS: We also worried about the whole provider in and out. If the basic goal is the treatment, and there are whole chunks of visits to different providers.
DR. COHN: Psychiatry and Gyn from this list might be pretty sparse.
DR. FRANCIS: There are some pretty important things. Suppose you leave out any visits to a gynecologist. You don’t know if somebody is on birth control. Then isn’t that silly, because if the same prescriptions came from a family practice doc, they would be in.
DR. COHN: As I say, I am completely comfortable with the principle. We are digging one level below and trying to figure out what makes sense.
MR. ROTHSTEIN: We are actually two levels below. We set out more or less in the June last year letter the framework or principles. Then hopefully by the September 2007 letter we are going to set out another level down. Then at some point, December, February, whenever we can get finished, we will be able to get out a third level down to more specificity.
What about in each of the various categories? Maybe you can give us some guidance on who to line up. Mental health, we have heard from some of them already.
MR. HOUSTON: Do you want to hear from health care NIT then?
MS. BERNSTEIN: If you want to hear from mental health providers that are in communities or in different kinds of settings, you want to talk to MSW types who have a different kind of clientele, I would think, and have a different kind of practice, but are mental health professionals. There are people we haven’t talked to.
MR. REYNOLDS: What are we going to ask them? Let’s talk about the questions. When you bring somebody in the room and say, here is what I want to hear from you. I think you said eloquently in the thing from Kolodner. We heard from zillions, to quote, zillions of people. What is the differentiating question?
MR. ROTHSTEIN: Here is what I would like, for example. In the mental health, I would like to hear from primary care docs, and ask them about the type of mental health information that is routinely stored in their file, the kinds of garden variety moderate kinds of mental health conditions that are treated by primary care docs, and ask them about what effect it would have on their practice, how hard it would be to separately code information
within a visit.
So I go for my annual checkup to my internist, and he asks me all sorts of things, some of which may be on that list, and lots of things which wouldn’t be on that list. Now the question is, what new burdens are we going to be placing on my doc and his staff to put this information into the shape that we want.
MR. HOUSTON: You were saying primary care in this case, but that is just one class. Is there a reason why — I’m assuming you want to hear from other non-primary care people also.
MR. ROTHSTEIN: Yes. But the point is that mental health information is dealt with by more than simply psychiatrists.
MR. HOUSTON: Understood. It is handled differently in each case. I would suggest that there is also another view, not just primary care, but you also have to deal with mental health in an acute care setting, in a hospital, because many times people come in with some type of a condition and have a psychiatric consult, or there is a tier two issues which is psychiatric issues. The mother that gives birth and has serious postpartum depression, and she is in the hospital because she just gave birth, and then there are issues. As well as the fact that you see enormous numbers of psychiatric consults that occur. I know that at UPMC, a patient in a psychiatric facility may get transferred to one of the acute care facilities because they have some other medical problem. So what they are doing is, they are treating the patient or medical problem who has got serious mental health issues.
The reason why I bring it up in that context is, you want to talk about both data sharing as well as how data is segregated. I think there is also value in looking at the IT side of things.
MS. BERNSTEIN: Do you think there is a value in this group looking at the IT stuff?
MR. HOUSTON: In the earlier discussion there was a concern about what the systems can currently do. I’m not always convinced, and I have said it before, that we should tell them what needs to be done. But it might also be helpful to understand what the state of the technology is today. We might find that the state of the technology is much further than we expected on the EHR side.
DR. FRANCIS: We could probably find out pretty readily that they can design a separate field. You can have a separate information field. The hard questions are how the decision gets made to put the information there. That is the hard question. One way to do that is to have either the facility or the primary care physician do it. So that is Mark’s question about the burden.
The other question would be to have the software do it. That is much harder.
MR. HOUSTON: It is not necessarily much harder. It depends on the context. The system I work for owns a company that makes psychiatric EHR software. It is one of the companies that we run. There are other systems out there for an acute care setting that might handle psychiatric information differently and segregate it differently. I’m just saying, there is an opportunity, if we wanted to delve into what is the current state of the technology. I’m not saying we have to.
MS. BERNSTEIN: My question is, is the current state of the technology really that relevant to the policy that is going to be implemented over the next two years, five years, whatever? By then, they will be looking at something different.
MR. HOUSTON: I’ll answer your question. I think there is a value in one sense, because the state of the technology may also be a surrogate for asking a question of what do the 50 state laws require us to do. If a software vendor wants to do business in all 50 states, and they have to develop their software in a manner that will allow them to meet their customers’ requirements in all 50 states, which will be meeting regulatory compliance, it might be a surrogate for asking the question about what is the standard.
MS. BERNSTEIN: But we are not recommending anything like that.
MR. REYNOLDS: We keep getting pushed on by the technologies. I want to be real clear in what I am saying, because I am not going to back off this. That is, this technology or that technology, we don’t understand the requirements of what we are trying to put together. We are building the picture of a ten to 15 year Nationwide Health Information Network, how data flows around it and everything else.
Part of technology is not the technology itself. It is how you think about the requirements that you are going to ask everybody to align to. That category is requirements. If you don’t take the whole spectrum into play — and I keep hearing everybody try to shove technology; technology is not the hardware.
So I am not going to relinquish the discussion of the fact that if we don’t have a structure and we don’t think through how everybody would use it — let’s remember NPI. We can’t get this industry to group up to pick numbers. We are going to try to get this industry to group up. I think your point is great, how do we capture the data, what packages are we putting in. If you don’t have that as a filter, then you are not really thinking about how it can or can’t work or will or won’t work. I’m not designing the detail of it, I’m designing the understanding of it.
So this is a privacy committee, but more and more, we have all said, you cannot separate these discussions.
DR. FRANCIS: I think we really do need to think through — we need to be assured that the kind of thing we are thinking about is doable. We don’t have to propose a specific way of doing that. I absolutely agree, we have to hear from the —
MR. ROTHSTEIN: And we don’t need to hear what existing systems are capable of doing today. We need to hear from people who have some degree of foresight, who can say, we are not there now, but within the next two or three years when X, Y or Z happens, then we are likely to be able to do it. Or, we can do this so long as we have got data in such-and-such form.
MR. HOUSTON: You’re talking about the IT vendor side?
MR. ROTHSTEIN: Yes.
MR. REYNOLDS: I’m not even there.
MR. ROTHSTEIN: What I want to hear from the docs is, what would it mean to — the primary care docs, I’m not talking about mental health stuff — what would it mean to your practice if you — let’s say you are going to use some natural language software that is going to convert certain words into mental health — automatically earmark them for the mental health file as opposed to the blood pressure. Is it going to slow you down? Are you going to have to hire more staff? Are you going to have to think about — would you tend to compartmentalize your examinations sticking in these terms? You have got a patient for their annual physical, and now you have to know, I’ve got to store the mental stuff and the substance abuse stuff separately from the hypertension. Now I am going to start structuring my examination differently in terms of separately — I don’t know.
MS. BERNSTEIN: Mark, do you know any doctor if you asked that question, could really answer it? They are not going to know until they have seen the software.
MR. ROTHSTEIN: I want to know if that is a fair question to ask primary care docs, and whether they would be able to respond in a way that would cast some light on what we are trying to do; what would be the practical implications in primary care to spin off these masked areas.
MR. HOUSTON: It is also fair to ask the question, what is the current practice today. We are making an assumption as to what the current practice is that they don’t. It is probably a pretty fair assumption.
DR. COHN: I think I can reflect, and I think Paul could also reflect pretty much the current standard. A record that is held by a psychiatrist or somebody in the psychiatry department, one of the mid levels, is handled separately. Typical substance abuse is handled as a record separately.
I will tell you that a primary care provider who is also handling depression, which is pretty common, of course you would note that. I don’t know of any natural language parser that is good enough to make a fine distinction between, the patient is not depressed versus, the patient is only a little depressed. The patient’s dog died yesterday.
MR. HOUSTON: You know as well as I do that there are artifacts all over the place. You have artifacts in the pharmacy system.
DR. COHN: I agree.
MR. HOUSTON: You are going to find artifacts in a lab test that might be done.
DR. COHN: The devil is in the detail.
DR. FRANCIS: One of the things that I think we really have to have a handle on before we go very far with this is what exactly are we talking about when we talk about a mental health record. If we are talking about a record generated by a mental health professional, that is one way to talk about it. But even your example about blood pressure; suppose the discussion turns to stress very quickly. Is that a mental health record or is it not a mental health record? Or the question we were talking about earlier today, where I was raising the issue of suspicions of dementia, which might be — I don’t have a clue about whether that is something that in would be in your mind a mental health record or not.
Once we venture beyond the territory of defining a mental health record as a record created by a mental health professional, I think we have to have a clearer understanding of what we mean by mental health record.
MR. ROTHSTEIN: And we may want to hear from neurologists, because there are many disorders that are complex in that area. There is Parkinson’s, Tourette’s, Huntington’s disease, all these things. Are they mental disorders? They have mental symptoms.
MR. HOUSTON: Doesn’t that have to rise to the level of being a mental illness? A good example, we had a case where a priest in the ED — the ED doc said that part of the diagnosis was that the person appeared depressed. He noted that the person seemed depressed. This caused such a firestorm. The priest saw the record and was angry about the fact that he had been diagnosed as depressed. He was afraid of what it meant. It was taken out of the record.
The physician felt strongly, he was. It wasn’t anything severe, but nevertheless you wouldn’t even argue that it rose to the level, the way it was presented, as being a mental health issue. But the fact that even a side notation or something he dictated made it into the record caused a patient to be quite upset about the fact that it was even noted.
DR. TANG: Can I bound my comments by two facts? One is, we have got to do right by the patient clinically. That is just an overriding concern.
The other is, remember, we triangulated based on the testimony we heard in April that .03 percent of folks really did want to have this kind of granular control, if they could. So we have the overwhelming need to do what is right by the patient clinically, and the fact that most people would prefer strongly, by 300 to one, over protected sensitive data in some technical way.
So in some sense, most of primary care involves some aspects of either somatic ramifications of mental health or vice versa. It is almost impossible and it probably would be harmful to separate those two, just in primary care alone. So is there a way you can separate them?
I think the way we do it now is probably okay. In other words, typically because most state laws do require us to cordon off mental health provider care from other. That seems to protect a lot of things that have a whole lot more stigma. Depression just doesn’t have a lot of stigma in this society, for better or for worse, as we know.
So I’m not sure it is either worthwhile from a practical point of view or worthy to try to extract mental health statements out of the primary care record. I just don’t think it is, one, practical or two, at all worthy, because you would hurt the majority of people in this country if you did that, in terms of their care.
MR. HOUSTON: It doesn’t get separated anyway.
DR. TANG: It is by law in California, you do not have to separate from the problem list, from the medications or from your tests.
MR. ROTHSTEIN: I value your opinion, but —
DR. TANG: I just happen to be wrong.
MR. ROTHSTEIN: No, Paul, it doesn’t go the question that I asked.
DR. TANG: I wasn’t here for that.
MR. ROTHSTEIN: The question that I asked was, in trying to reach the kind of conclusion that you reached, who should we hear from in terms of a hearing that we are going to have on the mental health issue.
I raised the question of, would it be valuable to hear from primary care docs about specifically the question that you answered, and I am guessing that your answer would be yes?
DR. TANG: We absolutely did hear from at least one, if not two.
MR. ROTHSTEIN: We heard from David Kibby. But we didn’t ask him, I don’t think, specifically the issue of mental health information.
MS. BERNSTEIN: His answer as I recall was, sensitive records depend on who the patient is. If the patient has a different version of what is sensitive to that patient —
MR. ROTHSTEIN: I would also add to my list of people I would want to hear from patient advocates, specifically in the mental health arena, and substance abuse.
MS. BERNSTEIN: We heard from the substance abuse people.
MR. ROTHSTEIN: But we are also making an assumption which I think is correct, but I would love to have more evidence, that is, that there are public health benefits by promising and maintaining confidentiality of information through a masking mechanism.
So in other words, we might be able to get somebody who comes in, who is a psychiatric researcher, let’s say, a utilization of psychiatric services researcher, who could come in and say, the willingness of people to seek psychiatric care in a timely manner is directly proportional to the degree of confidence that they have that their mental health information will be, whatever.
That kind of information that those of us around the table have educated guesses about would be strengthened by experts who could make the case one way or the other.
MR. HOUSTON: A couple of points. It would be interesting to go out and have somebody do some research, maybe just go as far as the Web, to see whether there are already white papers or position statements out of patient advocacy groups or associations that might be a surrogate for testimony.
Some of these groups may have already thought about this as an issue and put position statements out there. It might be a way without having to go out and try to find testimony to get good information.
MR. ROTHSTEIN: I know for example a couple of months ago Deborah Peel’s group in Texas put out a statement on the issue of mental health information and primary care docs’ files, with case histories of people who had all these terrible things happen to them. The HIPAA carveout only applies to —
MR. HOUSTON: Given the anecdotal evidence, I am thinking of a more structured approach towards position statements.
MR. ROTHSTEIN: But it was a position statement.
MR. HOUSTON: I went to a dinner for a bipolar conference my wife’s institution runs. I sat beside a patient advocate from a very large group out of Chicago. She is bipolar and has some serious problems. I thought it was interesting, because people with bipolar also have medical issues, and I’m sure their PCP has to know about their bipolar condition.
So even people who may have a some depression are being treated, or really have a serious medical problem, but still have a PCP or other specialists who are dealing with the other part of their care.
MS. BERNSTEIN: What is the name of this organization?
MR. HOUSTON: I’d have to go back and look.
DR. TANG: All those drugs have serious drug interactions.
MR. HOUSTON: No, let’s just say this lady has bipolar and she is being treated for it. She still goes to a PCP for other parts of her care. She still may have high blood pressure or — my point is that there is also a piece of the puzzle that relates to not just the fact that somebody has slight depression and maybe is being medicated for it, but their PCP is handling their treatment. My point is that there is also a class of individuals who have serious mental health issues who still has a PCP, and their information is also in the PCP’s record. So you have two classes of mental illness.
DR. FRANCIS: So it is the same question. It may be an easier question to segregate out. Presumably, going back to your discussion this morning, if a patient with bipolar is being treated by a psychiatric and also under the care of a primary care doc, the psychiatrist’s record is not originally with the primary care doc.
MR. HOUSTON: Absolutely. The primary care doc probably has a lot in his notes or her notes about —
DR. FRANCIS: Right. So the question we are then asking is, are those notes segregable because it doesn’t do the patient a lot of good to have the psychiatrist’s notes segregated if —
MR. HOUSTON: The PCP doesn’t.
DR. FRANCIS: Right.
MR. HOUSTON: That’s a good point.
DR. FRANCIS: I tend to think that we focused more on what the primary care physician needs to have in the last hearing. We were focusing on questions about what you would want to have as the treating physician. I think we all agree that there needs to be access, whether it is through a decision support tool or something like that to prescription medication. But we didn’t focus with the primary care physicians on the question Mark is asking, about whether they could segregate, whether there is any segregability. So that is a question I would want to couple with that.
I think a group we didn’t talk to are physicians who specialize who specialize in treating elder adults. I think there, the question of whether you are including under domestic violence elder abuse.
DR. TANG: Just like we respect the lawyers for the practice of law.
MR. HOUSTON: No, you don’t.
DR. TANG: Pretend I did for the next five minutes, please, John. I am on an IOM committee about health care of the elderly. They absolutely have to have and encourage every person who comes in contact with the elderly to ask about potential depression, as an example. It is central to their health.
We cannot divorce the mental aspects of the holistic health of an individual. It would be hard to divorce it in either segmented ways and even having a conversation, or your documentation without doing injustice to patient care. That is separate from mental health that is taken care of by a psychiatrist or a psychologist. The day to day care of the elderly and everyone down to the child is totally integrated.
DR. FRANCIS: So the conclusion then is, we take one off the list. That is the conclusion.
MR. ROTHSTEIN: No, the conclusion is that it is tied to providers.
DR. FRANCIS: We do one only as tied to providers.
MR. ROTHSTEIN: But that is his conclusion.
DR. FRANCIS: That is your conclusion. That would be the conclusion of what you just said.
DR. TANG: Yes, but Simon and I heard it from the other doctors who have spoken to us. It is not as if you had to have a doctor be called for one question. It is not a new idea. It is inculcated in everything we do. In fact, you even have to have CME credits to practice in certain states on this issue.
MR. ROTHSTEIN: But I would respectfully suggest that if we brought in patient advocates, they would see it totally opposite.
DR. TANG: I think we need to find these people together, because we can’t let testimony be anecdotes. That is not the way to make a decision.
MR. ROTHSTEIN: The purpose of our discussion this afternoon is not to reach agreement on anything. We are trying to figure out what questions we need to ask and what witnesses we need to come up with.
I have another question that I don’t know what the answer is, but I want to ask you whether you think it is something to explore. If I am with my primary care and told him that I was feeling depressed, and he asked me a couple of questions, and he suspected it might be major depression, and he referred me to a psychiatrist, would it be routine for the psychiatrist to send back to my primary care doc, thank you for the referral. I saw your patient last Tuesday, this is what I found.
Now, they do that in all sorts of other referrals routinely. The question is, are we saying — and I am just thinking out loud, are we saying that that kind of information, if it is in a masked category, can’t be sent back to the primary care doc or any doc for that matter without another level of consent from the patient? Is that what we are saying? Maybe we want to say it. Is that an issue that we need to take up?
MS. MC ANDREW: It depends on your assumption about communication. The primary doc had a treatment encounter with the patient, and made the reversal based on information that he already had. When that went to the mental health provider for that diagnosis, would you consider any further communication around that referral to be some sort of implied consent?
MR. ROTHSTEIN: I’m raising the question.
MS. MC ANDREW: Yes, but what would your conclusions be?
MR. ROTHSTEIN: You could make an argument that it is part of treatment overall. You could also make the argument that the psychiatrist should get additional consent before giving more information back to the primary care doc. I may have been willing to tell my primary care doc that I am really tense and blah, blah, blah, and I tell my psychiatrist that it is because I had an unhappy childhood, my mother didn’t love me, my father was abusive, who knows what. That is more information than I would have given to my primary care doc, who I play golf with every other Saturday.
DR. TANG: If that is what you are asking, then no.
MR. ROTHSTEIN: No to what?
DR. TANG: The referring back letter does say, thank you for this consult, and will not talk about you and your mom. They understand that. I sought outside specialist consultation for this patient. I want to know this patient is getting better and they are under some treatment. Also, somehow we have to keep apprised of the things that impact your other health through medication.
MR. ROTHSTEIN: But is it because it is a sensitive matter? Or is it because the information back to the referring doc is routinely minimal?
Let me just change the example. I go to my primary care doc and my knee is bothering me. He refers me to an orthopedist. The orthopedist is going to send, thank you for the referral. I saw your patient. He has lateral meniscus damage, blah, blah, blah.
DR. TANG: And did you hear about this mother.
MR. ROTHSTEIN: Are they going to give more information than just, thanks for the referral? My question is, I am thinking about this in terms of someone who teaches medical students, do we need to start telling them, when you write your letters, if you receive information that might be sensitive, you can’t disclose it without —
DR. TANG: The psychiatrists are taught that. I think that is a learned, required and expected behavior on the part of the mental health providers. I think it is completely inculcated in the training.
DR. FRANCIS: Our worry isn’t the psychiatrists actually. Our worry is, if you start with the twin goals or maybe triple goals of protecting the integrity of physicians in the liability question, protecting patient privacy and insuring good quality of care — and I put that last, I think it probably should be first — when you start with those three goals, are there questions or things that might be done differently in the primary care side. That is where we are worried. Or in some other — you go with your knee, you get referred to an orthopedist, and while you are with your orthopedist it becomes clear from the nature of the injury that it is an abuse injury. Does the orthopedist say that back to the primary care? Those are the kinds of questions.
What would happen from the privacy perspective or from the treatment perspective, or from getting people into treatment, are there worries about what is happening. That is the question.
MR. ROTHSTEIN: I have no answers to anything. I am raising issues to ask you whether it is something we need to pursue at the hearings.
DR. TANG: And your concern is in the primary care practice?
DR. FRANCIS: The concern is not with what the psychiatrist does, because I think they are taught not to write about your mother coming back. They live with for good or for ill much stricter standards with respect to privacy.
DR. TANG: So you are concerned that the primary care provider will disclose information to whom?
DR. FRANCIS: The worry is that as electronic health records — in the past, what happened was that a lot of what the primary care physician wrote down just stayed in the primary care physician docs. But now it is not going to be. So the question is, given that there isn’t this natural silo, is there any kind of a role — maybe we can’t separate out and maintain good care. If that is true, then we don’t try to separate out. Maybe we can’t separate out and accomplish what patients, even a small percentage of patients, might like to have. If so, then we can’t do it. But I think it is worth asking the question.
DR. TANG: But you still didn’t answer the question, disclose it to whom are you concerned about?
DR. FRANCIS: Other people.
DR. TANG: Other providers?
DR. FRANCIS: We are just talking about treatment within health care now.
MR. ROTHSTEIN: I would like to know the answer to the question of, if we adopted the policy that Paul tentatively suggested earlier that we key mental health information to the provider and just protect that, would patients be less likely to bring up mental health issues when they see their primary care doc. I don’t know what the answer to that is. I don’t know that anybody knows the answer to that. But is that something worth exploring?
In other words, what are the consequences to mental health?
DR. TANG: Of cordoning off and flagging? You are saying that would be a potential concern to patients to disclose it if we were to mask it.
MR. ROTHSTEIN: No. Would I as a patient be less likely to divulge mental health information to my primary care doc if that were not cordoned off and masked because it is not given to a psychiatrist? Are you with me? If I went to a psychiatrist under our model, it would be separated and masked.
DR. TANG: Yes.
MR. ROTHSTEIN: For discussion purposes, it is not going to be masked if I tell it to my primary care doc.
DR. TANG: The mental health — if you complained about depression or whatever.
MR. ROTHSTEIN: Correct. So my question is, if we go with that model, is that going to make patients somehow reluctant to give mental health information to their primary care docs? I don’t know what the answer to that is. I am raising that to see whether you think that is an appropriate question for us to pursue.
MS. BERNSTEIN: Are you asking whether they are less or more reluctant than they are now?
DR. FRANCIS: But it is less scary if it is just the primary care doc writing it in a paper —
MR. ROTHSTEIN: It is not as scary in the non-electronic, non-linked world.
DR. TANG: You are not assuming we can cordon it off. What is your assumption when you want to present the question?
MR. ROTHSTEIN: What I am saying is, what would happen if we did A and what would happen if we did B?
DR. FRANCIS: There is no assumption either way.
MS. BERNSTEIN: If I invite people to testify, I need to give them something to work with in terms of what we want answered in the testimony to prepare. It is hard to get your hand around what exactly the questions are.
MR. ROTHSTEIN: Simon, a new observation or did you remember what you wanted to say before?
DR. COHN: I think a new observation. I just wanted to bring up another piece here, and I am sitting here trying to struggle with it now. We have only been talking about item one here.
MR. ROTHSTEIN: Correct.
DR. COHN: I think in all of these, there is probably some things that Paul and I would agree fit in fields and you could suppress the field, as opposed to things that stream through a medical record. But I did get AAFP to talk about mental health and primary care, and I think that is fine.
The question I had, and it goes back to — I hate to use the term secondary uses of data, but the fact that data streams all over the place. I am just trying to figure out how many hundreds of hearings we are going to have trying to figure out how to shield a particular bit of information from one provider to another versus all of this stuff streams up to the payor. It will be out on your personal health record for your access because the payor has information, unless I am wrong about that.
The question is how deep to go here versus all of these other streams where the data flows that we don’t seem to be —
MR. ROTHSTEIN: Oh, we are concerned about this.
DR. COHN: Okay, well, how are we handling that?
MR. ROTHSTEIN: In our June ’06 letter, we certainly mentioned the issue of contextual access criteria for disclosures pursuant to authorizations.
DR. COHN: This is not an authorization.
MR. ROTHSTEIN: We also said we were concerned about role based access criteria within the health care settings. This is another piece of the same puzzle that we are working with, and I don’t think we are opening up a new door. I think it is just a level of detail that is greater than we have had before.
I think we recognize everything that you are saying. I agree it makes it complicated.
DR. COHN: I was just trying to figure out how deep and how many hearings we were going to spend drilling into primary care and depression versus some of the other things that we should —
MR. ROTHSTEIN: One.
DR. COHN: We are going to do one for the entire group?
MR. ROTHSTEIN: No, one that deals with mental health. Maybe a half a day or a full day, depending on how much stuff we come up with.
DR. TANG: I am still searching for strategies. In that letter in June, we said there may be ways of finding a simple algorithm to hide or make irrelevant —
DR. COHN: Screen.
DR. TANG: Thank you. One of those ways was age of the history.
MR. ROTHSTEIN: Correct.
DR. TANG: I think that might be a better approach. Explore things that can be done practically and taking good care of your patients. It is really hard to take this stuff and not take away from the first person who worries about it.
One of the examples you talked about, you said when I was a teenage boy I did the following. If it is important, then I will ask you again, or you will volunteer. You will recognize that it is important and volunteer. But I can see age as one of the ways that you take it out of this NHIN that goes around to everybody. I get that.
Otherwise, I think you still should have control, but I don’t see another way, other than the all or nothing approach.
MR. ROTHSTEIN: That is why I put those other categories, provider and date of service. But that is the question for us to think about, not for our September letter, but for the followup. Do we want to revisit those sorts of approaches as a way to reach a level of granularity that is more feasible than some of the other ones.
DR. FRANCIS: I start with your sense that we want something that is workable. But when I think about having the goal of good patient care, it seems to me that neither provider nor date is a particularly good surrogate for that. It would be better if we had something that was more fine grained. There could be very important things that happened when you were younger.
DR. TANG: I would like to ask you about the important thing or you would like to volunteer because you recognize there were very important things that happened to you when you were a kid, like I had my appendix taken out. Those things seem to be more obvious to either the provider asking about a certain symptom or to the patient who knows something that everybody else had been interested in. But to shackle the physician or the health care provider who is trying to handle today’s problem seems to me a far less thoughtful or practical way to do it than finding some arbitrary thing that the physician can get their head around; I know everything about you for the past five years.
MR. HOUSTON: If you had a diagnosis of bipolar, that is going to follow you for the rest of your life.
DR. TANG: As it should.
MR. HOUSTON: But I guess it is going to continue to come up, so it will always be within that five year window you are talking about.
MR. ROTHSTEIN: Let’s keep in mind hearing strategy.
MS. BERNSTEIN: On the different ways we are talking about of possibly masking, Simon seems to be saying that because of the evolution of diagnosis codes and procedure codes, that there are standards for those things now that are pretty well settled for what we have now.
Yes, I understand there is ten or 11, whatever is coming next, whenever we get to it, but if those things are really well standardized and generally agreed on, is that another way to slice the pie.
As I understand how the diagnosis codes work, there is a high level category, a middle level category, and then details. So you have the 600s or whatever in some category, and then the 601, 602, 603, and then there is dot, something else that comes after that. So you could cut it in big categories and say all the 600’s or something, or you could say all the 601’s, and then whatever comes after the dot is included. Or you could take 601.232 and that one is out or something like that.
But because of the standardization of these things that is something I know a computer can deal with, I know the technologists can deal with. We have a standard for what a code is and what it means in a pretty lot of detail. So if somebody wanted to go through and put a little star next to the ones we want to be masked, theoretically we could do that. It would take time, there would be maybe disagreements about which ones are in and which ones are out, but there is a way of doing that with things that are quite well standardized that people tend to agree on, both for treatment and for claims. Isn’t that the point to make that crosswalk?
DR. TANG: I’m trying to find out a way to put it in legal, the case law. If we cut you off by date or by an individual judge’s decision that I do not think we ought to consider this piece, how can you operate, if every case presented to you had different restrictions?
MS. BERNSTEIN: When I think about the rules of evidence, often a judge will hear something and say, I just heard that, but I am not allowed to consider that. We tell juries all the time, don’t consider that, or you can’t consider that, or it is going to somebody’s reputation, you are not allowed to look at it, and the jury won’t hear it. A jury is asked to make that kind of decision all the time.
Now, a jury doesn’t know what they are not seeing. Maybe some judges will come afterwards and talk with the jury and say what you didn’t know was, this guy had ten priors, but you didn’t get to see it.
DR. TANG: But if you are on the hook like a doctor is to say, you are not allowed to consider the ten, when you know the ten priors clearly influences materially whether this person committed the crime.
DR. FRANCIS: You changed the question Mark was asking. You are asking the question, what would it do to patient care if the information were masked. That is one set of questions, and we heard people talk about that. There would be a flag that there has been information in one of these fields, so the physician would know to ask. But there might be problems for treatment. That is one side of it.
The other question thought that I don’t think I have an answer to at all is whether it is even possible to do, and how much patients really care about it, too.
MS. BERNSTEIN: You mean in terms of day to day practice of a physician? You don’t mean technology wise.
DR. FRANCIS: I take it there have been both kinds of questions. One kind of question is whether it is even possible in any way other than provider specific to segregate out some of these sensitive kinds of information at the time the information goes into the record, not at the time the doc makes the treatment decision, but at the time it goes into the record.
I am very sensitive to the question of what it would look like to have this be realizable. I think that if it seems very important to people, and I do think it is very important to people — I think in the elderly treatment area, it is a deterrent for people to go to doctors if they think this information is going to get — I think it is true for younger people, too.
So I think there are real consequences to not protecting the privacy. I want to think through the question of, can it be done and what would be the cost of it being done.
MR. ROTHSTEIN: So what we are trying to move toward with these hearings just as a strategy is, our second level recommendations to the Secretary are going to be basically, do the benefits outweigh the costs of going at one level or another. Which way would benefit the health care best, which way would burden health care? Which way would cost more, which way would be more burdensome on docs, et cetera.
What I am trying to generate is a strategy to get enough information so at some point in October, November, whatever, we can sit around here and try to weigh those interests based on the experts we have heard.
MS. BERNSTEIN: Do you want to also ask the question, if we had a scheme like the one I described, if Paul is more likely — if he knows that diagnosis code 601 dot whatever it is, has got an asterisk after it, it is more likely to be masked, do you want to know who is more likely to use it or not use it, for example? Is it going to change the way he codes?
DR. COHN: Let me just address what you were describing in your scheme or whatever, and talk about why it may not be able to help us a whole lot.
I think what you are describing is different that would probably be pretty effective in the diagnosis field to make sure the diagnoses didn’t make it to the next provider, or somehow was suppressed. So you might be able to get major depression off of that field. Some people wouldn’t pay, would be their answer.
MS. BERNSTEIN: What?
DR. COHN: They wouldn’t pay, because it would be suppressed and they wouldn’t know what the reason was for the visit.
MS. BERNSTEIN: Or you pay cash. That is what we do now.
DR. COHN: That’s fine, but then they wouldn’t go to Harry’s people anyway. The issue that Paul was moaning about as well as I was is, the body of the record, you have got the diagnosis off of there. You take a quick look at it, 37-year-old female, history of major — can’t sleep for the last three weeks, being suicidal, or history of bipolar. That is an area that you can’t with the coding methodology screen it out, because that is typically free text in most any system that I can imagine for the next 20 years. So you get part of the problem, but not the other one.
MS. BERNSTEIN: But in the scheme that Leslie was talking about, the notes never go. You get a certain level of stuff and you don’t get those notes. You get some of these things, but the open text might not be one of those categories.
DR. COHN: You could suppress the entire record. I don’t think anybody — that is one model, where you suppress the whole thing. I was just referring to suppressing certain fields.
MR. ROTHSTEIN: I would ask that Harry have the last word on this, and then we are going to move quickly through the rest of the list. I think we have had a broad discussion about our strategy, so the other ones should be much quicker.
MR. REYNOLDS: We mentioned diagnosis. To me, the key things that start the finding of the patient’s condition are diagnosis, the procedures that you have done, the lab results, the drugs they are taking, the doctor notes, which we just talked about, and the provider types. Those are the kinds of things, as we build categories, if we don’t take these things into consideration, the diagnosis, the procedures that you have done, like surgery, that could be an image, that could be all kinds of stuff, lab results, drugs, doctor notes and the provider type.
These things are all on all the treatment records that we all pass around. So now if we talk about taking them up to the NHIN, so we take those categories and you take this information. That is why I have been trying to talk about the package that you use and how you think about the package that you use to move this around the NHIN, this is what is going to decide.
So if I go to a primary care doctor, and whatever diagnosis, procedure, lab result or anything they do can immediately under some circumstances fall under mental health or substance abuse, or it could fall into a number — their notes could fall into there.
So that is why I am trying to get to this level, and I am not very happy about being labeled a technologist. I think I understand the industry, and I’m not going to stand for it much longer, actually. But I think the important thing is that these are the real things that are on the real street in the real day. That is how we do and don’t do business, all of us amongst ourselves. We are going to continue to do business that way.
MR. HOUSTON: You can argue that a number of them, if we want to make any advancement in health IT, are absolute core elements. You talk about drugs being prescribed and what the test results are. You can argue they are so fundamental to trying to —
MR. ROTHSTEIN: What we are ultimately going to have to do is, for each of these categories decide how we want to slice the pie.
MR. REYNOLDS: This is a set of filters to use in the decisions on how they play.
MS. BERNSTEIN: I am observing in the conversation, you are talking about two different things and not differentiating when you are talking about the two different ways of looking at this. It seems to me that we have the model of the core group like Harry was just describing, the core group of stuff that you need in a basic record. We could say you get that core group of stuff and you don’t get anything else unless it is specifically requested or whatever the rules are, so it is with everything else that is in the record.
Then this model seems to be, you get everything unless the patient somehow picks out one of these categories. Those are two different models. Those are opposite.
MR. REYNOLDS: No, you can’t separate the two. In other words, what I am saying is, these might be core elements in every record. However, when we put the diagnosis in there, if the diagnosis is even from a primary care physician, you can talk about acute depression or whatever you want to call it, immediately to fall into that category. You can’t separate.
They are not two different models. They are two filters to use on the same discussion to make sure that you have got it covered.
MS. BERNSTEIN: I’m not sure I agree with that. Let me explain why I am thinking about it differently. In your core group model or whatever, those elements —
MR. REYNOLDS: It is not a core group. It is the things that identify immediately attributes, what is going on with that person, and could be picked out as a single data element to go, uh-oh.
MS. BERNSTEIN: Fine. But what I am saying is, those could be the only things, or those could be a piece of a larger record.
MR. REYNOLDS: I totally agree.
MS. BERNSTEIN: So if you look at it as, those are the things I minimally absolutely need to describe that patient in basic form, in the way that CCR or whatever other standards there are —
MR. HOUSTON: What Harry I think is saying here is, those are the five or six types of information or types of data that would be indicative of a data type we have listed up here.
DR. TANG: There is almost nothing that you put in a record that couldn’t be —
MR. REYNOLDS: But this is the information that infers conditions or diseases.
DR. TANG: What is an example that is not on there? That is what I’m saying.
MS. BERNSTEIN: The address.
DR. TANG: The demographics?
MS. BERNSTEIN: It could be. I live in a place that has certain kinds of environmental conditions. I am more likely to be susceptible to Lyme disease or something like that.
MR. ROTHSTEIN: I am going to use my prerogative to move us along and ask, on number two, other than SAMHSA which we talked about earlier, who else do we need to hear from on substance abuse?
MR. HOUSTON: I renew my comment that I think we look to see doing something in research to see whether there are consumer groups or other organizations that might have position statements already formulated with regards to the treatment of all of these.
MS. BERNSTEIN: We heard from a consumer advocate on the record. Are you not satisfied with that?
MR. HOUSTON: No, my point is that it is to some degree anecdotal evidence. I agree that we need to get testimony, but we may find that there are organizations already out there that have already thought long and hard about this, and can provide really good structure —
MS. BERNSTEIN: You want to do a literature review?
MR. HOUSTON: Let me finish, in the form of a white paper, a position statement in the organization, or something else that they have done. I think if we did a little research, we might get —
DR. FRANCIS: Just to try to instantiate what you asked for, one thing is a web crawl on research. Another thing is, we could call up the person who gave testimony, we could ask them if they know of any such, or if they could give us a list of six, eight, 23 organizations that are in business that might.
MR. HOUSTON: And we call them.
DR. FRANCIS: We either call them or we Google them.
MR. HOUSTON: But you call them and you ask them whether they have a position paper.
MR. ROTHSTEIN: John, let me tell you what I think the problem is in what you are suggesting. If you call all these groups, they are going to have a position statement, guaranteed, about the importance of privacy and blah, blah, blah. They are not going to have, I would be shocked if they had a position statement dealing with a specific issue that we are dealing with.
So in the context of the NHIN, what should be done in terms of identifying the certain subset of health information that should be masked, et cetera. So my concern is, we would be doing a lot of work, but what we are likely to uncover is at a level of generality or a level not relevant to these discussions.
MR. HOUSTON: Mark, as we have spoken on a number of occasions, what ends up happening and what we need to try to prevent is these organizations from coming in and testifying and giving us their general statement about the need for privacy. It is a recurring theme, and we have to be extremely aggressive about telling these people that we understand privacy. What we want them specifically to speak to, and then drill down on the AHIC bodies, drill down on the hypothesis that we are trying to answer, the working hypothesis, I think is what the CPS is now using, developing a working hypothesis to support or refute or build upon these hypotheses.
DR. FRANCIS: I thought the substance abuse people that we heard in April or whenever it was actually did a very good job that way. I am one of these service wonks. In the interest of service, I wouldn’t mind having us ask the question. There might be something there that would be enormously helpful. None of them brought it. Maybe they weren’t asked.
MR. ROTHSTEIN: What I would like to do for our fall witnesses is to give them a copy of the — I have got my fingers crossed — the letter that we approve in September that we haven’t drafted yet, saying what we are recommending at a broader level, and saying, the purpose of this hearing is to focus on one of these six things, and what is your opinion of the effect of doing X or Y on your patients, on your interest group, whatever.
DR. FRANCIS: Well, first is whether you can do it. That is one question. Then there is Paul’s question, what is the implications.
MS. BERNSTEIN: And the third thing is, you are not having this hearing until December. The letter isn’t going to happen until the end of September. You want it send it out. You need to give people time to schedule it, prepare testimony, or come up with a response, digest, and have their organization come up with a position that they can respond to.
As you say, they are not going to have something already caned, so you need to give them a lot of lead time to come up with something that is a thoughtful answer, like John said. You can’t force people to testify about what we want them to do. They are going to take their open forum and talk about whatever they want. As much as I can control them, once they get up there I can’t make them talk about what we want to talk about. We can only encourage them so much.
That is a good way to encourage them, by saying here is the letter, can you please specifically to this letter. But every organization has its own agenda, and they are going to advance that agenda in every opportunity.
MR. ROTHSTEIN: I agree. I have been fighting with witnesses for seven and a half years on this.
MS. BERNSTEIN: It happens on the Hill too, all the time. There is only so much I can do. But it means that if you want to do that in the way that you said, you need to give two months for them to schedule it, to read it, digest it, come up with a position, prepare testimony and get there. Just in terms of timing, that’s all I’m saying.
MR. ROTHSTEIN: We are not going to worry about that right now. Anybody want to add anything from any of the columns, any of the items of suggestions of who we need to hear from, other than the obvious sources?
MS. BERNSTEIN: I am feeling uncomfortable, because we seem to come to this, continuing to drill down on the separate sensitive topic areas. Whereas, I felt that at the end of the last hearing we were starting to move in a different direction, based on how the conversation went.
And that’s fine, but I want to make sure that that is what the subcommittee wants to do so I can help you do that. But I need to be clear.
MR. ROTHSTEIN: What I think we may have misunderstood is that there is no effort underway to develop a uniform cross provider CCR/CCD. What I heard at that hearing, and perhaps misinterpreted, was that somewhere magically from all the diverse encounters with people in the system, the providers in the system, there was going to emerge this document that was going to be like the face page for every future encounter.
But what I am hearing today suggests to me that that is not true, that it doesn’t exist today, it is not going to exist in the future, and that what we have is an example of a CCR that is going to be a provider specific CCR. So we can’t use that model as saying the doc starts out with very little and you have to add on stuff. We are going to have to start out with —
MS. BERNSTEIN: Actually, I wouldn’t go that far yet. I think we have a lack of information. We have one model from one guy with one example, and we have some people in the room who know more about this than I do, and there is apparently some disagreement in the industry about how to approach this kind of thing, CCR versus CCD, or maybe one is a further evolution of another, or something like that.
We, this group, have not heard a lot about that. We have heard as a sideline from a couple of people who happen to know about it, who happen to be witnesses, who were asked to talk about something else other than what we ended up talking about. If we want to look at that, we can go look at that.
I haven’t felt very competent because it is not my area, so I feel not so able to help you with that if you want to look into it.
DR. FRANCIS: It is fairly easy to look at this and see what could be pulled out; what is the chief complaint.
MR. ROTHSTEIN: My question is, who does the pulling?
DR. FRANCIS: The fields. I’m going back to Harry. Who saw the patient, what is the chief complaint, what is the diagnosis. None of the subject of information, all of the object of exam, the lab tests, any medications and vital signs.
MR. ROTHSTEIN: I’m going to start over again.
DR. FRANCIS: When you pull that out, you have got what Paul needs.
MR. ROTHSTEIN: But I am the doc, and Maya is my patient. She comes in and I have never seen her before. How do I get this information?
DR. FRANCIS: You sit there with your laptop, and you have got this template, and this is what gets filled in. The only question is, what goes to the next provider. It is some fields, but not other fields.
MR. REYNOLDS: Or you gather this initially from the health information exchange that is going to go with the NHIN.
MR. ROTHSTEIN: So I query the HIE and somehow that is what arrives?
MR. REYNOLDS: Yes. In other words, right now the claim is the standard package. Whatever is the standard package that the HIE or the NHIN or somebody delivers, you get the same stuff from all the doctors that you have had. However, you have got to parse it there.
MR. HOUSTON: A caution, though. As this all gets more sophisticated, I would expect that we will see a much greater desire to get additional information, whether it would be image data or other types of data that is outside of the —
DR. FRANCIS: But that is test results.
MR. HOUSTON: But I am saying, there is going to be an expansion above and beyond. So we have to be prepared for the fact that —
DR. FRANCIS: I actually reached the conclusion at the end of the hearing the last time that it is not — I am happy to go either way, but I think it is going to be really hard to try to parse out as a primary care doc what is mental health and what isn’t mental health. I think it is much easier to look at which fields from this are normally part of the pull.
MR. REYNOLDS: Again, back to what we said this morning. The reason I think there is such a pull for us to make a difference now is, if you just take history, we all know that the CCR and the CCD and all this stuff is on the table and being discussed and chatted about in different places. The minute it stands up to a standards organization, and the minute it gets accepted, and the minute it becomes a vehicle — right now there is a claim record. If you act like you are going to have anything other than that claim record doing it a lot of different ways, you have got a problem.
So the reason that I think this is such a critical time, we are not the only path. The privacy discussion is one path, and there is a lot of paths going on, and there are a lot of people doing them, and they are all moving at the same time. We are about to start secondary use. So everything is moving this way, and everybody is going to make some kind of decision.
This is one subject that plays across the entire picture. The minute we start setting standards, and those standards have certain data, and that data can’t be dealt with in certain ways, or it is information that by inference undoes privacy in numbers of ways, then that you find yourself in a situation that things are being done in an individual vacuum at times.
So that is why I think it is very important for us to continue to adjudicate this hard, and have the tough discussions, because if we don’t lay some of that stuff over top some of these other things that are going to happen and that are happening now — there are RFIPs going on right now for HIEs and lots of money, that is where Jeff is right now. There are going to be decisions made.
Some of the systems that have been in place for 20 years are going to have to change, and some of the systems that are in place for ten minutes are going to have to change, and some of the ones are going to be in five years are going to have to change. So we have got to play this hard.
MR. ROTHSTEIN: I’ve got a question. I am more confused than usual. I thought that our discussion in April on the CCR/CCD was in the context of emergency room visits where the question was, what does the ER doc who has an unconscious patient, what do they need in 99 percent of the cases to treat somebody. The answer was, just this information.
Now I am hearing that instead of, start with everything, chop out stuff, we will start with the bare bones CCR and add on stuff in all encounters. That is where I am confused. Is that what we are talking about now? Instead of the presumption that the doc gets everything unless the patient says chop out this area by masking, to a system where via the HIE the doc gets two sheets of paper and then has to add on stuff? Is that a description of where we are? Or am I getting more confused?
DR. FRANCIS: That is a strategy. I don’t know if it is where we are, but it is a strategy that is a better strategy than Paul saying it is either all in or all out. It could be all in, minimal data set in, or out. The minimal data set is a way of getting some of your health information shared electronically.
I can see some things to be said for that as a strategy to protect privacy, because the minimal data set in —
MR. ROTHSTEIN: But minimum data set meaning CCR type stuff with these filters.
DR. FRANCIS: No, you don’t need to have those filters, depending on what is in the minimum data set.
MR. ROTHSTEIN: If it has got current meds, you are going to have to filter out the anti-psychotics.
MS. BERNSTEIN: But it is a different strategy. That is the point. You could do a lot for privacy by saying, as a strategy we are going to say, there is this data set that everybody is going to get, meds, diagnoses, whatever, similar to Harry’s list or something like that, or the kind of list that we heard at the testimony, and everything else is out unless you specifically ask for it. That is a way of keeping out a lot of stuff that might be unnecessary.
MR. ROTHSTEIN: Here is my question. I am satisfied with the answers that I heard from the ER guy who testified in April. I haven’t heard from the rest of the world of physicians, maybe you guys can help me, what that would do in terms of your practice.
MS. BERNSTEIN: Nothing.
MR. ROTHSTEIN: What concerns me is, you have got docs who have eight to ten minutes to see a patient, and now you have got one sheet of paper that is supposed to have everything you need to know.
MR. HOUSTON: Wait. If the doctor has never seen that patient before, that piece of paper is just one piece of paper that may be the only thing they have to see. But hopefully or otherwise, you would hope there would be some type of intake form that would give them additional information. If they are a regular patient of the practice, they are going to have other information from prior visits. I don’t believe it is ever intended to be a vacuum that that is the only information a physician is going to have.
MR. ROTHSTEIN: No, but I am concerned about the time to generate additional information.
MR. HOUSTON: But that is always the case. If you go to a new PCP, at least the ones I have been to, they take extra time if you are a new patient coming through, and they go through a much more exhaustive examination. My PCP took a half hour or 45 minutes when I changed PCPs.
MS. BERNSTEIN: When you go to a doctor and you look at the form on which they code the visit, it is like, visit type A, I saw him for five minutes or I saw him for 15 minutes or I saw him for an hour. There is a different charge for an intermediate visit, a two minute visit for an established patient.
DR. COHN: A lot of times we come into this room and I think I understand all of this, and then we start talking about all this stuff and I get wildly confused.
Just to remind ourselves, I don’t think anything we are talking about right now really affects our desire and interest to try to figure out ways to screen something around this data, and maybe that the perfect is getting in the way of the good on some of these conversations, which I am reminded of the last time we talked about HIPAA, when HIPAA came to. It was like, we wanted to do everything perfect, but we had to settle.
Now, first of all, the CCD is the Secretarial standard at this point. That is my understanding.
MR. REYNOLDS: The CCD is what we talked about.
DR. COHN: Yes, as opposed to CCR. So we probably ought to be focusing on that more as something we find out more about.
I do have to admit to you that this looks to me like an encounter that is somehow formatted in a CCD or a CCR format. I think there are other ways of doing it, what looks more like a summary medical record, which Mark, I think you were talking about. As I say that, I get at times a little confused myself. But it is probably something that we ought to hear about if we are going to have a hearing on these topics to understand what its applicability may be, which I think is where you were going. I think that is reasonable; there is probably some other information.
Paul, you may understand. This looks like an encounter record.
MR. REYNOLDS: It came from David Kibbe. We asked the question, there are 17 categories under the CCR, and he said, there are really only five to seven that are key ones, that it was recommended for use on a regular basis. That is the entire tenet of this —
DR. COHN: Well, this looks like an encounter visit. Maybe I am wrong about that one.
MS. BERNSTEIN: There is another page to this e-mail which is his response. There is a piece of this e-mail missing, it may be my fault, where Kibbe responded to my e-mail asking for this information. So it wasn’t just this attachment, but he wrote me a covering note.
DR. TANG: But as Simon said, CCR is history. CCD is what we are supposed to talk about. David Kibbe is still in the history part because he has his own political agenda.
I am struggling either to find strategies or to find a concrete one or two proposals that we can lay out and get feedback. Leslie’s latest was, what if we went with some summary document that helps anybody anywhere, which takes care of 99 percent of the ER visits, and gets everybody started. Let’s call it minimum data set. That is available to HIEs everywhere, unless you specifically opt out. We can do that, too.
Then I am going to throw this on as one option, an all or nothing for everything else, just because I can’t seem to separate all these things. I can delude you and say we can parse it all out, but Simon and I know it is going to be the text. So everybody gets their opportunity to opt in to having some minimum data set that anyone could access that they need to know, then you can opt in or out with the rest of your medical record.
MS. BERNSTEIN: But you wouldn’t have to do the rest of. You could say, in addition to the minimum data set I will take everything from my gynecologist. Just get that record over there for the gynecologist, as opposed to everything that is also my psychiatrist and internist.
DR. TANG: That’s fine. So I walk up to a provider, I get three choices. Do you want my contribution to your minimum data set on the NHIN. I say yes or no. Do you want the records that we are going to construct, you and me, I am your obstetrician, your psychiatrist, your internal medicine doc, to be available to those who you want to have it. You say yes or no. And that’s it.
DR. COHN: Every visit?
DR. TANG: I can’t deal with the —
MS. BERNSTEIN: That is the model, right?
DR. TANG: That is the model. That is option one. Option two might be, you cordon off these six segments accurately, and then we make here, is it necessary, is it useful to the patients, is it useful for the docs, and is it technically possible, for each of these options. Maybe there are three options.
MR. ROTHSTEIN: So are you saying that we probably ought to hear from the CCD people to find out what they are doing?
DR. TANG: Don’t even get into CCD. Let’s talk about something called a minimum data set.
DR. COHN: I think that might be where the CCD people can help us. I think they must be promoting something that is already formatted, as opposed to a potential space. I think that is what the CCD uses.
DR. TANG: At the policy level, and to explain to anybody else, I don’t need any three-letter acronym. I just say your current problems, your current meds, your allergies.
DR. COHN: I think there is a piece that we are missing here also, which I have always figured — this is sort of like a Markle Foundation issue, but we are getting technical in all these terms. There is a directory typically that I think all of us envisioned.
The question is, when you go into the HIE, how do you visualize what there is on Paul Tang. And do you visualize it through a summary form that has all of this stuff? The question is, how are you interfacing with all of this, which may be what you ar asking, and at that level can we screen various things or not, or is it a long list of things which get knocked out or not.
I don’t know, maybe I am putting words in your mouth, but it sounds like that is what you were thinking DaVid Kibbe was talking about.
MR. ROTHSTEIN: What I am now wrestling with is the idea — before lunch, I seemed to have some notion that we had agreed on the concept that the default is that the doc gets everything unless the patient says, mask from one of these areas.
MR. REYNOLDS: We agree. We are still there.
MR. ROTHSTEIN: Now the issue is raised — and I am just wrestling with it, I’m not taking a position — let’s not start with the default that the doc gets everything. Let’s start with the default that the doc gets a minimum data set of certain elements, unless the patient agrees to disclose more information.
MR. REYNOLDS: No, that was discussed. We haven’t agreed.
MR. ROTHSTEIN: Now that is being discussed. Is that where we are?
DR. FRANCIS: To be honest, I’m not sure which strategy is better for both protecting patient care and protecting patient privacy. I can see issues about both, because obviously if you get a minimum data set, there may be stuff in it you don’t want, there may be stuff in it that you really do want.
On the other hand, if we start down the road of trying to separate out some masked fields, we may run into some areas where it is really hard to mask, and where it would be better in terms of the twin goals of protecting patient care and protecting patient privacy to start with the full model.
DR. COHN: I am thinking of our letter that you wrote and sent to the Secretary. Mark, correct me if I am wrong on this one, but I believe in the letter what we said was, people can opt out of the complete HIE, NHIN, and that is one option. But if you are going to opt in, you really opt in fully, with the exception that there may be some sensitive areas that you want to suppress. I thought that is what we were working on until I came into the room here.
MS. BERNSTEIN: I think we did not. I think the committee did not say — they said there should be an opt in or opt out, but did not choose which. I think that is what the letter said.
DR. COHN: Is that what it said?
MR. ROTHSTEIN: It says, R-4, HHS should monitor the development of opt in/opt out approaches, consider local, regional and provider variations, collect evidence on the health, economic, social and other implications, and continue to evaluate in an open, transparent and public process whether a national policy on opt in or opt out is appropriate.
DR. COHN: And it goes on, however, if — wasn’t this a logic tree?
MR. ROTHSTEIN: No. Then we go on in R-6 to say, HHS should assess the desirability and feasibility of allowing individuals to control access to the content of their health records by NHIN, and if so, by what appropriate means.
R-7. If individuals are given the right to control access to the specific content of their health records by the NHIN, the right should be limited, such as by being based on the age of the information, the nature of the condition or treatment, or the type of provider.
MR. REYNOLDS: Were you finished?
DR. COHN: Yes.
MR. REYNOLDS: All the data is going to be available. Whatever providers you use, they have got X amount of data. Then it is decided what gets delivered to the next provider. Right now, we are saying if you opt in all the way, you get everything. If you say, I would like to parcel things, all this is doing is having a debate about what this parcel will look like.
Maya said earlier, as soon as you say mental health, are you talking about the diagnosis? How are you going to parse it? Then you start getting into those discussions. So I don’t think we are any different than we were, and I don’t think you should feel any different than we did, because we have all used different words because of our day jobs and other things.
I think we are exactly where we left this morning, but the real issue gets into some of the parsing. As soon as you say to somebody, everything from a primary care doctor can go, and if it gets busted by a filter, it doesn’t go.
As we get into this, that is where the differences are coming up. But I haven’t felt any different this afternoon than I felt this morning. I think we are right where we were this morning. We are just exploring now, if we are going to do that, where do we bump into things that make us go whoa, time out, let’s think again. But I don’t think we have changed any direction.
MR. ROTHSTEIN: I have another question. Am I correct from your statement, Harry, and other peoples’ views that it is still possible and appropriate for us to move forward with a draft letter, that we don’t have to resolve the issue that we have been spending the last half hour, about building up or working down, to say what we want to say about the filters to the Secretary?
MR. REYNOLDS: Absolutely. We may bump into something in one of the hearings that shuts us down.
MS. BERNSTEIN: I’m sorry if I stuck a stick in the spokes. All I was trying to figure out is, in the next hearings that are coming after these letters, what should the subject matter of that be. Should we go through these categories subject matter by subject matter, or did you want to explore the concept of this minimum data set in some way in part of the hearing as a different way to approach this? Or are we not doing that?
I am just thinking ahead about what does the hearing look like and who would I want to get for you and so forth. That is all I meant to do.
DR. FRANCIS: Just to take an example, take sensitive social history. You can think about that either way. You can figure out what would be included in sensitive social history categories, or you can think about, is there something you want out of the minimum data set that would be a sensitive social history category? Either way, you have got to hear about it.
MR. REYNOLDS: Both discussions get you to the same point.
MR. ROTHSTEIN: So we ask somebody what in social history that is sensitive, what is the medical value of obtaining that information, what are the costs of removing it or not including it.
MR. REYNOLDS: And regardless of where it is identified.
MS. BERNSTEIN: So maybe I misunderstood. What I was thinking was, you would be asking the PCP, could you work in a practice where you had the minimum data set and not the full record, and were able to get more information on request. Could you run your practice by getting referrals that looked like that or creating records that looked like that.
DR. FRANCIS: There are three questions. First of all, what is sensitive social history. Second of all, —
MR. REYNOLDS: I’m right there with you.
DR. FRANCIS: The second question is, could you, either you or a data sucker from the data that you put in, something that picks out certain fields, could you work with — you are on the doc’s side, you are building a record, it is going in electronically. Is the way you build it or the way it goes in electronically workable, sucking out sensitive social history. That is on the initial treating doc’s side.
Then there is Paul’s side, which is, you are the next doc seeing the patient. Can you work with a record that has — here we have got Wilma B. Flintstone. We have got her address, her phone number and her date of birth and her gender. You probably can do just fine without the address and phone number, at least from the former visit. I don’t know about Wilma’s date of birth, whether you need it or not. You might. I’m just thinking about, you are on the treating doc’s side.
MS. BERNSTEIN: If you have got Wilma’s age, —
DR. FRANCIS: You don’t need it, just the year.
DR. COHN: If you know for sure it was Wilma.
MS. BERNSTEIN: That might not be the physician’s job. That might be the job of the record locator service.
DR. COHN: I think at the end of the day, if you are dealing with Robert Smith — Harry Reynolds is probably unique enough, but if you are dealing with Robert Smith, you would want to have lots of certainty that this was really the right Robert Smith.
MS. BERNSTEIN: I understand you would want that. The question is, whose job it is to give you that certainty. Is it your job to insure it or is it the locator service’s to provide that service for you?
DR. COHN: The question is who gets sued if there is a problem.
DR. TANG: We are making this job insolvable. It already is, but to have a hearing that asks all these open ended questions, I don’t see how you can possibly get to any reconciliation. You wouldn’t even be justified, because it is all hearsay, anecdotal.
It is probably more effective to have people react to at most three scenarios. With all the testimony we have had — and it is not as if we are all holding personal beliefs, we all get out to our communities, and just come up with something that seems to make sense and can elicit the kinds of opinions that you want to see.
But to throw it open and say what do you think is — I don’t know where we will get except for losing time.
MR. ROTHSTEIN: We can give them some examples.
DR. TANG: But we don’t need that information, I don’t think.
MR. ROTHSTEIN: What do you mean you don’t, as a physician?
DR. TANG: No.
MR. ROTHSTEIN: As a committee member.
MR. REYNOLDS: But he says we don’t need it.
DR. TANG: I don’t think so.
MS. BERNSTEIN: We can decide ourselves what is sensitive social information.
DR. TANG: Or it could be decided later. But we are going to either cordon off some stuff or not, continue to do it or not.
MR. ROTHSTEIN: Let me tell you where this is, and maybe we are trying to be more granular than we need to be. We are going to present the concept in the draft letter that we are going to work on over the next month that we are planning to get the full committee approval in September.
What we were contemplating was holding additional hearings even past the letter to provide the Secretary with more information in implementing this. Maybe not to cop out on this, maybe what we should do is wait and see what the letter looks like, and then decide whether it would be beneficial to even drill down another layer.
DR. TANG: You want to write one letter based on that one day’s hearing?
MR. ROTHSTEIN: No, because the letter is going to reflect what we have been talking about for the last two and a half years.
DR. TANG: But it has no conclusions. The reason I think we weren’t mentioned here is because we gave no recommendations.
MS. BERNSTEIN: What do you mean, we gave no recommendations?
DR. TANG: We said, you ought to think about a whole lot of things.
MR. ROTHSTEIN: We gave a lot of recommendations. There were a few areas where we couldn’t reach agreement. The reason we were not mentioned there was an oversight.
DR. TANG: Just to cut to the chase, I don’t think we have formal conclusions based on the hearings to date. I am worried about writing you ought to think about letter. I would rather come to some kind of —
MR. ROTHSTEIN: Paul, if you recall, right before you left this morning, you very quickly were able to rattle off four or five things that we reached agreement on that we wanted to put in a letter.
DR. TANG: But I thought we were discussing some of these.
MR. ROTHSTEIN: No. My impression is that we are still all aboard, that nothing has changed from the time that you rattled off those four things. We are still planning to write that letter. Should we write that letter including those things that you mentioned, that in my view would be — if we got it through the full committee and everybody was happy with it, would be a major contribution, don’t you think so, Harry?
DR. TANG: Then you said, if there are things after we see the letter that need further exploration so we can make more refined recommendations, then you are saying we will hold hearings.
MR. ROTHSTEIN: That would be my suggestion now. I think we are spinning our wheels. This is tough stuff, drawing lines and figuring out all the possible horror situations.
MR. REYNOLDS: The next step down is serious business.
MR. ROTHSTEIN: I think we map out the broad areas. If we get committee consensus on just those points we talked about this morning, I am going to hold a party. It will be wonderful. The details, should we need to do some additional stuff, will go forward. If not, we will just be confident that Sue McAndrew will take care of all the things that we left over.
MR. HOUSTON: As you have been talking, I have been doing a quick browse of the Web. I think there are some materials even just on the Web regarding things like mental health and electronic health records.
Again, very quickly, the National Council for Community Behavioral Health Care put out a document called the electronic health record road map. So I think there are documents out there that may, not saying they will, may provide us with some background on some of these subjects. There is a SAMHSA newsletter which is talking about electronic health records in the 21st century.
DR. COHN: There was a major conference last year.
MR. ROTHSTEIN: I was the keynote speaker. Actually Rob Kolodner and I were the —
MR. HOUSTON: But I would renew my comment that we should look actively look to see what is available. There are people out there that have thought of some of this, and I think it would be worthwhile trying to find it and to use that as background, because it might be more informative.
DR. TANG: To try to get some kind of consensus.
MS. BERNSTEIN: How would you want to use that information?
MR. HOUSTON: There might be some discussion —
MS. BERNSTEIN: Do you want me to send you a ream of paper? What do you want me to do?
MR. HOUSTON: Just go through and see if we can find topic discussion that is responsive to what we are looking at.
DR. FRANCIS: I would raise the question in the following way. The question is how and who would do that. So for example, I could volunteer to take a day or get a graduate student to get online and look at the various — I am on the ethics committee of the American Society for Reproductive Medicine, so I could without too much trouble look at what they have to do not have.
MR. HOUSTON: We may find nothing here, but we may find that there is something extremely responsive to what we are doing. But my point is, from doing a very short quick search on the Web, there are materials here that might help us out.
DR. FRANCIS: Sometimes those road maps, they will say, what is an electronic health record.
MR. HOUSTON: I understand that, but if it helps augment what we are —
DR. FRANCIS: I don’t disagree at all. I’m just saying, I think you volunteered to do one of them.
MR. HOUSTON: I’ll try to mental health. I don’t have a problem with that. But we may find there is a gold mine out there.
DR. FRANCIS: I am happy to do reproductive medicine. It wouldn’t be hard for me to do reproductive medicine.
MR. ROTHSTEIN: I think Maya will check, but I think the main value of such a literature review would be at the lower level that we are going to put on hold for now. In other words, I think we can make a very good case for the initial four or five points that we agree on this morning without resort to that, but should we decide that we want to go ahead and have hearings and do research, then I think that would be an appropriate time for that.
DR. FRANCIS: What I don’t want is, I think it is really important that we have buy-in. I think part of having buy-in is that groups know that their statements have been read and looked at. I think another part of how you get buy-in even among us is, we all have the sense that we have done whatever is due diligence and so on. I think all of that really matters, but I don’t want it to be a roadblock.
MR. HOUSTON: I don’t want it to be a roadblock, either. I only brought it up as a way to argument what we are doing and make sure that we are not way off base. We take lots of testimony, but sometimes it is maybe good to go back and try to get a sense. We may find that all the mental health organizations — even if they are talking about EHRs, nobody has talked about the granularity that we have talked about. Maybe it says it isn’t an issue to them, or it may say that we are on the forefront and we need to help them define the requirements. But we also may find that they are in lockstep with what we are talking about in the approaches and the issues. If we cite them or indicate that we have done this type of research, it helps.
MR. ROTHSTEIN: Considering the four or five points that we want to include, I think we have enough information, enough consensus, enough agreement to prepare the letter. Then to be honest with you, personally I would need to reflect on the letter. I think it is a major dance, but we all need to think about strategy, what is the most workable, what is the most feasible, what is the most politically likely to sail and be accepted by all the various stakeholders involved in this. I just can’t answer those questions yet, but whatever it is that comes up three or four steps down the road, I am quite comfortable that we have identified the principles that it must contain.
MR. REYNOLDS: And nobody is adjudicating this in an open forum someplace.
MS. BERNSTEIN: Yes, I think that is right. Nobody is addressing these kinds of issues except this group in the way that we are doing.
DR. TANG: I would be interested in the folks here’s opinion, which is more desirable or less undesirable, to promise to segregate all that information and have it leak, or to say we are going to make available all records?
DR. FRANCIS: That is a weird question.
MR. REYNOLDS: Could you ask it again? Say it one more time.
DR. TANG: Is it better, Harry, if I say you can opt in to me segregating all information dealing with mental health, social issues, blah, blah, blah, or not? Then you sign it, and then inescapably in the text I have disclosed one of those items. Which one are you hurt more by, by saying sign this — do you want me to segregate this and you say yes, and then I inadvertently disclose it in my text, a progress note? Or for me to say, Harry, you have a choice of either me sharing this information with your authorization to other providers or not, I can’t really guarantee that I can prevent our discussion about your feeling blue at times from getting to other folks. Which one is more preferable?
MR. ROTHSTEIN: I think it is the wrong question, actually, Paul. I think the question is, what system would better protect privacy and would promote better health care, not what harms would befall individuals from A or B.
DR. TANG: I’m not talking about harm. I am talking about, which would satisfy your privacy need better?
DR. FRANCIS: You are assuming you can’t deliver. That is why I thought it was a weird question. It is like, have you stopped beating your wife.
DR. COHN: I’m not sure that we have reached the place where we have made a decision.
DR. TANG: I was gathering the information myself.
DR. COHN: No, but the question of mental health, I think we have been talking back and forth about, is what we trying to do is to prevent things in a primary care provider note from getting out, or are we trying to segregate psychiatry records. I’m not sure what it is. We talked back and forth on that one. I would think that we can say pretty well that we can segregate psychiatry records. If that is what we decided, you could probably feel pretty good that that would leak out.
On the other hand, that other conversation about that one-liner about the patient being depressed, I think that is one of the things that —
MR. ROTHSTEIN: It is so tempting to keep drilling down.
DR. TANG: I wanted to understand what folks like you —
DR. FRANCIS: I agree, Paul. I think the premise behind your question is — I would agree with you that it is worse to not have my confidentiality protected —
DR. TANG: If I say something.
DR. FRANCIS: — and believe that it has been, than it is to not have my confidentiality protected and know that it hasn’t been, because if I know that it isn’t going to be protected, I can protect myself against the knowledge that it won’t be protected.
But in either case, what I am going to do, if I know that my confidentiality is not going to be protected, I would be very careful what I share.
DR. TANG: Or you opt out and say, please don’t share my record.
DR. FRANCIS: Or when I come in for care I opt out in some way or another. I think it is a very bad option for patients to have the only choice be opt in and opt out. I think if you opt out under those circumstances, the quality of your care is going to be seriously compromised as we move toward an electronic records sharing world. So I want to try in my own thinking of this to generate a situation in which people are not faced with just that black and white choice.
Now, it may be that that is the only workable option. I would like to try to see if there are ways we could be players in creating some additional options.
MR. REYNOLDS: It may not be the person’s decision. More and more companies — as better information flowing back and forth is proving to give better care, more and more people that are offering insurance are saying — we have already heard enough testimony of people offering PHRs and this other stuff. So I think you are going to have other players in this game that says, fine, if you don’t want to do that, then Leslie, you are going to pay a whole lot more money.
But Paul, to answer your question, I would like to have one more set of debate on that and the list I made, and then I will be more than happy to answer you. I don’t know whether it is practical or not.
In other words, from your standpoint, the fact that it is going to be electronic, the fact that it is going to be electronic, it adds a degree of risk, period. We all know that going in, because now it is available. So I’m not sure that you telling me that one way or another, whether you accidently do it or it accidently gets out concerns me more, somebody breaks into a doctor’s office and takes the records. I’m not overly concerned about that, but I am trying to talk about how practical is it to break this stuff down. Then I would have a much more learned answer.
MR. ROTHSTEIN: Let me share with you one other concern that I have that we have not addressed today that we may want to keep in mind for post September. I am trying to weigh in my mind how best to minimize the stigmas associated with certain conditions. By treating mental illness separately, by treating genetic disorders separately, we may be further contributing to the stigmatization of these conditions and putting into the future the time when there will be no difference between mental illness and other illnesses and so forth. Balancing that with the sensitive nature of the information at the present time.
I don’t know where I am on that issue yet, but I think it is something that we need to think about as we move forward.
MR. REYNOLDS: But if you are looking at it from a care standpoint, those may be equal at some point. If you are looking at it from the standpoint of where that data could end up because it is electronic, it won’t be.
MS. BERNSTEIN: It won’t be — ?
MR. REYNOLDS: It won’t be the same. I’ll give you an example. Right now, banks that clear payments for hospitals also many times have the original claim because of the 835.
So all I am saying to you is, when you go to electronic and data starts flowing around, from the standpoint of the treatment of somebody, whether you get employers and all these other people involved and it is electronic, as soon as it becomes electronic, then you bring a whole other set of characters into the fray as to how easy that data can be passed around, accessed, dealt with and so on. So that would be another thing to discuss, based on your comment.
MS. BERNSTEIN: Is it the subcommittee’s intention to have a hearing between now and September of any sort?
MR. REYNOLDS: No.
MR. ROTHSTEIN: No. It is our intention to get a draft letter out by the first half of July and circulate it to the subcommittee and then hold at least two conference calls in late July or August in which we try to work things out.
DR. FRANCIS: You might want to think about available dates for conference calls.
(Discussion off the record regarding future meeting dates.)
MR. ROTHSTEIN: Like many of my other predictions, we did not finish in the time.
MS. BERNSTEIN: Is there anything we still need to do right now together?
MR. ROTHSTEIN: That was my last question. Is there anything else we need to work on?
DR. COHN: Did you guys deal with the questions that I had about the letter?
MR. ROTHSTEIN: It is no longer millions, it is zillions.
MR. REYNOLDS: You had already given him some, and I gave him some.
MS. BERNSTEIN: Is it on our letter, Mark?
MR. ROTHSTEIN: Yes, we made some changes in our letter. I’ll go over those.
MS. BERNSTEIN: Does anyone have anything to say about the HIPAA report? That is an exec subcommittee thing.
DR. COHN: Yes, I saw that.
MR. ROTHSTEIN: There are some questions, like we need to add stuff. We are now adjourned.
(Whereupon, the meeting was adjourned at 4:30 p.m.)