[This Transcript is Unedited]

Department of Health and Human Services

National Center for Vital and Health Statistics

Subcommittee on Privacy, Confidentiality, and Security

“Net Steps for Community Data Use”

April 18, 2012

Double Tree Hotel
8727 Colesville Road
Silver Spring, MD

Proceedings by:
CASET Associates, Ltd.
Fairfax, Virginia 22030
(703) 266-8402


P R O C E E D I N G S (9:17 a.m.)

Agenda Item: Introductions and Opening Remarks

MS. KLOSS: Our meeting this morning is called to order, and we will begin with introductions. I am Linda Kloss, a member of the Committee, a co-chair of the Subcommittee, and no conflicts.

DR. FRANCIS: I am Leslie Francis from the University of Utah, a member of the full NCVHS Committee and Co-Chair of the Subcommittee on Privacy, Confidentiality and Security and I don’t have any conflicts.

MS. MILAM: Sallie Milam, a member of the full Committee, a member of the Subcommittee, no conflicts.

DR. TANG: Paul Tang, Palo Alto Medical Foundation, a member of the committee and full committee, no conflict.

MR. BURKE: Jack Burke, Harvard Pilgrim Health Care in Boston, a member of the Subcommittee, a member of the full Committee, no conflicts.

MS. HORLICK: Gail Horlick, CDC, staff to the Subcommittee.

MS. GONZALES: Natalie Gonzales, CDC, a guest of the Subcommittee.

MS. KHAN: Hetty Khan, National Center for Health Statistics, CDC, staff to the Subcommittee.

MS. PETERS: Iliana Peters, HHS Office for Civil Rights, sitting in for Sue McAndrew.

MS. JONES: Catherine Jones, CDC, National Center for Health Statistics.

MS. COOPER: Nicole Cooper, staff to the Committee.

DR. FRANCIS: There are people on the phone.

DR. MAYS: Vicky Mays, member of the Full Committee, member of the Subcommittee.

Agenda Item: Subcommittee Discussion

DR. FRANCIS: So this is Leslie. I just went briefly through four prior documents from this committee. The 2007 letter, that Sallie had referred to, the original Secondary Uses Report, the Stewardship Framework, and then the CHIP Report. And what I was doing was pulling out either general principles or more specific recommendations, that I thought might be relevant.

And I will just look at them quickly with the group, while Jeannine — Jeannine has now got it up. The first thing is that the topics for our meeting yesterday, just to remind ourselves, were governance models, small groups, engaging communities, and consumer attitudes. Our focus is consumer side and what warrants community trust.

And I just also put up here that although our focus is public health uses of data, essentially, to improve community health, I think one of the things that came out yesterday was that just as quality and research blur, so do public health and research. We heard a lot about research things, what is the difference between public health practice and research in certain respects.

Our 2007 letter, just to remind people, we have a letter called, Harnessing the Power of Federal Link Datasets to Improve the Nation’s Health While Protecting Confidentiality and Security. Primarily in that letter we were interested in how the federal government could actually reveal its data. But we didn’t say anything specifically about that.

The one thing we said that I think is potentially relevant as we think framework, which Linda is going to be tracking us through, is that standardized data linkage and sharing agreements should be developed to facilitate efficient sharing of data among HHS agencies, and to the extent possible with other government agencies. So something about standardizing data sharing.

MS. GREENBERG: That was actually from population health. They took the lead on that.

DR. FRANCIS: I am quite sure it was a population lead letter.

MS. KLOSS: Do we want to discuss these as we go through?

DR. FRANCIS: Sure, if anybody has comments. This is just what I pulled out and that is a paraphrase but it is essentially a quote. Then we had the stewardship framework for what we called the secondary uses report, which was a mega report in December of 2007. But before I get to that, I don’t know if there is anything else that people remember from the 2007 letter, or anything that they wanted pulled out, or anything to say about the —

I think the reason we said standardized data linkage, I was not part of developing that letter but I think the reason was not just facilitation but also the thought that if you had some common framework when data gets shared that people would know what is up when data gets shared.

MS. MILAM: If you are not defining, say, address in the same way, you are not going to be able to link data at all.

MS. GREENBERG: Part of the problem as I recall with that, that they were really trying to address, was that although there were mechanisms to even share data that couldn’t qualify as a public use data because it had small numbers or whatever it was taking forever even to share data between two parts of the department.

And things I know have progressed in this area in a positive way, because we had the research data centers but they had to go to them. And so I think now it is easier to do it remotely. But it wasn’t sufficiently standardized, certainly across the department or the government, that these were all one-offs as opposed to a process, that yes, you have to go through but you can go through in a rather expeditious way, you know what to expect, et cetera. So I think that was a good part of that issue.

And of course, this has now really blossomed into this whole liberating data initiative in the department. So I think it is the yin and the yang. It is protecting the data and liberating it, all at the same time.

DR. FRANCIS: One other common that I would make with respect to the idea of sharing data, I think a theme that came out yesterday that we should really not lose sight of is the frustration that communities feel when they get asked over and over again, the sort of helicopter research image. And if you don’t share data you run that risk of communities —

MS. GREENBERG: Well, almost everything seemed to have a yes and a no, in the sense that they are trying to respect the community, and if it says we don’t want you to publish this data they are not publishing it. And then people don’t know that people have already been there, and then more people come.

Almost there needs to be some kind of a clearinghouse, some kind of way to know at least —

DR. FRANCIS: — what research has been done. Yes, let’s not lose sight of that. Anyway, so the 2007 report on stewardship, let’s just scroll down.

MS. MILAM: Leslie, which was the report that the principles were taken from? I just was skimming through that 2007 report and didn’t find it. I see them in the primer.

DR. FRANCIS: The principles are taken from the 2007 report.

MS. GREENBERG: The guiding principles are in that 2007 report. That was the one that we spent all summer on. Was anyone involved with that? Paul?

DR. FRANCIS: Paul was.

MS. GREENBERG: It was an ad hoc group.

DR. TANG: With the secondary use?

MS. GREENBERG: Yes, secondary uses. Yes, Paul was.

MS. MILAM: What subcommittee did that come out of?

MS. GREENBERG: They developed an ad hoc group on several different subcommittees.

MS. MILAM: I am just trying to find it on the website.

MS. GREENBERG: You can just find it chronologically. Look under reports and recommendations. It is December 2007, I think.

DR. FRANCIS: The basic principles were so broad that I wasn’t sure how to make sense of them. I pulled out the recommendations here that seemed relevant. But somehow it is not coming up.

DR. TANG: In some sense the world has moved on. This is 2007, Obama wasn’t president, we didn’t have open government, there was no HITECH. So the world has moved on, and for the good. And already we are dealing with the standards just in meaningful use and stuff. There is no reason for us to go backwards.

MS. GREENBERG: No, but sometimes these things have staying power.

DR. TANG: I understand, but I am just saying that the world doesn’t need to reiterate what we are already working on. I think the thing that we heard, and it was both our previous inclination of this, the CHIP stuff, after CHIP, is really the people thing, working with people and communities.

And I think what could be a service from us today is getting model language on the sharing and the governance. So if people could get a head start and say look, this is what is out there, let’s start with that, it starts the conversation about do you have the rights now or do you have the rights later and can you reneg it, all that stuff.

You can spend all those years and then you say, well actually, I don’t want that to go anywhere. And that is a bit deflating. So in the sense of having a template for what are the rights and responsibilities of each party as they were discussing, as a template rather than having to recreate everything — we heard from our CHIP stuff — I think it would be a real contribution.

MS. MILAM: Can I build on that? I agree. I don’t think we should dive back into that content. I am looking on page 26 of that report in there. It gives us a framework. And when you look at privacy frameworks, this one, it is stewardship framework but it is very similar to privacy frameworks.

They are in use around the world. They stand the test of time. You may change the application of a principle. But you have a framework that is fairly constant and as technology and laws evolve, you go with it.

So I guess I would suggest — and we have already built upon this framework, and there are elements of this framework that people in population health and in communities really don’t know how to apply to themselves because there are gaps in law. There are gaps in knowledge and best practices. And I think that is what we are hearing needs to be fleshed out.

So I would suggest we really utilize the framework we have already adopted, not get into any of the detail but make it relevant for today and the people who are requesting this guidance.

DR. FRANCIS: So just to follow up on that in a couple of — so here is the framework.

MS. GREENBERG: This was in the 2007 report?

DR. TANG: Basically fair information practice, right?

MS. MILAM: It is very similar. That is a point.

DR. FRANCIS: A couple of things from the 2007 report, there are a couple of things that I think we shouldn’t lose sight of, framework wise. Really we heard here, too, transparency was one of them, over and over and over again. Chain of trust, harmonization, let’s see if we can keep going down. This is very frustrating that we can’t see it.

MS. MILAM: I think it is easier to read just by simple words. Like harmonization of research, that is not listed as one of the principles.

DR. FRANCIS: Those were the specific recommendations. But if you want to just read it, I think that is helpful.

MS. MILAM: Sure. And some of this has already been figured out and some of it needs to be. So the first is accountability and chain of trust. The second is transparency. The third is individual participation. Fourth is the identification. Fifth, security safeguards and controls. Sixth, data quality and integrity. Seven, oversight of data uses.

It is presented as a list, including but not limited to. So this is called the stewardship model. We could compare it against any number of privacy frameworks and see if there are any principles missing, and then we could adopt it as a privacy framework, stewardship and privacy.

A lot of this we have talked a lot about. Some of it, like deidentification of population health, we heard from NADO, that that is sorely needed. We have heard some of that yesterday.

DR. FRANCIS: We also heard some moving away from deidentification. So let’s just go from the framework. The other thing that was up there, you all have copies of the CHIP Report. I just typed out page 30 and 31 of the CHIP Report. Linda is going to take it over now.

MS. GREENBERG: You had mentioned yesterday you wanted each of us to come up with something. I was just thinking about it over my cereal this morning. There are two related issues that to me. And I haven’t thought it through yet but I wanted to put them on the table, what the role of the committee is in these. There are things we certainly talked about — obviously we have to focus on the data side of it — that just kind of resonated with me.

That was of course this whole issue of relationships, which may sound kind of touchy-feely, although it is really what life is built on, obviously, without getting too philosophical here. But whether it be in your personal life or your professional life or whatever, relationships are critical.

So I was thinking, okay, well what am I going to do with that? And then I tied that in with these workforce issues, because as indicated by one of our testifiers, some people are just good at relationships, or good at communication. Other people are lousy at it, but everyone can be reasonable at it. So, some people should be the ones who are leading the relationship stuff, and others are better working on the behind the scenes data analysis, or whatever.

But recently there has been a fair amount in the press about how in this economy, where there are jobs but there aren’t people properly trained for them, and that there is less money going into training now than there has been in a long time, and that is a problem when there is such high unemployment and everything.

And maybe what I am going back to is my very first job in the government was with the Manpower Training Program and the Labor Department. But we have talked about workforce issues related to health data. We have talked about it in relationship to the community health report. Not enough people to analyze the data at the local level.

Then when we were talking yesterday about trying to partner with the community and you want this to be a real partnership and so you want people who really have the skills. I was quite impressed by the woman from the national tribal group or council or whatever, how they are really trying to push that type of skill development in the tribes, and education.

So all of this just kind of came together to me, that maybe we know what the principles are and we know what needs to be done, but there really is a dearth of training and skills in these really important areas, which in fact you can learn.

You can’t learn to be the most charismatic person in the world, but you can learn what works, what doesn’t. There is all sorts of training that isn’t going on, and that is needed if you are really going to have these successful partnerships and relationships.

MS. KLOSS: Let’s grab that thought, and keep it as an area of recommendation, because I do think that kind of development of competencies and skills can be done at all levels.

MS. GREENBERG: And should be required, as much as to know how to do a regression analysis, if you are going to be doing this work with people.

MS. MILAM: So if we go to your list — can I build on that real quick? Along those very same lines, we also heard that that sort of training and ethics training is not part of current curricula. So we might also include a statement. Going to the list, when I look at it, number three is individual participation.

My takeaway yesterday had to do with the different kinds of individual participation required in the different environments. We heard different kinds of — it sort of pulls in consent, and it pulls in notice, but different for maybe government population health versus research. And I think right now there is almost no participation in some of those areas.

MS. KLOSS: That was one of the questions I had. As we think about a framework, framing this from the community health perspective, are there two streams? Is there a framework or publicly available data? And a little bit different take on that framework, if it is new data research? That did keep coming up.

I saw some disconnect between some of the recommendations being made yesterday relating to new data research, versus what was covered in the CHIP Report with regard to getting access to data and then learning to use it. And so that seemed to me to be one of those possible splits, as we look at a framework.

Now maybe a lot of the characteristics of the framework are the same, but there may be some that diverge. I thought that would be one of the questions that we needed to discuss a little bit.

DR. FRANCIS: Can I just jump in there? I really agree with you on that. Although the question of how much they split I think is a really hard question. We do now have it up there so we can go through very quickly. This is from the 2009 report. I think it is instructive on exactly the point that Linda just made.

Our framework there — and I just reproduced them, with the recommendations that came under each framework — individual rights, which included access for an individual to his or her data and the opportunity to correct, transparency, individual participation and consent for the use of the data, and education.

Now when I looked at that, it seemed to me that two of them — transparency and education — applied both in the clearly public health context and in the clinical use or new research data context.

MS. KLOSS: That is what I heard from one of the speakers yesterday.

DR. FRANCIS: Yes. I think everybody agreed that education applies.

DR. TANG: Why is it an individual right? Individual right to be educated?

DR. FRANCIS: That’s what it was in our report. That is why it is there.

MS. MILAM: I have never seen education identified as part of individual rights. But it is nice that it is somewhere.

DR. FRANCIS: It was something about what individuals — it was listed in the specific recommendations.

MS. MILAM: Typically you would think some people would put education with the principle of notice. I don’t see that we have notice.

DR. FRANCIS: We don’t. So anyway, that is one. But I think we heard a lot more controversy or different views about even thinking about access for an individual, or individual participation consent. The next one was responsibilities of a steward.

And here the adherence to appropriately determined set of privacy and confidentiality protections. And I put appropriately determined in quotes, because I think something for us to talk about is how do those get determined in this context. Is it the group? How do those get determined?

Use, purpose, specification, use limitation. We pulled out the minimum necessary standard. When data gets shared we talked about verification of receipt, we talked about data deidentification and data quality. That was all under that. Then security safeguards and accountability and remedies, those were the aspects of the framework. That is just a reminder.

I found it — to go back to what Paul said a few minutes ago — I found it really interesting to look at that to see what fit, and how things have moved on. And then I just wrote down the rest of this, and we have it in our packets, is what the CHIP Reports say. So that is all.

MS. KLOSS: It might be useful to start thinking about principles that come out of yesterday’s discussion and then go back and examine them against past work. I think there were some fresh new ideas, or at least some new takes. I probably came up with a list of a dozen things out of my notes, and I am sure everybody else did. Maybe we just start there.

DR. TANG: Are there a dozen new things?

MS. KLOSS: Let’s not worry about if they are new or old. Let’s do them the way we heard them in this hearing, and then look back and see if it updates or it is a little different take. I will just start out. I thought the issue of privacy as a societal and an individual issue, that could be a whole paper in itself.

MS. MILAM: The whole issue of tribal and community consent. How does that apply to other situations?

DR. FRANCIS: How do we get governance beyond the tribe?

MS. MILAM: Well how do you get governance beyond the individual?

DR. FRANCIS: Or how do you deal with the community? How do you think about community governance?

MR. BURKE: Community engagement was my overarching takeaway. But the notion gets diluted as the group gets larger, as it is more difficult to identify the community, or at least its leaders or its structure.

MS. MILAM: One other thing I heard sort of new, had to do with this whole role of educating individuals with population health data. Public health is very far removed from the consumer, and there are typically what you call required by law disclosure. They are exempt from HIPAA. They can be required to be fully identifiable.

And currently, public health organizations who receive this data have no legal obligation to educate their community. And I would imagine some would feel like it is outside of what they currently do, and possibly would argue they don’t have resources for it.

So that is an area that I heard new, beyond research. And I think that is an area where you have research and then you have public health. We could decide that they should apply the same. But I think the considerations are different. And we didn’t hear a lot about use of those large government datasets yesterday. We heard more about research.

We heard folks opining on its application, but we didn’t hear people who are stewards of the datasets, or if they are using the datasets they didn’t speak to them and talk about how that might work, or how they have done that.

DR. FRANCIS: Brad Malin did make the point that without — and I will just hearken back to the chain of trust — without some level of knowledge of who is using it, I think what he said was something like indiscriminate release of the data, so that all comers can use it, he saw as risky.

Because I think he doesn’t see the line as deidentified, non-deidentified. And that is not because of the possibility that people could reidentify. It is because of a whole additional set of questions, like how the data get presented when they get reported. Dissemination issues as much as initial use issues.

So I think one of the things we do want to — something I would call out, is something like beyond deidentification, that we need to be thinking through whether it is accountability, whether it is community input, whether it is community education, we need to be thinking about a set of principles that apply when data are used in deidentified form to HIPAA standards for public health purposes.

DR. MAYS: To Leslie’s point, I think the issue of the chain of trust is really critical on two sides. I liked what Leslie was saying, because I think it helps us to make a distinction between the people relationship issue, which really is also a chain of trust. I think it is important to highlight on the people’s side that people aren’t just distrusting totally, but that there are degrees of separation that will cause that trust to come back, that might be important.

And then the chain of trust on the other side, which really has to do with our process and procedures and policy, and all of the things that can go wrong, because I think if we do that, we help people to see a little bit more that it may start out that this was the federal government’s funded data collection.

But then once it gets into the hands of others, what happens, for example, when we have to give that data to the public to use. So that it would really help, because then we can see the places at which we can rebuild the trust, both in terms of what policies and procedures we should do, and also in terms of who the people are that seem to be perceived as more or less trustworthy.

MS. KLOSS: Thank you, good points. I heard one of the aspects of chain of trust that seemed to come out from Brad’s comment was relating that to the life cycle of the information. And that may actually be a way to frame up the issue of what the responsibilities of the researcher, or the team that is doing the research, or using the data, and their obligations through the stages of the life cycle of the information, contrasting Vickie to your point that there is also a dimension of chain of trust that relates to how you manage relationships.

So how you manage relationships is one aspect. How you manage data through a life cycle with chain of trust principles.

DR. FRANCIS: Just to jump in very quickly on that, the point that the underemphasized aspect of data dissemination issues, that the life cycle of the data is, first it gets collected, then it gets used, then it gets disseminated.

MS. KLOSS: The stages.

DR. TANG: I think we haven’t adjudicated if you turn personal data into post-deidentified data do you still have any rights or control over that, that speak to your life cycle? We didn’t deal with that. We heard from Brad on how they have, down the chain, data usage agreements about, oh, and I am going to ask you not to do anything more than what I have given it to you, to keep that chain of agreement going.

But we really need to weigh in on is, deidentified, now gives you carte blanche. Throughout I don’t think it was the intent of the contributor of the data that you would do anything you please. That has been part of the principle of HIPAA. I certainly have never been comfortable with it. But I don’t know how to express it. I should ask that question of those folks, but I think that is something we need to weigh in on.

MS. GREENBERG: Getting back to relationships, another thing that struck me was that it is not as simple as, well, we need to involve the community. There are a number of issues here, such as you pointed out, the community has only so much bandwidth. And so how do you involve the community in a way, how do you figure out who the right people are in the community to work with?

Some people want a lot of information. A lot of people just want to know that somebody is dealing with this that they can trust. Then there is also the issue of confounding the situation. I don’t know if that’s the words, but if you use community people, maybe that is a form of coercion.

I know we heard from some of the communities where people in the community were involved in recruitment of subjects or as being intermediaries, which seemed to me to be a good thing. But apparently, I don’t know, somebody said the IRBs don’t even allow this sometimes because it could be a form of coercion. Or then, does that person then become identified with the research and then get into a complicated set of relationships in their own community?

This is not so simple as just, oh, involve the community, use people in the community. In some cases it is unethical, maybe, to use them. Everybody thinks their research is important. And they are saying advocates can actually be coercive. So obviously, Vickie, you probably know a lot more about this, and I am sort of mumbling here. But just the whole area of research and knowledge, it is complicated and we don’t want to be simplistic about it.

MS. MILAM: I guess I am almost visualizing a spectrum. Hearing about consent, we heard a lot about what consent should look like, and maybe some boundaries of what needs to go on with consent. And then you sort of fade into education and notice and transparency. And it is all really sort of wrapped up

As Marjorie was saying, with some kinds of data and some situations, the consumer doesn’t really want huge amounts of information, but they want enough. And consent may not play a role. So maybe you move on one end of the line from consent to notice. And what are minimum standards for each kind of data collection and each kind of purpose?

You have some legal requirements that get thrown in there. But maybe really what we have is a continuum. Without a stop and start, you have overlap for some of this. Or we should have overlap. We heard from some of these folks who were really inspiring that they do have overlap because they know it is needed. They know the communities want it. But maybe it has not been required by anybody, even the IRB.

MS. KLOSS: That would reinforce the point that we really heard strongly, that no two communities are alike. If you have this continuum, you could frame up some questions that the community might use to determine what level of rigor it might use.

DR. TANG: Although no two communities are alike, and the ways you deal with people in that community are different, the questions to ask are similar. Which is why I think everybody can get a kick start from some model or template. Principles only go so far. You have a bunch of principles and we have to start all over again. We have some words to debate but we have to start all over again.

If you have a model then you have got a much better start, and then you can actually wordsmith and discuss the principles and concepts as you wordsmith. But then it seems like you could do it in a matter of months rather than years.

MS. KLOSS: A model for assessing?

DR. TANG: A model for sharing agreements. And essentially, in the physician world, the word that is used is compact. So an individual has a compact with the organization, and the organization has responsibilities to the individual. It is the same thing. I think we started it here. I think the add is one, the obligation of steward to communities, that is the engagement piece.

So you don’t just go grab their data. You work with them on what are we planning to do with it, what are your rights and responsibilities, what do we owe you, and the feedback. That was really important. That is an obligation, but also it is incredibly helpful for engendering trust and future participation.

On the other side, the individual — we didn’t touch on — has obligations too. You decide either to actively participate yourself, or in the governance community model you delegate it to someone, then you have to live up to the expectations that were agreed upon.

I think those elements are missing, because we didn’t have an organized body. We still don’t. But we now know that we need such a thing. And I think that can advance — just the notion that there is somebody that negotiates on your behalf, is a useful concept. And if we say what the obligations are to the data receiver and the data donor, I think we can help the thinking along.

MR. BURKE: Another element you may have thought but I didn’t hear, was involvement from the community or its representatives in the design of the

DR. TANG: That seems specific to research. Just like we are saying, public health. It is not designed in the study. It is how will my data be used, and for what benefit to whom. If I understand that as a community member, as a community representative, then I can help communicate this and understand our obligation.

So if you want to study the community’s rate of X, then when the X is known, you don’t back out. We are doing it because we want to publish it so that resources can be made available to solve X. You can’t reneg on what that is for. Do you see what I am saying? And that came up. But I think that is important.

DR. FRANCIS: That actually came up in the discussion that you missed, Paul. There was some discussion about how if it gets to the point where the community doesn’t want it published, there has been a failure along the line. There should be an ongoing process about framing questions, considering data uses.

And this isn’t a new collection of data. This would be use of existing data as well, or data linkages. So that the community — and I will go back to a word that you have used a bunch — isn’t surprised by the use of the data. I think it was Spellecy who said that if we get to the point where the community doesn’t want it published, there has been a breakdown.

MS. HORLICK: I have two points. One, what I also heard so much yesterday was — we talked before about cultural sensitivity. But I think we have always sort of operated on how do we do these things, get the data, share the data, while protecting privacy and confidentiality.

And even that comment we heard about, well what do you mean about confidentiality? You mean my name won’t be on it? It even caused me to step back and think, wait, our starting premise is that we want to protect that and we ought to not even take that as a given. So that was one thing.

The other thing is, coming from the public health perspective, I know we are talking about the research or how will we use the data. But picking up what Sallie said earlier about these government databases, I think a lot of the data that public health has, people aren’t even aware that we have, maybe because it is mandated that it be reported, or maybe a physician said, I have to report this. Maybe they don’t say that, they just do it because they are legally bound to.

But then it almost ties back to the ethical issue in public health of how do we use the data where we have traditionally used it, to track disease, to do outreach programs, to do education where it is needed. But as we look at new ways to use that data, there is a question do we even have an ethical obligation to use this, let’s say, to contact individuals?

They have got it legally, there is no requirement that the people be informed most cases. So I would love to see principles that apply in terms of education in that broader sense as well.

MS. KLOSS: Back to Paul’s suggestion that we go beyond, that we do principles or framework but also go beyond that — is the thing we would be trying to describe the participatory governance? I thought that was a really important phrase that moves the bar. Because when we think typically of governance, we think okay, let’s all of us insiders get all of our roles and processes down pat. And then we can say to people, okay, trust us, we are doing this right. But this does take that beyond.

DR. TANG: But you the individual decide you have the right to participate and you have two ways. You sit at the table and you come to all of them, whatever. Or you delegate. And you are obligated to live up to your delegates’ commitments. Because otherwise it just won’t work. So that is redefining governance. It is. But we need to communicate that is what it means.

DR. FRANCIS: It is much more like a democratic theory picture of governance. Now if we were going to start with that participatory governance, the first step — the thing I found most illuminating about our earlier stuff was the importance of transparency. As a theme, you can’t participate or know you would want to participate unless you know what is happening.

From the Texas blood spot debacle on, we heard over and over again about the importance of transparency. We also heard — and I thought the first panel was just really interesting on this regard — that community participation has to be inclusive. You have to reach out to different — you have to tap into different places in the community, or at least make it possible through education or whatever.

It can’t just be, oh, well we have a local advocacy group. We heard with the tribes sometimes there is a clear governance structure. And there, there is a government structure to do the governance. And they wanted that government structure to do it. But we really need to think about how that does or does not translate into the governance area.

MS. MILAM: I thought that was interesting yesterday to hear the difference that it makes to involve consumers in the different phases of the project, including design, and where consumers want to fit. It would be interesting to think how participatory governance might work with public health.

We didn’t really hear that yesterday. And when you look across the country, it exists to a greater or a lesser extent based on local laws and regulations and the wealth. A lot of communities or states or governments collect data and really have no privacy board. Some do.

But if you look at some of the new data streams, like All Payer Claims Databases and others that are getting set up around the country, they have an opportunity to take a fresh look at their privacy laws. And they are doing that. And if you look at some of the regulations that are out on the APCD Council’s website, they typically include a privacy board.

And they have a participatory governance process. They even have a lot of transparency around posting data requests that come in. And you don’t see that in other areas. So there might be an opportunity for us to look at how you can have a participatory process in government, or with public health different from the other. But I think we would probably need more information on it.

MS. KLOSS: A theme that also recurred throughout the day yesterday was the value of using stories to explain these complex concepts. And when you were describing that I thought that you could set up some vignettes or stories under the rubric of participatory governance that show just how flexible that is and needs to be for various applications. It might be kind of an interesting way to illustrate.

DR. FRANCIS: Sallie, this goes back to your point about public health. This is a way of kind of conceptualizing what HIPAA does about public health. HIPAA’s view seems to be that if it is done according to state law, okay, that’s an end of it. And I think what you are saying about the All Payer Claims Databases is, is that that isn’t enough.

Some kind of guidance to states about what things should look like. So maybe there should be community advisory boards.

MS. MILAM: I think it would be helpful for communities at whatever level to understand that there is a value in these additional processes that take time and resources.

DR. TANG: So should we start mailing some of these additions to our FIP — one is the notion of community, right? I think the thing we heard about is community. Everybody belongs to a community. We have the prototype, really, because it is almost a statutory community here. But we all realize that we belong to a community, and what are the rights and obligations of being a member of that community?

MS. KLOSS: We have to describe that in a way that gets to the notion of community as a network of people, so it gets personal really quickly, I think.

DR. FRANCIS: So use of my data could affect you. That is the relationality point. Or non-use of my data could affect you. So that is the individual responsibility point.

DR. TANG: You might put it in the individual versus steward. We will just try to add to which one — so when we say community — let’s just start here, then we can merge. So on the individual side.

MS. GREENBERG: What individual? Which individual are you talking about?

DR. TANG: The individual whose data are being —


DR. TANG: Yes, that is right.

MS. BERNSTEIN: Whose data are being used, yes?

DR. TANG: Yes.

MS. GREENBERG: The subject.

DR. TANG: The subject.

MS. BERNSTEIN: The respondent, or subject.

DR. TANG: So we are asking that person to take an active role in discussing how their data is used or protected, and acquired, let’s say, captured. And there are two ways you can do that. So these are sub-points. One is by you personally taking an active role, and the other is through this participatory governance. And then we will define what governance is.

MS. BERNSTEIN: You mean representative governance?

DR. TANG: Yes. And the role of the governance entity is to represent
individuals in that community with regard to —

MS. BERNSTEIN: I know you have a third category here. Right?

DR. TANG: No, it is still part of individuals.

MS. BERNSTEIN: Well you are talking about what the governance entity is doing, not the individual.

DR. TANG: Well I guess I am lumping it. The people who were contributing data — and there is a structure associated with it. This is the new add, this is the add. There is a structure associated with that. So that is a sub bullet under representative governance.

MS. GREENBERG: But before you even get to that individual, isn’t there pre-work that needs to be done in the community?

DR. TANG: Correct, that’s correct. The obligations of the governance entity is education, solicitation of opinions, and then fulfilling the representation to the steward.

PARTICIPANT: And it is organized?

DR. TANG: It is organized, yes. So it is the community organizer. Now we are going to have to test this and say, well can you do this for every community for which data is requested? So every time you do either public health or do — is this is expectation? Or do we have situations where this is required? Is there such a thing as sensitive, versus when it is just the status quo?

MS. MILAM: So we need community up there as well, as a separate actor.

MS. KLOSS: That is true. That is a big change.

DR. TANG: So there are two groups, the people who contribute data and the people who are acquiring and stewarding the data. And maybe instead of individuals, maybe there is the data subjects, and we are adding organization to that group, instead of adding groups, adding more actors, we are actually structuring one-step actors.

MS. MILAM: We are organizing our lumping.

DR. TANG: Yes, we are organizing the lumps, exactly. That is because of my lumping.

MS. MILAM: We are splitting our lumps.

DR. FRANCIS: I think we have learned that there is no one way to do that. I think we have learned that there are some things that are really important, making sure the donors know, trying a bubble up strategy so people who really do want to say something can.

Something that Paul missed yesterday that maybe we should — because you weren’t here for the last session — was several of the community survey data indicate that there is a small percent, that almost everybody wants to be, quote, asked. Now what asked means is complicated, because it is not straight out, informed consent. That goes back to that continuum that Sally was talking about.

But it is some sort of an ask. And this is about data that is already there, not new data for me. And perplexingly, a smaller percentage than say it’s okay if I am asked, actually say they would agree to participate. And that goes back to the individual responsibility question. We did some talking about what might explain that, possibly that people just don’t know what the study is going to require of them.

MS. KLOSS: They are interested but not ready to commit. And it is like 80 percent versus 50.

DR. FRANCIS: When Spellecy talked about that data, I think what he described was, it was a very capsule version of the study so that made sense, what Linda just said about not — but there are a couple of data driven studies.

MS. MILAM: Something you just said made me agree with Paul. I think we want to think about the target or the data subject, because at times we will have a community stand in as a proxy for the individual, depending. So we want both.

DR. TANG: So going along is there some way of dividing the world — so the traditional opt out ends up being in the high nineties. So in other words, most people opt in. Just like most people who are asked, will. But the principle is, you need to give them the ability to opt out.

So when it is like that, where 95-plus are going to want to do that, maybe you delegate to an institution we already have, which is IRB. So in theory, IRB — one, they have public representation, and two, they sort of cover the large population’s view on such and such, just trying to represent it. And that probably will work for 90 percent of all of these uses.

And then we define what it is where there could be sensitive because of what you want to do with it, or because of how and what you need, and how different we are. So the tribe, there is a certain amount of — one, it is more homogeneous, and they have special needs, and have special concerns about, let’s say, spirituality is an example.

And you want to respect that. So that would call for setting up, in addition to IRB, some other kind of community advisory board. Do you see what I am saying? I am trying to figure out how to make it —

MS. KLOSS: This is to Sallie’s continuum, that in different participatory governance models and opportunities, depending on where you are at, and illustrative stories about each.

DR. TANG: So if there is a way to draw a bright line, that would be really helpful. The good news is that we think the line is 95 percent over here. So IRBs can represent, at least the non-profit IRBs, can represent the general population until we find out more.

DR. FRANCIS: When IRBs do consider, like the defibrillator studies, when they consider some kinds of studies where you can’t get individual consent even for an interventional, the model that IRBs have used is, considering what kinds of community risks ought to be taken into account as the study gets designed.

Maybe I didn’t say that quite right. Long-term community risks are problematic for IRBs. They are not supposed to, under the federal regs, they are not supposed to consider that. But IRBs, when they make a decision — for example, about whether to approve the defibrillator studies — actually built into that requirement what should be done with respect to consulting the community.

So there were different things that got done, publicizing it on radio stations or whatever, depending on the nature of the community.

DR. TANG: You know what? I stated it wrong. So it is traditional opt in ends up being in the high nineties. I said it wrong. You captured what I said, but I said it wrong. Traditional opt in ends up getting a high nineties participation.

MS. KLOSS: Could we go back to the assumption that the IRB covers a big swath of this? Is that true? With the initiatives that you heard about through the CHIP hearing, were those IRB related? Or were they — they were grass roots.

MS. MILAM: Some I think probably used an IRB. I don’t recall. But I think it was a mix.

DR. TANG: So I guess my point was that there can be a general consumer advisory board, and an IRB is an example of that, rather than creating a CAB for every study and every public health — do you see what I am saying?

MS. MILAM: I see.

DR. TANG: So you can pass something that probably ca represent human, and try to do that weighing thing.

MS. KLOSS: But today, of the kind of community initiatives that we are looking to offer some advice to, most would not be IRB.

DR. TANG: Now remember in HIPAA there was the notion of a privacy, where there isn’t an IRB, there is a privacy something. That is probably the counterpart. So for non federally funded X, use of population data, there should be somebody that is trying to represent the needs of a larger community, the population, and weighing the risks and benefits.

MS. MILAM: And maybe we just have even something more basic — privacy governance community, a board that would involve the community, and where you have boards that can meet that need, like an IRB or a privacy board, that is great. But we ought to sort of flesh out what that board should do, or who should be on that board, categories like consumers or people who might understand privacy, or whatever it is.

I know in many situations those boards don’t exist at all. It would be helpful to identify the sort of interests that would be represented on that board.

MS. BERNSTEIN: Isn’t the issue in part that the boards, whether an IRB or the privacy board under HIPAA, it is not really constituted to think about the kinds of questions that we are talking about. They are thinking about individually identifiable privacies. They are not thinking about community protection, small group protection, whatever.

For better or worse, what IRBs are doing is protecting the institution from getting into trouble. They might be on the way to that trying to protect individuals, but really that is not their main focus. They might sort of have to do that as an obligation. But they are really there to protect the institution from getting into trouble with the granting organization.

And they are really not constituted to do the kinds of things that we are interested in here, in thinking about all these community things that we are talking about. It might be that we need, even though they exist now in the Rule or they exist now under the Common Rule, they are not required to think about any of these things under those rules.

MS. MILAM: So in addition to this, it seems Ryan Spellecy gave us one, too, that we would want the boards to do, and that was to give the findings back to the community. That could be an additional requirement for those boards.

DR. TANG: The EU is much stronger in this. Does somebody know how that is structured. The EUs have much stronger privacy rights and governance. Do they have it at the —

MS. BERNSTEIN: I wouldn’t say that as a statement. I wouldn’t agree with that as a statement. I think they have a different model of how to do things.

DR. FRANCIS: They apply the same model to all types of data, so it is an all-encompassing. But whether it is stronger or not is a different question.

MS. BERNSTEIN: I don’t even necessarily agree with that, because they generally don’t apply to government data, where we do.

DR. FRANCIS: That’s right. National security data they do not.

MS. BERNSTEIN: They tend to trust their government and not trust their private sector, whereas we tend to trust our private sector to do things and not trust our government, and therefore we relate to government more.

DR. TANG: My question was, do they have a governance model? No?

MS. BERNSTEIN: No. It is quite difficult actually for us to do cross border studies.

MS. KLOSS: There are some trust criteria in the NHS that I have found useful. But they are more imposing obligations on providing organizations rather than community.


MS. KLOSS: NHS. There is an information governance trust document or set of criteria.

DR. FRANCIS: Actually in the UK, and I am forgetting what, there was a report maybe a few years ago and they call it, it is sort of like every national trust organization that is going to have their data used, whether it is for public health or quality purposes, has to have a — it is kind of like a person who represents the community, kind of like a data ombudsperson.

It is the name of the report. It is a so-and-so trustee. Maya, do you remember the name of that? I can look it up and I will tell you.

MS. KLOSS: I think you raise a good point and we should do a little bit of research on that. I think there is some really good work going on in information governance, taking the whole health service in Alberta, Canada and from the provider organization onto the government.

And I think they are doing some work that is looked to in Canada as a model for how this will advance the health services in Alberta at all levels. They are developing a province-wide model for information governance.

DR. TANG: So we can figure out who does it, and really get the principle. So we have some notion of an organized way of dealing with information donors. And then the stewards need to be responsible for education.

MS. KLOSS: For that information lifecycle, for administering that or managing that.

DR. TANG: They just like the transitive example from Mayo is, when they get data, then they have to then turn around and be the lifelong steward of that data somehow. They must actively involve the community. That means that they need to educate them and feed back the results.

MS. KLOSS: It raises the question of how does one become a steward, or how does one behave as a steward. And that might be an area of fleshing out that could be useful to raise that dialogue, because I think that now is an informal process where it is healthcare organizations, it is HIEs, it is IDMs, it is private companies who are holding data.

DR. TANG: So we heard also about ethics training. Maybe more than taking an online course, there is some ethics. So the nominal head or operations person for the stewarding agency has to be ethics trained. We have to define that, but they have to have ethics training.

And at the super level then — so from a federal government — some kind of model data use agreement or way of communicating, having agreements between stewards and communicating would be useful. So that multiple communities can get jumpstarted on —

MR. BURKE: Stewards can have a very important role in controlling subsequent dissemination of information gathered from a community to another entity that wants it, whether or not they need it. Those are the risk benefit decisions that a steward with ethical training can make, or a body with that training can make.

MS. KLOSS: There was a big national discussion about whether there needs to be some stewardship entity. Remember that?

MS. GREENBERG: Yes, sort of an Advance Notice of Proposed Rulemaking, but it

MS. KLOSS: Well AHRQ did it.

MS. GREENBERG: It was sort of like 50/50, I guess.

MS. KLOSS: A survey, and it really hasn’t gone anywhere since.

MS. GREENBERG: No, apparently there was such — were you following that?

MS. KLOSS: No, but maybe rather than a big entity, it is again a set of stewardship practices that need to be promulgated. The question came to my mind as I was listening to testimony yesterday. There certainly must be some guidance or guidelines from HHS when these datasets are made available.

DR. TANG: I don’t think they are. Is that true?

MS. KLOSS: The new public use datasets that are being made available.

DR. TANG: I think the theory is that they are, quote, deidentified.


DR. TANG: So in some sense part of the answer to Linda’s question is, I don’t think there is any special guidance.

MS. GREENBERG: If they are public use data tapes are pretty much just out there with of course all the documentation so you can use them, and with small numbers suppressed or whatever. Then there are other data that can be used, but only under certain protected situations, whether it be through these research data enclaves or whatever.

MS. BERNSTEIN: And there are other techniques besides deidentification that perturb the data, other statistical techniques to hide identities.

MS. GREENBERG: Usually these data are national or regional. They are not going to be at the community level.

DR. TANG: And do we think we want to take a stab at or say this is work that we want to do in future? Deal with the deidentified data? Let’s give an example, and it really comes up with the Indian tribes. You can quickly, even though it is national, figure out what pertains to Indians. And that could come back to effect regs, laws, benefits, of this population.

MS. GREENBERG: Something like deidentification — that’s what I asked yesterday — doesn’t even have any meaning when it comes to a Native American community.

DR. TANG: It doesn’t.

MS. BERNSTEIN: If you are talking about deidentified under HIPAA, they live in a particular, small area, that information is not going to be available because zip codes are not available. I am not sure what you are saying. If you name the tribe, that’s one thing.

DR. TANG: Well if you collect data on tribes, no matter what the zip code is, you can aggregate them to a level that could come up with some findings that have potential impact on benefits. You can imagine that. But then our revelation is that we are all parts of communities. We just don’t know it. And so this is going to happen to us.

I will give the examples of patients like me. It happens to them right now. And all we have to do is eventually figure out what our genetic communities are, and it will happen to all of us. So this is our chance to get ahead, or at least stake this domain and say somebody has to work on it, and possibly us.

MS. MILAM: I may hear it differently because of my day job. But I think I have heard that there is a real need for guidance around deidentification of population health information because it is not covered by HIPAA. But I have also heard that it is a threshold, that you need many, many, more things on top of it, that in today’s world — and I am drawing on the CHIP hearings — it is completely inadequate.

But it is still fundamental. And people don’t know how to do it, so when we say it doesn’t matter any more, I think it may not matter to us because we think typically in a HIPAA environment, but for people who have those data they really don’t know in some situations what to do with them at the community level.

But if you look at any of Brad Malin’s work, it is on his website, one of his reports shows that data, just by the diagnosis alone, made it identifiable. So there are people out there who say that nothing is truly deidentified. But at the same time you have people with these datasets.

And so I think they have to start somewhere, but recognizing that you need to wrap it in all of these other governance protections so that you can prevent redisclosure and reidentification and any contact of the individual.

DR. FRANCIS: I agree with you, Sallie. But I also think that the point that is being made is that the problem isn’t just preventing reidentification, that certain kinds of principles should apply to the use of even data that has stayed deidentified beyond making sure that people don’t reidentify it or something like that.

I will just pull out two. The one I have been saying a bunch, which is that there should be openness, transparency about the uses. And the other is the one that Paul has been pulling out for awhile. There should be some purpose specification and use limitation. So there aren’t huge changes in use of data.

And then a third, which we have been in a variety of ways talking about, is that there should be some community engagement with respect to new collection, use of existing, and dissemination.

MS. MILAM: I agree. I have been lumping all of those other things into governance. When I am talking about wrapping governance around deidentification, I think maybe we even have a third level. I think people still need guidance on how to release the data deidentified. But then I think they would benefit from guidance on governance.

And then the whole community engagement, and defining the community, and community versus individual. But I guess I don’t want us to lose sight of the deidentification issue that is out there. Because it is a separate issue, part of the whole package of infrastructure that is missing.

DR. TANG: We probably need to be constructive on our letter if we are going to emerge from today with —

MS. KLOSS: Well it isn’t necessarily a given that a letter comes out of this, too. Maybe we also tease out some areas that need further work and elaboration.

DR. FRANCIS: I think the letter that should come out is a framework. I was actually trying to sketch something like that, so we could say — well one of the points we need — I am thinking out loud about what some of the points are, and the public health research line, new data, old data, thinking about that.

I am thinking about the community of the individual line. I am thinking about the deidentified-identified line, that we need something overarching that because those lines aren’t so clear, and they have been the guiding lines, but the principles that seem to apply across them are transparency, input and community understanding.

MS. KLOSS: But under the community is the focus, the starting focus.

MS. BERNSTEIN: What did you mean by input? You just said it — transparency, input and community understanding.

DR. FRANCIS: When either new data are being collected or when data are being used in a deidentified format for community benefit, or sort of a quasi deidentified format, some kind of community input. I am not sure what that ought to look like, whether that is state law.

Maybe that is enough under some circumstances. Whether it is tribal governance, or whether it is some way to negotiate the fact that we are all tribal members.

MS. KLOSS: Or having information available on results of research and studies available at a community level.

MS. BERNSTEIN: That is different than, that is on the other side of input though, right?

MS. FRANCIS: Output.


MS. HORLICK: I think another sort of overarching concept is the ethical component which is beyond the legal regulatory component, because it touches on all of those.

MS. KLOSS: Do we want to take a five minute break and come back and begin to pull this together and figure out a course of action? So we will reconvene at 10 minutes to.

(Brief recess)

MS. KLOSS: Let’s call ourselves to order. The topic on the table is the reasons why we want to go forward with a letter, not only because we have learned new things but because we have a new workgroup starting that could benefit from this.

MS. GREENBERG: At a minimum, this Subcommittee needs to provide a briefing to the Full Committee in June. Now whether that should also be a letter to the Secretary — well, if you have recommendations you want to make, fine. But at a minimum, I think, you don’t want to sit on this. We are going to, in the next few months, try to convene this workgroup in some way.

And so I think this new working group, I think it is called a working group now, but in any event, working group on HHS Data Access and Use.

MS. BERNSTEIN: We were talking yesterday about the way that the committee used to work, which is have a series of hearings. There is a whole lot of stuff here that we are talking about, we want to learn, we haven’t learned. It’s not required for us to do a letter right now.

This topic — although I don’t have any objection to doing that, but there is no deadline particularly for this although it is a hot topic now. People are starting to move in this area of research. Unlike some of the other things we have done, we could stick with this topic, if you were disposed to do so for awhile, and put something more full together if you wanted to.

We are not required, just because we had a hearing, to write something about it just yet.

MS. KLOSS: That was why I raised that question before we broke. I can envision how much work it will take to develop this model out so that it is really useful for dissemination.

MS. BERNSTEIN: I was responding to Marjorie’s comment that we shouldn’t sit on it. I don’t feel like if we do that we are sitting on it. I feel like you would be developing a more fulsome project.

MS. KLOSS: I frankly think that one of our goals going forward with this should be an update of the stewardship document.

MS. GREENBERG: That is what I was thinking yesterday.

MS. KLOSS: I think it isn’t robust enough for all the complexities.

DR. FRANCIS: So suppose we were to do, to think about what our goal is, is to take those guiding principles and re-look at what the points that need to be addressed under them are. That would be a way to update it. So maybe can we go back to those guiding principles that are in the stewardship — actually the best one to do is the 2009. If we were going to think about what we need to think about to update, these are the recommendations under the general principles in that stewardship report.

MS. BERNSTEIN: These are the existing ones. Okay.

DR. TANG: So our goal is to figure out where we need to beef up the previous

MS. KLOSS: Right, to do a 2012 update of the stewardship.

DR. TANG: So we are on track, right?

MS. KLOSS: We are on track.

DR. TANG: We had the two things, the, quote, individual. And our biggest thing is to expand individual to community.

MS. KLOSS: And doing the updates to what was previously outlined. I think it would be useful to try to flesh out some of the previous recommendations on stewardship. It was brief. It was good guidance, but it didn’t help you think, okay, I had better be doing this.

DR. TANG: And we didn’t have obligations of the steward to the community. Other than protection there was no engagement. That is what is missing.

MS. GREENBERG: It preceded our getting more into the community issues.

MS. BERNSTEIN: You want the stewardship one? September, 2009? You want to see it.

MS. KLOSS: I don’t know that that is the only thing that is the output. I can certainly see a letter. I think this is one logical —

DR. FRANCIS: This is where I copied what I had up there from.

DR. TANG: If that is the deliverable, I think it is useful, now that Marjorie reminded us that we have a workgroup that is going to deal about issues related to this, truly incorporate it and then get back out and do that.

DR. FRANCIS: But the workgroup is specifically about HHS data. Which could be community data but isn’t. And one of the questions is going to be consistency here. So here are the key principles and practices. Individual rights, access, opportunity to correct, transparency about uses, and participation and consent.

(simultaneous comments)

MS. GREENBERG: The education thing is spelled out.

MS. BERNSTEIN: And here is the education, which falls under the individual section saying that basically in order to participate meaningfully you have got to have education.

DR. TANG: So this is actually in just the wrong spot.

MS. MILAM: Is it really? These are principles that are cross-cutting. HIPAA has these principles, but I think what we are hearing they should also exist in other places that are outside of HIPAA.

MS. GREENBERG: Aren’t these fair information practices?

DR. TANG: What I meant was that HIPAA had a one record, it exists, kind of a mindset.

MS. KLOSS: Yes, a medical record.

DR. TANG: Yes. And that is what this is reflecting.

MS. BERNSTEIN: It is not what it says in here. This just talks about —

MS. KLOSS: Well it does. The first principle says, access to his or her medical record. And obviously —

MS. GREENBERG: This has to do with more than medical records.

DR. FRANCIS: But a lot of this data –

(simultaneous comments)

MS. MILAM: When you look at it, I have to agree with Linda. It talks about access to what is in his or her records, or the designated record set. So what we are hearing is, in the population health scenario it needs to be broader.

DR. FRANCIS: It is not even clear that if it is community level data that we understand what access to the individual means. There are going to be contexts in which it is community models.

DR. TANG: Speaking of which, the steward is different. To HIPAA, the steward is the HCO. The steward could be Facebook or Linked In.

MS. KLOSS: Or Microsoft. Of course.

MS. BERNSTEIN: Or a public health department.

DR. TANG: right.

MS. BERNSTEIN: This was a covered entity, if it is HIPAA, right?

DR. TANG: Yes, it is the covered entity model.

DR. FRANCIS: Keep going down.

MS. BERNSTEIN: We have talked about how that is a very narrow collection of information. It doesn’t cover a lot of the world, right? We had many hearings on that.

MS. GREENBERG: I didn’t think this was just addressed to HIPAA.

MS. BERNSTEIN: I didn’t think so either. It is personal health information.

MS. GREENBERG: It says, the term health data stewardship refers to the responsibility of ensuring the appropriate use of personal health data wherever you find it. The main thing here, it seems, as I recall it, was that chain of trust. Whoever is touching it, wherever it goes, it has got to be this stewardship principle. It isn’t just related to HIPAA.

DR. FRANCIS: Marjorie, while I agree with you I think HIPAA shaped the way this was written. So if you go on it says, exchanging, aggregating, analyzing and using data from individuals’ personal health information. This is larded with HIPAA terms of art. That is a HIPAA term of art.

PARTICIPANT: No it is not.

MS. GREENBERG: But just the fact that it says identified and deidentified data, where as HIPAA kind of just it is a term of art.

DR. FRANCIS: Yes, you are right.

MS. MILAM: And in former letters, I think the Privacy Committee — I read, I think, that when you had worked with Mark, you all used personal health information to differentiate from protected information, to be larger.

DR. FRANCIS: That is right.

MS. BERNSTEIN: But still I think there is a lot of this that talks about things that are HIPAA-ish.

DR. TANG: Designated records and that kind of thing.

MS. MILAM: We all agree that it is too narrow.

MS. KLOSS: It just needs to be expanded for the new stewardship —

MS. BERNSTEIN: You could decide that this is — it might be confining to you to start with this thing that was done in a particular time and place. You might think about that, too. And feel less constrained by that, so that the Subcommittee could go on and do what it wants. Also, as I recall wasn’t Justine the chair of the group that did this? I don’t know how you would feel about her recent baby being dated.

DR. TANG: Government is not a covered entity, correct?

DR. FRANCIS: If it is a payor.

MS. BERNSTEIN: That’s not true. CMS is a covered entity. IHS is a covered entity. TRICARE is a covered entity.

DR. FRANCIS: State governments in their role as payers or providers are covered entities.

MS. BERNSTEIN: Medicaid, some have got covered entities.

MS. KLOSS: Maya makes a good point, that maybe we don’t conceive of this as updating that prior document, but that we start fresh with a primer for community health data stewardship, and then see what we get and whether this in fact, does roll into that.

MR. BURKE: The skeleton of this could be useful, though.

DR. TANG: Then we are into a very big different – do we have room, money, for another hearing? Because in a sense, we would greatly expand the notion of the coverage of steward.

Like I said, it would include government, open government. But it would also include Google and Microsoft, et cetera. That is what society needs, is to figure out what the obligations are. I think it is going to be challenging.

MS. MILAM: But if we are thinking about community, I see those commercial holders of information different. It brings in FTC regulation of personal health record. I see that different than providing a model for communities.

DR. TANG: Those should be expected to be stewards. Otherwise we are going to continue this artificial line about covered entities. Are we always going to only talk about covered entities? No. So everyone who has donated information for a purpose should have obligated stewards.

MS. MILAM: They should. But do we take them all at once or do we just focus on one kind of steward?

MS. BERNSTEIN: I thought the purpose of this was to talk about using data to improve particular communities’ health or care or quality or whatever. Google’s reason for collecting data isn’t that. Google is a profit-making company and they provide service. But their goal isn’t to improve community health.

MS. KLOSS: I think perhaps ideally one would have this larger stewardship model in mind and then look at how it gets adapted to community and covering entities and other specific stewards. But as you say, that is just really by eating the elephant.

So maybe we do model for communities, so we can get something out to the folks who asked for additional guidance on a privacy and security framework to guide communities, using local data. Which was what we said, in the report. But I think the larger question is still, the elephant is still in the room.

DR. FRANCIS: I agree.

MS. BERNSTEIN: Yes, this committee — not this particular constitution of the committee — has said that there should be some, which maybe Paul is referring to our past work in saying that there should be some kind of framework, rules, whatever, for all health information, no matter where it appears, if it appears in Google or your bank or whatever. But that is a large chunk to bite.

MS. GREENBERG: I think we should keep the focus on the community groups.

MS. BERNSTEIN: And we haven’t heard from them at this point.

MS. GREENBERG: On the community issues, and as a follow on that community report. And if we think other things need to be done, then identify them. And really, as we said yesterday, it was much more on community based research.

MS. BERNSTEIN: That might be my fault, actually. We were talking about — I don’t come out of the health world. And this is something, as I understand, that public health, health, people talk about, is where is the line between public health and health. But that is not clear to me at all.

So when I was talking to people about this, I was very much kind of fumbling around. They would say, well what is it you really want me to talk about. And I didn’t really have a — I think probably Gail and Hetty could talk about this in a more sophisticated way than I could, given their background.

I was kind of fumbling around. And so I got people who I got. It might not have been precisely what we started out asking for.

MS. HORLICK: I think there are two. One is that what is public health practice, what is research, that distinction, that is still murky to this day. But also one of the speakers mentioned, there is a big difference between community-based participatory research and community engaged research.

And I am really not familiar with exactly what community based participatory research requires, and how that is different than engaging the community. And so I think we are looking at community engaged research, and the broader concept. But I would like to understand more about the first one.

MS. BERNSTEIN: It is a term of art which I couldn’t define.

MS. GREENBERG: Vickie had to go teach. Is she still on the call?

MS. BERNSTEIN: Yes, she had to go teach.

DR. TANG: The new charge, is it how do we handle the existing data that the federal government has? Or does it also include, and how do we handle the process of acquiring new kinds of data to improve health?

MS. GREENBERG: You are talking about this working group? It is, I believe, primarily going to be focused on existing data. It is called the Working Group on HHS Data, Access and Use. I am not saying it couldn’t get into issues related to —

DR. TANG: I know at least Todd, we just had him speak this weekend, so he is also open to — so let’s say we know certain things about social services for aging.

MS. BERNSTEIN: Could you get closer to the microphones, please.

DR. TANG: There might be other useful things besides their name, address, to know, so that you can do a proper match. He was open to entertaining those ideas. So in that sense, it really does involve —

MS. BERNSTEIN: Who are we talking about?

DR. TANG: Todd Park. It does involve enhancing and making more useful data the government — okay, so that means that there is no hard line about new data acquisition. So I am trying to figure out what is the problem to solve. And I think our contribution can help this project understand how to engage and provide additional usefulness of data acquired and maintained by the federal government.

What we learned yesterday certainly can shed light and can contribute to that cause. So it certainly can be included in this new group’s charge. So we just need to get and look for what is our output. Our output has to make the major points that would help the acquisition, use, and dissemination of information maintained by the health —

DR. FRANCIS: I can just drop in briefly a comment about the community based participatory research. Basically the idea of that is that there have to be trained community partners who function as equals. That is the conceptual idea, not just that the community has to be in some way engaged. And the idea there is that actually it is sort of a loose configuration by some funding agencies actually have separate funding initiatives that are for the narrowly defined participatory research types.

That has actually been a big thing on university campuses, not only service learning but getting grants that are community-based participatory research from granting agencies. There are some federal grants that require that kind of community equal participation. I don’t know if this is true, but I think the Colorado folks from Denver that we heard from look like that model. And I know they have some funding that might be that kind of funding.

MS. BERNSTEIN: That is why they mentioned Michigan yesterday, isn’t it, because they have a particular model like that where they are —

DR. FRANCIS: The Kellogg Foundation, the federal government, and there are some other foundations that specifically want you to meet a defined paradigm.

MS. HORLICK: So that means NIH is not allowed to have — somebody said they couldn’t be a co-PI, if it was an NIH funded grant.

DR. FRANCIS: I don’t know enough about the ins and outs of that. But there are specific requirements about —

MS. HORLICK: But that wouldn’t meet it, then?

DR. FRANCIS: It wouldn’t meet it, yes. So that is why some of the speakers, particularly in the last session, were saying hey, that is just different. It is a special animal. And when we talk about engaging the community we aren’t necessarily talking about that specific, very highly community participatory model.

MS. KLOSS: Can I suggest a sentence or two that describes what we might do? Prepare a letter focused on what we learned about stewardship and participatory governance for community health initiatives. With recommendations to the new data use working committee, working group.

MS. BERNSTEIN: Aren’t they just another subcommittee, a co-existing – go on.

MS. KLOSS: For communities themselves. I think it would be great to think, to itemize what they need to do. Recommendations for communities.

MS. GREENBERG: Take out that working group right now.

MS. KLOSS: All right, take that out.

DR. TANG: That is a different level. Ours has to be very formal and very thought out. How you started was to pass on this information to the new workgroup. And it has a different product to the public. When we go to a letter to the communities, this is a formal letter now.

MS. GREENBERG: Let’s get back to this working group. Because I think there is a relationship but we are not quite sure what it is. I am looking again. From what Jim said, the working group is going to focus on providing advice on using data that we have and making it available for greater use. It is basically to get feedback on how to make data, which is the data that HHS has, more accessible and available.

So this is somewhat different. But it certainly relates. And it says we are also interested in obtaining input on community health information and applications, quality of care information, comparative health information. It could be very, very broad. But that is why the charge is going to be important and has to be worked on.

The advice we want to give, the support we want to give to communities, comes out of what you were reading there, that we said how they needed —

MS. KLOSS: This is too narrow, now, based on what we learned. This said a privacy and security framework to guide communities in using local data.

MS. GREENBERG: That is too narrow.

DR. TANG: That was to us?

DR. FRANCIS: That is the first line of the CHIP Report.

MS. KLOSS: That is good. So we learned that to be useful, this guide is not privacy and security. It is stewardship and participatory governance, including privacy and security, but as a learning.

DR. FRANCIS: But very importantly, transparency, which is the other side of that, and dissemination.

MS. KLOSS: So I think we can get to some conclusions or recommendations, which we really all detailed this morning.

MS. GREENBERG: Aren’t these recommendations not only going to be for the communities, but also for the researchers?

MS. BERNSTEIN: The recommendations we make are to the Secretary. That is all this committee can do, as I understand it, is make recommendations to the Secretary. We can draft principles or whatever. The community can read them all they want and use them however they want.

(simultaneous comments)

MS. GREENBERG: We have a long history, the committee has a long history of making recommendations that, although they may be sent to the Secretary, they are really almost addressed to somebody else.

MS. BERNSTEIN: They are sort of in the context of you should fund, you should support, you should encourage, that kind of way of talking to the Secretary.

MS. GREENBERG: People should collect, things like that. It is not just to the Secretary. That is where the letters go.

MS. BERNSTEIN: I don’t remember that. I remember that we couched them somehow that the Secretary should promote, should encourage. And it gets to the community that way, but really somehow through the department.

DR. FRANCIS: I think we could think about writing this up as a primer which gets transmitted via letter.

MS. KLOSS: Six months ago we talked about a primer, right after the Community Health Data report came out. I can picture the meeting. I think it was over in Virginia. And then we moved away from it. But I think coming back to it, which I thought was a good idea, which you and I, I know, thought was a good idea right from the beginning.

DR. FRANCIS: Okay, so not a letter.

MS. KLOSS: But we are not ready to write the primer yet.

DR. FRANCIS: Okay, we’re not. I think we are ready to sketch it, to sketch the important elements for consideration.

MS. GREENBERG: And part of the letter to the Secretary, if we think it is time to do that, is to say — and we have done that in the past, too — this is what we are planning to do.

MS. KLOSS: That was the very last clause in my write-up. And recommendations for the future work of the Subcommittee in this area.

MS. BERNSTEIN: Just to be blunt, what is the purpose of sending a letter to the Secretary saying this is what we are planning to do, rather than just at the point we are ready to do it, just sending it.

MS. GREENBERG: It puts people on notice that the committee is working on this. It could possibly attract some partners or resources. Or it could result in the Secretary saying, I don’t think you should do that, which would be very unusual. Or saying, I think that is a good idea.

MS. BERNSTEIN: Our meetings are all in the public as it is. So everything we are doing is already out there.

MS. MILAM: The biggest advantage might be a group process, getting consensus, building upon it as a building block.

MS. GREENBERG: Is there a part of the department we feel we want to work with on this? That can be a reason to say, and we would like to engage —

MS. KLOSS: I think there is an awareness building. I don’t think that the way these topics are generally discussed, we are thinking about payers, providers, health information exchange entities, all things related to high tech. We are not necessarily thinking about the community. So there would be an awareness raising purpose to a letter, or primer. Well, certainly a primer.

MS. GREENBERG: There might be some value to engaging members of the data counsel on this. I know the data counsel just had a presentation, but I wasn’t able to be there, last week about workforce issues. I still think those are relevant here, the workforce issues.

MS. BERNSTEIN: Technically isn’t Justine an ex officio member of the data council? Simon used to go to those members. There is some relationship that is formal there, although we haven’t used it in awhile.

MS. GREENBERG: We had a time when actually the chair would go periodically to the data council meetings.

MS. BERNSTEIN: Gave a little update.

MS. GREENBERG: We have certainly had in the past the chair or the chair of the Subcommittee brief the data council on a particular report. We have not — I have suggested this back at the, I think the March 12 meeting, that as part of the dissemination of the community health data report it might be good to brief the HHS data council, which is made up of all the operatives, what have you, all the agencies. But it didn’t go anywhere. This would give us more to include in the briefing.

MS. BERNSTEIN: I was thinking that instead of after the fact, we could up front —

MS. GREENBERG: Yes, that is what I am talking about.

MS. BERNSTEIN: — in the way that you were talking about in terms of attracting resources.

MS. GREENBERG: They don’t have resources, but we could brief the data council. This is now what we have heard and this is what we are planning to do in the future. And get some feedback on it.

MS. BERNSTEIN: Attention, advice, feedback. They meet once a month.

MS. GREENBERG: And hopefully have people there from NIH, who don’t always attend, but HRSA, who would do the workforce. Get the right people there. We could do that as early as you are ready to – the July Data Council meeting? I don’t know.

MS. BERNSTEIN: As I say, they have one once a month.

MS. GREENBERG: The second Wednesday of every month.

MS. KLOSS: Take that as an action follow up item from this.

MS. GREENBERG: I think it is a way to try to engage the —

MS. KLOSS: I don’t know why we wouldn’t do it.

MS. GREENBERG: Yes, I feel we should.

MS. BERNSTEIN: Rashida Dorsey is the Executive Secretary of the committee. I will talk to her. She is one of my colleagues.

MS. KLOSS: We have one hour left. Do we have consensus that we want to do a letter on this and see how it shapes up? Maybe we will make a different decision. Maybe we will decide just to present the principles and have a dialogue with the full committee.

DR. FRANCIS: I think there are some aspects of this that I really do have a hard time seeing as recommendations to the Secretary. I see them as more general thoughts about areas in which progress is critically needed for the public health community. So the workforce point.

And that is very much — but there is an aspect of that which is a recommendation to the Secretary, which is that funding decisions that are so short term that they create incentives for helicopter research are deeply problematic. And we really learned that from communities.

Or research training initiatives, whether it is CITI or whatever else, that focuses primarily on interventional research, and doesn’t think about responsibilities of people engaged in that sort of public health research. Is it really public health practice?

Or the kinds of responsibilities that people have for secondary use of data, that that is deficient, and that there needs to be progress on that front. Now we are not writing the CITI questions or telling people what they should be doing. But we are pointing out that there is a huge gap here.

MS. BERNSTEIN: If there is an opportunity for resources to be applied, that this is the place.

DR. FRANCIS: Yes, so that is sort of a recommendation to the Secretary, but it is actually something much more for the broader community. So maybe we could do it as a letter to the Secretary.

MS. GREENBERG: I do think that is a role of the committee. You advise the Secretary. So part of your advising is saying, we have identified these issues, we have these concerns, we think these things need to be done, as opposed to just saying please find the National Health Interview Survey.

MS. MILAM: The recommendations and observations we have identified this morning, in my mind, I think they could all have direct application to the department. If you think about what the department funds in terms of research, it has funded a lot of community based research.

It also has a lot of population health programs that could benefit from community involvement. So if we shape it generally, then have some specific recommendations, I think we could probably tie them all.

MS. KLOSS: And engaging people in their health is certainly a critical goal going forward.

MS. BERNSTEIN: Let me modify what I was sort of pressing you before about, making recommendations only to the Secretary. We made lots of recommendations to the Secretary which the Secretary has not acted on. However, the industry has acted on. It is not the fact that the shape of our letters look like recommendations to the Secretary means no one else is reading them and no one else can act on them.

The industry has very largely acted on many of the things we have done in health IT and whatever, even though the Secretary hasn’t really been able to do it necessarily. So in that sense because it is a public document, I think it is worthwhile. It is just a matter of how the letter is drafted, the shape of it.

When we put out the CHIP Report or whatever, it has recommendations to the Secretary. But what we have been hearing is — what we heard yesterday, people are carrying it around, people are reading it, people are using it. People are doing all kinds of things with it, even though they are not necessarily the specific audience for it.

We have that in mind when we do these things, that there are other audiences that are using our material. I am proud of that.

MS. KLOSS: So we are okay with that consensus. What should it say? Let’s try to — I think if you could scroll back up, I think we have got all the observations captured from our discussion.

DR. FRANCIS: So it should say something about transparency.

MS. KLOSS: It should first frame the community, how we got here.

MS. BERNSTEIN: This list up here, there are two separate places where you were talking about this. You started talking about this framework where we were talking about sketching out.

DR. TANG: I think the new thought is community. Lay them out. Community as the donor, and the steward, and the responsibility to the community, that is the value add. Then there are things you want to educate the community about, and the steward has obligations about, and that includes the transparency.

MS. MILAM: And when we think about individual rights, thinking of community, it is broad. As Paul was putting together, you have the individual and you have the community. We were hearing about communities having rights, communities giving consent, communities needing to be educated. So we have a different actor in that box.

MS. BERNSTEIN: That is why I think that this dichotomy of community and steward doesn’t work so well, because there are different obligations and rights of communities versus individuals who might be the participants in a study, or the donors of their personal information, as opposed to the community’s role and then the steward’s role.

I think there are multiple different actors, and they have overlapping, perhaps, obligations. And rights, if you want to call them that. But I think just putting them in two boxes, I am having a hard time getting my head around that.

MS. KLOSS: I think we did learn that it is also not all about rights and obligations. It is about relationship, and relationship dynamics. And I think that is an important part that needs to come out. There needs to be fundamental rights and obligations. But it works if people are sensitized, skilled, trained, educated, supported, too. Craft, kind of, and maintain relationships.

DR. TANG: The practicality comes in that we cannot deal with 300 million individuals. So we have to have this governance as the practical matter, and that there is also, in addition to the steward having to relate to communities in addition to individuals, individuals have to relate to their community governance. Otherwise we just can’t do it.

We don’t want to cause a standstill in the very thing we are trying to help. In a sense, just like a citizen of the United States, you give up some of your rights to your elected official, because you actively participate in a process that creates a governance structure.

We are asking the same thing because we recognize that there is potential benefits and potential harms, to data use, and somebody has to worry about it. And we are suggesting a model, that you do delegate that to a governance entity. Both for your good, the continuing good, and because somebody else is probably going to be more knowledgeable.

MS. BERNSTEIN: You might do that. You might not choose to do that.

DR. TANG: Then you have to run for it.

MS. GREENBERG: Is that the governance? Are you going to be recommending that every community — and I don’t know how you are defining community — have some kind of governance structure? Or that when a study is going to be done, there needs to be a governance structure established before that study is done.

MS. BERNSTEIN: I would think for each initiative, not for each community.

MS. KLOSS: Initiative, yes. I think we should call it initiatives.

DR. TANG: But fortunately we have this out, in the sense of the IRB or Privacy Board that acts on behalf of 95 percent plus of the population, for 95 percent plus of the initiatives.

MS. GREENBERG: No, I don’t think so. I thought this revision of the IRB, the Common Rule, might not even include the data specific studies. I thought they were going to exclude that from IRBs, the data specific. This data studies.

DR. FRANCIS: Yes. That is the whole idea, that the IRB model was going to be applied to interventional research.

DR. TANG: I know. But there is this counterpart that has to deal with privacy of data use in aggregate.

MS. GREENBERG: What counterpart.

DR. TANG: Some mechanism.

DR. FRANCIS: I think what we were going to say — and maybe it is not the IRB model — but I think what we want to say is that there needs to be a stewardship approach to the aggregate use of data, which goes beyond what I will call the deidentification model. Where the deidentification model is just, did we deidentify it. And then maybe, did we hope that people won’t reidentify it.

And that one aspect of that is telling communities what is being done. Another aspect is engaging communities in what is being done, and then in an iterative way, so that there are no surprises.

MS. KLOSS: And then disseminating.

DR. FRANCIS: And that is part of the dissemination. And I think another aspect of that might be that there are contexts in which there are special communities, where maybe the more general point of that is that there needs to be attention to community relationships and structures and that is going to take different forms.

That may take going to the Cambodian community celebration, so people have a chance. It may take listening and honoring the decisions of tribal leadership, because there is a government structure, not just a governance structure. But that is going to be contextualized. But something is going to go on.

MS. KLOSS: That is my understanding. I think you have captured it well, the stewardship approach with all the learning that is going to go into that. But then acknowledging that there are certain types of community level uses where all the formalities of the IRB apply, and even that needs some perhaps tweaking to make it more relevant.

MS. GREENBERG: So I am hearing Justine in my head saying, okay, what are the problems that we are trying to address? And it seems that there are a few of them. As Sallie has pointed out to us, and has direct experience and knowledge of, communities need guidance on how to engage in this type of research. And research and dissemination with initiatives that seek to get data from their communities is a better way to say that.

So the communities need guidance. We know that, and they told us that. Researchers need guidance as to what type of — well on both sides, they both need it. But on governance and on how to be most effective, and on all those issues also.

The extreme case, I guess, of harm to, if not to individuals certainly to public health, is that case with the blood spots in Texas. So that is the extreme. But that can happen. That is sort of what happens when you haven’t handled these relationships.

MS.HORLICK: They lost the blood spots, but they lost the trust.

MS. BERNSTEIN: I understand that. But she said it was a harm to public health, and I didn’t understand that. It is just a harm to the availability of the data. The public’s health is still the same. But the ability to understand it in the future may have been harmed, right?

DR. FRANCIS: So those newborn screening samples are used for everything from looking at what are the changes in environmental exposures, infectious disease exposures. It is not just the genetic use.

MS. GREENBERG: Getting rid of those blood spots must have been a harm to public health.

DR. FRANCIS: Because this resource is no longer available.

MS. HORLICK: That they may have been required to give. But because there is a loss of trust, some voluntary data may not come to us, if people aren’t going to trust.

MS. KLOSS: Well it is certainly the loss of opportunity.

MS. MILAM: I keep thinking about — I think having just read Paul’s quality letter this morning, and thinking about some of the statements about Marjorie, keeping our eyes focused on what we are trying to solve about the community. I think about dissemination of results, and I think about some of the dashboards that we saw through the CHIP project.

So I think we need to consciously figure out, are we talking about web-based query systems, when we talk about putting information in the hands of the consumer? And that brings out a whole other series of issues around privacy and small cell-size issues and that type of thing.

I don’t know that we want to get into that. Maybe we want to specifically not talk about web-based query systems because they are complicated. But it is a whole separate issue. I would just put that on the table. And maybe we decide to exclude that, because it is a whole body of work separate.

But I think we ought to do that intentionally. Or it really expands the scope.

MS. GREENBERG: Web based query systems probably should be addressed by this new working group.

DR. TANG: So to go back to Marjorie and Justine saying what is the problem we are trying to solve — we have an enormous opportunity to make use of community data. We will not achieve that if we do not partner with a community to do that. That is what we learned.

MS. GREENBERG: And we have enormous opportunity to engage with community.

MS. KLOSS: Change happens at the grassroots.

DR. TANG: That is right. That is our main message. Let’s make sure we get that message out and address how, what is my action point as an individual, as a community leader. And what is my action point as a steward. And let’s just get that out.

DR. FRANCIS: At the risk of sounding scary, I was going to suggest that Linda and Maya and I, take a crack at actually drafting something and circulate it within a month, with Gail and Hetty’s help.

DR. TANG: If you already have everything, and I think probably you do, I would do it before a month.

DR. FRANCIS: So three weeks. I just know my own commitments in the next week and a half.

DR. TANG: The way we got it going was to have it today. Anything short of today, in a sense, won’t happen.

DR. FRANCIS: We will try as fast as we can, and hopefully two weeks.

DR. TANG: Because then you can be on the target for June. Your goal is to be on the target for June.

MS. BERNSTEIN: So are you suggesting we adjourn now and go to work on it in the next hour?

DR. FRANCIS: No, I was actually suggesting that if that is the process, we need to be sure that — I was then going to suggest that we go around and there is a lot that has already come up today.

But things that haven’t come up today that should be on the table — Sallie’s point about web-based queries. So that just reminds me to think about how these more general area concerns would work in the context of a web-based query. So that is a little test, is the way I was thinking of it.

DR. TANG: So there are these points you are trying to capture right now, to incorporate into the draft you are going to form.


DR. TANG: And where it came up was that the data integrity or the science integrity of use of this, this question Brad mentioned. So it turns out that nine out of 10 — and I actually went up him, I said are we only talking about unpublished? He said no, published.

MS. BERNSTEIN: Are we only talking about what?

DR. TANG: Unpublished. No, this is published data. Nine out of 10 findings you are going to have using associational data are going to be, quote, debunked. So there is a real risk in that. It is everything the tribes were concerned about.

And you might come up with associations that, one, are not causal, but two, can cause harm, whether it is social stigma or benefits, whatever. So the steward has a responsibility to do more than just do statistics on data it gets.

MS. GREENBERG: Are you talking about also if you get comparative data?

DR. TANG: The steward has to understand and be able to — you can’t just have these disclaimers in asterisks and expect people — first of all they won’t understand it, they won’t get it. Nothing will pass the headlines. So you have to be that socially responsible, that when you perform analyses of this associational data, that you have done the checking.

Remember, that consortium was to check whether what they find at Vanderbilt applies in Chicago, et cetera. And then essentially don’t go public, trying to capture headlines, before you have checked the equity of your findings. That’s important.

DR. FRANCIS: Maybe a general way to put that — and let me just test this out, if we are thinking about drafting it — is that principles of data quality and integrity apply at the community level, not just at the individual level.

DR. TANG: It’s almost more so. You are impacting an entire community. That is part of the thing that has not gotten into the mind of — first of all, they haven’t thought of themselves as stewards. They just thought of themselves as researchers. And you have to think societally in the new world, because so many people are impacted in ways that were not possible when we just had individually funded research projects.

MS. BERNSTEIN: That is kind of interesting because it sort of goes to the way that science works essentially. The way that science works is, you get your results out there and you publish them, and somebody else goes along and tries to knock them down or tries to replicate them.

And if your results aren’t out there in the public, fewer people can try to do that. So what you are suggesting is, before I publish my results I have to look for other people to try to do the same study and replicate them. And that is kind of a closed system in a way. I am choosing who to share my data with. I am choosing who can look at my results.

So that does go to some — whether or not that’s what you — it does go to sort of the way scientists think about how they do science.

DR. TANG: It is work to be done. It is on the list of the work to be done, that we are now, just like there used to be Consumer Union and Consumer Reports. Now there is anybody on the internet can affect the product and opinions.

MS. BERNSTEIN: Yes, but do you trust Consumers Union more or them more?

MS. GREENBERG: There still is Consumer Reports.


DR. TANG: So the same thing is going to happen. We had this debate on peer reviewed publication. And what we are doing is, we are arming even more people with the ability to make instantly available their thought about data that impact communities. So we are not prepared. We don’t have a critique here. But that is something that has come up, because we have been sensitized to the notion of the impact on what we thought were identifiable small groups. But they aren’t so.

MS. KLOSS: Maybe that is a new steward role.

DR. TANG: Exactly right.

MS. KLOSS: To be that — somehow you need a trusted —

DR. TANG: And we almost need an association of statisticians to go take this on as a policy initiative.

MS. GREENBERG: I don’t think you are talking about sitting on data, because I do agree with Maya.

DR. TANG: It is not so much sitting on data. It is sitting on conclusions.

MS. GREENBERG: On causal relationships particularly.

DR. TANG: What we are talking about is all non-causal. These are all associational. And they are all subject to incredible bias that even the researcher doesn’t know. He said these words but it is really hard to understand. So just your work flow in this organization or this EHR will determine the data you collect. Unbeknownst to anybody else who does not work there. That is the danger.

And that is what he was saying, when you compare Vanderbilt and Northwestern. They are very different. They could have identical populations. It is the policies in the systems they use. That is unappreciated by even the — this is a future science area.

MS. GREENBERG: I thought in what he was describing with that eMERGE, there was a real power of having that kind of consortium. And we talked about that way back when with this community. Remember, Sallie, with the community report, that shouldn’t all just — I mean, they can be, but we are losing a lot by these being kind of one-off situations. That there needed to be more of a consortium, coordination, integration, whatever.

So even though when you have seen one community you have seen one community, you also, there are a lot of similarities and best practices and things to be learned, too. So there really needs to be more integration, at least opportunity for integration of these different community efforts.

DR. TANG: One of the protections in the published literature is the peer review. We don’t have that peer review here. Actually, that is one of the suggestions and options for how do you try to improve the integrity of —

MS. GREENBERG: It goes beyond peer review. Some things get peer reviewed, but they get published in peer reviewed journals.

DR. TANG: They don’t have to be. A lot of the stuff may be published in the newspapers.

MS. GREENBERG: This last one, mechanisms to enable communities to share knowledge and information and stay abreast of —

MS. BERNSTEIN: We have identified this is a problem area, right?

DR. FRANCIS: I think the general point is the data and scientific integrity. And I also think a related general point is that because we are talking at the community level, if we are not super careful it could be really bad. It is not just that we have published a study that is going to get refuted. It is that there is a study that has been published that makes people really angry about participation.

And so I don’t think we are trying to say you don’t publish until you consult, and that you have to have a — but that attention needs to be directed to significant care in reporting study results so they aren’t over-reported. Possibly tiered disclosure, dissemination, that concept. That is a concept — tiered release — that I don’t want to get lost. That was Jerry’s point I think.

MR. BURKE: This is the notion of sharing information first with the donors?

DR. FRANCIS: So that they —

MR. BURKE: Sequencing later.

DR. FRANCIS: Right, and processes along the way. And then tiered discussion so that there aren’t surprises. But all of that matters in the community context, as well as ongoing work in attending to scientific methodology. But we are not saying you always have to have a consortium of this or that. We are saying, we are at a higher level.

MS. KHAN: Someone had talked about demonstrating the relevance of the project, of the research, to the community, to whatever is going on in the life of the community.

MR. BURKE: So it is a series of pledges, that the research, if it is not just health statistics but research, should be making to the community, engagement along the way, recruiting participants, first making sure the study has relevance, recruiting participants, pledging to bring back results, sequencing the release of information. There is a whole series of pledges and commitments that are made along the way.

MS. GREENBERG: I was looking again at this report, because we had 14 recommendations on the provisioning of federal role. And before we come out with another 14 or something, I think we need to look and see whether any of these really pop out as being reinforced by the hearing that we have just had, or whether they need to be modified. I think we need to relate to this list.

DR. FRANCIS: Some do and some don’t. And if you actually go back, if we go back to the list, the envisioning of federal roles on page 31, in the report. So facilitate and provide resources to strengthen communities’ capacity to collect local data. Well, we heard the workforce point. We heard the structure of funding point.

Drawing on the health indicators warehouse, continue to identify and encourage the adoption of standardized community health indicators and expand access to the underlying data. That is really two recommendations. And I don’t think we really addressed that.

MS. KLOSS: Because we were talking more about primary research.

DR. FRANCIS: Help communities develop frameworks for collecting comparable health status, health care, and other health related data, as well as frameworks for privacy protection. Well we are trying to suggest what some of those frameworks might look like.

I don’t think we are thinking at all about, or saying anything about the development adoption of a national common reference information model for public health.

MS. GREENBERG: Although I could see it fitting in here.

DR. FRANCIS: Talk about how. I’d love to know more.

MS. GREENBERG: I think such a model would include some of the governance issues. I am not exactly sure. I think it was Walter, who advanced that, and I am not exactly sure what he has in mind.

MS. KLOSS: I think he is trying to take the work being done on the common reference model, and using it for the public health data sets. Work that needs to be done. I don’t know that that is relevant.

MS. BERNSTEIN: My head is still on your question about trying to capture what hadn’t come up.

DR. FRANCIS: So I have got one that hadn’t come up that I would really appreciate people’s thoughts about that we haven’t talked about much. A theme that showed up in several people’s discussions — and this goes back to who is the community in a way, right at the very beginning — is negotiating diversity within communities.

And I will just highlight a couple of places where it came up for me, and get people’s reactions to this. One was in the first panel where there were a lot of back and forths about how much you go to traditional community advocacy groups, that they may or may not be speaking for the community.

Another was, the squeaky wheel issue, that there may be somebody with a really strong view, and I think it was Brad made this comment about community advisory boards, that you want people who are willing to take short terms on them, so they aren’t agenda pushing.

And a third place where it came up I will call the urban Indian issue, where what you have are people from many, many, many different tribes. And it is not even clear that there is an Indian identity.

And a fourth place where it came up was in the discussion of the Cambodian and the Laotian communities where the community elders who may have come from refugee camps have very different views than their kids who are second generation. So any thoughts about that I would welcome.

MS. KLOSS: Another point that came up that we haven’t discussed yet this morning, is the issue that privacy is not an individual issue only. It is societal and family. And I think that as we develop the opening paragraph, talking about community and this new orientation, that is why it is so relevant.

MS. BERNSTEIN: I think Gail sort of quickly made the point earlier that really struck me, since I do all this privacy work. It is that our default is to think about protecting the individual. And some of them don’t want protection. That might not be what is proper.

The community might want to be identified. So this dichotomy that I was asking a long and involved question about yesterday, about if you protect the community’s identity then the community doesn’t get any data, which is bad. Or, if you identify the community and give them back their data, then individuals are identified, which could be bad.

So that there is a conflict between the protection of the privacy and the identification of the group and so forth.

MS. MILAM: I was going back to the list of areas of a possible federal role in the CHIP Report. I am looking at number nine. It is focused on technical assistance to communities. I am wondering if we might develop all of our recommendations around how the department can offer technical assistance to communities and sharing models.

We heard lessons learned, some yesterday, but a lot through the CHIP hearings, about some best practices of engagement. And we have heard about different kinds of research that required different levels of community engagement, and realized that the community is a new actor. And so maybe we focus all around how some of these best practices can be shared, and any best practices that we heard identified.

MS. GREENBERG: And then we followed up about the regional extension centers. But I am wondering now, after what we heard yesterday, whether not only is there technical assistance that is needed to the communities, but to the people who want to do research in communities.

I think I heard that much more than — because we were hearing from the communities before, and now we were hearing almost more from the researchers.

MS. MILAM: Although we heard from the researchers in the communities.

MS. GREENBERG: Within communities, yes. And I think there is a lot of this town gown stuff too, which can be negative, but obviously it can be very fruitful. I was just having a thought about — I was so struck, I guess, and maybe it is because we had a number, obviously, of Native American, American Indian, whatever perspectives yesterday from several different ones.

It may be, because they present such an interesting use case and also have more formal governance issues, et cetera. But I am wondering if somehow the way we can make this real to people is to kind of lay out that scenario, of as a community, which is a much more formal community than most geographic communities.

But what you can learn from that, and what it says about the individual versus a community. Or not versus, but how it isn’t just about individuals, and how what you are saying about the individuals can reflect on the whole community, on the need for community governance and all of that.

I am just thinking of a kind of use case which is compelling. At least it was compelling to me. And that we could then branch off from, and say most communities don’t have this level of structure in that sense. But there are a lot of parallels. Just as a way to really grab people.

MS. BERNSTEIN: That resonated with me. When I was trying to recruit people, and I kept coming across people who — and even when we discussed who should we get for this hearing, we talked about trying to look at the Havasupai case.

I was admonished in talking to some of the folks who work with Indian tribes, and I don’t know if it was Dr. Smith, he was here earlier today, that we should — and this isn’t what we are doing, but — we should stay away from, and we’re not, making recommendations to tribes.

We are not doing that. And I made clear that is not what we are doing. In fact, what we wanted to do was to learn from them, and use them as an example of how we might apply their experience to these other communities.

Somebody made mention yesterday, that we haven’t talked about, the tribes and the relationship with IHS or NCI. It is like they have this long history of basically doing this already because of the way that they are structured and the governance model or whatever.

And that what we are now looking at is new entrants to this way of working, essentially, where the tribes have been doing this already for a long time and they have come up with particular structure that might differ among the tribes.

But the more formal model, as you are saying now, now we are trying to do community research with people who don’t have a long history of working back and forth, don’t have the IHS in the middle. And sort of what could we learn from them and apply to newcomers?

MS. MILAM: So maybe we look at the application to existing community structures that we have, our local governments. That is where we are seeing a lot of the community planning coming from. And we are seeing a lot of leadership from that area.

Maybe, we heard about it yesterday from the tribes, maybe we draw closer comparisons to community health centers.

MS. BERNSTEIN: It makes me think, the woman that couldn’t be with us yesterday, Cyd Lacanienta, I don’t know if I mentioned. I mentioned to some people privately, her father became ill and she had to turn around and head for the hospital on her way here. Unfortunately, I got an e-mail that I picked up later, and that is why she didn’t appear.

But she is working with an organization that works with the City of Baltimore. And what I like about that is that she was doing something very different than what other people were talking about, and working on HIV intervention in the city based on working with public health, and understanding what was going on with HIV based on public health information, and then using it to do interventions in the City of Baltimore.

And so she would have been working with a local government, all the things that we were interested in. And so we can perhaps get her to call, or make a short presentation or something since she is just in Baltimore. Marjorie was saying, maybe we can have somebody come once and present at the end of a full committee meeting, or something like that.

We might be able to get someone like that to add to what we have now. But it was disappointing, since it is right on the topic you just mentioned about local government, that Sallie was saying.

MS. KLOSS: Anything else that was in your notes that we haven’t brought out?

DR. FRANCIS: Nobody hit on the diversity point, and I would love to hear any thoughts anybody has.

MS. GREENBERG: I thought the woman from Maine was very good.

MS. BERNSTEIN: Linda Silka, yes, she had been doing this for 30 years is what she said.

MS. GREENBERG: When she said universities are changing and all that, are they changing as much as she says?

DR. FRANCIS: Well the service oriented stuff is, and community engaged research is huge, I think.

MS. BERNSTEIN: That is something we haven’t talked about, that sort of addressing some of these things to universities which are thinking about the world differently than they have more, in the past more traditionally.

DR. FRANCIS: Just a couple of observations about that. If you think about the Denver one, the area of the old Stapleton, that is an illustration of that kind of university partnership. And I also think it is why the CITI training kept coming up, because universities that have general assurances will require all of their investigators, as well as their IRB members, to take CITI training. And that is the research ethics training that they get. And the fact that it is so inapplicable to the community stuff is why that came up.

MS. BERNSTEIN: One thing that struck me about that was, somebody said we give them this basic training, but that we turn people without — people not necessarily of letters, into really good bioethicists. Somebody was saying that given some very basic level of training, community people turn out to be able to think in a very sophisticated way about these issues even though they don’t have a formal training.

It stuck with me, even though we have been down on the CITI training and it is kind of rote and whatever. For people of letters who want something more, for people who have never encountered it before, it apparently helps them.

DR. FRANCIS: But they were talking about the CITI training.

MS. HORLICK: I haven’t actually taken it, but we are looking at how we can supplement that training at CDC. It is very regulatory based. That is really not so much what we want from an ethical perspective or the community based.

MS. BERNSTEIN: I understood that is a very basic training and that is the training that they were giving people in the community who didn’t have anything else. Maybe I missed that.

DR. FRANCIS: Yes, I think they were developing different models.

MS. HORLICK: Also some of the communities couldn’t even access.

MS. GREENBERG: Can you send me a reference on that CITI training?

MS. KLOSS: I think that concept was embedded researchers, too, that discussion.

MR. BURKE: Collaborative, the T is training, the second I is initiative. I forget what the first I is. It is under CITI. Get through the Citigroup references and you will find it. One of the things that Linda mentioned yesterday that stuck with me — Linda Silka — was the notion about how extreme the diversity differences can be.

And her advice about stepping back before you step in, felt very appropriate, making sure you understand the differences in the community before you make generalizations about a research design.

MS. HORLICK: I thought that diversity was also related to the cultural sensitivity. I had written down yesterday, determine the community leaders by asking the community. So, even when you ask the community, they may all point to, say it is not really the past, or it is this other person. That other elder person may not speak for the youth. And so that whole concept of diversity.

The other thing, which I am not so sure it is related to the data dissemination, but I was struck how this might be something for the workgroup, but Malia Villegas had mentioned so many times, we are not even listed on these reports because the Native Americans are not even a category, or they are just too small to be even counted.

So you have the privacy side of it, but also that — I don’t know really where that fits.

MS. BERNSTEIN: You mean when she was talking about if somebody identifies as both Hispanic and Native American

MS. HORLICK: Only the Hispanic is reported, right?

MS. BERNSTEIN: Yes, that seems to skew data, doesn’t it?

MS. HORLICK: Yes, and that they are not even sometimes included as a group.

DR. FRANCIS: Anything else that people want to make sure is a theme to sound?

Agenda Item: Wrap Up, Next Steps, etc.

MS. KLOSS: So the game plan is to do a draft of this within a couple of weeks. It still feels a little bit like an elephant to me. But I am sure that there is plenty of meat here. It is just how it gets pulled together and what we decide to cover, and what we decide not to cover in this first, how we don’t make it just a laundry list of you should do’s, but rather a cohesive set of guidance. I am still kind of struggling with that.

MR. BURKE: What do you anticipate after the draft? Circulating it, and then inviting feedback in a sequenced way or coincidentally as we each get it?

MS. KLOSS: Could we use our SharePoint?

DR. FRANCIS: Let’s use SharePoint. I can see, for example —

MS. GREENBERG: We are really trying to get people to start using it.

DR. FRANCIS: — saying we need a paragraph here about this. Jack, will you draft it?

DR. TANG: I am always unconnected.

PARTICIPANT: We can download it and then upload it.

MS. KLOSS: It is the kind of application where that should be coming in handy.

MS. GREENBERG: I do feel we have probably gone about as far as we can go at this point. But there is so much stuff here. Even, I wonder if just starting with — although I am not good at doing outlines myself, but starting with kind of a high level outline.

DR. FRANCIS: I always write the first couple of paragraphs in an outline. And that may be the point at which to ship something around to people, because I think the first couple of points are going to have to be the how community shapes and why this is important now. And getting that right is going to be critical.

And what will be the points we will be following up on, and maybe even farming out some — like Sally, put in something here about states. Something like that.

MS. BERNSTEIN: As people go through the notes from the weekend that they may have taken, or thinking about the weekend, if you have something that you didn’t bring up today, that you want to put on the list, just send me a note and I will do it. Send it to Linda, Leslie and I, or just me, and I will forward it.

MS. KLOSS: Do you generally just circulate your rough draft notes?

MS. BERNSTEIN: If you want me to, I will be happy to do that.

MS. KLOSS: I think that would be great.

MS. BERNSTEIN: I usually give them to the co-chairs, if the rest of you want them. You know how they are. They are just sort of my —

MS. BERNSTEIN: But there will be a transcript in two weeks. This is for us. If you want it before then, if you want a draft in two weeks we can use this for now. But then we will have a transcript that is more accurate, and will tell me what you actually said rather than what I thought about what you said.

MS. KLOSS: Share it with certainly Leslie and I. I don’t know if anybody else wants it at this stage.

MS. HORLICK: I don’t know what stage you want input from Hetty and I, to work with you, then, notes would be helpful.

DR. FRANCIS: I think sending around the notes would be great. Input, the sooner the better. Any thoughts people have about — right now it should be any thoughts people have about stuff that didn’t come up.

MS. BERNSTEIN: Paul is walking out the door. I am thinking about busy people scheduling phone calls.

DR. FRANCIS: We will schedule a phone call. We will get Jeannine. That is our other quick action item, getting Jeannine to schedule, asking Janine to schedule us for a conference call.

MS. BERNSTEIN: How far out do you want it?

DR. FRANCIS: I am very appreciative of Paul’s let’s move on this – probably mid May.


MS. KLOSS: For a conference call?


MS. KLOSS: I think if we have that scheduled it is going to drive us to

MS. BERNSTEIN: I am also guessing just the whole month of May, the way this group is —

PARTICIPANT: Including the multiple graduations.

MS. KLOSS: Other business? Otherwise, are we adjourned? We are. Thank you.

MS. BERNSTEIN: Can I just thank Hetty and Gail in particular, for helping me to put the hearing together? And also to thank our administrative staff, without whom we would not be having this day at all, and our transcriptionists, and web guys and all that stuff, without whom we can’t really run these meetings. So thank you very much.

DR. FRANCIS: We underscore and emphasize that. And also Maya, you didn’t get to thank yourself.

(Whereupon, at 12:20 p.m. the meeting was adjourned.)