[This Transcript is Unedited]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS
SUBCOMMITTEE ON PRIVACY AND CONFIDENTIALITY
June 29, 2005
Hubert H. Humphrey Building
200 Independence Avenue, S.W.
Washington, D.C. 20001
CASET Associates, Ltd.
10201 Lee Highway, suite 180
Fairfax, Virginia 22030
- Mark A. Rothstein, JD, Chairman
- Simon P.Cohn, MD
- Richard K. Harding, MD
- John P. Houston, JD
- Harry Reynolds
- Paul C. Tang, MD
- Mary Jo Deering, PhD, NIH
- Maya Bernstein JD
- Susan McAndrew, OS/OCR
- Marjorie Greenberg, NCHS
- Anna Poker, AHRQ
- Jeffrey S. Blair, MBA
- Steven J. Steindel, PhD
- Stan Huff, MD
- Robert Kambic
- Patrick Hadley
- Paul Speidel
- Mike DeCarlo
- J. Michael Fitzmaurice, PhD
- Telephone: Cynthia Baur
- Gail Horlick
- Linda Faschetti
TABLE OF CONTENTS
Welcome and introduction Mr. Rothstein/Dr. Cohn
Discussion : Subcommittee Privacy elements of NHII Workgroup Letter to the Secretary on Personal Health Records
Collaboration on Privacy hearings in San Francisco, August 2005 35
P R O C E E D I N G S 3;38 PM
MR. ROTHSTEIN: Good afternoon. Let me turn the floor over to Simon who is Chair of the work group to talk about the privacy elements of his letter on PHRs and then after we spend the first hour or so or perhaps less working on that issue, then we will address the Privacy and Confidentiality Subcommittee issue dealing with our August hearings.
While Simon is doing that just to get things officially on the record we need introductions of everyone and so, Maya I will ask you to go first.
MS. BERNSTEIN: I am Maya Bernstein, privacy advocate of the department and lead staff to the Privacy and Confidentiality Subcommittee.
DR. TANG: Paul Tang, Medical Foundation, member of the work group. Anna Pooker, from AHRQ, staff to NHII.
MR. REYNOLDS: Harry Reynolds, Blue Cross Blue Shield, North Carolina, member of the Committee and the Subcommittee.
MR.HOUSTON: John Houston, University of Pittsburgh Medical Center, member of the Subcommittee as well as the Committee.
MS. GREENBERG: I am Marjorie Greenberg from the National Center for Health Statistics, CDC and Executive Secretary to the Committee.
DR. COHN: Simon Cohn, Chair of the Committee and a member of the various subcommittee work groups.
DR. DEERING: Mary Jo Deering, National Institutes of Health and lead staff to the NHII work group.
MR. BLAIR: Jeff Blair, Co-Chair of the Subcommittee on Standards and Security and member of the NHII work group.
DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention staff to the NHI work group and liaison to the full Committee.
DR. HUFF: Stan Huff with Intermountain Health Care and the University of Utah in Salt Lake City, member of the Committee, member of the Standards and Security Subcommittee and a member of the NHII work group.
MR. KAMBIC: Bob Kambic, Center for Medicare and Medicaid Services up in Baltimore, staff to the NHII work group.
MS. MC ANDREW: Susan McAndrew, Office of Civil Rights, obviously liaison to the Subcommittee.
MR. HADLEY; Patrick Hadley, Senior Health Information Privacy Outreach Specialist, OCR.
MR. SPEIDEL: Paul Speidel with the American Medical Association.
MR. DE CARLO; Mike DeCarlo with the Blue Cross Blue Shield Association.
MR. ROTHSTEIN: Thank you and I appreciate the traveling.
Okay, Simon, are you ready?
DR. COHN: Sort of. I think you have all now received a copy of a very early draft of a letter on personal health records or personal health record system depending on what the NHII work group decides to call this.
What I wanted to do was to, I mean given a piece of this relates to privacy I think we felt there was a useful sort of joint conversation to get some of your thoughts in relationship to the privacy sections that we have coming forward and given that you just received this literally in the moment and you do have a copy of it?
MR. HOUSTON: Yes, the version that we have is it the version that Marjorie marked up yesterday?
MS. DEERING: I don’t know whose version this is. I notice it only has some very small editorial comments.
MR. HOUSTON: I know Marjorie sent one around.
MS. DEERING: Did Marjorie send, okay, this is probably the one that Marjorie sent around then.
PARTICIPANT: You had one that you had incorporated everybody else’s.
MS. DEERING: Except Marjorie’s and so what they have printed out for you must be Marjorie’s.
MS. GREENBERG: I marked up what you sent out, something clean. So, it should have included —
DR. TANG: So, that is actually clean, free of people submitting edits?
MS. DEERING: No, we went on Monday morning. This does incorporate your comments, Paul. It does. This has got all your comments in it. It has got Steve’s comments in it. It has got some comments from Bob.
MS. BERNSTEIN: Look at Page 9 where there are some significant changes and see if those are your changes or if anybody recognizes those.
MS. GREENBERG: I moved the recommendations under the subject. This is I guess mine, but I did work from what I thought was the last version. I assumed you sent one in which you could see the, all the edits and the other one that was called clean.
MS. DEERING: I think then the question on the table is to ask Marjorie are these substantive efforts or are they more formatting edits?
MS. GREENBERG: That is a different question. I think the most substantive issue was related to the research recommendations and I think I said that I deferred to, that I thought there were arguments for and against having two separate letters which had been recommended by — is Steve here? Yes, over there and I would basically let that play out in your own discussion.
I wouldn’t necessarily call them word smithing but I think they were primarily organizational and somewhat minor. I don’t consider them in any way making any major change in the subject matter.
MR. HOUSTON: The only reason why I asked the question was because I marked up the version Marjorie sent out. I wanted to make sure is we were going through it was this Marjorie’s version.
MR. BRNSTEIN: The version we have doesn’t have any changes in the privacy section except for a comment at the bottom. So, if we are going to combine our comments in the privacy section I am not sure it matters so much.
MR. HOUSTON: The version that I marked up, if it is the same one passed out, then good.
MS. DEERING: The one that Marjorie sent out just yesterday?
MR. HOUSTON: Yes.
MS. DEERING: I incorporated your comments.
MR. HOUSTON: I just marked it up.
MS. DEERING: You subsequently marked it up?
MR. HOUSTON: Yes, I just want to make sure I had the same version.
MS. DEERING: We don’t have what you did?
DR. COHN: I want to remind everybody the focus of this conversation is not a read of the entire letter. We are focused on the sections related to privacy as well as any privacy-related —
MR. ROTHSTEIN: The folks on the phone,could you introduce yourselves and indicate where you are from so that we can have that on the record?
MS. BAUR: This is Cynthia Baur from the Department of Health and Human Services.
MS. HORLICK: Hi, this is Gail Horlick, from CDC.
MR. ROTHSTEIN: Welcome, Gail. Was there someone else?
MS. FASCHETTI: And this is Linda Faschetti from Veterans Health Administration.
MR. ROTHSTEIN: Thank you and welcome. Is there anyone else. Okay, we have the three people on the phone on the record and we are discussing in the first half of this joint meeting between the Subcommittee on Privacy and Confidentiality and the NHII work group, we are discussing the proposed letter or draft letter that has been prepared by the NHII work group on PHR and Jeff wanted to make some comments.
Were they of a substantive nature, Jeff, I mean about the content of the letter?
MR. BLAIR: No.
MR. ROTHSTEIN: Then please go ahead because I don’t want to get to the content yet. I have got a bunch of questions to ask.
MR. BLAIR: I have struggled to try to read everything before we come to the meetings, but i leave the house at nine in the morning the day before these meetings and I have no way of accessing the Internet. So, if you could please be aware that if you want us to read something I am not going to have access to it for 24 hours before the day we get here.
MR. ROTHSTEIN: Thank you, Jeff. Your comments are well taken. I have not seen this letter either until 60 seconds ago. So, we are at a bit of a disadvantage but I am not sure that it was contemplated that we would actually go through the letter. So, I don’t want to be critical of NHII or the staff.
I have some foundational questions. What is your plan in terms of your timetable for submission? Have you thought that through?
DR. COHN: I think our hope had been to bring this forward to the September full Committee meeting though whether that happens or not is obviously there is a hope versus whether or not that happens or not.
MR. ROTHSTEIN: And was it your expectation that the Privacy and Confidentiality Subcommittee would take a look at, because I have not done that yet, at the section or sections on privacy in this document and make suggestions or were we going to be asked to write, you know, whole new sections in addition? I am not sure what you view our role as.
DR. COHN: I think our intent was that wanted the Privacy and Confidentiality Subcommittee to take a look at the sections.
We thought that there were some privacy issues potentially as well as there is also I think a piece that relates to privacy research and we wanted the input of the Privacy Subcommittee on those areas and that is really the scope of the discussion.
DR. TANG: And there is going to be a joint — no?
DR. COHN: Not in August. There may be one in the future. If there was indeed going to be one in August we would be talking about it.
MS. BERNSTEIN: A joint hearing is what we are talking about.
DR. COHN: There was at one point a plan for —
MR. ROTHSTEIN: We had talked about that and in lieu of the joint hearing we are having this joint meeting.
MS. GREENBERG: Not necessarily in lieu of.
MR. ROTHSTEIN: In the short run we are going to have this meeting and then whether we need some additional joint —
DR. COHN: Yes, and I think the rationale for that was just to remind everybody that if we were talking about actually doing a letter for September we thought having hearings in the middle of August seemed a little tight for a letter coming forward. So, that was really the reason we said not to do that and that of course in no way precluded having a joint meeting or hearing later on in the year on any of these issues and/or other issues.
DR. TANG: Are you done with your foundational questions?
MR. ROTHSTEIN: Are you ready to move into the substance?
DR. TANG: Right.
MR. ROTHSTEIN: If you can help us identify the places where you want our input that would be very helpful and then we can talk about —
DR. TANG: Here is the issue I think that called the meeting together and the thought to have a joint hearing and that is at the last PHI hearing there were a number of secondary uses in the information was both gathered and then subsequently used that a lot of people were unaware of and caused some concern about the privacy aspects of it and in particular whether consumers who give up their information know that that is the use that was going to happen to it and that is what prompted the thought that we would have a joint privacy hearing.
Some of the concepts we raised were we thought that when consumers contribute information to a PHR system of any definition that there is transparency on the use, transparency of the privacy practices and understanding of any secondary uses that may occur and the ability for the consumer to opt in.
Those were the high-level concepts that we thought we would talk about. Now, we either are going to feel that we have enough information to make comment or recommendations based on our past hearings or we may defer on commenting on it in your September letter to when we can have a joint hearing.
DR. COHN: I actually agree with what you said so far. I think there was also sort of the more fundamental issue but a discussion we had around PHRs and holders of the information in PHRs and we were beginning to have a question about or maybe I was having a question given some of these are non-HIPAA-covered entities about whether or not this was an issue that advocating for industry best practices and transparency of secondary uses of that data by those holders of the PHR was sufficient or whether there was really some sort of a greater need for some sort of a legislative or stronger remedy.
MR. ROTHSTEIN: Jeff had a comment?
MR. BLAIR: I am in complete agreement with Paul, what you said, but we understand the word “transparency.” I think that if this ever rolls into a recommendation letter there may be many people that may interpret the word “transparency” in different ways.
So, I would like to suggest that when we express this recommendation that we indicate that we are saying that there should be full disclosure to patients and consumers of the entities that receive their personal health record information.
It is kind of plain language and I think that could help us.
MR. ROTHSTEIN: Harry?
MR. REYNOLDS: I think in a number of the Committee meetings that we are in and sometimes in the full Committee the whole idea of HIPAA regulations versus covered entities, I think to me it is already appearing that it is out of date.
In other words, covered entities were set up for some of the basic HIPAA transactions but whether you look at e-prescribing or look at personal health records or look at EHR, you look at anything we want to add an “R” to or anything we want to do, you find yourself in a situation where there are many handoffs and/or people that have access to it and more realistically I would hope that at some point we could find ourselves capable of making a recommendation that there is some class that is set up that if you touch it you are responsible. If you touch it you are responsible under all the appropriate rules and regulations and whatever those are or aren’t. Otherwise you find yourself, I don’t see how we can ever gain the trust of somebody that each person that touches it doesn’t have some jurisdiction and covered entity whether I am an insurer or somebody else is something else shouldn’t make a whole lot of difference from the standpoint of that protected health information in a lot of ways.
So, I am at least starting the discussion because we keep tripping over this and I know when we looked at e-prescribing it just went through so many hands that really weren’t covered.
MR. ROTHSTEIN: I have got Paul and then Mike and I just have a question, and please forgive me because I am starting behind where you are. Can you give me some sense of the paradigm under which you are working with the PHR because there are different models of PHR that we have heard about and they have lots of different privacy connotations.
Are you talking about some non-covered entity that is now the host of some site but PHR includes lots of other things as well? Okay, it is Internet-based versions that are — so, if you could give me it as, you know, we addressed this, if you could talk to that issue, that would help us.
MR. BLAIR: Could I make a comment on your question here?
MR. ROTHSTEIN: Yes.
MR. BLAIR: Because I think that what Paul Tang and what I am saying here gets to the lowest common denominator across whatever model exists today or may exist in the future in terms of a PHR system model.
So, what we were thinking of is not a complexity of recommendations, not a lot of different requirements, just one, one simple one and that is that the patient or consumer gets full disclosure of where the information goes and the reason that we say that is because there could be many of these PHR models where it is appropriate to have this information shared with certain types of entities that are not considered within the HIPAA privacy regs. So, we are not precluding that, and we are not getting into complexities. We sort of came down to one basic simple rule that covers everything.
MR. ROTHSTEIN: Okay, let me get Paul and then Mike.
DR. TANG: I think the primary principle is one of trust, creating trust with the consumer. We heard David Braylor and Scott talk about really in the end the consumer is paying and the consumer has to trust that — they want to feel the benefit of it, and they won’t give up either that or the race, ethnicity data until they trust the system.
To trust the system I think we have to promise and commit to them and back that promise that it is only used in the ways that they had intended it to be used and that is where the transparency comes in and that is where the disclosure comes in.
The part of the stimulus which is your question of why we got into this discussion was we found a whole lot of secondary, let me call them secondary holders of information what Harry referred to as other people touching it.
In the e-prescribing business, in the reinsurance business, in the employer business with the HRAs my eyes were opened up in terms of how many other people are holding this information, only a very small fraction of which are, quote, covered entities.
So, one way to address that would be and I think Harry is proposing if there were comprehensive and that was originally an effort done in the mid-nineties before HIPAA actually went — Congress gave itself 3 years and it didn’t make it, but there were a number of organizations that tried to pass comprehensive privacy legislation that would affect all people who touched that information.
MR. ROTHSTEIN: I have a question for you before we get to Mike’s comment and that is how would this holder of the PHR —
DR. TANG: PHI. Let us talk about the information network. The information that was obtained in the PHR no matter how it is designed appears to flow in many ways that were unbeknownst either to the consumer patient or even to many of us and so hence the concern that are they actually protected in many of these as they course through these different —
MR. ROTHSTEIN: I don’t understand yet, and I know there are different models but let me just pick a model. You are some third party, that is you are not my provider. You are just an entity and I want to form my own PHR and so I would use your services to gather my stuff, my information from different providers and now have this information, right?
My assumption was that even though you may have it in some sort of electronic form the essence of PHR, the P is that I have control over everything that is done and now what you are telling me is that there may be circumstances under which the holder decides whether to distribute it elsewhere and as long as I know the circumstances under which you are doing that that is okay. Am I correct?
DR. TANG: It is personal judgment whether what that third party does is okay with you, but as adults if you have informed consent and you opt in then we have to deem it okay for you.
MR. ROTHSTEIN: Okay, Marjorie are you commenting on this particular issue?
MS. GREENBERG: Yes.
MR. ROTHSTEIN: Okay, we keep bumping Mike but he will definitely be next.
MS. GREENBERG: In addition to all these little edits that I made I just had I think a little e-mail that covered it and what I said was that this document which I have found very interesting and I think it will make a contribution and I believe I said that, but it kind of skirts, it starts with what the President and the Secretary put forward as a vision for personal health records and that patients, doctors and other health care professionals could securely access through the Internet no matter where a patient is seeking medical care and in my mind what they were referring to there is the electronic health record because I didn’t think the vision for the personal health record was that anyone could access it wherever the patient is seeking medical care, exactly what you are saying but I think these terms, and they mention this in the letter, have been mixed. There is confusion about the terms.
When the President said that everyone should have a personal health record —
MR. BLAIR; He didn’t say, “Personal health record.” He said, “A personal electronic medical record.”
MS. GREENBERG: Okay, well, whatever, he said that. The point is that you hear people talking about these in a rather interchangeable way and I think I also thought that the essence of a personal health record as this Committee was looking into it was the one that was under the control of the person. They would put things into it. They might pull things into it from providers. They might push things out, but it isn’t really the record that everybody would have access to whenever you seek medical care. That should be your longitudinal health record but I mean maybe I am wrong there, but I mean if in fact it seems that there have got to be two different things here.
There is the record that the provider owns or is custodian of and there is the record that the patient is the custodian of and I think that maybe by providing your taxonomy you will make that clear but just by starting with the sentence you have here I think the waters are immediately muddied.
MR. ROTHSTEIN: Mike?
DR. FITZMAURICE: I wanted to kind of consolidate what Harry was saying and what Paul was saying, that yes, we do need trust and with regard to the privacy of health information in the middle nineties there were several bills that created a concept called the health information trustee, If you are a trustee then you have responsibilities and under the law you could be prosecuted if you don’t carry out those responsibilities. If you find the medical record on the sidewalk you pick it up. You might look at it to see whose it is and then try to find out where to return it. If you go through there in all kinds of detail and you start telling your neighbors about it that would probably have been illegal under some of these privacy acts that were proposed.
An analogy that I use is suppose you are walking along the sidewalk and you find a set of car keys. You pick up the car keys and you say, “Gee, I wonder to whom they belong. I am going to try it on the doors of these cars,” and you find one door that opens with it. I am still not sure. So, let me get in and try the ignition. So, the ignition works and a policeman comes along and says, “I am arresting you for attempted theft of the car,” and you say, “I am just trying to find out whose medical record this is or I am just trying to find out whose car this is,” but you didn’t need to have to go through all of that in order to find it and is that one of your responsibilities, and so to trust people with car keys or with medical records you want to have some kind of control over it.
It would be helpful if you had a law that governed the legitimate uses of it and that we are flexible enough to change over time as society permits more uses of the information under certain conditions.
MR. ROTHSTEIN: John and then Mary Jo.
MR. HOUSTON: I guess I have a little bit of a different take on it. Maybe it is the same but you know whether we have a law or not I think a law is, to try to fashion a law like that is going to be problematic. We are talking about water over the dam or water under the bridge or whatever the heck you want but I think that there are other strategies that are probably equally successful and I think that what Paul said is that if the consumer is informed as to the uses of his or her data within one of these personal health records then it is up to the consumer to decide whether he or she wants to participate and that a reasonable recommendation to try to approach these types of issues is to develop model privacy agreements that if the PHR provider is willing to adopt you can have through that sticker on the front of the web site that says that you have agreed to these particular privacy or acceptable use policy or whatever you want to call them and that a consumer can evaluate those agreements and say, “Okay, I am comfortable with those particular model provisions. I have read them. I feel comfortable that they protect my information,” and likewise a PHR could decide that they don’t want to agree to those terms and they can fashion their own and it would be up to the consumer to decide that whatever terms he or she is agreeing to are acceptable and I think they have to be in plain English and they have to sort of describe all of the different uses.
I think this is more workable than expecting somebody to try to pass a law that says, “Thou shalt or thou shalt not do this as it relates to PHRs.”
MR. ROTHSTEIN: Mary Jo and then Marjorie?
MS. DEERING: Actually I was thinking that I could, my comments are intended to help key up a discussion of actually our agenda item which was the privacy section of what is in front of you because I think that our discussion about that section can proceed without us having resolved all of these issues but having said that I think I will respond to Marjorie and to your comments about the different flavors and say that perhaps using that particular sentence was misleading.
Let us just set it aside for now so that we don’t get bogged down. As you will see in the privacy section indeed those people who talk about a personal health record when they use that term, whether they are using it rightly or wrongly they say that the control of the information is in the individual’s hands and our issue is is that necessarily true or not, but certainly I did add and I also want to take the opportunity to apologize to Jeff. The draft was sent out Monday morning originally but somehow Marjorie’s draft is what is getting circulated today.
MS. GREENBERG: I apologize I couldn’t get to it until Tuesday morning.
MS. DEERING: Right. I understand that but anyway she made no changes really to the privacy section for the purposes of our discussion and so in fact we can proceed.
Again, the discussion as it is farmed within the privacy section is predicated on the assumption that the individual consumer or patient is supposed to be and believes he or she to be in control of that information or sees that as a value that they were aspiring to and that the vendor and/or offerer no matter who it is is saying that they are offering, but No. 1 is it so? No. 2, how can they know what is happening and what can we do about it and what is the lowest common denominator, and I think the solutions exactly Jeff said will actually go across the continuum of different situations.
MR. ROTHSTEIN: Okay, I am getting a little clearer on this. We have got Marjorie, then Josh.
MS. GREENBERG: Okay, that was what I thought we were talking about, but because people were shaking their heads no as I was talking before I just want to ask, and you acknowledge that this opening might have not been the best way to start off, I just want to ask the physicians or nurses or clinicians in the room, the health care providers is this the record that you want to access wherever the patient, the principal record you want to access when the patient is seeking medical care or would that be the electronic health record as I understand it?
I mean I can see you getting some value out of this, but this I didn’t think was the record that you wanted to be accessing when the person is seeking care.
DR. TANG: Let me answer? First, I don’t think you were at the hearing where we sort of concluded that although there are multiple definitions of PHR, the one in most common use by orders of magnitude is the one, the old term was “tethered.” A newer term might be “integrated,” with the EHR. So, really the EHR in that case is a portal into the EHR from an access to data point of view, but it also provides communication which is what turned it into a PHR system.
Okay,so that was —
MS. GREENBERG: They are Inseparable in a way?
DR. TANG: They are inseparable in that way and that —
MS. GREENBERG: I didn’t think that tethered made them inseparable but maybe it does.
DR. TANG: If I understand how you all were using that term, but that actually is the predominant use and for the very reason you just asked the question you asked which is would a doctor find the stand-alone PHR of use, and you were implying no, and actually the business model also says, “No,” too because there are not many subscribers to that model. So, really people want it both ways, you know, have it your way, have all the information from your doctor and things you contribute yourself and have total control and so one of the committee’s discussion is is that possible or what kinds of control can we give patients who use that model.
MR. BLAIR: Marjorie, in a sense I think your question hit on —
MS. GREENBERG: Are you a health care provider?
MR. BLAIR: Should I wait?
DR. COHN: Let make a comment. I think Stan is also. You are a health care provider?
DR. HUFF: Just on that particular issue I would want to use a record that was created and developed by the health care providers not one that was entirely under the control of the patient.
DR. COHN: Is it my turn? I guess I was going to sort of comment I agree with Paul about the model that conceptually seems to make sense but recognizing there are lots of different models out there and a lot of things are being called PHRs and truthfully and this gets to be that control piece if you don’t have any data; any data is better than no data for an emergency physician and so I will take in the absence of nothing, I will take anything and you hope it is true and if it is indeed under control and I mean this gets to be sort of a worrisome issue as we move here and yet I guess I was hoping that we weren’t going to sort of focus on this part so much only because I think this still needs a fair amount of work in the document. It is why we ask for definitions. It is why we are asking for taxonomies because there is a whole bunch of things that people are calling this and they are taking principled stands based on their view and they may not even be meaning the same thing.
MS. BERNSTEIN: Yes, but if I could just comment on that little piece which is if we don’t have a definition of what a PHR is or what an EHR is it is very, I think it is very difficult to go into the privacy section. It may just not be right yet.
MR. ROTHSTEIN: I think we can come to that in just a second, but Richard is our final provider and then we will go to Jeff’s comments.
DR. HARDING: Theoretically I would want to see the entire medical record. Realistically is a primary care person has 7 minutes to see a patient they are going to default into the Reader’s Digest version which is going to be the personal health record, I am afraid and that would be then a difficult thing because it wouldn’t necessarily be accurate. It might be but it wouldn’t necessarily be very accurate. It would be what the consumer wanted the provider to see in a way and that would be troubling to me to have the Reader’s Digest version although that may be what I want, just as I read executive summaries before I read the full reports sometimes.
MR. ROTHSTEIN: Okay, we have got Jeff, Harry, Marjorie and Anna.
MS. POLKA: I guess it would be really important also when you say, “Control of the record,” what portion do the patients have control of? If I am a practitioner I want to know have they had the opportunity to change any of that data or did they just have the opportunity to just add medications. That is a huge difference.
MR. ROTHSTEIN: Right. I agree with that. That is what we are trying to get a handle on, what this thing is.
Okay, back to Jeff?
MR. BLAIR: Thank you.
MR. ROTHSTEIN: Don’t think about it too long or somebody will jump right in in front of you.
MR. BLAIR: I think that Marjorie’s question was a very important one and she was winding up saying, “Is it control or is the issue of whether it is a personal health record the entity of who has control over it or who is the primary user?” and actually the responses that I heard from all the providers is consistent with what I was about to suggest.
I had originally thought that the definition should be that the consumer or the patient had control of the information and I think that that is one of the items that Mary Jo indicated that that was one of the primary definitions of a personal health record but there are exceptions to that, important exceptions because if a health care provider or you know like the VA is the one that controls the information and makes it available to the consumer or patient control may or may not be the gating factor, but I think that if it is for predominant, if it is to be, if the predominant user is the patient or consumer rather than the health care provider then I think that that is really the main thing that defines a personal health record is the consumer or patient is the predominant user. That is how it is designed.
Now, given that then all of the different models that we were looking at, our personal health record systems, that is what I think supported our assumption that there is one basic simple premise which is that as long as there is full disclosure if the patient or consumer is the primary user then that is a very simple and effective way of covering the privacy issue.
MR. ROTHSTEIN: Okay, that is one point of view. Then I will give mine.
MR. REYNOLDS: i want to speak as an implementer. You had better get some real good systems if you are going to pull down their medical records. I couldn’t carry them in a truck. I think that is going to be one thing.
Second, I think it is going to be a number of years before there is a clear definition of what a PHR is. There are going to be some coming out from vendors. There are going to be payers who put them out based on claims. People are seeing so many doctors it is still not clear exactly how you are going to normalize all these. So, over a period of time there is going to be a lot of data floating around that a lot of people have access to. So, we also have to think about a transition period. There are a lot of people in here who can talk this stuff pretty good but you step outside this room and it gets real fuzzy.
MS. GREENBERG: It gets awfully fuzzy.
MR. REYNOLDS: What I am saying is we are supposed to be the ones who are tracking it. We are supposed to be the ones that are close to doing it. I am just saying to you that the transition is going to be difficult, and I still go back to privacy. We still have to make sure of that and fully disclosure. Let us go back to prescribing. You are going to hand me something and say that it is a large sum and it is this and that. I don’t know what that means. I don’t know what I am doing. I just think we need to make sure that we keep in mind what we really have, not just what we wish, we hope for or what we think is going to happen.
MR. ROTHSTEIN: Marjorie?
MS. GREENBERG: I would say that there are more definitional problems here than I began to understand or to influence or to you know understand the implications of and on the one hand I don’t think all of those have to be solved in order for the Committee to make some useful recommendations.
On the other hand I agree with Maya. You have to know what you are talking about and so one size fitting all doesn’t seem to make sense to me at all and particularly if the predominant model is this one in which there is really a combination and I must say I am no expert on this and I did miss at least one of your hearings but I did go to a half-day session that Connecting for Health put on around the report they did and it was definitely my understanding that the essence was that the opportunity was there to pull in stuff from the provider assuming the provider allowed it to be pulled in and to push things out to the provider’s records to the patient if the patient wanted to do that because they weren’t one and the same and frankly I don’t see any benefit to even talking about it as a separate thing if they are one and the same because I can think of lots of things I might put in my personal health record. I don’t want my providers to have access to all of that and what would they do with it. As Richard says really we are talking about things that I just want in managing my own care or whatever, I don’t want it all going over to the provider. That is ridiculous.
I think that that is not the way I understood tethers but it would seem that if the predominant model is one in which they really aren’t two separate things although interconnected but there is a different issue then I think I don’t even understand what we are talking about here with the personal health record. So, I don’t think we are ready for prime time with this level of confusion unless I am the only one who is so confused and then I will proceed to the Population Subcommittee to spread my confusion. Why should I just bless you all with it?
MR. ROTHSTEIN: Mary Jo?
DR. DEERING: These hearings were on personal health records and some people out there think they know what they mean and I have great trepidation with all of the health care providers being identified all over again. We are not talking about just the VA.
MS. BAUR: Mary Jo, this is Cynthia. Are you moving your head when you speak because we are only getting like every third word.
MS. DEERING: I am turning my head and gesticulating as I talk. Perhaps one of the take-home messages which we do say in one of the opening paragraphs is that this is an evolving concept. The discussion of privacy can proceed because there are implementations out there and there are circumstances where the consumer may not want to share the information.
MR. ROTHSTEIN: It seems to me that regardless of the way in which we use the information in health we are going to have an issue in the sense that suppose I have this trusted intermediary who has my chart. If I direct them to send that information to some other place which is part of our arrangement I need to be able to rely on the fact that some hacker is not going to be able to get into the middle of the communication. So, some rules of security are going to have to govern the transfer of information among the parties.
The next issue is privacy, informational privacy and what this goes to is the degree to which the individual has control over what is in the PHR and if you go on the assumption that the primary purpose of the PHR is to further the interests of the patient then the patient has ultimate control over what is in his or her PHR. They are not required to have one. They want to do it as a convenience for themselves and therefore it is going to include what they want. Now it may have secondary benefits including family members even health care providers having access to this information, but the patient maintains control and the third issue is confidentiality and that is the right to limit the exposure of information that would be exposed within a confidential relationship.
A normal situation would be the limitations, legal as well as ethical on health care providers not to disclose patient information without consent or authorization of that individual.
Now, if there is an intermediary that would be the choosing of someone who is given confidential information and normally we would say that you would need the authorization or the permission of that individual before you redisclose information.
Now, the question that we took today is whether to take that position which is so long as you provide notice to individuals then the first party or the intermediary or the holder of the records to disclose them for other purposes not specifically for the release of personal information or whether we want to take the position of saying, “Look these people this is their business model. They are holding themselves out as intermediaries to maintain a personal health record and therefore without express consent, authorization or what have you you can’t do that.
That seems to be the areas in which there is most disagreement. As to the other area, the area of privacy what goes into that means it can’t be hacked into.
Now, we will start with Paul and then Jeff and say what you want but if you would maybe comment a little bit about my model, whether I am on or off track.
DR. TANG: (Off microphone.)
MS. BAUR: I am sorry to interrupt again but when people turn their heads you really lose a lot over the phone. So, if people could talk into the mike that would be very helpful.
MR. ROTHSTEIN: I am sorry, I am falling down on my job. No head turning.
MR. HOUSTON: One area that I think is going to be problematic is state law depending on how you structure it and how we maintain it. There may be some state law implications that might get in the way. I just wanted you to be aware of that.
MR. ROTHSTEIN: Jeff?
MR. BLAIR: I began with the idea that the key definition with the consumer’s personal health records was that the consumer or patient has control, but we have seen at least three situations, the VA, the health record and several managed care organizations where it is all the personal health record because it is designed for us by the patient but there are various degrees of control. In some cases it is only access to the information and I feel as if we are going to lose; it is going to unravel if we include in our definition of personal health record that in all cases it is controlled. In some cases it is controlled. I know that is the kind of personal health care record that I would like where I have control and some of them do give me control but not all and that is one piece and because that issue arose where some of these services offered great value by providing the access where the patient didn’t have to pay for it and where it is a lot of good value where I would be hesitant to declare those systems illegal but they were not open about who they provided secondary access of that information to; it sounded so attractive; it was outstanding marketing, often good. So, that is where this idea of full disclosure seemed to be the common denominator.
That is a little different than Mark what you said when you tried to repeat my thoughts.
MR. ROTHSTEIN: I am sorry if I misstated them.
MR. BLAIR: What we are saying is that if we could get out as quickly as possible because this could be a very dangerous situation; some of these aggressive marketing campaigns with the idea of saying, “Gee, it is of no cost to you,” and you go ahead and put this information in your personal health information, but they are not open, transparent, open, full disclosure about where that information is going to go. We could have a rebellion on the part of a population, a resentment, a loss of trust that happens very quickly.
So, the thought here was that if we could quickly get out one common denominator, one issue that could be accepted no matter what the model is and a lot of the models are going to evolve, that full disclosure of where that information goes that that would be a quick thing that could be done that would address all situations.
We could later go into other questions. That is one that is sort of a bottom line that I hope that everybody should agree to that maybe we could get a recommendation out and some kind of a regulation out as quickly as possible.
MR. ROTHSTEIN: Jeff, what I tried to say was that is exactly your position, but my position would be that doesn’t go far enough and that it would not be enough for the holder of the record to make such a declaration, that the holder of the record obtain the authorization of the individual. You would be holding the —
MR. BLAIR: You are —
MR. ROTHSTEIN: — to a standard that is lower than a covered entity.
MR. BLAIR: It is lower than a covered entity because this is designed for personal use.
MR. ROTHSTEIN: And they shouldn’t have any business doing anything else with it, period.
MR. BLAIR: The key thing is here, please understand the thought of this was full disclosure before someone signs up and provides this information. It isn’t recognition after the fact. It is that there is full disclosure before they sign up with any of these private sector entities that is outside the covered entity.
MR. ROTHSTEIN: This has been very edifying, but now I need to know because we are running behind schedule and we need to concentrate on the second half, the privacy and confidentiality hearings in San Francisco.
The question, Simon is perhaps you don’t want any more input from our Subcommittee but assuming that you do what might that be?
DR. COHN: First of all I want to say that this is actually a very useful conversation. The conversation between you and Jeff was very informative. I want to thank you.
MR. ROTHSTEIN: It is just like we planned it.
DR. COHN: I guess the question is could the Subcommittee illuminate further. I guess it would be useful if we understand the issue.
MR. ROTHSTEIN: It may be that if you feel that we have made progress with the arguments on both sides, maybe the work group is now in a position to go back and move on and it may say that already. I haven’t read it. We will take a look at what you have done and then whatever the work group decides is the position we want to take.
DR. COHN: I think that may be useful.
DR. DEERING: There are some recommendations. I believe there are only three. They are on Page 8 and it is only the first two actually that are directly related.
Those are the recommendations that you would like us to look at.
DR. DEERING: I must say we (Off microphone.)
MS. BAUR: Mary Jo, we just lost everything you said. Sorry.
DR. DEERING: I was saying that the recommendations were very much straw men recommendations trying to capture some of what I thought was coming out.
MR. ROTHSTEIN: And of course I would say that they are weak recommendations in a sense.
MS. BERNSTEIN: Just looking at this my sense is that there is significant overlap. We talk about privacy policies and practices and one of the things you talk about is secondary usage. So, I think this perhaps causes more trouble than it alleviates.
MR. ROTHSTEIN: The other thing that I would say is that it may well be that the recommendations that come out from the Privacy and Confidentiality Subcommittee would be directed to NHIN. We will go a long way in the direction in which the PHR recommendations will be to the NHII work group. There is quite a bit of overlap.
MR. HOUSTON: Back to some of the comments at the start of the meeting on definitions we need to be very clear.
MR. ROTHSTEIN: You are in the working group and you are also on the Privacy and Confidentiality Subcommittee. So, it seems to me that if we were looking for a liaison as well as Simon, if I could ask the two of you to have one foot in each group and work with us, then we will work with you.
MR. HOUSTON: Simon is on those committees also.
MR. ROTHSTEIN: He is on every committee whether we want him or not. Is everyone okay with that?
MR. HOUSTON: That is fine.
MR. ROTHSTEIN: Are you on NHII?
DR. HARDING: Yes.
MR. ROTHSTEIN: Richard, also, has been drafted.
MS. GREENBERG: That is part of the reason we were going to have this hearing out in San Francisco because there is an overlap.
MR. ROTHSTEIN: We are having a hearing. Are there people that we still need to hear from before we pull together the information for our group? We heard from a couple of people. The top priority now seems to be hearing from these technical experts.
MS. GREENBERG: What I recall in talking with David Brailer and the discussions that we had at the executive subcommittee meeting it seems that what was really needed was some more conceptual vision and having done that it might be that we want to hear from people in that yes, maybe everything is possible and some things are so complicated that maybe it is not the way to go but this was premature to hear from technical people. There did seem to be a gap.
DR. COHN: Going with the idea of putting things back together, the question is you get theorists to talk about putting things back together. I actually think that just seeing some of the RIO(?) people because they are having to talk about putting it back together are a useful group to hear from and obviously there are California RIOs. There are RIOs on the — there are lots of RIOs.
DR. TANG: California is just getting started.
DR. COHN: Yes, California is just getting started but obviously listening to what they or other — you might just ask them if they have somebody or if they have some leads, and I know Paul is involved.
I am involved in the Cal RIO. So, we might be able to provide some perspective. Obviously we have talked about larger health care systems that have to deal with this one. There is one in Palo Alto that I know about and there is also VA. It is all of those groups that might help you look at it.
MR. ROTHSTEIN: Here is another possibility. It is a different kind of model that we have not used in the past and that is suppose we were to circulate a draft report that has not been approved.
MS. GREENBERG: Has it been written?
MR. ROTHSTEIN: Yes, I understand, and ask people to comment on it and what they think the practical implications would be.
Are there weaknesses in it? Are there things that they agree with and then we could use that as Subcommittee members in revising the draft before we work it out.
So in other words instead of having people come in and just talk in the abstract talk about a draft and to get us even.
MR. HOUSTON: These individuals necessarily, are they privy to all of the discussions we have had leading up to that point? Are they going to be able to speak from an informed sense based upon other testimony?
MR. ROTHSTEIN: It depends obviously who they are.
MS. GREENBERG: Do we have minutes, probably not from June 7, but do we have minutes from the two previous ones?
MR. ROTHSTEIN: Yes, I believe they are already posted
MR. HOUSTON: Rather than having to read through minutes we have to have to frame I think some of what we have —
MS. GREENBERG: I am not suggesting they just read the minutes but —
MR. ROTHSTEIN: No, what I am suggesting is read our report, the draft report and recommendations and then maybe they could —
MS. GREENBERG: Is there time to do all this by August 16?
DR. COHN: Are we going to reach agreement on the draft report?
MR. ROTHSTEIN: No, that is the beauty of it. We don’t have to agree to anything.
DR. TANG: As long as there are sufficient options. We do want to be productive. I like your suggested proposal in spirit. I think there are two basic problems we have to solve one is the taxonomy; what is it and how would you characterize it?
MR. ROTHSTEIN: What are we talking about now?
DR. TANG: PHR.
MR. ROTHSTEIN: We are not talking about that anymore.
DR. TANG: Okay, because No. 2 and control, and control is front and center of privacy and confidentiality, and if we could at least present something that we are talking about that is where the taxonomy comes in, then we could get people’s understanding of what they mean by control.
There are certain things that we think we cannot give. We can’t actually supply it technically, logistically, but maybe that is not what they are even asking for. So, the vetting is what do people mean by control, how much control and how do they draw that balance between control of information and availability for care as an objective.
MR. ROTHSTEIN: Let me suggest to you I have prepared a draft report and recommendations for sharing with the Committee, the Subcommittee at an appropriate time because I knew this was going to be a very hard thing to do and what I can tell you rather than relating it to you is I can give you the five questions that I tried to address in here and see if it addresses the issues that you want.
Should individuals have the option of having their health records maintained only in paper form? Should individuals have the option of not having their health records part of the NHIN and if so should there be an in or opt-out provision? Third, should individuals be able to exclude certain health information from their EHR or the NHIN and if so what if any limits should apply to these exclusions?
Fourth, should any limitations be placed on authorized access to personal health information in the NHIN for medical or non-medical uses and if so how should such limitations be developed and applied and fifth what other measures are needed to protect privacy and confidentiality of personal health information in the NHIN and to assure the public that their health records are protected?
MS. BAUR: I missed that last part.
MR. ROTHSTEIN: Okay, fifth, what other measures are needed to protect the privacy and confidentiality of personal health information in the NHIN and to assure the public that their health records are protected?
I think those were the five issues that we talked about and it really doesn’t matter whether you agree with what is in this document, but if that raises the issues sufficiently and people are okay with that, then what we could do is we could get this out in some form and then invite people who want to testify in San Francisco to contact us and then we can put together at least 1 day of sort of commenters.
We could give people 15 minutes each or whatever and that way one of the frustrations that I got from our first three rounds of hearings is that most of the people who testified, 90 percent of what they had to say had no relevance to what we were considering because they wanted to talk about the HIPAA privacy rule and why it stunk and whatever and we didn’t want to, you know that is not why we were there and if we tell them you have got 10 minutes to address any element here, tell us what you are interested in then we might have a panel of people talking about No. 5 and a panel of people or whatever.
So, that is just a thought. So, I will go Maya, Paul, and then back to Marjorie.
MS. GREENBERG: I just had a clarification.
MR. ROTHSTEIN: Okay, sure.
MS. GREENBERG: My clarification was are you suggesting just sending out these five questions or sending out your document because I mean if your document includes recommendations, etc., even if it is a straw man you can’t do that.
MR. ROTHSTEIN: We could send out the five questions.
MS. GREENBERG: Just the questions I would say or maybe some background, I don’t know but I mean once anything gets out there from the Committee it takes on a life of its own.
MS. BERNSTEIN: Thank you. That was point 1 I was going to make. Point 2 is that this gives me a feeling like an RFI to which we had 500 or so responses and I am guessing that just looking at the time line aside from whether it is a good idea or not a good idea I mean I think you have quite well articulated the questions that we want to deal with, but I am just worried that we are going to have more witnesses than we can put in for 15 minutes apiece because if the same number of people want to respond to those kind of questions that responded to the RFI which I think is not unlikely we will be in a position of first of all picking or choosing who gets on the schedule which would be problematic and also not being able to assimilate the responses for you, I mean as the staff just having the time to assimilate the responses for you in a way that will be timely for the report that you want to do in the fall.
MS. GREENBERG: I assumed you were suggesting that you would ask specific kind of opinion leaders from the different —
MR. ROTHSTEIN: We could address some of the people who have testified at the first three hearings, other people who expressed an interest in testifying that didn’t get a chance to testify in our prior hearings and other influential individuals and organizations that we have identified but that is an approach. I am willing to hear others.
The only thing that I think that I am, well, what I am more confident in than this approach is that there is not a huge subject matter body of information that we haven’t heard in order to come up with sort of approaches to the problem.
We have heard from lots of good people. We have had a lot of written testimony. We have heard from lots of different countries and from all over the United States and I think we should be having ideas gel. They may be half-baked ideas but we should be getting this moving along.
MR. REYNOLDS: I like your idea. I like your questions. I think we should, you and Maya should work together and pick what is the best subset of the people that have already testified and they can come back and address the questions.
If we open it up again it is a free for all. I mean you are liable to get anything.
MR. ROTHSTEIN: We may also need to have a short time period for public statements like we usually do and give everybody who wants to show up 2 minutes.
DR. TANG: I really like your idea. I think your questions are well formulated. They come under the basket of control. I might add one other thing because I am struggling, like you.
How are we going to learn what recommendations to make, and the other challenge instead of just answering these questions and there are pat answers to these questions of feelings is ask them to also portray what would it look like to them because that will ask them to think about some of these logistical and practicality issues because you can give one answer. I want total control and I want total audits.
MR. ROTHSTEIN: That doesn’t help.
DR. TANG: Right.
MR. ROTHSTEIN: So, we could say,”Here are some of the questions we have and how could you answer them in the context of some sort of feasible, workable system?” That is not the most confident look I have seen, Maya. For those of you listening Maya looks dubious.
Do you want to comment on that expression?
MS. BERNSTEIN: No. I am looking at Mary Jo. I am just thinking about practically how it will work for you in trying to get the right people.
If part of the issue is you don’t think that you have gotten the answers that you want or that there is some piece missing then going back to the same people who have already given you 90 percent answers that are not relevant to you might not be that helpful but I appreciate that you are going to try to get them to focus by giving them these questions to respond directly to.
MR. ROTHSTEIN: I think what I would like to do is let us say, you know, we send five questions to Dan Rody and say, “Look, would you have some response to these five questions?” not do you have views on health records but would you like to tell the Subcommittee something about your personal views on these five questions and how they could be addressed within the NHIN and he might say or somebody else, “Well, I told you what our view is.” Now we go to somebody else but that is what we need to do is give them the questions and then invite them at the same time.
MS. BERNSTEIN: Is it your intention that whoever it is that you think will have a helpful response will show up in San Francisco and we will have a hearing in the way that we have had the last three to show up and speak for whatever the period of time is and respond to questions from the Subcommittee or they would turn in written responses?
MR. ROTHSTEIN: Ideally they would come to San Francisco but if they can’t make it and they want to send us written comments I think that would be helpful, too.
This is going to be one of the most important things that this Subcommittee has ever done and maybe that the full Committee has done in a long time in terms of these recommendations and that is why I am willing to contemplate a sort of a method that we haven’t used before sort of a more structured interview or structured presentation from key stakeholders.
MR. HOUSTON: I agree with the approach. I think it is good. I think we should circulate the questions and everybody respond to them and make sure that we are not missing something or that it is you know really they are crafted in the right way.
MS. BERNSTEIN: Circulate to whom?
MR. HOUSTON: This Subcommittee. I, personally believe we shouldn’t limit ourselves to people who previously testified. I really think we need to look at others who might provide insight that maybe wouldn’t have thought to testify before.
MR. ROTHSTEIN: How are we going to identify those other people? I am convinced that just putting it in the Federal Register would be just awful.
DR. DEERING: I had a suggestion that you not limit it just to the people who have testified to your Subcommittee but to people who have testified on the PHR and on related issues over the past even 2 or 3 years because these things have been percolating for quite some time and I think that widens it somewhat but it is still controlled. So, that is one concept.
MR. ROTHSTEIN: And maybe people who responded to the RFI —
DR. TANG: Can we get that?
MR. ROTHSTEIN: We can get that.
MS. BERNSTEIN: I believe it is on the web site now, is it not?
MR. ROTHSTEIN: Steve?
DR. STEINDEL: I actually was going to comment on that because there have been some very RFI responses that directly addressed this. I don’t know if they are public on the web site yet.
PARTICIPANT: They were asked.
DR. STEINDEL: I know and I don’t know if they have been posted.
MS. BERNSTEIN: My understanding and I haven’t checked the web site but my understanding is at the time that the summary report came out they were out.
DR. STEINDEL: No, they didn’t post them then.
MS. BERNSTEIN: Okay, well there has been a FOIA request for them. So, they will be forthcoming at some point with proper exemptions if they are required but, Paul?
DR. TANG: I think it is a good idea to draw from the RFI because people put a lot of thought into it just like asking HIMA would be a good idea. I think there is a good pool of candidates to ask.
The other enhancement to you process perhaps is get the responses in writing let us say a week ahead of testimony and the reason is because Mary Jo put out questions for them to answer at this latest PHI hearing but they didn’t answer those questions.
So, maybe an additional filter is to actually get the responses so you can actually tell whether they are being responsive to your questions.
MR. ROTHSTEIN: But then it is hard to gong them after you don’t like what they sent in .
DR. TANG: No, when you invite them you say what you said. Can you respond to these questions?
MS. BERNSTEIN: Just practically you cannot make private companies answer the questions you want them to answer. They have an opportunity to give you input. They will give you the kind of input they want to give you and that is what you will get.
I mean just practically they will use it as a forum to tell you what it is they think their message is and so while you can guide them and attempt to get them to send you the kind of responses that you think will be most useful there is no guarantee that those will come in.
The other thing I want to say about the RFI is that we of course did look to the respondents to the RFI to find out who had already done some significant thinking about it and I am not trying to throw cold water. I mean I am sounding like I am throwing cold water on it but just to take the other sort of you know devil’s advocate point of view.
We did look to the RFI for people who had done significant thinking about these issues and drew from that witnesses for the hearings because we knew that those people had significant thinking about it, and I think another piece of what I am hearing is you don’t feel like you have gotten from the hearings that we have had what you really want. Maybe we should brainstorm a little bit about who we haven’t heard from, who might not have responded to the RFI. I mean you are shaking your head but who is out there that might be useful for us to hear from?
MR. ROTHSTEIN: Sue?
MS. MC ANDREW: At least in terms of some consumer advocates interested in privacy, I mean the Secretary did have a meeting with several people and I am sure that invitee list is available as a pool of people. I am sure not all of them have testified before the Committee but that would be another source of people that are interested in this privacy and the NHIN.
MS. BERNSTEIN: Several of them have responded to the RFI.
MS. MC ANDREW: Some of them may have done that as well.
MR. ROTHSTEIN: Mary Jo?
DR. DEERING: Did I just lose my thread? Oh, for Pete’s sake. Come back to me.
MR. ROTHSTEIN: You see there is a time when you want other people to have their hands up.
DR. DEERING: It had to do with how this would work and I guess I was responding to Maya who said that she sensed that the issue was that perhaps they had not heard from everybody and the way I heard Mark frame it that everybody seemed to respond very affirmatively to was it is a narrowing down of a key issue that is absolutely central and on that topic we have not heard sufficient clarity and diversity and input.
MS. BERNSTEIN: So, you haven’t heard the right thing on that.
DR. DEERING: On that particular array of issues and I think I certainly resonated very strongly. I thought you hit the sweet spot with those questions especially if we can take a look at them and refine them.
So, I think that that is logical and I think what one can always try to do in sending out these requests because as I understand it there would be people who just submit written requests and then there would be people who we will openly invite to testify.
That second piece to me is the logistical difficulty for staff and for you to figure out exactly who do you just say, “Please answer and then we will invite you to testify,” because I don’t think there is enough time to actually get this call out, get some thoughtful responses, have staff and Committee members sift through those responses and then determine their speaker list.
MS. BAUR: Could I just follow up on what Mary Jo said?
MR. ROTHSTEIN: Please?
MS. BAUR: I just wanted to add a little perspective from my own experience lately. I have been trying to go through this process of putting out for response through a contract mechanism fairly innovative ideas in designing consumer health information resources and after having gone through two rounds of trying to solicit bids from government contractors what the reality is is that I find that these companies haven’t even thought about the problems from this perspective and I am wondering if perhaps there is a little bit of that in what you are saying that partly it may be that you haven’t heard from everybody but another way to think about it is that people haven’t actually thought about some of these things particularly in the way that it is being framed by the Committee.
So, I am wondering if it is true necessarily that it is a problem of just not having gotten the right people or that because some of the things you are thinking about are so cutting edge that other people haven’t thought about them and that sometimes even posing the questions doesn’t necessarily elicit it because they haven’t gotten the benefit of sort of the collective thinking that goes on in a situation like this in the Committee.
MR. ROTHSTEIN: I think you have really put your finger on it. We have heard from really excellent people but I am not sure they knew what we wanted to hear because I am not sure we knew what we wanted to hear but now maybe we do know what we want to hear and you also may be right that the we have framed these questions is not the way that they have thought about these issues in the past.
These are sort of looked at more from the patient’s side and they may have been looking more from the provider’s side or the RIO side or whatever and so maybe they would have the same people that we heard from before would have vastly different things to say if they saw that we are interested in these questions.
MS. BERNSTEIN: I think that is probably right. I think that in the case of some of the associations we heard from, the provider associations for example they just didn’t yet have developed policies that they could articulate to us.
They just weren’t there yet and they could articulate perhaps some other questions that they were coming across and we heard some of that but they weren’t ready to take a position in the way that you are asking them to.
DR. DEERING: This is Mary Jo. If I could jump in picking up on these last few threads what I am sensing especially, Mark since you reaffirmed that in fact it does seem like people haven’t actually done the thinking and then as Maya points out anyone who stands up and officially testifies on behalf of an organization or a company by definition has to get it cleared.
So, therefore it has to be a pre-existing policy or they have to make it up on the fly and so that suggests that in fact it may be difficult even through this more innovative mechanism to get that kind of quality of response innovative thinking response from those kinds of speakers.
So, maybe what we send it out to are people who are untethered to abscond with a phrase, academics and experts and say that we really want to put to you as experts who don’t need to go to any authority behind you to make sure that it is blessed but get your best thinking on these cutting edge questions that are posed by the NHIN.
MR. ROTHSTEIN: We are running out of time and there is no reason that we have to go to five-thirty exactly. Let me make a suggestion? The members of the Subcommittee know who are witnesses have been.
If you have any other suggestions of people who were not on any of those panels who you would like to hear from please send Maya an e-mail with their name on it.
Also, there may be people who you have heard from who you thought were really sort of thoughtful and you would like to hear them address these issues or particular groups that are especially important that we hear from and so if you could identify those for us as well that would be helpful.
We have a day and one-half in San Francisco because the Executive Subcommittee is meeting for a day and one-half and we have the afternoon of the second day and all of the third day.
MS. BERNSTEIN: Actually the room for the next day but people may want to leave.
MR. ROTHSTEIN: People may. So, we can leave open the issue of whether we are going to meet for two halves or three half days depending ont he response for this. If we only, that is if we only take witnesses for two of the three sessions then we will use the third session for subcommittee discussion. Otherwise we will put off the subcommittee discussion until the September meeting of the NCVHS.
DR. DEEMING: My only suggestion was that if you were not the Subcommittee Chair you would probably be a very excellent speaker on this and so I would say let us put it out to people who you can think of. I hesitate to say your peers because —
MR. ROTHSTEIN: I did have several of my peers testify at the very first hearing. You will recall Tom Murray, Bernie Lowe, all those people at day one and so I will be more than happy to contact them and ask them if they, certainly Bernie is out there in San Francisco and it would be very easy for him and maybe some other folks that I know on the West Coast who are sort of respected bio-ethics, health policy types and we could use them.
MS. BERNSTEIN: If the people that you look to happen to be on the West Coast or let us just say west of the Mississippi that would be most excellent or in the Southwest of Canada for example or other places like that they could easily get to San Francisco. Think about those people.
MR. ROTHSTEIN: I know. Marjorie and Ed are sort of still, their aura is still here and I wouldn’t want to spend all their money.
The other think I want to ask the members of the Subcommittee is the following: I will distribute to you via Maya next week the five questions. Do you or do you not want my proposed answers?
DR. TANG: Your proposed answers on our behalf?
MR. ROTHSTEIN: No, well, yes, exactly.
DR. TANG: I would be interested in looking.
MR. ROTHSTEIN: It may be that you don’t want to hear them because it would bias you from whatever.
MR. HOUSTON: All of us are going to have our own answers to the questions and just sitting on the Subcommittee I think we sort of interject some of our own opinions even though we are listening to testimony.
I think we also try to use our informed positions on these subjects to fashion our responses in our letters.
MR. ROTHSTEIN: Okay, so, I will just send it all out. There is nothing in there that is going to shock you. It might shock you but it wouldn’t surprise you.
Anybody have any other business items for today? I just want to note a couple of things that we need to be thinking about for the fall hearings.
MS. BERNSTEIN: Could you put a deadline before we leave that topic on when you want the Subcommittee members to send, to identify the people that they might like to hear from because if you want to try to get responses for example a week in advance or we want to really nail down the people we want we should get on it?
MR. ROTHSTEIN: Okay, you will have the document next week and how about or maybe Friday. I need to get back to my office. How about if we give you 2 weeks from receipt?
DR. TANG: No, 1 week.
MR. ROTHSTEIN: One week from receipt, okay, that is fine. So, a week from when you receive it and you might have it Friday.
DR. TANG: This is basically reacting to the five questions.
MR. ROTHSTEIN: Correct, you don’t have to comment on my proposal, just the five questions, if you want to tweak those plus the — and then suggestions for other people.
MS. BERNSTEIN: Okay, so nods around the table. Yes? Okay.
MR. ROTHSTEIN: Mary Jo is that your —
DR. DEERING: No, I have an NHII business issue that I need to put on the table if it is appropriate. I wanted to remind or tell people on the NHII work group that we did poll for a conference call and it will be July 14, eleven to twelve-thirty Eastern time.
We will send out further information and a reminder that one of the reasons we did this is that CMS is having I guess they call it an open door forum specifically looking at personal health records and they have solicited the Subcommittee’s input and Simon I believe will be making a presentation and while Paul drinks red wine in France and so we will be taking a look at what we have got here, what we think would be appropriate to share with them and then a reminder again that we are meeting July, I think it is 27 and 28 from 1 p.m. to 1 p.m.
MR. ROTHSTEIN: Thank you. I just want to remind everyone that our fall hearing schedule that we previously approved has the following topics on it, minimum necessary notice of privacy protections and acknowledgements, amendments and accounting for disclosures. Those are four HIPAA issues plus the issue of patient identification and OCR data collection.
MR. HOUSTON: One of the things I wanted to bring up is I sort of propose that maybe we spend a couple of hours or however much time with OCR maybe to talk about some of our data needs.
It is something that you and I talked about a little earlier. I don’t know if that something OCR would consider or not but it would be nice to sort of sit down as a Committee and work with OCR to see if we can try to give you an idea of what we would like to try to see from a data perspective.
MR. HADLEY: We could talk with Sue to see if that is possible.
MR. HOUSTON: Could you take that back, again, nothing other than just I think sort of on an informal basis sit down and sort of go through it.
MR. ROTHSTEIN: Okay, if there is no other business thank you all very much and the Subcommittee meeting is adjourned.
(Thereupon, at 5:25 p.m., the meeting was adjourned.)