[This Transcript is Unedited]
Hubert Humphrey Building
Room 505A
200 Independence Avenue, S.W.
Washington , D.C. 20201
Committee Members :
HHS Executive Staff Director :
Executive Secretary :
Liaison Representatives :
Agenda Item: Call to Order, Welcome and Introductions and Review of Agenda
DR. LUMPKIN: Good morning. Welcome. Just to get started, we will start off with introductions.
My name is John Lumpkin and I am the chair of the committee and senior vice president of Robert Wood Johnson Foundation.
Why don't we go around the room and make introductions. Then we will review the agenda. We have a couple of housekeeping items and also as we go around the committee and do introductions, if you have any conflicts with the subject matter of the meeting that you need to declare, please do so at that time.
So, let's start off with Marjorie.
MS. GREENBERG: I am Marjorie Greenberg from the National Center for Health Statistics, CDC and executive secretary to the committee.
DR. LUMPKIN: Jim wants to clarify. That is financial conflicts, not emotional ones.
MR. HOUSTON: I am John Houston with the University of Pittsburgh Medical Center and I don't have any conflicts, either emotional or professional.
DR. CARR: I am Dr. Justine Carr from Beth Israel Deaconess Medical Center in Boston, Department of Health Care Quality.
DR. HUFF: Stan Huff with Intermountain Health Care, the University of Utah in Salt Lake.
I need to recuse myself from HL7, LOINC, and ICD-10 PCS.
DR. LENGERICH: Gene Lengerich, a member of the committee and from Penn State University.
DR. LUMPKIN: Stan, could you explain that?
DR. HUFF: This is a direction from the ethics committee. So, when I do the non-disclosure thing, they -- because I hold a position as a co-chair on HL7, they think I have a personal bias. I am also a co-chair in LOINC and so I have a personal bias. There is no financial interest there. And about two years ago, I was a one-time consultant to 3M, who produces ICD-10 PCS. I think that one -- actually there is no business relationship any longer. So, when I reviewed again, that one will probably go away.
That is the explanation, sir.
DR. LUMPKIN: I think the important addition I would make to that, it is not the issue that you might -- that you have personal bias, but it is the appearance of bias. Because we love and trust you.
DR. HUFF: Thank you for that vote of confidence.
MR. LOCALIO: I am Russell Localio, University of Pennsylvania School of Medicine. I am a member of the committee.
DR. WARREN: I am Judy Warren, University of Kansas. After talking with Stan, I don't know what I have because I am also a co-chair at HL7 with no financial bias and I am a consultant at the SNOMED Editorial Board with no reimbursement or anything like that either.
MS. GREENBERG: Just for some clarification, one's interests are defined broadly. So, it is not just a question of financial. So, if you have a leadership position in an organization, then generally there is a waiver that allows you to participate in all the general matters, but not matters that are specific to that issue.
MS. BEREK: Judy Berek. I am the liaison for the Centers for Medicare and Medicaid Services.
MS. TORIARES: Nancy Toriares(?) from the U.S. Census Bureau, reminding everyone that you have just seen your last decennial census long form. It is really gone.
DR. LUMPKIN: What if we long for the form?
MS. TORIARES: Well, they long for $12 million to do it. Reminding everyone that this replacement, the American Community Survey, starts in July of this year.
DR. ROBBINS: Aldona Robbins. I am the liaison from the Board of Scientific Counselors, National Center for Health Statistics, CDC.
MR. REYNOLDS: I am Harry Reynolds, Blue Cross and Blue Shield of North Carolina.
DR. STEINWACHS: I am Don Steinwachs at Johns Hopkins, Bloomberg School of Public Health, member of the committee.
DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention, liaison to the committee.
MR. BLAIR: Jeff Blair, Medical Records Institute, member of the committee.
MR. HUNGATE: Bob Hungate, Physician Patient Partnerships for Health, member of the committee.
DR. MAYS: Vickie Mays, University of California, Los Angeles, member of the committee.
DR. COHN: Simon Cohn, national director for health information policy for Kaiser Permanente and a member of the committee.
MR. SCANLON: I am Jim Scanlon with the Office of the Secretary, HHS and I am the executive staff director for the committee.
MR. SONDIK: Ed Sondik, director of the National Center for Health Statistics. I am entirely conflicted.
MR. FANNING: I am John Fanning from the Department of Health and Human Services.
DR. FRIEDMAN: I am Dan Friedman, an independent consultant in population and public health information services from Massachusetts. To quote the chairman of the committee, now I have a teenage daughter at home, so I have many conflicts everyday.
MS. LORRAINE: Kathryn Lorraine(?) Office of Policy, FDA.
MS. KOPPELMAN: Hi. I am Lacey Koppelman, Office on Women's Health at the Department of Health and Human Services. I am actually representing Suzanne Haynes, who is senior science advisor in the Office on Women's Health and she is a member of the subcommittee.
MS. PICKETT: Donna Pickett, National Center for Health Statistics, CDC.
MR. HITCHCOCK: Dale Hitchcock, Office of the Assistant Secretary for Planning and Evaluation, co-lead staff of the Subcommittee on Populations.
DR. KYLE: Frank Kyle(?), American Dental Association.
MS. JACKSON: Debbie Jackson, National Center for Health Statistics, CDC.
MR. RUMMEL: Nick Rummel(?), HIPAA Compliance Alert.
MS. KAPLER: I am Evelyn Kapler(?) with the Office of Public Health and Science at HHS.
MS. EVELYN: Brenda Evelyn, Office of Special Health Issues, Food and Drug Administration.
MS. FRIEDMAN: Maria Friedman, CMS and staff to the Subcommittee on Standards and Security.
MS. GRANTON: Good morning. Miriam Granton with the Office of Disease Prevention and Health Promotion and I staff the Subcommittee on Population.
MS. RYAN: Hi. I am Colleen Ryan. I am with the Indian Health Service and I also am render staff for the Subcommittee on Population.
MS. WILLIAMSON: Michelle Williamson, National Center for Health Statistics, CDC.
MS. WATTENBURG: Sara Wattenburg, Substance Abuse and Mental Health --
DR. LUMPKIN: That is what you get for testing the equipment this morning. If you hadn't tested it, it would have worked fine.
We have Peggy, if you would introduce yourself and state any conflicts of an interest, financial nature. We have stopped with the emotional conflicts.
MS. HANDRICH: I am Peggy Handrich, a member of the committee from Wisconsin.
DR. LUMPKIN: Great. Welcome.
Do we have anyone on the phone yet?
PARTICIPANT: Not yet.
DR. LUMPKIN: Richard Harding and Mark Rothstein will be participating in part of the meeting on the phone. Mark is recuperating. So, we wish him all the best and hope he gets back on his feet very quickly.
Let me start off with a couple of logistics issues.
MR. BLAIR: How about if they could turn the air conditioner on. That is a good logistics issue.
DR. LUMPKIN: This is March. This is a federal building in March in Washington. If we can do something about the temperature in here -- it is a little bit too warm.
We were discussing a couple of logistics issues. The first is if you intend to leave before the end of the meeting tomorrow, please let me know during one of the breaks, just so I can manage a quorum. I don't think we have a problem, but I just would like to know.
Second is that there is a caravan leaving tomorrow morning at 8:15, for those of you who want to go out to the wilds of Virginia to get your --
MS. GREENBERG: No, no, no, Maryland. Hyattsville, Maryland.
DR. LUMPKIN: The wilds of someplace out here east, outside of D.C., Maryland, I guess, for I.D. badges.
MS. GREENBERG: Opportunity to see the beautiful new NCHS building.
DR. LUMPKIN: And an opportunity to see the new NCHS building that is so accessible that -- who is going to go along so that the cab driver can find it? Gracie will go along with you.
MS. GREENBERG: This is to get your badges. It does make life easier once you have the badge.
DR. LUMPKIN: Okay. So, anyone besides Justine going? Okay. So, hook up with Jackie, she will give you the details also during the break.
MS. GREENBERG: Then if you are -- I guess before the lunch break, maybe we will take a head count for the dinner.
DR. LUMPKIN: Okay. We have two people on the phone. If you could introduce yourselves.
DR. HARDING: Richard Harding is on the phone.
MS. HORLICK: Gail Horlick.
DR. LUMPKIN: Gail. Welcome.
MS. HORLICK: I have tried -- I was the first caller before and they finally told me to hang up and try again.
DR. HARDING: That is what happened to me, too.
MS. HORLICK: I won't be able to stay for the whole meeting, but I will call in when I can.
DR. LUMPKIN: Great. Thank you.
Let's go through the agenda. The first item that we have on the agenda -- are there any additions or changes to the agenda? Mike Fitzmaurice, who is our liaison from AHRQ has just arrived. So, I am going to embarrass you by noting that fact and having you introduce yourself.
Any other changes to the agenda? Okay. Seeing none, let's proceed.
The first item on the agenda, we were just passed out a copy of the claims attachment letter. So, I am going to turn that over to Simon.
Agenda Item: Claims Attachment Letter
DR. COHN: Good morning, all.
This is a letter that is being brought forward as a result of hearings of the Subcommittee on Standards and Security. The hearings occurred on December 10th and yesterday, March 3rd. I think as you all know, claims attachment is one of the standards under HIPAA. This has been something that has been percolating around for awhile.
We thought we were going to see one a couple -- NPRM a couple of years ago and then sort of nothing happened with it. In the meantime, the actual standard was taken back to the standards organizations and was basically retooled. So, the subcommittee wanted to take a look, find out what was happening, as well as what needed to be done with all of that. This is really the focus of this letter.
As you know, this is typically an occasion to suggest modifications, changes, additions or others to letters with the idea that the action would occur tomorrow on the subcommittee. If there are major modifications, we will obviously deal with it during the subcommittee break.
So, John, with your permission, we will go over it paragraph by paragraph on this one. It is a relatively short letter.
DR. LUMPKIN: Please.
DR. COHN: Okay. This says, "Dear Secretary Thompson: As part of its responsibility under the Health Insurance Portability and Accountability Act of 1996, the National Committee on Vital and Health Statistics is responsible for studying, selecting and recommending standards for electronic health claims attachments.
"To fulfill these responsibilities, NCVHS's Subcommittee on Standards and Security recently held hearings on standards for electronic health claims attachments on December 10th, 2003 and March 3rd, 2004.
"The subcommittee heard testimony from providers, health plans, vendors, associations and standards development organizations about the need for both basic and advanced functionality in a claims attachment standard. For example, such a standard should be flexible so that providers with minimal infrastructure can electronically transfer claims attachment information to health plans and clearinghouses. At the same time, the standards should possess the flexibility to permit users with more sophisticated infrastructures to fully leverage their investment in information technology.
"Health Level 7 and the Accredited Standards Committee X12 have been working to develop a HIPAA claims attachment standard that can meet these requirements."
DR. LUMPKIN: Any questions or comments on that paragraph?
DR. COHN: I know, it isn't very exciting so far, is it?
DR. LUMPKIN: Okay. Simon, you are on a roll.
DR. COHN: Yes, I know. I am actually a little concerned that nobody is making comments so far, but we will encourage that as we go along.
The next paragraph, "The subcommittee heard the need for demonstration projects and pilot studies to document the benefits, costs, work flow requirements, implementation challenges, privacy concerns and best practices associated with the claims attachment standard. NCVHS urges the department to support..." -- and probably we want to say "support and encourage" -- "...several different claims attachment demonstration projects and pilots that would include a broad representation of affected stakeholders.
"A pilot proposed by Empire Blue Cross and Blue Shield is an example of the kind of projects that should be developed and funded. NCVHS recommends that these demonstration projects and pilots occur expeditiously so that the results and findings will feed into the development of the claims attachment rule."
DR. LUMPKIN: Any questions or comments on that paragraph?
Don.
DR. STEINWACHS: Simon, just one -- the one sentence that said the pilot proposed, for the naive person, who doesn't know what is going on, is there a little descripter of what that pilot is about? It just sort of hangs here that there is one organization who proposed the pilot should be encouraged, but it doesn't -- or am I
just --
DR. COHN: Well, no. You bring up a good question. I mean, we obviously, have testimony from them in a proposal, which we believe has been already proposed to CMS, which actually used to be a parenthetical here, but we thought it was a little strange --
DR. LUMPKIN: Is it safe to assume that what the pilot is is the pilot is a pilot testing a model of a claims attachment?
DR. COHN: Yes, it includes -- I mean, this is basically a Medicare carrier and Medicaid also, I believe.
PARTICIPANT: Medicare.
DR. COHN: Just Medicare. Maybe testing it with various institutional and physician providers and how it would all work. Do you feel that there is a need for a little more explanation of what the whole thing is?
DR. STEINWACHS: I would put a little more explanation or I would drop it, either way. But, you know, if it is important, I would give a little more explanation, just what you said, I think would be helpful to someone who has no idea particularly why you are citing this.
DR. LUMPKIN: Does that sentence really add value to the --
DR. STEINWACHS: We could drop it, too. I mean, that would --
DR. LUMPKIN: Because we say in the sentence before that urges the department to support several different claim attachment demonstration projects and pilots. It just kind of sits out there.
DR. STEINWACHS: It may be easier to drop it.
DR. COHN: It might be easier to drop it. I think we will have to -- maybe that is a subcommittee discussion to see if we -- I mean, the only reason to have that in there would be if we want to make sure particularly that that one gets some notice so that it gets funded and if there are any issues related to it not getting funded. But I think we can talk about that in the subcommittee --
DR. LUMPKIN: Were there other pilots presented?
DR. COHN: No. Some people are talking about pilots, but none were at the stage where they could come forward and say, yes, we have a pilot put together. It needs either encouragement or --
DR. LUMPKIN: You could --
MS. GREENBERG: How about if we say we heard about a pilot proposed by Empire Blue Cross to do x and this is the type that should be encouraged and funded -- or developed and funded.
DR. COHN: I would say the subcommittee can take back this comment and --
DR. LUMPKIN: If it is okay with you, I think maybe we could ask the subcommittee to work on that.
DR. COHN: That is what subcommittees are for, to work on these sorts of things.
Any other comments on that paragraph? I mean, the people we are sort of trying to talk about now, it is like a model that somewhat resembles the Medicare Modernization Act and e-prescribing with the idea that a new standard gets piloted before it gets nationally mandated and the results of that pilot get put into the improvements in that standard before it is announced as a final rule. So, that is the model here.
DR. STEINWACHS: That would be great.
DR. LUMPKIN: And I think just one other addition. If you do include that, you might want to add a modifier that does describe them as the Medicare and Medicaid carrier or intermediary because it sort of -- from a casual reader, why are we picking on Blue Cross/Blue Shield. It is because they have already got some designation and relationship with CMS as a designated intermediary. That is an important distinction.
MS. BEREK: I would use contractor because they are both a carrier and an intermediary.
DR. LUMPKIN: Okay. Whatever the appropriate term is.
MS. BEREK: They will have a new name in a few years.
DR. COHN: So, what do we call it, contracted?
MS. BEREK: If you call it a contractor, it covers both carrier and intermediary.
DR. LUMPKIN: See, and I still want to call them HCFA. I just can't keep up with these names.
DR. COHN: We will ask you to make sure that we are correct on this one, but the more we get into this, the more likely there is going to be -- you are not going to see that sentence when it comes back.
Next paragraph, "NCVHS understands that a notice of proposed rulemaking concerning electronic claims attachment currently is under development. We urge the department to issue this NPRM as soon as possible. This will motivate the industry to participate in pilot projects and invest in the needed infrastructure. We also encourage the department to provide for public comment on the results of the demonstrations and pilots before a final rule is promulgated."
Then, "NCVHS wishes to thank you for the opportunity to offer these recommendations." Are people comfortable with that final part?
DR. LUMPKIN: Now if I can sort of understand this, our prior recommendation was to hold off on doing the claims attachment rule until the field was clearer somewhat. Now we are saying we think the field is cleared up enough to issue the rule and use that as a basis for evaluating the demonstration projects and then coming out with the final rule.
DR. COHN: I don't actually believe we actually had a letter on claims attachments previously.
DR. LUMPKIN: Okay.
DR. COHN: I think that we had held hearings a number of years ago. You know, it is usually our practice to wait until an NPRM is published and then make comments about the NPRM.
DR. LUMPKIN: No, we did have a letter on -- way back when, we did have a letter on claims attachment. We did make a recommendation, which didn't proceed and I think at some point -- and whether we did it by letter or recommendation, we did say, yes, it is a good idea to hold off.
But that really probably doesn't have any impact on this. The important point is is this process that we are recommending, which is to use the NPRM to sort of set the basis for the demonstration projects and evaluation as they moved to a final rule is the approach that we are recommending.
DR. COHN: Is that said clear enough here for those to understand?
MR. BLAIR: One of the things that we struggled with for a little while was to get a balance. We recognized that software developers and folks that would be doing pilots might not invest until they saw a serious intent by HHS, ala in the form of an NPRM before they would really move forward on this.
So, we felt it was important for us to encourage that that NPRM be set forth as soon as possible. At the same time, we were also hearing concern that people wanted the opportunity to make public comment in the rulemaking process after the pilots -- after the results of the pilots were available and before the final rule was issued. So, it was the balance between those two things that we have reflected in the last paragraph.
DR. LUMPKIN: I would wonder if perhaps that -- what you just said might be incorporated a little bit more in that last paragraph because really the sentence says this will motivate the industry to participate in pilot projects and I think it would be stronger if we said that what we heard in hearings is that the industry is waiting for an NPRM in order to move forward and that there was concern that there be adequate ability to comment on the pilots. I think that would make it a little bit stronger paragraph.
MR. SONDIK: I have a question on the -- it says support and encourage or encourage and support, I think, might even be better. Where would the funds come from for this demonstration or pilot? I mean, do you know of a pot that is earmarked?
DR. LUMPKIN: I think they were going after your budget.
MR. SONDIK: Why do you think I told you I was conflicted?
DR. COHN: Money is always an issue in all of this. I think it is why we use the word "support and encourage." "Support" obviously has many meanings, financial support, leadership, et cetera, et cetera.
MR. SONDIK: Support and encourage, I like that, but the way it was written, when it said developed and funded, then it made it seem as if there was a pot simply waiting or that it was very clear how this would be funded.
DR. COHN: Maria, can you comment on that from the CMS perspective?
MS. FRIEDMAN: We just recently got our budget. So, the jury is out on this. CMS recently just got its budget and I know the folks on the Medicare side of the house are looking at this. I don't think they have made a decision on funding this particular one. But I think the broader issue that we heard in testimony, that because funding is problematic everywhere, this might be an opportunity to do a public/private partnership or in some cases we heard that the industry might be willing to kick in.
MR. SONDIK: My recommendation would be to less specific and if, in fact, the offending sentence is going to be dropped or the --
DR. COHN: It may be okay.
MR. SONDIK: And I think the words encourage or encourage and support, I think would be sufficient.
DR. COHN: It sounds like those nails on the coffin of that sentence are --
MR. SONDIK: You raised it.
DR. COHN: That is well said.
Okay. Other comments? The subcommittee will obviously take this back. We will do some modifications to the letter and bring it back tomorrow.
DR. LUMPKIN: I want to make sure that I understand the looks I am seeing and the body language that I am trying to interpret. I don't see any major obstacles to the intent of this letter just to refinement of the wording. Is that a fair statement? Okay.
DR. COHN: Thank you.
DR. LUMPKIN: Thank you.
We will move on -- has Mark joined us?
MR. ROTHSTEIN: Yes, I am on.
DR. LUMPKIN: Welcome. We are sorry you couldn't join us.
DR. COHN: Are you okay?
MR. ROTHSTEIN: I am barely hanging in there but I am going to stay on the call for as long as I can. I would appreciate if someone from the subcommittee -- I know that Richard is not present --
DR. HARDING: I am on the phone, too.
MR. ROTHSTEIN: Yes. Either John Houston or --
DR. LUMPKIN: John is right next to me.
MR. ROTHSTEIN: -- Simon could take the lead in discussing the letter. That would be very helpful to me.
DR. LUMPKIN: Great. Now, we have that under our Tab 4, I think. Thank you.
MR. HOUSTON: "Dear Secretary Thompson: As a part of its responsibilities under the Health Insurance Portability and Accountability Act of 1996, HIPAA, the National Committee on Vital and Health Statistics, NCVHS, monitors the implementation of the Administrative Simplification Provisions of HIPAA, including the standards for privacy of individually identifiable health information, the privacy rule.
"The Subcommittee on Privacy and Confidentiality of the NCVHS held hearings in Silver Springs, Maryland on November 19th and 20th, 2003. The hearings, the first of several to be held over the next year, were intended to gather information about the effect of the privacy rule on public health, research and health care providers, health plans and consumers. In general, witnesses at the November 2003 hearings reported less anxiety and confusions about complying with the privacy role than did witnesses at NCVHS hearings in 2002.
"Several witnesses said that materials posted on the web site of the office of civil rights, OCR, were helpful, but they also stressed the need for OCR to expand its outreach and public education activities so that the privacy rule can be implemented effectively. It was noted that not all covered entities and consumers have access to the Internet."
DR. LUMPKIN: Okay. Any questions or concerns about the introductory paragraph?
MR. HOUSTON: I had one in particular. In the last paragraph that I read regarding NCVHS hearings in 2002, I am wondering whether it might, rather than saying 2002, simply say prior to the compliance deadline for the privacy rule, because it sort of positions before versus after the deadline in a more straightforward fashion than 2002.
DR. LUMPKIN: Mike.
MR. FANNING: Excuse me. Wants the text to strike in 2002 and insert prior to the compliance --
MR. HOUSTON: Prior to the compliance deadline for the privacy rule.
MR. FANNING: Thank you.
DR. FITZMAURICE: On the second paragraph that starts out, "The Subcommittee on Privacy and Confidentiality," the second sentence says, "The hearings, the first of several to be held over the next year," it is hard to have something and say it is going to be part of the next year. I would say, "The first of several to be held over" and insert "a 12 month period," striking the next year.
DR. LUMPKIN: How about just first of several to be held.
We will proceed on to the public health -- let me just get an idea. For those who have read this, are there enough concerns paragraph by paragraph or do we want to read the whole thing and then just take -- let's do the section by section.
MR. HOUSTON: "Paid public health. The privacy rule explicitly permits disclosure of protected health information, PHI, for public health purposes without need for an authorization. Accordingly, the main public health issues involve covered entities that misunderstand the privacy rule and limit their disclosure and their coordination of the public health provisions of the privacy rule with other provisions.
"In general, the witnesses stated that misunderstanding of the privacy rule by many covered entities was adversely affecting the reporting of notifiable conditions to public health officials. At least one witness suggested, however, that some covered entities were merely using the privacy rule as an excuse to avoid the burden of public health reporting.
"Of course, it would be difficult to assess the motivation of a covered entity for being reluctant to make reports to public health officials. One of the witnesses representing the Council of States and Territorial Epidemiologists, CSTE, testified about a CSTE survey of state and territorial public health epidemiologists and Centers for Disease Control and Prevention bioterrorism grantees on syndromic surveillance systems.
"Thirty-five percent of the respondents said that the privacy rule had caused major obstruction or delay in disease reporting and 25 percent said that their disease reporters, health care providers, had a significant problem with the privacy rules requirement that covered entities account for disclosures.
"Immunization is another concern. Often, school nurses need immunization information to assess compliance with state laws requiring immunization as a condition of enrollment in school. State laws vary on whether a school is considered a public health authority and whether immunization records may be shared without the authorization of a parent or guardian.
"In many states providers cannot disclose immunization information to schools without receiving a HIPAA compliant authorization. If authorizations cannot be obtained for any reason, some children receive duplicate immunizations. If OCR indicated that states could designate school nurses as public health officials, the information on immunization could be released without need for an authorization, thereby benefiting the children.
"With regard to accounting for disclosures, the reporting of suspected cases of abuse and neglect has been a particular concern for social service agencies. In many states, agencies receive reports of suspected cases of child abuse or neglect are prohibited from disclosing the report or the name of the individual or entity filing it. The state prohibitions on disclosure, however, apply only to the recipient of the report and do not extend to health care providers, such as hospitals that file them.
"Under HIPAA, an abusing parent acting as the personal representative of the minor child may obtain an accounting for disclosures and learn of the report. This has the effect of discouraging the filing of reports of suspected abuse and neglect. An exception to the accounting for disclosures requirement for reports of suspected abuse and neglect would eliminate this problem."
DR. LUMPKIN: Okay. Let's split this up into three sections for discussion. The first one is just the factual discussion of the fact that the major obstacle of public health is in the privacy rule's misinterpretation, whether intentional or unintentional by potential reporters. Any comments on that first section, first couple of paragraphs?
Don.
DR. STEINWACHS: In the last line of the first paragraph, I didn't quite understand what coordination -- I understood limiting disclosures, but --
DR. LUMPKIN: Accordingly, the main public health issues involve covered entities and misunderstand the privacy rule and limit their disclosures and the coordination of public health provisions of the privacy rules with other provisions.
MS. GREENBERG: I think there needs to be a comma or something after disclosures because I was having trouble with that.
MR. FANNING: I had to read it a few times. That is the correct thing. The verb in front of coordination is involved, not limit. Possibly, the sentence could be polished up a bit just to make that clearer. I don't think there is any point in drafting it out loud here, but the intention is clear and we will make it easily readable.
DR. FITZMAURICE: With regard to that same sentence, what are the two different public health provisions that need to be coordinated of the privacy rule or with other provisions of the privacy rule. It reads to me like people looking at one part of the privacy rule and we are looking at another part of the privacy rule, being with public health and they are not coordinated. I don't know what that means.
MR. HOUSTON: I think the intent was to coordinate with other provisions of the privacy rule, such as accounting of disclosures and things of that sort. I believe that was the intent.
DR. FITZMAURICE: With you saying that, that makes it clear. Thank you.
But I have another question.
DR. LUMPKIN: Okay. Go ahead.
DR. FITZMAURICE: The next paragraph, the last sentence, "Of course, it would be difficult to assess the motivation of a covered entity...," I would put a period right there. At the bottom of the next paragraph, the one that starts "In general," the sentence is "Of course, it would be difficult to assess the motivation of a covered entity for being reluctant to make reports to public health officials." Because we might want to take that sentence out. It would be impugning --
DR. LUMPKIN: It is sort of redundant to have the -- okay. That is an editorial kind of thing. The thought is is that -- well, the first sentence above it says at least one witness suggested, however, that some covered entities were merely using the privacy rules as an excuse to avoid the burden of public health reporting. Then it would read, of course, it would -- actually it is difficult to assess the motivation of covered entities period.
MR. HOUSTON: Do we take out the whole sentence or just the --
DR. LUMPKIN: Well, the problem is is that the disclaimer on the first one, one witness alleged that. We think it is important to report it, but we are not going to impugn covered entities. It was because, you know, there was a lawyer in the meeting.
DR. COHN: I guess I am a little confused. I can't exactly see what you are doing here. You are leaving some of that last sentence?
DR. LUMPKIN: We are making a suggestion to the subcommittee on how to redraft that.
DR. COHN: I guess another way of handling it would be getting rid of the entire last sentence and changing "were" and then the sentence above "or might be using."
DR. LUMPKIN: Yes, softening that statement.
DR. COHN: I take a little bit of umbrage at this one, but it is --
MS. GREENBERG: Change this to some covered entities might be using the privacy rule and then leave out the last sentence.
DR. HARDING: It is pretty hard to hear what you all are saying.
DR. LUMPKIN: No, because actually you are bringing it back tomorrow. So, rather than trying to -- we are not going to try to wordsmith it, but I think as long as you understand what the issue was --
MR. FANNING: What is the choice now? What is the direction of the committee? Is it to strike the last sentence or is it to strike all after "entity"?
DR. LUMPKIN: It is to clean it up. We kind of agree with softening the statement that is made.
MR. HOUSTON: Here is what I think is -- the second to the last sentence simply says at least one witness suggested, however, that some covered entities might be merely using the privacy rule as an excuse to avoid the burden of public health reporting period. And then strike the following sentence.
MS. HORLICK: I like that.
DR. LUMPKIN: Anything else on the reporting issue?
Let's go on to immunizations. Michael. We are kind of walking through the public section. Immunization.
DR. FITZMAURICE: Right above there, the one that says 35 percent of respondents said that the privacy rule --
DR. LUMPKIN: Oh, sorry. Still on public health. Go ahead.
DR. FITZMAURICE: -- caused major obstruction and delay in disease reporting and 25 percent said that their disease reporters, health care providers had a significant problem with the privacy rules requirement. Significant problem, we don't exactly say what the problem is. I would offer a suggestion that the problem with the burden of the privacy rules requirement. Now, maybe it is more than burden, but my sense was that they had a problem with the burden of the requirement. Too much trouble. Therefore, you just don't want to do it.
MS. GREENBERG: Is the burden created by the privacy rules requirement?
MS. HORLICK: Yes, I like that.
DR. LUMPKIN: Is that true, though?
MR. HOUSTON: There is a discussion later in the letter, which describes accounting of disclosures. Okay.
DR. LUMPKIN: I just wanted to be careful because we are kind of editing the summary of testimony and I just wanted to make sure that we were being --
MR. FANNING: I think we would have to go back to the testimony. Now, this is sufficiently general that it doesn't go into detail about what the exact grievance is. Do you want to leave it that way or do we want extract from the testimony that pins down the issue.
DR. FITZMAURICE: I think it is well-explained later on, but the question here was we raised a problem and we don't see what the problem is, by putting "burden" in there --
MR. HOUSTON: Can I --
DR. FITZMAURICE: -- communicate what the problem is.
MR. HOUSTON: Maybe if we defer just until the end of the letter and then go back to this because there is a paragraph that describes in a little bit more detail what the burden of the accounting disclosures is or we move it up, either one of the two.
DR. LUMPKIN: But since it describes it as a burden, I think Michael's point is that we say -- had a significant problem. I think what he is trying to say is that the problem is burden, but we don't say that. So, we kind of leave it hanging. So, we could just add in and say that 25 percent of the disease reporters have a problem with the burden of reporting, which I think is the intent. Then we can leave the two paragraphs separate.
MR. HOUSTON: I am sorry. I thought we had already decided we were going to put that burden language in.
DR. LUMPKIN: Never mind. We are all on the same page. It is page 2.
Anything else on the public health reporting part?
Okay. We are going to move on to immunization section, that paragraph.
Gene.
DR. LENGERICH: A couple of things in the second last sentence where it says, "If authorizations cannot be obtained for any reason, some children receive duplicate immunizations." Is there any estimate of what that some is? And I suppose some already do even without this process and then is it more than just duplicate? Are these inefficient, harmful, unnecessary?
DR. LUMPKIN: I think that unnecessary is certainly the case but I think that probably that can be softened -- may receive.
MR. FANNING: The summary of the meeting says, "Some children receive duplicate immunizations --
MS. HORLICK: This is Gail. I think that it is accurate to say that some children do. I don't have any sense of the numbers on that. I mean, there are clearly children that receive duplicate immunizations because they don't have access to the records, but I don't know if you want to soften it anyway because I don't know how often that is happening, but it definitely is happening.
DR. LUMPKIN: Well, kids definitely receive multiple immunizations, but the issue is as this sentence implies that because they don't get the authorizations --
MS. HORLICK: The provider can't disclose the records. So, they give them the shot again so they can go to school.
DR. LUMPKIN: Or the parent may not have the record. I mean, there is any number --
MS. HORLICK: Right. That is true.
DR. LUMPKIN: So I think that by softening it, we don't imply that there is a one-to-one correlation cause and effect, but it certainly contributes to the problem that results in kids getting multiple duplication.
MS. HORLICK: Well, that is fine. I see that.
MR. FANNING: I am not sure how you would soften it. It is a fairly straightforward sentence. Describe the factual event; namely, testimony to that effect.
DR. LUMPKIN: But if authorizations cannot be obtained for any reason, some children may receive duplicate immunizations. We are not actually summarizing testimony in this line. We are actually summarizing the conclusions on the Hill.
MR. HOUSTON: We say testifiers indicated or --
MS. GREENBERG: No. They indicated they do receive them.
DR. LUMPKIN: Okay. So, you could say the testifiers stated that they believed that -- or whatever, stated, and that takes it off.
I have actually a little bit of concern about the construct and I was trying to work through this as I listened to this issue. HIPAA provides -- actually I am thinking when it voids the preemption, floor preemption to state law. As such, state law governs whether or not the restrictions on movement of personal health information from a clinical setting to a school nurse. So, HIPAA says -- if HIPAA were to say that is okay and state law says "no," it is not, it doesn't really matter because state law will then govern.
So, if we are concerned that state law is prohibiting in some states movement of immunization information to school nurses. Making a change at the federal level will have no impact.
MR. ROTHSTEIN: John, this is Mark. I think the problem is that states don't realize what is going on necessarily and if the Secretary could indicate that the states might want to take a look at their state law and see if it does permit this disclosure, that then the state, if they chose to, could eliminate this problem.
DR. FITZMAURICE: The state could also say that within the privacy rule if disclosure of information is required by law, by state law, the privacy rule does not override that. So, you can disclose it. If the state were to say we require by law that you immunize the students and so along with that, we require by law that you look to see if they have had other immunizations. So, that disclosure is required by the immunization law already. But if you don't state it specifically, it would have to take an OCR interpretation of that communicated to the states, maybe a Q&A.
MS. HORLICK: I think some states are interpreting it that way but other states are not.
DR. LUMPKIN: Well, you know, the difficulty I had is I spent three separate years in Illinois with the legislature trying to change the law, allowing immunization information to go from the public health system to the schools. They clearly did not want that to happen. I mean, it wasn't any ambiguity. They didn't misunderstand. They just didn't want immunization information without the parents consent going to the schools.
So, in a sense, you know, I totally agree with this principle and I agree with the concept, but are we trying to make immunization -- are we trying to make state policy or are we trying to clarify federal policy? So, that is my concern around that paragraph as much as I think it would be neat if that could fix the problem.
DR. FITZMAURICE: I think you raise a good point. If it is a matter of confusion, then I think what is here and my suggestion could clarify it, but if it is not confusion, they simply don't want that information moving. They want to protect the privacy of the individual. A judge might rule that that was more restrictive and, therefore, more protective of the individual's personal health information, even if it didn't protect the person's health.
DR. LUMPKIN: So, actually what we are looking for is clarification at the federal level that HIPAA privacy does not -- should not stand in the way of immunization information being provided to schools.
MS. GREENBERG: It may currently, unless the school nurse is considered a public health authority.
MS. HORLICK: Yes. The interpretation in a lot of the states is that because -- if it is not provided for treatment purposes, then they can't disclose to the school without an authorization.
DR. LUMPKIN: Okay. I think that -- I am going to remove my objection and let it go forward this way in that it may have a potential of doing some good and for those states where they are just bone-headed about it, since I don't live there anymore, it is not going to do any harm.
DR. COHN: Actually, I am sort of buying in, I think, to some of your comments, which is No. 1 that there needs to be probably some reflection that the suggestion here is necessary but not sufficient, which is I think what you were trying to say. I think that that is something that somebody needs to realize. This won't solve it in and of itself. I guess I am going back actually to the earlier piece, which is -- I mean, I think that the whole disclosure piece is a barrier. I am trying in my own mind to think of the fact case where, you know, patients don't get immunizations without some parental involvement, at least to my knowledge.
Now, the issue around immunizations is that people can't attend school unless they have appropriate immunizations. So, this creates a tremendous bottleneck, but if you were a parent and having to deal with the patient anyway and going and getting things -- I guess I am trying to think of what the barrier remains on that one. If you are already having to be involved and it is your choice about whether to sign an authorization for disclosure versus getting the kid a duplicate immunization, I am sort of -- still, I guess, I am thinking back on the testimony and trying to figure that one out.
One of the Johns, do you have a comment on that one? Am I missing the point here?
DR. LUMPKIN: I think your point is is that if the parent has a choice between getting a second immunization and signing an authorization, most parents would sign an authorization.
[Multiple discussions.]
MR. HOUSTON: -- is that it was very difficult in certain cases to have parents be responsive in any way, shape or form, whether it be to sign an authorization or getting a duplicate --
MR. ROTHSTEIN: Can't hear, John.
MS. HORLICK: Yes, we can't hear.
MR. HOUSTON: -- and that there were other cases where if the records weren't available -- I recollect at least in this last testimony we heard not too long ago, that, you know, that the school nurse was indicating that parents were driving hours in certain other cases either to get an authorization signed, especially where they are out in a rural area, where a physician office may not be close by. So, I think there were some concerns over all that just operationally you could solve by simply making these
people --
DR. COHN: I actually agree with what you just said. It is just that that doesn't say that here. What I was sort of thinking was is that the real issue here is is that it is, you know, a tremendous bottleneck. It is a tremendous hassle. Once again, my understanding -- and once again, I only have to speak for the state that I live in, but unless you have your immunizations, you weren't allowed in the school. So, it becomes sort of a major barrier there and that that is really sort of the issue.
It isn't that -- I mean, I guess people could choose to get duplicate immunizations, but, once again, as I said, you know, if you are a parent and you are being told that you can't go to school if you don't get the immunization or sign a disclosure --
MS. GREENBERG: The problem is I think it had to be a HIPAA --
MS. HORLICK: -- that they couldn't even do things by fax, but that was the clarification issue, but I think the major issue, my understanding is that for a lot of these parents in New Mexico particularly we heard these concerns. These were just parents that couldn't take off from work, couldn't go to the doctor, wasn't sure who had their records and maybe the information was in the doctor's office. The parent was willing to sign whatever they could, but because of all these logistical problems, the child was either getting duplicate immunizations or not being able to start school.
MR. HOUSTON: I recollect, again, this later testimony, though, that there were still problems in getting parents to even go and resign authorizations. So, there is a variety of issues that --
DR. COHN: I withdraw that. We will deal with it in the subcommittee level.
MR. HUNGATE: It is a procedural question on my part. It has been a long time since my kids got immunized. So, I am not current, but isn't there a consent form that the parent signs at the time of immunization? Isn't there some formalization of the authorization for immunization? And couldn't the disclosure be included as part of that so that it was done, the decision made at the time of immunization?
DR. LUMPKIN: Well, it could be if the parents so chose to do that, but giving authorization to release the data is not a co-condition for getting the vaccine. So, parents may choose not to sign it. Providers may choose not to have that form filled out.
This is tied in with -- in fact, a number of states have immunization registries, if not the vast majority of them because the CDC has been actively funding these. Another complexity to this, which leads me to say that I think this is fine, let's just go with it, is the fact that states that operate immunization registries could choose to provide that information to schools because they are actually mixed entities. As such, the entity that collects the immunization registry data is generally not a covered entity portion. So, the information is no longer in the HIPAA domain.
MS. HORLICK: John, that is probably true for most every case, but there are probably six or eight states where the entire state health department -- New Mexico, I believe, is one of them -- is a covered entity.
DR. LUMPKIN: And that is the reason why I think we should go ahead with it. Is there anybody here from New Mexico, who can stand up for their state? Jeff. Okay. Jeff was silent.
So, I think we are kind of -- okay. We see that there are limitations, but we think this may be the best way to deal with it.
Anything else on immunizations?
Okay. The last issue is on abuse and neglect. Any comments on that? My only concern on this one -- and I just don't know how to do it -- maybe we should do it in a summary -- this one is a bright light issue to me and I suspect would be to the Secretary. We just need to make sure that this issue doesn't get lost in this letter because this is one that probably will drive quicker action than anything else we raise.
MR. HOUSTON: There is a bullet point in the summary, third bullet point down in the summary. I think these were sort of taken in order of --
DR. HARDING: Please speak into the mike.
MR. HOUSTON: I am sorry. The third bullet in the summary really does describe this and I think the bullets were sort of added sort of in the order in which they were placed within the letter. But, I mean, we could expand or potentially move that up. In fact, if you wanted to try to emphasize this in the summary --
DR. LUMPKIN: Well, I suspect that our conversation here with our federal partners, some of whom might be charged with answering the letter once we send it will, I think, serve to highlight that point. So, I think we can leave it the way it is. But I think it is important for us to note that this is an issue -- the issue of children being abused and our protection as a nation is a very important issue, one that is considered very highly. So, this point here is not the same, I think, level as all the other points that we raised, as serious as they are.
Okay. Anything else on that?
MS. HORLICK: John, I just want to say that I need to sign off now, but I will call in for the subcommittee meeting tomorrow.
DR. LUMPKIN: Thank you, Gail.
Okay. Let's go on to research.
MR. HOUSTON: "Witnesses at the hearing provided frank testimony describing the potential detrimental impact of the privacy rules research provisions on research activities. The witnesses at the hearing overwhelmingly supported the privacy rules intent of aligning its requirements with those of the federal common rule for the protection of research subjects, 45 CFR Part 46 (common rule); thereby, promoting consistency and ease of compliance. In some key instances, however, the privacy rule diverges from the common rule in ways that cause either gaps in privacy protection or unnecessary obstacles to research.
"Additionally, due to the considerable confusion, compliance with the privacy rule provisions on research would be helped by clarification of expanded educational activity. An example of the inconsistencies between the privacy rules research provision and the common rule relates to preparatory to research activities. The privacy rule permits PHI to be reviewed by a researcher for the purposes that are preparatory to research without institutional review board, IRB, or privacy board approval and without a patient's authorization.
"Preparatory to research includes such activities, hypothesis, definition, protocol preparation and research recruitment. In fact, according to the department's August 2003 document, institutional review boards and the HIPAA privacy rule, the privacy rule permits a researcher, who is a workforce member of the covered entity, to contact potential research subjects for the purposes of seeking an authorization as part of the covered entity's health care operations.
"Even if such contact could be construed as coming within health care operations, the interpretation permits recruitment of potential research subjects (as an element of research) absent either a waiver from the IRB or patient authorization and thereby violates a fundamental principle of research ethics in the common rule.
"The privacy rule permits an authorization for the use and disclosure of PHI in research to be combined with an informed consent document, although many researchers prefer to use separate documents. According to the same August 2003 publication, the privacy rule does not require IRBs to review and/or approve authorizations either as stand-alone documents or when combined with informed consent documents.
"The permissive nature of this interpretation has created confusion about whether IRBs have the authority or responsibility to review these HIPAA authorizations. Because IRBs are charged with reviewing all written materials provided to research subjects, as well as considering whether privacy and confidentiality protections are adequate. A revised interpretation recognizing the authority of IRBs to consider HIPAA authorizations would promote clarity and help coordinate the privacy rule with the common rule.
"An area in which the diversions of the privacy rule and the common rule results in burdens on researchers involves general research authorizations, under the common rule, subjected to such limitations as an IRB deems appropriate, a research subject may provide informed consent for future unspecified research, including research using biological specimens.
"Under the current interpretation of HIPAA, however, an authorization may not be for future unspecified research and a separate authorization must be obtained for each trial or study. Unless the HIPAA interpretation is changed, it will be exceedingly difficult to compile research repositories, including the collection of biological specimens linked to medical records, which are essential to many forms of research.
"A January 2004 document, "Research Repositories, Databases and the HIPAA Privacy Rule," indicates that a waiver of authorization could be obtained from an IRB, but this additional step further complicates the process. Several other areas related to research also need to be addressed. Genetic researchers are concerned that any DNA sample, even if not linked with an individual, might not be considered anonymous because analyzing the sample could reveal the unique DNA identifiers of the individual.
"Clarification that unlinked DNA samples are not identifiable would resolve the issue. Clarification also is needed on the applicability of HIPAA to indirect participants (individuals who are not research subjects, but whose PHI may be disclosed by research subjects) in multi-institutional studies. The witnesses also identified some areas in need of additional outreach and educational initiatives to counteract the reluctance or refusal of some smaller institutions to participate in research because of misunderstanding HIPAA and the standards for the de-identification of individually identifiable information.
DR. LUMPKIN: Okay. Any comments, questions on the research?
MR. HOUSTON: I do. A couple things that I have on the second paragraph about halfway down, rather than "in fact," I was thinking maybe the word "specifically" might be a better choice of words. The second paragraph under "Research," about halfway down, there is a word "in fact" or words "in fact, according," the very top of page 3.
DR. LUMPKIN: Okay. That is an editorial change.
MR. HOUSTON: Then I did have some changes at the end or this paragraph --
MR. FANNING: Excuse me. Is there a choice to drop the term "in fact"?
DR. LUMPKIN: That is, in fact, the case, if I could be specific about that.
MR. HOUSTON: In its place say "specifically," I would think.
DR. FITZMAURICE: In the copy that I have before me, it has already been done.
MR. HOUSTON: Then you probably printed out the version I sent out to the committee that Mark said that we should not hold on -- this makes things a little easier then. I wasn't sure whether this was going to be distributed because I think Mark had indicated that he would prefer me to just bring the comments up when we discussed it today.
If we are looking at that document, I think from my perspective, the last couple of sentences of that same paragraph, I think, could use some further clarification.
DR. LUMPKIN: They don't change the content, just the wording.
MR. HOUSTON: I believe, though, again -- maybe I should read it and --
DR. LUMPKIN: Please.
MR. HOUSTON: These are the last two sentences of that same paragraph. "Even if such contact could be construed as coming within health care operations, interpretation permits..." -- this is where I added "...the direct recruitment of potential research subjects and element of research by researchers who do not have a preexisting clinical relationship with the patient." Then I had put a period and then started with "Absent either a waiver from the IRB or patient authorization, such practices would violate fundamental principles or research ethics in the common rule."
DR. LUMPKIN: I like your version.
MR. FANNING: Would you please mark it on your text and give it to me so I can incorporate it into this.
DR. COHN: Do you have a copy of this?
DR. FITZMAURICE: One is a minor one that -- at the top, where is says "Preparatory research include..." that probably should be "includes," just with an s at the end of it.
More substantial, the last one -- the one you just read, the even if sentence, it says, "Such contact by the researcher to a potential recruitee could be construed as coming within health care operations, which..." -- the interpretation is -- "...it permits the direct recruitment of potential research subjects, an element of research by researchers, who did not have a preexisting clinical relationship with the patient." I think that is probably false because a researcher can't do that unless the researcher is working directly with the physician, for the physician or if the researcher has a business associate contact for the purpose of contacting the recruitees to see if they would be willing to participate.
It is the same as if the physician is doing it either because of the labor relationship or because of the business associate contract. That is a direct clinical relationship the physician has with a patient and has extended that, have the researcher do something as a health care operation for him.
I disagree with describing it as researchers do not have a preexisting clinical relationship. If the clerk calls me up and says have you had your immunizations and I give that information, is the doctor's clerk now having a preexisting clinical relationship with me? I think it is all covered by being under the rule of the physician.
MR. LOCALIO: This is Russ Localio. I have a problem I think with the way you have revised the text; whereas, I didn't have as much problem with the way it was. Let's assume that a physician has an ongoing clinical relationship, clinical physician/patient relationship with a patient. The physician, the treating physician then wants to recruit the patient for a research study. The way I understand it, the physician would have to have IRB approval to do that contact. It doesn't matter whether the physician is the treating physician or not the treating physician. That needs to be clear because I think your point is here that the way the privacy rules might be interpreted is that they waive the requirement for IRB approval of research.
MR. HOUSTON: No, what it does do is waives the requirement of IRB approval for research recruitment activities, which are preparatory to research.
MR. LOCALIO: Fine. I think we are in agreement on that. I think the way you revised it, it tries to make a distinction between recruitment by the treating physician and recruitment by a researcher, who is not a treating physician and I don't think that is a distinction that should be made. Certainly, I don't think it is a distinction that is made by the common rule.
Research is research very clearly defined by the common rule and requires IRB approval, even if it is the treating physician. So, in other words, the surgeon who wants to do a follow-up of his patients and not simply call up his patients and say, you know, come back, I want to do a research study on these people. That treating surgeon would have to get IRB approval.
MR. HOUSTON: I believe that is correct.
DR. FITZMAURICE: I disagree with the interpretation. I think in order to obtain the patient's authorization, somebody has to contact the patient and who better than the treating physician.
MR. LOCALIO: That is a separate issue. I think here you are just talking about the IRB would have to approve anyone contacting a patient to recruit the patient for a research study. The IRB would have to approve contacting a patient, except --
DR. FITZMAURICE: You mean because of the common rule.
MR. LOCALIO: That is correct.
DR. FITZMAURICE: I don't disagree with that. I am just talking about the privacy rule.
MR. LOCALIO: Now the privacy rule, let's assume that that piece is clarified. The privacy rule would not prevent -- if the IRB approved it, would not prevent a researcher, who was not taking care of the patient from contacting their patient to recruit the patient for research.
DR. FITZMAURICE: One exception. If the patient does not have a business associate contract with the physician or is not the treating physician him or herself, then that researcher is prohibited by the privacy rule.
MR. ROTHSTEIN: -- in front of me the interpretation from the document, clinical research and the HIPAA privacy rule and it -- let me read the entire Q&A, if I may.
Question: If under the preparatory to research provisions, a researcher identifies subjects that meet the study's eligibility criteria, how can the researcher contact the potential participant to obtain authorization after identifying these individuals?
Answer: Under the preparatory to research provision, covered entities may use and disclose to researchers PHI to aid in study recruitment. They may allow a researcher to identify but not contact potential study participants. A researcher may do so without authorization from the individual under the following circumstances. There are two given.
First, if the researcher is a workforce member of a covered entity, the researcher may contact the potential study participant as a part of the covered entity's health care operations for the purposes of seeking authorization. Alternatively, the covered entity may contract with a researcher as a business associate to assist in contacting individuals on behalf of the covered entity to obtain their authorizations.
Second, if the covered entity obtains documentation that an IRB has partially waived the authorization requirement to disclose PHI to a researcher for recruitment purposes, the covered entity could disclose to the researcher the PHI necessary for the researcher to contact the individual.
So, basically what the interpretation through this Q&A does is say that you can solicit -- that is, a researcher can solicit authorizations from individuals before a protocol has been approved by the IRB and because recruitment is considered to be part of research, what this would allow is an element of research to go forward before the IRB has even seen the protocol. That would violate the common rule. That is the point we are trying to make here.
MR. LOCALIO: Well, I agree with the point you are trying to make, Mark. This is Russ Localio again. I agree with the point you are trying to make. It is just that my understanding is the way the proposed language to amend this was inconsistent with the point you are trying to make.
The point you are trying to make is IRB approval is Step 1 and then all the rest of the stuff is Step 2. The point that I thought I heard was that there was a distinction between recruitment done by the treating physician and recruitment done by a researcher, who is not the treating physician. If Step 1 has been completed, the treating physician would have to complete Step 1 and get IRB approval to recruit a patient for a research study that he or she was doing.
MR. ROTHSTEIN: Yes, Russ, I agree with you. The original draft did not even mention a treating physician. That was an amendment that John Houston is offering.
MR. LOCALIO: And, again, I think the original -- I agree with the original language. I have trouble with the amendment because of what I think is a distinction between treating physician and researcher, who is not a treating physician. Both have to have IRB approval.
DR. LUMPKIN: I think that if the subcommittee could get the message that -- I think that we are probably comfortable with the language that is right here and it would be easier not to change it at this point because I think the rest of us are pretty much lost on this one.
Mark, I agree with you.
MR. ROTHSTEIN: Okay. So, we can go back to the original paragraph 2 under B, research.
DR. LUMPKIN: I think that might be the best.
MR. HOUSTON: There is one point, though, that I think, though, is important then, based upon what Russ had stated, I think, is that there is still the issue of IRB approval that it isn't even discussed here, even in the original paragraph.
DR. LUMPKIN: It is and I think that what is missing from this thing, from this document, which I think may make it a lot easier, is under "Research," we should just say we think the common rules should govern and that the first -- that researchers need to comply with the common rule and then look to see whether or not there are any additional requirements that are placed on by HIPAA that doesn't deal with the issue about the separate authorizations. I think that one is an upcoming paragraph. But I think we should probably make that statement somewhere early as sort of a governing concept.
Then this just becomes explanatory rather than a statement of our beliefs.
MR. HOUSTON: When you say the common rule should govern, do you mean that the privacy rule provisions should be eliminated or should -- the common rule should come first and then the privacy rule should then be applied?
DR. LUMPKIN: You should first apply -- you should first comply with the common rule. After you have assured compliance of that, you should then determine whether or not you are also in compliance with HIPAA.
MR. BLAIR: New Mexico agrees with that.
DR. FITZMAURICE: Wouldn't you say you have to comply with both of them and where they disagree, you have to still comply with both of them at the -- if a common rule is more restrictive, then you go with the one that is more restrictive. It is not a matter of which one comes first. You have to obey both of them and where they do conflict, then you need to get a judgment.
DR. LUMPKIN: Yes, and our judgment is the common rule should govern. If there is a conflict between -- well, no, the more restrictive should govern.
DR. MAYS: We do not want them to actually bring up the issue that there is a conflict between the two and that they should go back and try and ferret out where there are conflicts because I don't know that you always want the most restrictive, but you have to really think about the most restrictive may end up creating problems in terms of research or vice-versa may create problems in terms of, you know, burden relative to kind of the clinical operations that go on. I don't know if you always want to say that.
I think it is better to send people off to try and determine when there is conflict that the common rule is the preferred but that they should really go through and try and see where there is conflict between the common rule and HIPAA.
DR. FITZMAURICE: Vickie makes a good point.
MR. ROTHSTEIN: That is why in the opening paragraph to the section on research, we note both that where there is a distinction between the privacy rule and the common rule, one of two things could happen. It could mean that it is a burden on research or it could mean that there is a gap in privacy protection and we have examples of both from the testimony.
DR. LUMPKIN: Okay.
MR. LOCALIO: Following up on that, yes, I think there were examples of both from the testimony because I was at one of the sessions. So, therefore, I would recommend deleting the word "potential" in the first paragraph in "Research." I heard testimony describing detrimental impact.
The degree of the detrimental impact is certainly subject to empirical clarification, but there was definite testimony about the detrimental impact.
DR. LUMPKIN: Okay. Witnesses at the hearing provided frank testimony describing the detrimental impact.
DR. VIGILANTE: Just to help operationalize this for me, the line that says "Authorization may not be for future unspecified research and a separate authorization must be obtained for each trial or study." Does this mean that, for instance, if you --
DR. LUMPKIN: Are you like in the fourth paragraph?
DR. VIGILANTE: I am in the fourth paragraph -- no, third paragraph of page 3.
DR. LUMPKIN: We haven't gotten there yet.
DR. VIGILANTE: Oh, okay. We are going to try to march through so we can sort of finish up on the first paragraph. Anything we drop potential, we will come back to that.
MS. GREENBERG: We added potential. Why are we dropping it. I know where you are, but why are you dropping it?
DR. LUMPKIN: Because Russell commented that they heard actual testimony of real harm that occurred because of the gaps in privacy. So, it is no longer a potential. The sentence says, "The witnesses at the hearing provided frank testimony describing the detrimental impact of the privacy rule on research and provisions on research activities.
MS. GREENBERG: That is different than on privacy. I think there were people who felt that this privacy rule's research provisions could have a detrimental impact on research activities. Do you feel that you heard that they already had had a detrimental impact?
MR. LOCALIO: Yes. Certainly, that is at least the way I interpreted it. I will just give you an example. You have 20 IRBs you have to go through and 10 of them say "no," because this is the way we interpret the privacy rule and 10 of them say "yes," because this is the way we interpret the privacy rule.
That is a detrimental impact on research because you have a biased sample. By the way that is a severe problem in research.
MR. FANNING: Is that the direction of the committee?
DR. LUMPKIN: Yes. We are now back to the second paragraph --
MR. FANNING: Could we just ask -- Mr. Chairman, you said that you wanted a general statement about the relationship between the two rules?
DR. LUMPKIN: I have been shown the lack of wisdom of my statement by my colleagues.
MR. FANNING: Before we leave the first paragraph, we have here joining the staff of the Privacy Subcommittee, Laura Cutcat(?) of NIH, who will suggest some factual issues in the first paragraph.
MS. CUTCAT: Good morning. I also work with OCR in the development of all the HIPAA research and educational materials that have been cited in this letter. I would like to suggest that the federal common rule for protection of research subjects be revised to reflect the accurate title of that subpart, which is Federal Policy for the Protection of Human Subjects.
These policies are codified for HHS at 45 CFR Part 46, not for everyone who has signed on to the common rule. So, we may also want to suggest adding codified for HHS before 45 CFR Part 46, just to be clear on what we mean there.
DR. LUMPKIN: Mindful of the time, I am going to try to suggest a procedural approach to getting through this document. For people who are on the Privacy Subcommittee, which will be meeting tomorrow, if you have editorial changes, please hold those until tomorrow. Let's try to get to the substance of the document as we move forward.
In the second paragraph we kind of had some changes that John suggested, but we are not going to go with those. We are going to sort of stay with the language as it is.
DR. FITZMAURICE: Except for specifically rather than in fact.
DR. LUMPKIN: The second one deals with the separate informed consent, I think, if I am summarizing that correctly, issue. Do we have any comments?
DR. STEINWACHS: You are on the third paragraph?
DR. LUMPKIN: Now on the third paragraph.
DR. STEINWACHS: I found the first sentence in the third paragraph a little bit confusing as stage setting for that paragraph. I was just going to suggest that the committee might want to just eliminate that sentence and just lead into it.
DR. LUMPKIN: I think it is a little bit confusing what the first sentence does is to say, okay, this paragraph is going to be about burdens, burdens on research.
DR. STEINWACHS: I believe you.
DR. LUMPKIN: It may not say that clearly enough. So, if you have some suggestions -- word changes --
DR. STEINWACHS: I was hanging up on the use of separate documents versus one document and it just seemed to me that it was --
DR. LUMPKIN: I don't think the second sentence talks about the burdens on researchers.
DR. STEINWACHS: Are we on the same third paragraph?
DR. LUMPKIN: I am on the fourth paragraph. I really apologize. I am with Kevin. We are on the fourth paragraph.
MS. GREENBERG: Whether IRBs have the authority
to --
DR. LUMPKIN: So, you are suggesting that we just eliminate that first sentence?
DR. STEINWACHS: It seemed a little clearer to me that way, but that is -- you know, as an outsider reading it.
DR. LUMPKIN: Okay. Any problems with doing that?
MR. ROTHSTEIN: Well, this is Mark. I think we need to set up the issue and that was the purpose of the sentence. Maybe we can make it clearer, but --
DR. LUMPKIN: Okay. Why don't we leave that for the subcommittee saying that we want to make that a little bit clearer. Okay.
MR. HOUSTON: Work on rewording the first sentence of this paragraph to make it clearer or a better lead in to the rest of the paragraph.
DR. LUMPKIN: Okay. Anything else on the third paragraph?
DR. FITZMAURICE: There was an issue that came up and resulted in a letter from the Secretary from OCR back to some group. The issue was that for FDA clinical trials, IRBs were reviewing both the informed consent and the authorization and it was taking up a lot of time and burdensome for research. The result of the letter that went out said essentially, yes, you are charged with reviewing informed consent, but you do not -- there is nothing that obliges you to review the authorization form. That was to reduce the burden on IRBs and to reduce the burden on researchers. I think that they already -- IRBs can already consider whatever they want to consider before they give the imprimatur because they already can. I am not sure I see what is required by this.
They have the authority to do anything they want. They are not required to by the privacy rule, to look at authorizations. But if they think they need to in order to protect the information, then they can.
MR. ROTHSTEIN: Well, the issue was that there is from the testimony great uncertainty among IRBs about what jurisdiction is and we thought that including this tier, that the relief we are seeking is only a clarification that IRBs have this authority and I think this is something that the Secretary's advisory committee will be taking up as well.
So, this will be sort of the HIPAA side of the same issue to try to clarify for IRBs what their jurisdiction is.
DR. FITZMAURICE: So, are you asking, Mark, that the department interpret the privacy rule as requiring the IRBs to look at the authorizations or allowing them to look at the authorizations?
DR. MAYS: Partly what I was going to say is that based on what you just said, it might be helpful to actually have a statement in there that then the IRBs would know that they are not required to do it. I think what it seems like the committee is trying to do is to let IRBs know that based on the typical and customary act of wanting to see everything that they can and that HIPAA doesn't prevent it, but I think it would be helpful in terms of the IRB burden for them to know that they should not feel obliged to do it because of HIPAA.
MR. HOUSTON: I don't think that was the point, though. I think the point was that this paragraph was intended to provide the state with the fact that the IRB should have the authority if they so choose to be able to. I mean, the difference between being obliged, having the right and having the authority, authority says that if somebody -- a researcher is working within an institution and the IRB of record decided that it has the authority to oversee and review all of these materials, then that researcher would be required to go through the IRB and have all those materials reviewed, rather than the thought that the IRB may not have the mandate to be able to review those materials and, therefore, the researcher could decide him or herself whether to have the IRB review those materials.
DR. LUMPKIN: Let me just suggest that if you look at the recommendation that generates from this paragraph, this paragraph really states the problem. The recommendation on page 4 says, "HHS should clarify that IRBs have the responsibility to approve stand-alone authorizations for research.
When you read the paragraph, it states the problem. The solution is not saying that they have to. It says whether or not the issue that is raised in the paragraph -- it is that they are unclear about their authority.
DR. FITZMAURICE: I don't see anything that gives them that responsibility. They have the right --
DR. MAYS: Right. I was just going to say now it is totally different. Here is the recommendation that has the responsibility. They have the right, but HIPAA doesn't make them have more responsibility.
PARTICIPANT: Maybe we should change "responsibility" to --
DR. MAYS: Yes, I think that would be good, yes.
MR. FANNING: This is -- to the recommendation?
DR. FITZMAURICE: It looks like it is encouraging IRBs to look at all the authorizations. That is burdensome.
MR. HOUSTON: I think Mark needs to weigh in on this one. Mark, could you -- Mark, was I correct in what I thought we were trying to do, which was to grant the IRBs the authority to be able to have the oversight of all materials? Correct?
MR. ROTHSTEIN: We can't as a subcommittee or even a full committee tell IRBs what to do. The Secretary might. In trying to act on recommendations from the Secretary's advisory committee, as well as our committee, say that they ought to do that or are required to do that.
At this point, I think the authority language is fine and maybe when the Secretary's advisory committee letter gets to the Secretary, the Secretary may want to strengthen that and change it from authority to, in effect, require.
DR. LUMPKIN: Okay. Before we -- I have to ask one question because as I have been hearing the discussion, the role of the IRB is to assure that any individual, who is a subject of research, is adequately protected and their privacy is protected and that is the purpose of the consent that they give that is reviewed by the IRB.
If that consent is adequate for IRB purposes, why are we concerned about the HIPAA privacy authorization, because the researcher has to comply with the consent that is given in both. As long as they have -- if the one that is by the IRB is more restrictive, then it doesn't really matter what is in the HIPAA one.
If one is looser, because the IRB is comfortable with it, then the HIPAA one is going to apply because it is not a research issue. It is a HIPAA privacy.
MR. ROTHSTEIN: The problem as described that I am hearing, John, is that many institutions do not use a single form, although they may, for an authorization and informed consent document. So, where there are two documents, the IRB clearly could pass on the authorization, the stand-alone authorization. Some IRBs feel that they don't have the authority to rule on the authorization because it comes under HIPAA and, therefore, they only approve one and the researcher is left in limbo because the authorization that is a separate document has not been approved by anybody and without an approved authorization, we are told that they are having trouble getting access to PHI.
MR. FANNING: Mr. Chairman, I think what the recommendation here is, the Secretary should make clear that just because the HIPAA rule does not require IRB or privacy board review of an authorization form doesn't mean that the IRBs can't address that issue. Is that not the point, Mark?
MR. ROTHSTEIN: Correct, yes.
DR. FITZMAURICE: And I would answer that, but they don't have to.
PARTICIPANT: Right. That is why authority is a good word.
DR. LUMPKIN: But my question is --
DR. FITZMAURICE: They have criteria that they have to look at, applied to the research. If to meet that criteria they want to look at the authorization, they darn well can look at it. But the authorization is a legal document and if it meets the legal requirements of the HIPAA regulations, then it is OCR's purview that either does or doesn't.
DR. LUMPKIN: But let me understand because I am trying to figure out why we are in this morass and it is taking up a lot of time. I understand the conflict, but is it a HIPAA conflict or is it an IRB conflict? Because our charge is not to advise the Secretary in relationship to IRBs, except as to the extent that there is a conflict.
Now, are we uncomfortable from a HIPAA viewpoint that IRBs are uncertain about their authority to review HIPAA authorization?
MR. HOUSTON: And I would say "yes," because IRBs are specifically mentioned in the privacy rule as having certain oversight rights or at least can be involved in the oversight of the privacy rule with regards to research.
DR. FITZMAURICE: They can look at anything they want to to make sure that the privacy of that information is being safeguarded.
MS. GREENBERG: Would it be correct to say HHS should clarify that nothing in the privacy rule precludes IRBs from approving stand-alone authorizations for research?
DR. FITZMAURICE: And I would add to that "or requires." It doesn't require them.
MS. GREENBERG: Nothing in the privacy rule either precludes or requires to approve stand-alone authorizations.
DR. FITZMAURICE: Mark, how do you feel about that?
MR. ROTHSTEIN: That is fine with me.
DR. LUMPKIN: Paragraph 4.
MR. HOUSTON: There is only one -- this is a clarifying comment. The sentence that starts, "Unless the HIPAA interpretations change, it will be exceedingly difficult to compile research repositories..." I think there should be a comma after repositories.
DR. LUMPKIN: We are going to leave commas for the committee, subcommittee. I don't think there is any objection to that.
DR. FITZMAURICE: On the sentence that says, "Under the current interpretation of HIPAA, however, an authorization may not be for future unspecified research and a separate authorization," I would add after that or IRB or privacy board approval, must be obtained through a trial or study.
DR. LUMPKIN: Read that again.
DR. FITZMAURICE: "Under the current interpretation of HIPAA, however, and authorization may not be for future unspecified research and a separate authorization must be obtained for each trial or study." I would insert and a separate authorization or IRB/privacy board approval must be obtained for each trial or study. Because you don't need authorization if you have IRB or privacy board approval to get access to the information.
MR. ROTHSTEIN: Well, that is what the last sentence goes to clarify.
DR. FITZMAURICE: But you can clarify it right there in that middle sentence so that people don't get misled.
PARTICIPANT: That was one of my concerns.
DR. LUMPKIN: Okay. We are going to add that in.
DR. VIGILANTE: Just for clarification, is the -- the next sentence that says, "Unless HIPAA interpretation is changed, it will be exceedingly difficult to compile research repositories, including the collection of biological specimens linked to medical records, which are essential to many forms of research." Does this include, for example, linking de-identified genomic data to de-identified tissue to de-identified clinical variables, such as, you know, the nutrition of this particular subject, the co-morbidity, survival, but linking all their elements, but having them all de-identified, is that viewed as problematic?
MR. ROTHSTEIN: If they are all de-identified, that would not be a problem. However, we also received testimony that we get into the next paragraph, that some genetics researchers think that even sort of anonymous DNA samples are not, quote, de-identified because it is the ultimate identifier and could be sequenced to identify only an individual. We are trying to, you know, clarify that in the next paragraph, but I think your concern is one that has been expressed to us by researchers and in the testimony.
DR. VIGILANTE: But the position of -- the current position, is there clarity around that or not? In other words, if you de-identified the tissue, if you have tissue samples linked to DNA, linked to clinical outcomes and they are all linked to each other but they are all sufficiently de-identified. Is that seen as problematic?
MR. ROTHSTEIN: I think the interpretation of the rule would say, no, that is not a problem. Researchers, I think, are mistaken and that is why we call in the next paragraph for clarification that de-identified genetic material is not, quote, identifiable.
DR. LUMPKIN: Okay. I am going to do a little bit of a reality check here because we still have a fair bit of the document to go through. What I am going to suggest is that because the Privacy Subcommittee is meeting tomorrow morning, there are no other conflicting subcommittee meetings and I wonder if we would feel comfortable with having this discussion continue tomorrow morning at 8:30 and then having those parties who are interested or have additional comments to make about the document, bring those to the subcommittee meeting tomorrow morning for -- bringing the document back to us in the afternoon.
MR. BLAIR: So, we are not precluded from attending, but we are not required to.
DR. LUMPKIN: That would be correct.
DR. STEINDEL: John, the only problem that I see with that is that we have arranged for some of the new members to go to Hyattsville for badge photographs at that time, assuming that there would be no conflicts.
DR. LUMPKIN: Then I would ask those who have additional comments and concerns, perhaps to share those with John, if they are going to be going out and getting the -- because we do have a full agenda for the two days and I don't think we can continue to delve into this. Obviously, there are some issues that -- and I don't want to make a slight because I think that some of the work, including the commas, are important clarifications and we don't want to because of the press of time to minimize that input.
I think having fuller time at the subcommittee will do that.
MR. HOUSTON: The only thing I would ask if they come to me, that probably we should have John Fanning around also.
MS. GREENBERG: If you have a cell phone on your route out to Hyattsville, you could call in to the meeting.
DR. LUMPKIN: No, this is like the good old days with the Privacy Subcommittee. Only the older members remember those days, back before we had a proposed rule.
Okay. We are scheduled -- we are going to take a ten minute break and then we are going to come back with our special panel presentation.
[Brief recess.]
DR. LUMPKIN: Let's reconvene. There are a couple of lessons for those of you who are new or relatively new to the committee. First is, as Kathy Coltin can tell you that and Lisa Iezzoni, who were members of the committee, is that if you are involved in a major project even though you cycle off the committee, you may not be able to get away as quickly as you think.
As two of our next panelists will tell you that even though you are gone, you are never really gone. We have a panel that is going to begin to address the issue of the health statistics for the 21st Century, which all of you have in front of you. It is a major report of our committee, which Dan Friedman took the lead on and sort of hammered through, despite all sorts of major obstacles.
We appreciate that. So, we have a panel. I am going to ask the panel members to introduce themselves. I don't think I know the order. Dan is going to go first and Carl is going to go last. So, by process of elimination, Barbara Starfield is going to go in the middle. Just a brief introduction again, although we had introductions in the beginning.
Agenda Item: Health Statistics for the 21st Century
DR. FRIEDMAN: I am Dan Friedman --
DR. LUMPKIN: And as you know before, I always interrupted you and said can you speak into the microphone for the people on the web.
DR. FRIEDMAN: I thought that I was.
I am Dan Friedman. I am a consultant in population health information based in Massachusetts and a former member of the committee.
DR. STARFIELD: I am Barbara Starfield. I am on the faculty of the Johns Hopkins School of Public Health and a former member of the committee.
DR. VOLPE: I am Carl Volpe with WellPoint and I have never been a member of the committee. I am going to be talking about the private sector view.
DR. FRIEDMAN: John, how long would you like me to -- about how long would you like me to speak for?
DR. LUMPKIN: We are scheduled to go until 12:30. So, I think the betwixt the three of you, if we could look at maybe 15 minutes apiece.
DR. FRIEDMAN: Before I get started, let me mention that -- let me emphasize that any of the obstacles or barriers that John alluded to in developing this report in no way resulted from either other members of the committee or staff to the committee because, first of all, I and the other people who worked on the report really appreciated the collegiality and the support from both the committee members and the staff, which was really just super, as well as from NCHS, which was a partner in developing the report and the Data Council, which is also a partner.
I am going to speak about three things. First of all, at Marjorie Greenberg's request, I am going to provide a brief summary of the 2002 NCVHS report on shaping a health statistics vision for the 21st Century. Marjorie asked me to do that. I will try to keep it very brief. Marjorie asked me to do that because there has been the addition of several new members since Barbara and I cycled off and since the committee was released.
Second, I am going to present a very brief overview, very brief, of state health data systems within the context of the report.
Third, I am going to build on the report and to describe three very simple tactics for addressing some of the issues around state health data systems. Even though the discussion is going to focus on state health data systems, let me add that some of these issues really could apply just as easily to national and federal systems. You have the report in front of you. One of the things that the report did, which was very brief and very simple, but we thought was very important, was for the first time actually define health statistics in the public health literature.
The report defines health statistics as numerical data that characterized the health of a population and the influences and actions that affect the health of a population. What is important here, the take-away point, as it were, is that our definition of health statistics focuses on population health.
We also defined the health statistics enterprise as the infrastructure and activities necessary to produce health statistics. In this country, that includes public and private organizations and individuals at all geopolitical levels that perform the processes of health statistics. Again in this country in particular, it is a very decentralized enterprise and it includes organizations that collect, analyze and disseminate data on the health of populations and the factors that influence health.
The mission of the enterprise, as it is defined in the report, is to efficiently provide timely, accurate and relevant information that can be used to improve the nation's health. Again, a focus on population health as the core part of health statistics.
One important part of the vision that we laid out in the report is the need for an overarching conceptual framework for health statistics, an overarching population health conceptual framework. In the report, we emphasized that that conceptual framework is important because it helps to focus the enterprise on needed data and it helps to guide the enterprise in identifying new and emergent issues. It focuses on health, the population and the community, rather than on solely much more proximate influences on the population health.
It emphasizes the distribution and level of health rather than just average health, delineates major influences on health and helps to define a research agenda for improving the population's health. In the report,we lay out a conceptual framework schematic. Barbara and I happen to like this schematic. At the same time, I think what is -- I don't want to speak for Barbara anymore -- I happen to like this schematic. Having said that, there are other schematics that perform exactly the same functions and the functions are basically laying out in an easily accessible fashion what are hypothesized influences on the health of the population. Here, we include a variety of community attributes, contextual influences, including the natural environment, the cultural environment and the political context.
The report includes a more detailed version of this. The report also includes ten guiding principles for the health statistics enterprise. I am going to run through these extremely rapidly with almost no commentary.
First, enterprise-wide planning and coordination. Second, broad collaboration among data users, producers and suppliers at all geopolitical levels.
Third, rigorous policies and procedures for projecting privacy, confidentiality and security. Fourth, flexibility to identify and address emergent health issues.
Fifth, use of data standards. Sixth, sufficient detail at different levels of aggregation. Seventh, integrated streamlined data collection for multiple purposes.
Eighth, timely production of valid and reliable health statistics. Ninth, appropriate access to and ease of use of health statistics.
Finally, continuous evaluation of the data.
Now, let me spend just a few minutes on state data systems. What I am presenting very quickly are an overview of archetypical state data collection systems. This is not an average picture of all state data systems. It is not a modal picture but it is based upon my own personal knowledge. It is based upon information that I collected from several states and I am going to -- very, very quickly -- I am not going to read everyone of these, but I am going to quickly run through it.
What is important to notice here, it starts with claims and billing, client case management, AIDS treatment, WIC within claims billing, from AIDS treatment to WIC within client management to each of these bullet points in most states are separate and discrete data systems, not in all states, but in most states. Each bullet point is a separate industry, discrete data system.
Now we can move on to your reports and then to encounter data. Again, each of those sub-bullet points are separate and discrete data systems. Environmental health data, asthma to water quality. Facilities surveys and reports, each of those bullet points for data systems. Licensure, health facilities and services. Licensure, health professionals, everything from acupuncturists -- I left off here, tatoo artists, but in those states where they are licensed, they are also usually a separate data system for tatoo artists, veterinarians, podiatrists, et cetera.
Occupational health, population-based surveys. Again, each of these -- the behavior risk factor surveillance system, community health surveys, HIV family of seroprevalence surveys, PRAMS, pregnancy risk assessment monitoring systems, youth risk behavior surveys, discrete data systems. Professional association memberships, registries, reportable diseases and conditions.
Now, what we have in what I am positing as the archetypical state are roughly 152 discrete state health data systems. One state I recently visited had 127. Another state that has a fine meta-data site up on the web, states which shall remain nameless, but the former state health officer chairs this committee, had 159 data sets listed.
Now, there are -- these roughly 150 data sets do have some archetypical issues around them, some archetypical questions that we can raise that cut across the states and then cut across the data sets. The first question we can raise is is there a unifying conceptual framework. A second question we can raise is is there interoperability among the data sets and a third question we can raise, is there communication among the data sets, among the data providers, data collectors and data analysts.
What I am going to suggest here is that one thing that the committee can do is try to identify relatively simple techniques for overcoming some of these issues, relatively simple techniques. What I am going to suggest is three techniques as examples.
The first tactic, first technique is conceptual and it consists of learning what data we have and learning what data we don't have. In fact, when you have got 150 discrete data sets, you really don't, my feeling is, have a particularly good sense of really what you have and what it adds up to.
In the interest of time, I am going to skip over here and say that one way of learning what we have is to focus on models of population health and to essentially use a schematic model of population health as a schematic, as a template for evaluating data holdings, literally for plugging in variables from data set to data set into the model and saying what information do we have about the influences on population health, what information don't we have, essentially using population health models as an organizing scheme for learning what we have and trying to be more reflective about what we have.
This is an approach that we really haven't done in this country. The Canadian Institutes for Health Research in conjunction with the Canadian Institute for Health Information in Canada is in the early stages of conducting a project somewhat related to this to basically develop what will probably be a meta-data site for researchers.
A second tactic is methodological and, again, this is what I would suggest is a very simple tactic. The 152 data sets for the most part do not have common identifiers. They don't have common variable definitions. This is despite HIPAA. They do not often have common content on their identifiers. Certainly they don't have common codes and common transaction standards.
Now, what I am suggesting is not the end -- I am going to emphasize this particularly for Jim here -- what I am suggesting is not a national health identifier. I am not even supposed to mention those words here. What I am suggesting is that archetypical state data sets can start using just a simple set of common identifiers, commonly defined with common content, common codes and common transaction standards and just using common identifiers. That relatively simple step would go a very long way toward facilitating linkage and facilitating intersectoral research.
The third tactic is a procedural one and it is somewhat more speculative. The 152 archetypical data sets has different data set holders, not necessarily 152, but certainly more than one or two different set holders. Different data set release protocols, different data set mandates, different data set governing legislation and different data set programmers, analysts and researchers.
Now even though these 152 data sets are held in all likelihood in most states by the state health department, at the same time, the health statistics enterprise, as I said, consists of a great many different organizations. Now, we can think of the governance continuum for producing data, health data for policy purposes, as basically being on a continuum, ranging from governmental organizations, like NCHS, the State Health Data Centers, AHRQ, Australian Institute for Health and Welfare and somewhere loosely speaking in the middle, quasi-governmental organizations, like the United Kingdom Public Health Observatories, Canadians for Health Information and non-governmental organizations, like the Manitoba Center for health Policy.
Now, clearly there is no single correct organizational model for turning data into information for policy and the choice of organization, the models, obviously, needs to be determined by the local and the national climate. Having said that, certainly at the state level one thing I think that we need to really start thinking about are different kinds of organizational frameworks and one of the things that I would suggest we start thinking of are virtual organizational networks as a new point on the organizational governance continuum
Ongoing, highly structured collaboration among participants, organizations and individuals within a clear legal or contractual framework, virtual organizational networks that would build on the strength and capability of each participant organization that would distribute some of the functions and responsibilities of the health statistics enterprise to where they are most appropriate that would maximize collaboration and intersectoral approaches.
Now, one of the requirements for a virtual organizational network is to have a real nerve center, a strong organization or body in the middle, an entity in the middle that would help to organize the enterprise for assessing population health information needs, establish priorities, convening participants, coordinating and planning of participants and facilitating data sharing and linkage.
In the interest of time, I am going to close here and questions at the end, John?
DR. STARFIELD: While we are getting up the slides, I just sort of want to get a sense of the table. I know some of you, but I am not sure I know how you are going to answer the question that I ask. I am going to ask you to try to identify your thinking, whether you regard yourself as basically clinically trained, if you sort of think about individuals, whether you are population trained, that is, you basically don't think of individuals. You think of populations or whether you think there is no useful distinction between clinical thinking and population thinking because after all populations are simply aggregates of individuals.
I was trained clinically. Okay. I originally was trained to think about individuals. I have shifted over the years, but anyway, what about yourselves. How many of you just tend to think clinically, tend to think of individuals? How many of you tend to think -- how many of you think of yourselves as population thinkers? And how many of you think there is no useful distinction between the two?
All right. Let's talk about population health and its implications for health statistics and we will see where you fit.
Challenges of 21st Century health systems -- by the way, how many of you have this presentation in front of you? That is good. I have a few corrections to make. I would hope, please, that you make those corrections when I point them out to you.
Challenges of 21st Century health systems: One, the poor and worsening position of the United States population health indicators, 15 of the most industrialized countries. For about seven or eight of the major health indicators, the United States is last in rank on all of them. That includes infant mortality, probability of death at under age 65, at under age 5, probability of death at ages 15 to 60; a healthy life at age 60, years of healthy life lost, percent of total life expectancy lost and several others. The United States is last of the industrialized countries.
I might point out a couple of things, that the position of the elderly in the United States has fallen in rank. We were among the top two ten years ago and we are no longer among the top two. We are worse off than that.
The third thing I might point out that was surprising to me until I thought about it and that is the percent of the population over 60 has actually fallen in the last ten years in the United States. It is not true in other countries, but in the United States it is true.
Okay. So, the poor and worsening position of the United States on population health indicators, I have some thoughts about why that is the case, but that is not the topic of my talk. So, I will save that for some other time.
The equality of health services and there are several things that might be said about poor quality of health services. One is responsiveness to needs. Now I want to distinguish responsiveness to needs to responsiveness to consumer demands because they aren't the same and I am talking about responsiveness to consumer needs.
I might point out that when evidence started to come through about the dangers of unopposed estrogen and even with the hormone replacement therapy with combined therapy, that those who were taking those medications did not agree with recommendations to stop taking them. They did not believe the evidence. So, there was continuing demand from postmenopausal women for these things and the appropriate course of action was not, of course, to go with demand, but, in fact, go with needs as we knew from the evidence.
Comorbidity, we have always had comorbidity. It is increasing or at least the recognition of it is increasing and that makes us think twice about disease-oriented guidelines. If we are interested in population health and population outcome, we probably want to go well beyond disease-oriented guidelines. Comorbidity.
The third one is coordination of care and that has always been a challenge for us, but it is increasing now, particularly with the increasing use of specialists, largely by virtue of consumer demand, rather than consumer need in my view. People are going elsewhere more often and there is increasing need for coordination.
Overuse. Overuse is something we probably didn't recognize before ten years ago. It is a major problem. Thirty-five percent of the increased costs in the United States health care system are a result of overuse and unnecessary use of services. What I would like you to add in is safety. It is related to overuse. But I would like you to add in there safety.
Now, we didn't really have much population-based data on safety. You could read it in the newspapers, but you couldn't read it in the medical journals before five or six years ago.
Best estimates is that adverse effects and errors account for a third leading cause of death. There is a big difference between the second leading cause of death, which is from cancer, and the third leading cause of death, conventional third leading cause, which is stroke. Estimates of deaths as a result of adverse effects and errors is closer to the rate of cancer deaths than it is to stroke deaths.
Okay. That is the quality of health services. Now there are a couple of challenges in quality of health systems and one is that population outcomes. We need to think about population outcomes, not aggregations of individual outcomes and the need to think about disparities. We didn't do that before five years ago, think about disparities.
I want to particularly distinguish quality of health services from quality of health systems. We focus in this country on quality of health services. Virtually all of our quality assessment systems are on health services and we focus almost not at all on quality of health systems.
I was interested to read an article by Revo(?) in a recent issue of Family Medicine, a supplement, and where he said, "Practicing effectively in today's health system, teaching systems-based care in medical school and in residency-based teaching..." We have actually never done that before. It was in the Journal of Family Medicine. The family physicians seem to much more -- we need to think population than other clinical specialties.
Is population health the sum of individual health than I already told you. What he thought about that, I think the way he thinks. Just think about it. Is the mortality rate, the number of deaths over the population? Shake your head. Is it? The number of deaths divided by the population, is that the mortality rate? Yes, no or maybe. It is. Well, it isn't. I mean, technically it is, but nobody ever uses mortality. That is over population. At least age adjusted.
All right. Now, what about births less than 2,500 grams over the number of births. Is that the low birth weight ratio or rate? Most people would say "yes." And I guess it is, but what does it mean? What does it mean when the low birth weight rate for the African American population is twice that of the -- I mean, would you make policy based on the low birth weight ratio as a number of low birth weights? Not if you are interested in disparities, you wouldn't. It is not meaningful.
What about the number of diabetics or the number of hypertensives in the population, divided by the population, is that the illness rate? No, it is not the illness rate. Okay. It is diabetes over -- but that is not the health of the population.
So, clearly population health is not the sum of individual health. We have known that like -- you know, we have known about mortality rates for a couple hundred years. Right, Ed? I mean, you have to age adjust it. You want information to be useful, right? Yes, you want it to be useful.
We haven't known about low birth weights for that long, but probably at least 75 years we have known that you have to think about low birth weight in the context of different population groups. But we still don't think about health except in terms of diseases. More about that later.
The distinction between a focus on individuals and populations or subpopulations is part of the distinctions among the branches of medicine. Now, I apologize to those who saw these slides the last time I was here, but I will go through them quickly.
Clinical medicine asks what disease might this patient have and how should it be managed. Clinical epidemiology asks what is the relative likelihood that this patient has or is at risk for this disease and what is the evidence to support its management? Now, this is relative risk oriented thinking, right, for both of these. Relative risk oriented. Given a constellation of risk factors, what is the likelihood that something will follow from that? Okay. That is relative risk.
Social medicine, why does this patient have this disease at this particular time and how might this affect management, taking into account the constellation of a variety of factors that influence the occurrence and severity of illness, the genesis of illness.
Community medicine, is this disease important? If so, how important is it, to whom and what is the overall benefit of management to the community. For the first time now, you are beginning to see the notion of attributable risk, community attributable risk, not relative risk, that is making the decision. How important is this in the population?
You know, the risk factor may be very important for a particular disease, but in the whole scheme of things, it is not that important when you talk about the relative frequency of different diseases in the population.
Finally, public health, what characteristics are most salient in improving overall health and the distribution of health in populations and what does evidence suggest should be priorities for intervention. Attributable risk, both in the terms of genesis of illness and in the terms of the effectiveness and impact of interventions.
So, here, you tend to see now why thinking about health of populations disease by disease might not be so important. It is the relative balance and frequency of the diseases and the impact of the diseases in populations that is important.
All right. Now, clinical epidemiologically and social views towards health, this is the diagram that goes along with that. I have a different diagram than Dan presented, but we were really motivated and coming up with a diagram that is in the report by simplicity and so we sacrificed a few things in developing that diagram. It essentially says what this diagram has, but it says it in a little more simple way. Let's start over here on the right.
You have health. We have health over here and notice that I have divided health in two. One of them is average health, which is the kind of thing we usually think about when we think about population health and the other one is distribution of health in the population. Clinically, we think this way. We think about genetic and biological characteristics and we think about sociodemographic characteristics, but from an individual point of view, we are also interested in developmental health disadvantage and those of us, who are pediatricians, really put a lot of focus on this because what happens earlier in life certainly happens in terms of manifestations, certainly reflects in later health.
Then if we are interested in social medicine, we are interested in the impact of these things on health and distribution of health, physiologic state, material resources, social resources, behaviors, panic stress and health services received. Most of social medicine focuses on this. Almost all the literature on social medicine, on social epidemiology focuses on the relationship between social resources and resulting health and distribution of health, in particular, in the last decade.
Now, if we are community oriented, we are thinking at the community level, occupational and environmental exposures, material resources, social resources, behavioral, cultural characteristics, psychosocial characteristics and health system characteristics, not health services, but health system characteristics, which all influence things at the individual level. Now, what this diagram that the diagram in the report doesn't have is it has got the interactions, all of these have interactions. They work both ways. That means that any of these, disadvantage in an of these things makes for greater vulnerability in other things because there are interactions, multiple vulnerabilities. Very important in the context of what we will deal with later is comorbidity.
Then some people will think of political and policy contexts as influencing the community level characteristics. That is an individual level diagram or at most a social medicine and a community medicine diagram.
Now, the community medicine and public health use towards health looks pretty much the same, but it focuses much more heavily on the political and policy context, as influencing these community level contexts. I have left out, mainly because I couldn't fit them in, all the individual level characteristics, as in the last slide. And you have health care again as average health and distribution of health, but you are not only interested in this, you are interested in equity and -- I am sorry -- correction, please.
Let me go back to the last one. This division of health is occurrence of illness and severity of illness. Different things influence occurrence of illness and severity of illness. That is why in describing health, I am thinking that we need to think about occurrence of illness, incidence and prevalence and about severity of illness, disability and death rates.
Now when we get to the population level, we are interested in this average health in terms of occurrence and severity, but we are also interested in distribution of health in populations. Okay. And no longer are we thinking now of individual health disadvantage, but we are thinking of historical health disadvantage.
There was a very interesting article in the British medical journal a couple of years ago that showed that the most important thing that influenced the health of different communities in London was what they looked like a hundred years ago, controlling for a whole lot of other characteristics, what the communities looked like a hundred years ago, more described the health of those communities than any other characteristics and you have got the community characteristics, the policy characteristics and the political context.
So, health system characteristics here, again, is key in terms of influence on distribution of health and on average health. Now, what are the implications for data systems? First of all, is linking individual or aggregated individual data with a contextual or ecological data, what is the difference between aggregated data and ecological data?
The contextual data at a community level really means an aggregation of individual level data. For example, average income of the population is a contextual level variable because it comes from adding up individual incomes and dividing by the population, but pollution level is not an aggregated measure. It is a true ecological characteristic. So, we have got two kinds of things in the community level to take care of things to deal with, things that are aggregated from individuals and things that are characteristic of the community and the new literature on multi-level analyses doesn't really adequately distinguish the two, but they are very important because they have got a lot of policy implications.
It is much more technically feasible to deal with population level in a community than it is to deal with individual incomes and changing individual incomes. So, there from a policy point of view, it is important to make that distinction.
Okay. Linking individual aggregated data with contextual or ecological data, so we have to link the clinical information with the systems information. Implications for information systems at the area level. We need characteristics of areas in which people live and work because we are now beginning to get lots of studies that show the impact of those community level characteristics on individual health and distribution of health.
Social and political or power characteristics of people in an area, the whole concept of what do we call it, social -- social capital, yes, is a very, very fuzzy capital. Some people use it as an aggregation of individual social power.
MR. BLAIR: Just a clarification because I am struggling on one piece and I am not sure that I really understood what you meant when you said was it the community a hundred years ago, individuals a hundred years -- help me understand what that means and --
DR. STARFIELD: Jeff, in that study in London, what they did was they described the health of the community in 1890 and 1990 and then they looked at the characteristics of those communities and they found that what determined the constancy of health was, in fact, the community itself, not the characteristics of the individuals in the community. Okay?
MR. BLAIR: Thank you.
DR. STARFIELD: So, implications for data information systems, the characteristics of areas, the distribution of social and political power in those areas, which is much broader than what Putnam called social capital, which talked about individuals participating on bowling leagues and the characteristics of the health system.
Implications for data and information systems from the point of view of health services, I want to take a few minutes on this. Now, this is health services, not health systems. The first thing I want to mention here is problems, patients' problems.
I think that ultimately if we were really interested in improving health, what we would do is to deal with patients' problems, not deal with diseases, deal with patients' problems. You want people to function better in the community. I am going to give you a definition of health in a minute. What is the purpose of health? Not to do away with diseases. It is doing away with the problems that interfere with people's lives.
So, we have got to be more problem oriented. I know you have discussed at some length in this committee the issue of problem coding and you have discussed the ICPC and I am very pleased, John, that you wrote a letter on behalf of the committee to the Secretary about the ICPC. I think if we are interested in improving health, we need to think about problems, rather than diagnoses. Of course, they are related. But they are not always related. So, we really have to think about doing away with people's problems, things that interfere with their life.
For example, I am going to use the data that Craig Gayon(?) and also that Hank Inga(?) had been working with. Shortness of breath is a risk factor for the diagnosis of the COPD. Any clinician knows that. But for patients, who eventually have COPD, it is an infrequent presentation. Now a clinician thinks of shortness of breath related to COPD, but, in fact, it is a relatively infrequent presentation of COPD; the difference between relative risk and attributable risk.
The second thing is diagnoses. We make a very big thing about di