[This Transcript is Unedited]
NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCOMMITTEE ON PRIVACY AND CONFIDENTIALITY
March 5, 2004
Hubert H. Humphrey Building
200 Independence Avenue
10201 Lee Highway, Suite 160
Fairfax, Virginia 22030
P R O C E E D I N G S (8:38 a.m.)
MR. ROTHSTEIN: I think it is important for us to begin, because we have to get through this letter. If you don’t mind, John Houston, along with John Fanning, because I am sort of off site and out of it for a variety of reasons, if you wouldn’t mind taking the lead on going through the letter, I personally think that John’s corrections from yesterday’s meeting are right on. We might want to just start taking that whole chunk and see if there are any problems.
MR. FANNING: I would point out that Mr. Houston had some other comments that he had proposed earlier, that we didn’t incorporate in our discussion yesterday.
MR. HOUSTON: Before we start the letter, I know Dan Rode wanted to address the subcommittee regarding the letter, but before we started doing additional edits to the letter. Is that okay?
MR. ROTHSTEIN: Sure.
MR. RODE: Good morning. Dan Rode, American Health Information Management Association. In reading the draft letter that was circulated yesterday, and knowing that the committee dialogued about this letter off line in a telephone conference as opposed to a hearing, I just wanted to point out some confusion I had.
I think my interpretation, and most of those testifying in November, indicated a problem with the accounting or the privacy releases, in cases of state law.
That is larger than the two items that are mentioned in the letter. It is larger than the public health piece, although most of the state laws are related to public health, and it is larger than just the abuse case that is cited in the letter.
I would mainly like to know why the other cases weren’t covered, because obviously we will have to write a comment to the Secretary.
Our recommendation has been that we ought to place in the privacy notice a notification that the covered entity will report, in all cases required by state law, or federal law, if you want — federal and state law — and that we believe that that ought to be excluded from the accounting.
If it is, it is our belief, from questioning our members and hearing the other testimony, that we probably have a very small amount of activity that then has to be accounted for, which is a very expensive process creating a significant amount of work.
We would further recommend to the Secretary — I understand the committee cannot necessarily do this, but we would further recommend to the Secretary — that besides the notice in the privacy practices, that entities also be required to have an appendix that they could change as laws change.
So, if someone asks, what are the laws that you must report on, they could give them a copy of the laws that are required, so that the patient is notified up front of any notification requirements, as opposed to accounting for them.
MR. HOUSTON: Can I make a brief statement? In the part that we haven’t covered yet, that John Fanning discussed, there is language that I thought was intended to cover that which is, in particular, many covered entities believe that the accounting requirement is burdensome as a result of many disclosures required by law.
Compounding the burden is the fact that many mandatory reports are submitted on paper because automated systems for filing the reports have not been developed.
At the same time, the number of requests by consumers for an accounting of disclosures has been extremely small.
I think that was intended to support that particular point that was made in the testimony, if I am not mistaken.
MR. RODE: In the recommendations, however, you used the word, disclosures for public health purposes.
MR. ROTHSTEIN: Dan, I wanted to address your comments. We did have an extended discussion about the accounting for disclosures requirement before we drafted the first version of the letter.
Basically, I think you made a very accurate observation that we discussed, and that is, if we change the accounting for disclosure, or recommended a change for the accounting for disclosures, to exempt those disclosures required by law, basically that would totally gut the accounting for disclosure requirement, because we already have an exemption in there for, you don’t have to account for disclosures pursuant to authorizations.
So, the only logical thing that would take place then would just be to totally remove from the rule the accounting requirement.
I don’t think the subcommittee was comfortable making such a sweeping recommendation, inasmuch as accounting for where one’s medical records go remain a fundamental part of what most people and, indeed, most countries would consider essential, in terms of fair information practices.
Now, we recognize that there are problems associated with this, but I don’t think a solution is to add an appendix onto a notice of privacy practices that people don’t read anyhow.
What we intended to do in the letter was to raise the issue and basically say to the Secretary, here is a narrow thing that you ought to do immediately, no matter what else you do or don’t do, and here is a broader thing for you to think about, raising the concerns that were addressed to us.
Personally, and I think the subcommittee as a whole, did not feel comfortable essentially recommending that the accounting for disclosures requirement be deleted from the privacy rule.
MR. RODE: I appreciate the explanation. That helps. Thank you.
MR. HOUSTON: I think the other thing, too, is the specific bullet point that we are going to discuss, that you wanted expanded, was one that the subcommittee isn’t entirely in agreement over already. That was one point we were going to bring up at the meeting this morning. Expanding it is a reach based upon the fact that we couldn’t agree on the original bullet.
Mark, do you want to proceed from where we left off yesterday?
MR. ROTHSTEIN: I think what we ought to do is first go over the changes that John made to the stuff that we talked about yesterday, to make sure that everybody is okay with that, make any changes that people feel are necessary, and then start proceeding with the last section that we didn’t take up at all, that is part C.
MR. HOUSTON: John, do you just want to summarize where there is any change?
MR. FANNING: Yes, i can do that. Let me explain one generic factual change. We have identified the rule for protection of research subjects a little differently, pursuant to Lauren Cupcat’s(?) discussion of what accurately represents the rule in question.
So, if the staff could be authorized to further refine that, if that should be necessary, we would be appreciative.
MR. ROTHSTEIN: Absolutely, I think that is fine.
MR. FANNING: In the second paragraph, there was a reference to hearings over the next year. That just reads, now, the hearings, the first of several to be held.
In the third paragraph, there was a reference to hearings in 2002. That now reads, prior to the compliance date.
MR. HOUSTON: One point on that. This says, the compliance date for the rule, and we have defined that to be the privacy rule above, so we should probably say, compliance date with the privacy rule, and put the word privacy in.
MS. GREENBERG: It just says it in the same paragraph.
MR. FANNING: Actually, you could just put a period after date. That simplifies it. Now, public health, in the second paragraph there was some discussion of the motivation, difficult to assess the motivation of covered entities for not cooperating.
We have dropped that, but note that — it still reads, at least one witness suggested, however, that some covered entities might be using the rule as an excuse to avoid the burden of public health reporting.
MR. HOUSTON: You missed the first paragraph.
MS. GREENBERG: You did exactly what I would have done, which is, you made it one and two in the first paragraph.
MR. FANNING: Oh, that is right, separating the two questions here.
MS. HORLICK: I didn’t receive the latest draft. Did we modify that last sentence to say, might be merely, or did we leave it as were merely?
MR. HOUSTON: Might be. It says, however, some covered entities might be using the —
MS. HORLICK: Okay, I am using yesterday’s draft. Thanks.
MR. FANNING: I apologize to the committee for not having a strike out and underlined text, but we can explain it as we go along.
MR. HARDING: This is a remarkably good thing, John, that you did. I appreciate it.
MR. FANNING: Now, there was some discussion yesterday about the sentence beginning, 35 percent of respondents, and 25 percent said that their disease reporters had a significant problem.
I don’t know what the question about that was, but I simply copied out the text of the witness’ statement, and that is the last sentence in the paragraph beginning, one of the witnesses.
It now reads: Thirty-five percent of the respondents said that the privacy rule had caused major obstruction or delay in disease reporting, and 25 percent said the requirement to account for disclosures to public health was a significant problem for their disease reporters. Now, that is extracted directly from the written statement of the witness.
MR. ROTHSTEIN: What was added was an attempt to clarify that statement, and I succeeded in making it more confusing. So, thank you.
MR. COHEN: Just a question there. I think it all sounds find and I am glad you quoted it. As I am reading it, it is still not clear to me.
I would probably say something there related to, according to the survey, 35 percent of the respondents. I am, once again, word smithing, but as I read that, I know where you are going on that one, and that is fine.
MR. FANNING: The first sentence says, the witness testified about a CSTE survey.
MR. HOUSTON: I just said according to the survey. I was writing the same thing. So, there is an opportunity to clarify it.
MS. HORLICK: You could say 35 percent of the survey respondents.
MR. HOUSTON: That is there. I understand what Gail is saying. Either way, I think it just needs to — actually, I like Gail’s better.
MR. FANNING: That doesn’t read as graciously as it might. Disclosures to public health is a little awkward. We usually say, for public health purposes.
Interesting, the law enforcement community speaks of law enforcement and that is the term they would use. I think we usually say, for public health purposes.
MR. HOUSTON: Then maybe we should keep Simon’s wording, which is according to the survey, and we can even quote if you feel more comfortable.
MR. FANNING: You mean put quote marks around it? Okay.
MR. HOUSTON: That way it clearly attributes it directly to the survey.
MR. FANNING: I will see that the text reflects directly the witness’ statement and put quotes around it. The next paragraph is about immunization. I polished up the first sentence.
We also learned that immunization is another concern. I have added the word, thus, in many states, but I am not sure that helps.
MS. HORLICK: I am sorry, where did you add the words?
MR. FANNING: The sentence beginning, in many states, I put thus there, but I am now wondering whether that helps.
Does the HIPAA compliance authorization make any difference in terms of state law? In many states, providers cannot disclose immunization information to schools without receiving a HIPAA complaint authorization.
MS. GREENBERG: That is not related to state law.
MS. HORLICK: My understanding is that the state laws that permit that disclosure would not be preempted.
MR. HOUSTON: Because it would be considered to be public health activities. Therefore, no authorization would be required.
MS. HORLICK: That is my understanding.
MR. HOUSTON: In the absence of that, you need a HIPAA compliance authorization.
MR. FANNING: Does thus help or hurt?
MR. HOUSTON: I think thus is okay.
MR. FITZMAURICE: I see it as referring back to state laws vary. Thus, because state laws vary, in some states.
MR. FANNING: Now, in the next sentence, there was some discussion yesterday about this line, if authorizations cannot be obtained for any reason. I attribute it to a witness. I don’t think there are any changes in the —
MS. GREENBERG: For any reason, to me, just doesn’t make sense. If authorizations cannot be obtained, some children receive duplicate immunizations. This, if for any reason, keeps hanging me up. For whatever reason — is that what you mean?
MR. FANNING: Yes, that is what it means. Do we need that phrase at all?
MS. GREENBERG: I think you can just get rid of, for any reason.
MR. FANNING: If authorizations can’t be obtained, some children receive duplicate immunizations.
PARTICIPANT: I just want to make a couple of comments about this paragraph, just to try to improve the clarity on a couple of parts.
In the second sentence, often school nurses need to obtain immunization information from covered entities. Otherwise, if we think of FRPA and the exceptions under the privacy rules for that, there might be some confusion over who they are receiving this information from. I think it might improve the clarify.
MR. HOUSTON: Where is that?
PARTICIPANT: I am sorry, under the second sentence in the same paragraph.
MR. HOUSTON: Read that again?
PARTICIPANT: Often school nurses need immunization information from covered entities or covered providers, perhaps.
In addition, in the sentence that reads, thus, in many states, covered providers cannot disclose.
MS. HORLICK: That is good.
MR. FANNING: I think that is true, but in terms of making it clear for the general reader, I am not sure that level of precision is necessary, the way it would be in a more formal document.
MS. GREENBERG: I think the change she made to the second sentence is good because, specifically, they need the information from the providers, if that is the point, rather than that they need it from the child or the parent.
MR. FITZMAURICE: That is where the hang up is with the privacy rule.
MS. GREENBERG: But I don’t think you need cover it in the other place.
MR. FANNING: So, thus, in many states, covered providers —
MS. GREENBERG: I don’t think you need covered there, but I think in the second sentence, I would agree.
MR. FANNING: School nurses need immunization information from covered providers to assess compliance.
PARTICIPANT: One last thought about this paragraph, and I don’t know if it was considered earlier, designating school nurses as public health officials would not ease the burden of accounting for disclosures on these covered entities. Have we considered whether this could be a treatment disclosure for that purpose of authorization where accounting would be —
MS. HORLICK: Oftentimes, they are just wanting the information to assess compliance with the school entry requirements, and it is not really for treatment purposes.
MR. HOUSTON: Even if there is treatment, they are not covered entities because they don’t engage in any HIPAA-related transactions.
MR. FITZMAURICE: The treatment doesn’t have to be between two covered entities.
MR. FANNING: That is right. The disclosure could be made without authorization if it was for treatment, if the school nurse administered them.
MS. HORLICK: Right, but in a lot of cases, that is not why the school wants the information.
MS. GREENBERG: If she is in a position to administer immunizations, it is for treatment. It is to determine whether treatment is necessary.
MS. HORLICK: Then it is not a problem. It is a problem in the majority of cases where they want the information to see if the child has what is needed to enter school.
MR. FANNING: If the child doesn’t have the immunization, the child is sent elsewhere to get it. In the cases where the nurse can administer it, that is a treatment.
MR. HOUSTON: Let me ask you a question. I may be making a stretch here, but can we fit that into health care operations? It would be an operational activity of the nurse who is a treatment provider, not necessarily covered by HIPAA, but she has an obligation to —
MR. FANNING: If she is not covered by HIPAA, then it doesn’t matter.
MR. HOUSTON: Except that the covered entity can release to a non-covered entity for treatment, payment or health care operations.
PARTICIPANT: For limited health care operations of someone who is a covered entity or not, there are restrictions on this.
MR. FANNING: May I suggest that it might be most helpful if the committee simply identifies the problem, if OCR and its lawyers can solve it through that analysis, let that be done, rather than the committee suggesting various fine grained interpretations.
MR. HOUSTON: In the absence of a solution, we punt.
MR. ROTHSTEIN: I think that is a good idea, John.
MS. GREENBERG: My only concern about this — and I guess this could be dealt with in the analysis — is that sometimes school nurses are not actually licensed nurses, but they are somebody who is like hired by the parents — this is not uncommon, I think, in an elementary school or wherever, where they just want to have somebody who maybe knows first aid or something like that, and serves in the capacity of a school nurse, just to have the kind of health suite covered.
It is not actually a licensed professional to provide health services, and doesn’t really provide health services.
I think, if they are a public health nurse or they are a licensed nurse in the state, then to have them recognized as a public health entity or whatever, or a public health official, is reasonable. This more informal kind of person might be stretching it.
MR. ROTHSTEIN: Marjorie, I think that is a good point and we can make this broader than just calling it the exception for school nurses.
We could say often school officials, including school nurses, need immunization information, and then change the language at the end of that paragraph to be consistent.
The person who needs the information, I suppose in some schools it might be the principal of a small school who just needs to verify compliance with the state law.
There is no reason why the state couldn’t designate that person, the school principals, even, as a limited public health official.
MR. HOUSTON: It would have to be limited. You wouldn’t want the principal to be in a position to get all sorts of health information about the kid.
MR. FANNING: But I think they already do under FRPA.
MS. HORLICK: They can get it under FRPA anyway, once they have it.
MR. ROTHSTEIN: Besides that, that is a matter of state law anyhow. What we are saying is, at a minimum, a state designated official at the school should be able to receive immunization information without an authorization.
MR. FANNING: All right, if the committee thinks that is good, we can strike the term, nurses, and just put in a generic word like officials.
MS. HORLICK: I like that, because they could always narrow that if they wanted to, in the implementation, if they were going to follow through.
MR. FANNING: Then, in the last sentence, designate school nurses as public health officials. Perhaps some line like, could designate school officials —
MR. ROTHSTEIN: Or designate school officials.
MR. HOUSTON: I don’t like that, myself. I think it is being too broad.
MR. ROTHSTEIN: Giving immunization information to the officials is a public health disclosure.
MR. FANNING: Mark, go through it again, please.
MR. ROTHSTEIN: What I think I said was that, if OCR indicates that states could indicate that disclosing immunization information to designated school officials is a public health disclosure, the information, blah, blah, blah.
MR. FANNING: Just a moment, immunization information to school officials —
MS. GREENBERG: Is a public health disclosure. I like that better, because it is not actually deeming —
MS. HORLICK: Do you want to say, to designated school officials, such as a school nurse, just so they get right on track and, if they want to narrow it, they have that clue?
I am just afraid they might see — I like that, but maybe they will see that as just too broad or just too nebulous.
MR. FANNING: Wouldn’t it be better to leave that to OCR?
MS. HORLICK: Okay.
MS. GREENBERG: I think designating this as a public health disclosure really limits it, rather than deeming a principal as a public health official. To me, that kind of goes too far. I don’t know; what do you think?
MR. STEINWACHS: Remember, the education system has responsibility for kids with disabilities and, therefore, a lot of health care responsibilities. It is a complex area as you move into it. Immunizations are probably the least threatening of all of this.
PARTICIPANT: Just one final thing to mention about this. I don’t know if we are directing OCR to exclude the other provisions under HIPAA that would permit this information to be released for purposes other than just verifying state compliance.
It could be that the school nurse does issue an immunization, but do we want to draw a distinction between those purposes here, so we don’t direct them to exclude —
MS. HORLICK: Then I think they could just get it under treatment.
PARTICIPANT: Right, I don’t think the last sentence would lead them to believe that is the suggestion.
MR. FANNING: Again, we can’t draft the OCR statement here.
MR. ROTHSTEIN: I think the paragraph now raises the issue and points the way for a solution to it. I am not sure we can go much further.
MR. FANNING: Okay, I think I have a text for that. I will pass it around a little later in the day to see if we have gotten it right.
I think there is no change with regarding to an accounting paragraph. Research, in the first paragraph, the only thing we have done is identify the rule, the protection of human subjects rule more precisely. Again, we can polish that up if there is some technical difficulty.
MS. GREENBERG: You took out potential, too, describing the detrimental impact rather than the potential?
MR. FANNING: Yes. Are we comfortable with that description of what it heard from the witnesses?
MR. HOUSTON: Back to the definition of the rule, it is referred to as either the common rule or the federal policy.
I know that down below it does become, in the next paragraph at the bottom, you try to refer to the research subject’s role. I know everyone knows it as the common rule. I think we should —
MR. FANNING: There was a difficulty about the technical definition of it, though. The common rule is simply one part of that entire regulation and so on. This is simply the more accurate description legally.
I think the recipients of the letter will understand what is meant, but it is just better to be technically correct.
MR. HOUSTON: If you look down below at the research subject rule, it is — I don’t know, or if they are federal policy, which is more broad.
MR. FANNING: Whatever the committee chooses to direct me to do, I will.
MR. COHEN: I don’t even know what section you are referring to. I don’t think you are referring to the first paragraph any longer.
MR. HOUSTON: I am just saying, when we talk about codifying the Department of Health and Human Services, at 45 CFR part 46, we had defined it up above as being the common rule.
Whether we change it to something else, definitionally, I always heard it referred to as the federal policy or the common rule.
Then, when we refer to it below, it is really unclear to me in the next paragraph. It just seems unclear. So, do we need to say something like, otherwise known as the common rule or whatever, so that — is the federal policy considered broader or is it still the same thing?
PARTICIPANT: Is it considered broad?
MR. COHEN: Broader than the definition of the common rule.
PARTICIPANT: The federal policy, yes, the concept is that it includes subparts A, B, C and D. The common rule is only subpart A.
MR. COHEN: Why don’t we simply say the federal policy, define it as the federal policy, and then we can refer to it as the federal policy below.
MR. FANNING: Read to me what I should write, because I don’t get it either.
MR. HOUSTON: Codify it for the Department of Health and Human Services at 45 CFR part 46, commonly referred to as the federal policy on research, something like that.
MR. FANNING: You have to tell me exactly what to say.
MR. HOUSTON: Commonly referred to as the federal policy.
MR. COHEN: John, right before it says, rule for protection of research subjects. Is there a problem with that statement?
MR. JOHNSON: My concern is when we go down below to the next paragraph. It is described as the protection of research subjects rule, which is nowhere described.
MR. ROTHSTEIN: Can’t we just add another parenthetical after codified, announcing what short form we are going to use to refer to it?
MR. HOUSTON: That is what I am trying to say, exactly that, known as the common rule and its subparts. Maybe that is the best thing.
MR. ROTHSTEIN: The way we have referred to it in the document later is, change the federal research rule or something.
MR. FANNING: Since the concern here is about rather fine grained drafting, I think the committee had better agree on a text and tell me what to put in. I mean, it is not — I can’t later go and fix it up on the basis of what I heard here.
MR. ROTHSTEIN: I understand.
MR. HOUSTON: Mark, I will defer to you as to what you think is best, in terms of how we want to title it.
MR. ROTHSTEIN: How about if we just call it the protection of research subjects rule throughout, even though it may be awkward in some places.
I think we have done that in most places and, where we need to do it, we will just change it. Is that okay?
MR. HOUSTON: That is fine.
MS. HORLICK: I am not sure about this but, if you do that, do you need to capitalize tat, the way you capitalize the Privacy Rule?
MR. HOUSTON: We will define it that way, with a capitalization.
MR. ROTHSTEIN: I think that would be fine, Gail, if we capitalized it.
MR. FANNING: One other thing. Laura points out that, at once, we commend, or the witnesses commend the privacy rule, the consistency with the protection of research subjects rule, promoting consistency and ease of compliance.
Then, what the committee is really saying, there isn’t consistency and ease of compliance, down in the last sentence.
It might be better to say, overwhelmingly support the privacy’s rule’s intent of aligning its requirements and so on, in order to promote consistency and ease of compliance, and then we go into the however mode.
Now, we are down into the preparatory to research section, are we? I think we are.
MR. ROTHSTEIN: Yes.
MR. FANNING: People, I think, didn’t like the term, in fact. I have replaced it with specifically, but please read that to see if it reads correctly. I am not sure it is an improvement over, in fact.
MS. GREENBERG: Could someone read that paragraph?
MR. FANNING: First of all, I have polished up the previous sentence. The concept of “preparatory to research” includes such activities hypothesis definition, protocol preparation, and research recruitment.
Specifically, 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 work force member of the covered entity, to contact potential research subjects for the purpose of seeking authorization as part of the covered entity’s health care operations. So, the change was to strike in fact and put in specifically. John, did you want to polish this up further?
MR. COHEN: Specifically or, in particular?
MR. HOUSTON: Specifically or in particular, I think either one works for me.
MR. ROTHSTEIN: That is fine.
MR. HOUSTON: Then will you change back, I guess, the last sentence, too. I went over this last evening. Did we want to discuss —
MR. FANNING: Yes, you have some suggestions here which we had not taken up earlier.
MR. HOUSTON: We sort of rejected them, and I would just like to sort of ask for consideration of one point in this next sentence.
MR. FANNING: This is the sentence beginning, even if such contact?
MR. HOUSTON: Yes.
MR. FANNING: As it reads now —
MR. HOUSTON: It is the same as we originally had; correct?
MR. FANNING: Yes. Even if such contact could be construed as coming within health care operations, the interpretation permits recruitment of potential research subjects — parenthesis — an element of research — close parenthesis — either absent a waiver from the IRB or patient authorization and, thereby, violates a fundamental principle of research ethics and the protection of research subjects rule.
MR. HOUSTON: When I read that last night again, one of my concerns was, that second half of that paragraph, absent either a waiver from the IRB or patient authorization and, thereby, violating a fundamental principle of research ethics and the protection of research subjects rule, really, what is required, even above and beyond a waiver from the IRB or patient authorizations affected, it requires IRB approval.
That really is the core of it. In theory, if you read the sentence, you could go and simply get patient authorization to recruit them, without ever having gone to the IRB, which also violates this rule.
What I think we should simply say is, strike everything after absent and then say, without IRB approval, thus violating the common rule or whatever rules.
MR. ROTHSTEIN: Okay.
MR. FANNING: Strike absent down to the comma and insert, permits recruitment without IRB approval.
MR. HOUSTON: In theory, an IRB would be able to grant a waiver as part of the approval process, and still be part of the approval process.
MR. FANNING: It must approve the mode of approach to the patient and that sort of thing.
MR. HOUSTON: That was the confusion yesterday. How could you go get a patient authorization if it hadn’t been reviewed by an IRB.
MR. FITZMAURICE: Can’t you go get a patient’s authorization to use their protected health information at any time without an IRB? I don’t see a problem.
MR. STEINWACHS: You need an IRB approval for research.
MR. FITZMAURICE: Any time you use it for research without their authorization, you need their approval.
MR. FANNING: I think this interpretation is under the common rule rather than under the privacy rule.
MR. FITZMAURICE: So, this is not a problem with the privacy rule. We should make that clear.
MR. HOUSTON: The next part of it then says, violates, and then you get into the common rule component of it. It doesn’t say it violates the privacy rule. It violates the common rule.
MR. FITZMAURICE: It also says it violates a fundamental principle of research ethics. I am not sure which one that is.
MR. HOUSTON: By the way, that is something I was concerned about next. We should strike the violates a fundamental principle of research ethics, because I think that we are really dealing with — I am going to use the common rule simply because that is one I am familiar with.
It does violate the common rule, and this discussion of research ethics, there are ethicists that will argue one way or the other. Mark, what are your thoughts?
MR. ROTHSTEIN: I don’t know anyone who would make a big fuss over it either way. If we want to pin our discussion or argument on the research subjects rule, we can cut out the fundamental principle of research ethics, although I would say that, even if someone could come up with some sort of strange interpretation of the common rule that would allow this, I would still argue that it is unethical.
We don’t need to go there, so I am happy to eliminate everything between the words violates, and the protect of.
MR. FANNING: Let me just —
MR. COHEN: I just want to know how the sentence will now read. We have been discussing subpart by subpart of the sentence.
MR. FANNING: Even if such contact could be construed as coming within health care operations, the interpretation permits recruitment of potential research subjects, an element of research, without IRB approval and, thereby, violates a fundamental principle of research ethics and the principle —
MR. HOUSTON: No, we took that out.
MR. FANNING: Thereby violates —
MR. COHEN: The research subjects rule or whatever we are going to call it.
MS. GREENBERG: The protection of research subjects.
MR. FANNING: Whatever we are going to use for that.
MR. FITZMAURICE: This is true only for those researchers who are covered by the common rule.
MR. FANNING: Yes, the letter doesn’t really make that distinction up front. However, the discussion if about the relationship between the two rules and those who are subject to both of them. I am not sure that this letter would have to be written with the same precision as some directive from OCR.
MR. FITZMAURICE: You are saying everything is all right with the privacy rule, that is fine. Everything else is somebody else’s domain. We are fine with this.
A researcher who is covered by the common rule is subject to both the privacy rule and the common rule. If the researcher were to do this, that would be in violation of the common rule.
MR. ROTHSTEIN: That is a very interesting point that argues for keeping in the fundamental principle of research ethics.
MR. FITZMAURICE: What principle is that?
MR. ROTHSTEIN: That would apply to researchers who are covered by the privacy rule but not by the common rule.
MR. HOUSTON: There will be those who will argue that maybe there are some countervailing ethical reasons why you should be able to contact prospective patients.
MR. COHEN: Maybe I have a slightly different take on this one but, rather than us trying to argue this particular point — and if we do, I despair of us having this letter done at this particular meeting — I am actually wondering if the title of the whole section doesn’t need to reflect, rather than just research, maybe research, colon, conflict between the protection of the common rule and HIPAA privacy or something like that, where it sort of states up front that that is really the whole point of this whole section, which is really what I think it is, rather than trying to discuss the issues of people that are not affected by whatever we call it today.
MR. HOUSTON: What this refers to is for the purpose of talking about it as a common rule.
MR. COHEN: I am just saying that by changing the title and indicating that that is what the piece is here, that might deal with this particular issue.
MR. HOUSTON: I think that is a good idea.
MR. FITZMAURICE: There is no problem. If a researcher is subject to both the common rule and the privacy rule, if I am OCR I say, so, what is the problem. They conflict. We are not going to make them identical. They are two separate rules.
MR. COHEN: The problem is that currently there is a lot of turmoil within the research community for those who have to apply both rules as to what is the appropriate standard.
I think what is happening is that some people go cite HIPAA for doing what they want to do and entirely forget the fact that they are still governed by the common rule.
That is something I know our institution is dealing with. A researcher goes off and starts to do recruitment and the IRB is saying, what is going on here.
MR. ROTHSTEIN: They say, look, it says right here we can do it.
MR. FITZMAURICE: So, the remedy is education, so they understand what their obligations are under both the common rule and the privacy rule.
MR. HOUSTON: I think we all agree that the harmonization of the common rule and the privacy rule is still helpful. Even for those who are not covered by the common rule, if they are truly in harmony —
MR. ROTHSTEIN: Michael, even for researchers who are not covered by the common rule, I don’t think they should have a lesser standard, and that the privacy rule should be the same as the common rule meaning that you can’t just willy nilly contact these people.
MR. FITZMAURICE: Then we should state that we think the privacy rule and the common rule ought to be identical.
MR. HOUSTON: We said that. I think we tried to say that. I think there was language regarding the harmonization of the rules.
MR. FITZMAURICE: One way to harmonize it is to educate it them that they are slightly different. It wasn’t the purpose to make them the same. The purpose was to say, this is entirely separate.
MR. HOUSTON: It says here, witnesses at the hearing overwhelmingly supported the privacy rule’s intent of aligning its requirements. Again, that is what the exercise.
I think what Mark is saying is that, if somebody is not covered by the common rule, then the privacy rule should, in its place, operate in the same fashion as the common rule did, in order to prevent a void from occurring that otherwise was not intended.
MR. FITZMAURICE: I think the committee could express that opinion.
MR. ROTHSTEIN: Let me remind everybody that we have got to finish this by 9:50 and we haven’t even gotten to the new sections yet. Can we reach closure on this one issue?
MR. HOUSTON: My personal opinion is that the last way that John read that last sentence — John, why don’t you read it again?
MR. FANNING: I have corrected the sentence further pursuant to Laura’s note. There is no if about construing that within health care operations. The guidance does say it comes within health care operations.
So the sentence would now read, even though such contact is construed as coming within health care operations, the interpretation permits recruitment of potential research subjects, parenthesis, an element of research, close parenthesis, without IRB approval, and thereby violates the protection of research subjects rule.
MR. HOUSTON: That, coupled with Simon’s recommendation to make the heading clear that this is a discussion of the common rule versus the privacy rule, focuses it on that, rather than a broader discussion.
MR. FANNING: Okay, can we go on to the next sentence? Authorization. I have changed the first sentence from the previous text.
It says, the privacy rule permits an authorization for the use and so on. I have made a new small paragraph here.
The role of the IRB in reviewing authorization forms has also raised questions. 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.
I think in the rest I am not sure we have made any changes. Oh, yes, we have. Let me read the whole new paragraph.
But according to the same August 2003 publication, the privacy rule does not require IRB review of authorizations, either as stand alone documents or when combined with informed consent documents.
The absence of any such role under the privacy rule has created confusion about whether IRBs, in their role under the protection of research subjects rule, have the authority or responsibility to review these authorizations to use and disclose information for research.
Because the protections of research subjects rule charges IRBs with considering the adequacy of privacy and confidentiality protection for subjects, it would be helpful to have a clarification that there is nothing in the privacy rule that prevents them from reviewing authorization forms and discharging that responsibility. Does that get it?
MR. ROTHSTEIN: I think it is fine.
MR. HOUSTON: I think it is great. My only comment here is, why would you create two paragraphs. I think this is one paragraph.
MS. GREENBERG: I do think this is heavy slogging, but if it says what you want to say, fine.
MR. ROTHSTEIN: I think it can be one paragraph, but I like the wording.
MR. FANNING: Okay, the next one, an area where the diversions of the privacy rule and common rule involve general research authorizations, we have added, at the end of the last sentence there, 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 or a waiver of authorization obtained from an IRB or privacy board. That part of it is new, and it simply conforms to the reference at the end of the paragraph about the additional step further complicating the process.
Let me just point out that the business of disclosing information from a repository without IRB review is problematic, and the best thinking about big repositories is, there ought to be careful review of all disclosures. Be that as it may, this text reflects what the committee found.
MR. HOUSTON: Can I make one suggestion in the first paragraph, after unspecified research? I should read the sentence. Under the protection of research subjects rule, subject to such limitations as an IRB deems appropriate, a research subject may provide informed consent for future unspecified research, including research using biological specimens.
We talk about research using biological specimens below. It almost seems like in two separate sentences in close proximity we talk about collection of biological specimens, linked to medical records research, which are essential to many forms of research.
I am just wondering whether we strike, including research using biological specimens in the first of those sentences.
I remember Mark wanting to talk about the whole concept of repositories of biological specimens, but we do talk about it in a later sentence.
MR. FANNING: Mr. Chairman?
MR. ROTHSTEIN: I have no strong desire to keep it in if the subcommittee thinks that we can delete that. That is fine.
I just wanted to point out to you, John, that there is language in that second sentence that attempts to reach the issue that you raised about the ethical propriety of allowing unspecified future disclosures from the repository without subsequent IRB approval.
That is why it reads now, under the protection of research subjects rule, subject to such limitations as an IRB deems appropriate, that language was put in there to succinctly recognize the issue that you raised.
MR. FANNING: Do you want to strike, including research using biological specimens?
MR. ROTHSTEIN: That is fine.
MR. FANNING: Do you want to combine the next paragraph, make it one long block of text? Okay.
MR. HOUSTON: I think we are on to covered entities now, and consumers.
MR. FANNING: Yes, covered entities and consumers, and I don’t think we took this up at all in our earlier discussion.
MR. COHEN: John, did you modify this area at all?
MR. FANNING: Where are we?
MR. COHEN: I was just wondering if there were any changes made to the covered entities and consumer section.
MR. ROTHSTEIN: We haven’t started that, Simon.
MR. COHEN: I thought we were just starting it now.
MR. FANNING: There was no discussion of it yesterday, and I didn’t change anything.
MR. ROTHSTEIN: Is everyone in agreement that we are okay up to part C? Anything else? Okay, great. Through part B.
MR> FITZMAURICE: I have got a question with the paragraph above part C. That is, does this say that if you have a list of the DNA representation, that that list of DNA representation is not identifiable? Is that what it says, essentially? There is a list of DNA representation. This is not identifiable data.
MR. HOUSTON: It would not be considered identifiable because in theory and in practice it really is ultimately the most identifiable.
MR. FITZMAURICE: One could say, here is a list of social security numbers. Would we also say that a list of social security numbers is not identifiable? I would say yes, to the same degree that this is not identifiable.
The violation would come when you link it with something else, or when the list represents something, like people in this room, people in an area, people in a particular study. So, if you know that somebody is in a study —
MR. HOUSTON: It says unlinked DNA samples are not identifiable, unlinked meaning just what you are saying.
MR. FITZMAURICE: But if you capture them, you capture them from some place, like here are all the social security numbers of people who have been to St. Joseph’s Hospital, here are all the DNA representations of people who were tested at St. Joseph’s Hospital.
MR. FANNING: I understand the point, Mike.
MR. FITZMAURICE: I am not arguing that it is or isn’t. I just want it to be clear that he list of social security numbers is not identifiable to the same degree that a list of this is not identifiable.
MR. FANNING: Do we need to address that to make this letter right now?
MR. FITZMAURICE: It is a further discussion.
MR. FANNING: I will give you my views on that later.
MR. ROTHSTEIN: I think it is really sui generis. These are materials that research is going to be performed on. Nobody is going to do research on the number of a social security — I think they are quite different.
I see the point that linkage is needed with both items, but we just want to raise this issue for the Secretary.
MR. FITZMAURICE: I just wanted to raise the point on the table. I am fine with it.
LAURA: I just didn’t know if we wanted to consider or acknowledge that OCR has addressed this issue in their December 2002, I think, guidance, where they state that genetic information is health information under the privacy rule, not an identifier.
MR. ROTHSTEIN: Can you repeat that, please?
LAURA: Yes, the December 4, 2002, maybe, guidance that the Office for Civil Rights issued addressed this issue by stating that genetic information is considered health information under the privacy rule.
MR. ROTHSTEIN: What that was referring to is genetic information about specific individuals, not unlinked information.
I think the better reference for OCR is where OCR has previously stated that physical specimens, blood and physical specimens, are not considered to be — that is, unlinked are not considered to be — identifiable.
If we didn’t come up with this rule or this interpretation, because there is DNA in everything, you conceivably couldn’t do any research on anybody without their authorization, even if it were anonymous.
MR. FITZMAURICE: Mark, it may be splitting hairs, but it is one thing to say, you have my hair, which contains my DNA, and another thing to say, here is the representation of it written down.
MR. FANNING: May I ask, is there anything in this discussion that is intended to lead to a change in this text? If somebody wants a change in the text, they should indicate what it is.
MR. HOUSTON: What we are trying to do is identify an issue that researchers are concerned about with regards to DNA samples.
I mean, it is an area of research that I guess is growing, although there is a more general OCR guidance, unrelated to research specifically.
This has specifically to do with the research and whether there is a way to get a clarification that still allows researchers within that realm to continue to use DNA samples that are unlinked for a variety of purposes.
MR. FANNING: So, the question is, does this text reflect the question that you want to call to the attention of the secretary.
MR. HOUSTON: I think it does.
MR. FITZMAURICE: I think it does.
MR. HOUSTON: Mark, is that a fair representation?
MR. ROTHSTEIN: Yes.
MR. FANNING: We can discuss later, not on the record, the comparison between SSNs and DNA and the like. I have a question about something else in this paragraph, and I am sorry i didn’t look into it earlier.
First of all, this really should be broken into two paragraphs, because DNA is one thing, but clarification is also needed on the applicability of HIPAA to indirect participants and multi-institutional studies. What is the issue about multi-institutional studies?
MR. FITZMAURICE: Conflicting burdens from different IRBs.
MR. FANNING: That is a generic issue in multi-institutional studies, and it has existed for many years.
MR. FITZMAURICE: In many cases, you could combine data and the IRB really didn’t care. Now the IRB is charged with looking at data.
MR. HOUSTON: We need to get through this last part, and I know in the recommendation section there are a couple of things that I want to discuss. Do you want me to read through that section C?
MR. ROTHSTEIN: Please.
MR. HOUSTON: Part of the hearing was devoted to permitting covered entities and consumers to protect testimony on a broad range of issues.
Several witnesses expressed concern about the privacy rule’s requirement for accounting of disclosures of PHI.
In particular, many covered entities believe that the accounting requirement is burdensome as a result of many disclosures required by law.
Compounding the burden is the fact that many mandatory reports are submitted on paper, because automated systems for filing the reports have not been developed.
At the same time, the number of requests by consumers for an accounting of disclosures, to date, has been extremely small.
Witnesses also expressed concerns about the need to distribute notice of privacy practices and to obtain and maintain the corresponding acknowledgement in non-traditional medical treatment settings.
For example, cholesterol and blood pressure screening are often provided at health fairs, and flu shots are often provided in such non-traditional settings as shopping malls and subway stations.
Witnesses questioned whether it was necessary for covered entities to provide a notice of privacy practices in these circumstances.
A witness representing consumers suggested that OCR should expand its enforcement activities beyond merely investigating complaints, to include compliance audits.
MR. ROTHSTEIN: Let’s take this up before we get to the recommendation bullets. John, did you have things you wanted to change on this?
MR. HOUSTON: No, actually.
MR. COHEN: Mark, actually, I had a question about just one sentence, which happens to be one paragraph, which happens to be the last paragraph.
I mean, it is not that I have a strong feeling about it but it just seemed like a very odd final paragraph to our substance here. As I read this, I can’t decide whether — I mean, we wrote it down but —
MR. ROTHSTEIN: We did have consumer witnesses and we didn’t have anything else in the letter that directly addressed concerns that were made to us.
So, this is a statement of what one witness representing consumers said, and it is not followed up by the committee in terms of a bullet or recommendation.
MR. COHEN: I guess that is fine. That is what it sort of sounds like. It just is odd being the very last sentence before the recommendations.
MR. ROTHSTEIN: I agree with you. An argument could be made to delete it as well.
MR. HOUSTON: Could I make a suggestion?
MR. ROTHSTEIN: I just didn’t want to write the whole letter and ignore the fact that we had consumers appear and testify before us.
MS. GREENBERG: The other two paragraphs don’t have anything to do with consumers; right?
MR. HOUSTON: This is sort of a catch all, I think.
MS. GREENBERG: If the only thing that has to do with consumers in these three paragraphs is this last sentence, or this one sentence, I would actually highlight it and put a little heading, consumer testimony.
MR. ROTHSTEIN: We don’t want to highlight it.
MS. GREENBERG: It is kind of a strange combination here.
MR. HOUSTON: Can I make a suggestion? Either one of two things, one, after that sentence and before, based on the oral and written testimony we need to have a heading that says conclusions or recommendations.
MS. HORLICK: I was going to say, in the last sentence of the paragraph that begins, witnesses, I thought maybe we could say, witnesses questioned whether it was necessary for covered entities to provide — and then insert, and maintain — a notice of privacy practices. I know we said it above, but I think that that is part of what the real problem was.
MR. HOUSTON: I agree. That was something I had actually tried to put in a different way.
MS. HORLICK: We say it is burdensome to give them out in those non-traditional settings, but also there is a big question about who is going to keep track of them.
MR. ROTHSTEIN: We need to make that language —
MR. FANNING: I have provided some text here which we haven’t given out and which hasn’t been incorporated that might help this.
It would cause the last sentence to read: Witnesses questioned whether it was necessary for covered entities to either provide a notice of privacy practices in these circumstances or require that acknowledging the receipt of the notice of privacy practice be tracked.
MR. ROTHSTEIN: That is fine.
MR. HOUSTON: I think that gets across the point. I know we want to get to the conclusions and we don’t have much time. Do we have any other comments? Great. Do you want me to read the conclusions, then?
Okay, we are going to put a heading on that, recommendations. Based on the oral and written testimony presented at the hearing, NCVHS recommends the following:
OCR should continue to expand its education and outreach activities, and special efforts should focus on public health reporting.
HHS should clarify that states can designate school nurses as public health officials, thereby permitting disclosure of immunization records to school nurses without an authorization.
MS. GREENBERG: We need to change that one, though, to clarify that a disclosure of immunization records to school officials without an authorization is a public health disclosure. Isn’t that the way we changed it?
MR. FANNING: Yes, so that has to be rewritten and I will do that.
MR. HOUSTON: Anyone have any objection to what Marjorie —
MR. ROTHSTEIN: I think Marjorie has it exactly right.
MR. HOUSTON: Next bullet. . HHS should consider creating an exception to the accounting for disclosure requirement for reports of suspected child abuse or neglect.
The next bullet point, which is one that I think we are going to have to —
MR. ROTHSTEIN: The only thing that I would say about that third bullet, based on what John Lumpkin said yesterday is, do we want to have the language say HHS should consider creating an exception or do we want to say HHS should create an exception?
MR. HOUSTON: I like your comment, Mark. Let’s make it an actual statement.
MR. FANNING: Is this the child abuse and neglect one?
MR. ROTHSTEIN: Yes, it is the third bullet. We would make it, HHS should create an exception.
MR. HOUSTON: It is a recommendation. So, it would make sense.
MR. FANNING: Laura points out that what we are really talking about is not the accounting, but the right of the individual to see the accounting, and we will conform that.
MR. HOUSTON: The next bullet point — this is a preface — is one that I think Mark had said, or we had decided, should go before the full committee for discussion. So, it probably doesn’t make sense to discuss this now, but at the later meeting.
HHS should consider allowing covered entities to perform accounting for routine disclosures for public health purposes, in a fashion similar to that currently permitted for research purposes. That was a proposal that I had made. Mark, I think we wanted to table that until the afternoon?
MR. ROTHSTEIN: Yes, because on the call it was just you and Richard and me. Simon was not on the call. Because it did not come directly out of the hearings, I thought that we would just insert this as a place holder and let you raise this before the full committee. That is still my feeling now.
MR. COHEN: For the record, I support John Houston’s position about this one. I think you are right, probably raising it to the full committee makes sense. I don’t know, Mark, what the vote of the subcommittee was on this one. I presume it was a split vote.
MR. ROTHSTEIN: I am not sure we took a vote. We were divided. It was going to be a two-to-one vote one way or the other and, given the fact that our letters come to the full committee, I thought it was not a good use of our time, to debate it among three people and then re-debate it among 15 people.
MR. HOUSTON: The next bullet point, HHS should make further efforts to harmonize the privacy rule with the protection of research subjects rule in the two following ways:
Sub-bullet, the permissibility of general research authorizations and, second sub-bullet, on the permissibility of soliciting authorization from potential research subjects before IRB approval.
I know I have a problem with this because I think what we had talked about was much broader than simply those two sub-bullets.
I think that either we should remove those two sub-bullets, because I think the body of the letter speaks more fully of what we had proposed.
MS. GREENBERG: I think you could just say, to address the problems described in section B, or something like that.
MR. ROTHSTEIN: I think that is an excellent suggestion.
MR. FANNING: I think we will not use the word harmonize. We will speak of addressing the problems about relationships between the requirements of the two rules. Is that the concept?
MR. COHEN: Harmonize was, I guess, a gentle and kind way, but I agree.
MR. FANNING: It is much less specific now.
MR. HOUSTON: So, you are going to propose some language for the final letter.
MS. GREENBERG: If you don’t say harmonize, then you are suggesting the common rule might be changed also, which might be one of your options. I don’t know.
MR. FANNING: That is up to the Secretary. Note the problem and — this is one department.
MR. HOUSTON: Next bullet. HHS should clarify that nothing in the privacy rule requires or precludes IRB review of stand alone authorizations for use or disclosure or PHI for research.
MR. FANNING: Does that capture it? That is what we discussed yesterday.
MR. HOUSTON: Sounds good to me. Final bullet. HHS should consider permitting an abbreviated notice of privacy practices for non-traditional treatment settings.
I think that that needs to be changed, personally, and I had to propose other language, which is, HHS should consider permitting an abbreviated notice of privacy practices for use in non-traditional treatment settings, or foregoing the requirement that the receipt of the notice of privacy practice be acknowledged or tracked.
MR. ROTHSTEIN: That is consistent with the language that we had. I have no problem with that.
MR. HOUSTON: It closes, we appreciate the opportunity to offer these comments and recommendations.
MS. GREENBERG: I don’t like that.
MR. HOUSTON: We have got to change that.
MS. ROTHSTEIN: Marjorie, do you want to change that?
MS. GREENBERG: That is fine.
MR. LOCALIO: I have two points I thought were not reflected in the recommendations. One was the testimony of people who said they were getting conflicting advice from CMS and OCR.
That I regard as inexcusable, and there is no recommendation about having OCR get together with CMS and make sure that advice is consistent.
The second point is, I want to ask the subcommittee, what is the role of the subcommittee in conducting hearings into the indefinite future to monitor the progress of the impact of the privacy rules on the affected parties.
Does the subcommittee want to do this indefinitely, or does it want to recommend to the Secretary that the Secretary at least ask OCR or another appropriate entity to regularly monitor the effect of the privacy rules on public health, research and whatever — immunizations, school immunizations and what have you.
MR. ROTHSTEIN: I will address those in reverse order. First, we had previously recommended, I believe last spring, in a letter to the Secretary, that a program be established to monitor the effect of the privacy rule on covered entities and beyond, in very general terms. So, we are committed and have already stated that.
I believe it is certainly within the responsibility of the full committee and the subcommittee to hold hearings periodically on issues that we think are important, and we have identified three more for our next round of hearings.
I also believe that they are very helpful. We learned a lot in this hearing that we are reporting on, as well as the one that we just concluded, that we will have a letter coming up in June reflecting our recommendations based on that. I think that the course that we are proceeding is fine.
On the other issue, we did not address everything that was recommended to us. That is correct. We have, on many occasions, suggested what you are concerned about, and that is conflicting information.
MR. LOCALIO: Do you want to do anything in this recommendation? Do you want to hold off on that? What do you think?
MR. ROTHSTEIN: I think at this point it would not be my inclination to try to draft language to reflect that.
MR. HARDING: I think that, if we were going to do that, that is something we had talked about before, and we would need to kind of review some of the recommendations we had made as an introductory paragraph, or something that I think would get us into time problems here today.
MR. HOUSTON: The other point is, too, we are going to hold more hearings. This is more of a global consideration and I think these were specific to the actual reactor panel’s concerns on specific topic areas.
MR. LOCALIO: Do you want to then leave open a hint in these recommendations that you will be forwarding additional recommendations as the hearings proceed, or something like that, just to leave yourself the open door to address additional issues as they come to your attention?
MR. ROTHSTEIN: We could do that, if the subcommittee feels it is necessary. We did indicate, in the opening paragraph, that this is — that the hearing is the first of several to be held.
This is like the 10th letter that we have sent to the Secretary over the last three years, and he knows we are sort of regular correspondents.
MR. FANNING: I wouldn’t presume to give legal advice, but I would note that these activities are within the statutory command to the committee. So, an assurance to the Secretary that we are going to keep doing it wouldn’t necessarily be needed.
MR. ROTHSTEIN: Are there other suggestions?
MR. COHEN: Yes, I would move adjournment.
MR. ROTHSTEIN: Before we adjourn, if you look in the book under our agenda items, Kathleen, of course, could not be on the call, and she and I will distribute to the committee members a draft of our proposed letter dealing with banking and the other issues that we discussed that will reflect, we hope, the subcommittee’s agreement on those issues, and we will get those to you.
We also identified the next three issues that we want to deal with, that are listed in your agenda. If there are no objections, we will distribute a survey on the most appropriate times in your schedules for us to schedule a hearing on those issues.
MR. FANNING: Sounds fine.
MR. ROTHSTEIN: Now I will entertain Simon’s motion, and thank you all. John Fanning, would you mind e mailing me a copy of the changes?
MR. FANNING: Yes, I will prepare a new text based on my understanding of this discussion and circulate it just as we did the previous ones.
MR. ROTHSTEIN: Thank you, and I would ask John Houston if you wouldn’t mind taking the lead on presenting our report this afternoon.
MR. HOUSTON: I will do that.
MR. ROTHSTEIN: Okay, thank you all.
[Whereupon, at 10:00 a.m., the subcommittee meeting was adjourned.]