[This Transcript is Unedited]
OPERATOR: Good morning. This is Em (ph) in the Berryham Center (ph), and I’m manning the recorder to Mr. Mark ROTHSTEIN's conference call.
MARK ROTHSTEIN (ph): Hello?
HORLICK (ph): Hello?
JOHN FANNING (ph): Hello. It's John Fanning (ph).
ROTHSTEIN (ph): Hi John (ph). It's Mark ROTHSTEIN (ph) and Gail (ph) and Kepa Zubeldia (ph)..
FANNING (ph): OK. Standing by. It's going to be an exciting and interesting discussion.
ROTHSTEIN (ph): Well, we'll try to live up to that, John (ph). So we're waiting for Simon (ph) and Richard (ph) and Jeff (ph) and Paul (ph), and I take it Marjorie (ph) is not going to be able to make the call. Is that right?
HORLICK (ph): I thought Marjorie (ph) was going to make this call. I thought it was another one she couldn't make.
ROTHSTEIN (ph): OK.
HORLICK (ph): I might be wrong.
MARIETTA (ph): Hi. This is Marietta (ph). I just picked up and Marjorie (ph) is in a conference in Bethesda all week. I don't think she's going to be able to make this call.
ROTHSTEIN (ph): OK. So, given that, we need to introduce ourselves. I'm Mark ROTHSTEIN (ph) from the University of Louisville, the Chair of the Sub-Committee on Privacy and Confidentiality on the National Committee on Vital and Health Statistics.
SIMON COHEN (ph): I'm Simon COHEN (ph). I am a practicing physician in the National Directory for Health Information Problems, (INAUDIBLE) and a member of the committee and sub-Committee.
KEPA ZUBELDIA (ph): I am Kepa Zubeldia (ph) (INAUDIBLE). And on the committee and sub-Committee.
FANNING (ph): Gail (ph)?
HORLICK (ph): Oh, I was waiting for Mark (ph). I'm Gail HORLICK (ph) at CBC Staff for the sub-committee.
FANNING (ph): I'm John Fanning (ph). I'm in the office of the Assistant Secretary for Planning and Evaluation of HHS (ph) and I'm back-up staff and here as a resourcer.
ROTHSTEIN (ph): Are there any other people on the call who want to identify themselves?
MARIETTA SQUIRE (ph): Marietta Squire (ph). I'm the support person for the sub-committee and I work at NCHS (ph).
DEBBIE JACKSON (ph): Debbie Jackson, NCHS.
PATTY HOFFMAN (ph): I'm Patty Hoffman (ph) with American Home Patients.
ROTHSTEIN (ph): OK. Welcome. Anyone else? OK. This morning is to go over the last two subject areas that we did not complete in our first letter to the secretary, and those are research and marketing. I assume all the members of the sub-committee who are on the call, that is Simon (ph) and Kepa (ph), that you both have received a copy of the latest draft document on research and marketing?
COHEN (ph): Yes.
ROTHSTEIN (ph): OK. So for the benefit of those people who don't have it, and I suppose when and if Jeff (ph) gets on, what we've been doing is just reading through it and then taking comments and language changes and such. OK. Let's begin with research, point one, which is now overview/identifying data. I will read the first paragraph it currently reads– Overview: The Identified Data - and then we'll take suggestions for revisions and, in fact, I have made a number of revisions throughout. And...
HORLICK (ph): Excuse me Mark (ph). Before you get started, is this a different– is this the one that went out with the conference call? With a notice about the conference call? Because I'm– mine just says overview.
ROTHSTEIN (ph): There was a revised version which– is this the one with the strikeouts and...
HORLICK (ph): I don't have that.
FANNING (ph): I don't have that. Unless it came out this morning. Did you send it out?
ROTHSTEIN (ph): No, this came out a long time ago.
HORLICK (ph): Oh, wait a minute. Wait, wait, I think– OK. I have circulated, let me just tell you, what I have circulated– you remember on the last call, we had the four issues in the letter. And so– and that should have strikeouts and so forth. So I just cut and pasted the last two sections in this new document and do there aren't, you know, strikeouts.
ROTHSTEIN (ph): So this doesn't have the strikeouts?
HORLICK (ph): Right, but it doesn't say overview the identified data.
ROTHSTEIN (ph): What's it say?
HORLICK (ph): It says research number one overview. That was just straight out of the last letter. But I thought it would be easier to read without...
ROTHSTEIN (ph): Does it begin by saying, "all the oral testimony?"
HORLICK (ph): No. Mine begins "witnesses express concern."
FANNING (ph): That's the one I have.
KEPA (ph): Gail (ph), did you send that today?
HORLICK (ph): No, no. What I sent was– well, I sent it out last Thursday. Marietta (ph) had to send it out last Thursday. If what I hadn't done anything from the original letter we did, other than cut and paste it without the consent and made it unnecessary and by putting it out on new paper, it sort of just got rid of the underlining part, or whatever. I mean, there's no changes, so I don't know what draft Mark (ph) is referring to.
KEPA (ph): Well, maybe Mark (ph) fixed up a presentation for us, or a...
COHEN (ph): No. Maybe Mark (ph) fixed up an old version that's already been fixed. Would you– can we take a one minute break. I'll see if I can get the address...
HORLICK (ph): And I'll put out my notebook in see if I can figure out...
COHEN (ph): Who just came on the call?
DAVID WARNER (ph): David Warner (ph).
COHEN (ph): Hey there David (ph). Welcome.
DEBBIE (ph): Hi. This is Debbie (ph). While we're waiting, could I remind everyone to state your name as we proceed with the commentary. When we had the transcript from the call, they're not able to foresee us, so all they can go by announcement of our names. Because in the September meeting, we had some real problems with names not in there. So that would be helpful.
ROTHSTEIN (ph): OK. This is Mark. I do have that other version. That comes from the September 17, 2001 draft to Secretary Thompson, which included the consent and minimum necessary provisions, the weekly draft version of that.
HORLICK (ph): Hey, all I did was just cut and paste it on a fresh documents, but I didn't make any changes.
ROTHSTEIN (ph): OK. Now does everyone else have this back version?
FANNING (ph): This is John Fanning (ph). Do I understand that this is the one that Marietta (ph) sent out on October 18 at 10:43? OK. I hate to– this is John Fanning (ph). I hate to play the old grumpy bureaucrat here, but the lesson learned from this is always put a date on the top of every document and mark it draft, all right?
MARIETTA (ph): Thank you.
FANNING (ph): I've made my contribution, and I'll probably hang up now.
ROTHSTEIN (ph): That's a good contribution. OK. So we now have a document that begins by saying "Research Number One Overview." Correct?
FANNING (ph): Right.
HORLICK (ph): Correct.
ROTHSTEIN (ph): OK. Everybody's on the same document.
COHEN (ph): And Mark (ph), before you get started here, I think that you will see there's various "ors" here. And I just need a little clarification because my memory's failing me. Are these "ors" for each paragraph that are related to...
HORLICK (ph): "Ors" are alternative language.
COHEN (ph): For the actual paragraph?
HORLICK (ph): Right. That would just go right where I guess where the star is,or...
COHEN (ph): OK. So it's not just a sentence replacement?
HORLICK (ph): Yeah. When I sent out your e-mail draft, some people painted it. Well, no one had a chance to review those changes. But that's what it is. It's like what we had and then what was suggested.
COHEN (ph): OK. Just for clarification. Thank you.
ROTHSTEIN (ph): OK. Here– and given this version is the fact that there's so much confusion, it's obvious that what we're going to probably achieve today, if we're fortunate, is an agreement in principal on what we want to do. And then we will send out another draft with the date on it that reflects what we're trying to do and then we can worry about changing the language as needed, even before we get to the full committee meeting.
HORLICK (ph): I figure that's one procedural question. When we– the next letter that goes out will be a draft letter with– to the Secretary, would we then, sort of, be the introductory paragraph in reference, you know, on October 1, we sent the first letter? The first two issues and then this letter is the other two? OK.
ROTHSTEIN (ph): Right. I think that's what I would recommend and of course, that decision will ultimately be up to John (ph) and the full committee.
HORLICK (ph): But I mean that's what the next letter...
ROTHSTEIN (ph): OK. Here we go. Witnesses express concern that the cost and administrative burdens involved in compliance with the privacy rule will have a detrimental impact on researchers’ access to essential medical information and on their ability to pursue their mission. I'm just going to skip wherever it says “see below”.
One witness recommended revising the rules to include research as an activity for which covered entities are allowed to disclose for technical information without patient authorization, along with treatment, payment and health care operations. NCVHS (ph) does not support this recommendation and, of course, when we redo this, we're going to redo it in the same format as the last letter where that sort of stuff is pulled out in the recommendations.
COHEN (ph): OK. Can we have– John (ph), is this open for discussion now?
FANNING: Yes.
COHEN (ph): OK. I think, I mean, you know, it's just 7:00 in the morning (INAUDIBLE). But I'm finding this– a lot of this stuff to be very confused, because a lot of the concept seems to be sort of the co-mingled together. I just fully agree that the first sentence is probably a very good sentence. I'm having a little trouble figuring out how to narrow it out to the second sentence. And I think the second sentence seems to be one of the many options described by researchers that they proceed to make things easier. And I guess that would even, from my view, but my question whether that would actually even make things easier, because I thought about it. I don't know if we want to discuss that, but I– I think the first sentence is basically a good one. The second one I'm sort of scratching my head on.
HORLICK (ph): You might want to– well, in that other letter, just going back to the second one. What we did is sort of enhance a paragraph or two, you know, on the overview of each issue. In this case, the issue, unless we structure differently, it would be research as you know, for consent, and as necessary, we sort of broke it down.
But then we have to decide if there are specific aspects that you want to write down, so if you read the first sentence, and then you go to where it says "or" right below it in italic, that's sort of a little more elaboration on what the different panelists were expressing concern about.
COHEN (ph): OK. Mike (ph), I guess my thought is that it seems like we ought to have a sentence or two of introduction, rather than a one sentence of introduction and then start throwing in what various witnesses were describing. And I think there's a whole set of issues here.
One of them is sort of access information, which has to do with I think with this issue around– gee, should it be– the problem that is part of the solution here is like here's half of an issue and one of the solutions offered with this, and then there's the issue of de-identified data and confusion regarding that, that's another issue. And I think these are all issues, aren't they?
ROTHSTEIN (ph): Yeah.
HORLICK (ph): Those are two topics. I can certainly manage those. We sort of gave a broad specter of what kind of tests are in the (INAUDIBLE) and then we took the issues. In other words, some said we institute content and others said to get rid of it. And then we said OK, I'm not going to see access. OK this. And here's what we heard. So we might want to parallel that structure.
ROTHSTEIN (ph): Well, I agree. And if you take a look at the following page, the same language is contained in the fourth paragraph, where it says, "or a panelist recommended dividing the..." blah, blah, blah. That's the same thing. So I think what we ought to do is simply delete from the place where it is now, that sentence that begins "one witness recommended." And just take that out and we'll take the issue up when we get to the recommendations at the end.
HORLICK (ph): But first what we want to do is that overview of the testimony on research in general? That's what I was...
ROTHSTEIN (ph): Yeah. I think...
HORLICK (ph): I'm sorry.
ROTHSTEIN (ph): I think we're all in agreement.
COHEN (ph): OK. Good. And where is the– oh yeah, the fourth paragraph of the first page? Where is it?
ROTHSTEIN (ph): It's the last paragraph before number two, recruiting research subjects.
COHEN (ph): OK. We're getting– this issue of (INAUDIBLE). That's fine. I'm happy to consider it down there.
ROTHSTEIN (ph): OK. So we've just taken that out and now we go to the next paragraph.
HORLICK (ph): Wait a minute. So what I'm seeing is that we have the first sentence in the overview section "whatever express concern." That's...
ROTHSTEIN (ph): Right. That ended with the word "mission."
HORLICK (ph): Right.
ROTHSTEIN (ph): OK. And I think everyone's OK with that, unless there's...
KEPA (ph): I think the problem that Simon (ph) is having and I'm having too is referring in the overview to one witness here and one witness there. I kind of wanted to avoid that kind of reference to one witness specific in the overview. Because it goes with the generic information.
HORLICK (ph): Well, I thought we did by moving that one witness to deal with it later. I thought all we had was...
KEPA (ph): Well, we had the same problem at the very bottom of the (INAUDIBLE) and said all. It finally recommended revising the goal.
COHEN (ph) Yeah. We haven't gotten to that yet. We're going to get to that yet Kepa (ph). We may want to change that, you know, when we get there. My question is is the sentence that begins "weaknesses", the very first sentence, and then using the word mission, is that OK?
ROTHSTEIN (ph): Yeah. I think that we may want terms to change "will" to "make."
COHEN (ph): OK. May have a detrimental impact?
ROTHSTEIN (ph): OK.
HORLICK (ph): Now, do you want to look at the sentence that ends in italic, after the or and...
COHEN (ph): Yes.
HORLICK (ph): Is that generic enough?
COHEN (ph): Well, I think now that we are...
ROTHSTEIN (ph): I think that's that another issue that needs to handled later.
HORLICK (ph): OK.
COHEN (ph): Traditional, I think.
HORLICK (ph): OK. So you mean the whole introduction is only one sentence?
COHEN (ph): Well, I'm wondering actually if it goes to the second full paragraph, which looks like it also, at least, the first sentence looks like part of the introduction.
HORLICK (ph): Oh, OK.
COHEN (ph): I mean, I don't know. Mark (ph), you're going to have to help on this one. I'm not the– I mean, I'm pretty good at editing but I mean...
ROTHSTEIN (ph): You see, this version– I'm not sure– this version has repetitions, because if you go to the second and the fourth paragraph, they begin the same way, particular concern was expressed. You see those were the same, pretty much?
HORLICK (ph): Because the part that's not in italic is the way I wrote it originally. But then somebody else with italic said we could put that– what's in italic– right up there in the beginning. So that's why I've got it both ways.
COHEN (ph): I see. Yeah.
ROTHSTEIN (ph): Gail (ph)? A question? Did anybody say anything good about the privacy rule on the research panels?
HORLICK (ph): Yep.
COHEN (ph): OK. Well, we might want to put a sentence somewhere early on about (INAUDIBLE) opposed to easily jumping into the set of concerns. It isn't by way of introduction. I mean, you don't have to (INAUDIBLE) right this moment, but it might...
ROTHSTEIN (ph): The sentence is if you go to the paragraph at the end, "is also concerned about civil penalties" and then the third sentence in that paragraph says, "on the other hand, a written testimony expressed reviews the privacy rule will build public trust and research and help insure that research has received complete and accurate health information for their study in this testimony", blah, blah, blah.
COHEN (ph): Yeah. We might want to put that early on and...
HORLICK (ph): Mark (ph), that was really not the bulk of the testimony, so I thought I would, I mean...
COHEN (ph): But I thought...
HORLICK (ph): But, I mean, we could put that at the end of the first paragraph.
ROTHSTEIN (ph): Yeah. So we can move that up and those two sentences, beginning with "on the other hand" to the– in the introduction so that we would round that off. So...
HORLICK (ph): You want that whole paragraph or do you want the penalties?
ROTHSTEIN (ph): No, no. Just the "on the other hand."
HORLICK (ph): OK.
ROTHSTEIN (ph): So that would go to “witnesses express concern", but on the other hand, there was some written testimony that praised the rule and the department.
HORLICK (ph): I understand. The only reason I said the penalties is because the concern about penalties is a different concern than the cost and administrative burdens and those were other concerns about the words (INAUDIBLE), but I don't have strong feelings about it.
ROTHSTEIN (ph): Yeah. Maybe after we have that introduction though, we can talk about the specific areas of concern.
HORLICK (ph): The first paragraph would be the first sentence and ending with admission, and then "on the other hand," the third?
ROTHSTEIN (ph): Correct.
HORLICK (ph): OK.
ROTHSTEIN (ph): And then we go to the particular areas of concern. Those areas, the first one was the use of de-identified information. So we can now go to– I don't know which one to go– there are two different versions. One says, "particular concern was expressed about (INAUDIBLE) using the identified information for the research".
Several panelists indicated that stripping the date of identifiers as specified in the regulations, whether a date is an essentially useful for research, there was also concern that the alternate engagement (INAUDIBLE) as a practical matter, research would be impossible.
You know, I think we should talk about the de-identifying issue or...
DAVID (ph): Yeah. Let me tell you how I re-written this and see if you think maybe that's more in line with your thinking. I have several panelists indicated that stripping the data of identifiers as specified in the regulation would remove so much information as to render a data of satisfactory use for research.
There was also concern that the alternative of engaging at that efficiency to direct the identification process would prove so burdensome that, as a practical matter, the identified research would be impossible.
The result would be that there showed all research would be on an individual identifiable basis pursuant to authorization.
ROTHSTEIN (ph): I agree with what you're saying. I'm actually reading through this as rough, you know, a little bit on the de-identification discussions. And I think my observation on this one, in addition to the things you said, which I think are all right, I am in agreement with, is that there is a fundamental confusion around de-identification in relationship to both (INAUDIBLE) de-identification and there's also, I think in the research community, I have a call out to somebody to see whether it's referenced in the common rule or not.
But there's also several more common set of de-identification that (INAUDIBLE) research community, but it just removes an identifier or take the names out or take the words out, birthdays out, or something like this. And I think everybody sort of typically uses that level of de-identification for a lot of the research that they do. And that's something we would want to continue, because that's sort of a lonely concept that's not even necessary.
Even when you do research, you should not be using more data, exposing privacy risks, more than what you have to do. But that is not the same thing as de-dentification in the (INAUDIBLE) world. And I actually keep wondering in my own mind whether there's really any intent for research to be done except in the most abstract form, truly using de-identified data according to (INAUDIBLE). Because when you think about it, the data implication in (INAUDIBLE) is really saying that you de- identified at this level if your kind of, sort of freely de-identifiable and not subject to any protections.
DAVID (ph): Well, I think the problem as I see it is the following. When they put the roll together, they were concerned that what currently passes for de-identified information can be, in many instances, readily re-identified and that to escape (INAUDIBLE) provisions that is being de-identified, and not there for protective health information, you have to remove X, Y and Z.
Well, the fact of the matter is, that when you take off so much stuff, it makes it very impractical to use the research and the information anymore. So in protecting privacy which we all want to do, the rule has the effect of actually discouraging use of de-identified information, because you can't use it in a way that's useful anymore, and the consequence is that research, instead of being better de-identified information, it's going to have to be identified information. And it sort of arguably, by going to such an extreme in the rule, we have now defeated the whole purpose of encouraging the use of better de-identification. That's my impression.
COHEN (ph): OK. Now, I guess I would ask you, Mark (ph). You may have a sense of this also is that in this current world, I'm talking about this world opposed to the new (INAUDIBLE) world, is that the de-identified data that people talk about is still relatively protected. I mean, people just aren't taking means off and then posting these– this information on Web sites or anything like that, or just sending them off, but these things of de-identified, but still being used under research protocols, IRV (ph) approval, common rule, rules, and all of these other things. Isn't that correct?
ROTHSTEIN (ph): Well, I think there is concern that there has been some abuses and that some information is being used improperly. There have been reports of– for example, pedigrees that have been published in journals where they haven't been sufficiently de-identified and people know who they are when the study is published, because it's a rare disorder, that sort of thing.
COHEN (ph): OK.
DAVID (ph): Well, I'm sort of agreeing with everything that you're saying, and I'm just trying to figure out what the, I mean, I'm still trying to dig down to figure out what the issue is, and whether or not there was ever really the expectation that this de-identified data would be being used routinely in research, or whether we're really now talking about three sorts of things.
You know, fully identified that sort of normal research de-identification, which I would agree with you, is not enough to make you feel real comfortable sending the data around. And then this full de-identification that is not subject to even the (INAUDIBLE). And obviously, that middle one is not in any way referenced. And it might even cause the firm out of confusion in the research community.
ROTHSTEIN (ph): Yeah. And I think that was certainly the testimony that we heard from Johns Hopkins and Genentech (ph), as you recall, those people that– one whole panel. That was their main concern.
COHEN (ph): Well, so, I mean, do you have any thoughts of any solutions around those...
ROTHSTEIN (ph): Well, the way– the recommendation that we have now is if you go to the very bottom where it says, "However, the committee recommends that HHS (ph) OCR (ph) provide additional guidance on the use of de-identified information for research." That practice is the specific example of said (ph) such statistical risk associated with various or assessing approaches for these would be particularly helpful. That's the way it is now.
We could add a sentence in there that, you know, recommends that HHS (ph) OCR (ph), we consider to make sure that the– that the provisions on de-identification are not so stringent that it's impossible to do de-identified research with the results stating that all, you know, most of the research would have to be in identifiable form, that sort of thing.
DAVID (ph) (?): We (INAUDIBLE) we could also, I think, encourage researchers to consider who is their data along with (INAUDIBLE) concept of minimum necessary, as has been prescribed for treatment payment in health care operations. And I don't know if that is helpful or more confusing.
That may be a more confusing concept in this context. I think that action which you're describing makes some sense. In fact, I am very understanding of the researchers' confusion regarding this, and I just said, I don't know the common rule well enough to know whether de-identified data is also discussed in the common rules. Does anyone know?
ROTHSTEIN (ph): It doesn't specifically talk about that, no. But there are statements on de-identification that have been published widely, such as from the National Biological Advisory Commission (ph). They have a report on when it's appropriate to use what forms of research.
DAVID (ph): OK.
FANNING (ph): This is John Fanning (ph). The common rule describes the human subject as a living individual about whom an investigator obtains data through intervention or interaction of the individual, or identifiable private information.
The problem is that prior to the– to this regulation, the (INAUDIBLE) regulation, there has not been very much– in fact, as far as I know, there was nothing in any legal type of action about what the standard of identifiability was. Now, we're sort of at the cutting edge, here, of specifying what identifiable means. So I just thought of that, for whatever help it gives.
DAVID (ph): So there's no help in the offing, huh?
FANNING (ph): No. The regulation and you people are the help.
ROTHSTEIN (ph): So, do we have an agreement in principal of such that it would be a way of proceeding for Gail (ph) and I to redraft, at least on this particular issue, something that reflects our general concern and then we can take another cut at it? I apologize. I'm very uncomfortable with the state of the draft that we're using because we're using, you know, sort of an amalgam here, and I'd like to take the initiative to try to get sort of a more unified dated draft out to everyone, so that we can at least work on it independently.
MARK (ph): Yeah. I mean, we need to have another conference call before the full meeting, but we'll see whether that's necessary or not. Yeah. I agree with the direction. I absolutely want to see exactly what the rest, I mean, you know, (INAUDIBLE) of the world can (INAUDIBLE) questions and what to do about it.
HORLICK (ph): Right. And I think, I mean, I have a– I think the rest of the letter is broken down more into what the issues are and then we can decide if there is a recommendation or not.
ROSTIEN (ph): OK.
HORLICK (ph): It's just because I got the most comments on this and I didn't know what, you know, you know, that more than one person commented on a draft, so I thought that was the best way to do it.
ROTHSTEIN (ph): All right. The second issue was about– you see where it says, "there was also concern of civil and criminal (INAUDIBLE) for the improper use and disclosure of information created just for an incentive to share information with researchers." And it would have the opposite effect. That certainly was stated to us but it's not something that we have chosen to act on.
HORLICK (ph): That's why I thought it would be good to just put it in the overview of concerns expressed, because then we don't have to really come up with a recommendation on it or highlight it.
KEPA (ph): I think it fits better in the section for "other concerns." The other of the overview. And it would have something at the end.
HORLICK (ph): OK.
KEPA (ph): It just puts too much emphasis on it and especially would (INAUDIBLE).
HORLICK (ph): I guess we can see if we have other concerns that would go in that same paragraph.
ROTHSTEIN (ph): Yeah. So we might want to move this and– because we have five points and, four points now. We might want to make this number five and then just say the NCVHS (ph) does not recommend any changes or whatever on this issue.
HORLICK (ph): Well, we can see as we go through if there are other concerns that we don't want to deal with that we want to just sort of put in a general paragraph, if that's the only one.
ROTHSTEIN (ph): Right.
FANNING (ph): Yeah.
COHEN (ph): We know that there's several recommendations here that goes along with the de-identified recommendation which is– maybe this doesn't need a modification to the rule. But I think everything I've heard from the research committee leads me to believe the general– either that OCR (ph) needs to really extend a hand to the research community and work with them closely to resolve their concerns and issues, especially along the level of clarification to reduce any of these perceived variables.
ROTHSTEIN (ph): Yes, I couldn't agree with you more. From my travels and talks, (INAUDIBLE) a very high state of anxiety.
COHEN (ph): Yeah. And a lot of this, I mean some of it probably going to declare modification to a lot of it. We're just not sure what this means, can you be a little more precise? Does that mean what I'm doing is OK or not or how do I– exactly how do I need to change it?
ROTHSTEIN (ph): Right. OK. We left unresolved the issue of the statement for the recommendation that– which is at the bottom of number one which we moved. With regard to the rule to include research and other activity for which cover under these are allowed to disclose PHR (ph) without authorization, or with PPO (ph). NCVHS (ph) does not support this recommendation.
COHEN (ph): Can I come in on that a little bit?
ROTHSTEIN (ph): Sure.
COHEN (ph): Because I see support review but I do think its the whole context which I think we heard a couple of times being expressed. I actually believe it's counter-productive in the sense that you think about it, at least my view of research generally is that research requires a disclosure, as long as you go through IRV (ph) and common, you know, IRV (ph) approval and all that doesn't require an actual authorization by a patient, as such, at least my understanding is that the data is not revokable, that there's not a consent issue in relationship to use of the data.
It's more of an IRV (ph) authorization whereas if you choose it to be included under treatment payment health care operations, some of that data becomes specifically revokable and consentable for the purposes of research.
ROTHSTEIN (ph): Well, there's another reason that I– why I think this is a really bad idea, is because no IRV (ph) that I can think of would consider a general, what we call front door consent, to be adequate for research. Because it's so informed consent, you don't know what you're consenting. You can't just say I consent to any research that you might do on me or any use of my records to anyone you want. And so, even if we adopted that, it would have no value whatsoever and I think it's a statement we just don't want to make.
COHEN (ph): Well, I think if you did this, it would supersede all of the parts of the rule that relate to IRV (ph) approval. In terms of, you know, the privacy boards, all of this stuff. It would become something where patients sign that they can have their data to be used for research by any way the organization wanted to or the provider wanted to, and that would be part of the payment information packet document.
So I (INAUDIBLE) agree with you. I think it has a lot more unintended negative consequences that are current by people recommending this. I think we just sort of need to sort out that there are, I mean, obviously, you want to give people– researchers reasonable acts as to research data and we don't want to wreck their areas, but this is not the solution to their problem.
ROTHSTEIN (ph): Exactly.
FANNING: This is John Fanning (ph). Let me just say that I think Mark has gotten it right. You understand that if something is described as identifiable and it's going to be used for research, under the common rule, even a researcher within the institution has to get IRV (ph) review. So I'm not sure where you get that, you know, you might make it work like pulling an operation.
COHEN (ph): So maybe we can flush this one out a little bi,t so that there isn't just a one-liner, it's like a reason, or do you think it's a bad idea?
ROTHSTEIN (ph): I think that's probably a good idea. In the next draft, there'll be some explanation of why this is really a bad idea. You know, it's the kind of thing that sounds good to, you know, an advocate, but if they really thought it through, I mean, it wouldn't give them what they wanted, anyhow.
So is there anything else? Now I think I have enough of an idea about how to redraft this paragraph, at least for the next draft, to move on unless somebody wants to add something else to number one.
OK. Let's move now to recruiting research subject. There's also concern that the rule does not allow providers without an authorization or prior permission to use protected help information e.g., patient prognosis of the departmental patient was seen to contact a prior patient for possible improvement for participation in clinical trials.
Absent prior permission, researchers are unable to search medical records of former patients or national databases to identify subjects with specific characteristics and/or diseases who would be candidates for a particular research study. And here's our recommendations. ACVHS (ph) recommends that HHS (ph) clarify the provisions regarding the roll of IRV's (ph) in the recruitment of subjects with clinical trials and other types of research.
COHEN (ph): Can I make a comment there?
ROTHSTEIN (ph): Yes.
COHEN (ph): I used to think that this was sort of a muddling of two different issues. I mean, certainly, I actually agree with– or sort of the first sentence, that you don't' want– the rule does not allow a researcher to contact a patient for possible recruitment without IRV (ph) approval. But I think that that's actually probably a good thing.
And I don't think there's any– that there's a defect in that piece, however, the rule the company does allow in the process in parts of designing a research trial, people ought to have access data without authorization. So, and I don't think that we are– we are not in favor of supporting having researchers directly contact patients before IRV (ph) approval to be involved in research trials, are we?
ROTHSTEIN (ph): The IRV (ph) would approve before they contact them.
COHEN (ph): That's right. But this is– well, that's right. I mean, normally, I think how it works. And the way this– the way this first sentence is characterized, it would almost appear that there's a problem with the current way things work on that.
ROTHSTEIN (ph): Right.
COHEN (ph): And on the other hand, there actually is authorization in the rule, in the law itself, to allow people to access the information so they can develop their research protocols without prior permission or authorization. So I'm trying to figure out what the problem is here. And then it goes on to the second sentence, which I think is actually wrong. Absent prior permission, researchers are unable to search medical records of former patients or national databases. John (ph), help me with this one. I...
ROTHSTEIN (ph): It's really– it's absent IRV (ph) approval and we wouldn't want it any other way.
COHEN (ph): Well, no. Actually this is something where you can do it in the process of making a...
FANNING (ph): (INAUDIBLE) Simon (ph).
COHEN (ph): I'm confused now. Section 512 (ph), I1. What page is it?
FANNING (ph): It's page 82816.
COHEN (ph): OK. I had it there and– so basically, reviews preparatory to research?
FANNING (ph): That's correct.
COHEN (ph): Covered entity. Uses or disclosure is solely to review protected held information as necessary to prepare a research protocol, or for similar purposes, preparatory for research. That seems to cover that issue. Am I mistaken?
FANNING (ph): That's there. It's the preparation of the protocol. You might want to do a study of every woman in the hospital in Baltimore County who’s had an elective caesarian. You can go down and look through some of those departments to see whether there's enough of them to make a project. But then if you want to– if you want to further use their record for an in-depth study, because that involves the use of disclosure for which IRV (ph) for plastic (INAUDIBLE).
And likewise, going to contact them, to ask further information, is the actual conduct of the research project which needs IRV (ph) or privacy board approval for use of the records.
COHEN (ph): Yeah. I guess, and John (ph), help me with this. Is that as I look at number two, I got number two, I mean, look at this again. I thought the second sentence is just wrong. Because actually researchers are able to do that.
FANNING (ph): That's correct. Not only have to have prior information, you have to have a privacy board approval.
COHEN (ph): But I see that these concerns to me is just, once again, serves the fact there is confusion.
HORLICK (ph): I believe, I think that I took that straight out of somebody's testimony, so that say to me that there is a lot of confusion.
COHEN (ph): Yeah. Well, I think that's what going on, so I, rather than making this a point where there needs to be (INAUDIBLE), you know, the rule because there's something unclear about the rule, I think what we're doing is noting that there is like widespread confusion by the research industry– community about the implementation and how all this works and the things that aren't even allowed, because of the complexity of the rule appeared of them not to be allowed.
ROTHSTEIN (ph): Well, let me– in defense of OCR (ph), on page 32 of it's guidance, the July 13 guidance, it specifically addresses this issue and says that you can access records without authorizations where there are representations from the researcher either in writing or orally that the use or disclosure of a PHI (ph) is forwarded to prepare a research protocol or for similar purposes, preparatory to research.
That the research will not remove any PHI (ph) from the covered entity and representation that PHI (ph) for which access is sought is necessary for the research purpose. This provision might be used, for example, to design a research study or to access feasibility of conducting a study. So I mean, they said that so maybe, I mean, do we want to say that what needs to be done is better public education or...
COHEN (ph): Well, I think so. I mean, that's like, I agree with you. I'm just scratching my head because part of this is an issue to be heard. And Gail (ph), you were right that this represented testimony. But I think what we're observing here is in the testimony is a variant of actually what the provisions of the rule. And so what are we to do and I think– Monica (ph), I think you're right. I think this is – this speaks of a greater public education and...
ROTHSTEIN (ph): We need to get Kathleen Pfifer (ph) on the scene, here.
COHEN (ph): That's right.
ROTHSTEIN (ph): I don't think she was going to take off over the research community. I think she was going to handle all of us confused providers, I think.
FANNING (ph): Well, no. I think one of our (INAUDIBLE) here is to make this clear to everybody and it is an all department job. You know, actually we do have an internal committee to sort of work on these things.
We have two covered entities. They're doing fine. They have the organized process these things to implement in their new procedures, however, the agencies that fund research are getting a lot of queries and part of the plan is to work together with OCR (ph), now particularly that they have an outreach operation to prepare more usable informational material.
The center for disease control, for example, has already extracted materials from the regulation and the guidance and sent it out to public (INAUDIBLE). So...
CAROL BLUMM (ph): Excuse me. I'm not a member of the committee. Can I help offer what I think is the issue here? My name is Carol Blumm (ph) and I work for the council on governmental regulations. I think people brought up this issue about reviewing data in preparation for a research protocol is that they would have seen the (INAUDIBLE) of these people and would want to retain them so if the research is approved, they could then contact them.
But given the way the rule is written, you can't retain that information. It has to stay in the covered entity. You still might not want to support that, but I think that that's came forward on the issue, not that you couldn't see it to prepare the protocol, but once having seen it, you couldn't retain it.
ROTHSTEIN (ph): You can't remove it from the covered entity.
BLUMM (ph): So if someone went to fifteen hospitals in Baltimore County, they could find 100 women who had elected caesarians, but then if the researcher's was approved, they would have to go back to all of these hospitals again, and pull that data once again, and I think that is the question of being able to temporarily retain it or hold on to it briefly in anticipation of protocol being approved, so it was not provision of not removing it from the entity. I'm sorry to interfere in your conversation.
ROTHSTEIN (ph): Oh, that's OK. I appreciate the comment.
COHEN (ph): Gail (ph), do you think that was the issue?
HORLICK (ph): I never heard it that way, but it's quite possible that that's what they were thinking, you know. I mean...
COHEN (ph): There would be nothing in the rule that would prevent a researcher now to go through the records of hospital acts and identifies 50 patients from giving to hospital acts for safekeeping that list of 50 patients, and so once it's approved, they call and say would you send that to me. What the researchers would prefer, I gather, is that they can the list back home with them.
BLUMM (ph): I think that– again, this is Carol Blumm (ph). I think that may be part of the clarification that you might want to offer but yeah, I think that that's– I mean, that's a duplication of effort people would slow down the process.
COHEN (ph): I guess we need to figure out how we're going to handle this particular piece. I certainly was going to suggest that we take this paragraph and rather than the title being, recruiting research subjects that go towards sort of the end as sort of along the line of need for wider public education and outreach efforts. And using this as an example of people, researchers being unclear and confused by the rule and that they need further guidance, clarification, education. This is an example of things that we heard that are really not true. Now, of course, with this other clarification, that may put a slightly different spin on it, but I still think it probably still fits well as an example. Just to show that there really does need to be wider outreach.
ROTHSTEIN (ph): I think that it's possible and with your consent, I'd like to take a crack at reworking this paragraph to get both of those points in.
FANNING (ph): Great.
HORLICK (ph): Yeah.
ROTHSTEIN (ph): Will that be all right?
HORLICK (ph): That would be great.
ROTHSTEIN (ph): OK. Anything else on number two? OK. Thank you for that comment. We appreciate that. Let's move now to number three, post-marketing surveillance, and I think we all remember this testimony. Several panels express concern that the rule only allows for the disclosure of protected health information, (INAUDIBLE) and post-marketing surveillance studies where such registries or studies are required by law. Most registries are not required by law but are strongly encouraged by the FDA. There is also concern about the need for a data for research in the event of a complaint about a medical device for a product. In such a situation where a patient's health may be at risk, investigators need to obtain data on all patients and in addition receive the same device and there may also be a need for data from other medical institutions. Here are the recommendations: NCVHS (ph) recommends that HHS (ph) revisit clarify and appropriately amend the rule to insure that the rule does not have the unintended consequence of hindering compliance of the letter and spirit of the FDA requirements. Comments?
FANNING (ph): That sounds good.
ROTHSTEIN (ph): Kampra?
KEPA (ph): I think this one looks great.
HORLICK (ph): I guess that minor thing, in the event of a complaint about a medical, should it be device or product or would one work better than the other?
ROTHSTEIN (ph): I think or product. OK. To number four.
KEPA (ph): I'm sorry but you have the same team and line break below that at the end?
ROTHSTEIN (ph): Eric (ph) we'll receive the same device or product.
KEPA (ph): I see.
ROTHSTEIN (ph): Yes, thank you Captain (ph). You hear that Gail (ph)?
HORLICK (ph): No.
ROTHSTEIN (ph): There's– as a– the next sentence after the one that you mentioned that begins...
HORLICK (ph): Oh, OK. I've got it.
ROTHSTEIN (ph): OK. All right. Number four– modification of the common rule. There are tests (INAUDIBLE) that substantive modifications to the common rule are beyond the scope of HIPPA (ph) and that some of the waiver criteria are impracticable and duplicative of the criteria in the common rule. There was concern about the ambiguity of chronic care such as a requirement that "privacy risks must be reasonable in relation to the anticipated benefits." It was suggested that the commonwealth criteria be modified to insure that IRV fully consider the issue of privacy. Here's the recommendation: HCVHS (ph) does not support any weakening of existing protection or protections required in the common rule.
COHEN (ph): Question. Is this really– shouldn't this be part of the introduction, maybe?
ROTHSTEIN (ph): In the overview?
COHEN (ph): And not maybe said quite the way it was, but more along the lines of the NCVHS (ph) protest unrelated to the common rule. The NCVHS (ph) strongly supports the current strong protections in the common rule, and feels that the HIPPO (ph) privacy regs are welcome in accompaniment, or something like that.
HORLICK (ph): I like what you said about instead of does not support any weakening, saying strongly supports the existing.
COHEN (ph): Yeah.
ROTHSTEIN (ph): The existing measures to...
HORLICK (ph): But in terms of placement. I wouldn't think it would go in the overview because they're not giving a recommendation in that section. You know, I think you wanted this to be sort in text, you mean?
COHEN (ph): Well, that's right. I mean in the introduction, in the introductory part. That's what I meant by the overview, I mean, in that introductory first paragraph or two, before we get down to specific recommendations. It says you commented (INAUDIBLE) supporting the common rule and do not recommend the weakening (INAUDIBLE). That doesn't seem like a real actionable recommendation, it's more of a comment that we're making.
HORLICK (ph): Actually, it's sort of power of what we do with consent when people said, don't get rid of it, we said, you know, we're not really addressing that issue anymore. Or we said in general of we support the minimum necessary provisions, but I don't think that went under anything specific.
ROTHSTEIN (ph): So the overview then would have the sentence– the first sentence now, witnesses express, then we would have the sentence that we moved into that where it says on the other hand about written testimony, praise the rule basically, and then the third element would be this one about the common rule. Is that correct?
COHEN (ph): Yeah. I'd try it on for size. I don't know how that complies when you write it down, but...
ROTHSTEIN (ph): And then the three specific areas that we would address separately from the overview are first, de-identified information; second, recruiting research projects; and third, postmarking surveillance.
COHEN (ph): Well, the recruiting research subject, I think, becomes this issue about need for wider publication.
ROTHSTEIN (ph): Correct.
COHEN (ph): And then there's another issue we haven't gotten.
HORLICK (ph): Wait a minute. The first issue was de-identified information. The second was...
ROTHSTEIN (ph): Was recruiting research subjects which includes those two issues and you know, removing from the documents from the covered entity as well as seeming need for clarification about recruitment and then the other was postmarking surveillance.
HORLICK (ph): Right. And then we talked about a paragraph on other issues.
ROTHSTEIN (ph): We haven't taken up the issue of civil and criminal penalties. So that's the last one that we have to come to. I mean, I'm comfortable moving that to the beginning as a sort of an overview thing. KEPA, what do you think?
KEPA (ph): I think the overview is getting too big.
HORLICK (ph): I don't think it's going to be that big.
KEPA (ph): My impression would be I would rather see a one-paragraph or two-paragraph overview of things getting to the different topics because we may be duplicating things in the overview of topics and we only have one paragraph in the topic, and we're duplicating in the overview.
COHEN (ph): Well, I think it should be moved KEPA. I don't think it should be replicated here.
KEPA (ph): Yeah. That's what I said. The overview maybe should be just one paragraph, something short.
ROTHSTEIN (ph): Well, maybe what we can do is when we move this, what is currently now called four, modification of the common rule, to the overview, it can be shortened at the same time. I don't think we need to go into as much depth as we have here. Especially since we're not recommending any change.
HORLICK (ph): OK. I don't think we did more than one or two paragraphs there to the site, and I don't think it will be too long. I mean, it's hard look at now but the other topics had, you know, one or two paragraphs in the overview. This just had more issues.
FANNING (ph): Right Gail (ph).
ROTHSTEIN (ph): OK. So we're going to move that. Gail (ph), do you want to take a crack at that?
HORLICK (ph): I'm going to work on the introduction part. And you and I together are going to work on the de-identified.
ROTHSTEIN (ph): We'll have to talk separately.
HORLICK (ph): Yeah. I mean, but yeah. I definitely– aren't we strapped that I think we will be able to read it better and see. Maybe you and I at the end of the call, we'll schedule a time.
ROTHSTEIN (ph): OK, that sounds good. And now the only thing that we have left that we have not done in the research section is that one part that we pulled out and we said we'd take up later, and that was the sentence that begins there was also concern that the civil and criminal penalties for the improper use and disclosure of information create a (INAUDIBLE) incentive for covered entities to share information with researchers.
COHEN (ph): And we haven't talked about disclosures yet, either.
HORLICK (ph): The accounting. Right. What's in bold, is that what you're talking about?
COHEN (ph): Yeah.
HORLICK (ph): Yeah, I know. I was just going to mention it.
COHEN (ph): Thank you Gail (ph).
ROTHSTEIN (ph): One witness stated that rather than achieving the goal of encouraging research, the protection and privacy rule might have the opposite effect. Now, that again, comes with no recommendation.
HORLICK (ph): Now, yeah, that's part of the overview. Because– on the other hand now is sort of some people said no, there's more protection as opposed to a (INAUDIBLE) giving an opposite effect.
ROTHSTEIN (ph): Right.
HORLICK (ph): Let me fool with that, you know, and get it, you know, paragraphed and...
COHEN (ph): I think that there's actually– this is actually an important issue. This is called access– failures to access or received failures to access of information. And this is one example of that, the first sentence of the overview was another example. And I think the committee needs to come out strongly in support of maximizing access under appropriate safeguards to information for research. And we need to be saying that there needs to be clarification help, ease researchers and institutional concerns about access information. And as the issues are identified, that our barriers, HCVHS (ph) urges HHS (ph) to consider modifications if needed as issues become more apparent.
HORLICK (ph): I didn't get all of that.
COHEN (ph): Well, I'm not sure I can say it again. (INAUDIBLE), I think that's an important issue and I think that the title, here, is proceed barriers to access of information for research. And the response to this one is OCR (ph) needs to work with researchers around issues of clarification, and if there are issues that really do require modification to the rule. And actually, OCR (ph) needs to work not only the researchers but also the institutions. Because they are the ones that are asking to have the information, but if there are– if it doesn't appear that there are barriers, you know, HHSV (ph) may need to make some modifications to the final rule. I don't see any right now but it leads me to believe that there actually do need to be modifications. But if there really is substantive examples of things that need to be modified to deal with institutional concerns to allow researchers to get information, we obviously want to support that.
HORLICK (ph): Now I wasn't sure when you said perceive barriers. Were you talking about doing another section, or you just kind of using that as a...
COHEN (ph): I actually think it's probably another section.
ROTHSTEIN (ph): So Simon (ph), are you suggesting that we take this sentence, civil and criminal penalty sentence, and integrate that with the discussion that we're going include about the need for better outreach and clarification, education, that sort of stuff?
COHEN (ph): It certainly could be. I mean it could be that, or it could be a separate bullet itself. It's an important enough issue. I mean, don't– the legal penalties are probably not– I mean, it's the legal penalties plus the administrative burden really is what people are talking about, I think. I mean, you just don't want to create this incentive in barriers to allow legitimate health research to be declined.
HORLICK (ph): It seems to make, I mean, I don't know if it's criminal penalties, if that's considered a perceived barrier or a real one, but certainly there might be perceived barriers that are not, in fact, barriers. It could be addressed with clarification.
COHEN (ph): Yeah. But I think it's more than just OCR (ph) and for that it's worth more than just what the researchers who would be working with the institutions that have the data.
HORLICK (ph): But that would be good for a paragraph on education or...
COHEN (ph): Except that this may also, I mean, look at it. I'm not seeing any apparent needs for modifications, but there may actually need to be down the road some modifications to the rule, I mean, to the privacy rule, if indeed there are issues here that need to be modified somewhat to ease institutional concerns for what's happened.
COHEN (ph): And I think it's a real controversial issue.
ROTHSTEIN (ph): No, I don't think it's controversial at all. We're just trying to figure out how to– where to put it.
COHEN (ph): OK. Well, I'll defer to you on where to put it. I mean, I'm just throwing the idea out.
HORLICK (ph): I think but, you know, Mark (ph) and I will talk about when we can do this, but even just the overview, but I think that I can sort that out, then we might be able to– it's hard to– I don't know.
ROTHSTEIN (ph): Sorry.
HORLICK (ph): Well no, no. I mean, I think what you're saying, I mean, it's hard to say. I mean, part of me thinks that civil and criminal penalties should just go right up in the overview as one of the things that was mentioned and then on the other hand, people said it gave a lot of protection and, you know, that's your overview.
COHEN (ph): Right.
HORLICK (ph): It's raised cost, penalties, protection, you know, and then go into your specific issues.
ROTHSTEIN (ph): How about if we take a look at it and we'll see if it's too long or see if it makes sense and we're going to have to have a meeting or either conference call or some e-mail exchange or something and– because we're at least one draft away from getting anything to the full committee.
COHEN (ph): Sure.
HORLICK (ph): OK.
ROTHSTEIN (ph): OK. Gail (ph), do you want to explain the bold stuff?
HORLICK (ph): That was just a statement of Simon's comments. And I just didn't incorporate it as a separate issue.
COHEN (ph): And this wasn't– this was actually an ANC (ph) in Johns Hopkins which I can actually understand. I mean, I think they're really concerned about the issue of tracking disclosures in a research environment. I think there's enough confusion on this. I mean, I don't know the area of confusion, but you know, I'm a little confused on this one.
HORLICK (ph): You know what they're required to do now? I mean, what is the rule requiring that they're...
COHEN (ph): Well, I guess the question first of all is, for example, this use– this reviews preparatory to research. Is that– I mean, that's a preventive disclosure but that's still a disclosure, isn't it? John (ph)?
FANNING (ph): I don't know how that's covered.
COHEN (ph): Yeah. Well, I was just looking– I'm here scratching my head, because I don't know the answer to that one either. And then of course, you might wind up, you know, those all may be disclosures when you're looking through preparatory to the research project you have to track, and then of course, there's all the research that you're doing that's IRV (ph) approval that you have to keep notes of.
And I don't know, I mean a disclosure is sort of a messy area. I mean, you could also bring up the issue of like well, geez, if you're required by law to some of the things to a public health department and you should be, I mean, I don't– I mean, I don't know where you sort of get into this closure tracking issue. But certainly, researchers I think can have– could get, this could get to be very overwhelming for them.
FANNING (ph): May I make an observation?
COHEN (ph): Sure John (ph).
FANNING (ph): The– generally considered, a pretty basic fare of information practice, write if you will. But you should know where your information has gone. Regardless of what this said, the federal government itself will have to retain records of disclosures for research and for everything else.
There are some exceptions relayed there, but I might also point out that the interpretations of the Federal Privacy Act are that you don't actually have to make a mark on the record saying that (INAUDIBLE). If you can reconstruct the disclosure when someone wants to know where it has gone. That's a bit of background from the existing, you know, law.
COHEN (ph): Well, I mean, at that point, your solution to this one is that if you have a research database or you're going to a facility that what you do is you just ask or what you say is just definition– you've looked at every single piece of record or whatever potential exists with that facility? And that because if you can just make a deal with these issues of disclosures?
ROTHSTEIN (ph): Well, one of the things that we might be– we could easily do is section 164.578 on accounting, disclosures are to protect the health information, has not yet been the subject of any guidance and we could recommend that the OCR (ph) come out in it's next round of guidance on some discussion of specifics regarding accounting.
COHEN (ph): OK. Well, I mean, I think the issues are clarification issues or modification issues?
ROTHSTEIN (ph): Well, I don't know yet how– what their interpretation is going to be and it may be one of these areas where we need to see what they come up with before we make any recommendations. I don't know how, I mean, there is great concern that it's going to be onerous and all that stuff.
I don't know for a fact that OCR (ph) is going to interpret it beyond what their information practices would dictate. And we certainly can revisit this issue along with all the others that that we're going to be taking a look at.
COHEN (ph): Well, surely in that case sort of say if there was significant concern evidenced by the research industry– research community related to disclosures and is observed by the NCVHS (ph) that this area of the regulation appears to be open to multiple interpretations and we urge the office of civil rights to, in their next guidance, to address– provide guidance for this area. We will, based on what their guidance is, potentially hold future hearings on this subject as it becomes more clarified.
ROTHSTEIN (ph): I think that would be fine.
COHEN (ph): OK.
HORLICK (ph): (INAUDIBLE) with the issue disclosures or the accounting for the disclosures?
COHEN (ph): Accounting for disclosures.
HORLICK (ph): OK.
ROTHSTEIN (ph): Gail (ph), do you have– did you get what Simon (ph) said?
HORLICK (ph): I got– let's see. We're concerned by the research community that– about the accounting for disclosure provisions appear– and there's something about...
HORLICK (ph): ... but that we have the impression that it appeared to be open to multiple interpretations and so we recommend clarification on these provisions and...
COHEN (ph): That we need (INAUDIBLE) that we hold future hearings on this topic to provide greater guidance to the department.
HORLICK (ph): So would that future hearings, that is what I was going to say, would that go– usually we end with HCVHS (ph) recommends. We just add a sentence on after the recommendation?
COHEN (ph): Yeah. We recommend that this be the topic of a guidance.
HORLICK (ph): But then what's the same thing saying that we would hold future hearings? Would that follow the recommendation? Information again.
COHEN (ph): Well, we don't have to...
HORLICK (ph): ...you know, maybe offsetting it is open to multiple interpretations and may be a need for future hearings, or something.
COHEN (ph) Yeah, depending on the guidance provided or maybe a need for a future, you know, future hearings on this.
HORLICK (ph): And with the recommendation which is actually...
COHEN (ph): I'll let you word that for me. I can't think of, I mean, I think that you could probably put both of those in the recommendation without it being terrible (INAUDIBLE).
HORLICK (ph): OK. I'll try.
ROTHSTEIN (ph): OK. Is there anything else on research? OK. Part or marketing?
DEBBIE (ph): This is Debbie (ph). I'll give you my view to state your name please and several people joined us after the call, after the phone call, and Carol (ph), other than you, is there anyone else?
SUE ANDREWS (ph): Yes, this is Sue Andrews (ph).
SUE (ph): Thank you.
COHEN (ph): You've been very quiet in there.
SUE (ph): Well, I just got on a few minutes ago. I had another meeting.
COHEN (ph): OK.
ROTHSTEIN (ph): OK. We're on to marketing now. And the document– this is Mark ROTHSTEIN (ph) again from Marketing and Disease Management. The testimony of marketing indicated that there is a great deal of confusion about distinctions between marketing and disease management. There was testimony that disease managers engage in health promotion rather than marketing when they communicate about a product or a service that is directly related to a patient's or populations' plan of treatment.
One witness asserted that promoting a sale of particular drugs, relations or durable medical equipment should be considered marketing. There was a request for clarification that disease management services and related communications with patients fall outside of marketing unless their primary purpose is to fill a particular product service, truck or device. They were so were requests for concrete examples of what marketing is and what it is not.
The only thing I would say about this is the sentence I read that begins, one witness asserted that promoting the sale of particular drugs, relations or durable medical equipment should be considered marketing. I think that– I don't know whether we need that because that is actually in the (INAUDIBLE) itself under the definition of marketing. So is marketing needs to make a communication about a product or service a purpose of which is to encourage participants from the communication to purchase or use the product or service?
HORLICK (ph): Well, Mark (ph), I think that means that as opposed to disease management. Well, let me make just one comment on this section. You know, this section just has one, two, three, and then because they have an overview section that's like– because on a lab call, we didn't really decide what recommendations we wanted to make.
COHEN (ph): Right.
HORLICK (ph): So I'm just trying to...
ROTHSTEIN (ph): I have actually drafted recommendations.
HORLICK (ph): I mean, this could all flow as an overview of the issue range depending on what we decide or the full committee decides as recommendations. But that's just something I wanted to point out. That's why this was written differently then the other sections.
ROTHSTEIN (ph): Here's a proposed recommendation that I drafted for number one. And I think it's consistent with our discussions. The NTVHS (ph) recommends that HHF's (ph) OCR (ph) clarify that efforts from multiple sale of particular drugs to (INAUDIBLE) or durable medical equipment constitutes marketing and not disease management.
HORLICK (ph): Oh, I like that.
COHEN (ph): Mark (ph), can you give me like a thirty-second overview of why...
ROTHSTEIN (ph): What the problem is?
COHEN (ph): No. Yeah, why it's important that we differentiate in the rule providers can do some limited marketing?
ROTHSTEIN (ph): The reason that we– well, as it was raised for us, there was great concern that disease management is– should be treated differently than marketing, that it should not be subject to the constraints on marketing that are lifted in the (INAUDIBLE), and that– you know, I think it's particularly important should the committee decide, and this is one of the things we need to discuss later, that we want to tighten up marketing. In other words, limit the kind of marketing that can be done, for example, changing the opt out provision or whatever. Then that would not apply to disease management.
COHEN (ph): OK. As the rule is currently written, it doesn't really matter. Does it?
ROTHSTEIN (ph): As it's currently written, the definition of marketing, I think, is similar to disease management or in the treatment, and I'll refer to Sue (ph) on this.
SUE (ph): I think by to the extent that what a disease manager does meets any of the categories that we say are not marketing and we know a lot of those are treatment invaded or individual focused when it gets to that level, I've seen by and large disease management as just one of the many activities that drop out of the definition of marketing.
There may be some more activities that go on with respect to disease management that's more population based, or which goes to defining and cracking the (INAUDIBLE) management itself and in those cases, some of the material (INAUDIBLE) in those individuals may have to go to the (INAUDIBLE).
COHEN (ph): Somebody needs to mute their phone. All right. John (ph)? I think it's John (ph).
ROTHSTEIN (ph): Yeah, sounds like it's John (ph).
FANNING (ph): No, it's not John (ph) Fanning. My phone was muted.
ROTHSTEIN (ph): I'm sorry.
FANNING (ph): I can hear it in the background. Someone's talking.
ROTHSTEIN (ph): That's such a deep voice. I thought it was you. So I suppose Sue (ph), what you're saying is that there might be some minor differences between marketing and disease management as it currently stands. I think the point I was trying to make Simon (ph), was that should we make some of the changes that we've been talking about. It may be– or recommendations, it may be that there would be even a bigger distinction between marketing and disease management.
KEPA (ph): I think it's the government's perception– I think that the public in general was not understanding a difference between the two, and maybe this goes into the same section that we had before on to foresee problems that can be solved with clarification. Maybe it doesn't even need a clarification anymore.
COHEN (ph): Yeah. I think that also the problem, of course, is that probably more than almost anything else, even despite our testimony. I would observe that disease management gets mighty close to the line. I mean, not always, but frequently that line is wiggled right around disease management.
ROTHSTEIN (ph): Well, let me propose something. That we put this on the back burner, and do the other sections of marketing and then it will be...
COHEN (ph): If it was based on that, we can figure out whether we need to do something about marketing and disease management?
ROTHSTEIN (ph): Exactly.
COHEN (ph): OK.
ROTHSTEIN (ph): Is that all right?
COHEN (ph): Sure.
ROTHSTEIN (ph): OK. So let's skip over one and go to number two, marketing/off care operations. Concern was also expressed about the fact that marketing, including fundraising, which I think we– I think we ought to take out the fundraising, because we're not really talking about fundraising...
HORLICK (ph): The only reason I put that in is because some of the people that did give recommendations, you know, they made it for both and I thought that if we decided to include it, we'd have it and it was easy to strike it.
ROTHSTEIN (ph): Yeah. I think– I think we may want to take a look at the issue of fundraising, you know, separately, but I don't want to just throw it in there. Concern was also expressed about the fact that marketing is considered part of health– of health care operations and thus health care providers are able to engage in certain marketing activities once an individual signs a general one-time-only consent form which need not refer to all the potential marketing uses and disclosures.
There was testimony that marketing should be deleted from health care operations and there was a recommendation that HHF (ph) include disease management by name within the definition of treatment. And just to put something on the table, we could have this recommendation. The HCVHS (ph) recommends that HHF (ph) OCR (ph) amend the definition of health care operations to exclude marketing.
HORLICK (ph): We had that discussion, I think.
ROTHSTEIN (ph): We did, but we hadn't reached any decision on it.
KEPA (ph): OK. Was that discussion (INAUDIBLE)?
COHEN (ph): First of all, if we don't– we need to put fundraising somewhere, immediately deserves to be back in research because I think we've heard a number of what I thought were very legitimate concerns from some of the major research institutions in the United States about the fact that they are very dependent on fundraising and I would agree that they should not be in any way prevented from legitimate fundraising activities.
So I think if we stuck in marketing, because we somehow thought it was marketing but maybe it really needs to be over in research. So we need to consider that. Now, beyond that, I recommend, maybe you guys can help me with this rule, because I– we in the marketing, as I read the rule. I didn't think that marketing was listed as a aspect of health care operations, but it was more that there was a separate section where there was some marketing that was authorized by covered entities that was covered as part of all this stuff. Am I mistaken about that one? It is not unlimited marketing with its provider.
ROTHSTEIN (ph): Well, under the definition of health care operations in 501, it includes...
COHEN (ph): What page are you on, Mark (ph)?
ROTHSTEIN (ph): OK. I'm on page 2804 at the very top.
COHEN (ph): OK. Thank you. You're obviously teaching me about parts of the rule that I don't remember. OK. So page 2804?
ROTHSTEIN (ph): Yeah. It's at the very top under "v". Consistent with the applicable requirement to file 14 creating de-identified help information fundraising to a better recovering of an entity and marketing for which (INAUDIBLE), authorization is not required as described in 514 (INAUDIBLE).
COHEN (ph): Yeah. Which is the page that I was making when I was referencing. So if you remove that, then what would be the 514, let me see if I can find that one.
ROTHSTEIN (ph): 514 is on page 819.
COHEN (ph): OK. So if you remove that reference, then what do you do to all of this other stuff that relates to marketing?
ROTHSTEIN (ph): Well, in other words, we would– this would be clearly a major change in the rule and it would affect several sections that would need to be rewritten, but basically, what it would mean is that you would not be able to conduct marketing without specific authorization. It is the out from the general consent.
HORLICK (ph): You know, maybe Mark (ph), I don't know. This is just a thought. But maybe, you know, because we don't have an overview on this section, we don't have it broken down, if we could just read through everything and then see, you know, because I think that the issues are so closely related. You know, the definition of what is can't talk about opting out of marketing if you don't know what the definition of marketing is.
ROTHSTEIN (ph): Well, that's all true and if we– if we voted to take marketing out of health care operations, then opting out would be moot. Because you'd have to opt in.
HORLICK (ph): And this really might not, I mean, we did talk about raising the whole issue with the full committee. I mean, I know that it will be hard to get– to do in a way, but this is a major, you know, the committee was just so unresolved about even do we want to tighten it or do we want to leave as it was.
COHEN (ph): You don't want to– I guess my concern about this particular issue, I recognize this, I mean, you can tell I'm a little confused about it and I keep looking back and forth because it's all through the regs. One would observe that at least with the hearings that we had, prominently what I remember for this particular set of testimony had to do with the disease management saying no, we're not marketing.
HORLICK (ph): And they make the distinction with the sale issue which sounds self-legitimate to me.
COHEN (ph): Well, that's right. But I didn't hear, and it was probably because of the way we set up the panels, was the fact that people really needed to focus in on this one area. That we didn't hear from any of the actual legitimate providers that helped our surfaces about if we start changing all of this stuff, is it going to impact their ability to deliver care?
ROTHSTEIN (ph): Well, we certainly did hear from various consumer witnesses who complained about, that the marketing provisions were too weak and the proposed rule should not have been changed when it came out in its final form. We also heard from witnesses who were concerned about the effect on the physician/patient relationship, once people were contacted, will that opt in authorization and putting the burden on the patient to opt out and so forth, so...
COHEN (ph): Well, Mark (ph), I don't mean that we disagree with what you're saying. All I'm observing is that we, for example, didn't hear from many of the large physician groups or (INAUDIBLE) providers, you didn't hear from any of the hospital groups, we didn't hear from any of the health plans, specifically relations (INAUDIBLE), because we structured things that people had to make a choice of what they were going to testify on.
And most of them felt, at least for the purposes of this hearing, that issues that we dealt with previously were more important than this particular issue. And I'm not saying that we should not weigh in on this one, but I'm just wondering if we have enough information to begin to sort of say well, geez, we ought to move from opt in to opt out and base our– on these couple of hours of testimony we heard, that we can reliably feel that we really have talked to the health care industry that will not have any untoward or any unforeseen effects.
And then I guess my thought was that maybe we actually do need to have a little more focused, like a day's session, on marketing and what really let, if everybody wants to come talk to us about marketing, talk specifically about marketing. And that was really what I was suggesting. This may be a variable we're really not ready yet.
HORLICK (ph): And just to add to that, we do have the written testimony of the– from the– of the man from the direct marketing association that was not able to testify at the last minute, and as I remember, I haven't reviewed it, he was sort of OK with the rule but it was like he was in the middle, you know, but I agree with what you're saying. But it's that we didn't ask a provider. I mean, I thought we had, you know, we had the advocates and we had the disease management perspective, but we didn't have the provider perspective.
COHEN (ph): Yeah. It's just that when you start going in to so many changing this all around and saying, geez, you know, if you're a provider and there's provisions here that as a provider you can do some marketing, and of course, I'm not sure about, I mean, is it a marketing product or are you just saying geez, you know, you should sign back up for this health plan or whatever, I mean, God knows. You know, is that going to provide– is that going to create problems for people and I...
HORLICK (ph): The other thing that I, you know, was after this, remember, Dr. Velong (ph) sent us that definition of this management?
ROTHSTEIN (ph): Well, I think to some extent, we got really preoccupied with this disease management issue. And didn't spend enough time on the more fundamental issue so whether the rule strikes the right balance in marketing. And making– maybe the disease management delivers a very minor issue that we got (INAUDIBLE) in it.
HORLICK (ph): I mean, we would still, it seems to me, want to convey pretty much the essence of the testimony that we heard, right? In this letter? Even if we didn't make a recommendation?
ROTHSTEIN (ph): Well, maybe not if it's the will of the overall committee, what we could do is just send a letter to the secretary on research and continue our deliberations and schedule another public hearing on marketing. And if we do so...
ROTHSTEIN (ph): ... it would be my recommendation to give them specific things to address. In other words, should harkening be removed from health care operations, should the opt out provision be changed, et cetera, et cetera, et cetera. And let them focus very clearly on those kinds of issues.
HORLICK (ph): Part of that I think has really been addressed, you know, the advocates are going to say, yes, it should be changed. You should have authorization, I don't know. I mean, all I'm saying is it's not right to get the provider's perspective, but I guess just part of me, I mean, it doesn't matter, I mean, we can include this in the letter, but part of me feels like we heard a lot of testimony and in some way, we can at least capture it and if we're still really unresolved or need more, then we should say that without making a recommendation, but I think that, you know, we heard, you know, what some of the issues were. I mean, that's just my view, but...
ROTHSTEIN (ph): Well, that's another option we could do is...
HORLICK (ph): You know, writing those text...
ROTHSTEIN (ph): ... that we heard testimony, we've identified these issues, the committee thinks that it wants to hear additional witnesses on this topic and we'll have the recommendation, you know, as soon as possible.
COHEN (ph): Yeah. Well, it's just that– I don't mean to– yeah, I can actually sort of agree with that. Yeah. I do agree that we would want to comment about it, but obviously, the question is going from a comment about that we see there's lots of issues versus coming up with recommendations.
HORLICK (ph): Whatever it is it's essentially one page, you know, if you don't space it out, I mean, we could do like three or four paragraphs on the essence of the testimony.
ROTHSTEIN (ph): Well, I don't, I mean, I guess we need to...
HORLICK (ph): Maybe we don't think, I mean, I don't know. I just thought because we had that, it seemed like that was part of our...
ROTHSTEIN (ph): Well, I guess we have a couple of levels of choices here about how deep we move into this. As you begin to reference testimony, you're suddenly sort of (INAUDIBLE) what you're referencing and what you're not. You begin to sound almost like you're making recommendations.
And I think we need to be careful only because you make inadvertently make people think that we're making recommendations on this. I certainly would agree that we need to say something like we heard testimony on marketing issues. I mean, you observe that there's a great deal of complexity in relationship to this from confusion about distinctions between marketing and other types of health care operations.
There is strongly held feelings about issues of opt in and opt out, the committee recognizes that, I mean, believes it to make significant recommendations on this issue, we'll have to hold more hearings and get back to you as soon as we have completed those hearings with substantive recommendations. I don't know, maybe that's, I mean, we can get into there all the way into sort of, until there's a large amount of information.
But I, you know, some of this stuff is so dependent on one thing or another, as Mark (ph), you commented. You know, if things are staying the same, the issues of what's marketing and what's disease management, I mean, it's an interesting conceptual issue, but it doesn't really matter. But if we start trying to pull things apart, suddenly those issues become real, real important.
ROTHSTEIN (ph): Well, it seems to me that, I mean, first of all, we only have three of the six members of the sub-committee here.
COHEN (ph): Then we should ask some.
ROTHSTEIN (ph): I don't know– I suppose– it probably would be wrong for us to come out with any rather dramatic recommendations at this point and maybe what we ought to do is just– when we distribute the research draft, then maybe kind of poll the other members of the committee and see how they are feeling about the prospect of making recommendations versus not making recommendations, versus holding more hearings and that sort of thing.
COHEN (ph): Are you talking about the sub-committee or the full committee?
ROTHSTEIN (ph): The sub-committee initially.
COHEN (ph): OK. Well, I feel comfortable with that one. I– you know, we certainly– and the question is are we going to do more work on this section right now, or are we going to come up with a– maybe what we need to do is come up with a different ending that's a paragraph or so that sort of– that gives people the option thinking that this is something we're going to defer and recommend versus something we sort of like what we have here now and get the wider view, which I'd be very comfortable with. Certainly regarding this, we do need– I do think that research fundraising issue is somehow an issue that we should not lose in all of this.
ROTHSTEIN (ph): Well, the other thing that we could do– I'm glad you mentioned that– if we did have a hearing, we could have a separate session on fundraising. And I would be uncomfortable now making any recommendations on fundraising, given that a couple of people just made reference to it in passing, when it was not the main thrust of their testimony, and we really didn't make any conscious effort to get witnesses talk about fundraising as such.
COHEN (ph): Well, and that would, I mean, I would defer to you on that one. I'm– I guess somehow in my own mind, I don't think of fundraising for research institutions being the same thing as marketing, but I am well aware that thinking from another view that they could all be included very similar. I would defer to you on that one.
ROTHSTEIN (ph): OK. Gail (ph), do you feel comfortable writing a paragraph talking about some of the issues in marketing and the fact that we are still going to be continuing to look at that?
HORLICK (ph): Essentially, what Simon (ph) said earlier?
ROTHSTEIN (ph): Yes.
HORLICK (ph): OK. I could certainly draft it. I think I'd like to just, you know, I can take off what we have here or put it separately or something, but I'd like to sort of hang onto it, in case we go backwards.
ROTHSTEIN (ph): Oh yeah, sure.
HORLICK (ph): You know, but– so you don't want the details? You're really just talking, in other words, the way we've gone through, we've just thought it would be on research and then say marketing, and just give our paragraph basically saying we heard a lot and we need to hear more?
ROTHSTEIN (ph): Something like that.
HORLICK (ph): I mean, something, I mean, I'm just being– I mean it would be essentially one paragraph in the marketing.
ROTHSTEIN (ph): Right, because I think in the last letter to the secretary, we said we'd be saying something about research and marketing, so...
HORLICK (ph): Exactly. That's what I'm saying. So say here's the research and...
FANNING (ph): What is that further reflection we have?
HORLICK (ph): I mean, I guess that's right. In the introduction of the letter, we'd say, on this letter, we'd say– you know, we sent it on October 1 and said we'd– and so this letter now contains our recommendations for research and comments or something on the marketing.
ROTHSTEIN (ph): Right.
HORLICK (ph): We want to show that it's not recommendations.
ROTHSTEIN (ph): I think that's– I think that's right. We need to distinguish between what we're saying on research and what we're going to say on marketing.
HORLICK (ph): Right. Well, yeah. I'll try to, I mean, sure.
ROTHSTEIN (ph): OK. Well, this was an interesting (INAUDIBLE). And Gail (ph), maybe you and I can stay on for just a minute after everyone hangs up to try to arrange a time to– or maybe we'll even just do it now and just do it up the research sections about who writes what. And then figure out when we can...
HORLICK (ph): Now one just general issue procedural. You know, one thing you and I work on something and then we circulate a draft. When people send me comments, it's like, you know, here we had all these, you know, I don't know quite how to– it's hard to incorporate different people's comments and, you know, if Marjorie (ph) sends something and Marge (ph) sends something, then those fit in and, you know, I mean, I could use my judgment, but that's really the role of the committee to look at those. So people send them to me and if it's just sort of, you know, words and everything, I can make those changes, but if it's substantive, I'll want to...
ROTHSTEIN (ph): Well, then don't incorporate them, just add them, and then we'll...
HORLICK (ph): Yeah. I'll try to, all right.
ROTHSTEIN (ph): ... and italicize them or...
HORLICK (ph): Well, that's what I did before, but you can see how hard it is for us to read. But maybe this will be better because we've moved it along, so maybe there will be less need for that.
ROTHSTEIN (ph): Well, if there's no more official business, I thank all of you and the sub-committee conference call is adjourned.
COHEN (ph): Mark (ph), thank you very much.
ROTHSTEIN (ph): OK. Thank you.
FANNING (ph): Nice meeting Mark (ph). Thanks a lot.
ROTHSTEIN (ph): Thanks John (ph). Bye.
END
We welcome your feedback on this transcript. Please go to http://www.emediamillworks.com/feedback/ or call Erica Corwin at 301-883-2482 x114.