[This Transcript is Unedited]
Hilton Garden Inn Hotel
815 14th Street, NW
Washington, D.C.
Agenda Item: Call to Order, Welcome and Introductions
DR. COHN: Well, welcome everyone. Good morning.
I want to call this meeting to order. This is the first day of two days of meetings of the National Committee on Vital and Health Statistics.
The National Committee is the statutory public advisory committee to the U.S. Department of Health and Human Services on national health information policy.
I am Simon Cohn. I'm Associate Executive Director for Health Information Policy for Kaiser Permanente and chair of the committee.
I want to welcome committee members, HHS staff and others here in person to our first meeting of 2008.
I also want to welcome those listening in on the internet and it sounds like those just calling in, members, I think, at a distance who will be participating in the meeting today.
And, of course, remind everyone to speak clearly and into the microphone.
Let's now have introductions around the table and then around the room.
For those on the National Committee, as always, I would ask if you have any conflicts of interest related to any of the issues coming before us today, would you so please indicate during your introductions.
Now, what we'll do is to ask people around the table to introduce yourselves, people present in the room, and then we'll ask those who have just called in to also introduce yourselves.
Marjorie.
MS. GREENBERG: Good morning. I'm Marjorie Greenberg from the National Center for Health Statistics, CDC and Executive Secretary to the committee.
MR. BLAIR: Jeff Blair, Lovelace Clinic Foundation. Member of the committee and I don't have any conflicts that I'm aware of.
DR. STEINDEL: Steve Steindel. Centers for Disease Control and Prevention. Liaison to the committee.
MR. HOUSTON: John Houston, University of Pittsburgh Medical Center. Member of the committee. I have no conflicts.
MS. MC CALL: Carol McCall. Humana. Member of the committee and no known conflicts.
DR. GREEN: Larry Green. Member of the committee. University of Colorado. No conflicts.
DR. OVERHAGE: Marc Overhage. Regenstrief Institute and Indiana Health Information Exchange. Member of the committee and no conflicts.
DR. FERRER: Jorge Ferrer, Veterans Health Administration. Liaison to the committee.
MS. TRUDEL: Karen Trudel. Centers for Medicare, Medicaid Services. Liaison to the committee.
DR. LEPKOWSKI: Jim Lepkowski. University of Michigan. I'm liaison to the NCHS Board of Scientific Counselors.
DR. W. SCANLON: Bill Scanlon. Health Policy R&D. Member of the committee. No conflicts.
DR. FRANCIS: Leslie Francis. Law and philosophy at the University of Utah. I'm a member of the committee, and no conflicts.
DR. CARR: Justine Carr. Beth Israel Deaconess Medical Center. Member of the committee and no conflicts.
MR. REYNOLDS: Harry Reynolds. Blue Cross and Blue Shield of North Carolina. A member of the committee and no conflicts.
MR. ROTHSTEIN: Mark Rothstein. University of Louisville School of Medicine. Member of the committee. No conflicts.
(Introductions around the room.)
DR. COHN: Would those members who have called in please introduce yourselves and identify whether you have any conflicts of interest?
DR. WARREN: This is Judy Warren, University of Kansas, School of Nursing. Member of the committee. No conflicts.
DR. COHN: I thought we heard a couple of other beeps there. I guess it was people connecting and disconnecting.
Well, Judy, welcome, and we're sorry that you can't join us today in person.
DR. WARREN: I know, but Secretary Leavitt's here in Kansas City. So I'm meeting with him this afternoon.
DR. COHN: Well, good luck with your meetings, and, obviously, we're glad that you're able at least to call in for the sessions and we appreciate your participation.
DR. WARREN: Thank you.
DR. COHN: Okay. Now, before we move into agenda review, let me make a couple of opening comments.
Now, first of all, I want to welcome Jim Lepkowski, our new liaison from the Board of Scientific Counselors.
Jim, thanks for joining us today.
Jim was also present at our Executive Subcommittee retreat.
Without being real mindful of your CV, Jim is with the University of Michigan and is a professor, I believe --
DR. LEPKOWSKI: Professor of Biostatistics, yes.
DR. COHN: Okay. And we're obviously very pleased to have you joining us.
His alternate is Michael Grady, who, maybe you'll remember, is a former Assistant Secretary of the Office of Planning and Evaluation for HHS, and we're obviously pleased to have him also serving as an alternate, though he's not here today.
So thank you for joining us. We'll look forward to obviously close and cordial collaboration with the Board of Scientific Counselors.
Oh, Don, welcome. Would you also like to introduce yourself and indicate whether you have any conflicts of interest?
DR. STEINWACHS: Don Steinwachs. Johns Hopkins University. No conflicts of interest.
DR. COHN: With that, first of all, I want to begin by congratulating everyone on what's been a very positive and productive 2007.
Obviously, we talked last time about the many things that we did in 2007, but I want to observe that even since our last meeting after Thanksgiving, there have been a number of things that have happened.
First of all, we have finalized and published the report on so-called secondary uses of health data.
We have also finalized and published the report on quality measurement and data reporting from the quality workgroup that we had discussed and balloted(ph) earlier last year.
There have been hearings from Standards and Security on both HIPAA and e-prescribing issues, and I know some planning from their point looking into 2008 and beyond.
There have also been conference calls from both Populations, Privacy and Confidentiality and Quality on sort of planning for 2008.
And, finally -- and we'll talk about this a little later on this morning -- there was an Executive Subcommittee retreat that we'll sort of talk about some of our musing and thoughts about sort of after the introductions and before our first break.
So as we begin in 2008, I just want to thank you all for your hard work, dedication and leadership.
Certainly, as I've looked at this -- and I think we all know that the NCVHS is known within the federal space as one of the most hardest working and dedicated subcommittees. Certainly, our perspective and our sort of position is to be providing sound, practical advice for the department in really being a step ahead.
And, really, we've had wide influence on a lot of the activities over the last 10 to 15 years in the sphere of health information policy beyond HIPAA, e-prescribing, Medicare Modernization Act, issues around privacy, population, as well as quality measures issues.
And I think we're also providing thought leadership on many of the issues relating to the developing national health information infrastructure, be it the overall broad vision, be it privacy and confidentiality in the NHIN, be it secondary uses of data, NHIN functional requirements, future health and vital statistics, which we'll talk about.
But, obviously, you know, the view is to provide useful data now, but also provide a vision to help the department move forward.
Having said that, of course, our impact is not just felt within the administrative branch. We make regular reports to Congress. We are asked on a regular basis to brief congressional committees on work of the committee, as well as important initiatives, be they privacy, standards or otherwise.
And what one would observe over the last several years, even though we haven't seen any new HIT legislation recently, but, at least on the ones being proposed, our name is frequently mentioned as a player in this whole activity.
So, basically, NCVHS members, key staff surrounding us, I really want to thank you. Obviously, this reputation, this national impact is because of your commitment and vision.
And, of course, I want to especially acknowledge Marjorie for her help in all of this.
I keep acknowledging Jim Scanlon, but he's never here to be acknowledged in person.
But we do appreciate both of their leadership, and, of course, the leadership and support from all of the skilled and dedicated staff to our committee, subcommittees and workgroups.
DR. COHN: So let's move into agenda review and talk about the new modified agenda that is on your desk today that many of you probably have not seen before.
We've been switching things around a little bit because of people's availability.
Now, we've been adding things, but it's more changing the order.
This morning, we begin with a review of the executive subcommittee retreat, as I commented.
The main focus of the retreat was on transition planning as well as a review of committee priorities, function and structure.
There's a sort of PowerPoint in Tab 4 that Justine Carr and Harry Reynolds will lead us through in just a second, sort of talking about, I think, some of the recommendations and perspectives that came out of the executive subcommittee retreat.
Now, after the break -- and after that, we will be looking at Version -- is it 17 or 45? -- of the privacy letter.
PARTICIPANT: Excuse me, that's the final --
DR. COHN: Final version, yes.
Now, this is being brought forward for action at this meeting, and we'll be reviewing it this morning. It's in Tab 3.
As always, given that this is 12 pages long, we obviously gratefully accept wordsmithing, but unless it's wordsmithing that specifically deals with content, let's take it off line and we can sort of deal with it in the final version of the letter.
Certainly, if there's any wordsmithing that deals with content or impacts content, this is certainly the time we need to be talking about it -- an agreeable that process discussion.
Now, after lunch, we're having Jim Scanlon in attendance, and we'll be having an update from the department as well as from Karen Trudel really to what's going on in CMS.
At two o'clock, we're having John Loonsk joining us to spend a little longer time than we had last meeting talking about what's going on in the Office of the National Coordinator.
I also want to direct you to Tab 6, which is a report from the National Academies of Science looking at the function of the Office of the National Coordinator, not an explicit topic for conversation, but something that I think is useful as you sort of think about the functions and role of the Office of the National Coordinator going forward.
At three o'clock, we will break into subcommittees. At that point, we will talk about sort of the next day's agenda and how that's going to play out, but we obviously have Subcommittee Population in this meeting. Privacy and Confidentiality will be meeting.
And then after that is the Quality Workgroup, and all members are invited to sort of that discussion, given how crosscutting quality is.
Now, tonight, we have dinner at -- and I think we need to get a show of hands. It's about two blocks away, I believe, and dinner will be at six. So pretty much immediately following all of our meetings and workgroup sessions.
I think we just probably need a show of hands for those who are planning on coming and joining for tonight.
(Pause).
DR. COHN: OK. Look forward to seeing you.
Now, I do want to remind everybody before I hand it off to Justine and Harry, meeting starts tomorrow morning at 8:30, and we think we'll be adjourning by one o'clock.
OK. Well, with that, I want to turn it over to Justine and Harry to sort of take us through the discussion from the executive subcommittee retreat.
Agenda Item: Highlights From Executive Subcommittee Strategy Session
DR. CARR: Thank you, Simon.
I think that Harry and I put these thoughts together to just take a moment in time for the committee to think about, as I've outlined here, where have we been, where should we be going and how should we best organize ourselves to get there.
So we've split this up a little bit, and I'll start with a little bit of the history.
So, as you know, we're coming up on our sixtieth anniversary, and I wanted -- I took the occasion to go back and read the charter and also some of the history from the fiftieth anniversary. And I'm going to highlight for you the things that jumped out to me.
But just looking at our charter and our areas of focus, it reminded me that our focus is data needs assessment, emerging data issues, data collection strategies, particularly multipurpose, integrated, shared, multiple uses of data collected once.
We also strive to achieve data standards consensus on uniform data standards, health terminology, definitions and classifications. Also focus on information system, network design, interoperability, privacy, security, and, of course, HIPAA.
So I point that out just because sometimes I think that we -- there are many dimensions of the topics we issue, but it just -- for me, especially in quality, we want to stay grounded in the piece that we are charged to do having to do with data.
On the next slide, again, reading through the history, I just took a look at – Okay. Let's see. There we are -- at selected history, and what struck me as I looked back through is that from time to time there is a major event that changes -- that has significant downstream impact.
So if we look back to 1949 where we were focused on mortality, morbidity and reportable diseases, our data sources were more or less raw statistics, and the benefit of those raw statistics was increasing national awareness on these mortality, morbidity and reportable diseases.
Fast forwarding to the 1980s, a major thing happened in that we developed care delivery site data sets. So the hospital data set, ambulatory and long-term care with that ICD-9 codes.
And the result of that was that we improved our understanding of diseases and particularly disparities. Minority, indigent, mental health, disability, long-term care, race and ethnicity issues came to the fore.
Obviously, 1996 brought HIPAA and all the issues about privacy and security. We began looking at electronic transaction standards, and, with this, we had increased opportunity for aggregation of claims data, better understanding of disease management and resource utilization.
And then, of course, in 2002, NHII, NHIN, e-prescribing. We had more information now about clinical data, lab, medications and the potential to define and assess longitudinal episodes of care and person-centric focus.
This, in no way, is an exhaustive review, but it just struck me that every couple of years, something major happens that fosters many significant developments. So this is just my mini-perspective.
Again, reading back on the review in the 50-year history, I was struck by the fact that 1986 the committee developed characteristics for assessing emerging issues. And it was noted that the work moved away from technical work to conceptual, consultative, looking at analyzing problems, reviewing research, talking with experts and those affected by the issues and recommending approaches and urging further study.
And that the function, again, had moved away from the technical analysis more toward drawing attention to issues, providing a forum for legitimizing and reenforcing new ideas and facilitating dialogue.
And, again -- and I raise this just as we think about what role we play best.
So on the next slide, this was me counting all of the -- and I realize I made an error. So we may need Mark's letter to get us to the 100 point. I think I counted a response as a letter. So no pressure. No pressure.
But I think looking at the production of the committee in this way tells several things. I mean, across the top for those listening in, columns are privacy, standards and security, populations, NHII quality and other, and year over year from ‘97 to 2008.
So, clearly, most of the production comes out of standards and security, and that includes all the annual HIPAA reports to Congress. So a little bit padded there, Harry.
And then I think privacy certainly has been an ongoing issue, but you can see that around the time of the privacy -- HIPAA, you know, certainly in 2004, seven letters and reports coming out at that time.
Populations has been steady, although, as you see, more standards and security than populations in recent years. And I think this is telling a bit of the story about the fact that we're 18 people and we have to focus year over year on different things.
And, of course, we had a lot of work on NHII, NHIN. And quality, you know, I put that up there for myself to see what -- the reports that have come out of it.
So later today, I'm hoping as many folks as possible can join in on quality workgroup, because I've taken the opportunity to review the report from ‘04 -- 2004 to say what's happened, and a lot's happened since that report was written, but, also, what's the right direction with all the rest that's going on in quality.
And then under column other, I have the uses of data. I think we should get double credit for that because it was 60 pages.
MR. REYNOLDS: We're going to get to 100 today somehow.
DR. CARR: So it just -- it shows how productive -- to Simon's point earlier -- how productive this group has been through the years, and continues to be, and how the focus shifts, because we can't do everything all the time, and as we think about going forward, I think this is a helpful landscape.
So, for now, I wanted to just go to the next slide, you know, where should we be going? And I'm going to just summarize two things. One is the core values identified in shaping statistics for the 21st Century, and, then, also, the guiding principles.
So next slide.
With the core values -- and there are four -- these would be, one, maintaining confidentiality, and, then, secondly, maximizing the scientific integrity of all aspects of health statistics while acknowledging the specific ways in which political, cultural, business contacts may affect data collection, analysis and interpretation.
The third core value is optimizing the enterprise's accountability to its users to ensure the availability of information that's needed for improving the health.
And, fourth, ensuring the enterprise's accountability to its data suppliers to minimize their burden and provide them with timely feedback.
And, then, finally, I'll just summarize the guiding principles of shaping statistics for the 21st Century, and, again, not reading all of it, but going through, one, enterprise-wide planning and coordination. Two, broad collaboration. Three, rigorous policies and procedures for protecting privacy. Four, flexibility to identify emerging health issues. Five, use of data standards to facilitate sharing and comparability. Six, sufficient detail at different levels of aggregation to support decision making. Seven, integrated streamlined data collection for multiple purposes. Eight, timely production of valid and reliable health statistics. Nine, appropriate access to and ease of use of health statistics. Ten, continuous evaluation of the completeness, accuracy and timeliness of health statistics and of the ability of health-statistics enterprise to support their production.
So I hand it off to Harry now.
MR. REYNOLDS: This is the third time we've done this, and every time it starts getting closer to a debate than a collaborative presentation, but in the spirit of the political environment, our record stands and will be attacked by others.
So moving forward to Slide 11, balancing the portfolio, as we take a look at who we are, what we are and what we're going to be doing, all of you are aware that a number of people -- up to seven -- could be moving off of the committee. So that changes the landscape quite a bit. It changes some of the leadership of the committees.
And so the executive subcommittee wanted to take a look at it while a lot of people that have been here a while were in place to take a look at the types of things to put on the table for discussion by everyone else as to how we ought to approach going forward.
So, you know, we always have an ongoing oversight. Whether it's the privacy, whether it's the regular population's quality or standards, we have to do some base things that we have to keep an eye on.
We're collaborating, obviously. We've done some work with ONC and others to get some things done. Emerging issues. We always have to keep in mind that we can get stuck in the current, but we always gotta keep pulling ourselves to emerging issues and envisioning the future.
So this really needs to be the kind of portfolio we look at in each committee, because sometimes it's easy to get pulled into today and it's easy to get pulled into what somebody says they want us to do, but going back through the history and listening to Justine and Marjorie and the others that have been around a while, you know, we've really been about making a difference in multiple levels. And I think these four are examples of that, not the only examples that you could use, but we have to keep that in mind as we go forward.
Next slide.
And speaking of a changing landscape, as you look at the electronic health records, the whole idea of the NHIN, the AHIC -- the change in the structure of AHIC, where it's moving to a private organization. The whole quality agenda, which you heard earlier. Legislation. Be a lot more -- continued focus on whether there'll be continued legislation in this environment.
Population strategy to ensure, again, that processes and data enhance its success, because a lot of what we've done in populations has been to talk about populations at the end of the process. Maybe we ought to make sure we get populations more to the beginning of the process as more and more data is getting collected, so that we make sure that it enhances the ability to use it once it's there. So just how that works or doesn't work is something to consider.
And then the key drivers of standards, as you see here, and then data, as we all know, the uses of data that we did, the whole idea of stewardship quality and then the support of future needs.
So those were just some examples of the changing landscape, not to be every example, but some ideas of the things that need to be considered as we go forward.
So going to the next one, so how should we organize ourselves to get there? You know, we've got standing committees right now, and those committees are made up in certain ways.
Under configuration, which is Slide 14, you can see across the top how we're organized. And, then, most recently, we've had a couple of ad hoc -- NHIN and uses of data, and we've tended to build the ad hoc because the subject went horizontally more than vertically. And many of our standing committees have tended to have to deal vertically, you know, within a subject matter and drill down, but, more and more, we've got this horizontal flare going on because we are the ones that can look across at -- in its entire breadth as we do things.
And then if you look at the future, if you take the list that we put on Slide 12, most issues need representation from all areas, whether it be privacy standards, quality, et cetera, as opposed to being addressed by a single committee, you know, so a lot of these things over here, whether you're talking about electronic health record, NHIN, these other things, it's not -- it doesn't just come to your mind that belongs there or that belongs there.
And then some areas -- for example, standards -- will have ongoing issues. So as we said earlier, back in the balanced portfolio, standards is required, for example, to deal with HIPAA as part of legislation and report to Congress and so on.
So there's some things in place that we all have to do, but, realistically, these subjects may not fit quite as nicely as we have aligned ourselves.
So moving next to this idea of the -- Slide 15 -- the ad-hoc workgroup model, you know, the benefits that we've seen from our participant expertise alignment ensuring a fundamental knowledge base so you -- you know -- kind of pick people that were interested.
And then the other thing that I thought was excellent was we also had people that identified themselves as reviewers. So even though they couldn't be in the day to day, they, in fact, could stay with us, you know, in a parallel track, not that they were on another committee and it didn't matter ‘til we got their full committee. That was very helpful.
It really broadened the experience -- I know it did for me -- of being with people that tended to be in other spaces than the committees I've been on. And it allowed, again, each of us to grow, because the more we grow on the subject, the better we get.
Active working partnership with staff. They've been very helpful in that.
And then broad perspectives incorporated.
But the challenges, as most of us know that we're involved in that, the timeliness, the workload and the generation of new topics spawned by the original.
So once we do this, every time, whether it be in the privacy letter that we're going to talk about or whether it be in the uses-of-data letter, we say, “And, oh, by the way, these X things need more work. And, oh, by the way, we'd be happy to do it.”
But as it spawns out, does it fall nicely into one of our nice little structures that we have that says that committee should take that and that committee should take the other one? And that's a struggle that we continue -- So that's -- Slide 16 kind of depicts that.
So out of uses of health data, we have a whole discussion on de-identified data, which, if you think about it, really has a stream across numbers of things. Whether it be quality reporting, whether it be privacy and whether it be standards, what does it mean? Those alone would all be involved.
Data stewardship is a subject, not a committee, and that subject spans everything that we talk about or touch or do related to anything that we're dealing with.
And then this whole quality and research boundary has many tentacles that we need to make sure that we deal with.
So let's go to 17. So how do we balance and manage requests for our service? Because, more and more, depending upon how other things shake out as far as what's happening, we do have a lot of what we would call customers and/or sources of requests.
So how do we make a difference by staying at the right level of consideration, so that we don't just become the adjudicators at a certain level, we literally play across the entire spectrum that we listed earlier?
We have multiple sources of requests, and you can see some of the examples that we have here. All really good efforts and all things that we should do and we were excited to do, but we have to continue to have our own list, too.
And, then, topic selections, reactive versus proactive. Where do we want to play?
Broaden topics beyond HIPAA in the NHIN and ensure availability of necessary data to support the healthcare reform.
And that was one of the topics that came up the other day is there's a whole lot -- you say uses of health data and then you put it in that kind of a sentence, again, it takes it to a different discussion, you know, it doesn't just keep it as always a byproduct of care. It now becomes how will data really transform the health environment. So that, again, takes us to another level of thinking.
So you can actually take the same subject across our four levels and actually move the same subject across all four levels, possibly at the same time, which gets kind of interesting. You know, so data, if you put it over there, would play almost in every one of our portfolio items as we look at it.
So looking at our structure, should we reconsider the role of standing committees, rename or organize standing committees and workgroups?
So, for example, relocate security, possibly to make it privacy and security. Refocus quality to data usage, rather than quality. Don't know, but it's -- again, we're putting these things on the table as considerations.
And, then, for example, we had the group NHII that put out the excellent document, but hasn't kind of reinvigorated itself, but a lot of that, if you look at it, maybe that is a standing ad-hoc committee, philosophically.
No, no, I mean, because if you staff it with a broad knowledge, rather than maybe just privacy or standards or something else, you staff it horizontally, maybe that becomes one of the places that you do it, if that's the way it's done. But, again, this is all for discussion. Nobody's making decisions and so on.
So -- and then reconfigure around ad-hoc groups, and then designate across committee representation for each subject versus ad-hoc self-selection.
So if the privacy committee was going to have a subject and it needed and it was going to have a flair for some other piece, possibly adding somebody to that committee during that time to make sure that that got adjudicated in a low -- way, then when it gets to the full committee, and then all these things that you wish you could have handled or you wish you could have talked to people about or somebody would have brought up because that's their space would have been done in that committee. So looking at it that way.
So, with that, next thing is member participation. You know, what are the expectations? More and more -- you know -- it's hard not to want to be aligned with your expertise versus cross fertilization. You know, people want to be involved in what they know and what they do and what their day job is, many times.
Attendance and participation. Making sure that we get everybody to play at the right level as we're moving along, because as these subjects become more and more horizontal, settling it at the end in the full committee and trying to catch everybody up to the whole subject -- not the individual task or the individual piece, but the whole subject -- is becoming more difficult.
Distribution of work within the committee. What should staff be doing? What should members be doing? What should consultants be doing?
And many of us in the ad hocs and others have seen it done all three ways, as to exactly how it gets done, and we can show examples of that.
And then how to cultivate leadership to preserve continuity. So, you know, some kind of a philosophical succession plan, especially within the individual committees. Committee vice chairs. You know, it had been recommended earlier, but not completely implemented in all cases.
I know that on the ad hocs we were on it took Simon, as the chair, and Justine and I, as the vice chairs, all three of us, split the work up and labeled it you know, did not have somebody just buried with all the responsibility, but doing that as a purposeful thing in everything we do, so that we share the load, rather than just on one person.
And then this whole idea of if you think of all these subjects that we put up there and the things that we have going forward, educating new members. I know I came on four years ago, and the subjects now are dramatically different, and they are much more extensive and intense as we start moving towards these things. So how do we actually educate new members? And we had some discussion on that.
Last slide that I'll touch is writers, consultants and staff. Who writes the letter report? You know, has to do with content and editorial polish and so on, dealing with that.
Balancing discussion between staff and members, how we make sure that we have all voices at the right time for the right reason.
And then consistent look and feel to the documents and the website. So, for example, we're more and more putting out significant documents, and, as the subjects get larger, all of us that are in the subject are writing it or having somebody write it, but we didn't necessarily step back and look at it from an editorial standpoint and from a public-viewing standpoint.
We knew the subject. We wrote down the subject and we tried to masterfully explain the subject, but we didn't, but we may not be quite the writers -- For example, if a Susan Kanaan looked at some of these things, she would see it differently than some of us did, even though it reads fine and we all approved it, but it may have the same look and feel if we did it that way.
So, with that, those were the things that -- and then we -- as we say, other issues, we had significant discussion at the executive subcommittee about these, but it was requested to bring it here for discussion because you couldn't have a lot of votes there because most people are -- a lot of people there are actually scheduled to roll off. It would have been a bit of a hollow vote. “Yes, you all have a good time. You all think that's good, huh?”
But I think the point is that these are the kind of things that we wanted to bring forward for discussion, take a look at and then make sure that we build this going forward in the right way for the right reasons.
So, with that, Simon, we'll turn it back over to you and open the discussion.
DR. COHN: Well, it's not so much turning it back over to me, but it really is opening the conversation, and I'd look for -- you know, obviously, Harry was talking about a wide variety of issues. I think sort of pick your punch is what I would sort of say in terms of commenting, but we're looking to sort of a wider view of all of this as well as ideas about how we should best move forward.
John and then Leslie.
MR. HOUSTON: Yes, I have some specific comments and some general comments.
I've been advocating for a while that I think privacy and security need to merge, and I think that you touched on that in one of the slides, so I'm going to raise my hand and say, boy, I think that's a really good idea, one that I think is past due.
I have some other general concepts. You know, I think that one of the things that we also need to be mindful of is that part of our charter is looking at emerging issues.
Frankly, I think part of our charter is to decide what are emerging issues before they emerge. I mean, I think that back 10 years ago, or whenever, we decided to -- we provided the recommendation on the NHIN or NHII -- which is even before my time, arguably -- that that really sort of set the direction of a lot of people's thinking as what needed to be done, and so we got out in front of that even before it emerged, in some respects, I think.
So I think part of this committee also needs to decide -- part of this committee needs to be tasked with deciding what are the next topics before they start to emerge or to try to -- does that make sense?
And then I think also another concept or another concern that I have is being very intimately involved in privacy.
I think that -- I'm a little concerned with the way that I've seen some of the letters go through the privacy committee, and I think it can -- it's actually, I think -- I think Mark would agree with me -- Whereas, a lot of the other committees, if you have expertise on those committees, you participate, and rarely do non-subcommittee members really get involved in some of the substantive discussion about those topics, because, frankly, I don't know anything about standards and I'm not going to start jumping up and down about an 837 or a whatever, because I don't know. I may look at the letters and decide that maybe something needs to be worded a little bit differently, but I don't get substantively involved in the discussions because it's a fairly technical topic.
The problem with privacy, though, is that everybody has an opinion, and we can talk ‘til the cows come home about privacy. And I think what happens is that these letters we work really long and hard on in the privacy subcommittee, and, unfortunately, when they come to the committee, there's still an enormous amount of difference in opinion from the general committee. And I think what it ends up doing is it causes these letters to slow down to a pace that I think makes -- potentially causes them not to be relevant, because they've been in committee too long.
And I think we need to have a framework in which we can try to adjudicate some of these letters in a more timely manner, because I just -- You know, again, everybody's got an opinion about privacy, and sometimes I think it just simply causes these letters to -- the pace of getting these letters through to go to such a -- to such a slow pace that they just -- it becomes problematic.
DR. COHN: Is this time for rebuttal?
Yes, I think, Mark, you wanted to comment on this, and then Leslie.
MR. ROTHSTEIN: I just want to say, John, I agree with everything you said, and the point also is one that I tried to make at the executive subcommittee meeting when this issue was discussed.
And it's just too long a process. There's no reason that the letter we're talking about today should have taken 15 months or however long it took.
And I do appreciate the wide variety of opinions as well as the vigor with which those views are expressed by the members, but we're going to just play ourselves into a state of irrelevance if we don't get the stuff out in a timely fashion.
DR. FRANCIS: I'm fascinated by the selected history, the slide that Justine put up. And part of why it fascinates me is the shift in focus -- I'm thinking substance here -- from, on the one hand, what are patterns of disease and how is care dealing with it, what's happening to, for example, disadvantaged populations. That's really what's going on up through the end of the ‘80s.
And, then, after that, the shift is all about the management of the information, not so much about what's the information telling us, but how are we getting it, how are we protecting it and so on, which is a fascinating shift to me, if I look at your slide.
Now, that said, I think both of those are interesting, and I -- and both of those are crucial, and we shouldn't be losing one for the other.
So as I think about how to structure, we've got substance questions, which is what are we about, and then we've got process questions, which is how are we going to do what we're about, and I guess part of it is it seems to me really important to decide what the substance questions are, because, in a way, they're going to drive how we want to organize ourselves process-wise, which is why I made that substance observation.
I would just say one other thing which is that there are advantages and disadvantages of having a subject-matter committee, like, say, privacy.
The disadvantage, of course, is what Mark and John have just been talking about. The disadvantage of splitting it up and having one privacy person on each committee is the risk that things get diluted, and that could happen whether it's one populations person on each committee, whether it's one quality person, whatever it is, and I think we need to think about that when we think about process.
DR. SCANLON: I'd like to come back to John's point, which I guess I'm wondering if part of this is an issue of evidence versus values. Whereas, some of the privacy discussions may -- actually, people are expressing values as opposed to sort of pointing out that the evidence shows that this is going to be the impact of A versus B.
And it raises a bigger question about evidence here, because we rely heavily on testimony in terms of gathering information.
And testimonial evidence, in some respects is one of the weaker forms of evidence, because you say from -- what you say, in part is a function of where you sit. And there's a question of sort of getting sort of opposing viewpoints. And, then, also, it's sort of extrapolating to the rest of the world, sort of being able to put weights on the kinds of testimony you have. Even if you have all the viewpoints, there's a question of which one is the most important or which set of them are the most important.
And there's an issue for us, in terms of the limited resources that we have, of how do you reach a conclusion when you have this kind of fragmented evidence and you don't sort of -- and you don't have the ability to kind of go and to do the more extensive sort of information-gathering that would allow you to weigh things, allow you to sort of verify things, et cetera.
I think we do a very sort of good job with what we have, but there is that tension that we're always going to have to face.
And then there's a question of when we come to something where values may be playing a role, how do we introduce values sort of into this discussion?
And I think it's not -- I mean, my view of a committee like this is it's not that sort of the American people have designated these 17 people to decide what the values should be about something, but we should be raising the issues about values, you know, and raising them to the level of the Secretary and let the Secretary decide -- make the Secretary sensitive to what the value issues are with respect to a point, not necessarily try and reach a consensus here and say, “That's what the Secretary should necessarily do.”
That may have an impact in terms of trying to make things easier to put forward or it may not. I don't know. I mean, it's kind of like -- It would be interesting to do an autopsy on some of these letters in terms of why did it take sort of -- you know -- this many sort of iterations, kind of what were the diseases that were involved before we --
DR. COHN: Bill, let me just sort of ask, and I'll let Carol sort of comment also, is your observation, then, that a lot of the issues -- getting into values conversations may be where things sort of start getting into a very long and involved process? Is that what you're --
DR. SCANLON: Well, No, it's not that. I mean, I can't say that I've made that sort of correlation sort of over the time on the committee, but I think the privacy is right for values.
It's kind of like when you say it's very important to protect this information because people are sensitive to it. Well, you've already introduced sort of values into that statement. People are sensitive to it. It's sort of how people regard this.
And then, in terms of a policy, it becomes a question, in some respects, of sort of what are the impacts, and then how important is it to protect even sort of the very small minorities of people. I mean, and that's value.
You know, it's like the whole social sort of impact of something could be sort of very minor, but that's not the important thing. It's if it's in terms of some individuals being protected, my values may be that I regard that as very important, and I'm willing to do that.
And so it's -- I mean, this is -- privacy is just -- I think, is laden with this value issue, and so it's tough for a committee necessarily to come to sort of a conclusion about it.
And the question I guess I'm partly raising is what's our role in terms of coming to a conclusion about it?
MR. HOUSTON: Or what's our process?
Because I think part of the problem is, I think, it's fair to say everybody has a value and an opinion and that we need to respect that as well as the people that we ask for testimony on, but once we try to get all that information together and distill it down into a letter or recommendations, how do we move that forward in an expeditious manner?
I think that is really probably the most frustrating thing that I feel is that, boy, you know, part of the problem, too, with this letter was -- is that, then, all of a sudden, midway through the process, we got new members involved, and then you started to re-vet issues that we had before.
And there's nothing -- I'm not saying that's wrong, but it dragged out so long that then it caused its own -- we caused our own set of delays just because of bringing members up to speed and things like that.
So I think there's a process side of this that really is troubling.
DR. COHN: Okay. We have Carol and then Marjorie and then Mark.
DR. TANG: Simon, can I get on the queue also?
DR. COHN: Is it Paul?
DR. TANG: Yes.
DR. COHN: Paul, would you like to introduce yourself and tell us whether you have any conflicts of interest?
DR. TANG: I did that. I think my headphone was not working, but, yes, Paul Tang, Palo Alto Medical Foundation. Member of the committee. No conflicts. And I've been here from the start.
DR. COHN: Thank you. Okay. We'll put you in after.
MS. MC CALL: First some just kind of reactions, and the observation, mostly, on just kind of the old versus the more recent is fascinating in terms of subject versus process.
I guess one of the thoughts I had while you were talking is that it's become so overwhelming, you know, in terms of being that subject-matter expert, that I think that those days are probably gone for this committee -- right? -- just in terms of the quantity and things like that.
So I think my reaction would be that to think that we are going to be subject-matter experts on morbidity, mortality, whatever, you know, to kind of blow past.
The second, it's a fascinating thing about evidence versus -- and testimony, and how good testimony is as a way of gathering versus things that are more emerging.
So if we think about that and those become some of the tradeoffs in the topics that we pick, the subjects that we pick, I think that there are some consequences to that.
One is that I think where there's evidence and where our subject-matter expertise lends itself, we're going to -- process will be faster, you know, because we've worn a path and so we know how to do it.
And I think testimony probably can help, but if we're looking at emerging issues, if, in fact, we're saying our role is to look at emerging issues, I think they're always going to be more cross-cutting.
I think we will have issues around values -- Is that our role? -- and it's going to be slow. All right? And then we have to look at how we go about finding evidence, because, otherwise, we're just looking where the light's bright.
So when we think about that, I think there are process implications for us. I think there are capacity issues for us that we need to talk about.
And, then, I have a question for the group and also for you, Simon, which is where has our value been most greatly appreciated? Is it in more evidence-based subject matter -- we can tell you consequence, so recommend this, not that -- or is it in emerging? Because we can talk about putting ourselves on the path of emerging issues, and yet if that value isn't going to be able to be realized, then that's probably not a good use of all our time.
DR. COHN: Carol, thank you. Let me at least try to answer your last question, and then I will give it to Marjorie.
But I think what Harry and Justine and I think others have proposed is what we've described as a balanced portfolio, because I think what we've seen is value appearing in multiple different places.
I mean, part of what Leslie is commenting on is actually really the re-chartering of the NCVHS in 1996, where, really, the focus -- the Congress, the Administration asked us to change -- sort of lead division of health information technology, which changed substantively. And rather than just talking about core data sets, we suddenly started realizing, well, geez, if you have standards, out of that is generated interoperability in standardized data and sort of this realization.
But, at the same time as I say that, I think that's been very helpful, but, also, the NHII vision has been extremely valuable, I think, to the country and the 21st Century vision of health statistics.
So it's sort of this issue of trying to meet -- you know, there's not one customer. There's a variety of customers.
Anyway, that's my comment.
Marjorie.
MS. GREENBERG: Well, just wanted to make a few comments.
As I pointed out at the Executive Subcommittee meeting, not only have I kind of been around a while, so -- I really appreciated Justine taking on this sort of current role as committee historian, because I -- obviously, I think that's important, and so, you know, he who forgets the past is doomed to repeat it or whatever.
But, also, as I pointed out, whereas, members come and members go, but the staff kind of stay often, and so I appreciated --
I appreciated also the opportunity to reflect on the past number of years and the future, and I thought that Justine and Harry did a great job with these slides. They really stimulated a lot of discussion at the executive subcommittee meeting, and I hear some very good discussion here as well. So I just wanted to tip my hat to them.
As you'll be hearing later, I mean, one of the things we do plan to do is to update the history, the 50-year history that we did for the 50th anniversary, for the 60th, and I think what Justine has done will be a great contribution to the work that Susan Canon will take on in that regard.
Now, in reaction to a few of the things that have been said this morning, you know, on the privacy issues, and particularly this letter which is going to become our hundredth product, I don't think you should be too hard on yourselves.
There is a group sort of -- you know -- up on the Hill that hasn't really been able to deal with this issue from the point of view of legislation now for a number of years and sort of bounces it back to the department and to the committee. And so, obviously, it's a very difficult -- there are a lot of difficult issues, and, as Bill said, values, et cetera. So 15 months would probably look good to people who've been trying to get legislation on the Hill for all these years.
And maybe that's not the best way to go with legislation either, because of the fluidity -- sort of the more flexibility allowed without that.
But we did have an interesting discussion when we talked about this issue of length of time that it takes, and particularly with the privacy letter, as to whether -- how the members who were at the executive subcommittee meeting felt about the need for consensus versus just allowing some minority opinions.
And, certainly, our processes do allow for minority opinions, and we have had a few instances where there have been minority letters or minority statements, but there seemed to be -- at least in the executive subcommittee discussion -- a pretty strong feeling that they really valued the consensus, that it makes it harder and takes longer, but they really felt that what comes out is of greater value to the department and to the broader constituencies. So that might be an interesting thing to hear how those who weren't at the executive subcommittee feel about that.
The other thing, Leslie, I think, really nabbed it with the thing about substance versus sort of, in a sense, process or technical versus -- I mean, you could say technical versus broader or substance versus more -- you know -- sort of how you do things, which is -- and I have to admit that that was a great frustration to me when -- in 1996 with that change because I really valued the work that the committee had done with the data sets and with more substantive recommendations related to data elements, et cetera. It was helpful in many ways. But, at the same time, I think the vision work that the committee has done since then has been very valuable.
So I would, again, support the idea of this balanced portfolio. I think, you know, where you've talked about functional status or race and ethnicity data or some of the other areas, I think that continues. You can really make a difference in those areas, but, clearly, as has been stated, you can't be an expert in everything. So I think you need to balance both.
MR. ROTHSTEIN: Yes. I wanted to pick up on something that Bill said and also that Carol spoke to, and that is what should be the evidence base on which our letters are written? And, in my view, I mean, we have a very sort of unusual basis on which to support our letters. I mean, these are not IOM reports. They're not academic reports. They don't rely on references. They don't rely on independent literature reviews. They are based on a combination of the testimony that we have, written as well as oral, and our own personal experiences.
And so, given that, I mean, you have to keep in mind what our charge is as a committee and what our resources are.
I mean, we don't have a staff of full-time researchers to do the research on the issues. So what we're basically trying to do is to serve as a liaison between the public, broadly defined, and the Secretary, and translating the thoughts, concerns, opinions of a very broad range of constituents and individuals and try, from that, based on our own expertise, to formulate some sound policy recommendations, to the extent that we can formulate them.
But, I mean, it's a very difficult balancing act, because, since I've been on the committee, we've always been charged don't go beyond the testimony to make statements, and we've never had independent research analysis, so I think -- and I'm not speaking specifically about the privacy subcommittee. I'm speaking about all the work of the committee -- I think we've done a very good job of that, given our limited role.
But I think sometimes, maybe internally as well as externally, people expect too much of us, given what we have to work with.
DR. COHN: Paul.
DR. TANG: Thank you, Simon.
First, I want to thank Justine and Harry for, really, an excellent teeing up of this discussion, because I thought both the history and somewhat the philosophy -- was very helpful to bring into the discussion.
I don't know exactly what -- whether they were posing specific questions, but I think the two kinds of ways we've been working -- the standing committees and the ad-hoc committees -- are very complimentary and I think are actually both necessary to move forward.
Leslie mentioned sort of her take on the history, which was -- I think what she said was the initial point was to see how to use data.
And then we've been focusing more recently on how to acquire and manage data. And I wonder if we need to go back to the future and go back to as if we were to get data how would we make effective use to improve the health of individuals and populations. So I wonder if that's actually calling us to step it up a notch.
Having said that, I think -- and I think this is what Harry and Justine are proposing -- that we really need to continue to make judicious use of both of our mechanisms, not by excluding some other ideas, but there's certain work we have to crank out, sort of ongoing work, and standing committees are maybe the way to do that, and probably in particular -- standard subcommittee.
But the ad-hoc committee, I think has functioned very well to deal with the emerging issues and populate it with people with cross-cutting expertise, and, typically, certainly this last one, we turned up the heat on the timeliness, and I think that's -- it's a lot of work, but it actually makes our product come out in a more economy(ph) manner.
And possibly that may be one of the answers to some of these privacy questions. Maybe it needs to go through an ad-hoc committee, but I think we've been using both of them -- we've certainly evolved in having two main tracks -- way to get work done, and I don't think we should give up one or the other, because they're both necessary, but I think other people have said that as well.
But so the parting words are sort of to come back to the roots of making sure we make effective use of the data, and that means we have to find ways to capture it efficiently, but also effectively in the sense of preserving its meaning, and then make sure that the aggregate value, the knowledge that comes out of it, gets back out to the deployed folks in taking care of patients in the front line.
That seems like a tall order, but I think that we've been working up to that point, and I think we should continue in that direction.
DR. COHN: Paul, those are very useful comments.
Now, we have Larry Green and John Paul.
And then I'm going to try to wrap this up, not that we have an answer, and, obviously, the purpose of this conversation was not to have people vote at the end, ad hoc versus standing committees or this or that, but I think we want to begin to get some input.
And, obviously, this will be taken by the executive subcommittee and I think sort of further massaged. Probably we'll see it again in May, especially as the transition progresses in terms of thoughts about how to move forward from here, but I'm -- It's useful, I think, that at least the executive subcommittee framework has turned out to be somewhat helpful in terms of, I think, really crystallizing the issues.
Now, Larry, you're next. John Paul, you'll have the last comment, and then we'll get a break.
DR. GREEN: Well, Simon, I want to build on Paul's comments, both the thank you he gave Harry and Justine -- I share that thanks -- and, then, I want to go back to this word, data.
The way I've been provoked to think about this by the materials sent before the meeting, and now that I feel like I've just about completed my orientation to the committee, this committee, it seems to me, is fundamentally about data. It's a data committee.
Data are the granular substrate out of which grows information that's critical to the seasonal issues of the day.
And as I read the statutory charge of the committee -- and I went back and looked at it again -- and I particularly found that 50-year history booklet very, very helpful -- it seems to me we would do well to center and anchor our thinking about what we're going to do and how we're going to do it around the issue of data and how data are moved into information that can be used for multiple purposes.
Data have to do with classifications and ordering principles. They have to do with vocabularies and terminologies. They have to do with standards and conventions, and they have to do with units of analysis.
It seems to me that this committee is charged and positioned to do that sort of work on behalf of the nation, and that that sort of work is timeless and captured -- there are nets that go by that attract data that have to do with values and political issues.
At the moment, the establishment of the National Health Information Network is probably the strange attractor for data from a complexity science, one of you, and it seems to me that we would do well to organize ourselves not so much to comport with what I would call the seasonal issues of patient centeredness, but whatever privacy -- whatever those are -- those will come and go, but it seems to me that our charge and our duty from our statutory obligation is help the nation have the data that can be organized in information so that we know about the health of individuals and the health of populations.
If we did that, then it seems to me we can discuss further how we accomplish what seems to me to be the only two options we have. So far, all I've seen us do is we assess things and we write letters. So it's assess and recommend. Assess and recommend. Assess and recommend. It seems to me that's our common pathway.
So I'm trying to get my arms and head around this. I think in two-by-two tables. It's a curse, but data go to information. Information goes to policy, and it seems to me that my question will be is, as we think about May and what we want to talk about, I'd like for us to answer the question is how does this committee get itself organized to be sure that the nation has the data it needs to develop the information it must have in order to get value out of the healthcare system and produce a healthier population.
DR. COHN: Larry, thank you. Well said.
John Paul, I think you have the last comment here.
MR. HOUSTON: Thank you.
Being involved in the AHIC a little bit, one of the committees, it's interesting that their pace at generating recommendations is much, much quicker than ours. And I think they're probably more driven on setting deadlines and internal expectations about how quickly things need to get done.
And there might be some value, when we start to entertain certain topics, like the secondary-uses letter, that we put together maybe not necessarily deadlines, per se, but expectations on when we want to have things delivered and when things will be available for review and what the expectations are in terms of review and when you need to get comments back, things like that, so that we can try to maintain the pace on some of these letters, I think, that are -- that I think are dragging.
That's the one comment I want to make, and the other comment I wanted to make goes back to something I was thinking about before and it was where do we troll -- what waters do we troll in?
And I think one of the areas that I think might be of interest is, as NHIN's coming together and people are starting to adopt electronic record systems, is does it have value for this committee to be involved in assessing the advances or the improvements in healthcare based upon the adoption of electronic information systems and regional, as well as, potentially, the national system of interchange?
So -- and I know we've talked a little bit about that before, but I don't -- in some respect -- but I think it might be a topic where this committee maybe needs to spend more time.
DR. COHN: Marjorie wants to make a comment, and then I'm going to wrap up and give everybody a well-deserved 10-minute break. So Marjorie.
MS. GREENBERG: Well, I don't want to misquote Mark, but he made an interesting observation -- and it may be related to the amount of time it takes or whatever to get some of these things done -- but about how this committee was different from other committees he had served on in that the members really are -- the members aren't just reacting to recommendations and documents that have been developed by staff, which I think is more the way the AHIC has worked, and I know, certainly, a number of other groups do as well.
Do you want to -- and I just thought it was an interesting observation, because it is true that is a different way that this committee works.
MR. ROTHSTEIN: Yes, at the executive subcommittee retreat, I mentioned that I thought the NCVHS, in its operations, was different from many of the other federal advisory or comparable committees on which I have served, in the regard that it really is member driven. Our agenda, the substantive output is member driven. The role of the staff -- and the staff has been great to me over many years -- is to support us, to help us. It's not to frame the issues for us, to tell us, “This is where we're going. Don't you approve?” sort of thing, and it really is driven by the members. And that presents some other challenges to us, but we should be aware that this is quite a different thing. And, frankly, it's one of the leading things that makes service on this committee so rewarding, because we do have the opportunity to shape our agenda and our work products, and that's a source, personally, of frustration in other contexts.
DR. COHN: Well, as I commented, without trying to solve the issues, I'm glad at least we did have a chance to talk about them. We'll have the executive subcommittee sort of reflect on this one. I think we'll be coming back with additional conversation.
Obviously, as the chair, I get to make some final comments that don't get a rebuttal, at least immediately, but I am always fascinated -- And you all have to realize, of course, I'm an emergency physician. So time is of some meaning to me, but I find myself in an environment where the lawyers are being impatient and the emergency physicians actually not really terribly upset with the time frame. So I find myself in a very unusual circumstance, one that is almost against nature, I think.
But having said that, I do want to observe that -- and, John Paul, you actually began to touch on this a little bit -- that one of the things that we've tried to do over the last couple of years -- and, obviously, it's once again that question of balancing portfolios and what we do, but we've tried to -- much more than ever before -- make sure we have customers for the work that we do.
And one of the things about having customers is that it does drive time lines and urgency and everything else. And I would just reflect on it that it -- I mean, one of the ways we can handle that -- because not everything is going to immediately have a customer, but, in those cases, we need to be diligent and self-impose time lines or other things to make sure that things remain relevant and timely.
But, certainly, in a whole variety of other areas, we sort of look at -- you know -- we need to know. We need to do this by this time and then we develop the work plan to meet that.
So, I mean, once again, it's just sort of an observation of how -- of how sometimes we do things differently on a committee.
Now --
DR. TANG: Can I --
DR. COHN: Oh, please, Paul. Sure.
DR. TANG: The thing is I observed that the -- what was called the Secondary Use Ad Hoc Workgroup was able to deal with very much the same substantive issues dealing with privacy and were able to make a deadline and produce a -- and I think a good product. There must be -- there's probably something to look at there, too.
MR. HOUSTON: We set the deadlines up front on that letter. It was very clear what the time lines were. So it was a different model.
DR. TANG: Well, I think it was run differently, too. So, I mean, I think we need to just look at all the things that went into making that product good and delivered on time and see if there's lessons to be learned there.
DR. COHN: Well, Paul, thank you, and I think you're the final comment before we give everybody a 10-minute break.
We will get back together at 10:35, and then we'll start off on one of our hopefully more successful letters, even though it's --
PARTICIPANT: Centennial letter.
DR. COHN: Centennial letter here. OK.
(Break).
DR. COHN: Okay. We're going to get started again here.
Now, as discussed, this part of the discussion is really reviewing the letter on individual control of sensitive health information, accessible via an NHIN. This is Version 17-A or -C or whatever, at this point.
We're asking Mark Rothstein and Maya Bernstein to sort of go through it with us, not word by word, but more section by section, just to address any changes, especially substantive changes, to the document, which, hopefully, we can be able to do literally on the screen as we're sort of talking about it and see what sort of changes.
At the end of that, obviously, we'll sort of see where we are, whether it needs to go back to subcommittee for final adjudication, whether the changes all have sort of come together, at which point -- you know -- we can choose to act today or tomorrow or whatever.
So we will sort of hold that as a sort of a decision to be made after we've looked at sort of where we are now versus the additional changes and comments that have come in.
So, Mark, I will turn it over to you.
MR. ROTHSTEIN: Thank you, Simon.
As you know, this is the letter that we discussed at our November meeting. It's been substantially rewritten since that time. You all should have received a separate document electronically dealing with our comments in response to the discussion at our November meeting that explains to you why we did what we did.
Since the letter was circulated in your briefing books, I have received comments from a few people, either directly or indirectly.
PARTICIPANT: (Off mike).
MR. ROTHSTEIN: Well, comments made to Maya were relayed to me or comments made to someone else were relayed to me.
So I have comments from Larry, Simon, Paul and Justine as well as a few other minor typos that I've corrected in the document, but I think everyone has had a chance to review it on several occasions and like to see if I could go through it with you and just point out the general thrust of the letter and note for you the suggested revisions that have been sent in that would affect the version that you have.
The first page, of course, just presents the background, and we have one suggested change. It's in the first sentence, the second line, to change the word “defined” to “limited.”
MS. BERNSTEIN: I think we've changed that back and forth several times, right?
MR. ROTHSTEIN: Well, yes. We've gone back and forth on that, and the change would make it consistent with the language that's used on page 2. So, unless anyone has an objection, we'll make that one change.
Anybody have any other comments on the first section of the letter, which, as we say, is just background. It goes through the top of page 2?
The next section is on the importance of individual control. This is the section of the letter in which the committee makes the case for why individual control is important. It follows up on the June 2006 letter, and also sets a framework for what goes to follow.
I do not have -- well, let's put it this way: I have not received any suggested changes on this section.
DR. OVERHAGE: Sorry. Marc Overhage.
As we talked briefly this morning, I have a fundamental problem with it. I think this is the heart of my problem with the letter, and that is I don't know that we have yet -- as we said in our 2006 letter -- have a decision about whether individuals should have this right, based on an open transparent and public process, and this paragraph presumes that has happened.
And while, certainly, deliberations of this committee are open, public and transparent, I don't know that that's a sufficient discussion about the desirability for us to make a recommendation.
MR. ROTHSTEIN: So let me see if I understand you -- and we did have this discussion earlier -- that I think it's your view that no recommendation or letter of this sort would be appropriate until such time as there were developed an evidence base of either individual preference in the country among users or some evidence base of problems without affording that. Is that fair?
DR. OVERHAGE: I think that's fair, and I think it builds on some of the discussion we had earlier this morning about how strong we have to be.
But we're making recommendations in this letter that will cost hundreds of millions of dollars to implement. And I don't think we should do that lightly. I think -- because there are many other things that we probably can and should be doing in our healthcare system and with our data and with privacy. And I'm not sure this is the most important one. Matter of fact, I'm quite sure it's not.
MR. ROTHSTEIN: Okay. Other comments from subcommittee members or full committee members?
So, basically, I'm just trying to see if there is some way of accommodating -- basically, your position would be that the whole letter ought to be scrapped, because it's premature?
DR. OVERHAGE: No, I have a more positive response -- suggestion than that.
MR. ROTHSTEIN: Oh, okay.
DR. OVERHAGE: Paul might suggest that, but I have a more positive -- and that is that it seems to me that we should focus on determining the desirability, rather than proposing a solution to a presumed problem.
MS. BERNSTEIN: Well, patients have -- may I?
MR. ROTHSTEIN: Please.
MS. BERNSTEIN: Patients have many of these controls in the current system that we have --
DR. OVERHAGE: Could you say that more slowly? Maya, sometimes you speak --
MS. BERNSTEIN: Sorry.
DR. OVERHAGE: Slow down a little.
MS. BERNSTEIN: Get more to the New Mexico and less to the New York.
Patients have the ability to sequester one way or another a lot of the information now, under the current system on paper. It's partly because the system is fragmented.
But I think what you're saying is when we go to a nationwide health information network we will be removing basically the rights that patients have now from them, because we are not --
DR. OVERHAGE: Disagree with that assumption.
MS. BERNSTEIN: Well, but -- OK. So --
DR. OVERHAGE: We're not changing any patient's rights.
MS. BERNSTEIN: Well, okay. They're not rights in law, but they're de facto in practice the way that the world works. And what we're -- we would be saying -- I think what you're saying is when we go to a nationwide health information network, it's not clear whether we should have those same abilities or not. Is that a better statement?
DR. OVERHAGE: I think the assertion that we built this letter on is that HHS should assess the desirability of allowing individuals to control access to specific content of their health records via the net.
MS. BERNSTEIN: OK. You're reading from somewhere.
DR. OVERHAGE: Right. From Recommendation No. 6 in our June 2006 letter.
MS. BERNSTEIN: OK. Where are you reading?
DR. OVERHAGE: Hasn't been done, as far as I know. And I don't -- I would assert we haven't yet done that in this committee.
MR. ROTHSTEIN: I think it's the view of the subcommittee that HHS not having done that, we -- and this is why we took up this letter, frankly -- we felt that it was important to get a policy recommendation out on sensitive information, because the failure to recommend anything would, in effect, be the default position of recommending no action.
In other words, as we have talked many times in the past, the private sector and the developers of electronic health records and networks are moving ahead at a very rapid pace. And if we do not take the position that there should be sensitive information controls built into the system, then we -- and waiting until there's an evidence base, it seems that we are, in effect, saying let's go ahead, and if there's a problem, then we'll step in and try to do something about it.
And so that, I think, is -- that's not an answer to your question on the merits. That's an attempt to answer why the subcommittee felt that it was appropriate to take up this issue as a follow up to our June 2006 letter in the absence of HHS doing something. OK?
MS. BERNSTEIN: Well, and I think the other reason is that -- which is what Mark raises -- is the cost of it, that if you work changes into the system as we're developing it, they're much, much less expensive than if you try to retrofit a system into it later.
MR. ROTHSTEIN: OK. Leslie had her hand up and then Larry.
DR. FRANCIS: Yes, I mean, we're not going to have the evidence base about a system before the system is implemented, right?
DR. OVERHAGE: I don't think we need an evidence-based system. We need an evidence base about desirability.
DR. FRANCIS: Well, what -- I mean, what we're saying, I think -- As I read this letter, what we're saying is, right now, we're in a situation in which there are clear benefits of sharing information, and there are potential risks, and so -- but things are going along so quickly that if we just let them go along and essentially not paying attention to a particular risk, we are in a situation in which that risk goes unexplored, may materialize at a point at which it is enormously expensive, then, to go back and revamp the system.
And so I don't -- I mean, I don't know how to deal with that conundrum other than to say that, as I read this letter, what we're doing is we're asking that NHIN design to take these issues into account at the get-go.
Now, it may turn out that part of what the NHIN design would do is get some much more -- you know, get some evidence.
I mean, part of what -- you know, we, as a committee, don't have the ability to do that kind of research, but I think part of what ought to be on the table is getting more evidence about what the privacy attitudes of people would be and what would be the most sensitive.
I mean, we're not writing in stone a particular set of categories of sensitive information, but unless that's on the table, we don't have anything.
MR. ROTHSTEIN: I've got Larry and then Simon. Oh, Jeff. I'm sorry, Jeff.
MR. BLAIR: Thank you.
MR. ROTHSTEIN: Jeff, then Simon. Sorry, Jeff. So Larry, then Jeff.
DR. GREEN: I think Mark makes two good points. One is the context of the letter and the other is the ignoring of any financial implications of the recommendation.
And I'm wondering if Leslie didn't basically just speak, but would address both of those if it were incorporated up front.
My simplistic notion of this is the letter recommends that a design feature of the national -- information network be -- the option for individuals to sequester by category personal health information, and that the reason this letter is coming when it does is because Recommendation No. 6 from the 2006 letter has not progressed. But the NHIN is progressing and we have this sense of urgency that this design feature needs to have attention called to it now.
And then, perhaps, there's some way in the recommendations to say all those recommendations -- about study this, research that, evaluate the other, evaluating the need and operational characteristics of this could be incorporated.
I'm looking for a way forward that does not ignore Marc's concern.
MR. BLAIR: Number one, I wanted to start off by once again saying how beautifully written this was. It's so complex and so sensitive, yet, it's something where it could be read and understood, and that's not a minor achievement. So I don't care how many versions of it you might have gone through, I think that is worthy of mention.
The other piece is I have been a little bit torn between some of Marc's concerns and those of privacy advocates. With the experience that we've had in New Mexico, there's legislation that we were part of crafting to try to see if we could come to accommodation in terms of legislation that would protect the privacy of individuals when their healthcare information is in electronic form and the NHIN and HIEs. And it has sensitized me to the tremendous concerns that significant portions of our population have about protecting their privacy of their health information.
So I -- on the one hand, I think that the basic proposal of this letter I support.
On the other hand, I'd like us to recognize two of the points. I think that Marc really made two points, because when I was reading through this, an individual I just happen to work with was reading this, and while it was my view in reading this that we were moving forward and doing things to protect rights, there are individuals who automatically assume that these rights already exist and they don't know that they don't.
And I think it would help us, number one, to point out that these -- a number of the elements that are proposed here don't exist in federal statute as rights today. I think we should clearly say that.
And the second thing is that we are proposing policy here. We're proposing policy.
And then the third thing is that we're making a proposal that is a major step forward and neither the technology nor the finances for this have been fully explored yet and that we're recommending that that be done.
So I would like to see all of those elements in there. I think that that would help us to maybe broaden the acceptance of both the folks that have extreme concerns about privacy, on the one hand, and I think it would also maybe address the very valid concerns that the finances and technologies of this proposal haven't been examined yet.
DR. COHN: I'll be speaking as actually a member of the subcommittee, as opposed to necessarily my role as chair.
I did, obviously, want to just reference to Jeff that, at least from my view, the research, development and implementation section, which is at the end, really is meant to sort of recognize that, I think, the view of this letter is it is intended to be more directional, rather than saying doing this tomorrow, because I think there's a recognition that technologies and whatever really don't exist well to do all this in the current world. And, therefore, we're saying this is a promising direction that needs to occur, but unless we start now with research, development and otherwise, we're not going to be able to be implementing this. And if we don't architect it in, it's -- there's not going to be an opportunity.
So, I mean, it doesn't explicitly mention finances, but I think it's -- the view is is that HHS investment needs to occur.
Now, I actually wanted, however, to go back to -- I'm hearing from Marc a very fundamental question, and I just want to -- and we're been sort of talking around it. And I'm just trying to figure out whether -- I'm not hearing wordsmithing recommendations to deal with concerns. What I'm hearing is a very fundamental question -- and maybe I'm mistaken about this one -- which says, “Geez, you don't believe that at the basis that NCVHS, through its process, assess the desirability of -- this going forward.”
And I guess -- and I think that's what I'm hearing you say, and I guess I'd have to look to the subcommittee to recommend -- Normally, in the subcommittee processes, part of the hearings are to assess the desirability.
Now, I think what I'm hearing you is saying -- and I'm just not sure where -- I mean, is your view that the NCVHS process was not sufficient to assess the desirability or that more needs to be done or someone else needs to do it? Just so that I can understand a little better.
DR. OVERHAGE: I think that I wanted us to ask ourselves the question: Have we -- because we're making use of this was directional, and, yet, when I look at the recommendations, they are far beyond directional and are rather proscriptive.
When a healthcare provider accesses health information with one or more categories sequestered, a notation will appear. I mean, that's a very explicit policy recommendation not directional in any sense, I don't think. And I think you could make similar points about many of the others.
I would challenge -- at least for me, I am challenged to stand up and say, “We have determined desirability based on what I have seen,” and that's partly a process question.
I understand we have limitations on our resources, but, then, we shouldn't make recommendations beyond our ability to do it appropriately. You know, making a decision based on poor information is never a good idea.
Second, I think that if we, indeed, are trying to address the question, we think we have thought through desirability and we can come back to this, but the next section is entirely missing, which is what are the costs and risks to the individual and society of autonomous choice and the individual's limited ability to limit access? And what are the implications of educating an individual?
And if something like this were going to go forward, I would really strongly like to see the individual have to be, much as you might do with an abortion decision or something, the individual counseled with written decisions about the implications of this decision for them, because the thing is they have no idea what they are deciding about.
For example, if they choose to sequester their reproductive health information -- and that includes birth control pills -- they may well get pregnant, because they're going to come in and see a doctor, think there's absolutely no relevance, and they're going to get an antibiotic that inhibits it, and that's going to happen.
And you can't -- that is a very long, deep discussion to have on each of these topics that are proposed.
So I think that we have not adequately, my view, in the letter -- and I'm not sure we have in our discussions -- addressed the implications and cost to the individual, to healthcare providers and to our healthcare system. Nor have we asked the question: Is this so important as to be worthy of the Secretary's attention and the cost associated?
MR. ROTHSTEIN: May I use the prerogative of the chair just to explain the process?
This letter really does follow on the hearings that we held before our June 2006 letter. We held five hearings across the country in which we heard from literally dozens of individuals and groups representing all the major medical societies, all the other major providers of healthcare. We heard from the nurses. We heard from chiropractors and et cetera, et cetera. We heard from patient groups. We heard from all sorts of people around the country.
At that time, we did not have as directive, if you will, a recommendation in our 2006 letter. So our discussion on this letter and our recommendation is much more granular and more assertive, if you will, than the 2006 letter.
For this letter, when we were contemplating deciding whether to recommend additional steps for sensitive information, we did have a hearing in April of 2007 in which we invited to present before the committee representatives of organizations and providers who deal with sensitive information, the mental-health and substance-abuse community, ACOG, et cetera.
And it was on the basis of their testimony and the individual testimony as well as the older -- earlier testimony that we reached our conclusion that this was an appropriate topic to do.
So I just wanted to just deal with a process issue before the substance.
So can I -- you'll get another chance. I just want to make sure everybody gets heard. We have Carol, Steve and then Harry.
MS. MC CALL: OK. It seems to me that, Simon, you captured what started out to be the question, and I believe the question was originally whether or not to accept the premise that individual control is important and that you were suggesting that we put a question mark at the end of that, as opposed to a statement. And, honestly, that's not something that I could support.
I agree this is policy. There are a lot of places where we talk later about things to be determined, technology not necessarily ready.
But I believe that this isn't about money. This is about the why, not the how. And what I believe is happening is this: There's very specific testimony around privacy, and in a world of ambient informatics, where information flows, unless you stop it -- unlike today in a fractured system where it does not flow unless you push it, and I mean push it hard, and, even then, it doesn't -- to maintain privacy, which is understood in all hearings that we have to be of paramount importance, one must design in specific control.
And as a policy decision, I think it's also right to call out, Jeff, as you pointed out, that this is not in law today, but it is an idea whose time has come. And if there were anything to be added, it would be that, and because that becomes a policy issue of paramount importance that this is unprecedented stuff in a world of ambient informatics.
So I do believe that we have established it. I think we hear about it all the time. I think that you have captured it here when you talk about other countries, when you talk about the testimony you specifically call out and you quote people by name.
And so I believe that we have established this as a statement, that it is important, and I think that -- so I would recommend that we keep that in there and add whatever we must in order to enhance some of the things that Jeff had added.
DR. STEINDEL: I'd like to comment just from a -- basically what happened this weekend at another meeting I was at.
In 2006, when we made the statements that we made in R-6 and R-7, it was actually somewhat of a far-reaching statement. It was the summary of a lot of views that we had heard over the years, testimony presented to NCVHS, our own knowledge from other sources and a condensation that people wanted control of the individual electronic records, and we didn't state there really what the control was. It's just that we wanted control.
In this letter, we're being a little bit more specific. We're saying, “OK. We said there we wanted control. These are some areas that we have found that are sensitive issues that people have raised. These are the recommendations we're making on how to control it,” and, as Mark points out, we're specific in some of those recommendations.
And then we go on at the end and we say, “We don't realize the real impact of these recommendations. So we want you to go out, install them, start them and investigate them.” That's from an NCVHS point of view.
But since 2006, the world has evolved. ONC is now making these same statements that we made in 2006. They're saying that we should have some level of individual control over the records. They are charging the NHIN cooperative in some of its studies to actually implement individual control and start to show the impact of that. It doesn't reach as far as this letter, or it may. It depends on what they design. But ONC is starting to look in this area. So this has been accepted, you know, from a department level.
And what I want to point to, just from this weekend point of view, I just happened to go out to an American College of Medical Informatics annual symposium, which is kind of a high level discussion session, and there were questions and comments and discussions raised by that group on the very topics that we are raising in this letter, and nothing to point to as to references to say, “OK. What does some authoritative body or what's the groups that have looked at it?” So this, first of all, will put a stake in the sand.
And, then, we had an interesting discussion on forming some recommendations for the meeting, when I was actually sitting next to Rob Kolodner, and Rob was actually saying, “This should be the most important thing that we talk about,” you know, the very topics here about individual control.
And, surprisingly enough, I actually said, “No, I don't think this is the most important thing that ACME should be talking about,” and I was very specific. I said, “This is because of the nature of the group that we're in. You know, if I was in another group, I would feel identical to what you're saying. It's just I feel ACME has another place to put stakes in the sand.” But it was very interesting that Rob took these positions.
So I really think that this letter needs to go forward. It needs to go forward from the point of view that NCVHS has a very good job of doing and that's putting something out there that the public can discuss.
Our role, obviously, is to recommend to the Secretary, but we have to realize there's a secondary nature of our letters. They come out there and they serve as a focal point for moving public discussion forward.
MR. REYNOLDS: Going back through some of the slides we had this morning and thinking about value, this is -- we're in a value discussion right here.
But cost also has -- part of the value of cost is timing and where does it get -- does it get in the front of the process or does it get in the -- halfway through the process or does it get after the process?
Having sat through every one of these hearings, when we did the 2006 letter and so on, and not being a privacy lawyer and not being a doctor, I have had the opportunity to be comfortable that we have debated emotionally, passionately, structurally. We have had people that came in that took us far further afield than this and people that wanted to do nothing.
The NHIN is still a ghost. It's a philosophy. It's still a ghost. But, for example, health information exchanges have already failed in the United States, and where's that data and what is that data and how is that data and so on? So there are things that have gone on that are electronic.
So as we -- and having just come off our stint of uses of data, that ought to scare -- I mean, that got all of our attention significantly.
And, again, this letter looks like a small subset, but it's really part of a journey. And I'm telling you, it's been a long one and it's been a tough one and it's been one where no voice has been withheld and no -- and meetings have been very visible and the discussions have been visible. And it's probably been as contentious a subject in the four years that I've been on the committee, because of the fact of the values, and the values really come in. And we have had to adjudicate those values, and, many times, each of us have had to step back and be very independent in looking at this. You know, you can debate each side. You can debate each value. We did.
Our process is imprecise, as we discussed it. We don't have endless staff. We don't have endless time. We did do it in a public forum. We did allow for -- We did receive in one case, 1,100 emails about it, which would mean that maybe people think it should go stronger than this. So we have had more than enough visibility to do this.
The other thing is, as we've heard about the impreciseness of opt-in/opt-out, and any of us around the table who have read any of the documents that are out from lesser esteemed environments than maybe, Mark, you or others, some of those documents do not give the person any idea where their data is or what it is or what it means. And I have personally had an opportunity to challenge a few.
And so I think what we are saying is we think of emerging issues. Everybody -- I don't think -- the NHIN is not here yet. It is an emerging issue. It is an emerging issue, and the issues may be a capital loss, because we just don't know what it looks like.
I could vote dramatically differently if somebody told me what the NHIN was. If they told me exactly how it was going to work and what it would look like and where it would reside and who would own it and who would drive the data and where did this connect and where did that connect and what did it do, then I may recommend different things.
We had an interesting statement made at the executive subcommittee, where somebody made the statement that they had spoken to the person -- one of the key executives at Visa and said that they used opt-in for use of credit cards over the internet and look how many people, and everybody -- We said, “How many people in the room would use a credit card over the internet?” And it was pretty much most of us. OK. We had the opt-in. And so the point is but the industry right now is running towards opt-out in a lot of cases.
And so all we're trying to say here is if there's not some stake in the ground to say, “Your attention, please. This is an issue” --
And as an implementer, cost is foremost in my thinking. And so I've heard enough all the way around, sitting there a little more -- maybe a little more independently than somebody who had a dog in the fight on this particular one.
I'm proud of what this committee has done. I'm proud of what Mark has led us through in difficult times. I think we've been very open.
If you give me two more pieces of data, I'll change the letter. If you give me -- if you tell me a month from now exactly what it's going to look like, I might recommend changing the letter. But we are dealing with such an imprecise discussion right now, and nobody is taking up the stance that the person -- that there are individual -- We heard enough of them. There are individuals who truly worry about their data and how it would be used and secondary -- other uses, reminded us of that over and over again. Just the difference between quality and research and just some of the things that are still on the table, de-identified.
So I'm not -- this is not -- it's not a lecture or -- I'm telling you, we have sat through this and through this and through this, and we could sit through it for another year. All we'd know is more about where it is, then, and we might change it. But, right now, this sets a tone. This is a little bit like, “Your attention, please.” This isn't going away. “Your attention, please.”
Tell me everybody's going to opt-in and maybe I'll pull most of this out, because maybe people won't want to get in, because they would understand what it was. That's all I'm saying.
I'm not saying right or wrong, but -- So that would be why I am in support of this, even though I could equally go through and if you gave me two more pieces of data take pieces of it apart one at a time. But that's not where we are, and it's imprecise, and some people are good at the NHIN and good at HIEs and good at -- and others aren't. And others don't even know what it is yet.
So thank you.
DR. STEINDEL: Harry, if I could comment very quickly. The person who made that opt-in comment at the executive subcommittee meeting was Rob Kolodner.
MR. HOUSTON: Yes, to expand on both Steve and what Harry said, the first thing is is that just having participated in an AHIC confidentiality, privacy and security workgroup meeting, this topic did come up, and I counseled that group that, “Hey, we're getting done with this letter. You don't need to investigate it yourself.”
And there was a lot of interest in what's the timing on this, because it is clearly a matter of great interest for that group as they were planning on what they wanted to do next. So I think this is extremely timely, based upon what they think is important.
Secondly, I think some of the things we heard regarding cost and the financial issues and the like related to this type of recommendation was almost -- this is such a fundamental component that is necessary for the NHIN to even succeed that the cost associated with this may almost be a secondary issue in some people's minds.
“If you don't have this, I don't know how we can support you having an NHIN.” I've heard that from a lot of privacy advocates. “You don't give me this capability, I don't want to participate, and I'll do everything I can to stop it.” I've heard that, and there's very clearly a sentiment in that regard out there. So I think it is absolutely important that we make these types of recommendations.
MR. ROTHSTEIN: Thank you, John.
I have Larry and Leslie on the list, but I just want to pick up one thing that you said. I was at a meeting a week ago of the National Governors Association and their task force dealing with electronic health records, and specifically privacy issues, and they are just getting around to take up the issue of sensitive information. So it's an area that is of great interest, and somebody's got to tackle this, whether it's us -- If it's not us, it's going to be somebody else.
We've got Larry and then Leslie on my list.
DR. GREEN: Mark, I have a question basically for you.
I've heard Leslie and then Carol and Jeff and Harry and now John provide quite articulate and cogent context for this letter. And I'm wondering what your opinion is about adding a -- something akin to a preamble paragraph or an introductory paragraph that incorporates the scope that I've just heard here in the room.
The conversation that's gone on in the last 20 minutes positions this letter into the national dialogue in 2008 when it's being rendered. I'm wondering what your opinion is about the possibilities of adding such a paragraph.
MR. ROTHSTEIN: I think certainly it's doable.
The question that I have is a very practical one. This is draft number 17, and it's taken a long time to get here. The letter is not perfect. It's not -- it doesn't represent 100 percent of the views of any of the subcommittee members, I'm sure.
And I'm afraid that if we decided, as a committee of the whole, to direct the subcommittee to come up with new language that does various things, some of which, I think, were very good suggestions -- Now, I don't know whether we can do this and still get an approval at this meeting, and it would be very unfortunate if we had to bump the letter back to May. So that's a practical --
DR. GREEN: Well, I'd like to register support for moving the letter at this meeting.
My own view is that I would hope that you and the subcommittee might be able to write a three- or four-sentence paragraph that we could look at and that it would be our intention for it to not be perfect, but for it to be good enough.
DR. FRANCIS: Larry, where we tried to capture that is actually, I think, the second sentence of the letter, the critical considerations, both, on the one hand, protecting concerns about privacy and confidentiality, and, on the other, encouraging participation in an evolving NHIN to improve patient care and so on.
And those are the concerns that are on everybody's mind as the discussions go on at, for example, National Governors meetings and so on. So that's where we try to do that.
I wanted to say to Marc that -- I mean, obviously questions like what informed consent would look like, those are all really important questions, but I don't know how you answer them, at this point, until you get the design questions out on the table. And what this letter is doing is saying get the design questions out on the table.
I mean, we don't want to blow by those issues. I mean, I think an important question about the quality of patient care would be some of those kinds of questions.
But if they don't -- if this doesn't get to first base, your questions are like third base, it seems to me. We won't get there. And my worry is that unless we get a letter like this getting us to first base, many of the advantages of electronic records are actually going to be lost, because, you know, people were talking about the opt-in strategy about credit cards. There are a lot of people who don't buy things, say, off of eBay for exactly all those little email messages that you get about your Pay Pal account and what it might mean.
MR. ROTHSTEIN: Thank you.
Simon, then Marc and Marjorie.
DR. COHN: Yes, I'm going to trade spaces with Marjorie and let her go --
MS. GREENBERG: Gee, thanks.
MR. ROTHSTEIN: Because he wants to rebut whatever it is you say.
MS. GREENBERG: Probably. Probably.
OK. I think this has been a good discussion.
My bottom line is what Marc -- I think he underestimated the risk of deferring this to May, because you have to realize that we may actually have new committee members in May. We could have as many as seven. Nomination package is going through the process now, but we have put the meeting back to May just because we know that seven members' terms end June 1st, and with no wiggle room. And so in case we don't have those new members by then, at least we knew we could have a meeting.
But you cannot leave this to a bunch of new members. I mean, you're just starting then. That would be ridiculous. I mean, you can't have the majority -- almost the majority be all new members. I mean, it wouldn't be fair and you couldn't expect them to deal with this. So I would say it is now or if not never, now or not for another few years.
I'm not trying to be an alarmist. I mean, I think that is just really realistic. The timing of those members being named is completely in the hands of the Secretary.
But, frankly, as we put -- I mean, it's only responsible for us to be putting through a nomination package and our hope would be act on it sooner rather than later.
So I think it's now or never. I mean, if not now, never -- not never -- you know, take another few years.
Last, at the November meeting, many of these issues came up and the committee and the subcommittee had quite a lot of discussion. And the bottom line was that the committee told the subcommittee to go forward with this. The possibility of just ending it, you know, pulling it off the table was there, but the decision, at that time, was made, no, the committee -- subcommittee -- this is not a letter that should be withdrawn. It is one that needs some work.
There's been -- I can tell you because I've sat in on most of the conference calls -- it has been an enormous amount of work, not just wordsmithing, but really thoughtful discussion that has gone on in the past several months, which has been open to any of the members if they wanted to participate. And I think there's been quite a lot of -- there was give and take and quite a lot of good discussion that went on. And that was -- the committee was -- the subcommittee was encouraged to do that.
There is a document from the subcommittee that describes how every single comment -- We've never seen this in my history of working with the committee, which you know has been 60 years. I started I was just a little older than my grandson, but, in any event, I've never seen this where every single comment made by the committee has been, if not rebutted, at least responded to in some way.
So having said all that, I guess you can see where I'm going, but I do think there are a few things that maybe could be added, if they could be added without -- but I can tell you that every word that is changed has taken a lot of time to agree to. So just like writing three or four sentences, you have to have participated in this process, Larry, to know that is not as easy as it may sound.
But I don't see anything here in the letter that actually says -- it refers to the one hearing -- but says what often we do say is that there have been like 15 months of deliberation. I don't think that's said anywhere, and I think that kind of would emphasize -- That's just a factual piece of information, but it would emphasize that there really has been a lot of thoughtful deliberation, not just this one hearing on April 17th.
MS. BERNSTEIN: I thought I'd just leave the caption at the top that says, “Draft 17 -- “
MS. GREENBERG: The other thing is I do think there are quite a few escape valves in here, even though some of the recommendations are quite specific, because all the calling for pilots and for research and for assessment of, you know, the impact, I think is certainly an escape valve for someone who feels that they're not ready to embrace everything that is suggested here.
You might want to, in Recommendation 5, add the issue of costs, because it only refers to liability and human factors, and I think costs -- you know -- could be added there. Probably everyone would agree to that.
And there is -- As I mentioned in our previous discussion before the break, there is always the possibility for any member who feels so strongly about not wanting to sign on to this to do a minority letter or of course to abstain or to vote against it, but, also, then, to document why he or she did that. And I think despite the committee's desire always to have a consensus, that is always an option. So that's what I wanted to say.
MR. ROTHSTEIN: Thank you.
We'll go to Marc, and, then, Simon will have the last word. Then we'll try to wrap --
DR. OVERHAGE: And I guess what I'd like to say, rather than trying to go through and address issues like Steve's comment that ONC supports this one -- In fact, ONC's recommendations that came out of the prototypes explicitly restrict their comments about patient control to PHRs, for example. They may talk about a lot of things, but their documents do not reflect that.
So there's a lot of specific things I could cover here, but I guess the thing I'm struggling with, and I'm still not comfortable, and I'll shut up and go on, is that I heard Simon describe this as directional. I heard people talk about raising this as an area of great interest, which I agree it is. I think it is of great importance to get a recommendation out.
I just feel like we've gone way too far in specificity of a set of actions that we can't -- I think it's very hard to support.
MR. ROTHSTEIN: Well, let me just say what our overall approach was that we tried to have in this letter and that was we are making, I think, a statement about the importance of individual control of sensitive information and saying there are lots of ways to do it. We think the most promising way is sequestration and to -- I think that's the -- sort of the minimum level of directiveness, because we didn't say which of those we preferred. That wouldn't really advance the ball very much.
So we're saying that this is the option that we prefer for the following reasons. We recognize that there are all these issues. We don't recommend categories. We say you need to decide on categories. You have to decide on inclusion, exclusion criteria. You have to have pilot programs to see if it would work and so on. And it may affect the physician-patient relationship and we need to be cognizant of that. And it may affect liability and you need to be understanding of that and so on and so forth.
I think to do less would really not be of value. If we didn't select one of the methods of limiting disclosure or giving individuals the right to do that, I think it really wouldn't be a valuable letter, and we tried not to go any farther than we did in terms of recognizing all the things that it would entail.
And you remember November we had the discussion of, well, what about break-the-glass features and all that sort of stuff.
So we put a minimum amount of things that had to be in there because we wanted to display the fact that we do appreciate these issues. We raised the issue of clinical decision support, but are non-prescriptive at all in terms of clinical decision support. We say this is an issue that needs to be studied.
On the notice, we couldn't agree in the subcommittee about what the notice should say, whether it should identify the categories that were sequestered or just a general notice. So we said, “Well, you probably ought to be notified as a provider, but we're not saying what, when or how.”
So it's a philosophy and I think it's balanced. We certainly worked very hard to do that.
DR. COHN: OK. Well, in the interest of subcommittee time and process, I actually want to sort of move beyond this particular conversation.
I think this has been very valuable -- begins to get everybody's views, values, opinions out on the table.
I do have to agree with Marjorie that -- I mean, even though I think we strive towards consensus, that isn't in our charter. It isn't absolutely required. And, certainly, at the end of the day, there may be honest differences of opinions, there may be needs for certain people to either abstain or actually vote no. And I think we have to confront that after we've reviewed the letter and had a chance to reflect on it.
Certainly, Marc, just -- and I'm very respectful of your views on all this stuff -- if, as we -- you know, I would just observe that the comments, at this point, are a high enough level that it's sort of hard to know necessarily what to do with some of them in terms of the context of the letter.
So it may be that as we move from section to section there may be places by changing a word, changing the strength of a recommendation that you may want to propose that might be something that you want to bring up for the full committee to discuss, and I think that's a very appropriate role the full committee and full committee members to do.
I obviously -- you know, the issues you've brought up are much more fundamental than the issues of a paragraph or whatever. It gets to be really at that level of do you actually support even a letter going out, and, once again, you know, committee members can certainly decide to vote no. The letter could actually go down because a majority decides not to support it.
So I think -- having said that, I think we -- we've heard a couple of things. I'm hearing, for example, other suggestions for wordsmithing. I think whatever it is we pass -- assuming we do pass something -- could certainly be further wordsmithed by the executive subcommittee, including, if we can't get a couple of sentences at the beginning that are appropriately strategic, you know, that could be something that is done if the executive subcommittee -- actually, the privacy subcommittee doesn't have a whole lot of time to do that.
But, with that, I'm going to suggest, Mark, that we move on into some of the other areas, assuming that everybody's comfortable with that as a process moving forward.
Marc, are you OK? OK. And thank you for bringing up the issues.
MR. ROTHSTEIN: So thank you all for your comments. It reminded me of one of our conference calls.
So let's move to the next section, which begins on the middle of page 3 and continues through to basically the -- well, we'll stop at the end of page 4.
This is our discussion of why it is that we are recommending sequestering, what the advantages are, what the disadvantages are, what some concerns are. And this was a section that, according to my records, I did not have any specific comments on.
OK. No one has any additional comments.
The last part of that section is on page 5, where we have the example categories, and we just need to do a couple of minor things.
One is there's a typo in the mental-health information. Second line should be “diagnoses of mental illness or therapies.”
The major thing that we might want to consider is, in the paragraph after substance abuse, where we talk about liability issues, and Justine called to my attention the fact that -- well, do you want to make your point, and then I'll say what we're going to try to do?
DR. CARR: So in that last paragraph we talk about legitimate concerns raised about how sequestering categories of health information would affect medical malpractice liability.
And it says, “Liability could potentially be affected in at least three ways.” The sequestration of critical information might do the following: One, cause providers to give less than optimal advice or treatment. We understand that.
The second sentence says, “On the other hand, without sequestration or other limits on the scope of health records, the potential for liability could increase because a provider might be held responsible to know and take into account every detail of a patient's health history” via NHIN. And I think they are two separate issues.
Whether you sequester today's -- you know -- special category is separate from whether, with the NHIN, you are accountable for reading every note in the history. And, actually, that's true with paper records anyway. I don't know that we ever resolved that.
So it just -- I think we just need to separate out that limits on the scope of health records is an issue unto itself, and sequestration of a particular episode, whether it be today or 10 years ago, is what the focus of this letter is. So I just felt that that was inappropriate.
MR. ROTHSTEIN: So let me see if I can respond to that. I think Justine is right that this paragraph is not parallel, and rather than hashing out in the full committee the wording of how to correct that problem, what I would suggest is that -- actually, I drafted new language to take your concerns into account.
What I would suggest is that we can take that -- either take that up with the subcommittee this afternoon or if you need a vote -- We gonna vote tomorrow?
DR. COHN: Well, probably, I think.
MR. ROTHSTEIN: OK. So if there's no objection, we will try to make that fix-it that Justine suggested.
DR. SCANLON: My fix is to drop the sentence.
PARTICIPANT: Yes --
DR. COHN: Yes, I was going to say that's my --
MR. ROTHSTEIN: So which sentence are you talking about?
DR. SCANLON: “On the other hand, without sequestration -- “
DR. COHN: Yes.
PARTICIPANT: Yes --
DR. COHN: Yes, I think that's a very simple fix.
DR. SCANLON: This involves issues of liability and sort of practice that goes way beyond sort of what we're talking about here.
DR. COHN: Yes.
PARTICIPANT: I agree.
DR. COHN: Yes.
DR. SCANLON: So I think we need to be there.
DR. COHN: Bill, interestingly, that was my comment to Mark also that if we just get rid of that sentence it doesn't hurt anything.
DR. FRANCIS: Just change it to say, “Liability could potentially be affected in several ways. The sequestration liability might also be implicated as a result of violations of confidentiality,” and drop the middle sentence. Because that's a general question about the NHIN.
MR. ROTHSTEIN: I spent a half an hour working on this paragraph.
DR. OVERHAGE: Mark, two thoughts about the example categories.
One is I would suggest that we drop signs and symptoms from the mental-health example. I think it sets a very risky precedent, because it's impossible to distinguish signs and symptoms and attribute them appropriately to the condition. So it implies a level of ability to distinguish things that simply doesn't exist.
MR. ROTHSTEIN: So -- excuse me -- so your suggestion would be that it read, “about diagnoses of mental illness or therapies.” Is that correct?
DR. OVERHAGE: Yes.
DR. COHN: Did we come to a conclusion about that other paragraph? I think we're --
DR. OVERHAGE: Oh, I'm sorry. I'm sorry. I apologize --
MR. ROTHSTEIN: So the suggestion is, on page 5, under “Mental health information,” that it should now read, “This category might include information about diagnoses of mental illness or therapies.” OK?
PARTICIPANT: Therapies to treat mental --
MR. ROTHSTEIN: Therapies to treat mental illness or treatment --
PARTICIPANT: Or treatment.
MR. ROTHSTEIN: Diagnoses of mental illness or treatment?
PARTICIPANT: Therapies is --
PARTICIPANT: OK.
MR. ROTHSTEIN: Therapies is preferred? OK.
DR. OVERHAGE: And that really relates to the second -- which is there were edits made to the last paragraph on the end of page 4 to address the specific issue about information that sort of spills over, medications being a good example.
MS. BERNSTEIN: Where are you, Marc?
DR. OVERHAGE: I am under Example Categories and the subcommittees responses to the comments you suggested -- you changed some of the wording to say give due consideration to existing state and federal laws.
I would like to strengthen that a little bit by adding into the examples and explicitly saying that information such as medications and diagnoses are not in these categories.
PARTICIPANT: I don't understand.
MR. ROTHSTEIN: I'm sorry, could you tell us exactly where you are?
DR. OVERHAGE: Sure. I am -- well, it's a suggestion for an additional addition under Example Categories to include counter examples.
MS. BERNSTEIN: Where would you put that?
DR. OVERHAGE: I would put it after “Substance abuse” would be my thought.
But the reason I think that's so important is that -- the wording is very tough, because “Mental health information,” we say, “and therapies.” Well, what are the therapies? Well, many of them are medications, you know. Yet, we sort of -- we're talking out of both sides of our mouth.
In one case, we're saying the example is exclude medications, but then we're saying, but we're not going to exclude medications or implying that. And I don't think we go far enough in implying that in the last paragraph of page 4 in response to the comments from last meeting.
MR. ROTHSTEIN: First of all, does everyone understand what Marc is suggesting?
(A chorus of no's).
PARTICIPANT: Where does it say to exclude medications?
DR. OVERHAGE: It does not say that now. I think it must.
DR. STEINDEL: And I think that's impossible.
MS. BERNSTEIN: I think -- yes, in addition to -- He's talking about this -- if I could highlight it here on the screen. I'll read it. It's -- there's a sentence above the list of categories that says that the process of developing the list “must be open and transparent and give due consideration to existing state and federal laws, as well as professional and accreditation standards.”
And I think -- if I remember the conversation at the last meeting, Justine raised the issue of what the joint commission has been doing, and if I remember Justine right, you raised the issue of the fact that they want to -- at the end of each encounter --
DR. CARR: They are, not they want to. This is today, every EHR has a medication reconciliation tab and every provider must enter every medicine every time from all categories. So, I mean, that's -- I still have that.
I noticed that you've mentioned it under clinical decision support on --
MS. BERNSTEIN: So it's --
DR. CARR: -- make reference to how that would work, but, as of today, this is kind of an irreconcilable issue.
DR. OVERHAGE: It is. And I think that's why it's so important to explicitly say, because the casual reader reading this kind of says, “Oh, mental health -- OK.” You know, but you can't.
MS. BERNSTEIN(?): It doesn't say drugs, though, right?
DR. STEINDEL: Marc, I think there's a specific statement in this section that says, “These are examples,” and then there follows a very specific statement that the actual details of what would be sequestered needs to be worked out because it's a very touchy subject.
And because of what's just been raised with regard to medications, which I totally agree with. It's an extremely complex subject, in a letter like this, we cannot make a statement one way or the other about it. It needs to be handled at a much more detailed level by other groups.
DR. OVERHAGE: Then I'm okay with that, but then let's take the explicit example out that is here.
MR. ROTHSTEIN: What explicit example are you talking about?
DR. STEINDEL: -- example?
DR. OVERHAGE: “Or therapies.”
DR. STEINDEL: Therapies can be anything. We have another in reproductive health where we're talking about sexually-transmitted diseases which is treated by drugs.
DR. OVERHAGE: But therapies, how many therapies do we have? We have surgeries. We have drugs. We have psychotherapy. It's one of the major therapies.
DR. STEINDEL: Well, so are drugs for STDs.
DR. OVERHAGE: I agree.
DR. FRANCIS: Could I try something --
MR. ROTHSTEIN: Please. Try anything.
DR. FRANCIS: Instead of playing around with what's in the example categories, where Mark started us was the paragraph, “We have listed below some categories.” OK? The sentence that, “The process of developing such a list must be open and transparent and give due consideration to existing state and federal laws, as well as professional and accreditation standards.”
Is there a way to, for example, reference JCAHCO standards, such as JCAHCO standards about medication?
DR. OVERHAGE: All I'm saying is our examples should be consistent with our language.
DR. FRANCIS: Right. Well, they are consistent --
DR. OVERHAGE: No.
DR. SCANLON: Well, to support Marc's point, mental health is the only one that has therapies. The rest are all conditions -- information about conditions.
MS. GREENBERG(?): Abuse of illicit or licit drug obviously has to do with medications.
DR. FRANCIS: Well, interventions to deal with the --
MS. BERNSTEIN(?): Interventions to deal with --
MR. ROTHSTEIN: Look, I have a suggestion. How about we put simply, “This category might include information about mental illness.”
PARTICIPANT: Yes. Yes.
PARTICIPANT: It's not might. It would.
PARTICIPANT: How could it be anything else?
PARTICIPANT: Well, there's also in the substance-abuse example --
PARTICIPANT: Exactly. And under genetics.
PARTICIPANT: -- it says, “treatment for such a condition,” which is a therapy. So it doesn't use that specific word. So --
PARTICIPANT: And genetic, it says, “interventions” need to deal with genetic disorders.
PARTICIPANT: Yes.
MR. ROTHSTEIN: This is --
MS. MC CALL(?): I'll confess to being confused on what is the specific point with which you are taking exception, Marc?
DR. OVERHAGE: That we, on the one hand, are saying we must allow and exclude from these sensitive categories information which is required by state, federal laws or professional accreditation agencies, and then we turn around and give explicitly in our examples things that are required by those laws.
MR. ROTHSTEIN: No, actually, we're not saying that. I think we're saying, given due consideration for it. And so it may well be -- I mean, we're not here to decide that issue now. It may well be that the people who are deciding that issue are saying federal law needs to change in some way or another.
DR. FRANCIS: Or it might be that the definition of mental-health information would have a specific exclusion.
MR. ROTHSTEIN: Right.
DR. FRANCIS: I mean, that's all open. That's the point. I mean, that's why it says, “might include.” And, of course, it might include information about therapies, but some of those might be included and some of those might not be.