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HIT Policy Meeting 1/13

Posted Jan 13 2010 12:00pm
The HIT Policy Committee met on Wednesday, January 13, 2010. The meeting materials from the ONC website and the rough draft transcript of the meeting are below. Also be sure to check out the FACA blog and the Health IT Buzz blog for the latest updates.

Meeting Materials:

Transcript:

Thank you, Judy. Welcome to our committee members and audience and public that is participating remotely. We are pleased to be able to me, again, in the new year. We are in a the very important point in the implementation of high tech and with this committee. With the Committee's held and the standard's committee, we have now issued two of the three critical regulations that we were tasked with producing. First was the interim final rule on certification, which had to be issued by December 31st. The second, issued by CMS, was the no notice of proposed lawmaking on meaningful use, which was issued simultaneously and will be published in the Federal Register on January 13th, which point, a 60 day comments period will begin for both of those regulations, which will conclude on March 15th . As Paul will review with us, part of the day today will be informing the committee about those regulations and to discussing them. We have also now, just before the Christmas break, ONC has completed it plans for allocating all of the discretionary funds that were appropriated for as under the high tech Act. We now have approved spending programs for all of those moneys. Very few of the moneys have been spent. The necessary request for s, and requests for debt proposals have been published. Nearly all of our proposed programs, which account for that most of the funds we will be allocating, some $1.7 million have been made public, and we are receiving large numbers of letters of intent and applications, happily exceeding our expectations in terms of numbers. Over the next weeks and months, we will be announcing awards. We are very pleased with the community, not only the help informatics community but the local government, state government, community organizations, nonprofits, academic organizations throughout the country have been responding vigorously to these opportunities. The combination of this work constitutes an important point of reference and a milestone in a very long journey. I hesitate to say that we are the end of the beginning, but we are certainly at a point where we should, I think the committee should take pride in what it has accomplished. I think you can see from the notice of proposed rulemaking that your recommendations had a major effect on the thinking of the CMS and the Department and the government in formulating that notice of proposed rulemaking and, certainly, the standard's committee recommendations have a major influence on the interim final rule. I have said before here that we could not have done this work without you, and I think you can now see evidence of why that is.

Today is an opportunity for direct us to reflect, particularly, on the regulations and also, in the afternoon, we will move to forward looking work, as we always do, exploring some reports that Paul will tell you more about. Just, again, welcome. Thank you for your help, and we look forward to reap an equally vigorous agenda coming forward in the new year.

Thank you, very much, David and thank you for all of the outstanding work done in the office and other departments. It is clear that the office and CMS have been very busy in preparing the almost 700 pages of proposed rules and IFR and all of the grant RFAs you have issued. I think the community is appreciative. It is very exciting work. Today's agenda is broken into three sections. A big part of it will be the committee's comments on the two documents that have been released. One is the NPRM for the meaningful use and the second is the IFR for the standards implantation and certification criteria. The second piece is that the NHIN work group has prepared and series of findings and recommendations they will discuss with us right back after lunch and conclude with our preliminary ideas in terms of the strategic plan workgroup as we prepare over the next few months, a document to forward on to you as you put together your strategic planning process. I would also like to get approval from the minutes from December 15th, previously distributed to you. Are there any motions? Any other corrections or discussions? All in favor? Any opposed? Thank you. I will turn it over to Tony and Farzad to cover the NPRM.

Okay, good morning, every one. I want to echo what David said about the work of the committee and how much of that contributed to the effort that we had in pulling together this NPRM without the work and recommendations that the committee made to the Office of the National Coordinator, it is quite clear that we would not have gotten as good of a product that we did end up with. Obviously, a number of people might have things that they have problems with with the NPRM. We will talk about that. As we said before, it is the NPRM, a notice of proposed rulemaking and will be additional opportunity over the next several months to provide comments and, certainly, help us as we look at the final regulations that will be out later this year.

With that, how do we move this thing? Here we go. As David said, actually, if you have your copy of the Federal Register, the NPRM has been published and was displayed on December 30th and is published today and the comment period will close on the 15th of March. Hopefully, it is not any kind of omen of what will be coming in over the next several months. What is it? The definition of meaningful use common definition of a hospital-based eligible professional, which many people have a very keen interest in. Of course, the incentive programs for Medicare fee for service and the Medicaid program as well as the impact Analysis and paper reduction act. These were laid out in various sections of the announcement. Of course, the ONC regulation, they have the initial specifications and as David mentioned, the establishment of the certification programs and procedures to become a certifying body will be in the future NPRM that ONC comes back with. Looking at this from a very macro view point, I think this NPRM does not make number of things that are fairly unique, as well as scaling the program of this across a national scope. Number one, I think the harmonization of the criteria across the CMS programs, as much as possible as we have done here bring in the Medicare and Medicaid programs when we look at the quality measures and some of the other criteria we used to develop the meaningful use matrix is critical and something that will have a very interesting ramifications in becoming years. The state has had an opportunity to provide additional comment in terms of meaningful use criteria, but sets a base that we can build from. It close links with the ONC certification and Standards IFR. We spent time with Farzad and Jodi and others in ONC to insure we had as much and close coordination as possible. We recognize the definition of the certified EHR is critical in developing the meaningful use criteria for this program.

Of course, we mentioned the HIT policy committee and try to coordinate with existing CMS quality initiatives and harmonize that. As you see throughout the document, especially in the qualities sections, we refer to the various CMS programs. It builds a platform for implementation overtime, and as you know, the committee was very vocal in several meetings talking about a and staged approach and for the idea of the stages being geared, not only to the years and infrastructure, but also when the professionals joined the programs, we have taken that into account as we did with the NPRM.

I do not think I need to tell you about this because you were involved in a big way, starting with the NCVHS and starting back in June and July and the policy committee of recommendations in August and the clearance process as we received additional input from the different departments operating divisions and the Office of Management and Budget. This is another familiar picture to all of you, the idea that in the stage one we are focusing on data capture and sharing and moving out to more advanced process these and improved outcomes as we go through the different stages of meaningful use over the next number of years.

Stages, as we have talked about many times will be three regulations. The one out now for comment, we hope to learn from what we have put out this time, the initial stages and year paths of the program to begin the build, stage for 2013 and the infrastructure work that ONC has been doing will help us with that. Then, stage three, that coincides with the Medicare penalties beginning to kick in, we hope to have moved onto the stage three as we have defined it in the previous slide and in the NPRM.

Stage one focuses on the five areas that the policy committee recommended and were taken from the NQF work from several years ago and provides a nice platform. We took that and have added some additional measures and other information that we will talk about in a few moments how we move from the original policy recommendations. The status, of course, we have mentioned this that you can do the escalator approach, as David has talked about numerous times. You come in 2011 or 2012 in stage one and move to state 13 by 2015 but allowed professionals that come in the later years until 2015 to come and move of in a staged manner that will be defined in the later years.

The meaningful use summary, it just quickly, the EPs, 25 objectives and measures, as much as possible we wanted them to have a numerator and denominator and in some cases was a yes or no but as much as possible we wanted to require that. If the hospitals, the same way, many required a yes or no. With the reporting period, the focus was to get the stage one of the escalator to allow a 90 day reporting period to continuous meaningful use in year one an awful and Vernette a full year subsequently, which we think is a balance between recognizing the challenges and ramping up. Quality measures, we require a station with a numerator and denominator and moving towards requiring electronic submission in 2012. We divide it into two areas and have a core group of measures and clinical measures, most appropriate to the EP specialty that they can self select and continue reporting in the specialty of. The eligible hospitals are required to report the summary measures. The accord measures the tobacco use inquiries, blood pressure management and drugs avoided by the elderly are measures that all EPs are required to report on and have developed a number of specialty measures for the different specialists. These are ones, for the most part that cart NQF endorsed. We tried to be consistent with measures that are already being used and, of course, we will get feedback on that. Hospitals are required to report summary data. This is consistent with the [ indiscernible ] program. They can select a alternative set. This is to recognize the differences between the programs. This, also, of course with the hospitals, they can receive potential incentive payments for of Medicare and Medicaid, whereas in the EP area they have got one opportunity to change from Medicare to treat Medicaid or vice versa in the EP area but the hospitals can collect both. The other issue is the ePrescribing area but cannot be received by anyone who signs up for Medicare, but those in the Medicaid EP side will be potentially eligible to receive the MIPA incentive, as well. This is a? Summary of the differences between the programs. The incentives in Medicaid are much higher. The bar for becoming eligible is much higher in Medicaid and in medicate you can implement and upgrade in year one and in Medicare you have to be numbing meaningful user. There is an initial payment received in the Medicaid area that you do not receive with Medicare. With the Medicare area and you have a penalty in 2015. The program payments stop in 2016 whereas with Medicaid they can go up to 2021. There are different eligibility requirements in both programs.

This is probably the area you are most interested in and the areas where there was some changes from the HIT policy committee recommendations and why I brought my colleague, Farzad, to help explain some of the changes. I want to share the hot seat with Farzad. [ LAUGHING ]. He wore his bow tie for the location. As you can see, we made some changes and deletions and the one that most people were concerned about is the documentation of progress notes, and a recorded advance directive is also one that drew them lot of interest from the main number of people. Providing the summary care record was the items that the Social Security Administration, as well as others, wanted to see added. We did a number of changes in the objectives to reflect what we thought were more indicative of where these objectives should be going the in terms of adding growth charts, limiting the smoking status. All of these are about for comment, but these were changes we made. The measures we went and fine-tuned to make sure every objective had not made measure, added thresholds, calculated sum based on you need patient has opposed to office visits because depending on the measure, there might be some reasons why it would be more appropriate to have the patients seen. We have asked for that comment, but they were our best shots, as well as getting plenty of help from others within the department and the Office of Management and Budget to help us write some of this.

The timeline, right now, the period where we focus within CMS to make sure we make the implementation dates, making sure systems are in Place, the outreach is out there. The Regional extension centers that ONC is working on and making sure that that is all in place so that we can meet these the deadlines, which are no sooner than January, 2011 for Medicare in the EP and the hospitals is October, 2010 and if you forward that on the three months timeline for reporting, people can then began reporting on Medicare, the EP side of April, 2011 and January, 2011 for the Hospital site. With Medicaid, we have not establish a specific date at this time, but sometime in 2010, we want to make payments toward adopting, implementing or upgrading. From a system and process standpoint, even though we do not have the final regulation out their debt, we have a very short timeframe to role out the National Program.

[CAPTIONERS TRANSITIONING]. Will want to hear from you and the comment period, as I said, ands in March. And then we have a period of time where we review them and we have to pull together a final regulation, causerie major clearance process and we hope to get it published in the spring of 2010. And of course, a lot of that depends upon the types of comments we get and how extensive they are and what types of decisions have been made at the policy level before we reach the final regulation.

Did you have any further comments?

I will open it up to the Committee for comments or questions.

Paul. You were going too lead the response?

If you could go to the next set of slides please.

Per Tony's direction, we wanted to make sure that the community had its opportunity to provide input to NPRM in time for them to go through their clearance process, and that meant that we had to get the final letter in by March first. The way we have organized ourselves is we had a preliminary call before this meeting just to identify some of the topic areas, so I will present that to you shortly. And that is what the workplace release is planning to do in terms of flushing out and what the work group would like to present to the committee as possible comments back to ONC in reference to the CMS.

This is not an exhaustive list but it was comprehensive about some of the issues that we felt were significant to provide feedback on. We will have an all-day meeting on January 20 eighth in order to get that work accomplished.

To remind you, this is a list of the work group members, and these meetings are open to the public. It refers to express our appreciation to all of the great work that went on with CMS and ONC in putting together this NPRM, and we also noticed that a lot of recommendations were incorporated and the framework was largely adopted. Very grateful for the amount of attention they paid to the work that came out of this committee.

We did that did our comments and into three buckets. One baby philosophical policy comments, a second would be areas needing further clarification, and a third would be a regular comments on specific elements of the NPRM, just a way of giving us an opportunity to organize our thoughts. And that may be more in the first category.

Here are some examples that came up. One is in the clinical quality reporting requirement. The number of times we tried to propose an approach to when we thought of two kinds of extremes, one is an exemplar, meaning that, if you were able to report on this measure and improve upon it, that probably meant that you got one, a comprehensive understanding at the NPRM and certified [indiscernible] that is capable of preserving results, and it never to, you probably happen -- that is what we meant by an exemplar major and we try to come up with a few of those.

The alternative approach, we labeled the 500 measures approached, is to have all of the measures you could think of, and have people pick and choose. So, whereas we might have recommended more towards the it simpler approach, the NPRM came out more ports the many measures approach, and that is one thing that we would like to look at and discuss and see what kind of comments we have.

The other on clinical quality reporting is, it is probably a moment in time when we have the opportunity to fundamentally change the quality reporting that has been done. We have been tethered to what every data is available and that has typically been claims and administrative data. Most of the existing indorse quality measures are based on the kind of data. At that we're trying to accelerate the adoption of EHR, which includes a lot of high quality Bridge Data gives us time to retool and almost reinvent quality measures as they now exist. So that is something and we would not want to miss that opportunity. So in the process of coming out with incentives on clinical quality, should we really spend some time, and maybe this is part of the strategic planning to issue up two essentially redesign would know now as quality measures. That is another type of comment that we wanted to explore further.

The second area is the maintenance of up-to-date information in EHR. Clearly, that is the goal, and the original lot from the work group was, when we said maintain a problem, it was every time we saw that person. And in the NPRM, it was every time there was a problem. So that was another area of wanted to discuss. The third area is the stratification of the quality reports by variables that would indicate that disparity of care, and we notice that was missing and wanted to follow-up on that. The fourth is, this whole notion of the glide path. One of the reasons of staging it and even start putting in place holders for the out years of 2013 and 2015 is to get everyone a chance to start planning. Clearly, it takes more than a year to get things going, whether it is on the provider side or the vendor site. We wanted to make sure we got as much intermission out to the industry as possible to signal the direction, and that will help both providers and vendors of the system.

Tony already mentioned of the hospital based physicians and its area of intense interest, and stage three, we heard a number of comments about the number of criteria and although there was an adoption of the adoption of your strategy, one of the consequences was by 2015 when the adjustments can, or all of a sudden up at the escalator toward the cliff [laughter]. So that is something that we are gone to work on further and see if we can't come up with constructive comments back there.

In each of these, we were hoping that we will outline what the differences are, understand to rationale for the NPRM approach, and if we thought necessary, propose an alternative [ indiscernible] rationale.

So the missed opportunities that Tony mentioned, some of the things dropped from the matrix, all of these topics did come back up in our work group called and some members thought that there was a reluctance to not have these. And I will just go through a couple of them. But say that progress note, the rationale was that it may not contribute to care coronation and there certainly was a lot of feeling that it may very well come up but will develop that thought and bring it back. Yet it is the sum of the other ones that people thought were missing from the NPRM that were still important.

Areas or further clarification, and Disney said to be a fine-tuning of the work when the final rule comes out -- This may centipede a fine-tuning of the work when a final rule comes out. Is that CPOE intended to be by the authorizing provider or is any person able to get in, and one possibility is on behalf of or for a physician. And that would be two kinds of intent. The whole relevant encounter, and I take it is in it that there be responsibility lies with the worker who did not come up with a crisp definition of that, and we may need to circle back and help that out.

The denomination for the measurement, some of them may require some manual processes, and the mental capability, is it testing the software in some way or does it actually mean testing with some recipient of that information?

Finally, granular comments that individuals may submit have to do with the care summaries, and if that were all transitions or transitions from one site to another.

And does that have an impact on weekends, for example? And patient reminders over 50 years old, that was one decision that was made and there may be comments about and it looks like that is a cuff that may eliminate some of the benefits.

So these are some of the areas that we talked about, and as we said, as a work group, will focus on the philosophical comment and provide some structure as you laid out with the NPRM, provide feedback to you.

At this point, maybe what I will do is open it up two perhaps questions from the full community to CMS and as input to the work group as it begins its preparation of Commons to submit back for consideration.

I had a couple of comments about submitting to the NPRM.

One thing I wanted to make clear as people to comment in this venue or as the official comments, what we're looking for is, if there are areas that have clarity, we would like to see them emphasized. And what is not clear. If there is something that you think should not have been in there or needs to be changed, that we need to not just say it is it that idea but explain why it is a bad idea, and if there is something that would accomplish the same result for a better result, we need that to be explained.

For example in hospital based EP as we defined it as wrong. But you have to give us a reason on a national scale, what is a better way to do it, and why that is a better way to do it and back it up with data, if possible. Because some of this is done based on existing policies in the Medicare program, and how we have treated for example Hospital based professionals in the past, they have been paid at higher rates and, if they wanted a change for this particular program, this certainly looked for the definitions in the statutes and some of these are defined in statutes, and other in the quality measures, which I am sure that Farzad can talk about in far more detail than I can were based on input from others in the Department and OMB. So if you have concerns about them, if you need to be clear about why these particular measures are not appropriate or why they need to be changed in some way. But I wanted to make sure that we were clear. You cannot propose things that are now in the NPRM, you can basically take what is in there and modify it. But it is not a logical extension as defined by the lawyers, that we cannot change that in the final.

Let me ask a question on that then. So some of that is not eligible to be accommodated on?

Well, we have a couple of things -- you can always comment, and the question is not, if there is something that has never been mentioned in the rule itself, and we can be challenged. It would put in new requirements that we didn't -- Whittaker about that in the preamble and we get a lot of comments, that arguably we will not have a logical of course problem. We would have enough to give people an indication that that may be a new requirement. If it is completely silent, then there is an issue as to whether or not. It would put in a new requirement, we can give people the opportunity to provide adequate input on that. You are welcome to comment on everything, but the things that are mentioned either in the reg text or the preamble are fair game. If it is something brand new, it would be hard pressed to go there.

We specifically made mention each of the specific policy recommendations, and if we are not taking them or modifying them, with we specifically provided for that. And I think that the policy recommended in terms of the objective criteria have been -- each one has been included in the recommendation.

So they need to be put back in if there is a rationale, that they are fair game, but if you come up with brand new objectives are measures not mention in the regulation, then they can't be put in because there is not any public comment on them before they can be included in the final regulation.

So it sounds like the ones dropped from the matrix can potentially be changed in the final rule? Is that what your saying?

If there are specific objectives, we discussed each and every objective is in the rationale and if there are counter arguments, they can be reintroduced as I understand.

That is correct.

There were some measures that were included, not objectives, and we did not comment on every major. But that is a different story.

Just to be clear, the measure on generics that were used and measures for indications on high-cost imaging we're not specifically mentioned, so those would be off the table.

Yes. We would have to get a legal from our general counsel, but I think that is probably a fair estimate.

Any comments?

Charles Kennedy.

I had an opportunity to meet with many of the blue planet and Blue Cross Blue shield associations, and one question that came up with the proposed meaningfully stage one objective included checking insurance electronically and submitting claims electronically. Wizardly support both of those objectives wholeheartedly but the question came up if the position already had the practice management system which is not electronic tells record, and can perform both of the functions, does that satisfy or in any way contribute to achieving these criteria for, to they have to find an EMR that does the same function?

What we were told by our office of general counsel was, it is defined under the umbrella of certified EHR, then it would be part of a meaningful use criteria. Farzad, I don't know if you want to say more about that.

We included every single one of the meaningful use objectives as criteria that need to be that by certified EHR Technologies as an aggregate and the IFAR. So it is said that certified Technologies must provide the ability for claims and eligibility checking. The recommendation of the Policy Committee on certification is now a certification discussion, and that was, that we permit modular systems where a combination of practice Management Systems, and an EMR might satisfy that.

That is fine.

We had the second meeting of our new privacy and security work group, and we spent a little bit of time talking about building people use criteria in privacy and security as well as the certification criteria. And this is just really our first bite at this apple. We will be discussing it further on their next call and coming up with more concrete, in essential recommendations. But on the meaningful use point and the requirement to conduct the security risk assessment, I think in general folks thought that was a positive development. But the one concern that did get Reyes was a lot of providers have no clue how to do one of these. And it might make this more meaningful for there to be more guidance or assistance provided to those providers who, while they have always had their current to conduct one of these, may have never in fact on one or have done one in a way that is not terribly comprehensive. And that could come potentially through the -- the Educational extension centers, or maybe through guidance from OCR in implementing this. And then we have more discussion quite frankly on some of the criteria and IFR which is quite a bit more specific but I will hold off on talking about that.

We didn't spend a lot of time as a worker talking about the fact that the criteria that the specified about HIPPA, and being under not formal investigation under HIPPA and sort of being a disqualify air until you get that resolved, for meaningful use pigments, I think we will talk about that a little more. And now I am switching into talking personal mode. I still get the point that the HIPPA criteria, everyone has to abide by them and there is sort of reluctance to put them as sort of more meaningful use additional criteria. But we don't have any as of yet for the law. And so to the extent we have someone in a situation where they have reached in violation point, the motion that they may have to pay a penalty and yet, still be able to draw down funds from the federal government, I have to say, that doesn't sit well with me that I am still sort of thinking through what types of comments that I personally file in that regard and I am not sure if the work group will agree with me, but we will have more discussion.

Jody?

I have one of the first point. We do have a plan under way and we are working on it currently. And with love any input that the worker pass on this but we're trying to come up with educational materials on security to use to regional extension centers. Any guidance or any input that the work group has to share on what I'd be part of that might be very helpful. But that would be something that we identified as a need and we are working with our folks in the regional extension Center program to do that.

I also wanted to point out also, we have published a number of documents and guidance including one for small providers that could be used as part of the education materials at the regional extension centers. So there is a lot of material out there but I understand the need that the extension centers and others can play in helping them walk through what is on the risk assessment.

In terms of the privacy area, if you could provide terms of more specific guidance and clarification that would be helpful as we look at this in the final role, I think there was concern about that it already exists, and also in terms of if a complaint lodged against someone or an entity, the complaint has not been resolved, what stage to begin to deny the person or entity the incentives? So there is some gray areas there that, if you could provide some guidance and suggestions, I think that would be helpful.

I would just add to that in my personal experience, you are absolutely right, there are providers who have never done this, although that is probably not unique to the meaningful use. There may be other meaningful use criteria that they have never done before, and we see the world at the regional extension centers as helping provide resources for them to be able two successfully achieve that.

Christine?

Christine Beighthol of National partnership.

To questions. Purse I wanted to say, the collaboration from CMS and ONC resulted in a role that was very strategic and pragmatic, I appreciate all of the work and thoughtfulness. It is an awful regulation and I appreciate that. I have to teensy little issues. [laughter] teensy-weensy itty bitty. One has to do with how the data collection regarding race, language and gender is probably used, and it is probably a technical question.

One of the things that the policy committee recommended was that it be stratified by race and gender and I believe also be asked providers to create list of patients with specific conditions so that we know that they are able two then look across their democratic populations. That is something I did not see in the roll, and some writers question is sort of a technical one, which is, you have quality major reports, you have disparities, data collection, and condition less, but there is no use of the data to cross cut those two areas. Fair game for a comment, I a ssume?

Absolutely. That gets back to Paul and wet he was saying at the beginning. If we can better subordination as to how we develop these measures and get to the outcomes, I think that is fair game for a comment.

Terrific. And my second question, Farzad, a that you can guess what this will be.

We to preserve the language in the policy committee recommendation that the objective that -- patients used for reduction of disparities, among other things.

So it is not a requirement for actually using that.

Now. It is not in the metric itself, although the requirement that they collect that information would certainly permit the motivated providers to do so. On the quality measures stratification, the initial here reporting is by attestation of summary counts of quality measures. We are hopeful that by 2012, it will have the [indiscernible] in place and the standards in place and the HIT systems at a place for that can be done in an automated electronic way. And the specifications for that could include stratifications. Whether it is by provider or other measures. So that would be very useful at a comet. If you feel like we missed an opportunity.

Okay. The second question I have is about patient education materials, takes the prize. I question is really, can you speak to the rationale for the exclusion of that element?

A couple of things, a couple things that we heard was, that there are many that are all good and we have heard a lot of concerns about the accumulation of all of the good stuff may be too much. So there was looking at scanning across the matrix everything that is important and saying, and there any that we can look at and objectively say, this may be something that we could try to slim down, and [indiscernible] said it is not quite ready for prime time using wide implementation using currently readily available technologies.

With patient education materials, there was concern that if we scanned across what is in the marketplace today, and I recognize that many of our folks -- Neil is sitting right next to you and he is doing some great work on this. But in terms of the marketplace on hold, the availability of patient education materials that are at the appropriate health literacy level that are in different languages, that are integrated tightly at the appropriate care to provide that information to patients when they need it is still not there. If there is information data that you can provide that says, actually, I got this wrong and 55 percent of the EHR systems currently do and according to the average readability scale of the commercially available tools is actually now at an appropriate level, that is certainly information data that would be extremely valuable.

Thank you. That is helpful. As a pretty to our comments, but we are hearing from the consumer organizations that were a lot with it are two things. One is the importance of information that we give patients access to and copies of, making that meaningful and actionable, but at the same time, being careful that we don't overwhelm the health-care system and health-care providers with lots of questions from patients, because they don't understand the information that they are being given access two. So I would say that we have to be careful about not letting the perfect the enemy of the good. I think there are lots of ways that providers can use their electronic information systems to deliver patient Education Information, but it doesn't happen necessarily in the first year have to be so stringently tied to a generated from the electronic health record, but rather, using the record to generate the right list and making sure that patients have access to broad resources that they can use to better understand the information that they are being given access to.

Can I tag team Neil?

Sure.

Okay.

On both of Christine's points, I think one thing that all of us are hoping is that the information will lead the industry quickly. And I think a great example of this happens, there was a big press release by one of the big EHR bandits and the last couple of days that are now exactly at the capability of linking patients Pacific and problem specific information, and you wonder where that came out, that came not because we have been talking about this for awhile. And sell that is a great example of having to build on what has to be done and not necessarily what is done now because an enormous amount of money that is being put out has to be transformational. And I'd think there is a good example of that. And I think you called us out on this, Farzad. The National Library of Medicine because of the prototype work that some of us have done and has the ability to directly link up with problems and is doing the same with medications and lab testing so that people will be able to link to Medline Plus their systems, and that is now available for vendors to work with them to make that interface. So these are great examples of motion that has been created by this discussion, and that is exactly what we were hoping for the system to transform.

But I have another point on a different topic. And then I was which.

Judy, then Gail.

Two things. One is, I think the goal is to improve health care for the U.S. Even more than the vendors have featured. And one of the things I have heard over the last couple of years as the problems with the U.S. and the huge problem of chronic disease and how that affects us not only with our health but also monetarily is the perforation that almost every talk gives with obesity and chronic disease. This was talked about that one of the very early policy meetings which was mention of obesity and childhood. And as I look at the core measures that we are focusing on and to tobacco use -- and tobacco use starts in childhood, typically. I dunno if it was too late, but I was wondering if there could be more emphasis on I think protecting the future health of the country through more of focus on childhood obesity?

Let me give you guys a little more information on the quality measures and also address what Paul pointed out about the exemplar prisses the 500 500 measures issue.

One thing that we heard loud and clear was that the measures should apply to the providers who are applying for the incentive payments.

And the initial set of the exemplar measures, if you took all of them, there maybe many specialists, including pediatricians that say, these measures do not apply to me and don't get at what really matters for me.

And what we have done as an alternative, we are trying to thread the needle on this, has been to say, maybe three, and where this proposed rule, we're looking for comments on that. They may be three measures that are truly not just measures that matter that are examplar, but at the broadest applicability. Again, it doesn't guarantee that every provider will find these applicable, but they will have the best chance of doing those, and then asking providers to do another set that meets their practice. And these are groups currently especially.

So pediatricians would have the option of looking at -- and we are seeking comment again on each of these sets saying, he should tell us which of these measures think best applies to your specialty and measures that matter.

And we have listed the NQF endorsed measures, by example pediatrics including BMI which is the N QF Major on child with obesity. And in addition, to chromatic use and childhood immunization status -- there is a sad that the pediatric community has said applies to us, and particularly for the Medicaid C M FL who had expressed high concern that these measures that we initially talked about were not relevant to the pediatrics population.

What I don't quite understand is, we have the two ends of life, pediatrics and the elderly, and we are separate and of the specialties. So shouldn't you either take geriatrics off, or -- if not use the fact that pediatrics is a specialty as a reason it is [indiscernible].

We have -- in measure 22, of drugs for the elderly, is in medication management. And prescribing and accusing adverse drug events is something that cuts across specialties more than almost anything. So for specialists to prescribe, which nearly every specialty does, there is a risk whether they are prescribing something for ophthalmology or prescribing something more kidney disease, there are dangers interactions in drugs that are not suitable for the elderly. So that was the reason why that measure was thought to be a measure that would be a could coronation that spans across specialties, not in contradistinction to -- or oppose it that way to pediatrics, but there are just many specialties who don't see that many children, and also feel that managing obesity in children is within their scope of practice.

If on the other hand your proposal is that BMI mission to be added for a major for all providers, I think that would be a highly inappropriate comment.

I think I was coming at this from a different direction, looking at the and the gold and working back, rather that we do prescribe drugs sometimes that cause interaction, that is bad, I agree. But the goal being the population of Health picking those key things being the most important for population Health and working that back into then what are our core majors.

My second question is very tangential but very interesting. They're is a certain amount of money to be spent. Has there been an analysis of the, with these measures, would we be over or under the amount of money to be spent?

The amount of money to be spent in terms of what? I'm not sure what you mean.

You are paid for meeting the objectives of meaningful use and regardless of what were put under that, we give you the same amount of money. We don't go per major of the objectives.

I am talking about the total which is 38 billion or 19 million or whatever that number is. How is this going to match the overall budget?

I think the point is, it is an entitlement program, Tony.

And what does that mean?

It means, and Tony can correct me, but basically there is no attack on the money. As long as the eligible professionals meet the meaningful use criteria, if they beat it, it gets paid.

I have heard from people worried about that. So it doesn't stop when you hit the cap?

Correct. When you see these numbers, there are estimated numbers and you see the numbers based on how we derive estimates of meaningfully his participation or achievement, I should say.

Gail?

Thank you very much. And I wanted to say thank-you for listening to this committee and this discussion on specialties. I know that was not on people's radar scope to start with, and I appreciate what you have done, especially in the specialty area.

However, as we move forward and start with that escalator, there are specialties within specialties and at some point, you may want to look at ethnology purses ophthalmology and. Specialties within specialties. And those that are appropriate for each individual specialty and such specialty within that period so as we move forward, certainly this is a good start in doing that but I don't think we are finished there.

We have heard some of these comments are ready for a difference of specialties, and I think we will be seeing a number of comments. I see this as the beginning of getting out there and getting feedback from the community and we can refine these as additional stages coming in with in future years.

I would also like to comment of privacy and security area. Here again, direct centers and assisting small physician groups out there, they are specifically geared for family practice and internal medicine. And there will not be small specialty groups that will be able to access assistance from those RECs. So I am very concerned again on how we will make sure that the privacy and security that needs to be built into this is adequately handled in those offices as well. I think we need to look specifically at assisting them and making sure that there are resources there for them to get the education to do those risk assessments. That the proper policies are put in place to make sure that those records are private and secure. That is the number-one issue for most patients out there, are my records secure? Are they private? A new approach people on the street, people will back up from this. So we have to ensure that it is not just a family practitioner or the interests, but across the board that we have the privacy and security assured. And as we start into the exchange of records and we start from one provider to another and one hospital to another provider, I see that in the rule we are all looking at one test. Is that within an integrated system? Does that meet your qualifications? Or is that one test outside of the integration?

Let me take the press conference. You are absolutely right, the need for privacy and security cuts across all providers, and those in small practices, including specialist, will have the greatest difficulty in having the resources and knowledge to address a consistently, and you are absolutely right, the regional extension Center program has focused on primary care providers.

The point to note is to fold. One, the resources and materials generated for their regional extension center will be made available to all providers, and we think they're will be some very valuable tools, resources and information in an easily digestible format, suitable for laminating, that will be made available in the public domain and made available as a resource to everybody.

The second point is, regional extension centers are not expected to be the only way that people access help. We think they're will be a wide radius of organizations that will help providers achieve meaningful use, including the societies and associations and so forth but also for-profit entities that provide and are emerging in the marketplace. And believe will help educate you about me please. And focus on the primary care providers with the recognition that they have fewer -- and the specialist might be able to access and consolidate market driven resources for achieving the help they need to get for meaningful use. So the regional recession program is important and will have positive externalities' that others can use but it won't be the only way that people can get the help they need that they really do need to get to me pleased abruptly and not just privacy and security. It's been back well by dots on the assessment are that it is just that, and assessment. What you do with it and moving on from that is critical. Obviously need to have a willingness and a lot of organizations are not doing any risk assessment today, but I think the work that Judy mentioned, the additional education materials and as we look at additional stages of meaningful use, we need to think about where we go beyond that. One way is people have talked about signing to the penalties that come out of the privacy and security complaint system, but other ways might be looking at what you actually do with the assessment and how you use them to approve the security -- improve the security and ultimately the privacy of what you are supposed to be protecting.

The second question would be on that one test, and I know we have got some feedback on that as well. I will have to go back and take a look. I think initially it was to show the capability for 2011, that was the idea.

The principal, as Dr. Paul has articulated is, by Information Exchange -- In an organization, however large, or within a practice or vendor community. The goal is information exchange that those were the patient needed to go and is needed for that patient care. So the intent certainly is that it has to be information across organizational boundaries.

The information exchange criteria is probably one of the most difficult balancing intentions here.

On the one hand, there is plenty of discussion in the meaningful use workgroup and in this committee, recognition that information is critical and it certainly a requirement for better coordination of care and better health, which is the goal. On the other hand, the recognition that there is the limited availability of organizations as we have currently conceptualized in the National Health Information Network which will provide access to the patients information wherever the patient needs to be.

Testimony that we will hear today from the NHIN work Group Mail slot with a dilemma. But I think this is one of the most difficult, how aggressive to make the information exchange in there and in light of its importance and get at the realistic capability present within the community.

I think the goal was to show that there was an intent to show the exchange of information, and if the capability is not there, that is one issue that Farzad mentioned and that will obviously change over the next several years. But the idea was to have something in there that day at least begin to make an effort to exchange data, and this one test is a high enough bar, or is this something that we need to take a bigger look at as we go to the final regulation and consider what the other members have as to how we can achieve that balance, as a Farzad said, given that the infrastructure today is not in place.

If I may comment on that, the Office of the national coordinator has an idea where they wanted to go. And that has an information flow with the patient is irrespective of organizational boundaries or practice boundaries or proprietary boundaries. The question is, how is practical to signal that and gradually rewarded at that time, and they want meaningful use users who at that time are trying to be meaningful use users but are inhibited by lack of infrastructure in their community. We want those people to be able to benefit from their efforts. And I think that was part of the rationale of the Committee and setting a relatively low were par-4 Exchange in 2011 first stage.

So the question becomes, how high to set the bar in 2012. And how the exhortations and comments that come in the preamble and other messages coming from the Office of National coordinator and the federal government, if that is enough to signal to providers, even if it is a pretty minimal test by 2011, it might as well get working on doing it better, because eventually they will have to do it better. And we welcome comments on what providers should look for all on that journey.

I think deal had his second round and then will go to Mark and then David.

Thanks.

I think by comments referred to this section of NPRM dealing with Medicaid. I think we spend most of our time talking about the Medicare piece, and the glide past on the pieces of the Medicaid cases are different because of the ability to integrate other sources of funds into just the incentive payment dollars and the ability to integrate some of that HIT and EHR grant. So that glide past could potentially be a lot longer I guess is what the point was for NPRM and Medicaid.

But what I am really saying is, if you happen to the provider in a state that doesn't have its act together, or worse yet, a patient in a state whose providers can access these dollars because the state does not have its act together, we end up creating some fairly significant potential disparities between states that are sort of moving in the a corporate direction and those that aren't. That sets it apart from the Medicare program which is moving at the same pace.

As of living in the same pace by qualifiers who are using the Medicaid provision, we worry about people in those states and the people who could potentially get the benefits of potential technologies at a much better point, and I worry about the providers who at the most will potentially be unable to access them because their estate plans have not been approved. And so do we have a process -- I guess my question to you all and Dr. Blumenthal, do we have a process in place across the country and that the federal level to provide assistance to states that do not have a history of being involved in health information technology and do not have an infrastructure in those states to move in this direction, and what are we doing about that?

I think there are several answers to that, and I will give it from the Medicaid to CMS perspective, and then David and Farzad have additional statements. From the medicate perspective, under the law if we can give out dollars to states that can help with the development of that petition and the development of plants, and we have certainly been working closely with ONC and the different states where we can work together with ARRA funding and ONC funding to provide the infrastructure there and infrastructure in various states. We have asked each state along with ONC to have a point of contact a central point of contact in the HIT area.

They're is a conference in February that the Medicaid folks in ONC are holding to begin publicizing more of the information that is available and funding opportunities, so I think we are building on some of the things we have had in the past, but there is a lot more [indiscernible], and work is being done under CHPR as well in the children's area, and there is a renewed emphasis by the Medicaid folks under CMS in this administration and are focusing on this as well. And one of the key areas which I will turn over to Farzad is the work that ONC has been doing, working very closely with exchange dollars and some of the other work with extension centers that we have been really working together to make sure that we coordinate leveraged funding as much as possible.

There are state grants from ONC of 500 million plus that were planned for the purpose of helping to establish the infrastructure in States, and we are coordinating closely, as Tony said, with CMS. They're is a requirement to have a state HIT coordinator and plan. The focus of the grants is around the health information exchange infrastructure, admittedly, but there are some components put in place and some of them will support HIT. The plan in place is an important one and there's a certain extent to which the federal government can provide resources and technical assistance, and as Tony said, in education and guidance and so forth. And there is likewise a very valuable role of provider is in care to preserve communities and those centers will be doing their part in asking for and clamoring for their states to have a plan that can help bring them the resources, not just in terms of HIT incentive payments, but also as Tony pointed out, the 93% federal match for even the administration of the program.

Just to follow up, to use an analogy from my practice, what we're worried about are the people not coming in. And we always answer this as to what we're doing for the people coming in and applying for the grants and moving the stuff and states that are not coming forward and identify people that are functional, and these are all because the innocent victims of this will be the provider is there and the patients in the state. That is what I am getting a sense of. So do we have a greater return somewhere that someone is following this?

Yes.

Mark?

First, thank you for listening to us. I think that is great. For knowing your spending some time doing this. There are a few things I wish I would have said a little better about where that escalator is leading and how quickly it is going, but the question I have is more of process question. I come from the mountains where the air is thinner and it not quite as appreciative of the federal process that we're going through with the comments. And as well as you have done on this, distilled some ambiguity and the 600 plus pages out there. And that wording may suggest that if you have a true medical record, if you took that into a secondary [indiscernible] sending in that information. And in looking for that answer, there is a whole series of those types of questions. And in the way that it takes to get that clarity, some comments and waiting to here a response back, or is there any mechanism for clarity and some of the wording that is within this regulation? Because I assume they're will be a fair amount of commons.

We assume they're will be a fair amount of Commons as well. [laughter]

I think there are several ways, Mark. When is ambiguity and the regulation, and that is in the form of public comments and comments from as formal comments are welcome. And there are certain things that are not clear from that perspective. And if there are operational issues that we need to deal with, we're working on ways to provide that information. And that will be in the form of questions and working through extension centers and other types of vehicles. So if there is something in the regulation that you think are not clear, I would certainly make a comment back to us, and it should be addressed in the final regulation. But if it is something in the operational focus, and is not specifically address, that is something we can talk about separately and provide chances to through areas like the web site were training material or other ways to get the word out on processes and ways to get the effort explained better I guess.

David?

I will Equimark with appreciation of CMS and ONC such openness, and I think hearing from all of us will give opportunities to improve the world. I was hoping that you could share a little bit about how you came to where you are.

The first was we had in the original statutory language, essentially subsidized -- by virtue of the adoption of the HIE and EHR. But the explicit efficiency measures with the generic and imaging machines. And of course there were a number of implicit measures that led to improved efficiency and health care like care coordination and so on. At the explicit opportunities to drive the user's attention to improving efficiency are I think most significant in the measures now.

Since those are both through the statutory language, and one of our primary objectives like the press pack line has the word efficiency in it. -- the first tagline has the were efficiency and and, I wanted to ensure that the concept is visible and given attention to by the users. Some of this question was, to have any thoughts on how you deliberated to capture the concept in the rule?

I guess there are a couple of ways, and one is certainly how we emphasize that in the preamble, and in the sizing on the efficiency area, that is something we take a look at as we move towards the final regulation. The other is getting it into specific criteria and objectives, and as you said, we do have some, but that did not come up in the discussions and it was not coming up in the regulations. But maybe they didn't get in there in the former with a logical extension that we could probably address. The latter would be much more difficult. But I'd think part of this may be looking at, what can withstand signal in 2011 and what do we need to do in the second stage to make sure there is a greater emphasis on this deficiency, or need we didn't have the same at this is that we needed as we did in some of the other things.

We actually looked very hard for measures. And we included, for example, under oncology, it avoidance of overuse of bone scan for staging low-risk prostate cancer patients. And under radiology, inappropriate use of -- well probably be nine now, but the radiology ventures in particular the we could find whether in PQ RI or N QF that addressed some of the overused issues. And under the Hospital issues that we could find track records looking at potentially avoidable events.

But I'd think that this gets to what Paul was talking about being part of the strategic planning process. This might be more appropriate as a recommendation to point out that the current quality measurement process is well aware that it has not given us either in speed it more in focus the kind of measures that are needed to be able to achieve all of the goals that achieved through want.

So the tension there, through the Health Information Exchange, this is the second most difficult area in balancing, is pushing the system into example of measures of what we think. We need to have, versus the availability of consensus defined measures that can be implemented HIT systems and defined as a standard way.

So certainly in your role, if you can do to a good deal to help push that and as part of strategic planning and look for advice on how that can be accomplished.

I would hope that the consensus measures that may be appropriate for quality performance assessments or even quality improvement may not be the only pool to look at for whether it is being improved efficiency. And I hope we don't confound one urchin process within the for the health process in America, and if we deploy all of these millions and to have some evidence that the users are being very serious and addressing unnecessary costs, I will be very disappointed and I would require assurance as to how this process would be done. And I wanted to comment on the advanced item that -- and I think one thing is advocating for the advanced directives Major was that it was in danger of a real patient engagement for stronger patient engagement and one many of our natures are actually passive measures. They're pushing data to a patient who may one may not engage them with the data. Whereas the advanced directives measures apply interaction between a [indiscernible] signature and hopefully a discussion about it. Ford health issue, and I hope we can find a way to capture the contract again in the battery nation is that we put forward so that we show that we are serious about having the patient engagement dimension being reflected in the tools.

Under advance directives come without a fair amount of feedback that pointed out several issues. One was the applicability issue. Specialists and others saying, do I really have to be discussing advanced directives with every patient who comes to see me, at not seeing that as being within the scope. And there would also be assurance about even for primary-care 20 year old that Missy, do you need to have that conversation with them as part of meaningful use of HIT, and then there are the absence of standards for the documentation of advanced directives and how they will be updated as well.

[speaker/audio faint and unclear]

As well as state jurisdiction issues and laws that pertain to that. So there are a number of reasons why that requirement to have a minimum level of the advance directives, which didn't feel comfortable moving forward with that as a requirement and defining specific metrics for that. If there are, I think you are one to get something deeper, S&P if there are the objectives you could think about, that would also be part of it.

I want to close of this section and thanks to CMS and ONC again for a really tremendous effort. Thank you for listening to your advisory committee as far as our input, and also I can sense that will have a vigorous discussion in the meaningful use workgroup in terms of present comments in a way that will be useful to you. So the comments and alternatives and rationale for any alternatives may be proposed and will get to you in a timely way. And that will come to you in a full community before we send them back. So in the February meeting, we will present these work group recommendations for you to discuss before we turn around.

I will turn it back over to Dr. Blumenthal.

I have the pleasure of adjourning us for lunch. And also, thank you again. You all give us an incredibly wise and thoughtful framework. And I don't think there is any country that has this kind of framework laid out for its electronic systems. And I hope and expect that the thinking you have done it will ramify not only within the United States, but beyond the United States in terms of trying to make concrete was the saddest can achieve and should expect with the creations of electronic systems of health information.

So we will see you in an hour.

[The HIT Policy Committee is now on lunch break until approximately 12:45 p.m. ET]

Okay.

Welcome back. We took the hour from when he said an hour than the scheduled time. We are going to continue now on the other document that was released. This is the IFR, and that is on the initial set of standards implementations, specifications, and certifications for the EHRs. We will begin with a presentation from ONC. This came from ONC this time. And then we will have the comments from the committee that can be considered.

Okay, let's see. We have Farzad, Doug and Jodi.

Hi. I'm going to -- since this is the policy committee, not the standards committee, I will do the presentation. If it was the standards committee, I would not stand a chance.

For those of you who could switch HIT and also could have served on the standards committee, I have brought Doug Fridsma here. We do have employment for all of you.

[ Laughter ]

So any of the technical yeses, I -- questions, I am going to turn immediately to my left, but let me talk to a policy principle that undergoes the certifications and standards, and to no prize -- surprise, the sources were yourself and the HIT standards committee. So in terms of the criteria, we took the recommendations that the certification criteria should be minimal and focused on the assured providers and they can inclusion the Meaningful Use. They do not include the basic EHR functionalities. They are very important, but they are not directly related to the attainment of the Meaningful Use. We also look at the key abilities and functionalities that can be tested. And then we focus on a minimal set, as minimal as we can make it, so there is a possibility of the innovation in this field.

When it comes to the standards, there are -- there are -- this is really fascinating from a policy point of view; but recognizing that whatever we do has to be incremental, signal the future, get people to start moving, but yet not push the industry too hard to implement standards that are not yet ready.

We thought it would be important to recognize the common methods that are already in place, it has the market, they have been ruled and they are the ones that are going to be used for the secured transport, and where we push the industry is to push them on the vocabularies and the terminologies. We have heard a lot, and the systems need to be capable of incorporating, for example, Link, or being able to enable the mapping as our ex-norm here. So where we did go a little bit further than the HIT standards committee recommendations, was on narrowing down and signaling strongly that we need to get there on the terminologies. On the security functionality, while we cement that very strong, we didn't -- while we kept that very strong, we didn't -- there is plenty of questions about that on the standards committee, but we came to understand the named specific standard for security, then any evolution in that standard, any innovation or standards in that would exceed the security around encryption would no longer be compliant, and we would run the risk of frozing the market -- freezing the market in sub-modern technologies. So we summed the requirements functionally while giving the examples of the current technologies that are moting that level of -- meeting the level of assurance.

That's the overview.

This is the concept of it. The Meaningful Use really drove the criteria. And then the sub-set of the certification criteria involved the standards that must be implemented within the Electronic Health Records and implementation. You have to provide a patient summary record. The certification criteria is the capability of the records, and then the standards are not only that the CCD or the CCR that must be used but it is also the vocabulary standards for each of the elements, the medications, problems, so on and so forth, and that must be included in that. That is the structure of our thinking. I do want to the underscore, and this, actually, wasn't immediately obvious to me and it may not be to some of the other folks, but the standards that we are requiring here are requirements that Electronic Health Record systems must be able to have the capability to use those vocabulary standards. It is not, other than problems, Tony, as far as the snow-med and the IX-ID, and the only one that goes to the Meaningful Use is for that standard. And for the IFR, which is where the standards are designed and the standards are encumbent on the EHR standards that are seeking certification, it is not upon every provider that is seeking to use Meaningful Use.

The systems must be capable if a laboratory is sending in a electronic laboratory with link code properly, and to manipulate that information cot the link code. But if a provider -- there is no requirement that the provider looks at the lab tests and then prove to us that we have a link code next to them. The requirement is on the systems being capable of using those vocabularies, not on the provider having to go out and force everybody else in the eco-system around them to use the standards; which they can't currently assure.

And just to point out that the initial set of standards are in four categories, as recommended. There is the content exchange standards. There is the signature standards, used to share, the clinical summary, and the descriptions, the documents. There is vocabulary standards, transport standards, and finally the privacy standards.

The interoperability standards are when they go from system to system and within the systems.

I will turn it over to Doug.

Thank you very much. I will give the committee to ask questions if they would like, comments or questions.

Paul?

Sure. I am Paul Hagerman.

I just want to say that the IFR is really excellent work. I want to say thank you for a terrific job. It's a complicated topic, and I have seen all of your work on the textual description, and that is very helpful. We have a lot of software vendors trying to figure out what to do, and to have it written down what you are doing, how you are doing, and it is very helpful. I would also say from the standpoint of those working in the work groups, it's also gratifying to see so many of our recommendations were accepted. Not all of them were accepted, but I am sure I am like everyone else who has a favorite one that hadn't been, but we can all say that. The IFR is fundamentally important to our economy. The concept of the modular, EHR, I think it has the potential to provide for a great deal of additional innovation in our entire industry, and I think that is great. And you also have some -- you -- you -- you go through a number of technologies that are fairly -- that are very recent and modern. I would call the IFR as a document that is fully buzz word compliant.

[ Laughter ]

You have done a terrific job in terms of making sure you have the right technology. The fact that you are talking about a modular EHR, one observation I would make for you is: That means when it comes to exchange or interfaces, interoperability, we also have to think about the exchange between the applications. So if you have this vision going forward that we are going to have all kinds of different modules made by different vendors, there's going to be a need for more clinical interfaces. There is really only two clinical interfaces. One is the laboratory, and the other is the ePrescribing. In the long run, we are going to need more clinical interfaces. Having made that observation, the question I have -- I have a couple of questions, but the first one is a process oriented question. And I am trying to understand how this IFR is going to relate to the Meaningful Use that we talked ability this morning-- about this morning. The IFR, if I understand it right, it is on a 30-day track. And after 30 days, it becomes law. And there is a 60 day comment period, and this is final right now. And so this is final, and we have comments, and we have this new capability, what is going to happen to the IFR that is already final.



Okay.

It's a great question, you are exactly right. This is a final rule. It's effective 30 days from the publication. We do have copies that are hot off of the presses. It is a final rule, and it is opposed to the Meaningful Use rule, which is the proposed rule. And it doesn't take effect until they incorporate them and publish them and the final rule. The word interim is in front of the words "final rule." We can make comments and modify it, and to reflect the comments and the changes that the CMS makes in their regulation as well. There is a desire, six this is a -- since this is a final rule, and people will start acting in accordance with the regulation, and I wouldn't expect that there is going to be a 180-degree shift, from what is being put out now, but to the extent there is a change in the Meaningful Use regulation, we have to coordinate the rules with the CMS rules, and to the exdebt that there is some new provisions that are requiring a new certification criteria, for example, that is something we would be working with CMS to determine. We do expect to get comments, we expect to consider those, and incorporate those as appropriate, and then we will publish a final rule, and, of course, to work closely with CMS to keep the integrity that we do have on the books and support the needs for their incentive programs.

Also, it may have no impact on the criteria. It's important, but it doesn't affect the certification criteria.

It is all providers or the physicians?

It doesn't affect the certification criteria.

And the number of things we have heard that could be the new requirements, it is severely limited by the administrative procedures act of what could be given back. I think the problem space is pretty limited to -- you know, the counter act of that is: Things could get dropped in the certification of the criteria, but the negative comments about that is relatively limited. It is a conceptional issue, and I'm not sure that it is a contractural issue. We have the ability to do that.



To put it differently, if I was a software developer or vendor --

Start building.

[ Laughter ]

That's the message here.

This is the blueprint that I should start building. It's a change, a 1% change, I should start building and it is not going to change very much? And that is the correct message that the city should -- industry should hear?

There is very little change to do these things.

That is very helpful. Thank you very much. I have other question, but I will give others a chance to ask questions.

Devin?



We did have a little discussion in our privacy and security work group about the security standards in particular. And a couple of things, again, we really got a first bite about this apple, and we are going to talk about it more in our meeting in the next couple of weeks. But one of the things the folks noted is, of course, as you explained, these are the technical functionalities. They need to be in the systems. There is no commitment to use any of them. For example, if you have got an encryption that is required to be in the system, but you decide that you won't turn it on, then potentially, you have the capability that is underutilized that could be advancing the security. We are still talking about this, but if it is your requirement, and it was not turned off, then that is one way to write the criteria that is hard wired in to the system. I don't know how workable that is. But for the providers that never worked with the encryption before, I think for some of them it will be an adjustment, and whether or not they utilize it, -- in some respects they may have to, we are going to do more thinking. In the privacy and the security space, there is more policy waivers than the Meaningful Use rule. We have the privacy and the security rule under HIPPA, for example, and other levers that ONC has itself. We are going to respond more particularly to this rule, per se, and then we will do some harder thinking when we have more time around how one could get the policies around security to catch up with where we are getting the technical functionality with respect to the records.

I would submit that it would not be appropriate for the certification criteria to make the policies.

Right.

It must have a system that is not going to be turned off.

That is a backwards way.

Right.

It's the backwards way --

Right.

[ Laughter ]

We have the regulations there, and there are things in the HIPPA rules that are addressable, and it might tip the calculus if it is addressable, and you have the capability to do it.

Right.

Some of that can be explored through the guidance or through the HIPPA security rule itself. Those are the things we are thinking about, as well, and some input would be helpful. The policy issues, you know, we have heard in the standards committee that the encryption is an important tool, and there are times when it is useful and it adds to the layer of security, and there are other times when it is more challenging and then it doesn't necessarily provide the same level of assurance. There is some -- you know, it wasn't all or nothing on some of these, and that is what we struggled with when we talked about the issues.

I know we recognized that. On the decision of choice, we are going to take that up on a policy standpoint, in the near future, probably in the next month or so, even if we didn't do another thing on that issue, we still have in certain parts of the law today, whether it's federal law, state law, a requirement that can be sent and provided first for the data to flow for a certain purpose and a certain category of the data, et cetera. If nothing else, we still have those laws in place today. I wads wondering -- was wondering where a technical functionality would be part of the systems to help the providers to comply with the law. In fact, many cases they have to comply with them any way. So I am curious whether that got talked about at all. It is not talked about in the IFR, and it doesn't sound like it is necessarily -- based on the previous discussions, we have had a likely candidate in round one, and I am curious to get feedback on any discussion that you may have had on that.

[ Laughter ]

There is some consent on the standards. I will let Doug elaborate where they are.

I don't actually remember if they are part of the standards committee recommendations.

Yeah, I don't believe -- I would have to go back and check, but in terms of the recommendations that came from the standards committee, certainly, there are technologies out there that can be used as a frame work to provide the electronic means -- that's what we are talking about.

Right.

It's the electronic means for the signatures, and the patient's consents. There is a lot of discussion trying to weigh those things that are out there and available, but they are not in the wide-spread use. But the things that are really, fairly solid and they have a fair degree of uptake. There is a lot of tension and discussion about where to draw that line, put that bar. Clearly, this is the first of the IFRs or the standards that will be established. And I am hopeful that this committee and the standards committee will continue to provide us with recommendations on how to -- recommendations on how to incrementally extend these. That wasn't something that specifically come from the standards committee to discuss.

Okay.

And to further elaborate on that, you all as a policy committee think that is an important area for the certifications criteria, and you can provide that information for us to make recommendations on.

We have it on our drafted work plan, and you will be hearing from us on this one one way or the other, so ...

Okay.

Thank you.

So other comments or questions?

Tony?

I think a lot about what Devin said on the different waivers, we have the DEA role on the controlled substances, and when that comes out, we will have to have the security criteria that will be weighed in, you have the privacy roles, you have the office of civil rights has come out with requirements. It's not only meeting the requirements of the Meaningful Use, but we have to make sure there is a capability for us to audit and looking at Meaningful Use for us to achieve it and the capabilities to insure they can meet the requirements of the Meaningful Use. It has to go a little bit further than that as well. I think what is critical is you set up a process here to evolve over time to meet the changes on the Meaningful Use criteria, and that is going to be harmonized on the regulations and the standards and the work of other things that is going on so we are not creating the dis incentives, barriers or other types of unintended consequences that we have moved down the road. You have started down the right path, but that is something that needs to be looked at as we are continuing to evolve the infrastructure and the criteria for the Meaningful Use.

Gail.

Thank you very much. I was wondering if we could have the same cross-walk to the Meaningful Use criteria as to what is in and what is out. I understand there is some things that are not included from our recommendations, and if you could give us a point by point as to the recommendations and what they were, and what is in and what is out. And if you have the synopsis and you could give us, verbally what is not there as opposed to what is there --

We were planning on going through that on the security committee. Doug?

We have tried to join the choices that were is there, but those who are unique to the health care and have the drive for that. When we speak in front of the standards committee, we will be going through in a little more depth.

When it came to the patient summary data package, the recommendations there was CCD, CDR, templates and 2-5.1. And that is four choices of possibilities. And what we incolluded was CC -- included CCD and CCR. And we realized that under the recommendations of this committee and the standards, we hope that we will be able to converge on a single standard there. And again, we will keep constraining the choices to improve the ability to support the interoperability. That's a big one. I believe that the initial standards of recommendation did not include the CCR, it was a variety of templates with the text, whatever, and there was a couple ofAs after the committee -- of actions after the committee that if we think that sharing the patient's summary is critical for Meaningful Use, pushing the community earlier is a good thing. And there are defacto to the current carer summary documents that are defacto to the marketplace today. And we should -- instead of allowing the three templates, we should make it greater r and have it on one of those two, or both, and then currently urge the division ahead that the strengths will be integrated over the long term. That was a big one. There are two others to highlight, and we can go through more, if you would like. With regard to the electronic prescribing, one of the differences there is that we recommended -- Orr that -- the -- or that -- the rule has elected to have local or proprietary codes that are used to describe drugs that are mappable to the IFR. And it will describe the vocabulary or the drug vocabularies that are mappable to our ex-norm, and they are a little bit prescriptive or directed to those description.

One other thing is the laboratory or the results, and we -- there, again, we were trying to push a little bit more, and not so much that internally -- and the regulation doesn't really address the internal representations of the vocabularies and the terminologies, but we wanted a certified EHR technology to be able to receive the codes that were link code sets, and then to be anal to persist those. So we didn't want the Meaningful Use criteria to be dependent on a lab system sending you that information. We wanted the certification criteria to say, we want the functionality so that we can receive those if they are available.

And then, I guess, the other broad area had to do around describing the security -- the security -- the security and the encryption technology rather than specifying a particular kind of security or encryption technology to use. Instead, taking the technology and describing it functionality, and then putting it to use with the technologies that enforce that. Those were the highlights.

I know in our sub-committee dealing with HIT and that become a real issue. Did you specify on the lab results?



The specifications for some of the changes -- we don't have -- you can correct me if I am not right, but we don't have the descriptions, but it goes to the point previously mentioned, we don't prescribed a laboratory clinical interface. There is some health reporting requirements for those laboratory clinical interfaces, and those are specified as 2.1 or 3.1, and that is is as far as interacting. And it's also important to note that there are some other state laws and restrictions as well that may -- that also have to be considered and the certification criteria can be proved within that if you are stating that as a particular way to report it. It can be certified there.

Rs if for



Any other questions or comments?



A follow up question, on what you had, Gail, but Doug, what you spoke about, it was helpful, and one of the recommendations in the certification work group is the interoperability, and it would be a hard edge around all of the specifications. And that is a subjective issue. It is a subjective issue, in fact, that I think you have with all of the activities that you did, and one of the issues is: The certifications will be looking at that area and you will get a lot of comments and questions on and that is: What extent do you have the hard edge on these specifications. You will have comments both ways, more specific, less specific, and they will want more flexibilities. That's a tough issue. I look at all of this and I want to reiterate that this is great work. You have advanced us and moved significantly forward, but this work, though, -- there is one other thing that has to happen. And that is more than the software developers who knows they can write the software to this and then they have to get it certified, and there is a ERPM, and it is yet to be released, can you give us any information on that? Are you allowed to give us anything?

Well, it wasn't published in today's Federal Register.

That's very helpful.

[ Laughter ]



Right.

We are working really hard on that. We are working on it and get it pushed through as soon as possible. It won't be today or tomorrow. We are trying to get it pushed through as soon as we can. Keep your eyes peeled for it. We don't have a specific date that we can let you know.

I am hearing, not days, but maybe weeks?

I will neither confirm or deny.

You have a nice smile.

[ Laughter ]

We are just giving you a break. We are giving you time to digest Tony's role.

Devin?

I want to follow up on Gail's comments and the lab on the certifications and criteria, and some of these were adopted, 1078 of them were -- some of them were tabled, and then they were dropped, and my co-chair and I are having discussions, like, what do we due now. One of the questions that did occur is: While there is requirements for the EHR technology to have the capacity to send the lab results to the public agencies using the full complimented standards that we had recommends, but, yet, we don't have -- it's almost as though we stopped one step short of saying, Well, hospital labs, as long as you have the capabilities to send it, why not send it to the customers who order the labs from you. I think we recognize that one of the issues with the standardization in this space is getting the labs to send the results in the standardized format, and we have a bit of a limited reach with respect to what we can do, and there is this, you know, independent labs in particular, and they are not subject to the criteria, but we have a lot of lab results being delivered by the hospitals, so how close are we before the first step of acquiring the technology and sending the health results to the various industries using the standards that we have recommended.

I have a couple of thoughts on that. One is: The certification criteria for the hospitals that send it to the labs for public health, and that stems from the Meaningful Use requirement, and there is know Meaningful Use requirement that is forwarded to this committee that the hospital labs send the results, link coded or other wise to the community physicians, for example. So the policy driver wasn't there. I will also make the point that there may be other policy levers, and we recognize that the Meaningful Use primarily bears on providers and hospitals, not laboratories. And as your work group as recommended, there is a need for the partners, the trading partners of providers to also be able to support the interoperability requirements, and there may be policy levers that would be more for the Meaningful Use and tied to that. Finally, as you have pointed out, there may be positive externalities, and if they have to provide that to the public health reporting and features, it may be a weak driver for the increase of the ability of the systems, for driving the mechanisms.

Thank you, but I know some of the folks want to respond to that as well, but I want to remind and reinforce -- remind the committee and reinforce the piece of the recommendations that the work group did adopt with respect to encouraging greater and interpretive guidance with the CLEA office in CMS to move the labs in a more positive direction, and my understanding is that this will be out very soon, and I want to reinforce how important that is, and how much we support getting that out.



Thank you.

I wonder if I can interject on a clarification for the Meaningful Use. I thought you said we didn't -- although we didn't -- we didn't have is any Meaningful Use 4 labs, -- four labs, but in the Meaningful Use matrix, we did say in order to get one of the criterias that you receive result in structured ways. That is as far as we can go on the Meaningful Use side. And that will open the door for the certifications and the criterias for the lab results, and in this case you have the scope over the hospitals, the hospital labs.

Yeah.



Let's see, anybody else?

[No Response]



All right.

Thank you, once again --

Paul?



-- for spending your time with us.

Paul, I have a question.

Yes, Art.

This is similar to the question to the medical capabilities that you receive to the Meaningful Users to ensure they are safe. How do we think that the states are lined up right now, especially the public health departments in the states, to receive the data that Devin was just describing to be sent to the health departments using specific versions of HL 7? And do we have a specific look at the landscapes, and do we have an understanding of the Medicaid and the ability to receive it when the other states are not. And we will be prohibiting and improving the interoperability in exchange. And if that is -- (Speaker/audio unclear at times due to echoing, audio cutting in and out).



-- how do we address that if it is an issue.

Well, Art, that would be part of your help.

[ Laughter ]

We are working with CDC on increasing the capability on the public health departments on participating in the Information Exchange, and there are funds that are allocated for this purpose specifically looking at the Meaningful Use requirements, those -- the specifics of those will, I hope, be made clear. But in recognition that they may be -- the recognition that there is, and there quite likely be some jurisdictions that cannot receive the information currently or do not have an interest in some cases, to receive, for example, the surveillance information, the Meaningful Use has the proadvised ERM, that is subject to the applicable requirements.

As I mentioned this morning, we have a number of planning and funding activities going out to the states to look at the gaps and where they are, and we are looking at ways to address the gaps, and as I said earlier we are looking at ONC and the fundings of the agencies and address the gaps as they exist. But part of the planned activities is to look at what we need to do to recognize those. Each state is different, and some are far more advanced than others.

Thank you.

Thank you very much to the panels again.

I will turn it back to Dr. Blumenthal. Thank you, Paul, and thank you to the panel. The next section -- I am glad we have a few minutes -- we are a few minutes ahead of time.

Two points I want to discuss. One: How are we going to get the states enrolled or involved in the Information Exchange, and they vary in their abilities to participate. That is one question that came up.

And the other question that is circulating, of course, is: How much exchange is going to be possible given the infrastructure for Information Exchange. And if we hold the Meaningful Users accountable for the standards that surround it, don't we have an obligation to make it feasible to do that. You can't create a community as an individual. The community has to take the shape around you. It has to be a collective effort. So the -- we have asked the -- a work group of the policy committee to help us think about our responsibility to create a backbone for exchange. What is the -- what is the federal role in that regard? How far? And in what form should we push the exchange capability? We have a history that we are both cognizant of continuing called a demonstration program called the information exchange health network, and it was high-tech and it has certain characteristics, and, in fact, we want to know if this is sufficient -- necessary and sufficient approach to create the backbone for interoperability or should we be head -- how do we support stating? How do we support the individual physicians? How do we support hospitals? What is the -- and how does all of that relate to making the Meaningful Users, capable of the Meaningful Use not just 10 years from now, but a year-and-a-half from now. This is a core responsibility, and we are trying to isolate and elaborate on the critical federal role, and the roles of the department, and of the Offense of the -- offense of the National -- Office of the National Coordinator, we have worked hard and fought and feel we are ready to make the recommendations. Dependent on the scope of the recommendations it serve -- receives here, it would be terrific if we could adopt all or some of them and transmit them as advice, taking off my national coordinator hat and putting on my policy hat, and transmit them to the national coordinator.

[ Laughter ]



And because this scenario, we are giving the time frames for the Meaningful Use. If there is new investments, policies, or aspirations we have to make, verbablize and -- verbalize and communicate, we have no time to lose. We value your help and direction. That is why we have gotten -- asked the work groups to work as hard and as fast as they have and to present the information as fast as they have. We appreciate you for your time and hard work in the work group, and we will introduce David Lansky.

Is someone going to introduce you?

Pardon?



Doug also?

Danny. Oh, Danny. Is Danny here?

I don't think Danny is here.

No.



Okay.

So you are David and Danny for today.



That is something I can't do justice too. I am fortunate to have Danny as a co-chair of this work group. He is phenomenally talented, it's unfortunately he is not here -- unfortunate he is not here today. It's unusual to have the strong and technical policy emphasis as we proceed. It's necessary, because this is a complex area. As Dave just suggested, it's interesting because we are at a place where we are dealing with the reality of a big country, and there tens and hundreds and thousands of people that need to be part of this whole process. We don't know where they are today, where to find them, talk to the EHRs, and to feel confident that the potential users are who they say they are, and that we can successfully manage the communications across the network. So solving that problem has been the thrust of our discussion so far.

We have had two days of testimony, and one focused on the question of directories and one focused on authentication, a few days ago, so we have the industry and the public policy input on some of them.

What we want to do today is walk through -- up to this point, -- is to include the findings we have recommended and that are included in these hearings.



So let me go through that.



[ CAPTIONERS TRANSITIONING ]









The work group members are listed here we had good support from the consultants and want to thank them for doing that and help shape our discussions. It is interesting, that the process has forced us to come back to the questions of what is the health information wide network, and we spent a surprising amount of time on the topic given how far we are a long in the process, and I needed was helpful and the definition we put forward today was a reminder that we are not conceptualizing the Health Information Network as a thing, or as a particular set of servers or wires that are being accessed by hundreds of millions of people. We are conceptualizing it, as they said, of policies, standards and services that allow the Internet to be used for meaningful exchange to improve health and health care. So we think this is a fairly potent descriptor of what we're talking about here, and we'll come back as we proceed with the question of what can the federal government do to enable meaningful users to exchange information that helps and satisfy the criteria for meaningful use.

We think the opportunity lies in this set of policy standards and services and that is what we wanted to recommend to you today.

We as a work group will enable a set of policy work groups that in a way is open and Foster's innovation in the way that we see our charge.

Many fleas criteria as we have now seen it in a proposed rule requires the exchange of health information among providers and with patients to achieve the goals we have described including efficiency, patient the engagement, coordination of care and quality of health. We have taken as our starting point, what can we do to help potential users exchange the information they needed to is to establish those criteria. So in other words, we are not taking a grandiose comprehensive view of what does that that work like, they're trying to drive our attention to those critical opportunities to enable meaningful used to be successful. As a look at this stage one criteria that we talked about this morning, we see several elements that involve direct communication patient data among providers primarily and secondarily, several cases with patients. Examples are included. And in the cases we're looking at for stage one, for the must point come apart the exchanges for treatment for pay period purposes. The sender and receiver are known, and the center may or may not have an active fire relationship with the recipient. These characteristics if you like of that ruling please criteria, again, they shake their discussions in the committee up to this point. What can we do in terms of available standards policies and services to help to Secretary dissatisfied [indiscernible] be satisfied? And-- privacy and protection that is -- this in essence limits the scope of the challenge of have to take on for this versus stage of recommendation.

Here is a recasting of the same bypassed we have seen before. And these are primarily push messages. This is the opportunity for someone that has a packet of patient data to send it to another recipient. So we have tried to scope our task for that particular transaction.

And this has are prototypical Exchange, and I describe this to you at our last meeting. This is imagines a doctor or over at the left, provider A sending information to provider B on the right, and we have a number of critical comments that is required to make this a successful translation or transfer even in the paper setting. We have to have some vocabulary or document standards to encapsulate the packet of information and we have to find to recipient by whatever technology is available. And we have to provide this as being authentic and in this case, we imagine a signature on it. We have to find a way to send a packet of information across based and has to precede and retained in a secure manner. And all the parties have to trust that the set of relationships was executed in a way that gives confidence that the packet they are receiving is who it was meant to be sent from.

And in this environment we discussed today, we think it work done in the offices of the commission never provides the tools they need. I won't belabor that. Our goal is to support wide participation by both individuals and organizations and we wanted to satisfy many please criteria. If we think we need to work incrementally because it is a large and complex problem given the scope of the country and therefore change will be evolutionary. However, whatever we do in 2011, we don't want to it to be a dead end, and we do want to build on the Internet and the availability and Internet protocols.

Of course our primary question as an outgrowth of this committee is, how does the government play role in the set of transactions. One could imagine an alternative state where we said, the incentive money is there in the criteria is there and the market will supply solutions. Think we are certainly open to that possibility but our deliberations in order to meet the aggressive time lines provided by the statute we feel there is some opportunity for the government to play a role in either enabling or providing key services. On some of the attributes of those goals that the government might play, but want to learn from the exchange on the Internet. But what to do the minimal intervention on the government, the government should do as little as possible to facilitate the process. The government should create stimulus for the exchange without getting in the way. We want to foster innovation and as the long-term expansion with the scope of information exchange.

Our earliest findings, and really we are looking at this set of transactional elements, and in order to achieve meaningful use, we think what we need to get our attention to its secured transferred on the Internet, directories to allow us to look at the recipients of the messages, and means to authenticate and demonstrate the key parties involved in an exchange, and the larger trust fabric that wraps around all of it so that all the parties believe that what we are all up two here is a trustworthy enterprise and save, patient information is being used safely.

The first broad category is the directories area. We did have a hearing date of directories and will learn about what is going on in the public and private agencies. We discovered many provider directories but each created for its own purposes, and is sustained by particular business models and provides values to a particular set of users. They have different types of data, they use different data definitions, but they may not collect the data we need to enable the kind of information exchange we are talking about for meaningful use, and there are certainly questions across the board in terms of accuracy, timeliness and maintenance of the data. And the quality of the data depends upon the value to the subject of the data as well as to use and incentives for accuracy. We do not foresee a make it directory, instead we proceed a private sector directory and government based directory will exist and will want to see them maintain and take advantage of the existing infrastructure of directory services.

We have a hearing last week on authentication, and we have increasingly broken apart our conversation into two categories. Identity proofing, task of verifying that a person is who they say they are and has the upper credentials they need, especially institutionally, on the issue of authentication, which is attaching a significant message to that person or their message that verifies they aren't exactly the correct source and a goth resource for the message. -- and authorized resource for the message.

And getting the presentation across the board, and we heard testimony from some of the agencies working with the standards, and we came to appreciate that there is a well developed set of procedures developing the press for that specific set of transactions, and that process of risk analysis has to be executed to determine how stringent the assurances need to be that the property proper identity proofing is happening. And we spent a lot of time discussing the context.

Would realize that the assurance process it to be approved but the carbon based life form is who they say they are, and in general, that is done as close to the provider as possible.

The implementation of the identity proofing and the implementation of the identity credential can be done in a variety of ways and we have not delved into the technical options before us. We're still sorting out who should be doing what.

The government has identified standards for both identity pricking and authentication and methods for providing reliable intermediaries also.

Last area of the trust fabric, some of this is stating the obvious, but it forces us to give attention to things we don't want to neglect. It provides and Exchange depending on pre-existing personal and business relationships that we wanted to take advantage of those and cannot ignore them. It requires an understanding an expectation of data usage. Assurances of some form that the exchange is taking place as expected, especially around identity. And some oversight and accountability mechanisms.

The implementation of testaments will differ based on the parties to the exchange, and if we do not have amateur policy and technical framework, it will be a bear for the exchange. People will trust the policy we put in place.

So those are our contacts and findings at this point and we have the prestige of the four areas briefly, and I will remind you of our definition of the health information that work as we set policy standards and services using the Internet, not a [indiscernible] enterprise that will the extent cheated in hardware the sisterly.

With regard to meaningful use, our recommendation is that the policy standards and services of Health Information Network should enable the broadest range of providers to exchange information to achieve meaningful use and enable consumers to access to health information, can provide support to States and other organizations.

Secondly, the government -- for the meaningful use in the near term.

Let's look to all of these and we can come back to them individually if we want.

The second recommendation regarding transport versus content, the initial focus should be on private and secure transport over the Internet, in which an increased focus on the data content over time. Here we are primarily focusing on the transport. All we believe the policy and standards services should be structured so that the bull intermediaries can provide required services for private and secure Redding of health information.

The third area of recommendations pertains to the directories. We note that the federal government already maintains provider directories to meet existing federal obligations, and it should therefore work with stakeholders to improve upon and leverage these existing directories for the nationwide Health Information Network.

We recognize that the government has a unique role in ensuring that authoritative provided directories are available to accelerate them exchange of information to successfully support an increase efficiency of meaningful use.

And finally cuffs government to define a core set of policies for the incorporation of trusted directories.

The fourth area is authentication. We recommend that we build on existing federal policies standards and practices for authentication and identity proofing. We determine the level of confidence for assurance appropriate for different exchange scenarios, that is, it is not a one-size-fits-all solution to health information exchange. Third, that we prevent innovation and local autonomy in the method of authentication, so that suggest again that if we don't imagine a single infrastructure to search proofing for authentication for everybody.

Fourth, if intermediaries are involved in the exchange, a sure that certification or independent. Verification of those intermediaries is done. And finally, there should be oversight mechanisms and redress of this mechanism surface that we are imagining.

Let me give you eight visual demonstration of this, and I know the text is hard to read, but this is a very preliminary, we are calling it a strong case. It is not a plan, just a way of illustrating a set of concepts we are all struggling to understand and away to illustrate this may not look anything like this but it illustrates some of depth policies that need to be addressed. So we walked around this illustration as a circle clockwise, starting in the lower left. We imagine provider actko wanting to send a message to provider B, and we imagine that want to send the case summary as we heard about in the last panel. Provider ack-ack is using a certified EHR Product packaging can estimate that she wishes to transmit. And she and her EHR product are attached to what we are calling in that blue bubble at about 9:00 and H SP, which is a hold information exchange provider. It could be offenders the network of customer or integrated delivery system. It could be the health plan or a variety of organizations which choose to aggregate services to EHR users. But the HSP is suggested by the arrow going up at about 10:00, the federal process that is talked about here. That is the HSP, the Health Information Exchange provider is competent to verify the identities of the users and attach the appropriate certificates to those verify the identity users as they transmit information across the network.

So we imagine there for but the message is being provide Potomac transmitted from provider A and they are verifying that she is who she says he is and isn't that attaching an electronic certificate to her message. That message is then the matter perhaps serious set of directories illustrated by the phone book at midnight there at the top of the picture. Around to another HSP which is supporting provider B and it determines that he is who he says he is and is the appropriate party to receive this message. The pieces at the top of this picture suggest that there needs to be process by which the nationwide Health Information Network determines who is eligible to issue the certificates which are in turn proof of identity and messages transmitted around the network, so there would need to be in mechanism by which there would be a nationwide route certificate Authority who in turn designates the various certificate authorities. And as much as it generates now in the commercial Internet space, we are recognizing and giving the special [indiscernible] and identity management that there could be some sensitivity specific to this picture to the health information.

The last step in a recommendation, we do not have a recommendation regarding the trust fabric, but we are simply describing to you that we have come to understand there are a lot of rules of the government could play in asserting trust of the network, greeting from taking actions to new regulations are statutes. At this point we're not at all prepared to address with those adjustments might be but that will be on reader as we go forward with this process.

Let me stop there and see if people have a general questions at a high level and if not, it can go back through the recommendations.

My question would be, could you expand just a little bit more on the definition of an HSP.

That is in turn to me and what role it might play, it appears on your chart that there is a certification body, to what extent it would be certified.

It would be very minimal, about a conceptual framework for an organizational structure. But I will say their is a general recognition that the health information exchange function properly need to have a number of services to enable to help people find other users and self epidemics if the transmit messages to those users. And issuer delivery system that you are attached to, issuer IDA, a vendor is -- or a health information organization that is regional, regardless of what it is, that will be facilitating our message transitions. There are some things that have to do consistent with rigorous standards of identity proofing and authentication, and everyone should be verified against the standards by somebody. Sell it is not met Annette HSP is a new entity, it is really a label on an existing [indiscernible] just one follow-up.

Is it your concept initially or maybe we could punch this out later in discussion, but are these entities conceptual as to be perform the functions of integration engines were there is translation going on, or just the facilitation of the four areas you were talking about?

We will not speak to that question for this point. There are probably a lot of ways to address that need and whether one of that will that's what this set of needs we have not talked about all.

Can I just answered a point of information? The committee is not being asked to consider this strong case. It is introduced -- this straw case. It was introduced to be helpful, but it is not definitive, it is preliminary. There are a thousand questions you could ask about this war spend days on it. It doesn't show up in any of the recommendations. It is not required as if you increase the recommendations. And, it is, as a question of whether it will cloud the picture or clarify the picture, I am not sure, but there is certainly a danger that it could cloud the picture if we spent a lot of time exploring it, and I only saw this last night and haven't had a chance to process it. Adjust wanted to cautioned us that we have four recommendations in front of us, and I would much prefer paper that is that the time thinking about the broad policy issues and thinking about this particular [indiscernible] this is only to illustrate how this might come together in some fantasy of the future world.

I am trying to clarify, it is said they're would be useful recommendations to further the work on the NHIN, these recommendations are fairly high level and the authentication of carbon based life forms and being able to find out where they are and using the Internet to get the information across to the purpose standards.

And although the NHIN as we have known it is compatible with these, might be compatible to the is, it does not have to be compatible to these.

[indiscernible] if we are going to get to meaningful use in 2011.

Tiny was up first -- Connie was up first.

My question is seeking just an additional comment on what probably relate to recommendation one end to can you make any related comments to personal health information? Or the interaction of the information that might actually reside in a PHR, and the relationship to that particularly in relation to number one and two.

We have not spoken about that much and we made an early decision to prioritize the tax in 2011 the provider to provider message sending and secondary provider to consumer message sending. But even there, for example, of the authenticating the consumer is one we haven't tackled because it is complex. And we have stated that we are sure to reflect PHRs as one of the technologies we need to address over time that we have not done that.

Thank you. I hope I am not adding clouds to this issue at all, but I wanted two, at a high level, to ask a question about the term Internet and what that actually means. Does that segue into a telemedicine approach? We have devices appears that are shaking the tables and communicating with us in a certain way. And with this affect communities that may not have access to Internet but that have access to Mobile phones as far as getting information back-and-forth? Did these things segue into that or is it the intention that the Internet be the firewalls?

It should be technology diagnostic in terms of the platforms used. We spent [indiscernible] provide authentication services -- I think there is a willingness to embrace a variety of ways of getting information around, but I don't think our recommendations have spoken particularly to some of the applications that you are racing, which as Paul said R at somewhat more of an abstract level at this point. But I think directory functions and Purse authentication functions that we describe here, would want to make sure that they speak to the different technologies that are available.

Paul?

Thank-you. These are very good and reasonable recommendations. I have an observation, and everybody talks about an exchange of information, you're also automatically assume that you are one to transport data. And you can do that without transporting data. The way you did that issue have directory services and authentication, but you allow read access to a summary at another site, and it's simplifies a lot of things. Especially the issue, about what happens from position A to position B. What happens to it and maybe this observation would be the suggestion of a different strong case, if that is the right terminology, for your work group to consider.

Gail?

Thank-you. One of the things that concerns me is in the first recommendation, and were talking about the federal government should focus on [indiscernible] that will exchange components without mentioning that, in order for further meaningful use, I think every time you talk about meaningful use in furthering that exchange of data, you must always say, insuring privacy and security. Any time -- that has to be foundational and every time we make a recommendation. That is the basis on which things have got to take place.

And any time you say that, if you say, while ensuring privacy and security.

Thank you. I appreciate you saying that. For example in the area of directories, there is a recommendation that it is not explicit here and maybe it should be, the directories themselves exposed intermission for a variety of potential misuses. In advocating directory sounds good, but making sure that the structure had access to those directories and self protected in the way it is described are particularly important.

Judy?

I do like a lot of people think it is very impractical. And just to expand a little bit on what you said, if it is really only, you would not be able to trigger it the alerts that may alert the physician if it is a drug-drug interaction because that would be a lot for the position to remember. And secondly, we would have to look into the legal ramifications of that, because they do need a record of whiting made the decision that has been made, and that also factors into that. But my real question is, what are the next steps?

A think the of dedication items in plan work to be done. Sell the bottom point on this one, we discussed the importance of getting on with the business of what needs to be in these directories to enable the kind of messes Exchange that we are talking about and the ability to guide these directories, but we haven't gone into that level of detail yet but that would need to be the kind of further analysis we have to do.

The instructions on -- I know with the Interoperability that our group does, that is what stops us from into operating with another group, and we don't have the rules yet for where you go to pick that up.

[indiscernible] level of detail.

Did you want to comment?

I think you raise an important point. The work going for it needs to be grounded in reality. We can't make decisions about standards or those rules for how it would pick up the data in the abstract, and so I think one of the things we need to think about as we do this is to see, are there examples or are there pilots or other things like that that may help us get to that level of specificity that is reflective of what is happening with this underground.

I think the other intent is passed to come back to this group with more specific ideas at a future meeting, perhaps in February.

So what these are our recommendations that set us in a direction, and we will sort of fill in with more concrete plans, and the ONC will actually try to begin experiments and pilots trying to develop the applications and implications that fall from these recommendations.

Jody?

I have a comment on recommendations and it goes to what Connie was raising. It talks about supporting full use in the near term but it only talks about enabling the range of providers and indoor air Road drawing of stage one, it talks about information to consumers as well as public health reporting period ended that limits the scope of what you're saying and try to accomplish which was the health Exchange or early report of meaningful use if we are limiting it just to providers, and understanding the challenge of [indiscernible] individuals, but it also excluded the public health authority.

I think our intention was to say to enable multiple [indiscernible] to satisfy meaningful use criteria. To do that, we have to [indiscernible] our discussion for example about directories has looked at, there are directories of pharmacies, of labs and public health agencies which would need to be unable to this network, so we do understand that.

I wanted to also congratulate you on the recommendations, and it does seem like the best set of steps forward to get us where we need to be inadequate time frame. I know that the emphasis on the trust and the need for policies, and certainly that is part of what we see as our duty to do and part of our charge as part of the privacy and security work group, and things that we have tentatively put on their agenda for the coming year dovetail quite well with identifying the issues that need to be resolved, but we have not identified as well the things coming up in your discussions, so I would love to stay in close touch and make sure that we're working together in a synergistic way and invite you to help us uncovered and resolved some of the other issues which are central to the Trust Building aspect of this.

That would be useful for us to do. We are sort of done in the basement working on the plumbing of some of these issues, and they are not as useful as privacy but they are important to creating a privacy of the structure. So we would be glad to work with your group on some of these things.

Recommendation number four, bear in mind that we are talking about the National Health Information Network, he make a recommendation for the local autonomy of authentication and it seems counter intuitive to a national model as opposed two, are we going to have authentication aspects and having difficulty working with those to get there?

As we used a strong case [indiscernible] the blew bubbles there, if you imagine, one of those is an idea of doctors, another is the day, and another -- authorize the yellow box up there and the upper left, and they maybe a set of criteria for new ones that we may come up with, and everyone has to meets the criteria but the way we meet them may vary. So if you go to the post office [indiscernible] working the emergency room today, or wherever you say you are, those are two ways that are solving [indiscernible] what we're saying by local autonomy, they may be equally acceptable ways of proving identity or that they may be used in a certain local -- and I don't think we need autonomy outside of this established implementation.

Let me see if I have gotten this correct. We as a community may have had some preconceived notions about what NHIN is. It may have looked monolithic or very intensive in the overhead, or even prescriptive. And I think it even opens up and is enabling or more permissive. And you have tried to identify core services that have to be in place, in the best way, and then having communication go over the Internet.

And then if you have to have meaningful use to be accomplished and paid out on, then it has to happen pretty quickly. Then it. Monolithic cumbersome one size fits all probability will look like that. So that is something that you do have to get right in robust fashion and then have the permission of the tabling of going through those things.

Gail?

One more question on the authenticating, that is a critical component of privacy and security. Knowing who that person is, that carbon NT is, to authenticate them. I am looking at the stocky stocky have put up there in the authenticating identifiers. Are you authenticating that the circus fire of the signifier, is that NHIN? Or who determines who the survivors are?

That is critical that we have not yet gotten to deal with that question. There are other parts where there is a mechanism where these 10 organizations are all modifiers, but we haven't done investigators yet to see which ones are here.

You are talking about things such as PKI?

Well that is the methodology but also to set fires bitches with the government has already done.

As you know, we're heavily involved in trying to think through a certification process of health records. And we are learning more than I knew ever existed about certification. But the indications of creating this elaboration on the traditional NHIN are still being fought through, and I think the work group wants to think some more and bring them back to us.

Christine?

This is very reflective of the need to get information moving in a sensible and secure way and in a way that is going to benefit both providers and patients. We were very clear in talking about the fact that consumer access to health information is a priority and like many things, we have some work to do to get there, but this is a set of recommendations that is very practical. And so whenever folks are done with the discussion of be happy to move.

I heard one comment, a very important comment from Gail about amending these to insert privacy and security in their recommendation, and one is what she pointed to but I think there are other areas in which it would be pertinent.

So it could be that we don't want to wordsmith these right now. It might be that we could modify them -- we could modify them and bring them back to look at them again next time. Along with some other thoughts that the groups may have ready by that time.

Any other additions or changes that people would like to suggest at this point?

David, this is art.

David, I believe that these recommendations. I wanted to take something that is maybe worth recommending and [indiscernible] local autonomy and method of authentication and wonder if there is anything of value in terms of committing local autonomy regarding [indiscernible] and it seems like the third recommendation focuses entirely on the federal government. And how might innovation be valuable at this level as well as HIEs try to spin up their own directories?

I think on the second bullet of the phrase, the most of the authoritative information is local, and it's very difficult to sustain it when it becomes aggravated to the national level by the health plan or anyone else. So it is a good suggestion, with its deadly taketh under advisement and come back with some assignments to these and maybe entertain that has a possible amendment.

Thank you.

David, for my intermission, could you say a little bit more about that and that?

Well it is consistent with the fourth point that aren't mentioned, we may consider whether it innovation and local autonomy is an asset in maintenance directories to inshore that they are very close to the source and dynamic in that sense, maintained.

So there is clearly a balance here between the local initiative and creating directories and making sure that directories can enter operate. And I guess the territory we are exploring here is, we need standards for directories and is bad enough in effect, is there an analogy between what we're doing with EHR and what we're doing with directories?

The word in sharing in the second bullet I think is a critical one. For the government to ensure that authoritative provider directories are available, I think we have to deal with the points that are just made. What is their standard or content or mechanism for maintenance.

It is critical. You have to know who is doing to the authentication of those directories. States run medical providers, they licensed physicians and licensed pharmacists and those kind of things are very valid and they are done by an agency taking have trust and confidence in. I don't anticipate a local group setting up a directory and then they become part of the entity, that would be very difficult in making sure that you are securing the privacy and security of any record and then being allowed to go to that entity.

Judy?

You have to entities, and have the entity of the organization's sending information back and forth and then identification of the patient itself, so you are getting into the directories. And having them work together and having them identify their authenticity, but also, are you want to be tackling the problem of identifying the patient?

We are not doing patient identification and we have not talked to cut that in this work group.

That looked painful.

I don't know how we get away from patient authentication either, and while I certainly understand the issue -- how do we get away from that?

In order for meaningful use in 2011?

Have a point, but it still has to be solved.

I would like to ask if anyone would like to move with that we accept these recommendations conditional on the two changes that have been suggested? Won by part related to entering a balance between innovation in the creation of directories and maintain the authority of nature and privacy and security of directories, and the other relate to ensuring privacy and security as a foundational aspect of any mechanism of Information Exchange.

And the opposition?

If I hear no opposition, a lesson that the recommendations are accepted. Thank you, David, and thank you to the work group.

And we will be back to you with additional more concrete suggestions and with modify the language for the next worker. Or for the next policy committee meeting.

Okay. And if we are now living to the last item of business, this is strategic planning exercise that we are required to do under high tech. And when will be hearing from two presenters. One of them is to my left, and the other is Jodi Daniel. Would you like to take it from where you are?

Okay. We have had two meetings now of our strategic plan workers, and we wanted to take the opportunity to update the full committee on some of the thinking of the work group. What we are one to talk about today is not set in stone. And there are at least a couple of areas where the rock group is still struggling to get it just right. Sell your input is very welcome and we plan to come back and update you all again as we go into more detail and at this more finalized. So this is just check-in and to let you know that we have been doing some thinking and getting some of your strategic thinking to weigh in on your discussions. So here are our work group members. We have quite a large group for this one which was intentional because we wanted to get a lot of different perspectives represented. This is an effort that ONC is required to undergo under high tech and we are required to get the stakeholder in put and reaching out to a variety of different stakeholders both on the policy and standards community as well as those that are not represented on the committee. And have some public input and have a session where we get more public input once we get more thinking into the final draft.

So this is our process at this point. We are looking for the strategic plan, this work group to provide recommendations to this full committee, and develop a strategic framework that will set up teams, goals principles, objectives and strategies to provide advice to ONC on our strategic plan effort. Those recommendations from the work group will come to the policy committee which will make a recommendation to the national coordinator on the list objectives and strategies.

Then ONC will go and take the input to us as we have with other input we have got from you on Regulations and such and craft a strategic plan that takes into account all of the hard work that out work group and the policy committee puts them and all of the advice that you give us, and our hope is that you have a strategic plan that will release in the fall of this year.

I will turn it over to Paul to talk about the vision and Means and talk about the one.

As we presented to you this time, which broke the worked up into four themes, this is not necessarily the way the final document will go in but this is the way we have chosen to organize ourselves. One of the things we have put as a vision for this whole experience which was the context of a why are we trying to promote the adoption and effective use of HIT. The sense we had up there was that we wanted to create a health impact to continuously improve health health care of individuals in the population. That is the vision that is driving this whole initiative that has sort of set out in statute.

Introduced a number of concepts learned in the health system, and accusing the intermission the matter what technology or methods are used to get that before people, and we sort of blurred the distinction between health and health care, so those are elements.

The next slide, but that theme one and this is the goal. The first has to do with meaningful use. Them goals are the same goals we had in creating a meaningful use free-market [indiscernible] Health System while reducing health disparities.

We do this through meaningful use, and one of the ways to promote that is through meaningful use of the HIT.

The draft principles there are really every articulation of the thought process behind declaration of the meaningful use free-market that was originally proposed by the meaningful use corporate. So let's focus on health outcomes. The track the National Health Properties, and these are not parties that ONC or any of us that, but there is a national consensus that these are the contemporary parties that wish to be focusing on. The focus on individual and population Health and fostering and patient engagement and increasing the efficiency and reducing the burden -- increase the efficiency of the health system and particularly reduce the burden of providers and patients of having to deal with the health system that we have.

Through all of this, there is the balance in trying to [indiscernible] on both the professional side and Hospital site that can engage and participate in this program as much as possible but still with the urgency of having all of the health information in EHR by 1214. And finally, there is an additional set of resources made available although it is still finite. So we need to prioritize the use of those resources to those with the greatest need and a lot of times that will happen with the small organizations.

Sell the crapped objectives that are derived from those principles are before you. One is that we still have the 2014 2014 cool out there. They're is a little bit of a twist on the 2014 goal. Instead of saying that all individuals have their health information in the EHR, with a sense of prioritization for the folks that start using the services of the health-care provider are probably the ones that you will involve first and there is a little bit of prioritization were staging built into that.

The second piece is to support team based coordinate care throughout the entire health system. The third objective is to support consumers in taking a more active role in their health and health care and managing their information.

The fourth and fifth are sort of combined to say that we want to use all of the policy [indiscernible] to emphasize the meaningful use in achieving meaningful use outcomes. It's also Courtney it's all of the public sector and private sector to do those.

Then to demonstrate and major the impact that these systems have had on health outcomes and efficiency, and finally to the jury that we don't forget the public health sector, and not only to report the information to health agencies but also get information back that would drive ended for decisions made every day on individuals. So those are a set of objectives under this meaningful use.

Going on to the into, the technical and policy infrastructure, the goal that the work group had come up with was to enable management and Exchange and Electronic health information through the development and support of appropriate policies and technical specifications. This section was an interesting discussion. Originally it was focused on the exchange of health information and there was a lot of discussion on how we needed policy and technical specifications particularly privacy and security -- as was the [indiscernible]. That is all built in to that goal.

The draft principles, the first with policy and technical specifications should at a minimum allow providers to provide the nucleus of Health Information transfer, so that is in the Michael but the policy and specifications of the federal government.

The second was that efforts by the federal government should leverage market and innovation at the average publicly available information and technology is two foster. Health information exchange. Originally, there was a comment on the left panel about the Internet. We had talked about this being done at leveraging the Internet and [indiscernible] Technologies since this is a five-year strategic plan that we are talking about, to make sure that we are talking about [indiscernible] Technologies which may come down the pike it may become more prominent in the next few years.

And this should enable all participants to exchange in health and health care, and this also goes to one of the NHIN recommendations about trying to support all of the systems in the exchange to be able to participate, were also contributing to health health care be able to participate in health information exchange.

Next that policy and technical specifications to be as simple as possible and should be defined by all participants. This was actually something that came from the standards committee and the recommendations from their implementation workgroup about trying to keep it simple so that less [indiscernible] participants may also be able to play a role.

Finally policies and technical specifications should be possible and promote patient specifications and access so that it is not just limited to provider specifications but trying to promote patient condition and assets for health information exchange.

And this is the principles that are recommended, or working principles that the community has been developing. For the draft objective, therefore that we have identified, and I just wanted to highlight, this is actually one of the areas that we struggled with the most in our last meeting trying to figure out how to articulate these objectives that were old comprehensive as well as appropriately focused, and so this is sort of the most draftee of all that was tacked is what we have here, and so anyone in the work group that is trying to -- very much a work in progress on this one.

And I will try to explain the concepts behind them so you understand what some of the thinking is. The first is to establish policies and technical specifications including standards and specification activity to [indiscernible] support me for years. Initially we were talking about standards and certification criteria and there might be other technical specifications, and the technical policies that may also need to be included, so this is about certification criteria as well as technical and other policies that could foster HIT per policy development and meaningful use.

And the supports health and health care improvement.

So this is incorporated in things like the certification process, product safety, and those sorts of things in no way to increase market confidence in the HIT products that we're trying to encourage meaningful use of. The third [indiscernible] and this is sort of looking apple the NHIN activities as well as other activities to support a change in capability of exchange. And some of the infrastructure and technical requirements that may be required for that. And the fourth was encouraging participation in health information exchange. This is really getting at the policies that are necessary to encourage participation in health information exchange. Some of those go to liability concerns that are being raised. And making sure there is a trust fabric to encourage participation in Health Information Exchange as well as government in NHIN. So those were concept or the thinking behind this draft objectives.

On a theme three, we haven't been specifically on privacy and security and I know the question will come up so I will mention it now. In all of the draft principles, some of them have privacy and security mentioned and it kept coming up, so it was a recommendation by the work group that at the very beginning of the document that there be a general principle in the way everything had to be done in a way that ensures trust in the Information Exchange and the technology, it's allowable not see that in each sets of principles, it was something that the group thought was important enough that it should be moved up to the fraud by the Mac as a guiding principle for everything and we are doing. So we do have a specific theme on privacy and security but there will also be messaging at the front end and this is something that is critical in every [indiscernible] of the plan. If the goal was to build [indiscernible] incorporate privacy and security solutions in every phase of development, adoption and use. For the draft principles, there was a long conversation about these. ONC had published a nationwide privacy and security framework for electronic exchange of information in December of 2008, and there are eight principles that are listed here that are based on fair information practices, and there was a discussion and agreement of the group that, rather than reinventing the wheel on some of those principles, those principles should be incorporated has principles for our strategic framework. And then there were a couple of other principals in this area that were important. First, that solution should enhance privacy and security while facilitating the appropriate access use an exchange of health information to assume outcomes, and privacy and security should be flexible to adopt technical capabilities overtime and this was [indiscernible] the approach they took on Security Standards and making sure that standards that were flexible enough to adapt to involve technical capabilities. So those were the draft principles Borodin three.

Okay, the board. This is sort of the forward-looking --

I'm sorry, I skipped the objective. So the draft objectives are cavities are fairly gentle at this point at a think a lot of the detail will come out in the strategies. First was, identified prioritized and security needs for all stakeholders, the second was to develop and promote and divorce privacy and security laws and a proposed dates for all aspects of health intermission Exchange, and if there was increased [indiscernible] protect privacy and security of health information. So the second one, I think there is a lot in there and that would be some discussion with privacy and security Workgroups to make sure that we are connected with their efforts and their prioritization, and this is where the privacy and modifications that are required by high-tech fall into an four strategies and reach notification.

And third one was actually [indiscernible] they were communicating [indiscernible] campaign and guidance of best practices and the regional extension center to make sure that they are helping providers to understand privacy and requirement.

I apologize.

Okay. The thing for is sort of the forward-looking, if we put it in the state turned it is getting into stage three, and that is, how to transform what we have today which is the health-care delivery system into a system of health care that is constantly learning. And that involves everyone, not only on the professional side but on the patient's side. But principle would be, how do you take this stuff and facilitate rapid learning? And that would not only change the diagnosis and treatment, [indiscernible] making increasing knowledge. That is really the guiding principle for this particular theme. And that would [indiscernible] the care is about work together to create new evidence based knowledge.

Finally, how would we apply these things that David talked about, the methods, policies and services, and helped create knowledge from the three distributed data sources, and those would be the goals and principles of what we wanted to establish in this theme that is really transformational.

To the objectives, and these are just there first draft, can you create knowledge and tools that would help professionals and their patients were together to make the best possible decisions? And second, how do we create learning communities? The professionals in this case need to find ways to store and manage and then derive new knowledge in order to advance the practice of medicine. How do we use HIT to do that? That is in bullet two.

And bullet number four, we talked about providers and patients, and a lot that goes on in the so-called chronic care model has to do with the communities. And as a country, we don't do a whole lot with communities, and yet, HIT can be important in making that happen. So can we use HIT to make that important outside of where we live? They work in schools and employers places, and they attend senior centers. And we reach out and connect Those and create services and knowledge that addresses the so-called determination. And finally how do we take this knowledge that we are creating and make it better? But the comparative effectiveness research and drug surveillance or drug maturing in also turning it around on how to develop the next set of drugs, all of those things would be useful. So these are kind of objectives to develop the new planning health system that we're proposing has graphs.

Below each of these that we have talked about, we talked about goals and strategic objectives, and we need to delve into the strategies that be the sort of practical date today things and programs that ONC creates.

That is where we are now, and we would love to have your feedback. Because we are on this path and the next iteration is one to update this on your input, and the second with the two delve into the strategy part, and we will be bringing you back a final draft document in March before we have a public comment in April, we have a hearing session, I think they are called, and will finally delivered to ONC a set of recommendations in May.

Comments please?

I really like the emphasis on the information as you did in the fourth bullet. That is the glue for the stuff that this technology is meant to support. So I think if you accept the schematic on enabling the information to be wide enough to support health care, that is great. I am wondering, if nothing at all that you presented I would disagree with your question has been valuable, so nothing strikes a wrong note, but I do have trouble picturing how you would get to a vision and it's links to the American people and says, here is what we're trying to achieve, and here are the major elements that we need to work out to get there.

And I do think what is still missing, not on this document but in the country is a convincing vision of how electronic and information flow changes our health. And I hope that there is the way to answer questions along that path. So for example, what is the government's role in all of this? Is the government's role to create incentives for certain behavior is answered technology products cracks some of the language in the draft is so high-minded as not to be very constructive in group health outcomes. And some of these theory technical and the nitty gritty of what is going on. So I am looking for an upper middle ground, which is high-minded, but it gives me the all of us a picture of five years from now, how things will look in America, who is connected to whom, what are the nature of the Bills and the exchanges, and I think it will be tough and I am sympathetic to the challenge, but I hope there is envisioning clear that can help the general public understand what we spend all their time turning on.

You are just looking for a straw case. [laughter]

Thank-you very much. Going to that leave for, I appreciate the principles and objectives that you have put together. I think this is something that live strong and the cancer communities are interested in giving the needs of cancer patients out there and what we're learning about the disease. Clearly comparative effectiveness research is a big area and we are talking about molecular Lee informed comparative effectiveness research as well. We are also going to see it molecular medicine that can very quickly. The use of genetic and genomics technology is making its way through the clinic very rapidly. What always lags behind is the regulatory policies and process these, so I would just ask as you look at the principals, clearly patients and providers are called out, but how this is informed regulatory bodies like the FDA, subsequently, CMS, for reimbursement based on technologies. Just more keeping it in the principals is something that all of this information should segue to in real time.

I have applied the notion of a health-care planning system and comparative effectiveness alike. One thing I didn't see, not so much from the perspective of having to focus on it, but if you use it real-world data and don't have an appreciation of things like benefit design changes, i.e. will likely come up with erroneous conclusions. So you just want to highlight the importance of a proceeding the dramatic changes that the administrative tinges can make.

Yes. I wanted to say something to the group for the capture of this innovation and thought. I have two areas of comments. The recommendations are infused with patient engagements and such, and I am wondering if there might be value in pushing that in a little further towards people in power that. So wide, but don't assume the patient dynamic and number two, it is not just about in casement but true empowerment. And second, this may be irrelevant or outside the scope of what we are about, but it seems to me that, pressure, we need an emphasis on the synergy between this whole agenda of we have been talking about and the synergy with education and development of the science of best practice, as well as the regulation of policy. So what the second comment is about is, I would encourage the group to consider confusing mess with the necessary synergy between all of what we're talking about, the IT and people's health, and not only how we educate the public about our next-generation of health-care providers and their discovery of new knowledge, etc.

Okay. Neil?

I also wanted to compliment you on that team for. I think it is the new part. And I think it is incredibly important. I just wanted to make sure that we don't see these things in some sort of temporal sequence, like 123 is what we're doing now and number four is what we're doing in the future. Still a lot like to put something out there.

They're is a couple of different ways you could look at north four. Right now, that is sort of the wrapper for the whole piece. In fact the whole reason we are engaged in this is because we believe we are implementing tools that have the ability of transforming the health-care system even though we don't know exactly what dimension that will take at the moment. So in a sense to it is not really like that.

The other way to look at it is there are people at high levels of adoption already and organizations and entities and systems at high levels of adoption and use. And while we are getting the rest of the country to adopt and achieve meaningful use, we should have another component of what we are doing that supports the front runners at the front running organizations, and I plead self-interest in this. To be able to say that some of the larger integrated health-care systems that are completely adapted and are already beginning to figure out how to use the technology they have to completely transform the work they are doing and reporting on outcomes and quality, we ought to have a component of our work that really supports that at all levels now because that creates the map that others are one to follow, just like the components of what they're doing now have been treated by answers who came before. So I wanted to make sure that we, as we support the end of the earth, people are drawing the map of what comes next, because I think it will help us define our can help keep us moving in the right direction.

I hope you applied for a beacon.

Unfortunately he can't apply for an individual organization. So you want Magellan to find his way home?

Actually, I would like to find his way away from home, and keep going.

We still don't know whether the world is flat.

I would also like to add from a public perspective, I think it is important to incorporate an aspect of public education and make sure that the public understands what this is all about. They're is a great deal of fear, a lot of segments of our population that health information exchanges going too lead in the ability of the government to control their health care. So I think that needs to be discussed as part of that committee. I think we need to make sure that comparative effectiveness research doesn't become the buzzword for rationing care, and we need to really look at how it is presented to the public, and that they understand that we are really trying to create a health care system that is one to improve outcomes and make health care better for everyone, and not killing about rationing were but the take care, but making sure that the very best providers are providing the very best care, and that they have the information and tools that they need to do that. To think that also needs to be addressed.

I think the whole translation is a challenge for every aspect of what we do.

And try to create language that people can understand is always a challenge as well, particularly in the highly technical area such as the one we are working in.

Any other comments on the strategic plan? Cure not being asked to process anything here, just an update, international. But wanted your midterm reaction.

Okay. Judy, I'd think we are ready to take public comment.

Thank you. And those in the room, there will be an microphone in the aisle. Please queue up. Those of you on the telephone already, if you would please press star one you will be connected to the operator, and those of you on the web, dial 1-877-705-6006. And we will take the first comment, if you'd please state your name and organization and remember that have a three minute time limit, Robin.

My name is Robin Rayford and I and the director at ... and I am also the co-chair of communication and when I got this great body of work, and badly turned into a and then I had forward, and oh no, no bookmarks. So I have fixed that and taken the robust table of contents and add to the CMS document at a want to give credit to the PHR from GE, cheap but marked the interim final rule, and I also took it upon myself to take the 59 tables and put it into excel. I sent it to Judy and I self and Keith are very active HITSP members and we send it to John and he put it on his block but I wonder if there might be in place to put it on the HIT buzz on ONC so others can find it is the art hooked into John's blog. So if you do put it on the blog and you don't get a thousand comments, if you take a PDF and Venci the two work and copy it into excel, it doesn't give you six rows of Excel for one Selig PDF.

And to extend 's comment, and Dr. Blumenthal, is said to our knowing [indiscernible] you have to tell us this stems out or if the system shall have the ability two and we will know exactly what to do.

The next in line?

Good afternoon. I am Bob Bryant with pediatrics Work Group, a national work group practice of more than 1200 physicians including 900 me on intelligence and 70 pediatric intensive this, pediatric hospitals, and at 140 Internal fetal medicine specialists and obstetric hospital is providing patient services for patients with high-risk pregnancies and premature births. We appreciate the hard work of the committee today is the sow with respect of the EHR incentive program, but we appreciate this opportunity to provide comment. The pediatrics group has successfully is Health Information Technology including Health Information Records, Advanced Health recommendation databases and -- to improve patient outcomes, identified meaningful differences and reduce disparities and outcomes. Our EHR is an internally developed system of today in Naples consistent documentation of care provided by physicians practicing across the country. The physicians additional documentation of character Daily progress notes populates eight the identified clavicle warehouse that now comprises more than 600,000 patient did counters and 11 million neonatal Pearson days. We are able to extract data, a sense of Commerce, did not strategies for improved care and make meaningful changes that continuously enhanced the delivery of care. Warehouse crise yield evidence based answers that Drive Research, continuous improvement and continuing medical education. In addition, two improving patient outcomes, this reduces costs in addition, to pass at pharmaceuticals and ultimately reduced average swing the state for patients. Pediatric assistance and help information technology area conserves a useful model for federal efforts to promote improvements in health care and health quality for the health intimation technology. Thank you for the time.

Mining is tenancy hackle and I am here on that behalf of the American dietetic association.

First of all, thank you very much for making such remarkable progress in this area and also for the opportunity to comment. There are several foundational things that continue to recur throughout which I think are great and helping other people that understand those been answering safety and privacy, making sure that there are good health outcomes and in gauging the consumer. Hopefully, we are at a point now after this progress to start in gauging the consumerist and not providers, not a physician providers, and the goals and strategies that you have.

While most of those did not receive direct incentive payments from the high-tech Act, we do get a great deal from that by being able to improve quality of care, and also allowing consumers to finally become engaged on health care.

There are several areas, in terms of patient education. I think there are a few American life projects, a great deal of Education, close to test the patients will find education whether we direct them too anyone not so it would be nice if we directed than in the right way. The other point there is that, which can still include piece of Education as part of the meeting fleetest by handing it off to a non physician providers. An example of that would be that BMI that we discussed earlier. That would merely be an inexpensive screening tool, but they should trigger reaction terms of a referral, education information, or some other discussion with a patient. So that gives us -- that could be another way of engaging both the patients and non physician providers.

The other area is an area of quality Major and I agree wholeheartedly that we need an incentive for all of us to be involved in that, and that we continually update those as we have more quality information in quality data from the EHRs. A good example of success of that is hemoglobin A one C where patients know their values and other non physicians know the values that that patient should have as a while as the provider. It allows that the mark to ripple through all parts of the act.

Thank you very much.

We do have one caller on the phone. Can we take that caller?

You have a comment from Don Mayes.

Thank-you very much. On behalf of the hospital, we do appreciate the work of the policy committee, and [speaker/audio faint and unclear] have developed a good product over the last nine months. So I wanted to start there and we appreciate the Herculean effort that you have had to take to get these rules out in the timeframe of this task. In saying that, we have also had the same concerns and goals that all of you do, that we bring an electronic health records into hospitals across the country in order to improve patient care and safety as we implement these new systems. And but think we have seen over time, and hospitals are putting these efforts as high priorities, and that means putting their resources behind them, it is think to some extent with or without incentives. And at the same time be able to access those incentives have made the intent that Congress put into the stimulus bill, I think it will be important. And I think we have some intent that ONC will weigh in on part of this comets process to help provide some more flexibility around to record events and some of the burden that we think the proposed rule and meaningful use and incentives really create.

I know that Doctor Tang highlighted some issues where there is going to be some concern for their that is around eligible providers work the burden of reporting for that denominator issues, a lot of this being outside the control of providers and hospitals. And we agree with many of the comments. At the part of what will what two to stress was versus the all or nothing approach that is put into the proposed rule. That is something we are concerned about being very inflexible. And that type of approach really fails to recognize something less than 23 objectives really cannot be meaningful. And I think the hospitals that have implemented systems, maybe not all 23 components, but there are many hospitals that have done a lot, but it would not count the system, so I and what really sure that that is what the Congress intended when they said, let's reward these providers that have done something. And we believe that this all or nothing approach is something that would have to change if we wanted to see this program really be an incentive and not further exacerbate the Digital divide.

The last thing I wanted to say briefly was we are very concerned about the timing. Whether it is standard queues or the lack of certification process, and likely a certification Q process where there will be a cue in getting certification, and just the fact that it takes 18 cleat 24 months to add a system is a real concern that we have, and we really really encourage you as experts in this field to recommend the CMS to expand some time frame differences, that would expand what is required and allows something less to be included as meaningful and 2011 so that we can eventually get what I think the policy committee and what we would like to see as a fully functional EHR and hospitals across the country. I am just concerned about the timeframe.

[Captioners Transitioning]

We found that we only have 10 of these objectives in the survey.

Can you please some of? Your three minute limit is up.

I apologize. As we look actual date of what hospitals have, they have no of lot of things in place but are very few, less than 50 hospitals that have in please be meaningful use objectives and would encourage a better approach allowing these to be fulfilled.

Thank you. We will have the Knicks, Mr. McNamara.

I really congratulate you on the strategic plan and thinking ahead and item four, I might suggest something you can add to it which is the use of social network to change behavior. When Peter was at Mayo, we develop a process-we did not finish it, basically, to make measurements of children's health behavior and habits and take a picture of them and threw visualizations, protect them as they would get older. At the time we did not have Facebook as developed as it is. We should have got one for every class and in America and based on good habits and bad habits can affect change. I am sure there is not better way to do it than I it does Edessa.

Thank you. I will turn this back over to Dr. Tang. Thank you to all of the participants for generating such wonderful products we get to review each meeting. Have saved travel back. Thank you.

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