[This Transcript Is Unedited]
Department of Health and Human Services
National Committee on Vital and Health Statistics
Ad Hoc Workgroup on Secondary Use of Health Data
June 22, 2007
National Institutes of Health
CASET Associates, Ltd.
10201 Lee Highway, Suite 180
Fairfax, Virginia 22030
TABLE OF CONTENTS
- Call to Order
- Discuss Development of a Preliminary Framework
- Plan Agenda and Testifiers for Hearings
P R O C E E D I N G S (9:10 a.m.)
DR. COHN: Good morning. I want to call this meeting to order. This is a meeting of the ad hoc work group on secondary uses of health information of the National Committee on Vital and Health Statistics. The National Committee is a statutory public advisory committee to the U.S. Department of Health and Human Services on national health information policy. I am Simon Cohn, Associate Executive Director for Health Information Policy at Kaiser Permanente and chair of the committee and work group.
I want to welcome committee members, HHS staff and others here in person and those listening in on the phone. I do want to mention that today we are not on the Internet, but given that there are people on the phone, we do need to make sure to speak clearly and into the microphone so that they can participate in the conversation and hear our deliberations today.
We do want to again thank NIH for what I think has been very exceptional meeting accommodations over the last couple of days. We will be talking to them and expressing our appreciation.
With that, let’s have introductions around the table and then around the room. For those on the National Committee, I would ask, if you have any conflicts of interest related to any of the issues coming before us today, would you so publicly indicate during your introductions. I want to begin by observing that I have no conflicts of interest.
DR. CARR: Justine Carr, Beth Israel Deaconess Medical Center, member of the committee and the work group and no conflicts.
MR. REYNOLDS: Harry Reynolds, Blue Cross Blue Shield-North Carolina, member of the committee and no conflicts.
DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention, staff to the ad hoc work group and liaison to the full committee.
DR. TANG: Paul Tang, Palo Alto Medical Foundation and member of the committee, no conflicts.
MS. AMATAYAKUL: Margaret Amatayakul, contractor to the ad hoc work group.
MS. JACKSON: Debbie Jackson, National Center for Health Statistics, committee staff.
DR. DEERING: Mary Jo Deering, National Cancer Institute, ad hoc work group staff.
DR. HOUSTON: John Houston, University of Pittsburgh Medical Center, member of the committee. I have no conflicts.
MS. RIAS: Fatima Rias, Booz Allen, supporting the ad hoc work group.
DR. VIGILANTE: Kevin Vigilante, member of the committee, no conflicts.
DR. SCANLON: Bill Scanlon, Health Policy R&D, member of the committee and no conflicts.
DR. GREENWOOD: Marjorie Greenberg, National Center for Health Statistics, CDC and Executive Secretary to the committee.
(Whereupon, the remainder of the introductions were performed.)
DR. COHN: Welcome, everyone. As I commented yesterday, I do want to thank everyone for being willing to participate in this activity. I think as we saw yesterday, we will have a full agenda of activities for the summer.
We spent a lot of time yesterday talking about the conceptualizations and the work plan. I know we are going to go back to that. As I look at the agenda, we are pretty much on schedule in terms of what we wanted to do. I think today we will be reviewing some of the work and trying to build on our conversations from yesterday, but as Harry and I were discussing, after about an hour we wanted to make a relatively hard stop to those conceptual conversations and move into the specifics of the testifiers and the testimony, knowing that for our July hearings we really need to get everything nailed down by the time we leave here today, and we need to be pretty far along for our August hearings.
So once again, we will be talking, we will be continuing to refine the work plan, but the important outcomes out of today are some comfort with the questions we are asking the testifiers and do we have the right testifiers.
With that, I am going to turn the microphone over to Harry and Justine, who will be leading this session. My appreciation for their work as well as work last evening along with Margaret in defining our scope and work plan activities.
MR. REYNOLDS: Thank you, Simon. Yes, we will spend this first hour — we took the comments that were made yesterday, and Margaret put some together. We have added to them a couple of times last night, so what you have in front of you now that you can see on the screen, and we are still having print issues so you won’t have any hard copies, so we will be working from the screen, are what we have put together as thoughts based on that.
So we would like to look at the next couple of pages, and then the updates we did to our axis of interest. Again, we are going to spend an hour on that. So if you have changes, we will make them substantive, which we appreciate your e-mails on. But let’s make sure we get the message, we get the focus.
So with that, Margaret, why don’t you take us through the first one?
MS. AMATAYAKUL: I took the premises from the scope of work. The premises as I reflected on that came out of a call in which Mary Beth Farquar suggested that the original statements that we received had HIT driving quality or quality use. I think the premise we were trying to express was that use should drive HIT, HIT should not drive use.
I took some of your language from yesterday. I have two options, or you could include both. HIT should optimize the value of the health data collected in the practice of caring for patients and/or serve the nation’s health and health care system, because it enables more complete and accurate data capture analysis and exchange.
MR. REYNOLDS: Comments?
DR. COHN: I would probably support having both. I might even add a third, just because we are talking about premises, that had something to do with improving health care quality, something along those lines, improve the health of all America. If we are putting premises down, I think we need to somehow connect this to actual improved health, as opposed to just improved data.
MR. REYNOLDS: Any other issues with what we have or with Simon’s addition?
MS. AMATAYAKUL: Could you repeat that, Simon? I’m sorry.
MR. REYNOLDS: For the first bullet, that’s correct.
DR. COHN: I’m sorry, Margaret, you’re asking me what I was suggesting? I was agreeing with one and two, and I was suggesting a third, which basically should improve the health of all Americans or something on that level as a third item.
MR. REYNOLDS: If you leave it capitalized, they will really know we mean it. Any other comments on those? Does that capture what we wanted to talk about, Justine?
DR. CARR: So health IT optimizes the value of health data collected in the practice of caring for patients. Is that saying that correctly? It is through HIT that the data is collected.
I am thinking about two things. Are we talking about electronic health records? Are we talking about administrative data? I’m not quite sure what this means, health information technology should optimize the value of health data collected in the practice and care of patients.
DR. TANG: It is the application of health IT that should help us optimize the value of health data.
DR. CARR: Should enable the optimization?
DR. TANG: Because otherwise we are still focusing on HIT, which has no value at all.
DR. FITZMAURICE: I see the problem that Justine was driving at, that HIT should do this. Who is HIT to do anything? It is, those who apply HIT should enable. That is a premise. If they don’t find it in their interest to do it, they won’t do it, but part of our job is, are there incentives, how could this work, et cetera.
MR. REYNOLDS: Any other comments on the first bullet? Moving to the second bullet.
MS. AMATAYAKUL: For HIT to serve its purpose however, there must be respect for patients’ privacy and adherence to the standards and appropriate confidentiality and security protections.
DR. TANG: There again, HIT doesn’t have a purpose in and of itself, but it is the use of health information that must respect the patient’s privacy and all of the confidentiality and security standards.
DR. CARR: That is true with any health data paper otherwise.
DR. FITZMAURICE: Paul, would you agree that those who use HIT might be a good way to start that sentence?
DR. VIGILANTE: It could be the way HIT itself is structured that may frustrate your ability, even though you want to. So there is something inherent in not only the intention of the user, but in the way HIT is configured. So there are two parts to this.
DR. TANG: I think it is the act that either does or does not respect the individual’s privacy. Regardless of the intent, whatever happens to their data is what causes good or harm.
DR. COHN: I would just mention, I think Paul’s conceptualization is right, and I’ll let Margaret wordsmith it. It isn’t to serve its purpose, but it is to reach its potential, rather than to serve its purpose.
DR. TANG: Back to Justine’s comment, this would work on paper as well as electronic. We are trying to gain benefit and avoid harm from the secondary or other uses of health data. It so happens that HIT makes that data more accessible, more malleable, and it makes it more distributed than it used to be. That is why the potential for harm as well as benefit arises.
DR. CARR: Right. In fact, to reach its potential, its potential may be contraindicated by privacy. So there is a potential for uses — that is the point. I would just put this to say use of health information must respect patients’ privacy and adhere to standards and appropriate confidentiality.
MR. REYNOLDS: So HIT is really not an issue in this case that needs to be spelled out.
DR. SCANLON: I was agreeing with Simon in the sense that if we don’t respect privacy and confidentiality, there is going to be a backlash, and we are not going to have the data available. But it really is an independent thing.
The second part here is a value judgment. You could do the first part, use HIT in the data that is generated and try to improve health and improve the health care system, and not respect privacy. Privacy is an independent value, and this is a value that we are imposing on this. I think it is an important one and more of a secondary effect in terms of the potential.
DR. COHN: I don’t want to belabor this one, but if Mark Rothstein were here, he would talk about, the people in the health care system don’t disclose data and therefore all of this doesn’t reach its potential. So that is the connection there, I think.
DR. TANG: Which is all the more reason to go back to Justine’s comment that this is data. It is all about the data, not the means of storing or transmitting it. In effect, that would give our conclusions — would have greater ramifications, I think, in how do you deal with other uses of health data. I think that is appropriate, too.
Just like HIPAA only covers if you submit your stuff electronically, we wouldn’t want to get into that situation of having a loophole, that all you do is bypass the media.
MR. REYNOLDS: Margaret, are you capturing this?
MS. AMATAYAKUL: What I had suggested was, use of health information must respect patient’s privacy and adhere to standards an appropriate confidentiality and security protection.
MR. REYNOLDS: So you have that noted. Why don’t you read that again, and if everybody likes it we will let Margaret catch up at some point with it. Read it again, please.
MS. AMATAYAKUL: Use of health information must respect patient’s privacy — we don’t even want to call it patient, must respect privacy and adhere to standards and appropriate confidentiality and security protections.
DR. TANG: Well, it is a patient by definition; it is health information.
DR. CARR: Did you want use of health information in general or health information technology?
MS. AMATAYAKUL: I think in general. That is one of those overarching principles. Health IT is a part of it.
MR. REYNOLDS: Any other comments? Next bullet. Yes, John.
DR. HOUSTON: Use of HIT must support individual privacy, or something.
DR. TANG: Just to wrap up this slide, I would take off that last bullet, because it is really not about HIT, I don’t think.
MR. REYNOLDS: The last bullet comes off.
DR. WHITE: Thank you for letting me say something. Most people talk about respecting people’s privacy. There has been an idea that is bumping around in my head that at the same time we want to respect peoples’ privacy, should there be some sort of responsibility on the part of individuals to contribute their information to the greater good?
Do you feel like that is captured somewhere in what you have got here? If not here, somewhere else. If you feel like it is somewhere else, that’s fine. Do you know what I am getting at?
MR. REYNOLDS: So give us some more. Let’s put it up there, because I think it is a premise also.
DR. HOUSTON: Maybe a way to make that a little more user friendly is that one of the premises is that we want to try to facilitate people or encourage people to contribute their data or have their data contributed for these other purposes.
DR. COHN: That was the item three in the first bullet, improving the health of all Americans. I’m not sure that we want to as a premise contribute data for other —
DR. VIGILANTE: Maybe there is a common good to be achieved by the individual contribution of data.
DR. GREENWOOD: That almost should be the first premise. This is common good, and maybe the second one is the privacy, or the first one is the privacy. The first premise is that you shouldn’t start with HIT, because HIT is a means to an end. The idea is that health data collected in the practice of caring for patients can contribute to improving the well-being of the population, and can improve the functioning of the nation’s health and public health and health care system. The use of HIT can enable this optimization of that, can facilitate the optimization of the value of the health data. This must always be done with recognition of the importance of respecting the privacy of individuals and adhering to standards and whatever. That seems to be the logical sequence.
DR. CARR: Are we saying application of HIT affords this new opportunity to leverage information for the national good? Is that what is really happening? I think that is a very strong thing to start with, that we have a national good. So I just was saying application of HIT affords the opportunity to leverage health information for improvement of whatever.
DR. GREENWOOD: I would start with the common good.
MR. REYNOLDS: Let’s go back up to the common good. We are editing two bullets at the same time. Let’s go back up to the top.
Time out for a second. Margaret was editing another one, people were talking. I just want to make sure that we are keeping ourselves straight. So we are back on the top one. There is a common good. It was reordered from Marjorie’s suggestion. Paul, that is the one I believe you have a comment on.
DR. TANG: I was going to comment on the whole thing. I am going to use the term federal government, just because it has the role of looking out for the public good. The federal government should optimize the value of the health data collected in the practice of caring for patients to improve the health of all Americans in the health care system. Its use must support individual privacy and blah, blah, blah.
Then the third one is that HIT should support the above goals. We have goals for the data and its protection and HIT is just a way to —
DR. CARR: I guess my question would be, are there three points here, the common good, an implication of HIT for a new opportunity, but that we must support privacy. Those are the three points.
DR. TANG: I would make privacy the second one. We have a common good to optimize the use of this for the health of all Americans. We must respect the privacy, and we can use HIT to enable the above goals.
MR. REYNOLDS: And that should be a common thread throughout everything we do. If we are really trying to build this thing, it may be good to keep it a little more prominent in whatever list we make as an approach.
DR. STEINDEL: I think we have drifted down into the world of motherhood statements. I liked the original one. I think it summarizes all that we said without going into the area of, there is a common good for the health of all Americans from the use of health information. That is a motherhood statement. I don’t see its place in the premise. It doesn’t really refer to what is a premise with respect to what we are doing with this report.
I think the bullet that Margaret has highlighted right now, if we take out the first sentence and maybe do a little wordsmithing, actually expresses all those thoughts. It says, those who apply HIT should enable the optimization of the value of health data collected in the practice of caring for patients. That thought is missing from, there is a common good.
DR. VIGILANTE: How about this? The common good is served by optimizing the value of health data collected in the practice of caring for patients.
DR. STEINDEL: If you combine the two thoughts, yes.
DR. VIGILANTE: I do think preserving the idea that — you are taking data that was originally collected to care for patients and you are going to use it for something else. By using it for something else, you serve the common good.
DR. STEINDEL: And that is missing in that first statement.
DR. VIGILANTE: So I think preserving that. Even the privacy issue, depending on how you want to parse it, is inherently important to the individual, but it is also important to the common good in the sense that the trust that is created by respect for privacy enhances the likelihood that people would be willing to contribute. That is a longwinded way of saying it, but privacy is important to the individual, but it is also important to the successful use of secondary data on a system-wide level.
MR. REYNOLDS: So you are saying don’t mention it?
DR. VIGILANTE: You at least have to say you respect it, but there is also a secondary gain to respecting privacy, not just to the individual but to the system as a whole. Whether we want to articulate that or not is optional, but I think it is an important point.
DR. WHITE: Let me say that in a slightly more abrasive way. There are some things that you may not want your data used for that they are going to be used for, anyhow. We have a great example now in public health. If my gonorrhea test comes back positive, it is going to be reported to the public health department. That has been determined to be a common good. I may not want that out there, but it is going to be out there.
Similarly when we talk about postmarketing surveillance. You may not want your general health information available in such a system, but your information being available may save peoples’ lives. So I understand that yes, it is a motherhood statement. Do you want to couple it with a fatherhood statement, a tough love statement to go with it, or what?
DR. STEINDEL: No, I like the way Kevin modified the motherhood statement, because I wanted to get the concept of what we are doing with respect to this report, which is the optimization of that health data. Before it was just saying health data is good. That doesn’t say anything to me. That is a motherhood statement. I know it is good. Good for what, I don’t know. But when I say it is good for the optimization of the health care system which is what we are talking about, that is a good premise.
Now, the second point you were making about the privacy, must support the individual’s privacy and adhere to standards and appropriate confidentiality and security protections, that somewhat skirts the second point that you were making, that there is a common good when we do violate or intentionally use the data that might compromise the patient’s privacy. That is missing in that statement. But I’m not certain that we need to add it.
DR. WHITE: The reason I mention it is because in the spectrum of folks that we see when we talk about this, in addition to the folks that say all data should be available for all reasons, there are also folks out there who say no, no, no, nobody gets my data without explicit permission. So I don’t know how explicitly you want to address those two here, or further down the line.
DR. GREENWOOD: I was looking through the letter that we approved from the privacy subcommittee. There are some nice pithy statements either in that or in their June 2006 about the issue of public trust, and we might just pick up something from that.
But I’m like John. It made a huge impression on me at the privacy hearing in San Francisco two years ago when we had people who were not off the wall, they were mainstream people, coming and bringing testimony that in order for the NHIN to work, for the first five years or something the data shouldn’t be used for anything except the care of patients.
I remember asking them, do you mean that public health shouldn’t benefit from HIT at all? He said, oh, no, and we just started peeling away at it. I know John has given examples of that as well. But again, it all comes down to the balance. I think that is powerful. I know that mothers always take the brunt of the criticism, Steve, but some of these motherhood things may have value, just like mothers have value. I don’t have a problem with linking it.
MR. REYNOLDS: I would want to think about having one concept. We never use the word understanding. We always are into privacy, security and confidentiality. But if we are going to use their data, we want them to understand, especially as we are using this term of secondary uses and others. If public health is going to get it, then they need to understand that. We are not really protecting their privacy, we are doing what is going to happen.
So I would somehow craft it in there at some point in some way, not to change the whole thing, but we always say privacy, security and confidentiality, but it is really what we want them to understand. We have got to have some way of them understanding those uses. When it is taken from there, whether it is through surveillance or anything else, it is going to be taken from there, but they understand that.
DR. CARR: I would like to amend the first bullet to say there is a common good for the health of all Americans from health data collected in the practice of caring of individuals.
DR. VIGILANTE: How about this? The common good is served when health collected in the care of patients is appropriately used for other purposes, including public health, research and — to be more specific about it.
MS. AMATAYAKUL: Could you read that again?
DR. VIGILANTE: The common good is served when the data collected in the care of patients is appropriately used for other purposes.
DR. GREENWOOD: No, I wouldn’t say it that way. That sounds too open-ended.
DR. VIGILANTE: Okay, for —
DR. HOUSTON: Why don’t we say appropriate secondary uses, because we are going to define —
DR. VIGILANTE: No, we don’t want to use that.
DR. GREENWOOD: We don’t want to use secondary.
DR. HOUSTON: We were trying to define it yesterday. I also don’t think we should limit it to quality.
DR. GREENWOOD: Appropriately used, I like having that up there. If you say HI must support individuals’ privacy, that can sound like an absolute statement. This is a balance, obviously.
DR. TANG: The original term was respect. Respect means there is a balancing aspect, and that balancing may fall on the individual to decide or it may be other.
MR. REYNOLDS: Let me take a little prerogative. We have got a statement we want to make on the common good, and we are trying to build something that is going to be for the common good.
Second, we are going to leverage the information and third — well, second we are going to talk about privacy or understanding or whatever we put in there, and then we are going to have a third one.
Looking at the time, I want to move on to the axis of interest here in a minute. We can wordsmith this. Everybody is going to get to see it, but I think we are starting to redo it way too much. Steve, if you have a comment?
DR. STEINDEL: I was just going to comment on this first one. I don’t know if you want me to continue. The common good for all Americans is served when health data is appropriately used for multiple purposes.
DR. GREENWOOD: No.
DR. CARR: So we have got one on common good, one on privacy and one on application of HIT.
MR. REYNOLDS: Let’s move on. Margaret, if you will move on to our scope. Let’s talk about the scope. This is what we are saying we are doing. The first one was what we are about. This is what we are doing, so we want to take a look at this and make sure that we are in agreement with this. If we have these two, then we can obviously build the questions, we can adjust the axis of interest and everything else accordingly. So if we can do this in the next 17 minutes, then we will move on to talking about the testimony.
So let’s go with A, incudes a taxonomy that describes types of uses and users of health data that may be transmitted through a health information exchange.
DR. HOUSTON: Is it transmitted through a health information exchange or maybe that it is transmitted through a health information exchange that could be used for — I hate to use the word secondary uses, but — transmitted to me is, it is already transmitted, or it is already available. It is a matter of the uses.
DR. FITZMAURICE: But there is a lot of data that are not today being transmitted that when electronified and coded will be transmitted. So I wouldn’t want to exclude those data.
DR. HOUSTON: But I think the premise is, they are already going to be transmitted for patient care related purposes. This is the issue of secondary uses. The data is already transmittable because we are just asking to then take the data that would otherwise be transmittable and use it for other purposes, I guess is my point.
DR. FITZMAURICE: But you are restricting it only to data that is currently being transmitted? Excluded those that might be transmitted in the future?
DR. GREENWOOD: What is wrong with that?
DR. COHN: Yes, future tense is fine.
DR. TANG: I think it is too restrictive. I agree with Mike.
DR. HOUSTON: I’m not so much beholden to the word is as much as, I am looking at maybe transmitted as modifying the uses and users of health data. I’m just saying it is data that is already out there, and what we are trying to do is express the way that it may be used, or data that will otherwise already be out there as this is developed.
MR. REYNOLDS: My question is, is the HIE restrictive? We are talking about EHRs, we are talking about NHIN, we are talking about HIEs.
DR. COHN: Maybe NHIN.
MR. REYNOLDS: And its associated capabilities, I don’t know. But I would rather look at that.
DR. HOUSTON: Rather than transmitted, can we maybe use the word available? My point is, it is going to be out there and available, how should it be used.
MR. REYNOLDS: I’m not necessarily comfortable that that is the first thing we should say, but that is one of our bullets.
DR. CARR: One of the discussions at the AMIA meeting was about New Hampshire, where claims information about drug use was sold to somebody. That didn’t go through a health information — where would that fall in this?
DR. TANG: I would support your question which went back to one of our premises whether we do or don’t restrict our recommendations to those things that flow electronically or flow electronically through an HIE, but really are we talking about other uses.
DR. CARR: Initially I thought we had electronically transmissible clinical data. I think that defines the data. Where it travels or how it travels today, there are many different routes. It may not go through an HIE, but it is electronically transmissible data.
DR. COHN: I think the way that 1A is turning out is actually pretty open ended, which is fine. I think the difference is between what may be available in the NHIN versus what may be available electronically locally is wordsmithing differences. I think it allows us to get to the same area, and this begins to tie it to the future vision of the NHIN, which I like.
DR. TANG: I still have a question in my mind whether we are talking about policies governing other uses or we only want to touch it if it goes through what will eventually be defined as an NHIN. Clearly people can get around this if you restricted policies that go through something called an NHIN or an HIE, et cetera.
I think what they are searching for is, the initial motivation is, if I want to make better use of this data to serve quality and quality measurement and quality improvement activities, I need to have policies that allow me to do so safely. If we restrict it to any kind of means and modes or something like that, it seems like we are missing the boat.
MR. REYNOLDS: So you don’t like the boat. What would you make the boat look like?
DR. TANG: We need a taxonomy that describes the types of uses and users of health data, other uses and users of health data.
DR. GREENWOOD: The first use can be care for the patient.
DR. TANG: I understand, but the first definition of secondary use. We tried to get away from the use of the word secondary and we just called it use other than for the care of an individual patient at the time. So I am thinking in those terms.
MR. REYNOLDS: Let’s read what is up there now, see if that catches us.
DR. TANG: I was taking out the electronically transmissible.
DR. COHN: I’m not going to argue about whether it is electronically transmissible or not, but I don’t think that we necessarily help ourselves by describing the 999 other uses, but also don’t mention the fact that there is a use that is called caring for the patient. I think we are developing taxonomies. I think it is sort of a silly work-around here.
MR. REYNOLDS: So you would take out what?
DR. COHN: For purposes other than caring for the individual. If you do a taxonomy, you might as well mention that in the taxonomy.
DR. TANG: Why is electronically transmissible still in there?
MS. AMATAYAKUL: Because I didn’t erase it yet.
MR. REYNOLDS: So it includes a taxonomy that describes types of uses and users of health data.
DR. TANG: And by the way, there is actually a taxonomy in the original 1991 IOM CPR, so you can start there.
MR. REYNOLDS: Moving to B, please, provides guiding principles that set up a mechanism for addressing the risk, sensitivity, benefits and protections needed for various uses and users as filtered by HIPAA regs, parenthesis, CEBA not addressed. Covered entity, business associate and people that are not addressed by HIPAA.
DR. GREENWOOD: Is that going to be in —
MR. REYNOLDS: Yes, it should be spelled out. People may not understand what we are saying when we say the whole HIPAA regs. They may be thinking about transactions and codes, and we are talking about the relationship of covered entities, non-covered entities.
DR. DEERING: Should we limit it only to HIPAA regs, or should we address other relevant whatever.
DR. TANG: Or why use the filtered by anything? We basically need guiding principles to set up the mechanism for balancing the benefits and the risks of these various uses and users.
MR. REYNOLDS: The one reason that we came up with yesterday, and I think the HIPAA still plays, is in the discussion there are an awful lot of things that fall under treatment, payment and health care operations.
DR. TANG: That is the way we handled the principles. This is not just for us that are sitting in the room today. In other words, this is going to be the premises we are going to be handing to other people. So if we remove all of our thought process and all of our discussion, when somebody sees it they will not know that we are going to include that.
So if we are going to have a testifier come in, and we are going to say something about, would that normally fall under what you are already doing under this law or this law, we don’t want to catch anybody off guard. We want them to have a sense of what we are doing.
DR. COHN: I think I agree with the spirit of this, in terms of trying to bound it. I would use the word filtered. It may just be that we need to — this work needs to be done with recognition. I don’t know what the right word is, but filtering isn’t the right word.
MR. REYNOLDS: Agreed.
DR. GREENWOOD: Or in the context.
DR. HOUSTON: Maybe use the word permitted, currently permitted.
DR. TANG: The suggestion, which you can reject, was to provide guiding principles that balance the benefits and risks of the various uses and users of health information.
MR. REYNOLDS: Period.
DR. TANG: Actually I shouldn’t have said users. It is the benefits and risks of various uses of health information.
DR. STEINDEL: I have to support Paul on that. Once we start putting in words like HIPAA and other relevant regulations and common rules, I am getting very confused as to where I would go with this. But if I just put it off as balancing the risks and benefits, then we can seek in testimony where that balance lies, where HIPAA comes in, where the common rule comes in, et cetera.
DR. HOUSTON: I agree. I think we are going in the right direction. I would just maybe add not just risks and benefits, but obligations, something that goes in the context. There are a couple of key points of risk-benefit obligations.
MR. REYNOLDS: Any other issues?
DR. GREENWOOD: That makes me wonder, though. From what you were saying, Harry, it makes me wonder if in the premises something should be said about HIPAA and common rules. Are we starting with the premise that we aren’t opening up HIPAA, or we are accepting HIPAA as a given for what it covers, and then we are moving on, and then we are looking at what it actually allows, where we think the gaps are in HIPAA. But we are not starting with a clean slate.
MR. REYNOLDS: Yes. I would withdraw my concern on the second slide if that is put in the premise.
DR. TANG: I would agree with that, too.
MR. REYNOLDS: That is a good compromise. I think that puts us in the right direction.
DR. TANG: And it is consistent with R-12.
MR. REYNOLDS: Margaret, the next slide, please.
DR. COHN: Yes, federal regulations including HIPAA, IRP.
MR. REYNOLDS: Just make a note, Margaret, that we want to put HIPAA there somewhere. Back to the next slide, please. Provides guiding principles, we did that.
DR. TANG: Just a small thing. End users is off there, because you don’t balance end users.
MR. REYNOLDS: So you are just saying protections —
DR. TANG: Of health information.
MR. REYNOLDS: C, clarifies terminology associated with various data use formats, e.g., anonymization, pseudo-anonymization, de-identification, aggregation to the understanding of all stakeholders.
DR. HOUSTON: Why do we care about terminology and data formats? Isn’t the NHIN going to establish all the different data formats? I am assuming that what we are really talking about is using data that is otherwise available through the NHIN. I wouldn’t want to say we are having to restrict it to a specific set of formats, but rather what we are talking about is to access what is already available, and it has probably already been defined and structured.
DR. COHN: So what are you suggesting?
DR. HOUSTON: I am suggesting deleting C, because I don’t know that it necessarily —
DR. COHN: I think we need to. The question is whether we need it around data use format. I think we need a clarification of terminology as part of the work.
DR. HOUSTON: But let me ask, through the NHIN aren’t the data formats all going to be established?
MR. REYNOLDS: Taking data formats off is fine. It is the next issues that aren’t coming off.
DR. VIGILANTE: I was going to agree. People are going to use words to communication with us, and those words are laden with meaning. We need to know what the meanings are in the context of each of those words. It is semantic interoperability.
DR. HOUSTON: I understand that. I thought you were talking about terminology, the data that is flowing through the NHIN.
DR. VIGILANTE: No.
DR. STEINDEL: Do we want to include the concept of how we use these terms as well, not just the terms? When do we use pseudo anonymization?
DR. GREENWOOD: That is more on the text.
MR. REYNOLDS: The other thing is, we are hoping to hear from the testifiers how these are used.
DR. COHN: Clarifies terminology and appropriate uses.
MR. REYNOLDS: Okay, that’s fine.
DR. GREENWOOD: You mean appropriate use of the terminology or when you should use pseudo anonymization? That goes beyond the terminology. That gets into policy, so I don’t think you can put it in the same — I don’t think that is part of the conceptual framework. That could be part of your recommendations. At least it is D. It is not part of C.
MS. AMATAYAKUL: I was just going to say the same thing. I think that it is really embodied in here, and if it is not there, we should add it there.
MR. REYNOLDS: So let’s go to number two, please. Develop recommendations for HHS where there is a need for policy guidance, regulation and/or public education on issues of health data, data linkage, in data aggregation with initial consideration on the data for quality management, reporting and improvement.
A, is authorized for use. B, may be temporarily or permanently stored. C, in process for use.
Comments on two?
MS. BICKFORD: Are you going to be talking about the disposition of the data? You have talked about storage, but is there going to be any consideration of the final phase of the life cycle?
MR. REYNOLDS: Give me a few more words on what you mean.
MS. BICKFORD: We have a lot of data cemeteries, and there is not a consideration of what do we do with those data. What is the disposition process? Is that part of the consideration of this whole life cycle, the generation, storage, analysis?
An example of that is when you have an IRB and they have a data set. One of the expectations is that there is clarification of what is going to happen to those data when the search is finished. Is there a time certain disruption date? I am just asking that as a question from the perspective of thinking about the whole initiative.
DR. WHITE: Was I talking to you about this yesterday? We were talking about, somebody in your institution pulls data together, and you need data for a specific purpose, and you use it for that purpose. Later the person comes to you and says, I want to know about adjusting the physical plant of the hospital, should I make the doors wider based on the information that you have got. Can you then give that information to them?
What we said was, if there is some entity that pulls together the data for you, you should then be able to point that person back and say, no, go back to the well. That is the purpose of pulling this information together. Your specific purpose can be looked at, approved, addressed, and you can get the data for it.
So in that respect, when you talk about data graveyards, which that is a good point, data lies around, do you need to address the fact that data shouldn’t be lying around, or should it be lying around.
DR. CARR: Is that beyond the scope of this group? Is that for us to do? I think that is a whole other conversation.
DR. FITZMAURICE: In such a situation that is usually covered, if it is a research study, by the IRB and by the authorization you get from the patient. It is either time limited, or in the case of a research study you can make it not time limited, but you have to go back to the well, that is, to the IRB, for each use that you didn’t tell the IRB you were going to use it for.
MR. REYNOLDS: So do we want to modify B at all?
DR. CARR: I think IRB has time limits. I think medical records departments have time limits. I think there are things out there, and perhaps we want to ultimately make a recommendation that they ought to be clarified. But I think it is beyond the scope of this group to say how long data should be kept.
MR. REYNOLDS: Is everybody okay with the addition to B?
DR. GREENWOOD: Take out destroyed.
MR. REYNOLDS: Where did destroyed go?
DR. HOUSTON: I tend to agree with what Mike was saying. If there is a process in place like the IRB has today for approving uses of data, it also typically reviews everything surrounding how the data is managed and insuring that appropriate controls are in place.
I would think that that is all consumed within A, and maybe by clarifying A rather than having a separate B might be more appropriate. There are processes for authorization, authorized for use, including the management of data associated with that use, or something like that.
DR. COHN: I like where Paul is going better and removing B, because I think that handles that. I think instead of temporality and permanently, I think it would be and/or permanently. So I would want to have that. But I think you are solving the problem about destroying B.
MR. REYNOLDS: The other thing, I would just caution everyone, we use terms like IRB and other things. We may have government agencies that are doing this well in what they are stating, but this is an industry issue about where data sits or doesn’t sit.
DR. HOUSTON: My concern though is, with regards to storing data, just like the discussion regarding information that is drawn down from the NHIN for patient care purposes, and the fact that every provider is going to want to add it to their record, so they have some record of what they relied on to make a medical decision, the same thing here. Having a transitory data set, or the fact that there will be a transitory data set, will be problematic. I know it is going to happen. These data are going to be drawn down and it is going to be acted upon, and it is going to be stored somewhere.
MR. REYNOLDS: Again, I wasn’t disagreeing with your point. I was making the point that we don’t drill down just to look at it from a government standpoint. That was my comment.
Margaret, where did everything go?
MS. AMATAYAKUL: I moved A and deleted B and moved C.
MR. REYNOLDS: We don’t see any of them.
MS. AMATAYAKUL: It is all a part of —
MR. REYNOLDS: All right. Let’s read three. Initial consideration is placed on how data for quality measurement, reporting and improvement is authorized for use, including the processing and management of data associated with that use.
DR. STEINDEL: I have two problems with that as it stands right now. On item two, which we have not mentioned at all, didn’t we just send a letter to the Secretary on that?
DR. COHN: (Comments off mike.)
DR. STEINDEL: No, that was on data linkages in the session that we held. We have made lots of recommendations to the Secretary in the past from the Population Health group on linking data, aggregating data. It is one of the purposes of this committee from the beginning. So unless we focus that on a certain subset that is beyond what we did before, I think we have already done that. It is in our history.
The second is, initial consideration is placed on how — I think for quality measurement should appear at the end of the sentence as an example, and our focus should be broader than just quality measurements, but we should use that as a key example.
DR. GREENWOOD: I think you can address Steve’s first concern by just putting that there is a need for further policy guidance, regulation and/or public education.
DR. STEINDEL: We don’t even know that. I think we have to investigate it.
DR. VIGILANTE: But the data linkages recommendations did not focus specifically on data collected in the care of patients that is used for other purposes. It really is more about research oriented data sets. So it is a different — you are right, it is a narrower scope. We have talked about this, but if we want to make it germane to this discussion, we may want to make it more specific.
DR. STEINDEL: Then I think we need to make that statement a little more specific, how these apply for the use of data collected in the care of a patient.
MR. REYNOLDS: Margaret, is this the only three things that were under our scope?
MS. AMATAYAKUL: Yes.
MR. REYNOLDS: At 10:15 we will finish this slide, take a 15-minute break, and between 10:30 and 12:00 we will go to testimony. So attention, please. You have got three minutes. If you don’t like what it says up there, or you want to change the flavor.
DR. FITZMAURICE: In looking at the excerpts from the ONC request for assistance, the second bullet reads, while quality measurement and reporting is a priority for HHS, there are other secondary uses of clinical data that could be potential sources of revenues to help information exchanges.
It seems to me that one of the underlying features of giving us this charge is that the four consortia reported that NHIN is going to support themselves, or public exchange is going to support themselves; 50 percent of the revenue, they projected, would come from secondary uses of data. So what is a legitimate use of this data for profit? I’m not sure that I see where that is located up there.
MR. REYNOLDS: Comments? Do we want to add that subject in two? Should we put down examples?
DR. FITZMAURICE: I’m just looking to see that we are responsive to what ONC has underlying this request.
MR. REYNOLDS: I think it is a good point. Paul, were you about to make another comment?
DR. TANG: I was going to take the opposite tack and just simplify it. You know me, just trying to keep it simple, and say, development policies and recommendations for HHS to facilitate the use of health data for purposes other than direct patient care while respecting the privacy of individuals that are the subject of that data. That basically covers everything that we might want to say about all the uses other than direct patient care.
DR. FITZMAURICE: I agree that you could cover it there.
MR. REYNOLDS: Any other major change to what we are doing?
MS. AMATAYAKUL: So which one do you want to keep in, two or three?
DR. GREENWOOD: There is one problem with what you are saying. What you are talking about is the use of health data collected for the direct care of patients for other purposes. We certainly aren’t going to developing policy on use of health data. That could be vital statistics, it could be health interview surveys.
DR. TANG: No, the recommendations are to facilitate the use for all these other non-direct patient care purposes while respecting the privacy.
DR. GREENWOOD: Oh, so not all health data that is collected in the United States. It is of data that is collected for the care of patients.
DR. TANG: Yes.
MR. REYNOLDS: John, you have the last comment.
DR. WHITE: So should these further recommendations then not apply to claims data, should not apply to survey data, should not apply to research data that is relevant?
MR. REYNOLDS: I think we have enough input to continue to put this together. We will work on it throughout the morning and make sure we get something to everybody and give another shot at it.
So let’s take a break until 10:30. When we come back, we will immediately move to the page that we passed out yesterday which talks about testimony and who might be testifying.
MR. REYNOLDS: Let’s go through the list of testifiers, and make sure if there is anything that anybody wants to do differently. If we could put those up, that would be great.
Again, what we would like to look at is, make sure that we put our scope up there, we put the premise, we put some other things, and make sure that when you look at that, whether or not there are people that are missing, there are people that — whether or not we have the breadth of the subject as we think about it.
MS. JACKSON: For a quick check-in for the conference call, did Mark check in?
DR. OVERHAGE: Mark Overhage joined.
MR. REYNOLDS: John, I’ll take your comment.
DR. WHITE: For HITSP, why Floyd Asberg instead of John Halumpka?
MR. REYNOLDS: We are interested in making this list. If there is a recommendation —
DR. WHITE: I suggest you put John there instead of Floyd.
MR. REYNOLDS: Fine.
DR. STEINDEL: I disagree. Floyd is the chair of the population health work group at HITSP. That is the area that is looking at the quality use case. John is at a higher level. We need somebody to inform us about what is going on with the quality use case and how it is interacting with the quality groups in the United States, and Floyd is the best person to do that.
DR. OVERHAGE: Is it just the quality that we want to hear about from HITSP?
DR. STEINDEL: There are two use cases in front of HITSP that are germane to this topic. The first is in the area of biosurveillance and the second is in the area of quality. They are both under the population health work group that Floyd is co-chair of.
DR. HOUSTON: This all seems to be quality centric. Is that the intent here?
MR. REYNOLDS: No, that is why we have got the list up here.
DR. HOUSTON: I think especially Mark Rothstein is going to have some comments about what he considers to be the compelled use type of situations, and some of those areas of compelled authorization in that regard for insurance purposes and by employers. But there is a whole range of secondary uses that fall outside of what is here.
Maybe the other question is, is this going to be the first round of testifiers in the sense there is going to be multiple areas?
MR. REYNOLDS: Margaret, why don’t you go ahead?
MS. AMATAYAKUL: I was going to comment on HITSP. We have started to address the first round of testifiers by contacting them, because it is only three weeks away. So we wanted to flesh out more people. That is why we are asking you who else.
MR. REYNOLDS: Why don’t you go ahead and note the ones that have been contacted? I think that will help the discussion.
MS. AMATAYAKUL: If you could turn to the page nine in your handout from yesterday. The second page has got the schedule that looks like this. It was passed out yesterday.
DR. TANG: Is it fair to say that we are throwing up some suggestions, but that is not the final?
MR. REYNOLDS: That’s correct. Well, except that we have started to invite some for the next three weeks. We have to do that.
It is up there right now, so let’s go through. We have got Clem coming to speak to us, then we have got Laurie Reid Forquet on taxonomy.
MS. AMATAYAKUL: Let me just clarify that those that are in italics have been contacted but are not confirmed, and those that are not in italics have been confirmed. Those that are in bold we haven’t contacted yet.
Laurie we put up at the top there because we have an NCVHS roundtable thing, so we stuck her up there. But I’m not sure that is the time slot.
DR. FITZMAURICE: I would like to strongly agree both with Steve and with John. I think Floyd has great specific — and the most knowledgeable person on quality measures and data. I think John Halumpka has broader expertise in terms of overall policy direction and what is possible under HITSP, and what barriers he sees outside of HITSP that HITSP is facing.
DR. TANG: I’ll just add my voice to that. I think there John Halumpka would be an appropriate individual to put up on the list.
MR. REYNOLDS: Wait a minute. He was mentioning Floyd and you just went to John.
DR. FITZMAURICE: I went with both.
DR. STEINDEL: And to make my comment, what I was objecting to was replacing Floyd with John Halumpka. I have no problems at all with John being one of the thought leaders. I think that would be a good idea.
DR. WHITE: I agree with that, I agree with keeping Floyd and John. Floyd has very specific knowledge of the EHR vendors, and efforts to pull out data for quality measures from his EHR, and has elaborated that work through the collaborative that they have going.
If you are looking for somebody who gets the current state of efforts out there with relation to the quality enterprise, I might suggest somebody from CMS or JHCO instead, if that is what you are more broadly looking for. Floyd does bring that very specific knowledge that would be very useful and good to have there, but if you are looking for somebody a little bit more broad, to look at all types of data that are out there, Floyd doesn’t do big claims databases, stuff like that. That’s all.
DR. FITZMAURICE: Do you have some names that you might suggest, John?
MS. AMATAYAKUL: I just want to make two comments. I think you really have to look at the testimony list simultaneously with this. Like for example, we already have somebody from Joint Commission on there, so please do look at both lists.
The other thing is, the folks from Booz Allen had recommended Glen Marshall for HITSP. I didn’t know that individual, but they suggested Glen Marshall. I don’t know who he is.
DR. GREENWOOD: If we are talking about John from the point of view of right up there with the thought leaders, what about John Lumpkin? He chairs the AHIC population committee. I think John Lumpkin would be a good addition to this.
MR. REYNOLDS: So then we are possibly talking about the first day from say 11:30 to 12:45. I agree.
DR. HOUSTON: This may turn into a question for Paul. This shows my naivete. NCHS, how do they tie into this, or do they need to tie into this?
DR. GREENWOOD: What?
DR. HOUSTON: NCHS, how do they tie into this?
DR. GREENWOOD: I can bring that up later. If you are building an overall framework, you need somebody from NCHS to talk about that.
MR. REYNOLDS: On those ones that aren’t on the first few days, we need to note that. We need to make sure we add that category to our list of testifiers.
DR. FITZMAURICE: I would say Glen Marshall is outstanding in the area of security, but you also have Laurie Forquet on there, and she is outstanding in the area of security. So I would look at the two and see which one gives you more, rather than have both of them testify. Just a suggestion.
Secondly, I would ask John if he would suggest from JHCO or from CMS who have knowledge of the quality data and measures that are being used.
DR. TANG: Do we have any framework for the overall structure of your hearings and sets of topics you want to cover?
MR. REYNOLDS: Our hearings, you mean?
DR. TANG: Yes, our hearings. As Mike was just saying, it is less helpful to draw up names than to throw up topics and coverage areas. Then we can select individuals and perhaps the right individuals for each of those topics. To even organize topics, I would like a framework of the overall hearing schedule. I am just having trouble dealing with how do we even vet names.
MR. REYNOLDS: One thing is, if you take a look at the bolded red up there, for the first few hearings we could try to do that. This is the first hearing, where we are talking about context setting, background and seminal work. Day two is continue background perspectives, suppliers of data and uses of data, and the third was perspectives, the same kind of thing.
So we are trying on the first day to make sure we get that kind of a look. Obviously we have got other hearings set up. The reason we have this planning session is, we need to get the first one going, but you need to help us decide how the rest of it gets structured.
DR. TANG: I don’t understand. Let’s say day two, the suppliers of data and users —
MS. AMATAYAKUL: I am just trying finding out where it is coming from, Paul. We have this axis of interest, so we had organizations that capture and use health data, and organizations directing QI activities. So we took those areas and identified people or organizations that may testify in relation to those, then those same ones we added to this structure.
DR. TANG: So for day two, the perspectives of suppliers of data and users of data, HITSP is not a user of data. HITSP is a standards panel to reconcile. So my head is hurting a little bit, because I cannot figure —
MS. AMATAYAKUL: Unfortunately they weren’t available day one. They were only available day two.
DR. TANG: That still doesn’t help me organize how to look at it.
MR. REYNOLDS: Well, Paul, rather than be upset, help us do it. I am saying, that is the purpose of this session between now and 12, is to figure out what is the best way to go about it. Put a straw person up, let’s chat.
DR. WHITE: I would just briefly say that Floyd as a supplier of data, as an HR vendor who really knows how to study it, he is perfect. He is the perfect person to testify to that end. Just strike HITSP in front of his name.
DR. COHN: This is just process stuff. John White is going to be leaving almost any minute, so we might want to take a second before he leaves. I don’t want you to leave and then say, I had five people that would make sense. If you want to just take a minute and give us any thoughts you have as you look at this particular one, or come up with a process to send us an e-mail over the weekend.
DR. WHITE: I think it is more important for you all to get the categories straight first, then I can shake down the usual folks. Thank you very much.
MR. REYNOLDS: Margaret, put up a blank page. Do we want to go through the categories?
DR. COHN: Actually I thought this was the categories.
MR. REYNOLDS: It is as it is, yes. So I would like input from the group as to whether those are the categories first. The highlighted red are the categories.
DR. CARR: I agree. Let’s put a blank page up there. This was an effective way of doing our other things. Let’s just take those things highlighted in red and work through it.
One thing that is on the title that I don’t see up there is background. The title of the first session on the first day I think is background, right? Or context setting. Context setting, background on seminal work. Is that an appropriate category?
DR. VIGILANTE: Is it too vague to be useful?
MR. REYNOLDS: No. All you are going to do is give us names under there that you think would be —
DR. GREENWOOD: And you really would include AMIA under that. It is just was that they couldn’t be there.
MS. AMATAYAKUL: They couldn’t be there that first day.
DR. CARR: Let’s just get the rest of the categories taken from the testimony things. So other ones were —
DR. GREENWOOD: Clarifying current law.
DR. CARR: — clarity of current law, taxonomy, then organizations that capture and use data, organizations directing quality improvement activities.
So what do you have there? Taxonomy is one, and the next one, organizations that capture and use data and organizations directing quality improvement activities.
MR. REYNOLDS: So that is the list. That is where we have broken it into categories to have this next hour and 15 minute discussion.
DR. OVERHAGE: What about organizations that provide this data? That is where the rubber is going to meet the road.
MR. REYNOLDS: Add that, please, Margaret, organizations that provide the data.
DR. OVERHAGE: The perspectives of the consumers and cloners of this data, or consumers in the sense of real consumers and the perspectives they are going to have about their data being used for any of these purposes; somebody to represent that group.
MR. REYNOLDS: We put down organizations that provide data, and I am still not — how does that differ from the ones that capture and use — help me with your thought again.
DR. OVERHAGE: For example, I could be misunderstanding capture and use, but I was thinking about, a hospital can provide data for HEDIS reporting, for example. So they would be a provider. I thought, when you said capture and use, I was thinking of organizations that aggregate and report the data.
MR. REYNOLDS: Yes, you’re right.
DR. SCANLON: You do have subheadings on what you passed out under what you capture and use, and they included providers, health plans and other users. So things that capture, use and provide.
DR. STEINDEL: I am picking up a little bit on what Mark just said. I would like to see each one of those as separate bullets, organizations that capture data, organizations that use data and organizations that provide data. I think there are three different things we will hear in those areas. We will want to look for testifiers in each one. These are not planning sessions or anything; these are just thought processes for us to group names. If we look at it that way, we will be more effective in grouping names.
DR. COHN: I just wanted to know the difference between capture and provide. There probably is one.
DR. STEINDEL: Like for instance, yesterday John Lunsk was talking about the service organizations that are attached to the NHIN. There might be a service organization that acts as a data repository, that its sole purpose is just capturing data and providing it for other people to use.
This gets to what Mike was talking about earlier, about how a lot of the HIEs are planning to drive themselves using this as a money making venture. The way they are thinking about using this is providing data to others.
DR. CARR: I just wanted to share, Larry Green had sent an e-mail recommending two groups. One group is called Practice Based Research Networks. There are 100 of these nationwide. They are composed of real front-line practices whose main business is taking care of people, but they unite voluntarily into networks for purposes of surveillance, discovery and quality improvement, networks from six to eight to more than a thousand. Does that fit here? And he had names.
Then the second group who have physician certifying boards leading the implementation of maintenance of certification part four of this new process on which being a board certified physician now depends. It is focused on measuring and improving one’s own practice. This train is out of the station, and the process is spreading through all the member boards of the American Board of Medical Specialties.
DR. STEINDEL: And I would look at those as people that use data.
MR. REYNOLDS: So put use beside those last two.
DR. FITZMAURICE: I find it hard to think about these different topics without talking about specific uses. Some of the purposes could be for quality measurement, for locating clinical trial subjects, for deciding where to build a for-profit facility. You wouldn’t want to put an AIDS clinic in a place where there are no AIDS patients in the state, for advertising for drug use, advertising to people who would be potential candidates for using this drug. There are different considerations depending upon the use.
So if I am looking at say the first category of seminal work and I am getting up to testify, am I testifying on, yes, let’s use it for research, research is good? Or am I being broader, some uses are good, some uses are not good under certain situations? I don’t know how to frame all of this. I don’t know how to direct what I would want to say about it without saying here are some specific uses that I think are beneficial to the country.
So it is secondary uses of health data, but for what purposes? For research? That is motherhood and apple pie. For advertising for drug use? It may be good if it will make my quality of life better. If not, I’m just going to get a lot of useless mail. Is there something we can do to focus, to have some purpose for this?
MS. AMATAYAKUL: We had these axes of interest, and had categorized in various ways that you are suggesting. So organizations that capture and use data, we had providers, suppliers of data, health plans, other users, promotional statewide public health. So there may be some things that are missing from there, but that is essentially what we had done already.
DR. FITZMAURICE: I think that is good.
MS. AMATAYAKUL: I am just saying that we are setting up a different taxonomy here for the testimony.
DR. FITZMAURICE: That is getting across. We want to hear from all of you about uses for the purposes that ONC thinks they might sell the data for.
DR. OVERHAGE: Mark raises his hand.
MR. REYNOLDS: Mark, I’ve got you on the list.
DR. HOUSTON: I’ve got to leave in a few minutes, so I am going to get a little bit out of order, I apologize. Maybe it is still relevant.
Thinking of other types of uses that maybe are outside of what we are currently discussing, I keep thinking about the Department of Homeland Security. I know that might be a little controversial, but I think that there is going to be law enforcement and homeland security and FBI and other types of biosurveillance. I guess biosurveillance isn’t the right word, but surveillance for types of diseases, whether it be man induced or whether they be naturally occurring.
I don’t see those groups in the current list. I think there are valid secondary uses. Some of them may be a little bit more controversial than others, but is there a value in trying to get those groups to the table also at some point. The Department of Homeland Security is one that comes to mind, but I know there are a lot of others. I know our local health departments is always asking for data, and do we need somebody to represent health departments or states.
DR. GREENWOOD: We have that.
DR. HOUSTON: I didn’t see it. Maybe I just missed it.
DR. GREENWOOD: Right above organizations, we’ve got public health departments.
DR. HOUSTON: Okay, thank you.
DR. DEERING: A couple of things, first, to add to the list but then to make an observation about the list.
This is a question. We have done a lot of — we have had many, many hearings on privacy, and we have heard from consumer representatives. Do we need to include them here again in this context? It does seem to me if we do that, then there are certain sub-categories of consumer representatives. We don’t just want the privacy advocates on behalf of consumers; we want people who might come from the groups. I know that we have found them for the purposes, so I just wonder whether we want to go back and get them here again.
But then my observation about the list is to make an analogy of how the previous ad hoc NHIN work evolved. What I am hearing us do now is the equivalent of, we are building back to those 1100 function requirements that they we decided our job was to strip away. Yesterday there seemed to be some enthusiasm for looking for simpler contexts and frameworks and cutting to — as we did with NHIN, to see as almost minimum but essential.
So just as a touchstone, is this approach helping us go there, or is it confounding us?
MR. REYNOLDS: I think this is an information gathering point right now. I think the reason we put the axis of interest was to move to that somewhat, but making sure whether or not the categories are represented appropriately or if we missed a category is what I think we are trying to create here today.
DR. TANG: Thank you, Mary Jo, because I think that is what I want to try to address. It seems like it is getting pretty complex. I’ll just offer a potential way of structuring our input. It is similar to yours, but it is the motivation and background for the work.
One of the nice things about having Clem up there is, he wrote this paper on uses of humongous databases. Just as a setting for why would we bother to do all this hard work, is because you can get a lot of good out of it. That is the benefit side. Health statistics in NCHS might be another example of where we can do linked data.
Another category is suppliers and consumers of health data. That is where Steve’s provide, capture and use groups come into play. Then there is an investigation on the method of data capture. One way is through EHRs. Another way is through surveys like NCHS uses. Another way is to steal it from somebody else and repurpose it. Part of that would be like the homeland security.
I just put Google up. There are ways of activities of daily living like surfing, where data becomes captive.
Then there is a topic of making this stuff useful. That is where HITSP comes in. You have to have it in some standard combinable way. And you have to have analysis techniques to make use of all the stuff in these humongous databases.
Finally but most importantly, we need to explore methods of protecting privacy. HIPAA is one tool. Federal Privacy Act. There are many tools, and some of those are technical tools. But that is a way of getting my mind around these things.
MR. REYNOLDS: Could I add methods of protecting privacy and insuring understanding?
DR. TANG: That might be another category, because that is really education and what it takes to have the trust buy-in and active participation of these folks who provide this data.
MR. REYNOLDS: Does that complete your list?
DR. TANG: It does.
MR. REYNOLDS: Then it is a different way than we had to put it together. I would like the committee to make comments. It is obviously a flow, it is obviously a structure, it is obviously a way to approach it. I am totally comfortable if it is the wish of the committee to look at it that way, or adjust these or do whatever, then that is fine.
DR. COHN: I am less concerned about global framework of testifiers and making sure we have testifiers that cover all of the needs that we need, how we clump them together. I am wondering in this particular structure where HIEs and NHIN and all of this fit. There would seem to be to be key questions in all of this.
DR. TANG: One of the reasons of putting up a structure that flows is because it will help us structure our thinking about it, rather than to have more random input. I think it helps us formulate the recommendations we are targeted towards.
I deliberately did not put HEI up there, because I was going off the premise that we are dealing with the uses other than direct patient care of data and how should we list those things and make it useful while protecting the privacy of individuals.
DR. HOUSTON: Can I just have a clarification? You are really saying that the transport, NHIN is inconsequential?
DR. TANG: It is not inconsequential in the sense that it is the quantum enabler to all of this, but we can’t allow an alternative path that is totally ungoverned by what we say or recommend.
DR. HOUSTON: So you are trying to be all encompassing, rather than the HIPAA solution, which is, unless it is electronic billing of information it is excluded.
DR. TANG: That is exactly right, so trying to deal with the uses, not the methods.
DR. OVERHAGE: Two things, if I may. The first is, we have listed AMIA as somebody to think about, but there are at least two other efforts that are trying to synthesize information about this topic, including Connecting for Health and E-Health’s Blueprint effort. I wonder if we would want to consider asking them to share what they have learned so far, even though both of them are fairly in the middle of the process.
The other, I am a little concerned. It feels like we are talking about the mechanics a lot and not perhaps talking about some of the policy issues and so on that are going to surround this. What I mean by that is, for example, we have got people who represents what happens today and so on, but when you start talking about re-purposing data, somebody says steal it from somebody, those are the kind of things that I am not sure how we tackle those. I think it is really important for us to address in this testimony.
It is beyond law I think, because I think a lot of current law doesn’t cover this area. I think we have to think about this policy question and what are the current, not just policies of individual organizations, but at a more macro level.
MR. REYNOLDS: Mark, looking at the list, Margaret had just adjusted it for one of the bullets. If I hear you correctly, we are really talking for each of these categories what are the types of policies that may need to be there or ones that are there that could be thought of differently to allow this to occur.
So are you talking about policies through all the categories, not just policy in one of the categories?
DR. OVERHAGE: That is certainly true. What I am a little concerned if we got covered is, for example, somebody aggregates the data for a purpose, and then somebody approaches them and says, this would be just great to answer this other question. Or would we have a dialogue about that kind of use?
MR. REYNOLDS: What we are doing right now is adding — we have three categories now. One is motivation and background. The next is policies for suppliers and consumers, methods of data capture, make data useful and methods of protecting privacy. Those are sub-bullets. Then our third category is assuring understanding, education, trust and buy-in.
DR. OVERHAGE: Okay.
MR. REYNOLDS: Does that capture what you are thinking?
DR. OVERHAGE: It wasn’t categories so much as whether we are bringing in people to talk about that topic. I guess we just insure that through our questioning.
MR. REYNOLDS: But what we are saying is, that second bullet is policy, so everybody that is other than motivation and background and even understanding people are going to be also directed at what are the policies that are going to need to be in place to make this happen. That is what we have restructured it to look like.
DR. OVERHAGE: There are the policies that the testifiers are going to talk about from their own organizational perspectives. I think we need to keep in mind that there are policies that cross these organizations that we are going to have to think through as well.
MR. REYNOLDS: And again, I think that would be a definite part of our questioning and a part of our asking them questions to answer before they get here.
DR. SCANLON: On this, it seems to me that each one of these groups, the buyers and consumers, talking about data capture, et cetera, they are going to need to talk about how they approach what they do. Then there is the issue of policies that benefit them, but they are going to be thinking about it from their interest. There are going to be things that cut across.
But then there is going to be an obligation on our part to cut across as well, which is with respect to what are the overall objectives we have here, and how can they be accomplished. There is going to be some sacrifice that may be involved among all of these groups, in terms of the policy and here is what they would really like to do. But it is not in the bigger common interest, because that is what our job is, is to identify the common interest and what is essential to it.
DR. VIGILANTE: I find this organization useful. I can imagine almost any testifier talking about each one of these things, almost like we were talking about yesterday, what are the things that we want each one to talk about from their unique perspective. I don’t know that it drives us to thinking about which people we want to testify any better than the previous taxonomy, unless I am missing something.
It just seems to me that almost any testifier would want to bring these points of view to the table about what are your challenges or your objectives regarding data capture and analysis and so forth.
MR. REYNOLDS: But I think what this chart has done as I am sitting here watching it —
DR. VIGILANTE: It is a useful thing.
MR. REYNOLDS: No, I think that it has probably changed the way that we would approach people and have them come in prepared to deal. As I was sitting here looking through the list while the conversation was going on, if every person tells their story and never tells our story or the story we have been charged to create, then we will have a whole lot of information.
DR. VIGILANTE: I agree.
MR. REYNOLDS: So I am in total agreement with you on that. I think if we can agree that this is the kind of thing, then I think we still need to go back and — remember, in the end we are going to have to invite people.
DR. VIGILANTE: So this is more a guideline for the conversation.
MR. REYNOLDS: It is turning into it.
DR. TANG: I would like to respond to that to say I would pick people for them addressing a component, and not let them speak on the whole thing, because we will not get the depth that we need and watch our thinking evolve if we let people talk all over the place at each hearing. That would be my approach.
In the supply, you can invite consumers on their submission of data through a PHR, for example. The people who capture like EHR vendors could be represented by Floyd and some of the other EHR vendors, EHR VA as an example.
The surveys. NCHS conducts a lot of its capture of information through surveys.
DR. VIGILANTE: But is that relevant to our discussion? That data was not captured initially for the care of an individual.
DR. TANG: You reuse it.
DR. VIGILANTE: Yes, but isn’t our mission to define the uses of data that were originally captured in the care of a patient?
DR. GREENWOOD: Yes, and right now NCHS in their provider surveys use the data that was captured, and abstract it.
DR. TANG: So I would say that we focus peoples’ attention on specific categories of that, rather than let them talk about everything.
DR. VIGILANTE: We may not prospectively know where their interests or expertise lies until they come.
DR. STEINDEL: Steve, you were on the list and then Mary Jo, and then I would like to move back to the list of testifiers, because in the end we are going to have to invite people.
DR. STEINDEL: When Paul was going through his original list, I thought this was a very good framing idea, and I think we have improved it with the discussion. The only thing I think we are missing from this list, we have to add something that meets the needs of what ONC asked.
At one point in this, we do have to have something that addresses quality. We are going to have a lot of high level stuff, a lot of good ideas, the basis of a very good report, but eventually we need to meet the need of our customer, and I think we need a bullet in there somewhere that reminds us that some of this has to focus on the quality area.
DR. TANG: We can do that by picking the names and the organizations.
DR. STEINDEL: If I was a customer and I was looking at this list and I was monitoring it, I think the first question I would ask is, look, I am paying for this, where am I, I would like to spell it out.
MR. REYNOLDS: I think that is a good point. Let’s move back to the testifier list, please.
DR. DEERING: May I just make one observation? Given that we are clearly still in the information building stage, and that we have the one schematic, but that may not be the framework that the report finally comes out to, —
MR. REYNOLDS: The framework is not for the report. The framework is for the testifiers to understand what we are asking them.
DR. DEERING: I am just again making an analogy to the way this worked beforehand. At one point we came up with something else that did drive the report, then we started orienting peoples’ attention to that.
We are not going to get there by July, so all I’m saying is, my comfort level about this being perhaps a little bit disorganized in July is suddenly a little bit higher, because we can’t yet quite see perhaps between now and then. We need to go through July, organize as best as we can, until we can get to the next phase.
MR. REYNOLDS: Our term is, we have to be courageous through July and then we have got to get real serious.
DR. COHN: I am not so worried about being courageous. I am worried about us making sure that we get our background and breadth and context before we start driving to conclusions and ultimate framework. I think if we start off — we may need tentative frameworks to help us investigate, but that is different than the final framework upon which we came.
I think that is another thing we saw with NHIN. We went to a number of different areas, and finally, based on our information and learnings, we came upon something that really worked.
MR. REYNOLDS: And a number of us around the room went through the whole journal. We haven’t been through that journey. We are trying to mirror it, but we have got to have a little more information and a little more framing before we pick it so we are comfortable, and we look forward to everybody’s help in that.
DR. DEERING: But could I just ask one question? I think my question is covered under repurposing, but I have heard people talk specifically about aggregation. In other words, your original data was not captured as a unique patient already. Number one, you may have already acquired it on a de=identified basis.
So just to make sure in the flow of things we don’t miss the whole purpose, which is aggregating data. It is not self evident.
MR. REYNOLDS: Let’s go back to the list, please. What is the best way to approach this list? We have a list of people that we feel would fit into these categories. We have a list of people that we felt would help us with the background, would help us with what they are doing.
DR. COHN: I didn’t want to lose Mark Overhage’s comment in terms of starting at the higher level and then drilling down and all of this. This issue about people that have been thoughtful at the broad level, trying to help us drill down, you mentioned Clem, you mentioned AMIA. But I think Mark is also coming up with a couple of other groups that are trying to do broad thinking in this area, and we should certain try to make sure to try to get them early in the conversation.
MR. REYNOLDS: So we had Clem, we had AMIA, and what were the other one or two you mentioned?
DR. OVERHAGE: The two other groups I am aware of that are taking a broad look at this are Connecting for Health, Carol Diamond, and the E-Health initiative through their Blueprint effort. They have got a working group that is focused on secondary use, though they don’t like that term.
MR. REYNOLDS: So hearing those, does anybody have any issues?
DR. DEERING: I just wanted to add one, but I’ll wait.
MR. REYNOLDS: No, add it, please.
DR. DEERING: I did circulate this to everybody last night. You may not have read your e-mail, and I always hesitate to represent my own office, but we have been working for three years on this in the oncology space, and I think you will see a very thoughtful piece of testimony in your inboxes that is being delivered today. It is exactly at the strategic level that you are looking for. So if you do want to consider it, I think it would go up there in these broad cross-cutting groups.
DR. VIGILANTE: These speakers may touch on this in some way, but I am thinking back to the issue of Health Affairs a couple of issues ago, the supplement on the rapid learning health care system, which telescopes the research piece and the development of an evidence base and then transmission into quality.
It is the interface between research and quality. It is a little different paradigm than we usually think of quality. I was wondering if we should look at that issue and see who are the folks we might invite. Among the researchers, people like David Eddy, the Archimedes model. Different types of perspectives might be interesting there.
DR. STEINDEL: I thought we had mentioned John Lumpkin.
DR. DEERING: This is probably what Kevin was getting at. As I recall, some of the articles there were from the large integrated systems, so they are microcosms of a lot of this. Simon didn’t want to push his organization, but either Kaiser or Group Health Cooperative, a lot of those do this soup to nuts, including probably getting some quasi-commercial, maybe not monetary value propositions out of it.
DR. COHN: To disclose, Archimedes was developed by Kaiser Permanente. It is owned by a separate entity at this point.
MR. REYNOLDS: So playing off of the current comments and going back originally to our three bullets, the first thing we wanted as a look at the general. So taking that list, it would seem that the first part of our first hearing, whatever length of time it would take, trying to get that context quickly is what we need to drive to.
So as we look at the first sets of hearings, trying to get as many of these people as we could within the first day of the three days would seem to set the context. Then as we select the others that we have on this list, and I do want you to look through this list and make sure there is somebody you think is missing, then in whatever order we select them, if we have this overall context of people who are framing this thing, then however we structure them after that, whether we use Paul’s idea of how we thought it through.
I think that is the same order we have up there on that second bullet. Margaret, if you go back to those three bullets one more time for me. If we started in that order and did it in that kind of a sequence, after we have the general motivation and background, which is the people we talked about, the thought leaders, if we could start inviting people in those categories, it allows us to start taking this list and getting people in.
DR. COHN: Even though we have a bullet here that remains NCVHS roundtable, I do want to disclose that we are not going to be having an NCVHS roundtable, but we will be using the expertise and the knowledge of all the people around the room extensively.
DR. TANG: Just to look at that, the context and background, Clem McDonald, John Lumpkin, maybe Carol Diamond and someone from Kaiser or the VA or Indian Health Service. That brings us down to the large practice and what can you do with all that data. I think all those organizations that I listed have great things that they could share that would motivate this whole work. So that is an example of a panel that could help us kick off.
MR. REYNOLDS: After you highlight those and make sure you get those from Paul, let’s go back to the chart again, please, the three bullets. I am trying to get an order together of how we get going, because when we walk out of here today, with Booz helping us and everything else, we have got to get these things set up, because we have got a pretty tight time frame.
If you look at the list, we have got other people on this list, we have got those categories, we have got the flow that Paul added. Is that the way you want to approach these things?
On the other slide that we had, we organized it by the policies. We got everything in there that we had talked about, but now we have got to start putting names under each of those suppliers and consumers and so on to make sure that we have these four hearings that we are looking for and we get the information that we need. So I really need some kind of agreement from the committee that that is an approach.
DR. COHN: I guess it is a question of how you define background. We talked about thought leader background, some legislative and regulatory background on HIPAA, for example, I think would be a very useful —
DR. GREENWOOD: That is on there.
DR. COHN: It is listed here. You can organize it however you want, but I do think a lot of this reinforces a lot of what we have here.
MR. REYNOLDS: If the first hearing focuses on that first category, gets us ingrained in the subject, then after that we started down the second bullet.
DR. TANG: I think we can already start down the second bullet. The panel I described would really set the context up. Then proposals to delve down into some of these uses and open our minds.
Privacy, but what is the scope of other uses that are out there. That will start driving us. Simon is proposing that we look at some of the techniques that are out there, and maybe HIPAA is one of the strongest. So we see what is the good, what is the scope of stuff, the spectrum of things that are being done, what are our tools. We will figure out very quickly that we need other ways of —
MR. REYNOLDS: Margaret, put the other side on. I totally agree with your comment, but what we are trying to get to now is, we listed the people that we felt should be in the motivation and background and so on. Now we are saying we should start down. The words are good; do you have people?
DR. VIGILANTE: In that first category where you identified some priority names, we are saying which names align in that first category. In your earlier suggestion, not everyone talked to everything.
DR. TANG: Just the background motivation. Now the suggestion I was making was, tackle the suppliers and consumers, and good names.
MR. REYNOLDS: But there is a gap, I see. You picked four. Right or wrong, you picked four. I heard six or eight others that were in that category that we had listed. Then when we look at our axis of interest, we are diving down into other people. I want to make sure.
If you look at that list under context and background, let’s go to the EHI Blueprint.
DR. TANG: I don’t think we need to hear from everybody we can think of.
DR. COHN: I think early on we need to somehow get information. Whether it is testimony or not, that may be the issue, but I don’t think we know enough at this point to know what the right framework is.
DR. VIGILANTE: Just because we don’t invite them to the first meeting doesn’t mean we can’t invite them later, even if it is outside this framework.
MR. REYNOLDS: No, I’m comfortable with that, but I want to make sure when we walk out of here, the next time we are together is in July, which means we have to have all the people invited for August and September and October, that is what we are saying.
So you are going to start calling people, and I just want to understand clearly what the wishes of this group are. That is what this planning is about. Not just say, yes, I’m okay with the categories, but we gave you a list of people. You just did a good job of checking off certain ones. Let’s go through the same thing. Whether we take that whole list under context and background, if that whole list is our first one or two days or three days, —
DR. TANG: I don’t think we need to spend three days on motivation and background. That is what I am saying. I really don’t.
MR. REYNOLDS: I’m not saying we do, either. I’m just making sure we — so put the list of testifiers back up.
DR. DEERING: I heard us jumping from a single panel of thought leaders directly into — and I think what I am hearing is that maybe almost the whole first day, or at least half of the first day or something, but more than one panel. If the first panel is the very broad high level cross cutting thinkers, then another bit of background could be what is the baseline legal framework or whatever. Another set of the people who are up there could be some instantions of those. There are so many cross cutting. It is still a pretty big picture, but they are a little bit more instantiated as opposed to just policy.
I am just trying to throw out types of panels where you are getting different inputs.
MR. REYNOLDS: I want to go to dumb process for a second. We have got a lot of people listed under context. There are other categories. Whoever we pick out in context, if we still want to hear from them, they have got to go and do another category, because as we start down through, we have got to understand who we want to see.
DR. TANG: This was some way of organizing a bunch of names. I don’t think it means that one, those are the only thought leaders and that two, we must use all the names under that heading only for that panel. So I am not seeing the limitation of picking four to do one panel.
DR. VIGILANTE: I’m okay with the ones we are prioritizing, if that is the question. I’m fine with that. I am fine with adding another one or two.
MR. REYNOLDS: I actually don’t care about that.
DR. VIGILANTE: But I’m saying, I’m trying to help you —
MR. REYNOLDS: I care about how we structure it so we can go.
DR. COHN: I think what I am hearing is, we are probably going to spend much of the day, maybe divide it up over a couple of days because of peoples’ availability, dealing with the high level stuff. I am hearing that we like that initial list. I think ones and twos are based more on what you think about in terms of what groupings they are going to be in as opposed to yes or no.
I think we have also heard that we need something about clarity of current law, which I think we are all pretty clear that we need. So let’s start calling people.
DR. VIGILANTE: Just because they are big thinkers doesn’t mean we don’t want to drive them toward specificity. I’m just concerned that if we just want background and context that we get a lot of pablum at 50,000 feet of stuff we already know. I think driving them towards some specifics around — whether it is the ones you listed or the ones you talked about yesterday, Justine, it would be an important direction to go.
DR. DEERING: Can I give an example of how you might approach someone like those I call the instantiators, the big ones like maybe the Kaiser, maybe the CAB, maybe the IHS or something. If you ask them to say, we want you to describe exactly how the data moves through your system, at each point we want you to talk about what were the protections that were already in place, what were the risks. The original list that we have already wiped off that Margaret came up with, not just risk and benefit, all that sort of stuff. That way, it is very real.
Then what are the gaps, what would you have needed to do this better, faster or stronger.
DR. CARR: My suggestion was going to be, let’s go line by line through this list and figure out are these people the people we agree on. I didn’t want to pre-empt Paul.
DR. TANG: No, I think that is exactly right. So I am going with Kevin.
MR. REYNOLDS: That is where I am going, thank you.
DR. TANG: Harry, there are a couple of people that have agreed with your first panel draft, working on panel number two. Panel two, perhaps two, three and four, are different kinds of uses.
DR. STEINDEL: Wait a minute. I’m not set on panel one. I have been tried to get into this conversation for ten minutes.
MR. REYNOLDS: Excuse me for not noticing you.
DR. STEINDEL: We had as panel one Kaiser, Geisinger, Group Health. It is up there in bold. Who can represent all of them?
DR. CARR: One of them. I am going to go through word by word, name by name. We will start with what we have for the background, Clem McDonald we agreed, Don Detmer, Charlie Saffron from AMIA.
DR. TANG: I was suggesting Clem McDonald, John Lumpkin, Carol Diamond and one of the representatives from Kaiser, VA or Indian Health Service as the background motivation. Kevin may or may not withdraw his support for that.
Then as a concrete proposal for panel number two, three and four is to start picking on uses and users of data. As an example, Mary Jo offered NCI. That is an NAH kind of research.
DR. CARR: Are we talking about day one, on the morning of? In the morning we will hear from Clem, Connecting for Health, John Lumpkin and a representative from one of those areas?
MR. REYNOLDS: Steve, since I have been ignoring you, I’ll let you back in again quickly, and then Marjorie.
DR. STEINDEL: If we are going to put any type of aggregated data up there, CAB, they may have given a lot of thought about it, but since this is quality, I think it should be a quality group. And there are some. So I would like to see CAB replaced with somebody like AQA or whoever. I don’t know the groups that well. We have three people in the room right now who know the groups better, who are actually doing this.
DR. GREENWOOD: I thought we were going to have maybe like two panels of context thought leaders, because I thought David Eddy was a really good suggestion. I thought you wanted John Halumpka. We have got Don Detmer definitely, and Charlie, although maybe they can only come the second day.
MS. AMATAYAKUL: Charlie can come the second day.
DR. GREENWOOD: Charlie can come the second day. But I don’t think it is overkill to have two panels, particularly if we do what Kevin says. You want to give them the premises, the scope, et cetera, that you have agreed to, and you want them to make the comments in the context of that. So I think that will drive them down from completely up on the stratosphere down to the more — then I think you want a panel on the whole current law thing before you get to these users and uses.
So I guess I was reacting to Paul immediately wanting in the second panel to go to the uses.
MR. REYNOLDS: One other person I may recommend on the clarity of the law is, it might not hurt to hear from Bill Braithewaite, since he was involved in HIPAA. I would like to move him in there, because the spirit of how this whole thing was set up, it might be good to have him kick that off. Then oh, by the way, here is what has come out of it.
So we have got the order. We are going to do the context and background. We are going to do the clarity, the current law, and then our responsibility is to go through these other categories. So we have got the content and background. Then we are going to start to hear from the clarity of the current law, and then we will go to our second bullet over there and start inviting groups. Remember our second bullet on starting inviting people to gather it and capture it.
DR. CARR: May I ask a question? As we look at the content and background, we have named the people who have a number one in front of them. What about number two and three?
DR. GREENWOOD: That was my question.
MR. REYNOLDS: That is the second panel.
DR. CARR: So when we say second panel, that means second panel on the first day?
MR. REYNOLDS: Or second morning or whatever it takes, yes. Margaret, go back to our bullets one more time just quickly. Now we have done the motivation and we have agreed that the first thing we are going to touch after the motivation and background is the clarity of current law. Then we would start inviting people in those other categories for the subsequent hearings accordingly.
DR. TANG: So respectful of your time, instead of doing essentially the same thing as wordsmithing, should we just give you names under each of thes categories?
MR. REYNOLDS: That would be absolutely wonderful. That is why I wanted to go back to those bullets. So let’s go back to those bullets, and under each one of those, since we just did the same thing under motivation and clarity of law, let’s go to those bullets. You’ve got a list here to pick from. Talk about who you are talking about, especially the top ones that you are talking about. Then as we turn people loose to start doing this, we have had your input.
DR. CARR: And if there are people on the list that you think are not appropriate, say so.
DR. TANG: Is it better done in private?
MR. REYNOLDS: I think it is better to go ahead and list the ones that we think are the top ones for each of those.
DR. TANG: So in other words, not everybody on the list should be invited. I don’t think it is like you get the list today and start calling.
DR. COHN: I’m sorry, Paul, say it again?
DR. TANG: When we suggest names, it is not an automatic.
MR. REYNOLDS: No, that’s correct, just suggesting. Suppliers and consumers.
DR. TANG: One of the suppliers is the consumer, the individual, the people, folks who have a vested interest in their data being used for direct care and other purposes.
DR. CARR: Who?
DR. TANG: Examples might include the traditional consumer types that are invited to the same meetings, but in addition, folks who represent disease clusters like the people with diabetes and other folks with chronic diseases.
DR. DEERING: You can invite the heads of those advocacy groups or representatives, and we can certainly supply some in the oncology area.
DR. CARR: So it might be the American Diabetes Association? Is that what you are thinking?
DR. TANG: I guess.
MR. REYNOLDS: Mary Jo thinks she has some people to supply for that.
DR. VIGILANTE: How about AARP or something like that?
MR. REYNOLDS: Any others, other than those categories under suppliers and consumers?
DR. VIGILANTE: Can I ask a question. It is a safety issue. Is postmarketing drug surveillance relevant here, because they are generally using data that is obtained from clinical care, but it is a quality and safety issue.
MR. REYNOLDS: Who again?
DR. VIGILANTE: Postmarketing drug surveillance, so it would be both pharma community and FDA, I would think.
MR. REYNOLDS: Anybody else?
DR. STEINDEL: I think the list that you have under other uses is still valid. The commercial, where you have some firms listed, statewide health planning, Minnesota community measures, public health departments. Those are still valid under suppliers and consumers, when you think about who in those areas to invite.
DR. SCANLON: I think payors, health plans as well as CMS. CMS is both engaged in quality measurement but also the issue of using evidence for coverage decisions. I think those are two different applications, and it is important to have them both represented.
DR. TANG: Then under the capture, clearly the EHR vendors are people that capture, but also folks like Google that capture your search history are people who capture information
about you. In fact, people like the EHR vendors not only capture, but they are one of the other uses kinds of folks. The same vendors who are capturing it for the provider to use in direct care, some vendors capture it to resell.
DR. DEERING: You could make the invitation today if you wanted to. You have a representative here. I sent around the example from oncology where the vendor captures, aggregates, reuses for quality reporting, both to the point of care and for external reporting. I was thinking that that might be under making data useful.
MR. REYNOLDS: Let’s say with methods of data capture. So we have got Google, we have got EHR vendors. Who else?
DR. COHN: The data banks, where are they getting this.
DR. TANG: You mean these proposed EHR data banks?
DR. COHN: I don’t mean proposed. I mean data banks.
DR. TANG: They capture.
DR. COHN: So is that under capture or is that under data use?
DR. TANG: That is capture.
DR. COHN: I think there are some people who can think of names there.
DR. VIGILANTE: I’ve got to leave in a minute, but as the national surgical quality improvement program that VA developed, it has been adopted by the American College of Surgeons as the gold standard for risk adjusted outcomes. I just wonder, as they move into the privacy sector, are they facing issues that the VA didn’t have to deal with.
Hearing from them or somebody who is doing it at the ground level would be perhaps worthwhile.
MR. REYNOLDS: Who are they again?
DR. VIGILANTE: Not the VA. I would go to the private sector now and look a the American College of Surgeons. The American College of Surgeons are the folks that are implementing it, or hospitals have tried to — it is contracted with the ACS to implement it in their private sector hospital. It might be an interesting thing to hear about.
DR. TANG: So this is a very long list, and that is what I think will consume the second and third days of our hearing. That would start one’s thinking. The general form of what Kevin was mentioning is registries.
DR. DEERING: It just occurs to me that by giving the title that we did, we left out one of the primary drivers of the ONC request, which is personal health records.
MR. REYNOLDS: No, personal health records are excluded from this discussion.
DR. DEERING: They are or they’re not?
MS. AMATAYAKUL: They are excluded.
MR. REYNOLDS: Yes.
DR. DEERING: We are not going to look at the use of personal health records? I thought that was one of the things that drove their interest. I’m just putting that on the table.
DR. COHN: We do what we need to do to come up with the answer, whether or not that is a high priority, because I don’t think that they feel the quality data is going to be coming very soon from personal health records.
DR. DEERING: I understand.
DR. COHN: So I think that may or may not be, but once again it is something that we can certainly ask.
DR. DEERING: But remembering also what we said yesterday. You don’t want to fix a regulation purely for one reason. We were deeply worried about PHI’s use of data for secondary purposes. So if this is the first crack we get on giving advice, I just want to put it on the table. It looks like there is no place for them, and I wanted to be clear whether it was or wasn’t in.
DR. TANG: All the things we have been talking about should be under bullet one, supplier and consumer. All those folks are — and by the way, it is provide, capture and use, which is what Steve said. And impact is one of those users of data.
MR. REYNOLDS: Steve. I want to get out of that category and get into these other categories.
DR. STEINDEL: I think we need to add the public health biosurveillance systems.
MR. REYNOLDS: Now, methods of data capture. We have got EHR vendors, we have got surveyors, we have got repurposers, we have got Google. Google fits in both categories, doesn’t it?
DR. COHN: This is an area we may need to modify, because I’m not sure I see a whole lot of difference between the first bullet and the second bullet, except for repurposing, which is a whole different issue entirely.
DR. SCANLON: In terms of the suggestion that Paul had earlier, which is that people may cover multiple areas, but when you bring them in you ask them to focus on a slice. You are bringing in a group that talks about data capture as opposed to their uses of it.
MR. REYNOLDS: How about making data useful?
DR. TANG: That is HITSP. That is the standards.
MR. REYNOLDS: And who else?
DR. TANG: The NCHS folks, the Data Council, the people who analyze large data sets.
DR. COHN: Isn’t that HIEs also?
MR. REYNOLDS: Health information exchanges, yes.
DR. DEERING: If you give out analysis, are you trying to give out the people like Thompson, for example? So that is where Thompson goes, under there.
DR. GREENWOOD: The statewide health people and public health surveillance and all that, aren’t they among those who are making the data useful? Aggregating, analyzing.
DR. TANG: Do they generate the techniques by which you analyze the large data sets?
DR. GREENWOOD: Sure.
DR. TANG: Then they are there.
MS. BICKFORD: You may want to think about ESRI in the GIS stuff, in relation to the large tables that are generated behind the scenes, and how do they do the analysis, the geographic information system stuff that is becoming extremely important in health care, not just in public health, but in other venues as well.
MR. REYNOLDS: Methods of protecting privacy?
DR. TANG: That is a bit under clarity of current law, I think. One method is HIPAA and all the laws. Another method is technology, ways that you — it is like what we heard from the international groups. They have technical ways of doing things.
DR. DEERING: That is where I might put the CAB then, because that is where they have drilled down, into the ways of doing it.
DR. STEINDEL: I think in that area, the methods of protecting privacy, that might be where we want to think about people like Laurie and Glen, because that is what they are doing. Laurie would talk about not security, but none of those words that we know what they mean, like de-identified, et cetera.
DR. COHN: That is under what we said in the background.
DR. STEINDEL: What I was pointing out, Simon, I’m not sure if it should be there or —
DR. GREENWOOD: I’m having a little trouble here. First you have got suppliers and consumers who provide, capture and use data. So how is that use data different from making data useful? There you are talking more about the standards aspects?
DR. TANG: Yes.
DR. GREENWOOD: Then I would say some of those groups — those groups that I mentioned, the public health surveillance or statewide health departments, they probably belong more up with the use data, but certainly you could address that.
MR. REYNOLDS: One thing we are all struggling with is, a lot of these people do a lot of it. So we are just trying to help ourselves focus on different pieces of it. They may be able to give us other input, and they may be sitting in the room when we were going through these other things.
DR. COHN: I just want to make clear, I am assuming that all these are in addition to everybody we have here.
DR. TANG: It is an organizational construct. It is either useful or not useful.
DR. COHN: What I meant is, there is a whole bunch of other names here on this list that I like, and I don’t want to see this at the exclusion of all of that.
DR. TANG: You don’t think those could fit into this?
DR. COHN: We haven’t so far.
DR. TANG: Just because we can’t see both at the same time, that’s all.
DR. COHN: I’m just saying in terms of names and people, is what I am wondering, as opposed to construct at this point. I just want to make sure that we are not in any way not being interested in the list here. That was my only comment.
DR. CARR: I think we need to modify the construct. So for example organizations directing quality improvement. I think the construct is important for our thinking, so where do organizations directing quality improvement activities go?
DR. TANG: Those would be users. The AQA, HQA or NQF and the quality improvement — the IHIs of the world all belong in the uses.
MR. REYNOLDS: You mean, make data useful.
DR. TANG: Most of those are users of data, so it is uses.
MR. REYNOLDS: Where is that?
DR. TANG: It is suppliers and consumers, consumers of health data.
DR. STEINDEL: Paul, I take a little exception, because a lot of these groups also develop standards for how to acquire the quality data. We have another side of that, where we have as suppliers and consumers, I think it was in there, but registries, because registries also define a lot of times the standards of what data goes into the registries. So we are again looking at dual —
DR. GREENWOOD: It is ten to 12, and I am concerned, as you have been all morning, that when we go out of here people have to start making phone calls. I am assuming that is going to be Debbie Jackson and Margaret and Mary Jo is willing to make some phone calls. Is anyone else going to be involved?
DR. CARR: Booz Allen.
DR. GREENWOOD: And Fatima or your team? We need to know who they are going to call and what we are going to ask them to do.
MR. REYNOLDS: Yes, that is what Simon was just reminding me of. The point is that we have spent this last period of time hearing from everybody as to what these lists should look like. We already had a list that we already were dealing with.
We come up with a structure, how to approach it. I am very comfortable we can call anybody we need for the first hearing, which is the July 17, 18 and 19, out of this discussion today. We will be continuing to discuss it with Simon and Justine and I as vice chairs. We will put together what we think these others ought to be, work with the staff and then start getting people ready for the August and so on with information coming out to you.
So I think we have got enough to do that, not necessarily filling every hearing through the rest of the year.
DR. GREENWOOD: We are leaving at 12.
MR. REYNOLDS: We are leaving at 12, yes.
MS. AMATAYAKUL: I just want to observe that there is only one week in between the July and the August hearing.
MR. REYNOLDS: Right. Remember, to the bullets, under suppliers and consumers, which would tend to be the follow-on after the first year, as we are starting down through there, we should be able to take that list and the list we have and decide who we are going to invite. We should be able to do that.
DR. COHN: I just want to go back and remind everybody that in terms of our purpose here, and maybe I am just reminding myself, what we are trying to do is ground ourselves in the broad framework, but we also have responsibilities to go deeper in the quality area. So we may want to make sure that early on in the first hearing we are hearing from people around quality needs, quality issues, quality concerns, and that we shouldn’t just — what we are talking about is fine here, but we also need to do a tilt.
My concern in all of this is that we don’t want to be blindsided in the processes about any issues or concerns. So any group that we think may have concerns, we need to early on hear from the first time so that we know as we move further what more we need to do with them. As I say, I think I am responsible for that along with Harry and Justine.
MR. REYNOLDS: Is there any other input from the group?
MS. JACKSON: Along with needing the names of course is a list of the basic issues, the top five, six points you want to question, so you get a take-home at the end of the day so you can analyze the material better. Otherwise you will just get what people want to tell you.
MR. REYNOLDS: No, we already have that in the axis of interest, what we want with that. That has been modified. That is already available. That is why we have sent this out and that is why we have talked about it two or three times. We can touch it and make sure we make any brief modifications. But that is what we will use.
DR. COHN: I think the one question I would ask is, as nice as it is to hear from a large organization, I am reflecting in my own mind about exactly what they might say that might help us. I am maybe a little more questioning than Paul is, just because I can easily imagine someone talking about how wonderful — they use the data to research, improve quality, and they of course follow HIPAA.
DR. GREENWOOD: We have testimony from some of those organizations, too. We got some as recently as Tuesday. So I don’t think we want to repeat — to the extent possible, not repeat the testimony we already got.
DR. COHN: I am always happy to get these large organizations. I’m just trying to think of what beyond that they might say that might be very helpful or insightful. Paul, you might have a thought on that.
DR. TANG: So we listened to the Indian Health Service, for example, another one of those large integrated systems, and understood how they use data, but also how to make data useful, and hearing that motivates what is necessary besides having numbers stored in your database. That was helpful. Then you could see the power of it.
DR. DEERING: Simon, what we might also want to hear is barriers, is the system making it really hard for them to do this. I think that is the inside view that would be helpful.
DR. CARR: We have two questions, what policies, enablers or restrictions would either facilitate or impede uses of — we have electronically permissible personal health data for other than direct patient care while protecting privacy.
MS. AMATAYAKUL: Those two questions came from yesterday’s discussion. I just captured it to add to other questions we had already.
MR. REYNOLDS: The testifiers will get a set of questions. I thank all of you for your energy. This is a journey that we have been asked to take on, a journey a little different than the NHIN that a lot of us were involved in. We had the 1200. We are making up the questions. We are making up the subjects that start this one out. We will quickly get down to what those are, and we will come out with what we need to do.
So thank you, all of you, for staying so focused, and we will proceed accordingly. Thank you.
DR. GREENWOOD: Thank you all.
(Whereupon, the meeting was adjourned at 12:00 p.m.)