[This Transcript is Unedited]
Conference Call-11:00 a.m. till 1:00 p.m.
Operator: This is specialist 474 with conference ID PJA5091 for Marjorie Greenberg.
Marjorie Greenburg: Good morning. Hello?
Gary Christoff: I'm still here. I don't know who the new one is.
Operator: Pardon the interruption, this is the AT&T specialist. This conference is being recorded.
Marjorie: I guess she's telling us that it's being recorded. Okay.
Gary: Yes.
Marjorie: That's all right.
Gary: Well does the extension of the window help having a second conference call?
Marjorie: I think definitely, otherwise it really might not be practicable. Hello, good morning.
Mark Rothstein: Hi, this is Mark Rothstein.
Marjorie: Oh Mark, good thanks. Gary Christoff from HCFA is on. I guess what we'll do is we'll let people come on now and then maybe in a few minutes take a roll.
Mark: Very good.
John Lumpkin: Marjorie?
Marjorie: Yes.
John: Good morning.
Marjorie: John?
John: Yes.
Marjorie: Okay, did you get the E-mail from Clem that I just forwarded?
John: I sure did.
Marjorie: Okay, good. We have several on right now, but I think we'll just give people a few minutes and then we'll take a role.
John: Okay.
Marjorie: Sounds like people are coming on the line here.
Simon Cohn: Yes, this is Simon Cohn.
Marjorie: Yes, we'll take role in a few minutes, okay? We're just letting people come on.
Simon: Sure.
Marjorie: We've been reminded, after Gary and I had a little chat, we were reminded by the operator that this is being recorded. What happened here? I'd like to just point out that the table we're sitting at looks like it's about to collapse.
Dan Freedman: Hi Marjorie, it's Dan.
Marjorie: Hi Dan. As I said, we're going to let people sign on and we'll take role. This is Marjorie again. Why don't we take a role now and then see whom we have on? Do the members want to start?
Simon: Sure Marjorie. This is Simon Cohn, I'm on.
Marjorie: Okay.
Mark: This is Mark Rothstein.
Marjorie: Okay.
Dan: Dan Freedman.
Marjorie: And I heard John Lumpkin at one point.
John: I'm here.
Marjorie: Okay, John Lumpkin.
Gary: Gary Christoff, HCFA.
Marjorie: I'm Marjorie Greenberg obviously, and I have here Kathy Jones and Suzy Burk-Bebee here at NCHS.
Gail Horlick: Marjorie, Gail Horlick, I'm on the line.
Marjorie: Oh, hi Gail. Thanks.
Jim Scanlon: Jim Scanlon, HHS.
Marjorie: Hi Jim.
Jim: Morning.
Barbara Starfield: Barbara Starfield.
Marjorie: Hi Barbara, thank you.
Barbara: Calling from Florida.
Marjorie: We never know where to find you.
Barbara: But I'll be back this afternoon.
Marjorie: It's raining here.
Barbara: Oh, I'm going to stay here then.
Marjorie: Yes, but it isn't snowing. That's the good news.
Barbara: Yes, that's the good news.
Marjorie: Did anybody else sign on?
Man: I count five.
Marjorie: Yes. As of Friday we were not sure we had a quorum, but I think we hadn't accounted for Mark and he's on. I know I ran into Kathleen actually Christmas shopping, Kathleen Frawley. She was planning to call in. We know that Bob Gellman is not available, but there are several others who confirmed. We'll give them a few more minutes. I know Clem is joining us, as I got an E-mail from him this morning. Let me see who else, the others who confirmed, Richard Harding, Lisa Iezzoni, Clem McDonaldY Is there anyone from the public who's signed on yet?
Cathy Lester: This is Cathy Luster from Shaw Pittman.
Marjorie: Excuse me Cathy, could you repeat that?
Cathy: Yes, Lester, from Shaw Pittman.
Marjorie: Okay, thank you for joining us.
Dave Shultz: Dave Shultz with the National Wholesale Druggists Association.
Marjorie: Hi Dave. I might mention, by the way, that we haveY
Lisa: Hello?
Man: Hi Lisa.
Marjorie: Oh, hi Lisa.
Lisa: Hi.
Marjorie: I was just mentioning that we did put the draft summary of the privacy and subcommittee conference call from November 23rd up on our web site. We don't normally put up draft minutes, but I thought, we thought it would be a good idea in this case since it isn't really time to finalize them before this call. Particularly those of you from the public participating, just let us know if we've misspelled your names or not included your names. We try to include who participated, but if you aren't someone we've worked with in the past we won't necessarily get the spelling of your name right.
We're a little short of a quorum and we're waiting for certainly Kathleen Frawley as well as a few others.
Barbara: How many more do we need?
Marjorie: Well for a quorum we actually need I think four more.
Man: Three more I count.
Marjorie: What was that?
Man: Three more, we've got six on the call.
Marjorie: Yes, don't we need ten for a quorum?
Man: How many on the committee?
Marjorie: Y plus one.
Man: Are there 18 on the committee?
Man: Oh.
Marjorie: Actually, good point, there are 18 members, but we only have 17 filled. So actually nine would be enough. I was thinking the 18, but we have the one vacancy. Also, even without a quorum we can certainly have a discussion, though obviously notY Yes? Who just joined us?
Anjolie Skoulas: Oh hi, this is Anjolie Skoulas with Congressman Ed Marquee's office.
Marjorie: Excuse me, could you repeat that?
Anjolie: Anjolie Skoulas with Congressman Ed Marquee's office.
Marjorie: Okay, thank you for joining us.
Anjolie: Sure.
Marjorie: Could you spell your last name?
Anjolie: Sure, it's S-K-O-U-L-A-S.
Marjorie: Skoulas. We're just waiting for a few more members to sign on.
Anjolie: Great.
Barbara: This is Barbara, I may not be able to stay through the whole thing, if it goes until 1:00 that is.
Marjorie: Well, it's hard to say how long it will go, I guess, but we'll try to get started in a few minutes. I know a few more members are certainly planning to call in, so I'd like to wait for them.
Dan: Marjorie, hi it's Dan. I also may not be able to stay until 1:00.
Marjorie: Okay, well let's just see how we're going. Well John, I think I'll call the role of the members that I know are participating. If anyone else doesn't hear your name let us know and I'll turn it over to you, okay?
John: Okay.
Marjorie: Simon Cohn? (here) Mark Rothstein? (here) Dan Freedman? (here) John Lumpkin? (present) Barbara Starfield? (I'm here) Lisa ______? (here) Who just joined us?
Clem: Clem.
Marjorie: Oh hi Clem, good. Okay, so we have Simon, Mark, Dan, John, Barbara, Lisa, and Clem, which isn't a quorum yet, but I think we can get started I think. If anyone joins us we'llY
Michael Fitzmaurice: Hello, this is Michael Fitzmaurice
Marjorie: Hi Mike.
Mike: Is this Marjorie?
Marjorie: Yes.
Mike: It sounds like you.
Marjorie: We're just about to get started. We have seven members and we're waiting for a few others, but we thought we could get started, particularly for those who aren't able maybe to stay for the entire two hours.
Mike: Okay.
Marjorie: So John?
John: Okay, I think what we have before us is the proposed letter from the subcommittee. I thought we would walk through the letter. Are there any general comments before we get started on that?
Clem: It doesn't cover 90% of what I think is a problem, but I didn't really study this thing until this weekend. I spent 12 hours on it. I think this could be a disaster if it's actually implemented as it is in terms of locking up care.
John: What I will do, Clem, on that, can you maybe give us some areas where you think thatY
Clem: I've got ten pages of comments, but, well two big things. I think it goes beyond what it has to do to accomplish what it's trying to do. The other thing is that it's really hard to figure out which qualifications apply to which conditions and which cases. A decision table would be a great help just to make sure we understood it. Knowing as much as I do about this subject and reading it for many, many, many hours, it's still really hard to figure, although it's well written. It's a tough subject.
It has a lot of good things. There's a lot of good things. And we needed something like it, but the two major areas that are problematic I think are the minimum data submission because it's a very tedious set of rules you apply. And without the qualifications, well as I understand it actually I couldn't see where regular patient care was exempted from it, which means if you read it literally that you'd have to do that check every time somebody made an arbitrary inquiry. I don't think that's what it means, but I can't find where it's exempted. And there's some place where it says that's the price we pay for having freer access in regular patient care communications.
I think the general notion about trying to get rid of identifiers is going to kill people. It's going to encourage the administrators in the hospital to just abolish identifiers and all kinds of places where we're going to have errors and we're going to end up with great harm.
Then the other general area is giving out the patients their records because it's really a very radical departure from current practice. It could cause a huge opening to privacy. I can tell you anecdotes, I've written them down. We gave out records 20 years ago and we were told to stop by our lawyers because we got sued by a patient to took home his gonorrhea result. His wife saw it and sued the hospital for, no divorced him. He sued the hospital for alienation of ________. We paid $25,000 in a suit.
So if we're going to have this thing where you can give the patients copies they can take anywhere, the physicians are going to need some kind of indemnification against these kinds of suits. And there's all kinds of other things, the estimates of the costs involved, 1.5%, that's without this $300 million advertising campaign we're putting forth, because that's what's going to happen in the privacy notices. And the E-commerce people are really hot to get this data. So there's all kinds of other secondary side effects. I don't think it's going to work through all the, this is a huge, huge computer program that hasn't been tested. We're going to launch a mission to Mars and we're going to crash because we haven't tested it. As most regulations are, they don't understand how big the system is and how many implications there might be to what seemed like simple ideas.
John: Let me if I understand, other than that you think it's great?
Clem: Well I've got a number of specific points where it's either confusing or I support, you know they were asking, arguing for A or B. And the other thing that looms over the whole thing is, like on the research question, it's reasonably good, and that's an area of my interest. But then it says, but we may review all this and change the common rule. So it's sort of like and then looming over there's currently no patient threat of action, but they're pushing for it. So that changes the complexion a lot when you're going to have these new regs, these new pressures, and then on top of that you've got a 30-day notice to get this out, the copies, you've got 30 days to get it to the patient. You can't make a mistake because if you make a mistake you've got their privacy violated. Anybody can call up and say, "I'm John Smith." It's not that hard to get fake driver's licenses and stuff.
Simon: Gentlemen, when Clem's done can I make a comment also? This is Simon.
John: Certainly.
Simon: Clem, are you done?
Clem: Well, like I said, I've got ten pages and I can fit it in a little bit. I'm not finished writing all that I mean to write about it. But there's some very strong, cleaver things in it. I would argue from a minimalist approach. What's broken, let's fix it and then run the system as a real regulation. See what happens and improve like most real life things. I know regulations aren't done that way.
John: Okay, someone just joined?
Kipper: Yes, Kipper.
John: Good Kipper.
Marjorie: Hi Kipper.
Simon: Well come to think if it, this is Simon, I obviously participated in the writing of this brief letter. I think, my feelings are about probably 160 degrees different from yours, since in overall I think it's actually a very good piece of rules. I generally support it. I think there are some areas that need to be improved.
I think the question's going to be that there are probably going to be some things here that we can all agree to as a committee. Then we're all probably going to have independent additional comments that we need to make. I do think, however, you are bringing up the issue, which I think others have also commented on that there is a lot in this and that we need to as a committee decide at what level of specificity we can reach agreement on. There are general comments that we may or may not be able to reach. There are also obviously pages and pages of specific questions, many of which were not addressed in the letter. And as I think we're all doing our analysis at this point we're all generating pages and pages of comments.
So this letter I think is a very good high level view. And if what we want to do is stay at this level, that's fine alternately as I think Bob Gellman commented we may want to look through what's here, decide that we want to, then re-review it sometime since we do have an extension to identify if there's more substantive comments we can make that we're all in agreement about.
Barbara: Does anybody know if Bob Gellman's comments are similar to Clem's?
Clem: I would doubt it.
John: I would guess they're on the other end of the spectrum.
Mark: But I think Bob's problem, this is Mark, is probably that he thinks that we should go into much greater detail in the nature of our comments without going into the issue of the philosophy.
Barbara: And I guess, Clem, you're really dealing with the philosophy I think.
Clem: No, actually I have detailed comments, and I think I'm really probably in line with Bob in that respect. I think that if we're going to say this is good, I don't think you can talk about this at a high level. This thing is a big mugger. Little things in this thing just like a bug in a program can break our system.
Mark: The problem that I see with going into the detail that you suggest is that a committee, especially one that is not meeting in person and is not spending hours together going over line by line, I think it's going to be very unlikely that we're going to be able to do the kind of detailed analysis and get the kind of agreement on particular bits of this. I know that I've submitted pages and pages of detailed comments for myself and my institute, and probably everybody has as well, but it's, I think, unlikely that we're going to be able to reach a consensus at that level of detail.
John: Other general comments?
Clem: Well I guess I was wondering if anyone else who read the minimum necessary carefully thought it could be problematic in operation?
Barbara: Well I guess I did too, but I think I'm more at the higher level and the philosophy is what are we trying to solve and is this the right way to go about it? I have considerable doubts. I don't really think this is all feasible because there is so many value judgements that go into it. There are people that are going to legitimately disagree on. We haven't really set out what the problem is here that we're trying to solve. Clem, you said that and I agree. We're trying to make a general policy to solve I think a rather limited set of problems, but I may be wrong on that.
Mike: This is Mike Fitzmaurice. Clem, you raised the minimum necessary. I think that's going to be a big burden, but it may turn out to be almost no burden at all. The reason is people who have this information will just refuse to share it and avoid the burden. What that means is that researchers won't be able to get access.
Clem: Well actually, yes, I actually had a specific concern. The fact that the entities are responsible and in trouble with it, not the researchers, and the fact that all the burden is on them to do this analysis it looks likeY See the other thing, like the IRB it seems like they should just validate that there was an IRB. They shouldn't have to redo that analysis. It almost sounded like they had to redo it. It said check out all the IRB and verify all the, something to that effect. So that I think it'll chill research except in very culturally attuned environments.
Mike: I think you're right, and one of the problems you point out really can't be fixed by the regulation because HCFA only applies to the three covered entities. It really requires a federal law. And maybe one of the recommendations isY
Clem: Well I disagree. They suggest contracts for the business partners so why not suggest contracts for the researchers?
Mike: Y could work, but Y
Clem: Of course that might be worse maybe.
Mike: Y who gets dinged by the regulatory authorities then has to go to court to sue whoever receives the data and call them to task.
Clem: Well I think if you took a third of this regulation you'd have a much better privacy situation. I think the announcements are great. I think a lot of the carve out I think is actually a good idea, but maybe others won't agree with psychological data. It's very well crafted and it'll reduce that real high sensitivity. I think having penalties, real civil, for misuse of data and getting it under false pretenses. Most of the problems we know about are people giving bribes to get medical data out of places. So I think you can solve immense amounts of problems.
This whole thing about giving out the patient data, I don't think that has anything to do with privacy, I think it has to do with information practices. And I don't think it's even covered under HCFA. Plus, I think it's actually a big opening to privacy. It's going to reduce the security and confidentiality.
Mike: I can see your point. You mean a patient takes the record home and other people see it and there's a breech of confidentiality and nobody really knows whether it came from the patient taking the record home?
Clem: Well even if they did, it still breeches their confidentiality. And who knows who you're giving it to? How can you really, you've got a 30-day do or die window and you're sort to figure out if it's the right patient. Not all works in a small private practice setting where when something's weird they just don't give it. Now you've got to do it in 30 days or you go to jail. So we're going to give out a lot of records that don't go to the right patient.
Okay, and it says things like you should give it in the form that they want. So you can give it as electronic E-mail and they're going to send it to their friends and then you're going to get in trouble for letting them have it. There's no indemnification against this downstream effects of this. And while I'm on that one, you're going to give them a record telling them about a transfer in two level of five, and what's that going to mean to them? I think there were some naïve statements about how helpful this all will be to patients. I think some of it could be, but it needs interpretation just like an AIDS diagnosis. You've got to have some counselor explaining stuff.
John: Clem?
Clem: Yes.
John: Are you responding to the novel or to the regulation itself?
Clem: I guess the novel.
John: Because I think that our focus really, while we may want to answer some of the questions in the novel, I think our focus really ought to be on the regulations.
Clem: I think all I had was the novel maybe. I don't know where it started or ended then.
John: Yes, it was like 300 or 400, it depends on which version of it you had. But there are about the last 20% or about 15, 20 pages of regulations.
Mike: By novel do you mean the preamble?
John: Yes.
Clem: Well I was reading everything. I guess I'm not sure whether I knew what started and what stopped in the document I had. Now maybe it was only the novel. It had the business case, it had the small business defenses. Does that not represent what's in the regulations?
Mike: It represents it, but it's not law. What's in the regulations are the law and the preambles or the novel is like a committee report that Congress passes, only this explains what was in the minds of the people who did it.
Clem: Well if someone's saying that you don't have to give out patient records that way then I don't have a problem. But I think that's what it still says.
John: Right, well I think that that's definitely an issue that we should put on the list. Did we get a new arrive? Did someone new join us? Okay, any other areas that we need to add to the list? Okay, well let's proceed to see how comfortable we are that the letter represents what it is that we want to say as a committee and then if it does then we can move forward. If not then we need to discuss how we're going to proceed from here.
Marjorie: John?
John: Yes.
Marjorie: Can we just take a role again of the members because I don't know whether anyone joined us? But right now according to my count we have one, two, three, four, five, six, seven, eight, and we need one more for a quorum.
John: Okay.
Marjorie: Simon Cohn? (yes) Mark Rothstein? (here) Dan Freedman? (here) John Lumpkin? (yes) Barbara Starfield? (here) Lisa Iezzoni? (here) Clem McDonald? (here) Kipper Secolbia? (here) Any other members that I didn't call? Okay, several who confirmed are not yet on.
John: Okay.
Marjorie: But, I mean, as I said you can go ahead and discuss, but we can't vote.
John: Okay. I'm hoping everyone has a copy of the letter in front of them. For those of you who don't have a copy of our E-mail, you can also log on to the web page. Anything in the introductory paragraphs, the three paragraphs before applicability. We're all comfortable with me saying I'm pleased?
Mike: Well judging from some of the comments, the third paragraph you might want to consider something more strongly than believes there is a need for federal legislation. Strongly or urgently believes there is a need for federal legislation. That may come out as we talk about more of the detail.
Clem: Actually I disagree with the last paragraph. I think this is a very, very rambunctious proposal. It goes all over the place, gets into all kinds of things. And I don't think that it covers, if someone could re-read the HPA, I think HPA says that the Secretary shall create rules and regulations to do security and privacy, right? It doesn't say anything about fair information practices.
John: Yes, but that particular line refers to the fact that it does not cover entities that are not covered under HPA. So if, for instance, you have a record that isY
Mike: Well okay, if you just say that it does not cover all of the records or entities, don't say it's limited in scope. I think it's pretty broadly scoped, too broadly scoped for the specific target it had.
John: Okay, the proposed rule is limited in that it does not cover all records or all entities?
Mike: Yes, I'd like to say that it may be excessive in other areas. But I don't know if I'll get any support for that.
John: Okay.
Clem: It kind of read to me like someone doing a huge grade research project and they just wanted to cover the whole field pretty well, rather than a particular targeted implementation to solve a problem. You might as well get into that. We're in the belly, let's take that out too.
John: Okay, any other comments on the first three paragraphs? Okay, how about applicability?
Mike: On this one, where it says is recommended that the extension of current authority under HHS utilized, you might explain it more by saying go beyond to cover existing programs under HHS authority. People may not understand what extension of current authority means. You might say such as conditions of participation under Medicare and Medicaid, etcetera.
Mark: I don't think that's what the intent of that section was. I think it referred to the statement in the novel part that it's HHS's belief that under HPA it has the authority to cover all kinds of records, but in the regs itself it didn't propose to cover purely paper records. So I believe that that last sentence is the current authority is HPA rather than, say, Medicare.
John: Was that Mark?
Mark: Yes.
John: Okay. I'm still catching your voice, thank you.
Mark: Sorry.
Mike: I'm not sure that the last sentence says that then. It's difficult to interpret.
Mark: Well perhaps it needs to be rewritten, but I think that was the intent of it.
John: Okay, so it is recommended that extension of current authority under HHS be utilized. This would expand Y
Mark: Or perhaps if we just changed HHS to HPA.
Marjorie: I actually did not read it that way, but I guess Kathleen hasn't come on yet. She wrote this.
Mark: Oh really?
Marjorie: I actually thought it meant other authorities.
Mark: Oh, okay.
John: I think what we're trying to say is that where HHS has authority over medical records or systems, for instance under the conditions the participation was mentioned these rules should also be enforced. Is that correct? Simon, are you on the call or Mark?
Mark: Well that was not my recollection, but it's a fair interpretation of what is says. So I suppose the issue is how do we want it to read rather than what's the legislative history behind the sentence.
Marjorie: Yes, I think Linda Sanchez, I believe, participated in the first call. Somebody from the writing team who stated that their analysis was that the probably did with all the different authorities that the department had probably could extend it to all records, but that they didn't feel that under HPA alone they could. So that's why I guess they were asking for feedback. That was what I thought I heard.
Mark: I think there's actually a statement in the novel itself that says that they believe they have the authority, but didn't exercise it.
Jim: Yes I think, this is Jim, I think this is sort of a two step process. The proposed regulation only proposes to cover electronic information transmitted or maintained electronically entered and its manifestation in paper. Comment, though HHS believes that it has the authority to cover all paper records of the covered entities as well. But comment is being sought. So if you believe that, not just electronic records, but all paper records of the covered entities should be covered in this reg. That's what you'd want to say.
You could also say that HHS should consider using other authorities available to cover other entities. You could say that.
Clem: Well really you've got an antecedent and a consequence. And if the question is should we have privacy rules apply to all records I'm 100% for it. If you say this set of rules should apply to all records, I think these rules, as a practitioner I think I'd be killing my friends and colleagues in practice. I think this will be a disaster. Until they sort out the clinical care freedoms from the other ones related to sending out for marketing and all, which are easy and good, we're creating a real big problem.
John: Would it be fair to say that perhaps as a substitute for that particular sentence that the committee believes privacy regulations should be uniform across all identifiable medical records?
Mike: Across all holders of identifiable medical records?
John: Well that's another part. So we're saying that it should cover all records, whether they be paper or electronic and should cover all holders of identifiable medical information.
Mike: The first two sentences of the paragraph I think state that and that's what Dan was commenting on. That last sentence, I'm just not sure what it applies to. It may apply to just what you said, John.
John: I see. So actually all it says is that, well, do we really need the last sentence then?
Barbara: Well remember, we had talked about this at the executive committee. The reason we put it in there is these rules really only are doing that pursuant to HPA. And under HPA you can't cover everything. But we are specifically making the point that HHS has the authority to do it separate from HPA.
Clem: Yes, but I'm not comfortable with the hint that, I at least as a member have a minority report think that these rules are the ones you should apply to everything.
Barbara: Yes, that's another question.
Marjorie: Well that's I think actually the way, this is Marjorie, that John phrased it, that the privacy regulations should be uniform across all forms of identifiable health information and across all holders of such information. It's more neutral.
Mike: But you can't do that under HPA.
Marjorie: No, right. So I guess that's why.
Barbara: That was the point.
Marjorie: It would have to be another sentence about encouraging the department to use its authorities. I was just looking at the summary of that November 23rd conference call. It does state the Linda Sanchez said the department's general council believes the department has the authority to cover electronic records held by covered entities.
Mike: That's right, but I don'tY
Marjorie: I don't know about held by non-covered entities.
John: Right, but I don't think we need to get necessarily tied up in the technicalities. If we as a committee believe that these should be uniform.
Clem: Well if you put a clause in there saying the regulations, there's not agreement on the particular ones being proposed.
John: Right, but see I think that what we're trying to do is not to wordsmith the regulations per se.
Clem: Well boy, someone's got to. Has anyone else read it all really in detail?
John: Well I think that will come as we discuss individual pieces of the regulation. But I'm saying for this particular issue.
Clem: But it's like saying I'm going to buy whatever you sell me. I don't like to do those kind if deals. I like to know what I'm buying. So I'm saying I really want a whole lot of this, but you're going to give me whatever you have. And I know I don't like what you have.
John: But in this section of the letter, which is applicability, either we say we believe that it's okay for certain privacy rules to apply to certain sectors, certain entities and certain documents, or we say that we believe that if there are privacy rules they ought to apply to all documents and all entities.
Mike: And if you want to say the latter, then you need to direct the Secretary to ask Congress to change the law. The Secretary doesn't have it in her power to cover all health information by everybody.
Man: You've already said that in your introductory paragraphs that you stillY
John: But we would urge the Secretary to use all available regulations to come as close as possible, all available authority, including HPA and others.
Gail: This is Gail. I have a memo that's to the Secretary, it's from November of 1998 and it's from Margaret Hamburg and John _____. They're talking about the different approaches that could be taken based on their analysis, of course this was at the time, and the OGC reading. And one of the options is to base the regulations solely on authority in HPA to apply confidentiality rules to information in HPA financial and administrative transactions. And the second option is to base a regulation both on the HPA authority and on other authorities available to the department, example Medicare conditions of participation to regulate information held more broadly by health care providers and payers. Then their third choice, of course, is to base it just on HPA authority and then at a later time to make it broader.
Then they sort of discuss the two options. I only have this in paper, butY
John: Well, but that's an internal departmental memo, whichY
Man: Yes, I don't think, Gail, you want to suggest sharing that, but I think the proposed rule reflects those approaches. I think what the committee is doing now is you're arguing over the content of the protections rather than this general principle of to what extent should the scope apply.
John: Right.
Man: And you may want to attack it separately.
John: And I'm trying to focus us in on just the issue of applicability.
Man: Yes.
John: Do we want to say that the department should use all available authority to try to achieve uniform regulations across medical records, types of records, and across types of entities?
Clem: Well if you say reasonable and uniform, some other cause, caveat in there.
John: Well, but Clem, this is not our only hit at it. We've got the rest of the document to address the other issues.
Clem: Okay.
John: I think we want to make this point.
Clem: Okay.
John: So is that a fair statement of where we think this committee ought to be? Does anyone disagree with that?
Mike: It's certainly a clear statement.
Man: It sounds good. I can't see how one could come up with anything else.
John: Okay. So I think in looking at this we need to change the last sentence to something along the lines of the HHS should use all available authority through other legislation in addition to HPA to achieve this end.
Clem: Well what's the reference of this end?
John: The end is having uniform regulations apply to all medical records and the proposed rule should cover more and privacyY So what we should do is just maybe to solve this is to edit this so that we don=t talk about proposed rule. We should sayY
Clem: Yes, potential rules or a reasonable and, practical and reasonable rules.
John: The NCVHS agrees that privacy rules should be extended to all individually identifiable health information, including purely paper records maintained by covered entities. Having uniform regulations supply all medical records would simplify the burden of these regulations for covered entities to comply with. The NCVHS also recommends that privacy rules should cover more than the three covered entities presently identified. HHS should use current authority beyond HPA toY
Man: Achieve uniform regulation.
John: Yto achieve uniform regulation.
Clem: Okay.
John: Does that work for folks? Okay, anything else under applicability? Okay, treatment, payment, and health care operations.
Barbara: In the second paragraph of that I actually have got a problem. I think the proposed rules are going to really going to badly interfere with good clinical care in my view. And the second paragraph talks about the example. I know the example is given in the proposal. The example if a physician consulting the records of several people. I think we ought to say something about a physician who's not the physician's own patient. It seems ludicrous to me that a physician taking care of someone might not consult the record of someone's child who's also a patient of that physician.
Clem: Well actually I think that that part of the proposal is good. I mean, what we're doing is we're radically re-engineering a system that no one understands. That's what we're doing. So the more we poke around at it the more we're going to break it. I think this is social engineering of a bad kind. If there's a need for privacy, the bad stuff that's going on, the marketing, we can cut that easy with all the regs that are in there.
So I think the problem with the treatment, payment, and care operations is that it's restricted more or it's not clear what conditions apply to what. So this example, I think this is actually good that they try to isolate that, but they kind of then get it all tied up in some confusing things in a number of places. It might just have been my poor reading of it, or it might just be that it could be clarified. But that separation's essential.
If they made it more clear that what we're trying to do is keep patient care efficient and accurate and good and we're trying to stop these obvious misuses, marketing and people buying it and stealing it and putting it in the paper and anybody looking at it who shouldn't be looking at it, the need to know I=m not against. It's just the meticulous definitional levels that are going to be a nuisance and impossible to implement. Then you put rights of actions on top of it and you're going to have people looking for ways to sue. Life is hard enough out there right now.
Simon: Clem, this is Simon. I participated in some of the writing of this section, which I'm not completely satisfied with. There's obviously two issues. One is in the first paragraph it's statutory authorization versus this informed consent.
Clem: Okay, that's right.
Simon: I guess we need to think about if ___ has an opinion or a physician, no I personally favor statutory authorization. That's what we do in California. It works very, very well. Now the other question is this second paragraph, which I thought previously was murky, doesn't really say what either you or Barbara is stating and maybe needs to be brought to a slightly higher level where we express concern that we need to make sure that we do have strong privacy, but that it also needs to inhibit minimally good care and treatment of patients, which is I think what you're saying also.
Clem: Well this particular example I thought was good. It said explicitly the physicians could do the usual things they would do to take care of patients as they do now. It's later in the thing that some of that stuff gets complicated with procedural things, that's all. So I would just take this last paragraph out. I think that that part of the proposal is good. It's trying to separate out the use of data for clinical care and the things that you have to use it for without putting sand into the cogs. But I don't think it's achieved it completely in some other places. So I wouldn't fuss about the last paragraph.
Now the question about forbidding the use of, there's a difference between having statutory approval to do certain things and forbidding the use of permissions. I think that, I'm scared about that actually.
Simon: Well which are you scared about?
Clem: I like the idea of statutory approvals. I like the idea that a patient comes and asks for care, that that's implicit. But if we just yank away that permission form, lots of other things go with it. Like the fact that you say medical students are going to examine you. Where do we put that? It's an awful lot of tinkering at once is really what I'm saying. It might be better to just say that you wouldn't have to do it, but you may if you want.
John: Well let's focus on the two paragraphs. Let's go with the first one first. What it says is that there are two sides. One felt that they are concerned, as Clem just said, that statutory authorization would undercut traditional codes of medical ethics and informed consent should be preserved. The other half says statutory authorization provided a better, more uniform level of protection. Are we agreed that we're divided on that issue? Is there a thirdY
Clem: Well there's a slightly middle ground. It didn't come across clearly that it was saying statutory authorization, what it became clear to me was that it said it was going to forbid the use of consent forms. And I think that you could get the best of both worlds by still allowing the use of consent forms. If they don't mean anything they don=t mean anything. But it makes sure that we sign that document before we treat the kid. There might be just a little fast to drop that off, that's all.
Marjorie: Jim Scanlon, are you on?
Jim: Yes.
Marjorie: Yes, I don't think it forbids the use ofY
Clem: It used the word prohibit. Again, maybe not in the regulation, but it used the word prohibit.
Jim: I think the only place where that occurs in this context, Clem, is where you couldn't condition payment or treatment on such a form. But if people want to continue using such a form, this is meant to be permissive.
Clem: Well I think twice in the document it used the word prohibit.
Man: But Clem I think that, Jim, at least my reading of it said that it was really more meant to be not as a way to condition the treatment on the basis of having to sign the form, which I think makes a lot of sense. You want to have statutory authorizations and you don't want to have to make people sign informed consent or else you're not going to treat them. I'm sure you would agree with that.
Clem: Well I guess I'm not crystal clear on what it said then. I thought it said something different.
Man: Okay, well I guess what we're going toY
Clem: I mean if it said we're going to have statutory authority an organization could still use the standard consent forms if they chose, then I think we have the best world.
Man: Well Clem, I guess maybe what we should do is to get somebody to clarify this one. I agree with you, I think that we ought to, people if they want to use consent forms they ought to use consent forms. I don't see that there's any reason not to do that. It's just that I don't thinkY
Clem: It's really the consent for treatment is what we're talking about.
Man: Right.
Clem: It is as long as the consent, but there's other things you put on there like in the medical centers you let them know that there's med students here and they're going to be involved in your care.
Man: Well I don't think that this would cover the fact that you're giving people permission to have medical students treat you I don't think. I think that's something that probably, Jim, maybe you need to correct me on this one. But I don't believe that the legislation covers people giving authorization to let medical students treat them.
John: No, not for actual treatment. This only applies to the authorization governing disclosure of information, Clem. So if there are in existence forms governing informed consent for treatmentY
Clem: No, it's not an informed consent document at all. It's not called that. It's called a consent for treatment document in most places. It's picked up lots of roles.
John: Right, but Clem, I think what we're focusing in on is the consent for disclosure.
Mark: Yes, this is Mark. I believe in the conference call I originally raised this. The issue that concerned me was section 2.31 of the preamble. Specifically, which is at page 59-940. It didn't go to the issue of treatment, what it was, and I'll quote, and this is from the preamble, for example in the course of providing care to a patient a physician could wish to examine the records of other patients with similar conditions. Likewise, a physician could consult the records of several people in the same family or living in the same household to assist in the, etcetera, etcetera, etcetera. All of these uses would be permitted under this proposed rule. My comment, and I think this paragraph was supposed to go to thatY.
Clem: The second paragraph?
Mark: Yes, was that if physicians could look at other patients with similar conditions or consult the records of several people in the same family, then that would run counter to current medical codes of ethics under which you can't just sort of fish around medical records even of other patients to try to find out information that would be helpful to an individual patient.
John: Okay Mark, is that addressing the first or the second paragraph?
Mark: Well this has been sort of mushed together. I believe that that comment that I made goes to the entire statement under treatment, payment, and health care operations.
John: Okay, but we're trying to focus in on the issue raised in the first paragraph about consent, informed consent versus statutory authorization.
Mark: Well I believe my comments go to that. I was opposed to the idea of statutory authorization. I thought that informed consent, which is the current method, should be retained, but there was divergence on the committee and I think that's what the statement in the letter was supposed to reflect.
John: Right, so the question is given the fact, and Clem was raising the issue that he was concerned about consent forms. And the problem, Clem, I think is that we need to understand that current consent forms give consent to many things. So you might actually consider them, even though they're the same document, they may be multiple consent forms in the same document. Part of it may be a consent to treat, part of it may be a consent to have medical students treat, and part of it may be a consent to authorize release.
Mark: Yes, you're correct, they're mixed. But my fear with the way the regs was written I think it blended them. But there's not, it really needs off conference reviewing of this to get it clear.
John: Okay.
Clem: In terms of the other side of it, I actually disagree with what current ethics now allows. If we have, as we did ten years ago in St. Louis, an encephalitis epidemic, there was some comfort in going and poking around in records to figure out that we had one. I think there's a lot of non-evil, it's very deliberate and it's very directed at good things goes on without having substantial boundaries about what you can look at. We didn=t have to go out and ask permission.
John: Right, so that's under Public Health Authority.
Clem: Well it was actually within the hospital, it wasn't with the Public Health Authority. I think the point is that physicians, I think there is some boundaries where we have a little bit of flexibility in clinical judgement to try to solve problems.
John: See Clem, I would argue that there are certain things that a curious physician may want to research medical records on that they may not be authorized to do.
Clem: That's correct, absolutely. I'm not disagreeing.
John: If they believe that they have an outbreak of encephalitis by involving the Public Health Authority then they are now covered under those provisions to the extent that they comply with that Public Health Authority.
Barbara: Well I don't know John, I tend to come down on Clem's side on that because what we're doing is trying to encourage physicians to do this kind of thing more so that they get the notion of things being in the community.
Clem: I guess it depends on whether you think things are awful right now or you think things ain't bad. The real hard problems we have, the ones we can nail down and identify are not in that area. There's very, very strong oversight about chart searches in our review and anyplace I know anything about. So there's a distinction being a research activity and something dealing with patient care are really quite different. The way this thing is drafted in the beginning I think is quite good saying we're going to allow these flexibility's using good clinical judgement, not research, not curiosity, not random poking around records.
John: Okay, but given what you said and everyone said, is there a way that we want to change the language that we have before us?
Clem: Well the first sentence, the problems is I'm just not in a position to know, I don't have the wording well enough in mind. I'm still worried that there's some wording in this proposal that's going to tangle up the treatment's consent form in a way that it wasn't maybe intended to.
John: Right, but Clem, we've got about another hour left on this conference call and we need to kind of knock this down.
Clem: Okay, what do you want from me?
John: If you could help us focus in on the issues of what we can or can't change.
Clem: Well I'm assuming this letter's not going to go out anyway. Bob's going to have issues. Are we trying to get this done today?
John: Well if we don't have a quorum then that becomes a mute issue, but I would like us to have some time to discuss the remaining paragraphs, and I think we've pretty much highlighted those issues. I'm trying to get now to whether or not, you've got a concern about whether or not this impedes other kindsY
Clem: Yes, my preference for a consent document had to do with the treatment to consent. I'm not in a position to argue a position.
John: Then what I would like to ask you to do is take another look at the regulation itself.
Clem: Okay, yes I will.
John: Okay.
Clem: And actually I like the idea of the statutory permission for informed consent. I just worry about giving off too much too fast.
John: Right, and we're notY
Clem: So I guess I'm more on the majority side on this first one with divergence.
John: Well yes, but we don't have a majority. We just are commenting on the fact that we have a divergence.
Clem: Okay.
Mark: John, this is Mark. Do you think, it's clear that we're not going to resolve this divergence. Do you think it's valuable for us to spend whatever time it's going to take in the future to work out language when it's going to still be prefaced by there was a divergence? Or should we just perhaps omit the whole section?
John: Well I think it will be useful for the department for them to know that we don't have agreement and kind of where people fell out.
Mark: Okay.
Barbara: We can always say there's currently a divergence.
Clem: Well I think this section header is really incorrect. I think the header is not all about treatment, payment, health operations, it's really about statutory versus open forum consent.
Mark: Well, the other headers kind of say what the paragraph's are about. This one doesn't as well. Or you have to add statutory versus informed consent for treatments, payment, and health operations.
John: Okay, we'll do that.
Clem: I guess I'd like to clarify, the second paragraph, are you really saying that under any of these circumstances they shouldn't have that particular authority, Mark, to look in other peoples records, or they just shouldn't have the open to do the clinical judgement sort of care things?
Mark: I think that my view, which is not the unanimous view, it may not be the majority view, it may not even be big enough to be a minority view, is that doctors don't have the authority to start snooping around in anyone else's file for medical information without the consent of those individuals.
Barbara: Well if it's a physician's own patient?
Mark: It doesn't matter.
Clem: Well see the word snooping sort of sets the tone, though.
Mark: Consulting, looking.
Clem: For good clinical reasons.
Mark: Correct.
John: So let me see if I understand this, I've got three patients. I see a patient who has a set of symptoms and some findings and I go back and look at a record, better yet, I go back and I'm contemplating surgery. I knew I saw a patient like this before, I want to see how I did on the surgery. Going back and looking at that second record would be a problem?
Mark: No, that would be okay because you're trying to learn general information about clinical outcomes with certain kind of care. What I'm objecting to, and the example that I use in the call is genetics, where in the assessment of patient A, now you want to start pulling out the files for patients B, C, and D who may be related. When they came in to have their genetic testing done it was under the assurances that this information would remain confidential and they may not have wanted other family members to know that they were even being tested, let alone that the doctor's going to rely on the results to advise other patient family members of their risks.
Clem: But in genetic testing you always do family histories.
Mark: Not necessarily. If somebody wants to come in and not provide the results of their own genetic test result to a relative, that's I believe their choice.
Clem: Absolutely. No one here is saying you should give it out to anyone else.
John: But if in doing the genetic history, because I am the doctor for all of those patients, I know something about one of the other patients that may effect my recommendation in the best interest of the patient who's before me I can make that recommendation without revealing the source of information other than this is my recommendation.
Barbara: Not if you don't remember it. Well I mean I think, Mark, you're logical end of your conclusion to your argument is we don't need medical records. Just give everybody a record of the encounter, let them keep it, then you don't ever have to worry about it. Why would you ever need medical records if you take the position you take?
Mark: The position that I'm taking is you're looking at it justifiably from the position of the provider and what makes most sense to the provider. If you look at it from the patient's position and the patient says this is personal information about me that you can use in my treatment for which I have given you consent. But if you want to use it for other purposes beyond the treatment of me you need my consent.
Barbara: But the physician doesn't have to have a record to do that. The patient can have the record. Well I just don't think there's any logic.
Clem: Well the other thing is, like at our university we ask for permission to look at their records and to use it for research. I guess we can't use it. So a lot of these places are given broader consent, which will be eliminated by this.
Mark: No, what will happen is the broad consent that you now have will be in effect codified and you won't have to get that consent.
John: Can I perhaps suggest that in the interest of trying to resolve this issue that there are three different scenarios? I'd maybe like to get a straw poll of whether or not we're comfortable. Scenario one is physician is trying to figure out a medical situation and they review medical records of patients who are theirs and other physicians. That's scenario A, the physician looks at medical records not belonging to their patients and those belonging to their patient. Scenario B, they look at records only of those patients that they have who are their patients. And in scenario C, which is they shouldn't look at anything at all. How many are comfortable with scenario A, the physician if they believe it's important to their patient care should look at records of their patients and other patients?
Barbara: I agree with that under certain precautions.
Clem: Yes, me too. Plus the fact if you're talking quality assurance or looking at bone implants you've got to do it anyway. You've got a blood bank usage, you've got to do it anyway.
John: So you're sayingY
Clem: You have to look across patients to run your hospital.
John: Yes, okay, but this is without consent.
Clem: Without consent. You have to look across patients to run your hospital. There's Public Health reporting, there's issues about operations, there's issues of expense. We're doing it all of the time.
John: There are separate regulations or portions of the regulation dealing with administration, Public Health, and those issues.
Clem: Well they lump it into treatment, payment, and health care operations. It's all of the same kind of regs. Treatment and health care operations are really entangled.
John: Got that. Scenario A, you've got two people who are comfortable with scenario A.
Clem: Under no snooping, no screwing around, you've got to be approved for research, all of the things we currently operate under.
Barbara: Right.
John: Scenario B, clinician looks at records of patient who they're responsible for. How many are comfortable with that?
Simon: That sounds good to me.
John: Who's that?
Simon: This is Simon.
John: Simon, I assume that Clem and BarbaraY
Barbara: Yes, are in favor of that.
John: Okay, so we picked up Simon. Anybody else?
Dan: I'm comfortable with B as well.
John: Okay, Dan.
Kipper: I'm also.
Lisa: This is Lisa. I'm comfortable with that as well, but I do want to underscore the other scenarios, John, that you brought up, the Public Health, etcetera.
John: Right, assuming that there is appropriate Public HealthY
Lisa: Exactly, or appropriate rationale for it.
John: Okay. Then scenario A, which the clinician should only look at those records in this endeavor for which they have informed consent for this particular examination?
Mark: Except where there are recognized exceptions.
John: Of Public Health andY
Mark: Exactly.
John: And administration.
Mark: Yes.
John: Okay, how many are comfortable with that one?
Marjorie: You said A, but you mean C, right?
John: That's right, correct, C.
Mark: I am.
John: Mark, okay. I think that we kind of outlined, see my problem with paragraph two is it doesn't really say anything, at least by my reading. If we could maybe look at being a little bit more expansive in outlining where our concerns are, that may be more helpful to those who are trying to publish the final rule.
Barbara: I agree with that John. I think it's very confusing the way it's written now.
Clem: Well I guess is the carve out for treatment, payment, and health care operations, which tried to be built, are people opposed to that?
Barbara: Say that again, Clem.
Clem: Well there was a big distinction made between the processes and the requirements and the procedures and the regs regarding treatment, payment, and health care operations then most of the other kind. And I liked that. I guess I'd just like to get a sense of whether many people thing everything should be under the same kind of rules and regulations?
Barbara: Well the problem with that is that's the whole thing. The whole document has that problem.
Clem: No, no, I mean that I think was a fundamental watershed distinction they made and I think that was really very healthy. People doing marketing, it's not the same. These are a bunch of external, some of them are good. Public Health, I mean there's ten or 12 kinds of things besides these, some of which we could argue about, some of which they are arguing about in this document, some of which maybe have been too restrictive, and I have a couple worries about Public Health that it maybe is too hard on Public Health. But this set of things, how the heck can you actually implement, how can you make it work without carving these out? And all my worries mostly are how they didn't carve some of this out well enough, not whether we've got permission or not. I frankly, if we just could continue doing permissions like we did now I'd be happy. But to say that we don't have to go through all of this other rigmarole every time we try to look up a patient's record, sit at a meeting and have a conference to decide whether it's appropriate or not, that's what it could turn into.
Mike: Well that's what I thought this whole thing is all about is to make sure you don't have to do that.
Clem: Okay, so you'd like to carve outY
Mike: If there's a good reason for you to look at it, which is the issue.
Clem: But the problem is if we, well I find that if you have to turn around and ask mother may I, we have a profession that's 100 years old. We're not doing that bad are we? Don't we have any trust in the clinical judgement processes? If we're just giving up on trust I want to get out of this business. It won't work. So that if we're really saying that we're just sure they're always trying to screw everybody so we just should shoot them all, well let's be done with it. But if we lost that much, is it that far gone? This is a business, I mean people care a lot in this business still.
John: Well Clem, let meY
Clem: How are you going to concentrate on keeping the patient alive, handling 15 phone calls, and following all the regs, the patients are going to suffer.
Simon: Clem, I'm not even sure what we're talking about anymore right this moment. I live, this is Simon, I live in a world of a lot of electronic comprised information. And I am not authorized as a practicing physician to just wander through patients medical records.
Clem: No one's saying that, but you don't have to ask permission if I have to look up a patient.
Simon: I'm not saying for patient care I have complete authorization to do it.
Clem: Yes, that's what I meant.
Simon: I just can't say well jeez, I'm going to take a look at a relative or whatever.
Clem: I'm not talking aboutY
Simon: And this is I think what this is trying to say.
Clem: But you're assuming that anyone would do that. You could do it if you want ed.
Barbara: What's missing from this document, I think the whole thing is purpose. What is the intent of looking at people's records? And that hardly gets distinguished at all. We're not talking about intent and mis-intent. And that's really what the whole thing should be built on in my view.
Simon: Well but I think that's what the purposes areY
Clem: What I'm saying is that I say before you can look at any record you've got to call me.
John: Can I have a little control here?
Simon: Please.
John: Okay, I might just summarize again, Clem, I think the purpose of the room here was to make by not requiring authorization was to allow treatment, payment, and health care operations to proceed without a lot ofY
Clem: No, I agree. I'm just trying to hold it that way.
John: Okay.
Clem: I don't want to give up any ground on that one.
John: Can I get a little control here?
Simon: Good luck.
John: We obviously have some concerns. Perhaps we need a paragraph, Clem, if you'd be willing to write it and then we can toss it in at the beginning.
Clem: Okay.
John: Which is to really talk about the kinds of things, the balance, we actually need a couple paragraphs. One is that there are real concerns. People have real concerns because there have been instances where when celebrities get into the hospital somebody looks at their record with no good purpose.
Clem: Yes, butY
John: We've talked about that and we've conducted hearings under security and there's methods to protect it. But on the other hand we have to be careful that whatever's put into place still allows the function of good medical practice.
Clem: Okay.
John: So if we could just, we need sort of a balance statement in the beginning of at least our document commenting that we are concerned that perhaps that's not clearly defined in the preamble or the regulations.
Barbara: Yes.
John: Does that speak to everybody?
Clem: Yes.
John: Okay, then let's move on to minimum necessary.
Barbara: Well I found the third sentence, minimum identifiable form would limit the amount of identifiable data. I think what we meant to say was minimal identifiable form would limit the amount of data that could identify a particular individual. Isn't that what we were after?
Clem: Well this whole paragraph, we could talk aboutY
John: Did we gain or lose? I guess I must have lost.
Clem: I guess you can't sneak off this call.
John: No.
Barbara: This is Barbara. I've got to leave in about two minutes. I don't have a big problem with the rest.
John: Okay, anybody else have to leave?
Man: I'm leaving in about 15 minutes.
John: Okay, well just give me a five minute notice so we can make sure that issues coming up that you want toY
Clem: I've got three problems with minimum necessary in the regs. One of them is it requires that you must make this effort, and there's like 20 things that you've got to check for every request, and I don't think that should apply to Public Health requests. I think that they're systematic, they're repeated, they should be able to do it by policy by past requests. It'll be way too much burden and it doesn't make any sense. I think it applies pretty well to the kind of external requests.
It also seems to apply as a duplication to IRB checking and I think it shouldn't have to. IRB or the privacy board should take care of it for research and not have to do it twice. The third thing is it still applies to patient care in ways that I think it shouldn't.
Barbara: Okay Barbara's off. Sorry, I've got to go. Bye everybody.
Simon: Well I thought that this did not apply to Public Health requests because I thought ____ was pretty clear.
Clem: I couldn't see where it was qualified out when you went through that, it was a different section.
Simon: So can we maybe resolve the issue byY
Clem: Offline, yes.
Simon: That somewhere in there add a sentence saying it is our understanding that this does not and should not apply to Public Health requests?
Clem: That would be good.
John: We can identify that Public Health requests are established by a state law and rules that are published with public comment.
Clem: I think that to reduce the burden so that hospitals still would like to work with researchers. We shouldn't have to have them redo the IRB work. The way that was stated it sounded like it might. If they said they had to verify they had it, that's perfect.
John: Okay, and then we should have another sentence in there, and Clem, if you could write that, that would say this should not require duplication between tasks that are already accomplished by the IRB.
Man: Or privacy board.
Clem: Well it=ll be one or the other.
John: Right.
Clem: And then the third thing is it doesn't seem to exempt patient care from this process. I actually think that could turn out to be dangerous because we'll end up stripping off identifiers and not finding bugs in shipments of data from one system to another. It'll be burdensome because if you read it literally I think it would mean you almost every time you think about a request for patient you've got to, I don't think it could mean that, but I couldn't find any exemption from it.
John: WellY
Clem: Patient care and operations. Some operations I guess you could want to have minimum.
John: But for patient care, if I'm giving care to the patient then I need to know most everything.
Clem: Well yes, I think you could say minimum unless there's a philosophy that could be applied to patient care, but not the procedural requirements that you have to check is there a better way to do this? Is it really the amount necessary? Could I hide the identifiers? Could I do a de-identification? It goes on and on. There's at least 20 steps you're supposed to explicitly decide and report on when you come to a minimum necessary judgement.
John: Did the committee _____ any of those who are on the committee that aspect that Clem is raising?
Mike: What specifically is the question again?
Clem: The way I read this text is that minimum necessary, all of those very specific details like five inches of a long paragraph on the right side of a page that I could quote you later. It says that it applies to everything. It applies to patient care as well. So in other words, saying that the philosophy of minimum necessary should apply and saying that you should segregate users and their access is fine, but the deep things that you'd want to apply to an external request for minimum necessary shouldn't be applied to patient care processing.
Mike: It was my understanding when I read through that and when we talked to it that it was not to take out any data that was necessary for patient care. Now you could stretch that to say could be necessary for patient care.
Clem: The minimum necessary rules are a long, tedious set of things you're supposed to do. I think it did not say, there was no place where it exempted patient care.
John: Okay, so let me give a scenario. I=m working in the emergency department. I've got a patient in front of me with a complex set of problems. I contact a hospital and say can you send me a copy of the medical records electronically. The question is does this minimally necessary provision apply to that transaction? Is that what you're saying, Clem?
Clem: I'm worried that it applies as a transaction when I asked the medical record room in my hospital room for the data.
John: Right, but does that adequately describe the concern you have?
Clem: That's a good example.
John: Do we have an answer on whether or not this provision would apply to that?
Simon: Well the minimum necessary would apply to, it doesn't distinguish between the, it applies to treatment, payment, and operations. You could probably understand the instances where you would want the minimum necessary to apply to payment or something like that. But if you feel that, and there are instances where some medical history a patient would not want to have shared with others as well. But if you think this would be an issue you might want to recommendY
Clem: I think this would be a disaster.
Simon: Ythat it not apply.
Clem: I think it'd be a disaster.
Simon: You might want to recommend that the minimum necessary not apply.
John: Clem, can you prepare some language that we can share with other committee members to see how comfortable they are with it?
Clem: Okay if I can, yes okay. I've got to find and send you an E-mail. You've got to read how much they're telling you to do for minimum necessary. It's not just the sensible.
John: Okay.
Kipper: Clem, this is Kipper. One of the things they ask you to do for minimum necessary is to remove the identifiers at the earliest possible moment. So after you do that then you can never retrieve the information anyway. So the whole thing is mute.
John: Okay.
Clem: It's really outlandish.
Simon: Except that if you ever anticipate needing the identifiers for patient care you just leave them on.
Clem: Well that's a whole other thing. That throwing away identifiers, I don't know where that came from. I've read no rationale for that and I think it's actually a mistake because if we have something happen five years from now that makes that data wishes that we could have gotten back to that patient and they're going to die because we couldn't use it. Like we did some study on the meat and they got mad cow disease and now we've got a treatment for it, I think that's a sin. I think if we want to hide it we should say we should encrypt it in a vault or something. I don't think we should be throwing away this stuff. And I don't know where it came from. I can't find a rational, I can't find a paper that says this is right and holy and the right thing to do.
John: Now this covers disclosure, not storage, right?
Clem: Well there's another part for this, this throwing away data heads for the research area. They're getting rid of their identifiers, destroying the data.
John: Right, but this doesn't cover in the medical record of a patient that I'm seeing.
Clem: No, the minimum necessary rule, though, is very, very extensive and it does imply if you get a message throwing away stuff like Kipper said.
John: But it's really when data starts moving, it's not when data's at rest within your location.
Clem: I don't know. I think these rules of minimum necessary are not just between institutions. In fact I know they're not. And some of them for business purposes it might make sense. You wouldn't want to have your clerks reading gonorrhea results when all they're supposed to do is check addresses or something.
Simon: Minimum necessary applies to youth as well, treatment, payment, and health care operations. So it would apply within an entity as well, but it doesn't mean the entity couldn't hold identifying information. It would have to be careful what it used for other purposes.
John: But doesn't it address when the holder of the dataY
Clem: No, it's everywhere. I may be a little bit energetic about this, but these are some deadly sort of requirements in this proposal, unworkable, gridlocked.
John: Right, Clem you've said that a number of times.
Clem: Okay, well now that you may be believe it because we've got confession ______.
Man: We've got opinions.
Simon: Well it does imply, and there's a lot of folks who are very supportive of the principle of minimum necessary use and disclosure who may have trouble with the individual application. And there are comments that ask for more detail an there are comments that ask for less.
Clem: Right, you're raising issues that are quite common.
John: So we need to revisit that issue because the concern is there is a need for there to be a medical record.
Clem: And some flexibility in its use.
Mike: Well if I could refer you to page 943 it says at the very bottom we note that all the uses and disclosures subject to the requirements of this provision are permissive. The minimum necessary provision does not apply to uses or disclosures mandated by law. Covered entities should not make uses or disclosures or protected ____ information where they are unable to make any efforts to reasonably limit the amount of protected health information used or disclosed for a permissive purpose. And so I think the drafters recognized that there are going to be difficulties and if it's difficult you just do what is reasonable and you can send them the entire record.
Clem: The way I read that was when laws made you give the stuff you could still do it. It doesn't say anything about patient care internally. It doesn't give you permission to do what we would now do.
John: Clem the issue I think, I can see your point if what we're talking about is, if the operating word is send then I think that's a different issue than if what we're talking about is that there is a medical record that exists someplace. We're now stripping identifiers off.
Clem: Well we're talking about many things at once. The minimal distrust ____, if you read that whole section you would not want to practice medicine if you had to apply minimal whatever that rule is to your day to day key patient care operations. Especially if you had sitting over you the right of action, that any mistake you made would cost you your family's future.
John: But this legislation does not give right of action.
Clem: I know, but it's coming. You can smell it.
Mike: This doesn't have the authority to grant such aY
Clem: I know, but if this is given, well that's separate.
Mike: And you can define minimal necessary to be everything that you want.
Clem: You have to have done a procedure. Just read the whole reg about it. You have to do this long, long procedure before you satisfyY
John: We're now starting to go over the same ground again. The issue is where do we move from this?
Clem: I think we should exempt patient care operations from the detailed minimum necessary requirements. It's not practical.
John: Well the reason why I'm asking where do we go from here is because I think we need to better understand what the term is patient care operations that you're using Clem.
Clem: No, I didn't say patient care operations, patient care. The operations sideY
John: Okay Clem, I think we need to define patient care. The difficulty, and part of the problem with these issues are is that people define patient care in all sorts of different ways. And people sometimes hide behind patient care when they're just curious and going searching.
Clem: Well we make that accusation about all these curious people, but let's, if we're going to make these regs why are we going to cover the least, worst, I mean we're covering the worst possible cases and we may shut the system down. If we put the law saying you go to jail if you use it when you're not supposed to, there's a lot of ways to stop the curious browser. I really don't believe there's that much left anymore of that. But where's the evidence that that's still a big problem? And the stuff you talk about the VIPs, they bribe for that. They pay the clerks to get it.
John: Okay.
Clem: So we've got criminal things coming into this. This should help that. We have a privacy policy. We require these regs that everyone must be trained. Those are all good things. There's lots of stuff in these regs that will help all those things without us having to worry about the last mile that anybody could have ever looked at something. You're burning the tapes is the best way to protect that. Or not having the record, as you were saying.
John: Okay. But can we, if we're going to get something done in the next half-hourY
Clem: Well I would say that we exempt all those things, patient care operations from the strict adherence to minimum necessary. It doesn't look like it was written for that.
John: Can you define what patient care operations is?
Clem: Well it's whatever this reg defines them as.
Mike: I think Clem means treatment.
Clem: Treatment, operations, and billing.
John: And billing?
Marjorie: You want to exempt billing also?
Clem: Well I can back off that. It's just that we're doing so much good with the rest of this, this is really tough stuff.
John: Okay.
Clem: I think the easy thing to say is we exempt patient care operations billing from the strict application minimum necessary, but that they apply the general principle. And we could go on to say such as you would certainly have limitations to what type of providers could look at what kind of data. Some of the wording here could still be maintained. The strict minimum necessary requires a whole bunch of criteria be met. And it's going to be very hard if you have a decision to be made every day and you have to go to a committee. Hospitals don't make decisions well.
John: You're right, it's two issues. One is patient care operations and the second one is billing.
Clem: Well I'm using the same carve out that the regs use.
John: Right, but if we're going to make a comment about the regs let's make it the way we want to make it.
Clem: Well I think the truth is it'd be best to keep that, to carve out the same and to give special exemptions for the strict minimal necessary to those three operations because they're operational. And you have thousands of those decisions every day.
John: Okay, but you're saying thatY
Clem: That I'd accept a compromise.
John: Ythat patient care and patient billing.
Clem: Actually treatment, patient care, what is it? Treatment, operations, and billing are the three categories.
Simon: Yes, treatment is the term used on the reg.
Clem: I'm sorry, I=m misstating it.
John: So you're saying that treatment and billing should be exempted from minimum necessary?
Clem: What I really meant to say was all three of those that are exempted, no, exempted from the strict minimum necessary. And there is a strict thing that gives us 22 things you've got to do.
John: Okay so you're saying that treatment and billing should beY
Clem: Treatment, billing, and operations, all the operational things.
John: What's operations?
Clem: It's defined in the reg. They have, it's called treatment, operations, help me.
Simon: It's literally called treatment, payment, and health care operations and they're defined in the reg.
John: Okay, and you're saying all three, treatment, payment, and operations should be exempted from minimum necessary.
Clem: From strict minimum necessary.
John: And what do you mean by strict minimum necessary?
Clem: That's four paragraphs that says all the hoops you've got to jump through. If I could find it for you it would be much clearer to everybody.
Man: Page 54.
Simon: Clem, I'm getting a little confused here. Now, are you talking about the minimum necessary use and disclosure or minimum identifiable form?
Clem: The provision is called I think minimum necessary.
Simon: Well in the paragraph of minimum necessary the committee is, are you saying that we should not have the minimum identifiable form orY
Clem: I don't think I'm saying that.
Simon: Y or treatment, payment, and health care operations or are you saying that we should exempt treatment, payment, and health care operations from having to send things in the minimum necessary use and disclosure?
Clem: I'm saying that I'm going to save your job, Simon. That if we get this out of here all our hospitals will still keep running.
Simon: Well okay, I=m a little confused because really what this addresses is, jeez, I want this part of the medical record so your response is send the entire medical record to the insurance company?
Clem: Well we're talking about bigger than an elephant or smaller than a breadbox. There's a lot in between.
Simon: Well that's right, but this is going along with that principle so I'm just sort of missing, I guessY
Clem: Well the obligation of the regulation is we have an obligation of minimal intrusion. We have an obligation of minimalism in regulations. We have to defend going further, not defend going back to the current state. I think that's all the traditional law and regulation.
John: Clem, we're just trying to define what it is that you think our comment should say.
Clem: I said it. We'd exempt them from strict minimum required, and I just can't find that section that defines it. But others on the conference I think know what I'm talking about.
John: Okay.
Mike: I think I may have a spot where you would possibly want to talk about inserting this. That's on page 60054 under, right about an inch down under B1 where it defines the standard for minimum necessary. It says a covered entity must make all reasonable efforts not to use or disclose more than the minimum amount of protected health information necessary to accomplish the intended purpose of the use or disclosure. Perhaps after that sentence this would be your view that you ought to add there should be a presumption that a disclosure among treating, among health care providers engaged in the treatment of an individual can obtain the entire record. Is that sort of what you had in mind?
Clem: Well that would help, yes. But again, I'm a little, with the 600 pages here I'm not finding the right tab.
John: Given that, and Clem, I'm just trying to pin it down because I thinkY
Clem: Well I think there'll be similar problems across the board in those other three areas.
John: Y that if what we're trying to do is to look at saying that it does not apply to certain things, you listed treatment, payment, and health care operations. Is that what you're saying it should be? Those three should be exempted from the strict provision, which is applying that test to those 28, 20, whatever those things are?
Clem: Yes, yes.
John: That's what you're saying?
Clem: That's what I'm saying.
John: Okay. We've got three things. Now, are there others on the committee, because let me take them one at a time. Are there those that have objections from restricting or exempting treatment from the applicability of the strict minimum necessary?
Man: Excuse me John, are you saying that we are in favor ofY
John: Yes, is there someone who's opposed to exempting that?
Mark: I am. I think it's fine the way it is.
John: Okay.
Simon: Yes, I think it's fine the way it is too.
John: Who was that?
Simon: This is Simon.
Mark: This is Mark.
John: Okay. Okay, Simon and Mark think it's fine the way it is. Anybody else think it's fine the way it is? Dan, are you still there?
Dan: I'm still here. I'm leaving in a moment. I think it's fine for, I think it may be fine for treatment, exemption. I think, however, for operations and payments I would leave it the way it is certainly.
John: Okay, Barbara's gone. Kipper?
Kipper: I think it's fine the way Clem is suggesting to change it. I like that better.
John: You like all three?
Kipper: Yes.
John: Okay, Lisa?
Lisa: I must say that my mind is totally baffled by this at this point. But I kind of agree with what Dan just said.
John: Okay.
Lisa: That I agree with it for the patient care. I'm concerned about the administration and payment.
Clem: Well in fairness, if one could wordsmith it a little more one would still say as a general principle and keep it in mind.
John: Okay and so I think I lean towards clarifying it for treatment, but not for payment and other operations. So I think I'd lean with the way Dan's described it. So we obviously have some disagreement. And I think our druthers in rewriting this would be to say that there is some disagreement on that and to kind of give it a feeling that it appears that the majority would favorY
Clem: At least exempting treatment.
John: Yat least exempting treatment, although there were some who felt that it was fine the way it is and others who are concerned about it, well there was a significant portion who felt it was fine that there was, a significant minority.
Lisa: This is Lisa. I'm concerned about words like significant minority given how many people we have on this call right now.
John: Well this is not going, I'm really talking about giving direction to the committee for the next draft because we do not have a, there is a minority and we can define it when we get toY
Lisa: Right, I don't think we can quantify anything about what we're doing right now.
John: Right. Even the majority.
Lisa: Yes, I agree with that.
John: Okay. And obviously we will have to try to have another call in late January.
Clem: Could I, I found the page where in the narrative it's discussed. It's 59943.
John: Okay.
Dan: John, I'm going to sign off now.
John: Okay, thanks Dan.
Dan: Okay thank you, bye.
Clem: There's like seven inches of column of text that describes what must be done.
John: But we're moving on.
Clem: I just suggest everyone read that.
John: Okay, law enforcement. Anything on law enforcement? Okay.
Clem: I don't understand the issues on law enforcement.
John: The issue is, what they're saying is that excess should be based upon a warrant, which is different, a higher test than just saying I'm the police chief, I want to look at a medical record.
Clem: Well I thought there was already a compromise, that they said they were going to have to do some judicial, there is some other provisions in it, but it's stronger than it used to be.
John: So what you're saying is that we want stronger protection?
Clem: Okay, I can't say that because I don't understand it.
John: Okay, well take a look at that because that we'll come back to the full committee when we take our vote in January. Anybody else on law enforcement?
Marjorie: That was a little, this is Marjorie. It's unclear to me. I don't know whether, Mark, you can clarify what the requirements that are in here I guess do stop short of saying that a warrant is necessary.
Mark: Correct.
Marjorie: Okay.
Mark: And this, the way it's drafted and the way we discussed it on the prior call was that if there's an emergency, you're chasing after somebody and he's bleeding and you want to see their records and so forth, you can do that, but there should be some way of monitoring to make sure that that isn't done excessively. So in other words, after there's been an emergency disclosure then there has to be some notification to the department that there was this without a judicial warrant.
John: Okay, anything else under law enforcement? Relationship to state laws?
Clem: I don't know what the issue is here too. Who's against what and who=s for what and why? This is asking for a change?
Man: In the proposal?
Clem: Yes.
Marjorie: It's just adding a suggestion.
Mike: It would add, Clem, the proposed rule allows for a state to request interpretation or ruling on preemption. And in this case I think they're suggesting, the comments would suggest that this be publicized so that citizens of the state knew. I don't think we have a requirement like that.
John: And I think it should say to exempt a provision instead of accept?
Mike: That's right.
John: So a state may write to exempt a provision from preemption?
Mike: Yes, that's right.
John: And then we're suggesting that notice be given to the citizens prior to that. Any problem with that?
Clem: No, sounds good.
John: Okay, definition of protected health information.
Clem: Well I'm not sure whether this then applies to their ability to get records then too. Because then you get into some real tangles about schedules and everything else that's in the record.
John: I'm sorry?
Clem: Well, I can't remember how the definition of protected information extended to the ability of individuals to get their protected information, get copies of it because if it does, I think it does, then the incarcerated person can get all the details about when they're scheduled to go where.
John: I see.
Clem: I think that some of the rationale, and I actually thought it was fairly reasonable, but I don't understand the strong ethical issues here because you have all kinds of special circumstances including, it's just tougher. Has anyone worked with the prisons? We do here and they're tougher because they often just want to get away. There's occasional attempts to free them when prior knowledge of where they're being sent somewhere is known. We had that happen in our hospital.
John: So you would be looking to say thatY
Clem: Well these things interlock a lot and just to say that you'd give them the protection and all of them that follow, I think some of them would be very, very difficult to operationalize.
John: This exemption would not include access to information that may jeopardize the safety of the facilities or the ____ incarceration or something like that?
Clem: Yes, but that's kind of what they said in the original rationale for the position in the document. Sort of there are special circumstances and special needs to know and special issues occur. But there's a contagion issue within the prison.
Kathleen Frawley: Hi, this is Kathleen Frawley.
John: Hi.
Clem: So I guess it would be nice to have someone who knew that side arguing about it. I just think that if you let them get their records you can have special problems.
John: Kathleen, we've been walking through the letter.
Kathleen: Yes.
John: We're now on definition of protected health information.
Mark: This is Mark. This was pointed out to me by the people who run the Texas Department of Corrections Health System. It was their view that the same rights that are accorded to other individuals with regard to their health records should also apply to the inmate population. If necessary for security reasons to clarify that I would be willing to support the language that John read with an exception for security and safety and other things. But as a general principle this is a vulnerable population that we recognize and have special regs for dealing with research. And now to make their medical records an open book and not subject to any restrictions under this law I think is a mistake.
Clem: Is that what it does? I didn't appreciate that.
Mark: Yes, they are totally exempt and not covered.
Kathleen: They have no protections whatsoever.
John: So would it be safe to say we need a sentence or something that would say that this would not be intended to give access to items that may jeopardize security such as schedules?
Mark: Definitely. And conceivably there could be something else in the record, contraband smuggled in by X givenY and you might need for security reasons to have an ability to redact some of that for safety reasons. But as a general proposition I think they ought to have it.
John: Okay. Well we'veY
Clem: Can we add one other point and that is the whole issue of distributing patients records at all with the discussion I had earlier? Firstly, is that covered under HPA? I think that should be addressed. Secondly, does it increase or reduce privacy?
Simon: You mean the set of fair information practices, Clem?
Clem: Yes, I think that's a very, very, very intrusive, it's awfully intrusive. And it's especially difficult when the ability to identify the person asking for it could be in question. In fact, the regs even confessed that that you can't be sure absolutely who they are. What we're really saying is that anybody can ask for their record and within 30 days you've got to give it to them. And you can't be absolutely sure who they are. Plus the fact they're going to leave it around all kinds of places. At the very least there should be some ability for the provider to have some kind of indemnification against suits if they use that record in some form and it does them harm because someone else in the family reads it.
John: WellY
Clem: I mean, I'm telling you, we had that harm here as a suit ten years ago.
John: Well yes, but they sued and a $25,000 settlement in my mind means it's a plaintiff loss.
Clem: Oh, well tell that to our banker. This is a county hospital, $25,000 is a lot of money.
John: Well that's true, but $25,000 says we just don't want to litigate. It doesn't say that they would have lost the suit.
Clem: No, that's true.
John: No, that says you go to a tattoo parlor and have them tattoo your medical information on your forehead and then you decide you want to go in and sue your doctor, I don'tY
Clem: But I think there should be something explicit in here because there is that real, they did sue. And they took the data. And now here's a case where you're passing it out and basically we're going to pass it out in error states, known error states, no doubt about it. The other alternative, I think there was an option, it's confusing, there was an option for letting them look at it in the site, which is safer for all parties because at least they can't then, if it's someone who isn't them they can't take copies around and distribute it.
John: The problem here is that you can't abridge a person's ability to sue through regulations.
Clem: No, but you can make, well you certainly can regulate, oh it's got to be law?
John: Yes. I mean, I=m not a lawyer, but there are other lawyers who are on the call, but my understanding is you cannot abridge nor enhance their ability to sue through regulations. It's got to be under law.
Simon: Well what we do, certainly this regulation doesn't give anyone a right to sue, but if the state allows certain kinds of suits to be undertaken now this is consistent with those laws. It doesn't give anyone any new rights.
Clem, the only thing I'm concerned about, the HPA itself when it said that we would have to draft these regulations said that we should include the rights that the individuals would have. And it would just be hard to envision such a proposed rule without the set of fair information practices at least as principles. You're worried about implementation I think in terms ofY
Clem: Well there's four or five things. Firstly, as the regulations confessed it's going to be hard to know for sure that the person is somebody who should have the record.
Simon: Well what do you do now?
Clem: Right now it's mutual consent so that it works. If the doctor's worried about it he just doesn't do it. Or mostly, a lot of times sends it to their doctor, not to them.
John: Yes, but Clem I think that that'sY
Kathleen: There's practices every day in the United States where patients are going into hospitals and getting copies of their medical records. There's state law that allows that.
Clem: That's fine. It's not the same everywhere and the practice was not being advertised. This is going to be different. Well, two issues. If it really doesn't matter why do we regulate it? If it really is the same as it is now why change anything? Isn't there still this principle of minimal law, minimal intrusion somewhere? You don't try to over regulate, you try to do just the right amount. So if there's not a problem we shouldn't do it.
If there is a problem people aren't getting enough of it, then we've got to figure out what it does, worry about both sides. What harm could it do? One of them is going to be those records are going to get out and get laying around and it's going to be, and the physicians just can't stall them because they're going to go to jail if they don't do it in 30 days.
The second part of it is that there's a great interest in E-law, I mean in E-medicine. It wasn't clear to me whether you could chose to allow the patient to just look at it or copy it. I think allowing them to just look at it would be safer from those points of view of the patients getting themselves in trouble with the record. But that could be expensive because you need maybe someone to watch them or help them do it.
The third thing is giving it to them without any promise of interpretation, the reg kind of suggests that this is going to be great information to everybody. And I think it could be. But typically you're going to need someone to explain it to you. And there's no reimbursement for explaining medical records as I understand it right now. There's going to be burdens on physicians that we haven't dreamed of. I would guess that with the E medical record systems they're going to try to get everyone to get their doctors to send it to them so that they can have their own personal medical records. And then I can imagine even worse things, but I won't go on with my worries.
I think physicians are going to have a big burden and no one's worried about them from this thing. I think the physician should scream bloody murder. I think the physicians haven't written their notes in any way to anticipate that they should be read by their patients.
John: There's only a few minutes left.
Clem: Okay so then maybe the free form notes should be only from the present forward so there's notice to everybody that it's now something that patients are always going to be looking at. So you can say it differently. And the old free form notes you wouldn't have to give out. That would be another fair split.
John: Okay, can I suggest, Clem, that we're going to have another take at this.
Clem: Yes.
John: If there's specific language that you'd like to insert since we can't do it on this conference call that you would write it up and send it to Kathleen, Marjorie, and myself.
Clem: Okay. Does anybody have any of these same sentiments because I may be standing way out by myself on this one?
Kipper: This is Kipper. There was a paper produced by Ed Sony, he's a professor with Washington University, the other day. He mentioned to how this would lead to dumbing down the medical record where you don't want to write anything down that the patient could construe as offensive or they don't like, things about their weight or smoking habits or family relations or anything that the patient may not like.
Mark: This is Mark. We've heard those same kinds of horror scenarios for 25 years when the first laws were passed giving patients a right of access to their medical records. Most state laws have done this and none of these problems that are being conjured up have taken place to any appreciable degree. So I just don't see it.
Kipper: Mark, I can tell you the last time I went for a sinus infection to my family doctor he wrote all his notes on the tear off margin of the super bill. And I said, "Why are you writing there? That's going to be ripped off." And he said, "That's exactly why."
John: Okay, I think thatY
Clem: Could I just ask, I think if there is evidence I would have loved to see that kind of, if there's evidence and experience that could alleviate concerns about these being great experiments without knowing the consequences. Is there documentation? Have these things been done with the same amount of promotion that this is going to be done with the requirements to send notice continuously? I would feel better if I understood that these experiences really have worked out well and how solid the evidence is. Or is it anecdotal?
Mark: Well I don't know that there have beenY
Clem: How many states have done this now?
Kathleen: 33.
Clem: And they require that all medical records from all sites be given, including psychiatric notes?
Kathleen: In some states there is exceptions and in some states there's a process for psychiatric access.
Clem: Okay.
Lisa: Clem, I think what patients are more concerned about is whether their life insurance company or somebody else is going to have access to their records. They talk to their physicians about withholding information from their records because they're concerned about third parties having access to the information. I think that there is some patient intervention in this too.
Clem: Well how many of these states allow you to send on to another physician and how many of them you can send it only to the patient?
Kathleen: It's 33 states that will allow patient access allow the record to go to the patient directly.
Clem: Okay, and is there any, is it promoted? Do people know in the state that they have that right?
Kathleen: Yes.
Clem: And are there limits on the cost they get charged?
Kathleen: There's variations from state to state what the charges are.
Clem: Okay, is that summarized anywhere?
Kathleen: HIMA has a document that has that.
Clem: I mean is there a paper or something that youY
Kathleen: Yes.
Clem: Can I get it?
Simon: Clem, being in a state where we do this, and we're a relatively large state, California, we really don't have much problem.
Clem: Okay.
Simon: This is not a major issue.
Clem: What's your time limit?
Simon: I actually don't know off hand.
Clem: And what happens to you if you fail?
Simon: What happens is that every hospital orY
Kathleen: Most states it's 30 days.
Simon: We create a process. You have to go to a certain place to apply for it. They meet with you and decide exactly what it is you want to get. They give it to you.
Clem: Do they review it before giving it out?
Simon: What?
Clem: Do they review it before giving it out? There's no reviewing it forY
Simon: What are youY
Clem: I just want to know how it works.
Simon: Prior to giving it out what difference does it make whether they review it or not?
Clem: Well I mean do they just copy the whole record and hand it to them?
Simon: Well I think the question is that you meet with the people to decide whether you want all the record or do you just want a part. Most people, some people want their entire record, others they want the last three notes, they want some lab tests, whatever, they're going to be traveling.
Clem: Okay.
Simon: This turns out not to be the major issue of the ages generally.
Clem: Okay, why are we putting it in federal regulation then?
Simon: Because people like to have the opportunity to do that.
Clem: Okay. I mean, you just said it's not a major issue and 33 states out of 52 have it.
John: Clem, I think what Simon is saying it's not a major issue implementing it.
Simon: Yes.
Mike: It's a standardization effort.
Clem: Okay.
Mike: I think it's a standardization effort.
John: But Clem, if you feel there is a concern we need to toss this into the bucket. We've got now five minutes. Let me just summarize the process that I think we need to go through. We did not have a quorum on this call so I don=t think we're going to be able to finalize it and I think there are enough issues raised that we probably ought to ask the committee to take another whack at the letter.
Clem: I think some of the other members will definitely have some strong opinions too.
John: Right, and I think that those who have strong opinions need to send notes in writing to the committee so they can have those available.
Clem: Okay.
John: Ideally I'd like to take this to a conference call at the end of February, I mean the end of January. And for those who, if we can get the letter available a week ahead of time and have people send in written suggested amendments so everybody will have the written suggestions in front of them when we take some votes. Then we can come with a recommendation.
I also want to remind all the members, and I think Marjorie, if we can send this out in a note, that what we're going to try to do is come up with as much of a consensus as we can and each individual member will be certainly is enabled and urged to send in their own personal comments where they may differ with the committee or they want to go into much further detail.
Clem: Well is there any possibility of getting sort of a table of the qualifications that apply to various parts of the reg? I found it really hard to figure out what limited what. And I think it didn't always limit the way one would have assumed.
John: Is there someone Clem can talk to maybe walk through this?
Clem: Well it's not walking through. I think it would be really helpful to everyone to understand what really applied to what. It could be done with a couple of tables, someone who was really familiar or authored the document could beY
John: Right, and what I'm suggesting, Clem, is that if you can talk with them and give them, by saying there's tables I think there's going to need to be some interchange.
Clem: Oh sure, I'd be happy to do that.
Simon: Yes Clem, I think maybe it'd be worth discussing with John Fanning.
John: If you could work out with him if you think there are some tables you could develop that would help everybody understand the issues I think that would be great.
Clem: Because some of them might just go away if it was really clear that this was excluded for this category.
John: Okay, is everybody comfortable with that approach?
Marjorie: John, let me just clarify. There will be a transcript available on this conference call. It's quite rapid turn around. It was the last time. So when the transcript becomes available I think it would be a good idea for us to circulate it to the entire committee.
Clem: Yes.
Marjorie: As well as to staff who will be working on the revision. Kathleen Frawley, are you there?
Kathleen: Yes Marjorie.
Marjorie: I know you weren't able to participate in most of the discussion, but given that there will be a full transcript are you prepared to prepare the next draft?
Kathleen: Yes.
Marjorie: Okay and Gail Horlick?
Gail: Yes.
Marjorie: Are you still there?
Gail: Yes.
Marjorie: Gail was on the entire call, but as I said there will be a complete transcript. So Gail, if you can work with Kathleen on that.
Clem: The next draft of this letter?
Marjorie: The next draft of the letter, right.
Clem: Well John, I worry about the principal author not being someone who heard it all.
Marjorie: Well, but as I said, there'll be a complete transcript.
Clem: I know, it's not the same though.
Marjorie: Well furthermoreY
Clem: Is John going to be involved in that?
John: Well I think that the committee will need to do, well I think we'll all get a chance to look at that. I think Kathleen will have the lead and then I will take a look at the letter after that.
Clem: Okay.
John: Simon, you're on the committee?
Marjorie: Well I think you mean on the executive subcommittee?
John: Well and on the privacyY
Marjorie: Oh, the privacy committee, right. So and I think that would have to be farther ahead, obviously, than one week before the conference call.
Kathleen: Right.
Marjorie: And so we'll have to work out a schedule on that. Maybe Kathleen, you and I can talk offline about that.
Kathleen: Okay Marjorie.
Marjorie: But meanwhile I will be sending something out to people telling them about this call. I'm really quite concerned about the people who did confirm for the call and were not able to participate. In fact if we can not get a quorum for the next call the committee will not be able to submit any comments. Obviously that's not a result that we want. Now because I'm known for always giving people the benefit of the doubt I'm assuming that some people made an assumption that this was not going to be the final call given some of the other traffic, and as a result had another obligation. But I can't emphasize enough, and I'm speaking to the choir here, but I will make this very clear in what I send out that we have to have as full participation as possible.
Clem: Okay Marjorie, Gallagher will almost certainly have major objections to many things that weren't raised in this discussion so we should be prepared to digest those in some way.
Marjorie: Right, well that's why I'm going to send out the transcript to everybody, urge everyone to send language, as John has said. Not just I don't like this, but this is what I think it should be. I think I would say if you send it to me I'll just make sure that it goes to everybody. Send it to Kathleen for sure and John and me. And John Lumpkin, do you have any objection to my immediately circulating it as opposed to waiting?
John: Not at all.
Marjorie: Okay because I think the more, this is unfortunate that we're not able to actually have a meeting in person around this, but the more people start hearing what other member's concerns are the better. And I think even dialog back and forth as to, like this was educational talking about the fact that the fact that the majority of states have these rules. Some members have better knowledge about some of these than others and certainly staff as well. That's what I=m going to do.
Clem: Kathleen could you give me a pointer to that particular document about the success and history of theY
Kathleen: It's one of the HIMA documents.
Clem: But how do I ask for it?
Kathleen: It's published in our journal. I'd have to research it and send you an E-mail message and figure out how to get it to you.
Clem: Well I could get it if you can give me a pointer.
Kathleen: Yes, let me do that. I'll research that for you today.
Clem: Okay thanks.
Lisa: Bye everybody.
Marjorie: Bye Lisa.
Man: Bye everybody.
John: Okay I hope everybody has a great holiday and Y2K.
Man: Thank you John.
Marjorie: We're losing most people here. Okay, John? Everyone's gone? Kathleen? All right. Bye, bye.