Friday, August 14, 2009

Rough Draft Transcript - HIT Policy Mtg - 8/14

#HITpol meeting to discuss meaningful use and certification of #EHR. The Health IT Policy Committee will make recommendations to the ONC on a policy framework for the development and adoption of a nationwide health information infrastructure, including standards for the exchange of patient medical information.

Committee Membership:


  • David Blumenthal
    HHS/Office of the National Coordinator for Health Information Technology

Vice Chair

  • Paul Tang
    Palo Alto Medical Foundation


  • David Bates, Brigham and Women’s Hospital
  • Christine Bechtel, National Partnership for Women & Families
  • Neil Calman, The Institute for Family Health
  • Richard Chapman, Kindred Healthcare
  • Adam Clark, Lance Armstrong Foundation
  • Arthur Davidson, Denver Public Health Department
  • Connie White Delaney, University of Minnesota/School of Nursing
  • Paul Egerman, Businessman/Entrepreneur
  • Judith Faulkner, Epic Systems Corporation
  • Gayle Harrell, Former Florida State Legislator
  • Charles Kennedy, WellPoint, Inc.
  • Michael Klag, Johns Hopkins University, Bloomberg School of Public Health
  • David Lansky, Pacific Business Group on Health
  • Deven McGraw, Center for Democracy & Technology
  • Frank Nemec, Gastroenterology Associates, Inc.
  • Marc Probst, Intermountain Healthcare
  • Latanya Sweeney, Carnegie Mellon University
  • Scott White, 1199 SEIU Training and Employment Fund
  • Roger Baker, Department of Veterans Affairs
  • CDR Michael S. Weiner, United States Navy
  • Tony Trenkle, Centers for Medicare and Medicaid
  • James C. Borland, Social Security Administration
Meeting Materials:

Rough Draft Transcript below:

Okay, the first action item would be to approve the minutes from July the 16th, are there any amendments? Christine?

I have one on page five, tasked to clarify under action item two, it says that that committee adoption meeting [indiscernible] by consensus, noting for inclusion in the final version of the number of specific at objections, and it used to say, about an aggressive timeframe and I don't think that reflects the entire [indiscernible] so if that could change to a few members, depending on what folks would like, I would appreciate it. And delicate that to Judy.

Any other amendments?

I will entertain a motion to approve them.

And its second.

Okay. Our first point of business is to get an update from that meaningful use workgroup, and George [indiscernible] is going to present. I and the other party that I will sit over here out by substitute job well George presents.

Pour all right, thank you Paul. Thank-you to the committee to the opportunity to present our progress since the last meeting. And I will do the presentation [indiscernible] three slides long.

So the work group before I joined it did a great job creating the 2011 majors, and a consistent set in the very short timeframe. Working [indiscernible] one your time frame and therefore we have a more bigger timeframe to adopt a pays part -- so what we have done in our last to fall meetings is mainly worked through the process and the timeline. Our draft timeline as shown here on slide and I will go through it briefly.

In this quarter, the first quarter 2009, [indiscernible] measures. Let me go on and I will come back to that.

The first thing we need to do is gather more information. So in the fourth quarter we plan to conduct international meetings to form the 2015 and 2013 development and I have a slide on that and I will come back to that. And the first quarter next year will reworking hard on those objectives and measures and around the second quarter will be ready to start working with the HIT Standards Committee to ascertain the availability of a relevant standards for meaningful use.

By the third quarter we will be refining the 2013 Emmy for his criteria to hand over to ONC.

-- initial 2013 Bentleys criteria. Placing back on the fourth quarter doesn't mean we are one to ignore industry for the next year, it just means we think that will be a good time to collect a lot of the data.

I will be covering this of little bit in the next slide, but ran at our last Policy Committee meeting, how we deal with specialties and how many police relates to them [speaker/audio faint and unclear] specialty and that is why that is on a timely and bear. But we will do other things.

For one thing, our choice of the national priorities partnership framework which over Jerry well we think with the public, and we want to continue to use the framework for Army fleas criteria however, the one thing that we discussed on the found is that we are the meaningful use grouping not the United States policy group so there are people working hard on setting the national priorities with health care and we want to work hard for those people rather than reinventing the wheel.

So the N PP is a good source and the others [indiscernible] objectives. Many of them are quantitative measures.

We have invited presentations from both groups of our last phone call and we're looking forward to working with both of them to identify HIT sensitive objectives that are appropriate for the meaningful use criteria and 2013 and 2015 so we see it as a collaboration.

As I said, we need more information to we want to identify public input on caps and measures. And I will have a slide on this to follow, so quickly, specialist and smaller hospitals, smaller practices, safety net providers and patients -- areas are areas we need more information.

We want to be able to assess financial industry response to the 2011 program and of course refiner meaningfully as criteria that was published. In other words, the part that was published in the matrix are not are filed answers, and over time we will address barriers to e our adoption and address mitigation strategies.

We are hoping to have an informational hearing on the people use criteria in October of this year, said the beginning of the fourth quarter to address those gaps. And we're looking for two dividing the meeting into two parts. The first part to cover the criteria per specialist, and the uses of majors relevant two specialist, whether we can use national registries as a way to gauge meaningful use for specialists, and assessing what needs to be developed in terms of new measures. So perhaps a half day on that.

The other half day, there are several topics, some I mentioned on the previous slide -- and I thought the first meeting we would go broadly and look specifically for feedback and -- from New provider organizations. So the spectrum of practices and hospitals and the safety net providers to inform us on not just how we are doing but what we're not doing that needs to be done.

Now I will take any questions.

Any questions from the committee.

Thank-you, Paul, I would like to first commend you for listening to some of the comments and I am delighted that you'll be meeting with the specialties and understanding the impact of the meaningful your secretary on them.

I wanted to clarify something. On that meaningful use definition and measures that are put in place for 2011, there are measures that are going to be required. Two questions, number-one, as a 10 percent that is was relative two hospitals also apply to positions on CP 0E, and also, is CMS going to be able to accept those measures in the documentation? Are they in a position to be able to do that? And so we have established majors and being evaluated on it, are we going to be -- able to do anything with it?

Purse let me say that all of my answers are about our intention because it is now and see him as a 's hands. CBOT is that hospitals would achieve -- 10% to apply to them because our feeling was, if you are going to install a EHR in your practice, or are you doing except documentation and orders, that is the work flow. In hospitals is different. CMS cannot judge the feasibility as far as doctors accomplishing that, but that was our intention.

Whether CMS can accept that, they have a range of options from anything from attestation to actual data that things were being done correctly, so CMS should decide how two best prove it.

I think I will defer to Tony, a member of the committee.

[speaker/audio faint and unclear] CMS, cell ... are you talking in terms of acceptance or terms of the regulation or terms of receiving the measures?

I am just quite familiar with the difficulty many practices are having with PQRI, and I am wondering if the system is able to accept data on things such as structured and what we're seeing with meaningful use. What will your system be? A lot of the question is, that were not ready to do that?

Well, we will not propose in the rule or accept in the final rule anything that our systems can't accept. So if you have something in there that are -- we don't feel our systems can accept in 2011, will propose it as part of the final rule.

Ball up?

So what you're saying basically at this point, attestation might be adequate if you are not there?

We will propose in the NPR M -- we are looking at our systems now and possibilities, and we have regulations and Clarence that will discuss that issue but I don't want to discuss it at this point because we are in a clearance process. But it will be discussed in the rule how we intend to do that. And then of course we have the public comment period where we can receive those comments. But we're looking at a variety of ways of power systems will currently and in the future be able to accept data, so whether we can do it in 2011 or later is something not we will propose in the NPR M which will be out in December.

Thank you.

Any other questions?

Passed by the debt the matrix, and I am kind of going back rates and we may not -- as I looked at the matrix, and I am kind of going backwards, but I am looking at the documentation and the ability to associate that with some kind of LOINK code, but there seems to be a missing piece. And it might be too late. Did I miss that, or maybe someone could clarify?

Image and documentation and dimension LOINK coats -- go ahead.

There will be scanned documents in any medical record that people are going to keep, and whether you associate back two '86 code so that you can bring it up in the context -- I don't suppose that matter is that you need the ability to store documents. I didn't see that in the matrix.

From the matrix point of view, we took the approach, do we do that 500 criteria from what a certified EHR might have or do we look at the Excel blowers that a comprehensive [indiscernible] chart is being used and being used meaningfully? So it didn't come to the forefront as far as being one of the exemplars that we may need to do. We are looking at examining that in the 2013-2015 majors.


Thank-you, Paul. I have a couple of questions also which may come to Tony. We do the meaningful use work and we talked a little bit last time about the challenge of beginning to encompass all of the different dimensions of American medicine. And two in particular, I am interested in what CMS can tell us. One is that the statute says that there are Hospital based physicians who are not subject to the meaningful use incentive program at least in this category for the Medicare funds. Do we want to address specialists.

Is there any clarification yet as to what the boundary is between a specialist who we should be developing measures for as part of the agenda that George described versus those that will be treated separately at because of the statutory plan which.

That is one question, and the second question, at the state level we have been discussing whether the Medicare meaningful use provisions are determined by CMS, or they are determined that the state level, or is there a relationship between federal requirements for the Medicaid [indiscernible]

The first one will be addressed in the regulation, the first one we have been meaningful [indiscernible] hospital based professional and we have some language in a regulation and as I said, it is in Clarence now so I don't feel comfortable about speaking about that. And the second one [indiscernible] and one option would be to have the Medicare program meaningful use objectives as a floor and then the state, if it wanted to add additional to that, they could go beyond that. But we don't want the majors to be below what the federal is, so we can think about it that way, but as much as possible, we want to harmonized and recognize and of course there are some differences between the federal and Medicare and Medicaid programs as well as who is eligible for both programs.

The other issue for the Medicaid is that the first year, the eligible professional is not prepared to meet okay, I have a continuing concern about the majors pipeline and I think the meaningful use subcommittee should give some attention to 2015 early, in order to provide direction to NQF or other major development bodies so we have the measures available to as as an as possible to implement the directions we are going in. There are several categories, like The patient engagement categoric an outcome area where the pipeline is not very robust yet, and I think by as declaring ourselves on those directions, we can attempt measurements [indiscernible] now. We don't need handicapped by using fisherman's that the cult 15 years ago. And the last thing is, does the community has talked about having also a hearing on a patient supplied data services as part of the strategy, and I continue to hope we do that soon because I think that is part of the longer-term pipeline.

Let me just comment on both of those. One, the importance of signaling early what kind of measure we are looking for so that both the industry and any QF who endorses majors early can have that advanced warning.

You will hear later in today's proceedings that N QF is already looking on the 2011 majors and that is the direction, so those are good things but notwithstanding should be working on a 2013 as well.

And the is a thing is as George mentioned, that patients applied or patient advised data is on the agenda to get -- as an as we can. We have other priorities that we need to act on as everything -- everything we have to act on as quickly as possible. But it is definitely in the queue.

And sorry, I've got buried, but it didn't go into the public record on that slide and that was the purpose, to make sure people didn't know that.

One more question, I would like to follow up on Medicaid because as you know, every state, their Medicaid program is unique to that state. Are you anticipating that CMS will allow states to set meaningful use criteria that, perhaps dealing with children, per instance, in Florida, 75 percent of our Medicaid recipients are children that address specific needs to Florida rather than are specific Medicaid program, or do you anticipate collectibles being set for Medicaid across the board?

I think it is premature at this point. Certainly what we're doing now is communicating with the states to find out what some of their needs and requirements are and we will taken into account as we develop the rules for the incentive program. That is about all I can say. I know that we are actively working with the states and also ONC and looking at some of the issues that are related to the state programs, particularly in the Medicaid, as you mentioned, the children's and pediatric requirements are things that we're looking at very closely.

One more follow-up on that. I believe the statute requires that you do 20 percent of Medicaid in order to be eligible. Is that accurate? And is there a way that that can be interpreted to include S Chip? Because we have any providers that do not reach the threshold of the 20%, especially pediatricians, and are not eligible under Medicare, but they certainly need to be part of EHR and it is important that we incentivize them to do that. For as SCHIP, bus practitioners take that.

As you said, they have specific percentages, so we will basically go by what the law says in terms of qualifying for the program.

Is there any committee members on the phone that would like to make a comment?

Okay, and any final comments from members of the committee here?

Okay, Mr. Chair, we have finished up with the first item which is the update from the meaningful use workgroup.

And thank you. I am sorry I am late. I think we will move on to the certification adoption of work group. I guess I should first say hello and welcome. I don't want you to think that we live here at the Holiday Inn, but sometimes it feels that way.

Could I ask Paul and Mark to share their thoughts with us?

Paul has all of the thoughts today. But I get to tee it out.

But you have the jokes.

I don't even have any good jokes. You have seen this before but I just want to reiterate how much work these guys are putting in. Every call and every meeting, they are very well engaged. And also, Paul, his leadership has been tremendous. Over the last month it has been busy for me personally and he has taken a lot of the load.

Nothing on this definition has changed. This is still what we believe certification is and it is focused very much on meaningful use, and that this is not intended to be the seal of approval process.

So as we go to the recommendations that are very similar to the last ones, although we did hear the comments from last time, we're still basing it on the same definition. So these are the recommendations and as I said, Paul will go through each of these. Our hope is to go through them quickly, we have fairly high level bullets on this and then we can get into discussion around certification.

I am appalled Ackerman, and I and the co-host with Mark probes on this. And I will take you through each of the five recommendations. I wanted to make sure that I explain why we are here at all this morning. Basically it is to -- two refresh everyone's memory, we presented last month at the meeting and the five recommendations that Mark Just went through or approved in general but we were sent back to say, provide some detail and make more recommendations on the detailed recommendations and also consider the feedback that you and other people have given us. So we're back today to say that we have done all those things and refined and change recommendation based on comments that we received.

So I will take you through the five recommendations. So now what you see on the screen is like a summary of each of the five recommendations but we have put down three major headlines or bullets on each of the recommendations. If you look at the appendix in your materials, there's a lot more details on each one of these and so that is also aware if you haven't already done so, you read through all of that detail in terms of how that all works.

The first recommendation is to focus on meaningful years. Basically what we're saying with the certification process is it needs to be driven by the meaningful use objectives that fundamentally we want to have what we want to call an outcomes oriented system of certification. And so this is a new certification process. A focus on meaningful use objectives, we are talking about the objectives and the measurements, and to do it at a high level with last specificity. -- less specificity. We're not trying to say how these will work, we're not saying if you have an alert, this is how you do feel there if you have an abnormal value, where just saying you have to have an alert. And we also want you to focus on the objectives. Poor example, if you have an objective with drug drug interactions, that is what you have to do. Even though it is at a high level, it doesn't mean that you don't have to have software that completes all of the objectives and that is fundamentally the road map of what we're trying to accomplish. So that is what we're saying with the first item.

The second item, pre specificity on Interoperability, we will talk about that in a minute, that is almost saying the last -- less is more when it comes to Interoperability. And that is if we want more detail and more specificity and more activity.

The third concept here which is very important is that the current kinds of certifications Tucker should continue to occur as what we call optional certifications that the marketplace might C place value on, and it something that has happened at the last meeting [indiscernible] opportunity to speak with and communicate with Mark Let's, who is the ICCO of HIT, he says he continues to offer the same kind of comprehensive certification processes that he does offer. And so the extent, the marketplace values that and that is terrific and can still be offered, and it even gets the sense that the process is starting to work, because they seem to indicate a lot of ideas as to who is innovative and how he might be able to do that to respond to various elements of our community.

So that is our first recommendation. The second recommendation really calls out the idea that, fundamentally, certification is like a really powerful tool that we have. It is a really powerful public policy tool and since we have this powerful tool, we should use it to address important public policy issues. That two issues womens' out here, the first one of course is privacy. And this is an area compared to the meeting last month that we did, provide a little bit more detail and described as a little bit more broadly, but basically what we're saying, when it comes to privacy issues, privacy relates a lot to policy as to how you do things and how different people interact with each other, but there are also things that the software itself has to do to enable a hospital or physician to implement a policy. And the HHS certified system must have the capability so that a physician or hospital can fulfil all of the requirements of the statute. So everything in HIPPA and everything in ARRA which includes everything like audit trails and consent, and that is like stating the obvious, if the patients don't have trust in the system, nothing else matters. So this is strong statement and should be a priority for certification. The second issue we will hear more about this afternoon as it relates to changes, but basically we are saying, to aggressively address for Interoperability and data exchange.

Fundamentally I think we all know that the exchange currently doesn't exist where we want it to be. And it has been some significant work that has gone on in HITSP and the target teams, but it is time to take that into second gear. Fundamentally there needs to be more work done in this area, and we need to go beyond just harmonizing standards. So there is more information in that in the detail.

The third concept is to create these things called test harnesses, which is basically a way for users to test the systems themselves to make sure the systems comply with the standards and perhaps indicate that something did not it accidently broken.

The third recommendation is where there has been I would say it the most interesting feedback in terms of discussion, but what will Racine that we wanted to do was make sure that we create -- it is better to say a more objective and transparent process. And basically, there are three comments here, but this should not in any way be viewed as any kind of criticism of CCHIT, but the recommendation that there is a lot of money and people involved and we are raising things to a higher level, so the entire process of monitoring and oversight also has to be raised.

The three concepts here are, the first one is two separate that definition of the certification criteria protesting cockpit criteria and testing process. There should not be one organization that it autonomously can handle both. This is not a shocking recommendation and it actually repeats something to the effect of what is in the legislation of A RRA, and the national coordinator Bill does determine the criteria.

The other concept is to permit and out multiple certification organizations, have some competition. The third is to work with the National Institute of Standards and Technology to establish a national accreditation organization and process.

But want to also say we did take into consideration the comments that are made last month, especially a comment by Neil cowman who said, there is a lot of change in the marketplace and how does this all gets communicated.

That is a very important issue and when you go through the detail on the recommendations, he will see that we did address that by recommending that there be a communications and our rich plan because there is a lot of information here, it is not only a change but information and people need to understand in terms of what it means to be HHS certified, and there has been some suggestions as to how to change that to avoid confusion. Perhaps call it HHS qualified, so that people understand that this is just qualification Corps the incentive payment, but a government seal of approval for the product, to make sure that is very clear.

The fourth recommendation relates to the flexible software resources. Basically right now, purchasers, physicians and hospitals sort of have like a menu of things they can choose from. From a single vendor, or do what is best of breed, get things from multiple vendors were developed concepts themselves, and our concept here was to make sure that the certification process did not alter that Joyce and they still have the same acidification to assist. -- same certification choices.

And the common response we heard last month, and particularly that comment from Judy Faulkner to clarify how this will all work, so you have seen this first comment that said, and share all systems are certified against technical criteria, regardless of source. That is basically an argument of level playing field. There can be multiple sources and at vendor and non vendor resources but they all have to be certified against the same criteria. This is a very American statement of the quality.

The second concept, whether it's this same concept of criteria, there can be flexibility to the actual process is themselves. So again, when you go through the detail, you can see that there are things to make things easier in the open source community, and something called the walk down, which sounds exciting but does not quite live up to its name, to make it easier for the open source people and these are people that are unbelievably enthusiastic about their work. We're fortunate to have people like that in our community. They love their work and are building on the good work that has been done in that the Virginia, so we want to make sure they can participate in this process.

The third process is the process we call the component of the system. The idea here is that it should be possible for a purchaser to obtain systems and not have to buy it all from one source. So if you have a vendor or hospital or someone that has a special emergency department system that you really like, you can buy that or buy everything else or develop one section yourself and advise things from someplace else, the schedule a way to do that, as long as you still follow the principle that everything has to be -- you have to meet all the criteria and get the different components from various sources.

So that is the fourth recommendation.

The fifth issue relates to the short-term transition, and this is probably the area that is most different, and we have the most amount of additional information from last month, and this is responding to questions that you had, Gail, and Neil, and in of number of other people, and how is this all going to work in schedules of time? You are pulling forward a new process and putting forward the information, and we have a lot to do, how will this all filtered out and how long will it take? And we have a lot more information to address that.

Purse I will take you through the major concepts of what we have here. There are three major concepts that -- the first one is a very simple concept which says, to leverage the existing certification work whenever possible. The issue here is, you look at all the meaningful use objectives and a fair percentage of that, there is already certification criteria written for that. So if there is already certification written for that, the concept is, why not use it? White reinvented when there is something you can use?

The second concept is in a little more tricky to explain because first you have to understand what is the HHS certification.

That just qualifies you for the incentive payments. So now we are introducing the concept that we call preliminary HHS certification. Well, the way to explain this is, fundamentally, you can't be certified, software can be certified until we know for sure what meaningful use is. But we don't know for sure what meaningful use is until it passes through this whole regulatory process, and we don't know how long that will take, but taking a guess, it will be early 2010 before that gets done.

So rather than just wait until that happens, the suggestion is to establish something called preliminary certification. It is based on the assumption of vendors willing to take a gamble and take a reasonable risk that has been proposed to the regulatory process is probably pretty close to what will come out the other side. It is hard to know if it is 90% or 95% or 98%, but presumably or hopefully it is pretty close, and the suggestion is Penders should prepare their software -- vendors should prepare their software and we should begin certifying against those and recall that preliminary certification, which does not have any standing in the statute. But the process of doing that -- the purpose is, hopefully there will only be small adjustments needed, there will be some adjustment but that will just be a small additional piece that we can attack on. So as rapidly as the regulatory process is done, we are in a position to have HHS certified or qualified products in the marketplace. So that is the preliminary certification, the second concept.

The third concept, and if you have two in Hale to make sure you understand this, we're talking about the 2,008 certification Jack criteria.

The best way I could describe that is, there are a lot of vendors that it all lot of work and get them certified against the 2008 criteria from CCHIT. So those vendors will say, I did all this work and I already got certified and I don't want to have to do that all over again. It is not fair.

Our answer to that is, we will not make you do that. So the concept is, to the extent that the 2008 stratification applied to say, half or three-quarters or some percentage of meaningful use, that part doesn't have to be repeated and it just has to certify to the parts they haven't done yet, kind of like the Gap certification.

So those are the three basic concepts. If you go through the appendix, there is much more detail. And if you read it through the appendix, you have to understand that to do this, we have to get the actual criteria from the CCHIT. We have to go through a whole process with the standards committee reviews the criteria and in the detail, our work group is adjusted to see if we could get CCHIT to submit a proposal by September, and I have to tell you that were extremely pleased by the way that marked Levitt and CCHIT responded to this. But could not have been more diligent and helpful and they have actually completed that work.

In the emails that you all received it yesterday afternoon, there is a complete detailed analysis of all of the meaningful use objectives and measurements mapped back to the 2008 CCHIT certification process indication where there are gaps. And so we now have proposals on how to fill those gaps, he and a rating of the intensity of the cap, so we now have all of the details we need to put this preliminary plan in place. That detail then, the hope is, that can be submitted to the standards committee next week, I understand at a meeting on August 20th, and through the month of August and September we can go to the comments and public reaction as we need to finalize that criteria so that starting in October, we can be any place starting to do testing for preliminary HHS certification, which is very exciting.

So to try to summarize this, because this was a lot of detail and a lot of words, we're looking at a news certification process. I could describe it as outcomes oriented, it is into meaningful use, it has a lot of focus on privacy and Interoperability, and we have a detailed plan and what we are asking for from the IT policy committee is for your approval today from these detailed recommendations, because if we could have these detailed recommendations approved and started on the process, I think -- meaningful use is going clarity on how the software products could be certified.

So that is our presentation. Do we have comments or questions?

I would like to thank Paul and Mike and other members of the certification adoption group, and this goes for all of our members and all of our working groups. There is no way that wicked by the kind of incredible effort and clarity of thought and commitment that all of these working group members have shown. And the wisdom the have brought. So it has been remarkable 4V has a new public servant to see how much public service is provided by the public and it is very gratifying. So thank you, on behalf of the committee.

Any thoughts or comments? And I am sure that you were reminded that this committee is a body that provides advice to the national coordinator, but not to the policy committee.

That was a great presentation. I have a couple of questions. One, I wanted to make sure that I understand -- I wouldn't call in a [indiscernible] qualification for privacy and security. It sounded like you said you're not looking presents to the policy-making but instead of looking to certify but I would refer two as the function of this necessary for the technology to be able to implement some of these legal changes. It is just that sometimes people talk about what they will survive for privacy and security and for many folks that have been much more extended [indiscernible] possible to do that when you are looking at functionality and technology, and that is what I thought I heard but I am looking to be validated.

That is what I intended. You said it much better than I could have. But that is what I intended.

Okay. By second question, with respect to -- I haven't had a chance to look at the work that Doctor Leavitt's said in or he listed the criteria that CCHIT has already developed in the nucleus, but I am wondering if they meet this sort of overarching recommendations that you all set forth which was a high level with respect to the standards so they're not dictating our particular way that something gets undressed except more specificity with respect to Interoperability, so we know we have criteria that will facilitate the exchange of data.

I am not a technologist, saw the cat these criteria and some of them look fairly general and some look for the specific and so I am wondering if that is something that will need to be assessed, because personally I agree, you don't want to have the criteria be so specific that they are hardwiring in a particular approach to addressing an issue unless it needs to happen to facilitate the Interoperability and the ability to exchange data, it wasn't necessarily a specific set of instructions that went to CCHIT under the old regime, so I am just curious if this criteria has been evaluated under that new standard.

I think CCHIT had what they had which was the it meaningful use Beatrix and at their current process, and trying to understand how the two align to.

As I went through it, I thought some of them are kind of detailed more so to the extent [indiscernible] and I think they have been doing an excellent job.

Great. It wasn't meant to be a normative comment about the work in the past but how the list of criteria that they have that has been identified as meaningful yes, to what extent do they meet this additional recommendation you are making today with a higher level with respect to some criteria and more specificity with respect to others.


In looking at HH S specification, will that be done specifically by them and do they have the manpower to do it or set the specific criteria, and if you have to be HHS certified, all that be the definition of HHS certification.

To meet certification requirements, if you are already CCHIT and you get a gaps and dedication, do you need an HHS certification? Also, is N IS T going to be the accrediting body for the other survivors?

I think that was more than one question but I will do my best with it. If I leave something out, I suspect he will remind me.

First, on the issue of N IS T, they will not be the accreditation, because they do not do that. They will be working with ONC to identify and accreditation organization, and to also establish what a good process is for monitoring and surveillance, and that is how that should work.

The other one, to go back to what this means to the HHS certified, but probably will happen is, we -- someone will come up with a different name for that or a better way to name it, but if you look at the definition, that is simply limited to what a hospital or physician needs to do in order to receive the incentive payments. In other words, they have to have a certified System test have to demonstrate meaningful use, so they have two either purchase out or get certified that they have it. That is the purpose for this certification.

And he asked about the CCHIT certification, that is one of those, one of those is the start exception. And that is one of those things that is too complicated to understand how it all works. But if you read through it, one of the things we talked about which is set in consultation with the ONC staff, is to be possible and will be possible that there is one of process that does both the age age as certification and also creates a stark exception if that is necessary.

Does that answer most of your questions?

I specifically wanted clarification as to what the process would be.

He would have to meet HHS certification if CCHIT continues to be the certifying body. You still have to have a certified product. You have to have a test certification, so you have to have two levels.

You only have to have one. You don't have to have anything if you don't want to. But if you want to sell a product or you want to attain the incentive payments, you have to have one. The idea of the optional CCHIT acidification is, if the vendors to stew, they can continue to do that. It is optional, almost like having a merit badge or a ribbon or a credential that is added to that vendors marketing campaign, this is something that they have achieved. But this is an optional thing, but to get the incentive you only need to do this one thing.

So the HHS certification would basically take the place of the CCHIT certification?

I don't want to say takes the place, but the CCHIT will continue to offer what they call comprehensive certifications, and that is there choice to do that, and that will continue to happen. The HHS certification is something that is required to get the incentive payments, so it doesn't necessarily replace it, and certainly no intention to replace it in terms of the marketplace and the value of it.

And is HHS going to delegate that out or are they going to accredit bodies to do that or how do you envision the process happening, and does HHS have the ability to do that at this point? Do they have the money and the allocation to make that happen?

Well, okay, I will try to do my best at some of these questions.

With all of the ONC people in the audience please stand up to ensure it them that we have the staff?

For those of you listening and there are about 400 people standing up behind me. [laughter]

It basically, what we envision happening during the transition period is that, once the criteria is approved by the standards committee, and the very issue that you raised as to be addressed to make sure [indiscernible] CCHIT offering this preliminary certification in October, and once the regulatory process is completed, but in addition, happening is, the national coordinator, we will do whatever the national coordinator does to say that preliminary certifications are now final, that that is how it all works.

On the issue of until we get the accreditation certification in place, we are hoping that will happen. Once the organization is in place, the accreditation organization will monitor the process and the criteria will probably go through some evolution, but there will be one or more acidification and organizations like CCHIT that will continue to do all of the work, and the national coordinator will somehow do whatever paperwork or processed -- I have this picture that you have some giant stamp and a stamp it down really hard and it says approved on it or something, that is the process. You ask questions about having the money or the people power to do that, and I have to defer to them. I don't know that, it doesn't seem like they have a ton of people over there but I then know.

Judy and then Neil.

This is a quick question. Sometimes when I [indiscernible] -- actual topics of meaningful use for much broader and deeper than the measurements. Are we talking about essentially study protest?

That is a good question. The certification process can't just be on the measurements, it has to be on the measurement. And we can't have a system where someone just as a spreadsheet and it tells you the percentage of of people that do that CBOT and the reason that measurement exist so that the objectives are a current.

So could there be a their mission of storm in that say, let's look for this as well?

That is not our issue. I mean, we put together a framework for doing this and if the measurements changed, and we did the right job and found the objectives, it should be possible to change the objectives without a huge amount of effort, but that is an issue for the prior work group.

Or any grouping tested that has a few [indiscernible] just check the depth and breadth rather than just the specific report or other issue being examined?

That is not our work group but I think it is a good suggestion. The second question is can a worker panel that, there is some complex complexity in there as to how they handle the mission of process.

[indiscernible] considerations. That is a good answer.

Purse I wanted to say thanks for focusing on the privacy and security issues and also the educational issue which I think it's incredible.

And then I wanted to ask whether or not you have considered the idea of the accrediting agencies that will allow to [indiscernible] this marketplace. Because I still feel enormous confusion about what will be created by this process.

Imagine that in have the CCHIT group that will have a gap process in place, but meanwhile we will have new organizations coming up, and will get into the accreditation business.

So they create processes used to certify the HHS certified process, and there could be five or seven or 10 of these, if we could say if any of these could show that there were able to certify and electronics [indiscernible] and up with a lot of these and a lot of them could develop HHS plus products. So just like a feature that will have basic HHS model and that they have the wraparound and all these other organizations could have multiple levels of certifications, organization A could come out with the five levels certification program or like an Nancy QA did with medical Holmes, three levels of certification. We just have to be careful because we are dealing with a market place and we're trying to drive adoption and trying to get people to get this to an understandable process as possible, and making sure that we simplify this will be an important.

So one thought would be to limit the number is, it not just CCHIT but no more than three. And I don't even know what the process would be to make that happen. There would only be three and they would be contacted to do this process or it could be completely open marketplace and there could be 10 or 12 different accrediting agencies popping up all over and all of them being accredited to satisfy EHR that they meet the HHS criteria.

We actually did not talk about limiting the number of accrediting organizations and that is something that ONC took the cat as they go through the process.

We saw that NIST as the organization that would follow this through and determine who could be the CCHIT type organizations or the accrediting were acidifying organizations.

It might be a bad analogy, but you could get your car, and inspection done at any number of crashes if they have defined what that car has to pass. Whether it is emissions or breaks or what it might be. The secretary is well defined, it seems to me that it could be a broader range of people and that is specifically what we focused on the criteria, it needs to be identical and very specific. But we did not talk about limiting it at this point.

Just a quick follow-up. I think the car analogy is a good one but it probably oversimplifies. I think what the process is for this other stuff, people will understand whether or not their headlight is out at better than the understand whether EHR meets criteria.

I think the other thing we need to be careful of is that there is a good flows through this process so it does become a roadblock for people, and as this process gets rolled up into organizations are gearing up, we need to make sure that we balance that. Those are my comments.

Actually, those comments are excellent. I just wanted to tell you, as we did this work, the certification thing is not easy to do. I understand your fear and concern the your racing, but I have a concern that maybe no one else will really want to do it when they realize how hard it is to do. So it is very hard to do to how that -- two know how that happens. And whether it is one, or two or 10, that they do their jobs right. That is the role of the accreditation organizations based on guidance that they get from ONC and also from NIST. There's certainly some risks and it is hard to know how they will work out.

David, can I ask a question? Is the office of the national coordinator point to be the one responsible for organizing the educational process around this and outreach or does that go somewhere else?

Everything is in process but yes, we take it as responsibility to educate our partners in this and we are thinking actively about how to do that right now.

By way of perspective, there is another fairly complicated product that gets certified and that is called the medical education. So we have a single accreditation for medical schools and it is run by the W. AMC like the medical organization and it is not clear, and maybe this body could give us more thought, on how the national coordinator would set a limit and at what the optimal limit would be and how it that will rule -- A federal rule would justify it one number as opposed to another number. It is to the right number for it is 20 or 50?

That is like with medical schools, the answer was one, that was the right number. So maybe one is the right number.

The difference between that accrediting organization [speaker/audio faint and unclear].

So thank you for the presentation. As I've looked through the criteria, the of this is you can see in privacy and security, and there are about 35 of those listed, there are only about five in Interoperability. And as the meaningful work group gets back together two look at 2015 and 2013, we might have [indiscernible] in the group to make it more clear for you because you say here, aggressively established new and very specific requirements. Have we given you enough detail in the meaningful use Interoperability?

It depends on -- is as it relates to the current candidates for criteria, those items are just for that. Candidates and given to you for informational purposes. Those committees do not make any decisions or recommendations on that, it goes to the standards committee. It could very well be that there should be more Interoperability required and put into that certification. And I do think that is it viable observation.


My question is about Interoperability and I am wondering if he could talk more about what you mean by Interoperability standards, if we are really focusing on how the that moves and their court standards around the move data purses that content, versus what you put in that moves. I am more concerned about the latter because I think that is how we got down this hole in the first place, but if you could tell me more about what you Edition with Interoperability?

I am talking about standards themselves in the data exchange.

Does that mean the movement or the content? To connect the best way to describe it is the detail, the sick with the data needs to be put in, and where you need to put a piece of information in a stream of data. And the problem right now is that existing standards have too much flexibility and wiggle room and different vendors but different data in different places. And so when you go through two exchange data from one place to another, you have to ask the vendor, where is this piece of information and where can I find it. And the other problem we have is that there is not uniform acceptance, so some just don't follow what the current standards [indiscernible] and to prepare the Second Company description, [indiscernible] did they do interfaces' according to the standard because the standard existed? If they use a standard, to they adhere to the standard? And this was like an obstacle to get people to use the system, and this is mechanical process in terms of how it all works. And if I explained it correctly --

Well, our recommendation really stem from the fact that there is such a lack of Interoperability out there in the market, and I don't think we focus so much on the content of the message or the format of the message, but the fact that we need more focus on whether that be through meaningful use or whatever to improve Interoperability between systems, and I don't think we really delve into what the actual criteria would be to do that, but just that we would like to see a greater focus in that area.

What we are talking about face on your answers is in the same vein that we have said, sort of a principal for certification needs to be a simple tied two meaningful use, and at the principal level, we need to think about certainly most immediately from a patient perspective, if we could facilitate the movement of data regardless of sort of what the data is at a basic level, but getting that data to follow it. , whether it is at a PDF level, that is enormous. I am worried that people will think about Interoperability but dive down to describing what is on the piece of paper so to speak as opposed two just get the piece of paper to go with me everywhere.

I also think standards will look at the real content that is there and I think we will spend this afternoon talking about the overall HIOs and what they're doing. That is a great point.

[indiscernible] definition and this may be overly semantic but there is a line that says the system is able to produce a meaningful your results [indiscernible] I think that it is about the interaction between the patient and the clinician producing the results. It might be want to say something that the system is able to support the meaningful use care goals and objectives.

When the talk about the need for years, to talk about pensions and outcomes. And so we say the system will be able to do it and we will say this offer has the ability to do it. It is similar to Devons comment about privacy. If the system has the capability to implement the privacy policy, it doesn't mean you have the privacy, it just means you have the ability to do it.

And what we're acidifying, it doesn't mean? By the product, it automatically get meaningful years, it just means that have a system that would let you do it or whatever it is you do, like CPOE for example. So that is a good point.

Roger, that David and Judy.

Let me die in here for a second, and pardon me for being late. If anything I said it doesn't go with something you said earlier, just ignore it.

DOD and Virginia at this point have a tremendous amount of experience with the issue of defining what Interoperability means.

We are under a law that requires us to have Interoperability of in our systems by September, and we're spending an inordinate amount of time trying to figure out [indiscernible]Interoperability. And to have conditions defined that, [indiscernible] provides the conditions within the at the point of service. So I would say, a lesson learned number one, as we define Interoperability, it goes back to what is useful.

And going down the path a little bit, we found on the medical side, for the most part, this ability into what is in the other medical record system it is what is needed. PDF 's work pretty good with the exception of certain things like that data and pharmacy information and things that we have demonstrated, if you have a computer perform, you can save lives.

So from that standpoint, I would encourage it, and certainly, we can then call the help and expertise we have learned over the last 10 years and doing [indiscernible] with things need to be compatible and what things need to be compatible, and we go back to having declensions commuting [indiscernible] that we have made along the path.

[indiscernible] we would concur complete the going down that road and it is the end of September, not the beginning of September. [laughter]

We will just note, that is September 30 second.

Are we back in the year of Y2K?

I think we should be sober that this is a policy that we are undertaking and your IT advising that we put in place durable long-term mechanisms that will effectively affect the market. So the effect of the private rule in certification [indiscernible] atoll slippers that support your taking, but the questions that others have raised about where the level of specificity should be that comes out of it federal process as opposed to the specificity that may be generated through market behavior of different functions is a very sensitive Maystadt, measure, and Christine's added to the committee is the same as what I edited myself. And a suggestion of what we want to do police in his callboy back to the beginning and write some kind of a short document out of the ONC process that lays out, what is the policy structure that we are advocating, now that we have of auditor as best we can, and in terms of whether it is supportive, the word here is produced. I think the minute please mechanism is a good way to address outcomes, but certification probably isn't a lot comes oriented process, and I think whenever the right answer is, we have to be more precise as we finish or the states of our sitting [indiscernible] and I appreciate that subcommittees' conservatism. In saying the privacy and security Interoperability are the domain of the roll, but an outcomes oriented approach says, [indiscernible] that the growth public process level. The market will continue to innovate ways to achieve the desired outcome, so I would assess all the caution in terms of our process but also a request that we come full circle their lease in and write down the policy profession that has evolved from his profession.

And David, do you feel that the policies as they happen now formulated are reasonable place to start from that discussion?

I appreciate them very much. I do have some interest in what we in that meeting by aggressive specifications of Interoperability. So that three times I think we have seen enough package [indiscernible] appropriate and important but very unspecified as to what that means, so I think that is one reaction is. [indiscernible] Interoperability is the place to have to give a lot of attention in a crosscutting way. It is not actually silo in these different subcommittee, is a crosscutting challenge that we have to.

Judy? [speaker/audio faint and unclear]

Suggestion will be taken under consideration. [laughter]

When we are certifying and we look at what the system will let you do, but we look at different software, a different reading bodies look at software, some of them look at what the software will do and some of them will look at whether anyone can use it that way. Those are two different levels, and just to throw out that all those the certification may show that the software can do it, you might find that that particular piece of software is never used that way because it is really not able to do it well enough. So I am just throwing that out as a thought that a higher level sometimes, we should look back on, not only can we do it, but it is it being used?

That is an excellent comment. Within that comment, I would make two observations. What is that when we go through the detail and recommendations number one, there is a recommendation that ONC possibly evaluate the use of these systems. It is not something we felt we could address right now, that [indiscernible] an issue, but it also makes the observation [indiscernible] presumably the it measurement indicates whether or not the soccer Billy is able to do whatever it does. Or whatever it is supposed to do. And [indiscernible] that could be the effect that someone has already been able to.

We have Charles Kennedy on the phone would like to ask a question.

This is just a follow-up comment on I think it was it David Plante's? 'S comment regarding Interoperability. We are talking about this notion of modular certification which by definition increases our dependency on Interoperability as well as older ability also.

During the said community we received testimony that to CCHIT certified applications from leading vendors were not able to be made to enter operate despite a significant amount of resources and motivation, etc. So just to kind of follow-up on David's comment, I think that we need to kind of address Interoperability in a bit more of a broader way. I don't think PDF are a good technical foundation for us moving forward. And I think this notion of data liquidity or being able to separate the data from the application from the algorithms is something we need to take a closer and more focused look at.

I think that we are discussing issues that we will probably be getting to this afternoon in more detail.

I would also recall for everyone that we are not recommending a process that will be fixed in time, or one that can presumably be change over time. Something that we might consider Interoperability in 2011 might not be considered Interoperability in 2013.

I would like to say that if we do that, with concrete blockages in getting to that involved stayed.

Yes, thank you, David. And thank you for your report. A lot like to follow up on the comment that was just made an originally introduced by Roger. That view commutable options, and encourage us to keep in addition, the science of Health and Benson, etc., and our ability to lead to measure criteria and that will be capable of moving target and that as indications for what we will then consider acceptable and fuel and of course, we are then in power to accommodate more computable data.

That is a good point.


I just wanted to go back on the Thoughts on the certification piece. I think this also falls upon David's point about the policy issues.

What we have really been talking about are the policies that are with people wanting to get incentive payments, but I am wondering what protections there are for a consumer that would go to the health-care provider that has chosen not to [indiscernible]. And no privacy and security. And I think that there is an educational piece, as long as we are only talking about incentive payments, we have two problems. One is we are only talking about policies that apply to people, but one is an incentive payments and the second is that our incentive payment system is going to expire in four years, and then absent any new legislation that comes on the road that fills this gap, we end up in sort of a free-for-all where people aren't really protected in any way from being engaged in some sort of inoperable systems that don't meet that requirement.

So we have a no problem a future problem, and I am wondering what our thoughts are about those, or if we have had any yet. Maybe we need to have some.

Just a matter of fact, there is a penalty clause that goes into effect in 2015. Two the extent of financial effects actually extends until 2018.


As kind of a closing comment, I know we have kind of beaten this hoarse of little bit but the closing comments are likely to make is, what are the realistic time frame is to achieve all of that? Can we realistically expect HHS to come up with a HHS certification? Do we have the dollars to implement that? Are the rules and regulations going to be written so that the vendor can be out there in 2010 or 2010.5 at have a product that people will be able to buy an opponent into their facilities and practices for their incentive payments in 2011, is this attainable?

Well, there is a group that enables vendors to be certified. But hold us back right now is waiting for the regulatory process to get completed.

However, there are specialties that don't have certified software out there specific to them, and that presents a real problem for a lot a specialties who want to get into this, and there is not a product to by even with cap certification, will there be a product for them to buy?

The answer is yes. The product to by will be the basic capabilities for things like drug-drug in interaction and CPOE, but whether or not their thing specific to their specialty, I can't answer that. That is things drawn by that many fleas criteria, and then say, that is what we need to do. This morning I got the impression that the meaningful use group will start to address issues related to specialties and I think how the people his group addresses that Will Drive the specification process -- certification process and that is how I live in this in that occurring.

Gail, I think with the preliminary certification we put out there, it gives you a lot of good material. And being from an organization where we develop our own software and we are certified and we have to get there, it is not that big of a talent to take what we understand today and align it and understand what we have to do to be certified. I think the plan is doable, now I cannot answer whether those types of answers but I think the process we are recommending is doable.


As a member of the Committee, the only thing I wanted to keep reminding our group of is, our intent is not to endorse any specific criteria that CCHIT has in place today, but rather two talk policy wide about how we might go about this about how we have made the criteria and how we have recommended that ONC be the final authority via the it --

To determine if Secretary was appropriate, and for TLS and this process to be -- for ONC and this process to be specifically on Interoperability, we are saying that once we understand more about what health information exchange [indiscernible] is, that more of the standards committee -- we are recommending that the standards committee be more specific in the area of the durability of both on how the technical interconnectivity and the content, but once they have been more informed by this discussion. And what we are more over asking is, something we could oversee with NIST assistance seeking a net creditor of desert fires that would ensure a level playing field and a consistent application of the criteria.

Now the criticism that we received that is spent a lot of time talking about was, it will take awhile before we can get to that point, so can we get those that have participated in the process may be a make up to get started towards what will eventually be bought only one certification regardless of the transition certification. Only the HHS certification when it is available to be applied.

Meanwhile we will get as close to is is as we can -- if people that do have systems available to cover their [indiscernible] to get the aggressive timeframe, realizing that some people and hopefully the marketplace will respond to that opportunity to the specialties that do not have systems to choose from. I hoped adds some clarification.


I have a couple things building of that, and one of thing is an influence and Policy at large at all is recognized [indiscernible] [indiscernible] taking greats the rights. I think it is not okay to hold up the entire process because we can't get there right now for every single specialty. I think you're right that the market is evolving and will keep evolving, but I also wanted to note that I will probably have 10,000 emails after I say that, but this is okay. I think that specialists and primary-care practitioners operate in a different payment inverted. They're is a broader pemmican permit in play here that does tend to report specialists in a different way than primary care physicians and that is why the high-tech legislation prioritize precarious Eighty Matt providers and those who serve the underserved and technical assistance element of a lot. So I think we have to keep accelerating the progress that we're making to drive a market and support adoption by those particularly those provider operations we have, we have to -- have the hearing and I think we're getting there that I've wanted to caution that I don't think we should slow down just because we can't get two every population was a population.


Maybe two build in some of the previous messages, everyone has recognized it has been an extremely fast time line. And also like to observe just as this work has done that all the workers have been very responsive and I think two both public comment and comments within this committee. And to address some of the comments you made, Gail, I think some of the things that came out of the meaningful use recommendations is to use and adoption year to try to help with the time pressures that all of the industry will freeze.

Another point is to reiterate what George said this morning which is, that many police criteria is under abolition. So for example 2013 and 2015 are being discussed now and built into the process is after the final rule comes out to sort of finally reassess with that industry is, in other words, the program is not baked in concrete, it is something that will responded not only to the comments but what happens to the industry, because we're trying to get things out and use meaningfully and we will try to adjust the program to achieve those overriding objectives.

If I could just draw people's attention back to the comments that deal made about the transitional period, I think that is where you focused a lot of your attention. Make sure this market continues to function while we are waiting for the federal government to go through a rule making process?

I would like to know, and I think the working group has given as a very thoughtful potential solution. I can't tell you whether it is workable or not, because I am not a lawyer, but I would go through the scrutiny of the Federal Council P.C. if the federal government could do what it to us to do what was suggested. But that is -- let's leave that aside for the moment.

Do you see, Gail, and in particular problems with the suggestions that have been made as far as the Gap or enter certification approach? And does this meet the short-term needs that you have identified?

I think that is absolutely necessary to have a short-term solution. I think that solution has got to address just a minute please criteria, whether you call it an HHS certification or whatever come so that individuals out there that have a stand-alone home grown system wherever can become part of this estimate that very specific criteria.

My very deep concern is, we are not going to be able to do that given the regulatory process.

First of all, who will HHS ONC going to certify to the credit to fortuity that? They will have to stop what they're doing and focus on that because every system out there and lots of other systems who want to get on board are going to have to go through that process. So there is a whole process that Purse of all, the regulations have to be written to do, and then you have to have the body to do it, and there will be a huge up surge in the market, and I think that is great. And then there is the whole decision making process that people have to see what the market has for sale, gather the resources to buy it, and then implemented. Is the tenable to do this and have those products in place in 2011? So those regulations and it back gap certification needs to be as specific and simple which is contradictory perhaps but the process of getting their needs to happen very rapidly. And if HHS is the a creditor at that point to CCHIT or whoever, that needs to be established, that they are doing that and they have two realize that the rest of the market will stop until that happens.

And vendors out there, smaller vendors in particular will have deep concerns about that I would think.

Any other comments?

Are there any particular aspects of these recommendations that people would like to change or amend or qualify? We hear several general comments, the need for a definition of Interoperability, the need for a policy context. And details concern, is not ill advised about the transitional process -- the ability to execute on the transitional process. We can note all of this, but perhaps Daniels suggestion to limit to the number of the creditors, I haven't heard any specific suggestions about changes in the recommendations that were presented to us.

There was the one suggested change for the definition of certification by Christine and David, there was change that I heard.

Could we repeat that just so we are all aware of what it is?

[speaker/audio faint and unclear] able to support the meaningful used supports [indiscernible].

But I thought I heard this system would have the capability to achieve -- [indiscernible] interaction.

To support.

So you would change the word system?

No, produce.

So it would like it to agreed, HHS certification means that a system -- he is able to support the minimum.

I have an issue with support. Support does not -- it isn't the correct word. It doesn't give the impact ad achieve meaningful use. Do you want the achievement of meaningful use? Support Team is very different than achieving.

Just to be clear, I think my point Gale is, it is not the system that achieves it, it is the provider clinician patient, and that is all I am reacting two, to say that the system might support the results but the result should come from the clinician and patient working together with the system. To get to the results.

I'm sorry two word Smith and subjective compromise but what we're saying is the system should be able to stop support the achievement of the monopoly is that the government expects.

In very simple terms what we were trying to imply is that the system could do it.

Whether or not you did it is up to you, but the system can do it. So whatever you want to do that --

Yes, he made a comment to answer, the first activity in the public's and federal government and also my first one, and I do understand that these documents have been portents and people read them very carefully, but picking up on what Mark says, our intention was to say that the software was capable and that it was capable of producing [indiscernible] capable of achieving.

Capable of achieving. [indiscernible] [indiscernible] government security and Interoperability. And the second produces meaningful results, that doesn't limit that to the first three categories, or subsets if you like, of meaningful use. My concern here is that I doubt that the subcommittee has recommended that we address the certification of the sub functional capacities to address all of the meaningful his criteria. That is, we're not recommending the government certify the ability to report in [indiscernible] one C 80% as a particular use criteria. So without doing the wordsmith in here --

Everything but the present we would want to certify.

Well what is different on this statement about security Interoperability is, what I would like to clarify here is that the charge to the certification of [indiscernible] marks point does address all of the meaningful use the objectives -- and [indiscernible] Interoperability is one pot, and meaningful use is the second thought and those are the two things that the system has to be capable of doing.

So did we have agreement on language at set of system?

Jody, did the write-down [indiscernible] -- the second phrase, the system is capable of achieving the meaningful his results.

I think Roger's language was, support the achievement.

Okay. I have both written down.

Without amendment, and being able to support the achievement, without other comments, and like to move that the committee to accept the recommendations of the working group specifications.

I apologize, but the best phrase it, the -- the systems don't achieve, but the people do, it is the same kind of point.

I think the language is, is it able to support the achievement.

[indiscernible] cell without objection, the committee will adopt those recommendations.

Very good work.

We are actually running a little ahead of schedule, and what I would suggest is that we start our break early, and come back earlier, because I am sure that everyone but like to work late into the Friday afternoon, but, I am not going to let us fall prey to that desire. [laughter]

So assuming that lunches 30 minutes? So we will be back here at 12:15.

(The HIT Committee Meeting is now on a 30 minute break, and will resume at approximately 12:15 p.m.)

Ladies and gentlemen, can we reconvene? Sorry we are running a little late.

So we have another in our group of work groups. And this is -- every one of these issues is really hard. Every one of them takes us to the edge of what we know and sets up and lets us peer into the future, and requires that people leave their comfort zones and think about a future state that is full of uncertainty. All that we can expect in that context is that people think hard and carefully and give us their best device. There is no question that all of the working groups have been doing that, and the federal government and the American people are deeply indebted to them. So Devon and Micki you reported to us last time and we are looking forward to your report.

Thank you to the committee. Let me begin by thanking the work group who have been working very hard and I want to give a special thanks to my co-chair, Devon, who managed a difficult process. Some tight time constraints while I was traipsing around, Montana on two weeks' vacation. So let me give a special thanks to Devon for managing that.

I am going next week [ laughter ]

So this is the work group and as I said I would like to thank all of the members who have been hard at work helping us go through some of these issues. Let me begin by telling us what our recommendations are going to be and I will do it quickly to orient us. Then what I would do is walk through some considerations that we made and then handed over to Devon who will go into detail. We have four recommendations. Number one is that there ought to be helped exchange requirements related to meaningful use that require health exchange. So that is number one. The Number two, we believe that there is a core set of requirements that they need to meet in the areas of interoperability, privacy and security which is consistent with what you heard from Paul and Mark's Group. We believe that that would be the case. We believe that there ought to be a certification of interoperability components to demonstrate that the air meeting those requirements. So that would be EHRs as well as introducing the possibility of other products that can meet the interoperability requirements. Fourth we believe very strongly that we need to have alignment from the federal and state requirements. Generally this would be true around meaningful use and specifically are around Health Information Exchange and on the federal level and have state Medicaid requirements that are not in conflict with that. So those are the four recommendations. Let me walk through some of the background and considerations that we made all along the way and then I will turn it over to Devon to elaborate on those.

First, thinking about the state of health information Exchange today, health information exchange occurs in the market today. But penetration is extremely low and not uniform. I think we covered that last time so unless there are any questions I will not be labor the point except to reiterate that it does, indeed, happen today and that we are making slow progress but it is slow progress. And even where it happens the most like e-prescribing, the penetration nationally is 4% of prescriptions, 4% of eligible prescriptions from roughly 12% of for scribers, potential subscribers as.

Just to make one exception that is outside the federal marketplace.


They are vastly different between the federal organizations at this point.

Yeah. I would not disagree with that. So what are the barriers preventing the market moving to work with health Exchange? The main barriers, and these are not in any priority here. There are certainly uncertainties under legal and liability issues there are a lot of things to figure out with respect to privacy, security and things like that that makes a significant barrier. And too little business in clinical. To exchange more information. There does not seem to be enough at the point of purchase for those that have to conduct health exchange to go through the pain and doing it and on the benefit side, too much difficulty of setting it up and maintaining the electronic exchange related to standards, certification, and a wide Friday of things that we talked about -- a wide Friday of things that we talked about so it will be some combination of incentives and penalties and a set of action will standards which is a somewhat aligned with what we talked about earlier with standards on interoperability and one entry in the mechanisms. We have not talked that much today about because I think that is probably something we need to give further consideration to. But I think an ongoing concern that I would have is that standards are not enough around things like -- you can have standards and certification that the end of the day to be able to monitor the those transactions are happening according to the standards in a routine way is fundamental to that happening being able to in this Chamber of the workflow on a date today basis -- in the stream of the work flow on a day-to-day basis is fundamental could I would point to administrative actions and forced by Medicare they get millions and millions of these transactions and they will report any code in violation of the standard qualification. Take a look at lab results delivery which most happen to from community hospitals. There is no entity in the stream from a community hospital to a physician. How would we know that that is something that a HL7 transaction was modified in some way to accommodate some unique local need and to monitor and enforce something going forward. That is a big concern. As I said, we will not cover that here [ laughter ] a huge, important concern [ laughter ]

So this leads us to the point if implemented judiciously we at the work group believe our funding can health create a proposition for health exchange. And how do we get a value proposition that is the only about the requirements and some comments earlier are fundamental here as well that we do not want to have a system where people are doing things just for the time period that they are getting an incentive and only the ones with a particular incentive are doing it. We want to create something that is more fundamental and foundational that will have the entire market move towards the types of things that we're talking about here. So some combination of Laureen the technical organization or legal costs or leave in the clinical and business imperatives for more exchange is what we would see as the orchestration of some of the things that we could provide to the federal government to be able to accomplish here. And in looking at that cost an average, source of the right now, we would argue that there are too many institutions that see the cost out and the benefits there which is why we have not moved forward for many of those institutions. When you think about the levels available to the federal government and things like certification and funding and in government are all examples that can lower health exchange and lower the cost of being able to exchange grid and the other hand the incentive payments for meaningful use and ARRA are the opportunities to raise the Business imperative. Because it's a business need or also because of the opportunity of the real incentive coming from someone who has been paid a substantial amount of money to do what we're talking about here.

So of these tools that we just talked about, it's certainly our sense that the meaningful use are the most powerful lever of change certainly in part because of the proportion in the amount of money that we're talking about here. The incentive category is $45 billion that we are estimated to be a part of HIT spending and the other point is that it directly affects the value proposition at the point of purpose to the extent that they are applied at the position level and you are talking about decision-making at the point of purchase which is the strongest level that you can get.

Obviously ONC does not have the ultimate decisionmaking on incentive criteria but it can create enablers that would allow CMS to create more incentive rules and some of the things that ONC does have discretion over and a strong% of incentives -- a strong per cent of incentives in rulemaking.

April look at the speed of great year and decided where the levers are going to be -- and if we look at the meaningful use criteria and decided where the levers are going to be. We may have missed one or two here predict and try to, which are those requirements that have helped informational exchange as something that could be fulfilled. As you see when you think about what will happen in 2011, 2013, starting in 2011 there is inappropriate ramp up -- an appropriate ramp up and the 2011 requirements are increasing the volume of transactions of the most commonly happen today. The incentives around trying to put more through those pipes that are already essentially there. And once you get to 2013 there is a substantial step up. That is where we talk about a fundamental change in the way that we talk about health care delivery because it seemed that we need to have not only lab to provider but provider to lab and clinical entity to clinical entity and make sure that their records are falling them all the way through. And you could imagine that if we were able to accomplish even subset of that by 2013, we would really change the complexion of health-care delivery. If we were able to accomplish a lot of that from a patient's perspective they would really see a difference. Finally, 2015 is getting to anyone to anyone. Maybe we have a platform or to the point where you can start to assume that exchange is happening and we want to make it more and more rich. Women think about the work and the Mets ahead for the work -- when we think about the work ahead for the work group, the consensus is that the work ahead is about providing policy direction around the requirement for each of these transactions. That is the work ahead. We are dependent on the meaningful use work group to define what those are. And so now for the work ahead is to provide a detailed policy direction and what Christine was alluding to when do we get to those details and how to define the steep hills. That is the work ahead. Obviously we will start with 2011. And you saw Paul and George's timeline and we will be filing that did so in the third quarter 2011, we will start to focusing in and in addition to privacy and security because those are fundamental and there is a lot of conversation around other aspects of privacy as well as security. So those will start. And then in 2013, the 2015 we will be following the path of the meaningful use for croup and you saw in the fourth quarter of this year and the first quarter of next year is when they will be digging in to provide more specificity among those in be talking on that in that committee.

The final slide before it turned this over to Devon is we kind of walk through what is the state of health information exchange today and what are the barriers and levers available to the government to try to increase demand for health exchange? We will walk through a little bit appalled been sentencing to be the most powerful ones and -- a little bit about how these incentives are the most powerful ones and then finally the consideration of how deep do you go? How do we think about the government's role in the market? You see here is spectrum. We have, of course, we have to make sure its savvy enough to define the extremes so that the recommendation is in the middle there. But there is a spectrum of government intervention. On the left-hand side you would imagine that meaningful use right now does set the floor and that is kind of requiring specific transactions. It is seen by 2013, what you need to exchange among entities and from whom to whom. That hospitals have to send information to physicians and physicians have to send him permission to hospitals and the next point of care. And how far do you want to get into how best to happen? That is what our work group is about to forbid the next step up would be for each of those transactions that are -- would be for each of the transactions that are already defined what would be for each of the standard for communication, content, privacy, and security and those are the category of the core requirements. That is will be defined as the categories. You could take another step that they will be about specific technologies or architecture is an organizational forms. For example saying that these transactions, have to have been through a specific HIO or in node would be an example of taking that one step further. There is a sense that the balance that we won two straight here is not to have too little structure because we believe -- that we want to strike here is not to have too little structure. On the other hand, the work group feels very strongly that too much structure will absolutely Channel product development and that is exactly what we don't want to do in the area of technology. So with that as backdrop and sort of thinking of the work group let me turn it over to Devon to elaborate on the recommendations.

Thanks, Micky. I appreciate it.

Micky went over these quickly before and now they are actually in front of you. You will recognize many of them. We started to introduce these when we were before you last month but there were a lot of questions raised at the time. There was a need to go back, continue to think about those, answer the question about how much federal intervention is needed and why and to provide a that a bit more detail to the extent that we could in the time allotted. So here is where we are in here is what we hope the policy committee will endorse today. That is that there need to be core information exchange requirements that are Technology and architecture neutral that will apply to all participants wanting to have at meaningful use with CMS. The core requirements should be focused on the capability to achieve the meaningful use subject to whatever word smithing that we came up with. Capability to achieve meaningful use and include interoperability, privacy, and security. Because we are the exchange workgroup we focused in a little bit more on those but to achieve capability for meaningful use there will have to be other requirements in place, too.

Federal government should certify the electronic health record and held informational exchange component on these core requirements to ease burdens on eligible professionals and hospitals for meeting in demonstrating at hearings with meaningful use requirements. And the last point is that federal and state government approaches should be complementary and any grants to states that come through the grant program and we will get into details about Medicaid they should require alignment with federal meaningful use use and measures and nothing is official until its official click okay. You got it.

Fair enough. So this is a little bit more detail on these recommendations and why we think they make sense. If you are going to set criteria that all systems and components have to meet, and then your doctors and other eligible professionals would have a choice about what Medal of exchange they want to use -- what's motive exchange the want to use so if they want to rely on some form of direct exchange or participate with their local organized exchange, RIO, HIO, HIE or some sort of national network, again, if there are a consistent set of standards that all of the component parts and systems need to meet then that choice will be there and we will not be locking in specific architectures. These would be the same standards applied throughout with respect to some courts Exchange criterium -- court exchange criteria. Systems that don't need to be certified would still have a tremendous market incentive to adopt those standards because they will want to be able to facilitate and exchange data with entities that do have to meet certification as well as -- you know, there is a certain limit to where these powerful tools go, the rest of it will follow because they will need to do that. And consistent with the certification work group recommendations came out, it really needs to be tied to the capability to exchange or a cheap or support meaningful use criteria in 2011 -- to achieve or support meaningful use criteria and 2011 p when the actual exchange requirement by be minimal in 2011 we talking about granting them up specifically in the near future. The systems will need to have the capability to support that over that period of time. And the core requirements really need to be focused on what is the exchange required to meet many police and that includes privacy and security -- to meet meaningful use and that includes privacy and security. And what is really required to make sure that the data can be exchanged? So what do we mean when we say interoperability? People probably have different definitions as to how expansive that definition is. But certainly what we agree on at least at this particular phase is that it's a basic level of you can call them Transport standards are communications and the package that has to go around the did anyone ever content standards are necessary to ensure that exchange can occur to be capable for meaningful use. Certainly a top priority ought to be the transport piece of this because the idea is if you are going to create technological and architecturally data between point of the care it has actually got to be a priority. Similarly taking a look at the measure definitions and would ever semantics' standards are going to need to be required for the clinical data that has to go with the reporting required in 2011. Biscuits to the point that Micky made in a much more particular -- this gets to the point that Micky made in a much more articulate point, if you set the criteria you have to have the out come and work backwards. What is consistent with transport, this has to be able to move from point A to point B and what circumstances do you needed to be structured is an additional set of issues that the policy committee ought to weigh in on and give guidance so that those can be developed. Before I leave this line, meeting the requirements with respect to privacy and security, those should definitely be a priority and as well as -- we did not say this on the slide but I will take the time to say this now and what Dixie refers to as the "ARRA 8" that have policy implications imbedded within them before we can move toward freer and on the issue of the federal and state interplay, but it's our feeling that they can enforce state level requirements to establish any state level meaningful use definitions. But any such requirements should be complementary. To qualify for meaningful use, again, information exchange that occurs to me to meet the federal requirements. They should not be allowed to fall below that with respect to their own requirements but with respect to whatever discretion there given by CMS with the Medicaid criteria that is not -- that is a discretion that we would support. That is a decision that CMS would make. Our concern is that what ever the states to promulgate that it be consistent at the federal level and that it not be conflicting P we actually made this before you actually suggested that perhaps the federal definitions would create a floor that the state could go above with respect to whatever additional requirements that they will put on the state Medicaid incentive recipients. But certainly not fall below. I forgot about this part. This is very important because we got a lot of feedback from folks who had some confusion about some things that we said about certification and HIOs, and this organized Health Information Network. We wanted to take this opportunity to clarify what our recommendations are with that. We are not recommending a separate certification path away for HIOS with a separate standard. We are recommending as we said and as the certification work group that helped information exchange component be certified -- that health information exchange components be certified whether its a component or a collection of components brought together by the provider. So one role that HIOS have paid in the past and may continue to play in the future along with other technologies and other technologies that we cannot imagine but there are probably some folks that are making them up as we speak. That is the ability to provide the components that will actually enable this heterogeneous system that we have that is like a -- like the federal government to exchange data.

It might be harder Jen is but it looks awfully homogenous -- heterogeneous but it looks awfully homogeneous.

Thank you.

And like all of our presentations this is a model of clarity of thought and expression so thank you very much. Questions or comments?

Once again, a great presentation by your work group and lot of good work on a very challenging area. One point of clarification that I would like to have is given the fact that you have combined the verb and noun definition of health information exchange and stated one set of standards for information exchange to exist and the deliberation between a government role and to a structured versus not, and is it your assumption that every access are triggered to authorize exchange of an individual patient's records that is given by the patient via HIPAA regulations? What triggers and tells an institution to exchange data? Might implication is that it is from HIPAA, is that your understanding?

The next thing that we will take up are details around privacy and security. I will answer you what is the state of the lot today with patient authorization bill with respect to what HIPAA requires it does not require a patient consent before the data can be disclosed for treatment, payment, and a list of activities called healthcare operations and that is regardless of the format. It is not limited to paper and was promulgated to enable electronic exchange of data for claims payment purposes. Having said that, there are state laws that are not preempted by HIPAA and they require some form of patient consent before the data can be accessed, used, disclosed. Sometimes it's based on the type of data, sensitive data tends to merit some special treatment. And Of course, at the federal level with respect to federally funded substance of abuse facilities there are specific requirements with that data. It underscores the challenges that we need to consider. Another thing is in addition to the law there are voluntary policies that institutions and some of these networks have established that have to do with building the trust of the patients in their communities. So in number of them, for example, have adopted policies where the patient has to opt in to having their data exchange for the patient has the ability to opt out. There is not a set federal policy along those lines although there was some work done on this in respect to the NHIN grantees. So a long winded answer to say there is a place where the law is today except for the state law requires said petrol law does not require patient consent for each and every movement of data. -- federal law does not require patient consent for each and every movement of data critic and as we are increasingly interconnecting these systems in a really robust way. I don't know if you want to add anything?

I think Deven did a fabulous job. This is an area where I think Deven articulated in this is an area that we have recommended that HHS look at the policies regarding opt in and opt out. It is something that we are planning to take a look at and what hope to talk with the work group about in thinking through some policies.

As a matter of process we are also talking about, starting it after this, privacy will be one of these things that we will dig in Holon and bringing in the lead this state of the work -- did --dig in on and we will have public hearings about this that are very spirited.

Also the aspect of your presentation, and how much they can require interoperability and I guess just want to know from the work group standpoint if our work group or your work group will take that on and recommend some how implicit in that will be what triggers and what authorizes an institution or provider to share data with another one?

To recommend federal pre-emption?

You said you were deliberating that and that will have to be harmonized with these privacy laws. The only thing I wanted to make sure is that as we go forward we see what we can address and what has to be in the realm of the other groups to deal with. We do not want to be in conflict with them.

Adam was weeding and then Gayle -- was waiting and then Gayle.

Kind of what stuck out to me and first, thank you all for putting this together. This work group out of the three is probably the closest to the patient. It did kind of stick out that patient control -- it is in here is a little bit but I don't think it's brought out as a unique point spread and when I say patient control I look at that as different from privacy and security. As a look at 2013 and 2015 when we get exchanges with the patient and it may be patient to patient, at least in my opinion we need to start in 2011 in the core requirements getting some recommendations from the work group to the policy committee about what patient control is going to be for their own electronic medical records outside of position to physician -- physician to physician and encourage the work group to really think about this one.

Thank you.

Is that a comment about this meaningful use criteria not addressing that or about whether we are dressed how we are going to address the meaningful use criteria?

I think probably the latter.

As I see its, HIE and patient control should go into what meaningful use is. Part of meaningful use should be patient control over this information and I look to the work group to try to develop the policies or recommendations under some of the score requirement.

I am curious but you have actually put your finger on some hot button issues and ones that we will deal with and we would welcome your input.

To you want me to answer that?

Let's leave it -- yeah.

Gayle, trying to get to use.

Yes. I want to go back to the basic issue going back to privacy and security in the patient's concerns about privacy. I think that is probably the core issue here that we have not talked that much about. I really believe that in the long run in order for us to be successful in what we have here is important that every patient has an electronic health record you have got to in -- engage patients and we must hold some public hearings to get down to this core issued and how secure is a patient going to be in that interchange, that exchange of their private information. I think it's essential that we listen to the public and the patience on this and I have made that recommendation. I hope that you will follow through on this.

Would you go back to the cost and benefit slide? I want to make a specific recommendation about that.

To me, we are always worrying cost and benefits. The opposite side of the privacy security concern is the extent to which consumers see a benefit in the exchange of information. I think in the green bar we ought to have in there the consumer comparative where there is a piece to the exchange that is part of the benefit. I think that is the piece of the benefit that balances the privacy and security. People are worried about privacy and security because we have not told them what the benefits are of this exchange to them and a huge piece of this that I mentioned before is their ability to see everything that is being exchanged and that that information to make sure it's accurate. I think that the sum of the stuff that Adam was talking about. Is it accurate? Is it relevant to the care? Is it relevant to this individual provider? Can they see everything? There is a lot of complexity around this but I think we should add that into the green part because that is a big part of what we should be pushing in order to move this forward.

Just so you don't think we are ignoring or neglecting that, this was particularly about what it looked like from the perspective of an individual or practice that is making the determination tomorrow, how much do I want to address in exchange and not about the societal benefits or costs.

When these the value proposition that has a much broader extend. The value proposition of exchange goes beyond that. That is why I think that is relevant. I don't need to edit the slide, it's just a point that we do not paid enough attention to one of the things that could beneficially drive this. For example in the database model one of the things that I have been reading about the extent to which the consumer is valued this. They actually provide some of the ongoing business value and contribute to the cost of the continuing exchange. So if we are just looking for the business model of it, one of them would be to sell it to consumers and make it so valuable that people would give a couple dollars a month to have their data securely stored somewhere and have access to it and other pieces. I think this is part of the discussion.

Deven and Micky I want to congratulate you for what I think is a good prioritization of these issues in terms of interoperability, security, and privacy. Because the fact is until we can interoperate, the concerns of around security and privacy are minimized. We are dealing with a one-to-one rather than a one too many situation. And in terms of identifying standards as the key to interoperability in terms of the transport and content. Because until we have meaningful data to share, we have not achieved meaningful use. Again, I think there's a lot of work that needs to be done and I will point TO roger's comment earlier this morning in terms of allowing the commission to determine what data is meaningful to them in terms of core needing care and the standards committee as well as the panel to identify specifically what data. As a final comment I will say that your point that one ever interoperability standards are established that they should be architecture neutral and Technology neutral is one that will facilitate adoption and interoperability. It will also complicate governance.

The question that this kind of a concern, a couple of times today we have talked about certified and uncertified Systems. In this we are talking about HIOS and certification including security and privacy cert. My worry in the Information Exchange Network World is right now when we exchange information we have an information exchange agreements. We know what we will exchange and how they will protect it. Now we are wrestling with a lot of our partners issues with getting them to agree to the security constraints that VA must have about our patients. And if you were going to provide information on that night that they will protect it in such a way that you are conveying their responsibilities in that world print so when we talk about uncertified Systems in the health information exchange environment IB, were read to the extent of what can I let go of and what can I not -- to the extent of what I can let go of and what I cannot let go of. And if I don't know everybody is approved to protect the information to the extent that I am required to protect it, I cannot participate.

Here is the thing. We have policy levers that we can apply but we do not have the magic wands that says everybody must be certified. We just don't spit at a minimum everybody has to comply with the law -- but at a minimum everybody has to comply with the law with respect to security requirements in some areas and you all have a certificate security requirements. There is a limit to how far we can get with some about we are recommending because these policy tools to not apply and labs is something that has come up in our discussion. You want the labs to be able to accept the same standards but we are not certified labs. However, all of the providers that want the financial incentives and want to be able to exchange and reseed the Lab Data and move it to another provider when that is appropriate will want them to do it. So someone that will have to be resolved with the piece agreement -- some of that will have to be resolved with the debt used agreements and some we can resolve with the law. That is what we were a listing there. We were not suggesting that that is an ideal set of circumstances but a recommendation of limitations.

And maybe as a look at the broader information exchange networks we should make certain that we have standards about what the neb protections have to be agreed to before the network can join.

There are other tools beyond certification.

David and then Judy.

I appreciate the direction that we're going and pick I took to lessons from what you said today. I think the recognition that no matter what you said, did it will not move until the users want it. And that goes back to the question of the structure that click and stimulate -- that we can stimulate which will make things like cert more easier because there is a demand to set standards and achieve goals. And this may not be visible enough to create that goal at the moment. So part of what I think we should take back to our subcommittee is -- I like this likely to account the 2011, 2013, 2015 measures that create that draw across the network. Looking at that and perhaps we have not done as much work that we need to in 2013 and 2015 to amplify the signal to the market on the interoperability and the debt exchange issue -- and data exchange issue which really call for data sharing across parties. I hope that we can take your report back to our subgroup and think hard about the opportunities there to increase the incentives. And the second thaw along those lines is one opportunity do we have or what does ONC have to communicate to the private paper market a set of signals to amplify that message again. So in California where there is a paper performance system that has -- And how do we married the signals on a chart like this to other paper performance systems so that we really get the value out there to everybody to start sharing information with each other for the patients benefit otherwise everything may just washout. The third thing that I want to mention is it's really just a question to you. How have you thought about the role of your subgroup and us as a whole in communicating to states HIE is strategic direction? I am thinking of it because Paul and I both work in California on the structure of the HIE and the support of the ARRA funding. And a lot of issues that we are wresting with without guidance coming from outside. I don't know if there's an opportunity to take some discussions that you have been and propagate them to the state so that they can build whatever they will build in a way which facilitates the fact of the adoption of this overtime.

When you say HIE, do you mean HIOS?

I will not answer that the.

We have adopted our own terminology.

I mean HIE facilitated by HIO.

Since this is an the advisory committee we will be administering state grants and we will be having a couple mechanisms by providing that to states with respect to the grants. So we can take some input and suggestions from you, David since there are some issues that you think we need to bring to the states. We currently have the state alliance e-health and that's something that we could use as a lever if there is some input from the committee that we think would be valuable to the states to have a forum to bring that issue up.

And two microphones away is Tony from CMS and CMS will be with respect to meaningful use and Medicaid so there are a lot of ears perking up.


I have three topics. The first is the incentive money what we're finding around the country is that it does not matter what the incentive money is. The real barrier is the legal concerns. Our customers are not -- who are not jumping on our because the lawyers and other advisers are much more worried about legal. I do not think the money matters as much. I think first we have to get those privacy loss figured out. Because then as long as they know them and can follow them we will be in much better legal sheet. Along with that in the incentives we have to look at what is sustainable over time. If we start up now, they need to be sustainable or we will lose people in the lurch or have huge government funding to sustain thinks things could there are a lot of different technologies out there. It's not sustainable we have a problem down the road. That was one. Number two is on the states. If what we -- if we say what we're doing now is the floor and states are welcome to add things to the floor if they have contradictory state laws they will have a huge problem with interstate interoperability and we have to be careful about that. The third thing goes to what you were saying, Neil. That the patient's ability to see the information and decide what is relevant. I know somebody who fiddled with his PHR that he could send and he changed some of his lab values. What does that mean to the position? Will they make bad decisions because that was done? What does withholding and misleading to do that and what does it do to the patient who wants to say, please hide the fact that I have diabetes or MS or congestive heart failure. You have the diagnosis and you can see by the tests what they're looking for and the results, the men, what do we do with an allergy? And we know that there would be a drug-drug interaction. What do we say? Do we not follow the privacy and let the patient be hurt? So those are in deep questions that go into the patient's ability to do things and you may jeopardize your care and number two, we may not be able to do it anyway. There is so much that is threaded through out the record. That is a huge issue.

I will say that I am looking for it to the hearing because I think it does touch those things can I also want to come back to what Neil said and reinforced what he said. And also ask that as we go full word with these recommendations, which our trip back that we bring in the perspective of patients and families. which are terrific that we bring in the perspective of patients and families. Having standards apply to all participants, and Barry provider eccentric which is inappropriate. -- which is appropriate and we often talk about their pain points in the health-care system and everything is about information and coordination did it was things like I have trouble remembering all of the prescriptions and how do I make sure one doctor knows and we threw at them a number of solutions. And HIT was the one that they most clearly grasp and understood. I think that this was the most interesting for me and when they talk about the information and coronation challenges that they experienced, these patients did not see it as a failure of the system they saw it as a failure of themselves. That is enormous. So when we think about Information Exchange and the patient to be part of the solution, I want to make sure that we are always coming with that perspective. Of course, with all of the privacy and security protections that make it meaningful but that is an important perspective so I just want to be on the soap box here for a minute and remind folks.

We really definitely had that in mind they look more provider centric in the slides because the incentives to not go to the patients, they go to the providers. That is why we were clear that the meaningful use criteria and to the extent that we're pushing very hard to have its also include that patients loop and prospective. That drives how the criteria can happen because the provider is such big part of that and is the one being paid.

We have done a good job overall to make sure that the patients' families are centers and that we use the incentives that are dear to our providers as the mechanism to drive patient families engagement and that is critical here.

Selecting Neil and then Rick.

I wanted to mention the pope did one of the things that I have been concerned about is the clinical -- the pull and one of the things that I have been concerned about is the clinical data and making use of clinical data and a large portfolio of what could be PDFs and all kinds of fears of rekindling -- years of stuff and that view is different than the German pilot is looking at a brash and the cardiologists who is doing -- dermatologist looking at a rash in the mechanics of the exchange and how that happens will we have not been caged in the discussion of whose response ability it will be to make useful information. And when I spoke to Judy she said not to put words in your now that the EHR vendors have some irresponsibility to keep -- have some responsibility to create intelligence around that. While I think we have been worrying about passing this stuff back and forth I am worried that we will pass this back-and-forth and people will not use it because the extent to which that information, the amount of that information that will be relevant in any given clinical encounter will be small. Somewhere the intelligence has to be built to go through that extreme library of information and make something useful audit. That is one point did I guess the question around that it is who are we contemplating is going to encage in that activity and how much -- and how might that have been? Because with clinical and clinical utility and how closely we can get representation of that data for a particular provider. The second point that I want to make is around that state and national model. If we are saying that one of our values that we are subscribing to add a national level is that we are not being technology specific, then I would put into our requirements or I would suggest that CMS put in the requirement that that be brought to the state level. I think to the extent that the state adopts a single model, they are violating our federal guidelines that basically say that we believe multiple models should flourish. So if patients in a particular neighborhood do not think that the exchange in their neighborhood is providing value to them they ought to be able to go outside of that and do whatever they want to do to some health enter into a national exchange of the information that not -- to somehow entered into a national exchange of informations. So are we subscribing to that not being prescriptive about the technology as a national policy recommendation and if so I think we need to drive that down to the state couple so we do not end of scene at a national level that we believe that there should be lots of trees is but it's okay if the state subscribes to only one particular - a lot of choices but it's okay if the still subscribes to only one particular model and everybody has to be in that model.

I don't think anything that we recommended would preclude a state from deciding for example, for California deciding that meaningful use around interoperability has to be conducted through this network in our state because that is our state network as long as they met the interoperability requirements that we are talking about.

For Medicaid.


Nothing that we said would preclude that. I think it's a fair .2 days but we did not specifically preclude that.

I am suggesting that we might want to consider precluding that because it does go against both on the provider side inpatient side a possible trace of wanting that information exchanged three different technology that they feel might be more secure or patient friendly. That is why I brought it up for your consideration.

I want to respond to what you said earlier about what I call the gobbley-gook of information and we will not be able to dictate it down to the extreme level. As it is, far too -- we had too few instances of the data moving. So certainly we wanted to make sure some of the possibilities was to allow the data to move. And we ought to be progressing to a system as it evolves and integrates with the positions are getting the data that the need to make the decisions. But the content standard aspect of this is one that I have heard described as holy war. Lots of people have strong opinions about and I think there are some different decisions that will have to be made about when to we need specific content because it can differ and where space are we not ready for that because that would violate our principles to allow for innovation. We did not spend a lot of time talking about standards content because in terms of where the work group was able to get was presented in our presentation today but acknowledging a lot more work has to be done in this area. There is a role for the policy committee to play and a high interest among the members of our workgroup because we had a robust discussion in trying to be more helpful on this issue but I suspect we're not the only ones.

Okay, Rick?

I would like for a minute to maemac visit the decision -- two revisit the decision and the health information exchange in the verb and noun definition and it seems like we have it interchangeably talked about a state health information organization and providers and a mixed the discussion. It seems to me that it is somewhat confusing.

I want to make sure I understand, are you saying that it's your interpretation that we have combined those? Because we have not been we have broken them be part.

When we say health information exchange, we mean the verb and when we mean a structure we say HIO.

And they do not have a separate certification criteria, is that Ray?

That was to -- from our last presentation when people thought that that was what we are suggesting.

I did spot --

You are not the only one don't worry.

I guess I would just endorse that concept and validate it for you. And my suggestion as we go forth and seek more public comments and segregate the discretion, it might health to clarify some of these questions that we're hearing. That would be my observation.

I started using "the little v" and "the little n."

By breaking apart that the recommendation applies to the verb and not the noun, we are not recommending that the Government do that.

Okay Paul and then Roger.

Thank you for the articulate presentation. We have been talking a lot about the technical data exchange standard and certifying the technical exchange components. My question is should we also be considering interoperable policies and be more descriptive? Because you said we will allow direct exchange and Fender -- and allow vendor hubs, etc., and if I'm going to join or share my patient stayed out on this exchange, don't we need to in addition -- my patient's data in this exchange don't we need to protect the data as it flows around? How can we say, should we join as a provider group? And how safe is it to join if we do not have interoperable policies? Should that be part of the mix? Should we be more descriptive on the policies as part of HIE?

That is certainly worthy of more conversation and we had a conversation in the committee where we started to step to the line is where those came into specific architecture considerations and if you look at that spectrum there was a sense as you start moving there to start to dictate architecture's so we backed off a little bit. That may warrant a further conversation and we would love your input and others on that.

The other that we talked about is whether certification which looks at technical functionality is the right vehicle for enforcing policy requirements and we came to the conclusion that certification is not a great vehicle for enforcing what should be good policies before networks as a noun to use much less exchange that occurs in a direct way. We do know that there are some other tools that the ONC has to set up some over arching policy and one could be to the grant program and any criteria that they want to establish.

You mean setting policies that are required to be licensed or whenever?

Yes, the analogy would be what Tony said about federal being the floor and if you think about how NHIN would go out and they might be the floor for any HIE.

I think its HIT semantic imperialism we start talking about the reconciliation of policy and making them interoperable we will leave Political science behind.

It may be as they considered the other levers, governance would be when the work group take that up as the area of recommendation.

Did you want to say something else, Paul?

Okay, Roger?

Back to Neil's comment, I would like to reinforce, Deven, what you were saying with that simple phrase. The scanned image is flowing today between users would be wonderful. I have seen this team doctor for a long time and he has something like this. And one of the things that I think is interesting is that we need to remember that it's important to separate the data from the presentation. If we do that we need a lot of room for innovation for what they could do exactly to Neil's point to make that a very useful. So one of the things that we need to remember is what we do will have tremendous impact on a lot of things we have no concept on relative to innovation and mixture in the Mexican that we do not preclude in addition. And from that standpoint to separate the data exchange from the presentation that is there and let innovation flourish from that standpoint.

[ Captioners Transitioning ] Dale?

I wanted to follow that thread and say, that is how that exchange happens and being architectural is very very important whether it is through the Mauna HIOs, we want to make sure whether it is a state entity or individual Rio or hub. Vendor or something like that, I think we want to keep everything as neutral and as open as possible to facilitate as much of that. And as much of that within the system to take place. We don't want to have a whole bunch of rules set or have the federal government set those rules and be prescriptive, we want to allow open an ovation.


I wanted to follow on to what Paul was mentioning before about these policies that need to exist to ensure an environment of trust for exchange. And you mentioned earlier in the presentation about the work Upper [indiscernible] and I wondered if comment on that. And also, I wondered about certification of Interoperability components, we might say that somewhere along the certification, we have policies that are -- maybe the meaningful use group needs to go back and figure out how to ensure that level of trust in one of the measurements they look at, and ensure that the partners within NHK are adhering to that over time.

I hadn't even thought whether there was room with in a meaningful use to make this happen. But what we did discuss was whether certification which again looks at technical functionality which either exist in the H.R. or components and again their capability to allow for the exchange set is required by and all of the other bucks nowadays that are required for medical use, that that can actually happen to discuss a fair amount today about whether or not it is dependent upon the other variables that can be address but that exchange. And I have given more thought as to whether meaningfully as was the way to do it or another vehicle was available for use. But I think you are just checking off one of many boxes when you say that technical pieces are in place.

Right. I think the components are not really enough here two say that we have an Internet where people are willing to share their information. Maybe you could, to back on the HISPC [indiscernible]?

Our group has been looking peers over state law -- and the project has been on going for a long time and maybe we need to get a better look at where their work is, and only to give a nod to that effort and say we need to incorporate it into what they're doing.

And as the person that has been responsible for that effort in ONC, I think we have had 42 states and territories looking at privacy and security policies and laws and how the variability might affect health information exchange in the states as well as across states.

The last days that at this project was actually pulling states together to come up with some comments and solutions for how to deal with some of these issues, some of which have certain to be a demented and some of which need more work. But there was a lot of discussions and collaborative is that were focused on consent issues, one of them looking at the availability of cross States and reaction will be coming out with a report sand that does the 50 state laws survey on all of the different consent laws across the states and show some commonality and the differences which will have on our web site in the next couple of months probably, and then another group that was looking at how you deal with the fact that there is variation. Congress had not made any decisions to preempt state law so we do have a federal for with state. Dili on top of that how we might be able to bridge that, so that the that a couple of different approaches, modeled laws, compacts, and some discussions about having HIEs and regions working together. Asian, so I think there is some good thinking and some suggestions and some things that may be further along than that that could help in your thinking.

If I could follow up on that comment, in Social Security, obviously we have interactions with each and every state. And health-care facilities in the states and would also mention, not to get two granular, but there are 148 health-care facilities around the country have their own release and Clarence forms process these that go beyond even the state requirements. So that is a challenge that we deal with everyday and so harmonized in the state rules will get us so far. But I think to create an Internet of trust, we must develop guidelines that everyone can live with, even the health-care attorneys. [laughter]

Good luck without one.

The Okay. -- Good luck with that one.

Okay. Let me see if anyone would seek to modify these recommendations at this point?

And if not, would there be any objection to accepting them as recommendations to the Health Information Technology Policy Committee?

I think that is a ringing lack of dissent. [laughter]

We will take it.

Thank you very much and we anticipate your continued work on the issues that have been raised here.

When I get back from vacation.

Yes. It isn't Montana though is it?

No, it is not Montana. [laughter]

Okay. We are ahead of schedule, I don't know what is wrong. [laughter] I don't know if we have people here from the standards committee, but --

Jamie is in the room and I think the other three are on the telephone.

Okay. If I can get ahold of my agenda than, Jamie is the first up.

We are now going to get comments from the standards committee, and and obviously we have been adding to your workload here. Or anticipating what you are going to be doing anyway. Maybe that is better.

Exactly. I end Jamie Ferguson. I have a relatively brief presentation here and should serve to further? Ahead of schedule, I think. What I will do is review the standards, and we talked about this last time that we presented a different and probably more easily understandable format of our standards recommendations that we're making for the standards required for the 2011 measures, both for certification and cell that certification could allow applicants to achieve meaningful use through the use of these capabilities of your systems.

So I will talk about our primary standards and then the framework within which we are making these recommendations.

I will just do a. Brief review. Generally we found that many of the standards that have been harmonized and specified by HITSP are useful for the 2011 any police majors, in particular, the clinical documents architecture at HL7 is very useful or structuring document. Also HL7 2.5.1 is useful for more traditional messaging or that is needed.

But found that the continuity of care document was appropriate for summary records, and the NCPDP script for prescriptions x 12 for the administrative transactions, I don't think there are any real surprises here.

Moving to the vocabulary recommendations, we find that for clinical problems and procedures, snow, meg CT is our primary recommendation.

Board drugs, are X norm. And that test would be identified by LOINC, and units of measure, and at ministries of terminology, the petition of the hippa standards.

The key concept I wanted to talk about though is that it will take longer than between now and 2011 for many applicants to implement and get to the full use of these standards. Therefore, we are recommending the standards for definitive implementation where the 2011 measures in 2013.

We're also said recommending a specific number of alternatives that should be allowed for 2011 meaningful use and examples of that are unstructured documents, pretext or PDF as long as they have the appropriate CDA ex em el header. We have also found that there are a number of legacy implementations, and so there are a couple of primary reasons for Really meeting to consider this delay.

First of all we have discussed in the work group that we do not want to place an undue burden on any of the mentor, and in fact there are implement jurors who have implemented some of these legacy standards to have yet to get value from their implementations. So we felt it would pose an undue burden on them to make the switch after they have imposed something else, and if it could meet the intent of the 2011 meaningfully is measures when they meet their current implementations while taking a longer time to transition to the standards. And at the same time, many information technology projects take longer than two years in order to provide and be cost effective, so as not to interrupt or disrupt operations, clinical operations. So for all of these reasons, we felt that the 2013 definitive implementation of the standards set 2011 standards was a recommendation that would not place an undue burden on any applicant.

Recon have a couple of remaining issues, we found that a couple of the standards we wanted to recommend were not quite ready and for one of them we have an alternative that we are recommending proportionate quality of major submissions. If we found that the standards that are being used for? Are I standard reporting through its EMS through registries is a recommendation in the process right now and we are still vetting that and we're still working on the Public Health Data Exchange recommendation aware that CDC 's method called gypsy we found was not quite ready to be recommended.

So our next steps with the standards committee is to move forward with the revised recommendation of the documentation which we think is much clearer. Have a lot of input that it was hard to understand what we are saying, so we think we have written it better patients fundamentally have not changed. We have also gone through with the help of the clinical quality work group, the have identified the individual data elements that are in each of the measures that are in the quality reporting and 2011, and we have recommended standards for those. So those are the basic things which are still working on. I would be happy to take questions.


There was one thing I didn't understand, just to clarify. On slide four, we are talking about. [indiscernible] also pretext image documents. That is as a limitation we have to wrestle around or is that a plan?

The plan is to use structured documents in that seat NCPDP format as the standard, but we found that we thought it would place an undue burden on implementors Board 2011. And we found that there was the [indiscernible] put a CD a -- structured documents. But because we found it would place an undue burden on them to get to that standard by 2011, we are recommending that these alternatives be allowed temporarily only.

Do we -- are we in general agreement that people can get around away from pretext PDF and other images by 2013.

That is our feeling, yes.

Wow. I would disagree with that. I think that it's. Very aggressive.

Well, from the gist of our conversations and our consensus in the committee, we say now that this is a 2013 requirement, we feel it is reasonable and does not place an undue burden to get there.

So we don't have to take a position on these right now? Just for everyone's information. The standards of committee will make recommendations and that ONC will then have to react to them.


On the medications. The units of measure on medications, for you taking into account pediatrics when New York dosages and are handling dosages on a weekly basis of the child? To have that capability with the standard of measure and the ability to do that, because I know that has been a real concern with the pediatric folks. Also, on the summary, when you are talking about that meaningful use Department of and encounter a summary or a patient summary, your recommendation is to use the continuity of care document?


This opens the door on the whole meaningful use conversation that we have had many times. When we come two, what is a clinical summary, we have to be very careful about what that definition is because, when a summary -- In normal terms when you think of a summary, I think of a complete clinical summary of what has gone on with that patient including history. Whereas for an individual practitioner, event ophthalmologist is seeing a patient, it is a very different summary, so that continuity of care, would that be specific to the specialty as opposed to a general clinical summary?

So is your question asking whether we are going to have different summaries for different specialties?

What is the summary as opposed to how -- there's a real difference in what that summary is depending upon their specialty.


I would say there could be different content, it's it's a specification that has sections for example medications, immunizations and allergies, so the content of the sections may be different for the different specialties but the basic structure and its standard for that the Cavaliers would be the same.

The structure would be the same, but how it is applied, Ida bell many podiatrists that make sure if you have had your mammogram, you know, in the clinical summary.

That is true, so the heart of whether that is populated or not it would be out of the heart of our purview.

Paul and then Arthur?

Jeanie, I have a question I guess on slide three were your recommended snow Med. And my question is, for billing purposes, you really have to use ICD nine and 10 and C PT, cell will everything be coded twice?

Oh well there are cross maps you can use and part of our recommendations, I accidentally omitted IC D. Tennant from that slide, sorry, but that is one of our recommendations proportion use in 2010. It is in our use recommendation for documentation that is nomad CT is recommended for clinical documentation. SCHIP nine antenna are recommended for classification purposes and other transactions, so we do anticipate that a standard at mapping for that exact purpose is being provided by the lack National Library of Medicine and on what can and cannot cannot [indiscernible] we do envision and we recommend as its general direction that documentation should move to.


-- every health-care organization is one to have both coding organizations and [indiscernible].

What is going to be required is that for purposes of Interoperability, outside the boundaries of that organization, that you be able to map into the specified standards. It doesn't say how you have to cut things internally or how you have to store data internally, but it does say that for Interoperability purposes in have to be able to represent more information in terms of the specified standards, and that is true for all of them, not just SNOMED.


Isn't there a lot of argument about SNOMED versus other things such as -- the international standard the support by that -- disagreement about physicians as to which one they preferred, am I correct on that ore and-remembering?

I don't think there has been a lot of exposure to this up until now. It is clearly two recognize standard.

I just thought there was disagreement.


I see on slide to there is an and this is on NCPDP 48 peppers grading, and as you know, that is placed in 2011 as one of our key objectives, and you also have prescription Norm on sliding three, but I want to stand a little bit about the third bullet on a fourth slide.

So if I am a provider and by fax and scanned a script to the pharmacy, and I actually structure that in such a way that it has a CD a header that says it is a backs script, does that qualify as E prescribing?

That would not be our recommendation for prescriptions, no.


Right, but what does the third bullet mean if someone did that?

This is a problem of taking a summary statement and applying it to a detailed case. There are particular cases where we are recommending that, for example, images of documents should be allowed for 2011 with a CDA header and prescribing is not one of those if you look at our detailed matrix.


And this is additional detail [indiscernible] additionally and that NCPDP script, we're recommending a HL7 version 2.5.1 prescriptions for indigent, but not for ambulatory. And that is consistent with the rules.


This is on page two. Jamie. Of course in 2013, it will be eligibility benefits and referrals will be the ONC.

It has Persian 5010 and version 1210 instead of ICD nine.

I don't think there is any danger of people confusing the standards experts suggest there with me if I am not getting it over here.

On slide four, is what you're saying here, I am sort of missing [indiscernible]. In those area, if you are doing lab results delivery, you can't do it PDF or via image of lab document. But that is not saying that your recommendation is that electronic health records never include PDF or images of Health documents.

What we're recommending is for the coordination of care purposes [indiscernible] -- those kinds of submarines CC A and CCD structured documents.

So if a patient comes from a specialist who is not part of this or doesn't have a record that meets the criteria, and therefore can't enter operate, with the specialist does primarily is printout a care summaries of the patient can't take it to their primary care doctor and the primary care doctor has bought back they can still stand in and store it, it is just a specialist from before cannot get any critical use of his time.

I don't think they're would be a prohibition on that, but what I am saying is, for the next encounter, in fact scanned document needed imported, that would not be part of the structured document after 2013 that would be provided to the patient after that.

I think there is no question that you have been interested audience here, and we could keep you here a while longer, but we do appreciate you coming and reporting, and IT were meeting next week I expect, and of these recommendations will be presented and hopefully some or all or adopted, and we can think about how we might want to get our input into those, if the committee wants to do that.

You think?

I second that.

Thank you, Jamie.

Our next presenters are Janet Corrigan and deployed Eisenberg, who are present by phone.

We are here.

Great. We have your slides up.

Wonderful. Let's go to the first one. And I should say my background, these recommendations have been delivered to the standards committee yet, and there is other recon process and they need to be reconciled across the barriers were Crips and the Standard Committee overall needs to weigh in on these. We need to get the latest intermission for the clinical quality work group. What have been doing is to afford that process and identify the appropriate standardized performance measures that correspond to the policy committee's 2011 measures. So left second, review the performance measures and develop guidance for a major retooling. Because virtually all of these performance measures have to be leased specified to run off of EHRs.

Third, identify the underlying data tapes and elements that must be captured in the EHR and PHAR2 produce the performance measures, and then head off to the clinical operations group to identify the specific information technology standards. Which you just heard about.

We started with the recommended set of 30 performance measures that the policy committee came forward with and provided to us.

Out of those, there currently exists for 23 of them NQF endorsed measures which are pretty close to what the policy committee requested.

About 18 of those can be produced from EHRs, and then some of the measures can be retooled but by that them must be produced in the near term 32011 through attestation.

One of the key issues we grappled with which affect nearly all of these performance measures has to do with the capture of diagnoses and through a problem list of some sort generally.

As Jeanie indicated, we decided there was used [indiscernible]. And what our work group not would be appropriate is for 2011 to have two versions of the performance measures, one which uses ICD HIE and one which is in SNOMED CT. One goal [indiscernible] CT [indiscernible] in the measure which is in the SNOMED specification. And we thought it was appropriate to probably have multiple versions of the majors during these early years because it for those organizations that already have the ability to use SNOMED CT, the last thing you wanted to do is to ask them [indiscernible] that is ICD nine or 10 in his earlier years.

I wanted to point out and I think this came out in the prior discussion, it is certainly anticipated that for many organizations, they would use their internal coats and obtain some SNOMED CT expertise to map those over to SNOMED.

It is also recommended by aircraft that EHR certifications should immediately begin to require the existence of a problem less.

And the other thing is we need to make sure that the NL and SNOMED CT chorus subset which is what we expect to use in the near term in terms of the problem [indiscernible] [indiscernible] to approve that terminology [indiscernible] 2011 and beyond. I think we will likely need for defined [indiscernible] to be able to map over and make sure that as the performance measures that SNOMED CT continues to evolve in the terminology in the course set set for the populace.

We recommend that a more comprehensive assessment of the inadequacy [indiscernible] the sooner rather than later so we are prepared going further.

The next slide, [indiscernible] that has to do with the exclusion.

[indiscernible] mission is to be perfect [indiscernible] to be accurate and 100 percent, and going forward, [speaker/audio faint and unclear] in the performance measurement community. For 2011, attestation likely be necessary. Exclusions from the EHR by 2011, that would be for 2013. And in 2011, there is currently a sea PT to code that is used right now from many nations that has three levels that indicates right now whether there was an medical reason for excluding ... system reason. So that is one of providers could readily adapt two because many were already using it. Now our overall goal and getting these measures retooled is getting it moving towards what we call patients entered measures. So what we would like to see essentially is all of the majors when they apply to acute-care settings were ambulatory or long term settings, that they have similar denominators, denominators that are specified to apply two whatever setting the patient may be in, and also that they use consistent protocols for the various age groups, and in general, we want to strive towards is harmonization is not only with the majors but across all settings.

I should mention -- long-term care facilities and members of our crew to come from the long term care community have been working very closely with us to try to make sure that we keep in mind applications, to long-term care settings whether they are nursing homes or home health or assisted living and those kinds of areas because somewhere in the future what all of this to be harmonized across all of the settings.

We also took a look at some of these measures, and in some cases, there is more than one major listed in the grid that you have as a handout. As it applies to a particular policy committee majors. And that is because we need to be sensed -- have some staging of majors over here. The first one, body mass index, for 2011, probably what we want as a measure that indicates a patient at that BMI or not. [indiscernible] capable of identifying that BMI percentile, and if that is recommended for this particular patient. You see a similar thing with asthma medication. In 2011, we would recommend use of a major, which is separate meds for patients with asthma, that in 2013, a more refined measure that works whether -- but that but that the medication it's appropriate for that patient's particular stage of asthma.

And that in 2011, it would probably suffice to have a mission that looked at whether we're not [indiscernible] to only be able to define some of the ability to look at [indiscernible] across the things the entire committee that the 2015 looking at the ability to recalculate commissions committed wide.

And the last slide here I also wanted to [indiscernible] [indiscernible] Some market needs to be done fairly immediately to begin to generate some issues of whether patients understand their treatment options, and whether we begin to underline HIT [indiscernible] aristocrats measures of capturing, the do not in today orders and things of that nature.

And Ellis, I would make it is, there clearly a lot of myth and parts here. Have to have measures that are ready to go, and that involves the development and the major stories that develop these measures and there has to be inappropriate time table laid out two will making and in have to identify all of those HIT standards. And our work group thinks it would be very helpful and strong the urgent for these standards and Policy Committee to work together to develop tide table and have some very serious thought and discussion with this that reflects the rulemaking process and it covers really the next 527 years, [indiscernible] 2013 will probably be a bit of a compromise and some very tight time frames for both the EHR vendors as low as the [indiscernible] [indiscernible] everything is in sync and there is adequate time table for various organizations and groups that have to participate in this rather complicated effort rather than just getting the work done appropriately.

Now will have this over to Floyd and Floyd has put together in the techs which I believe [indiscernible] the matrix, you have that in front of you that will just get an [indiscernible] of what that shows. A ticket recommended list from a policy committee, and identified the corresponding measures that we currently have this interest NQF measures, and using the free-market that is established by the EHR expert panel [indiscernible] which Paul [indiscernible] helped to chair, we identified all of the individual data elements for each of those measures in the appropriate column. So that we could work with Jamie's work group to identify those elements. The standards of course that they have looked at, they of course but at the terminology but that the standards for Interoperability. And he will see and some of those fun, specifically, it is a little more complex on [indiscernible] and has more comments and concerns and Things, data such as the anti robotic devices as opposed to medications, the devices themselves may be harder to identify, especially identification that they have been used. In most of them, the data elements except for the exclusions, as Janet already mentioned, are fairly well defined. So that is just a brief overview. I don't want to take a lot of time on it but I would be happy to answer questions.

Questions for the committee?

I know that 23 had current standards, and 18 it needed retooling and five would be done through a station. And by recalling that correctly?

That is correct.

Can you translate that into 2011, 2013 and 2015 terms in terms of the of availability of standards for majoring the quality metrics that were included in our meaningful use me to expect is that what addressing? And as far as the standards you would recommend it, five of them would be documented throughout a station.

That is correct. So for seven of the 30, there are no existing majors. Unlike could quickly tell you what those are, percentage [indiscernible] enter it through CPOE. Percentage of patients with access to health information electronically. So that is just an example of that but for seven of them www.have a major constructed yet, work would have to be done.

Sell for all of them that we have a major, you can specify majors with a [speaker/audio faint and unclear] for 18 of the 23 that we have measures for, yes. We believe that those can be generated from the DHR and Jim is work group is well along the road to identify the HIT standards that they needed to do that.

When they need five, which in 2011 [indiscernible] the goal of that would be to be generated from the EHR directly by 2013.

Okay. One last question. One of the issues we have been discussing is the issue of special pieces specific measures. To go beyond the primary care domain which is most of our measures have been concentrated to specialty specific measures, what is the implication of that for the availability of standards within the 2011 remark?

You identified.

Do you want to speak to those?

The reason you see asthma on the list is to address some specialty and also pediatrics. You will see one towards the end of the grid about -- for a stroke and atrial fibrillation and providing an attack like a nation which is, one, two at a hospital measure, but also two address the specialty. So we did address the specialties based on a review of existing measures around specialties, and there are standards to deal with those. And if that is what we're trying to do as far as addressing his specialty.

One other thing, our report report did a call this week and started to focus on issues for 2013, and we're trying to identify what is in the pipeline. Many of those our industry specific measures, but it is pretty slim the pickings. We are talking about maybe half a dozen or 10 nations that exist, we so we need to start sooner rather than later to edify the specific types of major so we are needed [indiscernible] the mini pool use Workgroups will go identify some of the existing measures that are in the 2011 set, but some apply ... A call out to try to grab some more specialty specific measures.

In answer to that seven majors, the reported measures that do not have NQF endorsed measures, some of these did not have the intended endorsed measures with the percentage of patients [indiscernible] electronically to almost an attestation, to make that available to all of your patients, that have major, it wasn't intended to be something that you measure out of the EHR system.

Another example is the compliance example with HIPPA, that would be a quality measure that NQF but typically indoors. Even though a hundred percent supportive lab electronically, they have interfaces to certain lab test results systems and not others and what 1 percent would have -- so some of those would probably never go to NQF the endorsement.


Janet, I have a question that is sort of a NQF process Development to question I guess. Your assay the pipeline baby than in some areas that may be important to us in 2013, so I guess I see it -- and correct me if this is not accurate. I see this process as accurate with a customer have NQF and people that defined need support measures and policy making for a for purposes. And in some sense, NQF and the pipeline that supports NQF is being stimulated by variety of demands from across the country. I am sure that [indiscernible] what can you as far as you go about [indiscernible] the needs we need to anticipate for 2015 given the range of other users of measures that are out there, I really want to avoid the situation of us booking under the lamp post to head for years from now with the things that we can measure ITI effective meaningful use of decisions and care. And I also worry [indiscernible] we are not the of providing for [indiscernible] measures, but there isn't one. We have these voluntary coalition attended by three groups, all of whom expressed themselves but we don't really have a mechanism to create national policies around these areas of emphasis. But we are contributing to that ourselves. So in the nucleus discussions we are going to happen next few months, and equates them operative discussion around, Janet, Cure other users to make sure that we can sync up the pipeline of developers and the other directions.

It is a very good point. Phonetically are actually a little closer to having a multi stakeholder national process for identifying the priorities for a major development and endorsement going forward. The me just sort of tell you where we are at with it.

We have a very expensive process in studying the six major national priorities which I know developing it's 2011 policies and measures and those are the major cost-cutting areas, whether it is care ordination were overuse or palliative care or anything in the major cost-cutting areas. [indiscernible] under development with a contact for HHS which is emphasizing the top 20 conditions using the set of criteria not only about incidents prevalence and the burden and the ability to impact high quality and ability to attack attack and things of that nature, [indiscernible] about eight weeks are now, I thank we are also going to be working, as we have those top 20 conditions, we are not -- we also want to make sure that the attics portfolio of measures that covers all of the leading surgical procedures as well and if they don't get reflected and separate we are covering [indiscernible] surgical procedures asthma are those cost-cutting areas that you have already got. But that a text and work is already over way -- underway in [speaker/audio faint and unclear] already have in the portfolio to the cells in the matrix and we will see where there are gaps. And where there are gaps, that then gets translated into a set of priorities for a major development. And that work will be completed by the end of this calendar year. There are already pieces of it that a good deal of progress has been made.

For example, the fifth major national priorities, the NQF art has projects up and running that are reaching out and try to obtain other potential majors that are out there and the major development fields have been [indiscernible] about seven great aunts with those prayers were released that those are going to beat beat a big area of emphasis on a good manager of development is already underway in those areas. So that is the division of the area Ford dimensional matrix as to having the highest of priorities for major development is what [speaker/audio faint and unclear]. ITI say it will meet your needs to a great extent but if it doesn't come provided input and will make sure that we no how they reflected as well.

Okay, I think we are one to move along at this point. They're just getting reports here. Janet and Floyd of terrific work, and with the court to do in the clever to work -- that collaborative work they discussed. It seems important that are meaningful use and standards development groups be continually coordinated. So we appreciate your presentation.

I just wanted to say one thing and this is in response to something Paul said because I wanted to clarify that CMS is in the room today and that was about the percentage of patients with access to health information electronically. And we talked to [indiscernible] and knew that would be an attestation process, but what I heard you say was different. This was I think designed it to be at attestation of perhaps 30 percent of patients and not whether you provide access yes or no to think about it being used or not that it with established a minimum or Max% but that with with what the present reported as opposed to a yes or no.

That is noted for the record.

Is Dixie Baker on the phone?

I am.

Terrific. Thank you for being here.

This has been very interesting.

What I am presenting today, as Janet mentioned in her introduction, this is summary of the full Standards Committee meeting and I would encourage the standard committee meeting, but I'll hopefully give you enough of feel for what your doing that we would feel comfortable with making good progress.

-- capabilities that are needed for what Devon referred to a while ago with the eight priority areas of focus that are enumerated in the American recovery and reinvestment act.

And that is the standards that were available for your product certification and then in identifying the issues that could be used for demonstrating that a certified product was being used meaningfully.

Last month, at the July meeting, we completed our certification. And the services that needed to be provided by the products as well as the standards that were available, and we gave them readings and the standards a readiness reading. That work was accepted by the committee last month but since then we have discovered a couple of standards that we wanted to add. It also discovered a couple of that readiness ratings that we wanted to change. Cell-- come up with significant changes secondly we have developed privacy and security measures and these are measures demonstrating that the certified EHR product being used meaningfully and being presented to that work next week as well.

Okay, this is kind of a summary of the standards update. Last month when it presented de [indiscernible] in the rank of rating 1 to 4 and this month we have added the 2011 and 2015 readiness.

We have added a bit more detail about the source references and last month we had a fight that this came from a HITSP contract, this month, and we had questions about this, so we had added specific references to constructs.

We identified the International common criteria for tested system in violation as one of the standards, and, we got a question at the meeting about that, and although it was accepted, we concluded that really, the assurance measures themselves should be included in the certification criteria, and that the PAL certification criteria is should be used as a module [indiscernible] this process.

We added to standards to the web services security, and the IET cross document reliable interchange particularly with the reliability exchanges.

We added three HITSP capabilities. We haven't identified any of these capabilities, at the last meeting, so we have added three. 143 is the managed consumer practices and consents. But all three of these have lots of things to do with consumer -- committee structured documents and for both 119 and 120, we passed by this this would be using the system to system possibilities within the capabilities. So this would be used for providing the consumer and electronic copy of their EHR and either an unstructured document which would be acceptable in 2011, and then by 2013 it would be a structured document. Two system topology as well as the portable media, for the case in which a provider might provide the electronic copy through PHAR.

We had quite a bit of discussion about the rest which is a much simpler messaging approach that is used for service oriented architecture solutions, and it is being used more and more. It is not a new standard, it uses traditional http and universal location indicators. And we added a note that will allow the use of breast as an alternative to sell pore service oriented architecture messaging.

And finally we changed to a readiness levels, and when heroism the wrong direction. And in the case of [indiscernible] we changed it from a level of 1 to 2 because it is probably at 1.5. It is certainly immature standard but it is probably not used by 20% or more of the people who have Unix security positions. And then personal White pages which basically uses LDP and domain name services and so we changed it consistent with those standards. And I will present most of these next week but most of next week's discussion will be focused on defining meaningfully is measures.

And since our objective was runups policy committee, I thought that you should now about the challenges that we found and we discovered and identified with these measures should be.

First of all, every objective that we identified is HIPPA compliant. And I identified the reason behind that and the truth is that already applicants are required by law to operate in compliance with the HIPPA privacy and security rules. And so the question is, can the impose any additional measures without prescribing new laws or new regulations? So that was a challenge for us.

We also had the new ARA provisions and it wasn't clear handle those so for now we are including the ARRA provision specifically in the majors that we identified.

We also didn't appear to be set setting HIPPA. We got about, well, maybe there are some standards for its petition specifications in the Security and privacy rules that we could specifically identify and say, well, you have to demonstrate these appalling five. But then you're coming across as saying, these five are very important from all of the others. But really, you don't need a full HIPPA compliance come you really need to address these five. So that was out of the questionnaire.

But the bottom line is, there is a strong recognition that I have heard reflected over and over in today's discussion, that the meaningful use of EHR technology on collectively brings new privacy and security risk to the provider organizations, and to consumers, and that are effectively addressing these lists is absolutely critical to the ultimate objective of furthering adoption and [indiscernible] of interoperable WHR F and interoperable the exchanges.

So our next recommendations that we will be presenting next week include the three basic types of measures.

The first R measures that represent a value EHR adoption is contributing to the organization's challenge of remaining HIPPA compliant. So if they have to audit access this to the information, and the fact that an EHR product instead of an automated way to do that gives them additional value. It is not a new requirement but the EHR steps up and plays a role in their hippa compliance. The second head of measures that they will be recommending are those that represent a fundamental change in an organization's approach to maintaining hippa compliance as a result of them having adopted an EHR product. So in other rates, these are like counter measures to a new risk that they didn't have before. Also, the configuration at Security and privacy capabilities that are inherent in the product, I recall at the last meeting of the meetings that I presented, if in fact I have a product that might have saved and encryption capability, is certified have that capability says nothing about how the organization uses the capabilities of that would be another type of measure that we intended to present.

Finally, measures that can be objectively assessed, and I know that we have been talking about this today as well as the other two work groups from the standards committee. We need to be able to figure out, or somebody needs to be able to figure out how they are going to objectively assessed how they're going to meet those measures.

So I will not present the details today, because that would steal my thunder for next week, but I encourage you to come to our meeting next week. Are there any questions?

Questions? Devon?

Thank you for that presentation, unfortunately I won't be here next week so I will miss the meat of your discussion at 42 catching up with you later.

The have said a fair amount today as a policy committee, although certainly not the definitive word on standards, but a couple of things we agreed upon to conclude that the standards be architecturally and technologically pitch well and that there be CCHIT for acidification been that many for years and not necessarily a greater list of criteria that products might be it sort of given a good housekeeping seal of approval by are not necessarily part of the certification for getting your meaningful use incentives.

So part of what has been done today has been looking at existing CCHIT criteria and mapping them, given that they are sort of putting some new shape on what the criteria ought to look at with meaningful use, do you have any plans of how to go back and look at those and assess whether they address some of the overarching discussions we have had today?

I think we are fortunate that we had very good guidance from the TLS early on, and with attacked the HITSP standards. And will ultimately go ended up going to the ARRA eight, and instead of really using the CCHIT criteria as a major input into our analysis, we have used that ARRA eight and HITSP standards as major inputs and the process. So as a result of that, everything that we recommended -- we are recommending can be traced back two either, and potentially Bowles, the eight priority areas identified in the ARRA law itself and for to the HITSP standards or constructs that with the port the security and privacy Services required for the ARRA eight priority areas.

I also wanted two just clarify that you want to see in the standards that you recommend, you won't see any HITSP constructs listed, but we use the HITSP constructs and with it at the standards that does constructs reference, and the standards are the ones where we majored their readiness and ultimately ended up recommending.

So, now, I don't see any need for us to go back because we went right direction to begin with.

I am not sure I agree that that addresses the question, but we can take that up later, because these are the new criteria we talked about today so it would be unreasonable to expect, but I think it is something that we need to talk about.

Let's talk about that because I haven't heard anything to cause me to change what we're recommending today. But I'd love to follow-up with you on that.


I think that we are questioned out, Dixie.

Thank you so much. This is such important work, and we really appreciate you and your work group 's activities.

We will now move to the public comment and at this point I usually turn it over two Judy.

[speaker/audio faint and unclear] the public to make public comments to the committee as well as anyone on the telephone. The operator can give you instructions on making a phone line accessible to the committee.

I think we will begin with people in the audience, but remember, we are capping your comments at two minutes. So there is a two minute limit.

[speaker/audio faint and unclear] you interrupted me a previous time. Pilot I sent a letter to Dr. Clement ball, who has -- Doctor plum and Paul, who has written my comments, which was interactive, and ask you to put this record on the record.

Number two. As I mentioned, how much time to have?

Please continue.

If you don't know, I will count.

It is [speaker/audio faint and unclear] illustrated very well. You cannot damage [indiscernible]. I do not know the term how to explain this.

The second point, I didn't understand why you don't consider [indiscernible] issue [indiscernible] because it is exactly input information technology for medical needs.

So I have may be used my two minutes, but I need to say to you, I have flash memory with me. Everyone has a computer, I can demonstrate how to solve the problem of verification [indiscernible] efficiently and bought back. Thank-you very much.

Good afternoon. I am Lynn [indiscernible] the vice-president of government affairs with s are as soft.

I have listened to York webcast over the internet but I felt it was important for me to be here today to deliver this book personally. This ask you to provide private -- these are the physicians who will have to achieve what they're EHR [indiscernible] have to be achievable [indiscernible] medical practice as he move forward.

The fact that a relatively small companies like ours would receive such a response in just a few weeks with minimal our reach efforts is an indication of the deep level of concern pervading that community. Two things are clear, as some selected was is not being heard and they perceive that the government's specifications are overly burdensome from a practical perspective. The signers of petition are not all clients. Other providers have reached out to us and as we stand up for them as well. As our S users are not, they're passionate about EHR and speak from a positive and negative aspects. Physicians will not adopt technology that compromises their productivity, they wanna become data entry clerk and will not jeopardize the patient physician relationship. No financial incentives or penalties will persuade these positions to take actions the team detrimental or non valuable to their practices.

150 signers of petition or so concerned that they took time to compose their own supplemental Commons to consider, and they are in this book. I hope that you'll take the time to read through even a portion of them. Baton intensity and content will provide insight in what will be necessary to successfully encourage widespread EHR adaption.

Okay. And we will take the next to the oven.

Mike Koppel. First of all affected Spence appreciation to all the members of the committee. Obviously you have spent a lot of time and our of our is dealing with some really tough issues. It is gratifying to see the level of the Matt you have two both HIT and to provide health outcomes. And certainly the hours expended and the best of intentions [indiscernible] best of intentions and [indiscernible] point out one of them distract from the credibility as a whole.

In your transition strategy for the certification process, I think the current strategy that you laid out and that you approved today has a serious flaw. And I believe this lot to be unintentional. But it is significant because it has market implications and it distorts the market. With the 2008 CCHIT plus gap approach, and I think -- in the spirit of the level playing field they talked about in hospital segment, there is only one vendor that has currently achieved HIT certification for 2008. [indiscernible] [indiscernible] so they went to or plan on applying the 2009 criteria which was more stringent. However, I would like to also point out to fascinate certification is no longer available. So as your approval of the 2008 plus gap appears to favor one company only in the hospital space, and the company unfortunately appears to be on the one represented on this panel. And I'd think this is unfortunate, because it reflects inadvertently, I believe, but an unintended consequence that has that potential that, we will say, distorting the market in hospital stays. So I would ask that either the national coordinator for considering the recommendations or Mr. Twinkle in development of the regulations would consider, is there a, we will say, a review process that would prevent such things and the unintended consequences from happening.

Okay and I believe we have a comment from the telephone?

Our first, it comes from Chester frenzy of covenant Health.

Chester Ramsey?

Let's go to Mr. Perot.

Good afternoon, my name is Ruth Perot [indiscernible] and I want to thank by acknowledging with appreciation three features of the current meaningful used craft. We certainly applaud the lifting up with high priority the addressing of Cyprus Party, and we also want to commend the panel for addressing the upper purchase of -- primary lead which data and first year of adoption, we also celebrate and commend you for the focus of the entire document. 70percent of the patients in California said they want the doctors to have it HIT. Second to that I have recommendations to enhance your fine work. Twenty-nine actually, I want to talk about all of them obviously. The first recommendation would be to look at the concept of safety net providers and expanded, and there are nearly as many free clinics as there are federal qualified health centers. And 50% of the ethnic and racial Pratt minorities seek their primary-care from individual physicians. Back to talk about the product safety net. And if you do you have to acknowledge that the safety net providers have to be more than [indiscernible] they need a friend [indiscernible] to acquire the necessary infrastructure and they need a decision report support. So think about the safety net, but broadly.

The second recommendation, you may recall the CMS our rich campaign to get beneficiaries of Medicare to adopt prescription drugs. The whole part D campaign. We think this effort is as important as that in terms of reaching providers and consumers about [indiscernible] the penalties as a seated and the benefits. And you think there needs to be that kind of investment by ONC, CMS, all of you to make certain that word gets out because it doesn't get out, will have a participation disparity that will aggravate the help disparity we already see.

The first thing we recommend is that back ONC plan to monitor as of 2011 the participation of safety net providers to make certain that they are indeed included. If the be terrible to wake up in 2014 or 2015 and find they aren't there. It is too late and it would keep them away from the [indiscernible]. And we do see despair disparity is [indiscernible] and me to eliminate disparity.

Mr. E10?

I am with the medical imaging and technology alliance, and that is the largest trade agency representing the industry. I have been have a number of these meetings but at this meetings of stock at how often the issue of Interoperability has. For example high-fat -- heard aggressively established remove requirements for Interoperability and the exchange, that was one of the recommendations that was made. Interoperability across challenges -- across clinic. And we need to know that death Interoperability is part of this whole system and there is no Interoperability without Interoperability standards. That is where it comes in. Have over 80 plus years of standards [indiscernible] and our members work dicom, and you know what that standard is. [indiscernible] you are the leader and development of the dicom standard and that was over 28 years ago.

You are in crunch time. I have a great deal of sympathy, and for job is very difficult and have a time crunch on top of that.

I am offering our expertise, our services, our knowledge and Interoperability testing and development, if you need us to testify, if you need us to write a white paper, I am very encouraged by about the October meeting we will be dealing with this subject matter. All you have to do is let us know what you need and who will put the boys voiced and power behind it. Keyes is us, we are all in the same boat here and we all support the same goal so I urge you to take it finish of our expertise.

Okay, to have someone on the telephone or a comet?

Yes, I have Christine right. Would you please proceed with your comment?

Okay, let's go to Robin [indiscernible] please.

Hello, I am [indiscernible] and I volunteer of thought for the tiger team and HITSP. And just have a comment about one that was made about detail and interfaces and Interoperability, and I like two-point out the new work that came out in [indiscernible] 1.7 and if you dig deep in the weeds and the document, there are 79 interfaces and 443 interfaces like to 7,000 pages of documentation. I would hope that is enough, and also, just in the perspective of talking about a shy owl and -- IET and HIE, section 453 of ARRA where it talks about the very 2010 with the individual has a right to request, did not disclose if the health insurance company did not pay for this, this an area of bury someone comes in for a routine physical, and they say, by the way, can you check for herpes, and they don't want that to go out, that sets out the situation with have to make a separate counter so that becomes, I don't want to disclose this. Because of the situation comes up where it some accounts are taking from a piece of level, to disclose this and this and this, you have an electronic health-care maintenance or need anything going on.

And I just wanted to point out one other thing. I just noticed that because there is one enterprise [indiscernible]. And I wanted to offer on the part of this committee, because there is one [indiscernible]. That CCHIT has Ashley broadened their website that you can actually filter out and say 2007 or 2008, two others are just for the record premarket which means they don't have a and live section yet.

We have time for two more comments. Dr.Peale?

I thought I would come in person today because I have tried to comment before on the phone, and I know that many of you, but not all of you. I am a practicing to position, and I have found privacy rights and I am still a volunteer and I am unpaid. Patient privacy rights has over 10,000 members in all 50 states, the bipartisan coalition for peace and privacy which represents 10 million Americans, and we have sent you all to detailed letters, very detailed comments about meaningful use, which, I not sure it's been in police work group has ever seen or heard from, and we are very concerned, because the process is happening, and we're trying to participate and trying to send you evidence that there are going anywhere, but [indiscernible] there is no place for the consumers to be heard. But the main thing that consumers want for EHR to be meaningfully useful, is the ability to control the disclosure of their information. Anyway, is that a detailed letter recommending both federal policy be used for meaningful use standards -- recommended an open source robust consistent management system that has been in use for eight years and it has enabled the exchange of 4 million patient records in eight states. Effectively that complies with the standards and 42 CSR. This was developed by the National Data infrastructure -- information infrastructure consortiums. So we think that there are. Robust solutions to health information exchange. -- Health Information privacy. We are also really concerned that there were several votes today at have been boats every day on documents that we don't see to it until we get there.

Again, for public input and for us trying to be a part of the process is, we really can't come when we get documents the same day as boats, we can't be involved in the planning process seas, and we have offered our organization have the members of our coalition including the atomic travesty Information Center, ACLU and others will be happy to provide comments of the work group level.

So again, another concern of ours is of course privacy. The word privacy is used in all of these presentations and documents, and we would urge you to adopt a definition of privacy, because to consumers and in a legal sense the term means process of information. But because HHS and ONC have yet to adopt the definition, the proposals are very confusing and the meeting of them is not clear about an actual definition.

The problems of the legal concerns over health information exchange that Judy Augmented could all be solved -- we don't have to do agreements or a legal contracts or business agreements to exchange data, if you simply get informed with robust patient consent. You don't need all of these agreements from stakeholders, because the person that can that the data immediately where it belongs for care and research really is the consumer, it is the patient, so we would recommend that to you again. And then, listening to the comments about quality, I would expect that the top 20 conditions would certainly include depression, that have the greatest prevalence and targeted the and mortality and costs, the depression would be one of the top 20. Depression is the second bus, a disease in the world. But I would have to caution you that if we had a system of electronic records that does not allow trust and segmentation of electronic information, we will never get that data. We know that from HHS as back on findings that 2 million people a year refuse to get treatment because they know it is not private. 2million refuse treatment and diagnosis for cancer because they know it is not private. If we don't have the privacy, we don't have the data to find what is comparatively effective in my field. I would really like to know that. We will never get that data about cycle analysis and psychotherapy, all the kinds of treatment a third at patients are off of the credit because they pay some of privately like me or go to and a court day. And if we designed a system that does not allow segmentation and privacy to look at from the is and missing data and that would be ashamed.

The last thing I would say is the comments that were made before me about how we should have to -- a patient should be able to block the transfer of data would have paid out of pocket. That is actually a new right that high tech conferred on American citizens. That is an important new right. If you pay for treatment, you should decide who it goes to for purposes beyond such as health-care operations.

The queue.

And last, a short comment from Tom Leary. [laughter]

I will save you the story of when I presented to the board and the Pope went out. I think Judy Faulkner was there. Discussion today particularly around health-care facilities. Either it is between DOT and [indiscernible] with 50 percent of their care going downtown, whatever. This committee is addressing the policy issues, you're not shying away from the policy issues that need to be addressed and so continue moving forward. Predecessor organization sometimes backed away from the policy discussion. [indiscernible] September 20 first through 20 fifth. We will have a Senate proclamation, house proclamation, and we are hoping that because it is in September, not in May or June, we are not going to be drowned out by the Thursday we're fathers stay at this year.

One hundred organizations have signed up including nonprofits or not-for-profit, so please pay attention. These are the folks and this is the activity that this policy committee is a result of, and we are the Can for more and more organizations to be part of it.

Thank you, and I will stop before I lose my voice.

Thank-you and I will turn it back to Doctor tank.

Thank-you to the committee at all the work that has been going on at all the members of the work group and a committee. Thank-you to the public hearing and on the Web for this thing in the and we will see you in September. Thanks.