AMERICAN HEALTH INFORMATION

NOVEMBER 13, 2007

______________________________________________________________________________________

Sheraton Chicago Hotel & Towers/Cityfront Center Ballroom 6

301 East North Water Street

Chicago, IL 60611

List of Participants:

Members:

· Secretary Michael Leavitt, Chair

• Kerry Weems, Vice-Chair

• Robert Kolodner, M.D.

• Craig Barrett

• S. Ward Casscells (also represented by Chuck Campbell)

• Cita Furlani

• Nancy Davenport-Ennis

• Leslie Lenert (representing Julie Gerberding, M.D)

• Gail Graham

• Jason Mitchell (representing Douglas Henley, M.D.)

• Kevin Hutchinson

• Charles Kahn, III

• Steve Lampkin (representing John Menzer)

• E. Mitch Roob

• Scott Serota (also represented by Justine Handelman)

• Daniel Green (representing Linda Springer)

• Lillee Smith Gelinas, R.N.

Presenters:

• John Loonsk

• Liesa Jenkins

• Margaret Gunter

• Mark Leavitt

• Jane Sisk

• David Blumenthal

• Don Detmer

• Charles Safran

• Simon Cohn

• Justine M. Carr

• Harry Reynolds

TABLE OF CONTENTS

• Call to Order: Secretary Leavitt

• Introductory Comments: Secretary Leavitt and Chairman Kevin Martin, Federal Communications Commission

• Comments: Kerry Weems

• Comments: Robert Kolodner

• NHIN Trial Implementations

• John Loonsk, Lisa Jenkins, and Margaret Gunter

• CCHIT Update: Mark Leavitt

• Health IT Physician Adoption Survey

  • Jane Sisk and David Blumental

• Advancing the National Framework for Uses of Health Data:

• Don Detmer and Charles Safran

• Enhanced Protections for Uses of Health Data: Recommendations to HHS on a Data Stewardship Framework

  • Simon Cohn, Justine M. Carr, and Harry Reynolds

• Public Comment

PROCEEDINGS (10:30 am CST)

SECRETARY LEAVITT: Good morning to everyone, and I want to thank you all for making it to Chicago today. I hope all of you have had a chance to see the displays that are part of the Informatics Community. Many of you were in attendance at the speech I just gave. It's a pleasure, actually, to interact with people as vital on this subject as they are.

A couple of things I wanted to mention at the beginning of our meeting, and then I'd like to introduce our special guest, Chairman Martin from the FCC [Federal Communications Commission]. First on e-prescribing. A couple of important things. Today, through CMS [Centers for Medicare and Medicaid Services], HHS is going to be putting forth a proposal to adopt new standards for aspects of e-prescribing under Medicare prescription drug benefit. Now, of course, this is an important piece of the equation that we're building.

We begin implementing the first -- we started implementing the first set of e-prescribing standards last year. At the same time, we launched a pilot to involve providers and pharmacies and plans to test the standards. The pilot was a very successful venture in that it helped us understand. We learned strengths and weaknesses, and we have incorporated all of those as part of this new proposed rule. All providers and pharmacies transmitting prescriptions electrically for Medicare will have to comply with CMS standards. Adapting this rule will move us considerably closer to the connective system that we're all working for, and it will be an improvement in the safety and quality of healthcare that all of patients receive. Kerry is sitting next to me, the administration of CMS. I'm going to ask him to give you more details in just a minute, but I wanted to note that subject.

The next thing I'd like to at least mention is the -- while the vision -- while the purpose of AHIC is actually focusing on standards development, and we've talked many times about the importance of adoption being hand-in-hand, I want to talk about adoption for a second and something we're doing to, I think, begin to drive adoption, and also drive adoption on the basis of standards that we're developing.

Two weeks ago, we announced a new Medicare demonstration program that promotes adoption of health IT. The demonstration will award providers who use certified EHRs to develop high quality care in small- to medium-sized practices across the country. As all of us know, and I think we'll hear a report today, this is where most Americans get their healthcare, and it's also the place where we have the lowest adoption rates in health IT.

Under the demonstration, again, I think that Kerry may mention some, Medicare will pay higher rate of reimbursement to physicians that use certified health records to improve the quality of patients. And we're going to involve 1,200 small- to medium-sized physician practices in this demo. It will -- when you consider the fact that it will reach as many as 3.6 million patients, this is a significant step forward.

Many private insurance companies that we've had conversations with have, since our announcement, indicated that they're going to take similar actions, and I think we'll see a lot of parallel play. I mentioned that those that are in the Medicare demo project will be using certified EHRs. We want to thank CCHIT for their efforts and their progress. That's, of course, the designation we will count on to determine those that are qualified for this demo.

Last year, CCHIT certified roughly 75 percent of the products that are now being used by doctors. As you know, they have recently added to that already impressive record. I think that Mark is here today, and he'll be talking some about CCHIT's announcement on the first inpatient records Their products will -- the products that they've already certified would account for about 25 percent of those in hospitals. I saw the slides that we'll look at later today, and it's clear that we'll see that ratchet up fairly quickly, just as we have with those of outpatient systems. So we're beginning to see serious momentum.

I also would like to mention our efforts to create AHIC 2.0. First of all, we have received a qualified, and I would say, excellent proposals. And I had hoped at this meeting we'd be able to announce the award. We're still working to finalize the agreements, so I just want to notify you that that announcement is imminent. I also want to indicate that I -- because of the time urgency that we're working against, I don't want to wait for another AHIC meeting to roll that award out. So with your understanding, I intend to announce it as soon as we're prepared and have concluded the discussions on the agreement. I think that we will have accomplished a broad coalition of significant players. They have been inclusive, and I think we'll be able to bring this together into a very aggressive effort to make certain we meet our deadline.

I want to -- before I introduce our guest today and thank him, I'd like -- for being here, I'd like to just point out that the clock on my desk says 434 days on it, this morning. The urgency that I feel just continues to grow. We're making great progress, but we still have a lot to do. I'm persuaded that's enough time to get much more done. We will have made the progress on certification. We'll have a process outline that will, in fact, begin to continue our work. We're seeing more and more and more efforts being made to bring the system together. But we'll continue to drive hard.

Along those lines, I mentioned that we have the chairman of the Federal Communications Commission here, Kevin Martin. The FCC is working to fund the delivery of broadband connectivity to rural and underserved communities. They are placing a particular emphasis on healthcare providers. I mentioned to Kevin that I think the more he learns about the network of networks that will emerge between what we're doing at AHIC and what we're doing in our quality initiative, will inspire their continued interest in this area.

There is not a part of our economy, Mr. Chairman, that -- where we could invest in the development of this kind of infrastructure that will pay more rapid or lasting social and economic additions, and I want to thank you for being here today and introduce you now for your comments.

MR. MARTIN: Well, thank you. And thank you for inviting me to spend a few moments with you today and talk about some of the things the Commission is working on. And also I do want to acknowledge certainly all of the distinguished committee members and the work that they're doing at AHIC. Although I do have to note, I constantly get complaints at the Commission about the foreign language we speak, and as you were talking about the CCHIT and the AHIC 2.0, I realized that there is other foreign languages from other agencies as well that -- and we're reminded of the challenges.

But I do appreciate your comments about the more that I learn about what's going on with you alls [sic] efforts, the more I think that you'll be able to see the -- we'll be able to see the important role that we're playing on trying to deploy the infrastructure that can make some of these things possible. And the work that you're all doing is not only important for healthcare, but it's certainly important for the overall economy as well.

Certainly since becoming chairman, I've made the broadband deployment the Commission's top priority. And broadband technology is a key driver of economic growth. The ability to share increasing amounts of information at greater and greater speeds increases productivity, facilitates interstate commerce and helps drive innovation. But perhaps most important, broadband has the potential to affect almost every aspect of our lives from where and when we work, to how we'll educate our children, and of most relevance to our discussion today, it is increasingly changing the way healthcare is delivered and received.

In April of 2004, the president issued his executive order to provide leadership for the development of nationwide implementation of an interoperable health information technology infrastructure to improve the quality and efficiency of healthcare. And I know a key goal of AHIC is to help Americans obtain access to electronic medical records. Electronic medical records will improve the healthcare treatment Americans receive by, among other things, ensuring the appropriate medical information is available, reducing medical errors, reducing healthcare costs, and improving the coordination among healthcare facilities. But all of these benefits rely on an underlying health IT infrastructure that is capable of sharing this information.

In order to receive the benefits of electronic healthcare records, healthcare providers must have access to underlying broadband infrastructure. Without this underlying infrastructure, efforts to implement electronic healthcare records, for example, cannot succeed. That's why a key element in the national health IT agenda, and all of Dr. Kolodner's efforts, is the creation of a nationwide health information network. This network of networks will facilitate exchanging information through common architectures, processes and policies. And I'm happy to say that we at the Commission, I think, have an opportunity to try to help in that effort.

It's our vision to see that every healthcare facility in the nation is connected to each other with broadband. This is especially important in rural areas of the nation that may lack the breadth of medical expertise available in urban areas. To make such connectivity a reality, we need to continue to encourage the deployment of broadband facilities that can connect network of networks of rural and non rural, public and not for profit healthcare providers within a state and a region, and as well as connect such state-wide and regional healthcare networks to each other across the nation.

Now, last year the Commission took action to try to address the lack of broadband for healthcare providers and tried to work to establish a true nationwide health information network. On September 26 of 2006, we launched the rural healthcare pilot program. This pilot program is going to provide funding for up to 85 percent of an applicant's cost of deploying a dedicated broadband network connecting healthcare providers in rural and urban areas with the state or region. And it also provides for funding of up to 85 percent of the applicant's cost of connecting the state or regional network to Internet2 and/or National LambdaRail, the dedicated national backbones, as well as the public Internet.

Now, the Commission has received an overwhelming response to our pilot program. Eighty-one regional and state health networks across the country have submitted applications. These broadband networks and this connectivity will be crucial to the delivery of advanced healthcare care information that you're discussing. And the FCC is preparing to dedicate a significant funding to spur the deployment of these broadband networks for these healthcare facilities.

So specifically, I propose dedicating more than $400 million over the next three years to the construction of broadband networks for statewide and regional healthcare networks in 42 states and three US territories, all connected to the national backbone providers.

This first map will show that the networks are going to connect -- that we've already -- we're going to be able to fund -- funding for the applications, we're going to connect over 6,000 healthcare providers across the country, including hospitals, clinics, public health agencies, universities and research facilities, behavior health sites, community health centers and others. And all of these networks will construct and innovate and build highly efficient regional broadband networks, either by building new, comprehensive networks, or upgrading significantly the existing ones.

And finally, all of these regional networks will be able to connect to the public Internet as well as one of the nation's dedicated Internet backbones, either Internet2 or National LambdaRail. So in the end, this is what the national healthcare network will end up looking like, that the Commission will end up being -- funding. So as you can see, there is significant connections throughout the whole country, and I think the types of projects that we're going to be funding involve not only large scale networks, connecting hundreds of facilities over multistate regions, to small scale networks, providing critical advanced broadband links for several regional hospitals or clinics. And particularly, we'll be connecting insulary areas and isolated regions, such as Indian reservations where transportation costs are high, healthcare specialists are concentrated in distant urban areas. Networks and states with a severe shortage of healthcare professionals will also be connected, enabling the healthcare and mental health providers to treat patients from hundreds of miles away.

Now, over these networks, applicants will provide telehealth to telemedicine services. They can support clinical care, consumer and professional health education, public health, health administration, research, and electronic medical health records. The pilot program is structured to encourage applicants to aggregate the needs of healthcare providers in both rural and urban areas and select the most efficient technology based upon their network needs. For example, the pilot program encourages multiple healthcare providers in a state or region to join together, allows flexibility and network designs that will be able to meet the specific needs of healthcare providers, encourages the creation of self-sustaining networks, and encourages broadband connections particularly for rural healthcare providers.

As we evaluated the pilot program, it became even clearer to me how well this program aligns with the goals of the Department of Health and Human Services and the Health Community is working to try to achieve. And I think that's why it's so important that the organizations participate in this pilot program, use their resources consistent with the health IT initiatives being promoted by HHS.

And this includes the implementation of interoperable health IT systems and the use of certified health IT products. Additionally, the participants are expected to coordinate with HHS and CDC during public health emergencies such as pandemics and bioterrorism events.

By providing public health officials with access to these telehealth networks, they will be able to share critical time sensitive information including risk management guidance with first responders and all the healthcare providers when they're responding to public health emergencies. And I appreciate working closely with Dr. Kolodner and making sure that we're meeting all of these additional goals.

Now, through the Commission's healthcare pilot program, I'm hoping we're going to establish the basic building blocks of a digitally connected healthcare system, regional and statewide broadband networks all connected to a national backbone. I think the broadband deployment at the core of the FCC's program blends perfectly with the work of AHIC and HHS to accelerate the development of adoption of health information technology and to advance the president's goal for widespread adoption of electronic medical records. I hope to continue to work with the healthcare community, to help deliver the broadband infrastructure that is going to be at the core of all these missions.

I appreciate the opportunity to visit with you all this morning, share of the work the Commission's working on, and answer any brief questions anybody might have.

SECRETARY LEAVITT: Thank you, Mr. Chairman. I'll invite my colleagues to ask questions. I would like to go back to slide 11, if I could, and ask, this is a potentially powerful energizing opportunity for the creation of our network. Obviously, there are network standards that are becoming well defined that -- with respect to the Internet. As you allude on slide 11, there is a need for us to make certain that the standards that we're developing for health information technology records are incorporated.

How do we actually go about assuring that those standards are built in? Would there be opportunities for these grants to be conditioned upon their acceptance of those standards? I mentioned the demonstration project that we are funding at CMS. One of the criteria is that they're using CCHIT certified records. Could you give me some reaction to that?

MR. MARTIN: We -- I don't think that we're able to explicitly condition it on having [unintelligible] the records, but we have conditioned it on trying to coordinate with HHS and CDC, and of also trying to -- and actually are required to having meetings to understand both the process and opportunities and of -- and of the best way that we could end up coordinating them.

Now, the grants, themselves, because they are through the Telecommunications Act, which has a different standard, we can't explicitly condition on the grant of coming into compliance with the work of another agency, but I think that we're going to be able to accomplish the same goals by the close coordination and requiring them to at least go through the processes of meeting with HHS.

SECRETARY LEAVITT: I see, so has that process begun yet?

MR. MARTIN: No. What we're actually -- what we're announcing today has actually helped broaden, and sweeping this program is going to be. We're going to begin announcing the individual winners of the grants starting sometime next week hopefully, and then as that process begins, we're going to be informing all of the recipients of what the process -- of what they're going to have to do to come into compliance and receive the money.

SECRETARY LEAVITT: So the window of coordination is just beginning.

MR. MARTIN: Oh, yeah, absolutely. The window is just starting -- the particular providers have -- they filed all their applications for the grant money, but they haven't even been told who is going to be receiving the money and who won't yet, so that process is just starting now.

SECRETARY LEAVITT: Good. Well, this is an enlivening event for this effort, and I think can drive the president's objective of the majority of Americans having electronic medical records in a profound way.

MR. MARTIN: Well, I think -- I not only hope that it will wind up driving that, but I certainly think it will be a building block for everyone to be able to take full advantage of these medical records.

SECRETARY LEAVITT: Comments or questions from my colleagues on AHIC? Ward? I see you scrambling for your microphone. I think you push the button and you'll --

DR. CASSCELLS: Ward Casscells, Defense Department. I just wanted to say thank you. I think this is a significant advance. And I remember two chairmen ago making a presentation to the FCC about this, and the context of emergency healthcare delivery regional networks of trauma and emergency care, asking for bandwidth and so forth. And we were turned down. So this is a -- having you embrace this is very, very welcome news for the emergency response community and I think eventually for the practitioners who, as Secretary Leavitt says, are rather elusive. It's hard to get their attention right now, but every little bit helps, and this is a big bit, so thank you.

MR. MARTIN: Thank you, I appreciate it. It's certainly -- it was a challenge for the Commission in the past to -- I think for trying to figure out a way to more fully utilize some of what we were doing on the healthcare side. We had a very effective program to connect schools and libraries throughout the country using broadband, but on the healthcare side, we've actually had a significant amount of money that's gone underutilized or not fully utilized. And I think the key to trying to unlock that was actually to try to think about this in terms of networks of networks, where we're trying to connect rural healthcare facilities back to the urban facilities, and paying for that -- for those regional networks as opposed to just individual grant applications. And I think that's been the key to try to significantly increase the awareness and the demand on the program.

SECRETARY LEAVITT: Thank you. Lillee?

MS. GELINAS: Do you have to keep it pushed down? I'll get it down. Good morning. I'm Lillee Gelinas. I'm chief nursing officer of EHA, and we have over 600 small and rural hospitals in our network. And I'm curious, just as a practical application, how we could be supportive of the implementation of the pilot. We can perhaps take it offline, but I have to tell you, this is really exciting for our rural providers.

MR. MARTIN: I appreciate it, and we should end up following up on how you can end up being most supportive and seeing which ones of those clinics that you're talking about may actually already be implemented in one of the different networks that we're trying to provide.

SECRETARY LEAVITT: Other comments or questions? Thank you very much for being willing to come to AHIC and make it, and you're welcome to stay with us. If you have to leave, we'll excuse you.

MR. MARTIN: I'll take advantage of that. I think I've got to end up taking off, but I appreciate it very much, and again thank you all.

SECRETARY LEAVITT: Thank you. And I'm going to, before you leave, just invite the vice-chairman of AHIC to make his remarks, Kerry Weems. I want to walk you out and talk a little bit how we can connect this together. So thank you. Kerry?

MR. WEEMS: Thank you. This morning we put on display in the Federal Register a proposed rule which will make strides in interoperability and safety. They are proposed standards for e-prescribing, and the proposed standards for formulary and benefits and medication history.

The availability of a standard for formulary and benefits will enable the prescriber to see upfront which drugs are covered under a beneficiary's drug plan, in this case, Medicare, as well as a list of alternative drugs that would allow the provider, in many cases, to distribute -- to substitute a generic drug, thus saving the patient money.

With medication history, providers will know upfront which drugs have been prescribed and which drugs could have harmful interactions. This type of information in real-time will streamline prescriber workflows, eliminating calls to the plans, as well as call backs from pharmacies.

We anticipate that the availability of these two standardized functions will be an additional catalyst for widespread adoption of e-prescribing standards. Although e-prescribing is voluntary under Medicare, if prescribers and pharmacies transmit subscriptions for Medicare covered drugs electronically, they're required to comply with any standards that are in effect. They're still four more standards that we are considering. We hope to be able to move on them rather quickly.

We are also looking forward to comments on these standards which fully met our testing criteria, so we expect to be able to move forward very quickly, moving even farther into a paperless healthcare system. So any comments that you have on those, please let's -- let's step through the normal regularity process. But we'd expect these rules would be in place very soon, and then the others that follow, we think these are really great strides for safety initially with formulary and medication history.

Also, the Secretary asked me to say just a few words about our demonstration project. Our focus over the next several months is going to be on recruiting the communities. We hope to recruit at a community level. That will be a dozen communities, and then the -- we hope to work with those communities, then, to recruit the hundred physician -- physician practices that would participate.

So we intend to be able to put out criteria probably in the very early winter, soon within -- I don't know. We hope a couple of months of what the criteria would be to become a wired for wellness community, and then we would hope to be able to step through that selection process fairly quickly, and then begin this demonstration. One of the things to remember about this demonstration project, we are going to pay bonuses to physicians who use an electronic health record, but those bonuses are going to be paid initially for reporting on quality standards, and then later, on pay for performance. What this demonstration serves to remind us is that an electronic health record isn't an end in itself. The end is patient safety and overall performance of the healthcare system. Thank you, sir.

SECRETARY LEAVITT: Thank you. When you link together what Chairman Martin has announced today, what Administrator Weems has announced today with respect to e-prescribing, and also the pilot, the conversation that will occur today later that -- with Mark Leavitt and his announcement of the certification of inpatient facilities, there is a steady march forward of important successes here. And I want to thank all of you for your continued effort.

I had a chance last night to meet with Scott Serota and some of his colleagues, and to talk about what private providers -- private payers, rather, and insurers are now driving with parallel play. I mean we're very clearly generating, I think, a pattern of moving forward, and this is a moment, at least, to stop and see all of that in the big picture. With that, I'd like to turn the time now to Rob Kolodner to lead us through our agenda, and Dr. Kolodner, you may have some comments in advance of those.

DR. KOLODNER: Thank you, Mr. Secretary. I want to welcome to the 17th meeting of the AHIC, which we have been able to have here in Chicago in conjunction with the American Medical Informatics Association. I'd like to start by having approval of the minutes from September 18th, and if there are no objections, we'll accept them unanimously.

DR. CASSCELLS: Dr. Kolodner, may I say, of all the meetings I attend, these are not only the most extensive minutes, but the most accurate. And elsewhere people correct my ungrammatical statements, but here they have been faithfully recorded for all time. [laughter]

DR. KOLODNER: If you'd like to correct -- no. Thank you very much. Next I'd like to welcome a new member of the AHIC, Department of Commerce Cita Furlani is joining us, and welcome very much to be part of the AHIC. She is the director of the Information Technology Laboratory at NIST [National Institutes of Standards & Technology], and has a master's degree in electronics and computer engineering, and in the past, has served as CIO at NIST, and director of the national coordination officer for IT research. So I appreciate your participation and look forward to interacting with you not only here, but also through our office as well. Welcome.

Also, I'd like to take this opportunity, and I think doing it at AMIA is actually very apropos to announce that Chuck -- Dr. Chuck Friedman has joined the Office of the National Coordinator as the new deputy national coordinator. Finally we're able to have one, and Chuck, thank you very much, and appreciate your joining the team. Chuck is a member of the College of the Medical Informatics -- Informaticists, and an active member at AMIA and throughout the community. So Chuck is a terrific addition to the team, and I think you'll see the benefit that he brings as we move forward and coordinate with others.

A couple of other brief comments before we get into the agenda. One is just to note that we did receive the report from the Institute of Medicine that we had asked for. It was one where we requested that they evaluate our standard setting activity, and we did receive helpful feedback from the IOM related to our standards work and other areas that are commenting about pace and other things, and noted that we do need to have some variation in some of that pace, depending on some of the complexity of the standards, and we'll be looking at that and seeing how to apply that.

They also, in their report, recognized that ONC and HHS have advanced the national health IT agenda over the last three years, and accelerated the development and advancement of standards. And they acknowledge that we've launched several standards related to organizations, and established a process that didn't exist before for harmonizing and identifying those standards, and have undertaken a full cycle of standards development into implementation process that Secretary Leavitt refers to as our turn to the crank and we're continuing through that.

And as part of that, Secretary Leavitt is scheduled to recognize the first set of interoperability standards in December of 2007, before the next meeting of the AHIC, which will, then, be incorporated into both the ambulatory and the inpatient certification criteria starting in mid 2008, and applying to that round of certification.

In addition, the IOM did recommend for ONC to develop a strategic plan to guide the national health IT agenda, and also, to develop a security and privacy framework, and both those recommendations are, in fact, now being acted on and are under way, and we look forward to bringing those back to you in the future.

And finally, we did have a report in September from the Population Health Workgroup on some recommendations. We're still working on those. And so we will be bringing that back to the AHIC in January, 2008. With that, if I can ask the first panel to come up to the table. We will be having a presentation about the nationwide health information network or NHIN trial implementations. And as you know, since the last AHIC meeting, we did award a number of contracts with communities that are participating in the initiative and we'll hear about that now from John Loonsk and from representatives from two of the communities.

So John?

DR. LOONSK: Thank you, Rob. Good morning, Mr. Secretary, members of the AHIC. There are a lot of things going on, and I'm pleased to indicate that the NHIN has taken very substantial steps since the last AHIC meeting. Rob mentioned the fact that we made announcements for the awards for the first NHIEs, nationwide health information network exchanges, which will be participating in the NHIN cooperative.

And we have with us, today, two of the leaders of those activities. With us from the Lovelace Clinic Foundation is Maggie Gunter, who will talk about the role and the activities of expectation moving forward. Also, another award is with the CareSpark Health Information Exchange in eastern Tennessee and southwest Virginia, and Liesa Jenkins is here and will speak to both participation in this year's NHIN activities as well as her participation in the last year's activities.

Also, on the screen in front of you are the other health information exchanges that have been awarded to participate in this process. The New York E-health Collaborative representing the State of New York, the West Virginia Health Information Network representing the State of West Virginia, the North Carolina Health Information and Communication Alliance representing the State of North Carolina, MedVirginia Health Information Exchange representing areas of central Virginia, and the Delaware Health Information Network representing the State of Delaware, and the Long Beach Health Network for Health, or Long Beach Network for Health, representing Long Beach and areas of Los Angeles.

Those nine health information exchanges we're pleased to say are being joined by the federal providers of care and other federal agencies in forming a 10th NHIE, and we are going to include in that context the recognition of the Indian health service regions that are participating, and will be participating over the course of the year in this activity.

The DOD military treatment facilities are represented on the graphic as well, and indeed, the Veterans Administration Medical Centers and Clinics will also be participating. So we have with this, with these announcements, identified a substantial core of health information exchanges that will be participating in this first round.

We're pleased to also indicate that others have already indicated their interest. Our target here is to increase the value of connecting up and participating, and we look forward to trying to work through opportunities for others to participate moving forward. I would like to point out that the opportunities there in the big tent of the NHIN include integrated delivery systems that act for health information exchange, as well as the developing area of health and data banks, and ways in which those are providing health information exchange services in support of a broader network.

Indeed, what we anticipate is the fact that as the Secretary referenced this morning, it is the participation of both the individuals and the providers in supporting health information exchange. We would add to that the population needs as represented by the needs, for example, of the quality initiatives also referenced, and that together, this triangle will support the core developing value for health information exchange and wanting even others to participate as well.

What we're doing now, with the NHIN, is we're identifying the specific core services, that minimal set of national standards that need to be advanced to have a network of networks. A network of networks is a complicated endeavor, and we have identified, through the course of the prototype architect work from last year, four basic standards, four basic services that need to be advanced to support networks working together.

Many of the health information exchanges have been thinking about activities in their own jurisdictions, and that's as it should be. These are -- they're working to advance sustainability in their jurisdictions, they're working to advance the value of participating and mobilizing health data. We are trying, in a minimal way, to identify the services for looking up patient data across health information exchanges, and supporting the retrieval and delivery of that data. The exchange of consumer access controls, so the consumer can have a say in who can access their personal health information, and whether they choose to or not choose to participate in the electronic network exchange. And the provision of care for -- a provision of electronic data for reporting and other uses. These four core services building blocks are a foundation upon which the NHIN will be developed.

The capabilities that those building blocks advance, dovetailed directly with the suggestions the Secretary made this morning for having nationwide standards and local control. Nationwide standards that allow access to provider organizations nationally. The ability to consistently access information and be able to exchange it. Local control in regard to the regional and state based information management that this vision expresses. This is a network of network, not a central infrastructure, and the opportunity to advance the kind of work that is going on here in the two HIE's that are referenced here, as well as the others whose are beginning to implement the other standards for advancing the nationwide agenda will be made evident.

And then to advance, in this context, a reusable infrastructure that upon which the end, as Kerry Weems referenced, can be implemented. The technology foundation is not the end, but using that foundation consistently, and over and over again, to meet the variety of ends is the goal of the nationwide health information network and the process that we've started on. By the end of this first year's performance, we will have essentially removed the technical obstacles for health information exchange between these HIEs. We will have HIEs that are demonstrating the exchange of live data, and have shown that they can implement these foundations, these building blocks, and indeed, can take the next step of actually going to production systems as those technical infrastructure pieces apply.

To do that, we have identified some critical leadership roles for the health information exchanges in this moving forward. The activities here in the spirit of the local control are being led by the health information exchanges, so the core content Working Group is being led by the representatives from the Lovelace Clinic as well as the New York Healthcare Information Collaborative.

The Core Technical and Security Working Group has co-chairs from West Virginia and from the federal health NHIE, the Data Use Working Group, which is identifying these complicated needs of not -- of identifying a solution to the complicated needs of not doing point to point data exchange, but indeed, one of many activities as this network of networks requires, is being led by representatives from the North Carolina Health Information and Communications alliance in MedVirginia. Testing is being advanced in conjunction with representatives from Cita Furlani's organization in NIST, as well as the Indiana University, the -- and the Indianapolis Health Information Exchange.

And we also want to point to a significant role of the partner contract that the Centers for Disease Control represented here today by Les Lenert, is advancing to indeed help advance that vision of a reusable foundation, a reusable infrastructure that can be used to many ends to advance public health needs as well as provider information exchange in individual health information access.

So we're pleased with the steps that have been taken in moving forward, and with that, I'd like to introduce Liesa Jenkins, who is the CEO of the CareSpark Healthcare Exchange, and is, in that role, someone who has participated in the first round of the NHIN work, the prototype architects, and is now also participating as one of the leads for this second round of work relative to these trial implementations. Liesa.

MS. JENKINS: Thank you, John. I want to start first of all by thanking all of you who serve on AHIC. I come into this not as a healthcare professional, not as a technology person, not as a government agency person, but as a citizen who became concerned about my community and the health there, and got involved and stepped up, as I think all citizens ought to do, to address the needs of the Community to participate, to speak up to their leadership, and to work where possible, to help resolve the problems. And I know that each of you serving on AHIC also has chosen to serve from that perspective, so I appreciate that very much from you.

We began CareSpark about four years ago. We literally were one of the early participants in the e-health initiative, and were pleased to be a part of the connecting communities in the first round when the national health information infrastructure was launched. We were also very pleased that those goals that we had already defined for our community and our region, which is multistate, aligned very closely with the goals that were defined at that time, engaging the clinicians, engaging the patients, working on public health, and aligning financial incentives. So it has been important for us to kind of stay in sync with the things going on at the federal level, and again, because we straddle state lines of not only Tennessee and Virginia, which is where the bulk of our providers are, so that's where we're focusing our efforts now. But we actually have patients that come from North Carolina, West Virginia, and Kentucky as well. So that is why it has been very important for us to stay in alignment with things going on at all levels, local, state, and federal.

And it was for that purpose that we participated in the first round of the NHIN prototypes. We were a partner in the eccentric consortium and demonstration project. I think we were lucky to be able to work with the folks from Kentucky and West Virginia, who were the other communities in that -- in that first round of NHIN. And we learned some things from doing that. Good and bad, I guess I would say. It was not an easy experience for many of us that were small organizations, and pretty entrepreneurial, and small amount of resources, to learn how to work with a large corporation and federal contracts. That was a learning step for us and for them as well, I think. But we survived. We were successful in our demonstration. I consider that a success. And as a result of that, we really gain some benefits from our participation in that.

First of all, we would never have had, in our region, the ability to kind of stay on top of the standards that were being defined, much less have a voice in them and contribute in any way to what those would be. And so the work that CCHIT was doing, that HITSP was doing and others, was something that our involvement in NHIN allowed us to kind of stay abreast of that, and be informed about that in a way that we would not have otherwise.

Secondly, I've already mentioned the fact that it allowed us to connect with and work alongside other communities who are trying to do similar things, not exactly the same. But we certainly shared a lot of common goals. And that built the networks that I personally, and others in our community, both from the provider side and from the business and technical side of things, as well as our policy makers, to engage with folks in Kentucky, in West Virginia, in North Carolina. And that has been a very important benefit for us that's really helped build the networks, not just a technical network, but build the infrastructure and connections between people that I personally believe are the real key to success in this.

Thirdly, it has, in our community, really brought a huge level of awareness and education to the folks in our region about health information technology. We have seen an increase in adoption of EMR's among our physicians in our rural area. We have seen an awareness about this among just the general citizens in the community who are engaging with us, who are very close to us, as we look at the issues around privacy and security. And where is the norm for our community around that? What are the expectations in our community?

It has educated our elected officials, quite frankly. We worked very closely with Virginia and Tennessee, and with our governor of Tennessee serving as the co-chair of the National Governor's Association State Alliance for E-health. That's something that he's been very interested in. So our involvement in NHIN1 and now NHIN2 has really helped us kind of be a conduit for those state officials to stay involved with, to stay abreast of, and to kind of align what they're doing, what CareSpark is doing, and what's happening at the national level.

So we are very excited about the opportunity to participate in NHIN2. We have high expectations for what's going to come out of it. And I can say with all honesty that the other things that are happening, the FCC announcement -- particularly exciting to us is the inclusion of the federal agencies in this second round of NHIN2.

Dr. Kolodner knows, because we have spoken about this before, for about three years now. Since our inception, we have been very, very interested in what do we do to connect with the VA medical center in our region, which is an important partner to us.

So we expect to see -- we expect to learn a lot of things this year. I know it's going to be hard work, and a major effort on our part to keep up with everything. But we are very committed to this. We did not get into this project in the first place because of a grant. Our community started this because we know we've got major issues. Probably more urgent than many other communities do. We have significant disparities in the Appalachian area. We have huge challenges to face. In broadband access, in health outcomes, in patient involvement. And we recognized, about the year 2000, that our community is going to have to step up to the plate and do something. We would have done it with or without NHIN, but it's a lot easier to do it with you guys. So thank you very much for your leadership. We really look forward to what's going to come out in this coming year.

DR. LOONSK: Thank you, Liesa. I think we'll have time for some questions and answers at the end, but I'd like to introduce Maggie Gunter, who is the CEO of the Lovelace Clinic Foundation representing New Mexico, and we're pleased to have a new health information exchange represented here in this process. Maggie.

MS. GUNTER: Thank you, John. I notice that we have two rural states and we're about the only ones in the middle of the country, aren't we? And we're both poor. Does that mean anything?

It really is an honor to have the opportunity to present to you, Secretary Leavitt, and Dr. Kolodner, and the members of the American Health Information Community. You're doing really important work, and you're supporting us, and we hope we're supporting you as well. And I did want to talk about some of my thoughts about both, as Liesa did, some of the things that we have done in our state to get going, and how important I think the NHIN trial implementation contract is, not only to our states, but to setting a test situation where we can really demonstrate the feasibility of interoperability of health information exchange. And that's going to be critical, I think, to the success.

I am a medical sociologist, and I have to tell you that every single sociological skill I've ever developed has been tested in working on health information exchange. I also lead a nonprofit applied health research institute called the Lovelace Clinic Foundation in Albuquerque, and as part of the work I've done there, we really created that organization about 15 years ago to really work in an integrated system, that some of you know, called Lovelace Health System, to devise and work with physicians, to see what kinds of real world on the ground inventions we could develop that would improve healthcare quality, cost effectiveness, and efficiency.

And as part of that work, we were sort of pioneers in the area of disease management, the kind of disease management that was sort of, before we knew that term, integrated into every day practice in a group practice. And we were in that pioneering work which reminds me very much of what we're doing now, because it was tremendously messy. Because nobody had a road map for how to do it.

And one of the things I realized, one would give feedback and so on to the clinicians, is wow, if we just had, and I'm not an IT person either, but if we just had health information technology tools to integrate what we're doing into every day practice of physicians so that it was seamless with their workflow, and would be sustainable, what a difference that would make.

And as part of that effort, because I spent the last 15 years working both with integrated systems and in the community, to develop, implement, and evaluate system level and community interventions to improve healthcare practice and quality, and for that reason, I think is why we were so engaged in this new notion, in about 2002 and '03, 2003, of sharing information across organizations. Because we knew that even as we developed electronic health record systems, and that's critical, we also had a lot of electronic data we already had, and that we used every day as researchers, as applied researchers. And that was -- we had lab results. We had pharmacy from claims data. We had a number of -- we had ICD 9 codes. And as imperfect as that secondary data was, it really was very valuable to looking at the patterns of care, to evaluating pre and post interventions.

And so we decided that, well, don't we really want to do something in the community to share this information? Because it's so frustrating, not to have this information across systems so that all physicians have, at their fingertips, the kind of data that they need from wherever their patient got care. So we, like Liesa, but I think a different source, applied for the AHRQ health information technology implementation funding, and we're really pleased to get into late 2004, an award. And what I thought was excellent about that, by the way, is that there were -- matching funds were required for us to participate from the community, and that engaged us already with the community to get their support. And I recall that Intel was one of the organizations, so it was not just healthcare organizations. But we thought employers were a critical -- had a critical role to play as well.

I should mention that in addition to that role, I am serving as the co-lead for the NHIN project, and many of you know, the lead is Jeff Blair, who is a well-known health information technology expert who chairs the -- co-chairs the standards subcommittee of the national committee on vital and health statistics. And so he brings his greetings as well.

So what's happened with us? We've had many adventures. After three years of effort, I think we have made significant progress in establishing, first of all, the critical necessary community governance and trust, because after all, these are folks that are competing with each other in some cases and have diverse points of view and motivations.

We have established the basic technology infrastructure, and we have done some pilot information exchange programs, also needed to provide a solid foundation for a statewide health information exchange. We worked with the Department of Health closely, and with the governor, who is quite busy these days, Governor Richardson running for president, but has listened to us, and, in fact, is trying to pass legislation upcoming to both reform healthcare in our state, increase coverage of the uninsured, but also sees very much that healthcare -- electronic health records and health information exchange are two key things that must be -- they're putting a plan together to require participation in those activities, because it is seen as one way to increase the efficiency and be able to cover more uninsured. We're one of the poorest states and one of the highest level of uninsured and Medicaid. So that's critical.

And also he's incorporating in that working with us privacy legislation, so we do it appropriately. So there have been some real successes. But I will tell you that like many other such efforts, we had frankly hoped that we would have made even more progress by now. You should see the list of impressive aims we put in our original proposal to AHRQ. I see Michael Fitzmaurice over there.

We had great hopes, because it seemed like a lot of community collaboration, a lot of people had said that they would provide matching funds, and people have not been, I think what I think of as other than supportive. It's just innovation is enormously messy. And it's -- I think we had planned that we would have a community wide disease management system by that time. We would have a fully operational exchange. Even though we didn't have full electronic health records, by any means, that we knew we had some electronic data. We expected to be providing comprehensive information across settings to the physician at the point of care.

And we also had planned, thought this was critical, because disease management includes patients and self-management, and we hoped to have a patient portal by this time, especially for patients with asthma and with chronic diseases like diabetes, so that they could better self-manage their own illness. And I will tell you that our division included the active engagement of our employers, as well as health systems and plans, because they, along with government, really do bear a great deal of the burden, of the cost of care across the country. And they're in a very strong position to bring providers and plans to the table to share their data, and the cost of establishing exchange. And a lot of you know about the dossier system that is -- that Intel and Wal-Mart and others, large employers are pursuing.

So despite this, we have not at all given up, you know, on accomplishing those aims, and on the importance of a health information exchange. But we do agree with what I've understood, as Secretary Leavitt's characterization, that building a health information exchange is more about the sociology than the technology. And as I said before, innovation is inevitably messy, and is especially so when it requires reaching consensus among many different community organizations with diverse and sometimes competing interests.

As many of you know throughout the country, RHIOs are taking a little longer than we hoped, not just in New York State, to develop into fully operational systems with solid business cases than we had anticipated and hoped. So despite all of this, I think there is enormous promise in the concept of interoperable nationwide health information exchange, and I'm personally grateful for the vision of Secretary Leavitt, Dr. Kolodner, and the Office of the National Coordinator to realize that it makes great sense to provide further federal funding through the NHIN trial implementation contracts to our nine states and communities. We all worry -- we all know that grants alone and contracts alone, from the federal government, are not the answer. But my sense is that they are a critical part of the answer of getting us to the place, since it takes longer than we hoped, where we do have a solid basis for having -- for the business case and the business model.

I will say that -- and we're so incredibly grateful to AHRQ, but these are millions of dollars to really have the technology partners that can help build a full infrastructure in each community and to test it. And I think it's a very expensive proposition to get to that place where we can show this solid business case.

So another round of federal funding is critical, and I think NHIN really represents that promise. I think it would have been an enormous pity and waste to have abandoned the solid foundation, built in so many of our communities around the country, just because we had not yet made sufficient progress to support a solid and operational business case.

One of the things about the NHIN project that I think is both scary and wonderful is it has a very aggressive timeline of one year for demonstrating and testing interoperable exchange across our nine sites. I think, as scary as it is, that an aggressive timeline is exactly what we need, because we must show the nation that health information exchange both within and across states and communities is feasible. I think we'll also expedite and facilitate the compliance with standards in each of our sites. These are hard things to do, and sometimes this is exactly the kind of catalyst that we need to do that.

I'm struck by how many -- when I talk to legislators and citizens about this, they kind of nod and say that's really important. I know how frustrated I am. I can never get all my records wherever I go, and mostly, they're surprised and dismayed that this doesn't already occur, that they said, well, I just supposed that we already had this kind of linkage across places. We have it with Jiffy Lube. Why don't we have it with our healthcare data? And we cannot afford to lose the momentum and the enthusiasm that has been built in so many communities. That's my biggest fear.

So the aggressive timeline is only achievable, though, by a very collaborative Workgroup structure that I am so grateful to ONC and John Loonsk and Dr. Kolodner for putting together, because then you're not -- any one of us doesn't have to have all the answers. Most of us have a great deal of expertise that together we can share and move forward so much more quickly. So that has been an enormous comfort to me, to have this Workgroup structure that John laid out for you. As I say, it's both an intelligent kind of infrastructure, but it's also enormously comforting to individual sites where we all have limitations and constraints in personnel and expertise.

Another significant strength, though, is we're not just talking interoperability, that this contract is going to fund and require work on the business case in each of our sites. And we all know, again, that federal grants are greatest catalysts, but we know that they can seed innovation, especially so helpful in poor states, especially such as New Mexico, but they must be replaced soon by a sustainable business model. And that may be more than one kind, depending on -- and depending on the needs of a particular community.

It's critical that we find and implement a variety of business cases tailored to our specific states. And as we work to sustain our -- to create sustainable business models, I think it's essential for us to engage our large national employers and our local employers, even more than we have in the past.

Employers in the US have a great deal at stake as healthcare costs continue to escalate, making them virtually not competitive in some cases in the global market because we have such enormous money going into healthcare. But it's also that they're in a strong position to bring providers, and health systems, and health plans to the table to share their money, to share their data, and to just work with us in an expedited way. But it's also that employers have central expertise in the whole area of business models, and I think we need that business expertise.

The other thing I'm excited about is that ONC is also funding, as I understand, or will plan to fund an initiative on privacy and security that was funded also by AHRQ. So we can make sure that as we do interoperable health information exchanges across states, that we've got -- that we understand some of the privacy and security issues about consent, and how critical those are across our states and organizations.

So I think that's a very nice -- some of us have both those grants and also the NHIN trial implementation grants, and I think it's really going to be very exciting to see how we can work together. The other is some of you -- I know that Julie Gerberding of the CDC is on this committee. I don't believe she's here today. And I think that the CDC is also funding an initiative on situation awareness, or what some of us think as biosurveillance through health information exchanges, and some of us are finalists through those. We don't know exactly the outcomes there, but again, if we can integrate and plan to, the CDC and the NHIN initiatives, that will really be very exciting and I think appropriate.

So on behalf of my own state team in New Mexico led by Jeff Blair, I really want to express my gratitude to all of you and to the Office of the National Coordinator for creating this initiative. I think it has a unique opportunity to transform, to dramatically move forward our effort to establish an interoperative nationwide health information network that can really transform healthcare quality and efficiency in the United States. The funding, the collaborative structure, and the rigorous timeline will all work together to meet our goals of testing interoperability in the short term, and establishing a true nationwide health information network in the longer term. Thank you.

DR. LOONSK: Thank you, Maggie. In discussing the NHIN, it tends to bring into focus a number of the different activities around privacy, around technology, around the social activities, the value of it. I think it's interesting today that we've teased out progress in several of these different layers, and one of the things that this Community and the American Medical Informatics Association is comfortable with, is the concept of a stack.

Several things that have to occur for movement to be achieved. We've heard about the pipes. We've heard about the broadband. We've heard about the quality activities, the IT. What's the outcome? And now we've heard a little bit about the -- in the middle of that stack, the health information exchange that is critical to helping move those things forward. So progress in all three aspects, I think, represented today.

SECRETARY LEAVITT: John, I want to ask, the last several months we've seen a whole series of private companies begin to develop platforms. Microsoft recently talked about the other health vault. Google is doing a lot of work on it, others have as well. And I noted on this chart the reference to consumers and obviously, they're going to want ultimately, the ability to populate those personal health records with information from providers, all those providers. Could you update us on progress with respect to the -- our ability to take health exchanges like this and send data to a Microsoft health vault or my own personal account?

DR. LOONSK: The idea of having a PHR, or health databank, or the individual representative, whether they're manipulating the information themselves, or having a surrogate, such as some of the project you mentioned, the health vault manipulating for them, has been a part of the NHIN vision from the start. And it was one of the activities demonstrated last year, was to think about how to connect that up.

We think that in this next round, there is a great opportunity for that to be even further manifest. If each of these individual personally controlled health record activities seeks to stake out its own direction, without the shared standards that the NHIN offers, it will be truly a one to one. And one of the things that's impressed us in the work we've done so far is the importance of that core, that core of health information exchanges that can, through their shared standards, make it a one to many.

Put simply, if a health databank connects up to either -- as a health information exchange, or connects up through a health information exchange, it would have access to -- with appropriate controls, the -- all the hospitals and ambulatory care data that resides below that, and in association with that. So thinking about this, the NHIN and the shared standards as both entree to that information, and as an access methodology to serve population goals that I think are critical in this regard.

SECRETARY LEAVITT: Do they see it that way? I mean not just the two of you, but I'm just curious about interaction with vendors that are doing this. Do they see the value of that stack we're developing in the development of their business model?

DR. LOONSK: I think one of the -- I think one of the challenges here is we have to get to this core of connected organizations so that that value is self-evident. You heard today just about the value of bringing the federal agencies into the NHIN, in terms of the data that will be accessible through that process in a consistent way, in many jurisdictions. Well, similarly, I think as we continue to build this core, it is inevitable that the value of connecting up to that, instead of going on your own, will be self-evident.

MS. JENKINS: If I may speak to that, Secretary Leavitt, in our region in particular, we sort of began with the acknowledgement that the clinical information was the most fragmented out there, and we kind of have to start there. The personal health record really needs that clinical information to be in it, so the HIE -- you know, our starting point was to do that first. And it was primarily because the patients in our region already are pretty passive health consumers.

If the health records bank is the model, our region is quite likely to fall even farther behind than we are now, because we have a lot of folks who really don't have the education, the income level, the computer access, and all the other things it would take to manage that. So we're literally building on the relationship between the clinician and the patient to figure out how to integrate that information from the patient and the clinical setting.

But it's very obvious to us, and it has been from the beginning, that also has to work with the claims, the billing and claims information, and the public outside. It's inevitable that those four streams have to come together, and not just at a regional level. At a state level, at a national level, but even internationally.

When you get -- when you get to the recognition that information has to cross outside of an organization, then it's pretty obvious that one of these days, healthcare pandemic kind of biosurveillance stuff is going to have to be global. And so the missing link in a lot of those is, I think, the HIE.

Do the vendors, who are rolling out those personal health record solutions, welcome that approach? All I can say is that I've had conversations with folks, maybe not at the highest level, but certainly folks who are involved in sort of promoting one or more of those, and I think they do have an interest and understand what the role of the HIEs are. Some are probably a little bit impatient with the amount of time it's going to take for -- to move a whole community in that direction, but I ultimately think that that's probably the only way that their investment in the personal health records are going to be very successful.

DR. KOLODNER: Other questions for members of the AHIC? Kevin and then Nancy.

MR. HUTCHINSON: John, this is a question to you. How does this fit into the CCHIT work that's going on, on certifying or creating requirements with respect to certification of standards? To do certification of networks on this building block scenario. I assume there is a level of coordination between requirements on these demonstration projects and the requirements gathering that's going on right now within CCHIT for network certification.

DR. LOONSK: I think, Kevin, that's right on, and we have been working with CCHIT to participate in the NHIN cooperative, the Health Information Technology Standards Panel is also participating. I think, as you know, the first year of CCHIT's work was ambulatory, second inpatient, the third year is on networks. And the working on a common -- common considerations for networks and how they would be certified has been an important part of thinking about carrying this forward.

To have a network of networks, like the NHIN, we're going to need particularly those connections between the health information exchanges, whether they be an integrated delivery season or a classic RHIO or a health databank. Those have to be particularly tight. They have to be clearly testable and they have to be something that there is a great amount of confidence that they will be reliable -- work reliably for many different participants, not just one to one. And that's part of what we hope and think the certification process networks can help move toward as well.

There are clearly going to be additional needs in a network of networks to think about governance practices about policies and implementations, and so we sometimes talk about developing accreditation, in addition to certification, in terms of moving those both forward to make sure that that network of networks is the kind of secure information capabilities that can move it all forward.

Mark Leavitt is going to be up after us, and he might want to touch on the networking certification as well. But I think we're on a good course to have that dovetail into the NHIN and to the general level -- general health information exchange needs and networks as well.

DR. KOLODNER: Nancy?

MS. DAVENPORT-ENNIS: I would like to thank all of the presenters on the panel for an outstanding presentation, and I must say to Secretary Leavitt and to the entire AHIC, it's a genuine pleasure to have a representative from Virginia present to us today, who did present at a similar meeting before the governor recently. So congratulations, Liesa.

I do have a question. As we look at the process of building these networks, and of the work that Liesa, you're doing, and Margaret, you're doing, I hear a lot about building a business case. And when we had the very first meeting of AHIC, and for several, subsequent meetings, Secretary Leavitt was very direct in saying that ultimately, the adoption of health information technology will be driven by consumers.

And so I have a couple of questions for John and your colleagues. And that is, what are you doing, within your programs, to engage consumers as you're building the networks, and in trying to measure with consumers and patients, what are they looking for specifically at the end of the day so that they do want to become engaged, and they do feel comfortable with the process? Thank you.

MS. JENKINS: That was a softball tossed to me, wasn't it, Nancy? Our region has done quite a bit of work, again. We have been very publicly now, for almost five years, talking to this about our community in the media, in presentations to everything from civic clubs to seniors groups to Sunday school classes, I mean you name it. We have actually done questionnaires. We've done fairs and focus groups, and solicited input from people in our community, just regular citizens, about, you know, what benefits would this bring to you, what risks do you perceive, what kind of information would you be willing to share, with whom, for what purpose. You know, who's responsible for the security, and all that kind of stuff. So we have been very, very public in about what we're doing. And literally invite people through our website, and every time we do, to get feedback to us.

We do have patient representatives on each of our committees that are involved with us as we are moving forward, and we're putting a mechanism in place which we locally call the health information control board, for lack of a better word. That's the word at the moment. Helping to formulate the policies around how the information will be shared and will be used, and how the privacy confidentiality will be protected.

That will be -- that's kind of our local mechanism for looking at what kind of information is exchanged, how, and with whom. But it's very much founded on what we feel -- what we've heard from our community and from people in our community, that they are comfortable with.

MS. GUNTER: I think in New Mexico, we had started, and I'll be honest. We're with the -- we were thinking of where the information was coming, and how it would be HIPAA compliant. And we were thinking initially of it being information we needed to get from providers. And we have changed substantially over the last three years, and have been much more oriented to issues of talking with privacy advocates and consumers to really understand both to tell them what the benefits are, because they -- we often find that unless you do talk about the benefits as well as the harms, the potential harms, that obviously people are not going to be interested in sharing their data.

We have taken a much more active consumer role in the last year, as we have understood that the concerns nationally about privacy are very substantial, that you cannot -- it is not only what you can do from a HIPAA standpoint, but what is wise to do from a consumer standpoint. So we have changed a great deal. We're working with lots of different stakeholder groups, consumers, about privacy; but trying to find a way to balance the needs of privacy and all of us, we're all patients. Every one of us. And every one of us in our family has somebody that probably has a mental illness or AIDS or something of that sort, where there is a great concern that they have about having their data shared.

My biggest concern, and I think we're going to hear about it a little later, is that frankly we share our data in ways we don't even know today, so we need to do something about that. And in this privacy legislation we're working on, with a number of other states, we're really pretty strong on the notion that patients need to control their data. The ownership isn't the only issue. The issue is that patients need to control their data. So we need to make -- I think we need to make more progress in this area, but we've changed greatly in the involvement of consumers.

MS. JENKINS: I want to finish up, because I didn't really answer your question about the business case. In our community, we really were founded to address the chronic disease problems that we have in our region, which are very, very significant, as well as premature mortality, and very high rates of prescription drug use, abuse, and death, from prescription drug not errors, but accidental overdose.

We know the health issues that are of high -- not just prevalence, but high cost, high impact on the quality of life for people in our community. And we have really designed our system to be able to exchange information and measure, you know, from the baseline, from our starting point as to how we're doing around those things. We've done a lot of work to investigate the business case from the perspective of the physicians, the hospitals, the patients, and the purchasers, and so we're tracking that as part of the metrics that we're looking at.

We have two really strategic outcomes that we're monitoring; health improvement, number one, in each of the areas. We have about five areas that we said these are high priorities for our region, but also what is the financial impact of health information exchange as we're doing it in that area. And I would welcome help from anyone with AMIA, who has some expertise that they would be willing to dedicate to help us in that regard.

MS. GUNTER: Just one thing on the business case. I certainly think without -- without making sure that we're meeting the needs of consumers, there probably is no business case. However, I will say also that I don't know that it's going to be consumers directly, that -- directly that are paying for this. We have to find ways where health plans through reduced duplication of lab results or all different kinds of things, where we demonstrate the business case to, I think, the providers and the plans and so on, because I think they're going to be some of the folks who are going to need to fund this on an ongoing basis. So they're critical as well.

DR. KOLODNER: Okay. Next is Steve Lampkin.

MR. LAMPKIN: Yes. Thank you all for the report. It was most encouraging. I wanted to add just a thought or two. As I think Liesa, you were talking about, how do you -- how do you motivate perhaps a passive audience, so to speak, in -- as we think about the private public cooperatives and the things that we're doing together? One of the things that hit me was the exact role that employers can play in this, and that's what we're doing with the dossier work. We see our role as an employer, as both to educate, to encourage, but also to enable our associates to get involved in this. So hopefully, that will be one of the things that we can do with the 5 million plus employees of all the companies who are participating in the dossier initiative. I think that is one of the things that we can do together to make a difference.

MS. JENKINS: I am familiar with the dossier program. I wish we had more of your employees in our region who would benefit directly from that. But we are working with major employers in our region and their health plans. And one of them is offering a personal health record, in fact, that's a part of our NHIN participation, to figure out how to -- how to pull the information from that, and match it with the clinical, and make that useful.

Our challenge is that that's a relatively small percentage of our population, and we really need to grow that. And in our region, this may be Appalachian, but we respond very poorly to you have to do this, and very well to let's do this. It's our problem, it's our solution, we can do this together.

MS. GUNTER: And I will say in that New Mexico, we have a pretty major presence by both Intel and Wal-Mart, and we have been talking with Brian Devore and others at Intel for at least the last year, including about a collaboration on NHIN. So we're pretty excited to figure out how we can all do these things together, because I think it's great that you're doing what you're doing.

DR. KOLODNER: Okay. Last question for the panel will be from Kevin Hutchinson.

MR. HUTCHINSON: This is actually for all three, maybe starting with John. Given a chance to have a reaction and a response to -- there was a lot of comments made by other networks and RHIOs and HIEs about the value of NHIN2 in moving their own strategies forward, and whether or not they could be supportive of participating in the trial implementations in the next phase, given the pressures they're under from a business perspective, as well as the demonstrations and the implementation of the standards that they feel they need to move forward with.

I think the question that I would ask is, what made these two organizations or other organizations feel differently to participate in these implementations, which we all feel are very important? And John, just your reaction to the statements and comments that have been made publicly.

DR. LOONSK: I will let our two other panelists address the majority of these needs. When you're thinking about a network of networks, there clearly are some needs for working together, and I can certainly sympathize with health information exchanges that are just trying to survive. They're trying to carry out their activities, and trying to work very hard to help advance this vision. So many of those needs are focused downward in this graphic, in terms of how do you connect, how do you handle those complicated challenges, particularly when it's not done in a consistent way?

So certainly, understand the needs to be minimalistic in terms of additional burden, additional tasks, and additional activities around that. But on the other hand, we do need to get to interoperability between networks, and so we think that in the context of this next round of activities, by trying to identify some minimal services and trying to have the leadership from the health information exchanges, help bring that forward, that we've hit a reasonable balance in terms of both the needs for health information exchanges to advance, but also the needs to develop this network of networks to accomplish this activity. And I think not all those that have participated have had a chance to speak up, because they have been part of the procurement process, for example, but now you'll hear from two of them that are very interested in that.

MS. JENKINS: So I've already expressed to you our attitude, I guess, about being a part of the solution, and feeling that citizens need to speak up and participate in governance, and that was very much a part of our decision. I think we also have a philosophy of collaboration, and we know that it takes work at various levels, but even more importantly for us are really kind of two things. Number one was probably timing. Had we been an organization that had a technical infrastructure in place for several years, and it was designed like this, and, you know, we wanted to keep that, that would -- that was different. But we were sort of at the sweet spot of having done a lot of the planning and tracking along pretty closely, so the timing for us was a good match with what NHIN2 was proposing.

The other thing was, and we made this very clear to John, our board -- my board and volunteers and partner organizations were very adamant about this, too. Only if it meets the needs and priorities for our community. The outcomes that we know we need to get in health improvement and cost savings, those use cases have to line up with our needs. If they don't, it's just a distraction for us to work on something that's not that important to us. Those were really the criteria.

And then, finally, it was a recognition that this will keep us moving forward and bring in resources that we can leverage at state and local levels, and from private partners that can multiple many times what we would be able to do without that.

MS. GUNTER: I will say that in New Mexico, when we first saw the RFP, we were daunted. We were concerned. We wanted to be sure that we could both pursue this, and that it would really add to what we were doing in our state, as well as make a contribution across the country.

And we felt, though, that we had been looking at major vendors. We were at about the point where we knew we had gotten about $600,000 from the state. We knew that that wasn't enough to engage a major technology partner. And we felt very much that this was worth doing, that it would bring us -- it would bring our partners to complying with standards. We worried because it was such an aggressive timeline. And the Workgroup structure has comforted us somewhere that way.

And we have kept our major committees, steering committees and so on, in -- we communicated with them to let them know what's going on, and to let them know that we haven't forgotten, what we're planning to do, that we think this will allow us to build the infrastructure necessary to do what we always intended to do in our state.

And without it, we would have needed to get probably a million dollars from each of our major plans quickly. And that's not something you can do so quickly. So for us, despite, you know, concerns that you had about the aggressive time line, we really felt -- and the fact that we didn't want to derail the plans, that we felt that it made sense to go ahead, and we're grateful for the opportunity.

DR. LOONSK: One final comment on that. Some of the discussion was around the use case, the AHIC use cases, in terms of how they were applied. And I think there was some confusion about whether there was an -- there were seven of them, and there was an expectation that all of them be applied. And there was confusion in that regard, and maybe we didn't get the message out clearly.

What we've asked is that each of the health information exchanges that participate consider two of them. And interestingly, we asked them to advance their priorities for what to work on, and interestingly, in that process, we have covered almost every single one and the top priorities that they've advanced. So the priorities are different in different places, and it's important to maintain that flexibility, absolutely. And so I think going forward, there will be other opportunities to do that, but still have them all working cooperatively as well.

DR. KOLODNER: Maggie, Liesa, and John, thank you very much for this informative panel. We look forward to tracking, as you move on that aggressive timeframe, and keep us informed as too to how you're doing, and look forward to a successful demonstration next September.

MS. GUNTER: Thank you.

MS. JENKINS: …Still alive by then.

DR. KOLODNER: We'll move to the next item on the agenda, and have Mark Leavitt join us to give us an update on the CCHIT. And you heard a little bit from the Secretary in his opening remarks, and we'll have Mark give us a little bit more details. Welcome, Mark.

MR. LEAVITT: Thank you, Dr. Kolodner, and thank you, Mr. Secretary, for this opportunity, and distinguished members of the Committee. We have the joy of having the shortest slot and being right at lunchtime, so I will be very concise.

I was here three months ago, so I'm not going to take you through an introduction to CCHIT. We're just going to update you on what's happened since then. So I will make an announcement about the first certification of inpatient EHRs for hospitals. I'll share some data and make some remarks on the market acceptance of certification. I'll update you on our development work on the 2008 criteria, which would go into effect in July of 2008. And then a few comments on our progress in accelerating HIT adoption. And you'll hear a lot about HIT adoption in the next talk, so I'm not going to steal any of their slides.

Okay. Just a week ago, we announced the first inpatient EHR products. As you know, we worked with ambulatory products for doctor's offices for the first year and got started on hospitals this year. And in the first batch, which we do on a quarterly basis, we certified six products, and they're up there on the screen. And I'm not going to read the names, because I try to avoid ever mentioning a vendor name, myself. But these vendors really are to be commended for stepping up and being leaders.

This is a tough test that we ask them to pass. And the test actually drilled deep in provider order entry, and in medication administration. So the actions in the hospital that are -- you could debate this, but I'm going to suggest probably the highest risk area, and the area where we probably have the most potential for improvement of patient safety is the medication chain, getting in the order, getting the medication, getting it to the floor, getting it administered at the right -- you know, the six rights or the five rights. So it drilled deep there. It was a tough test. This was a case where we had six applicants and all six passed, so I can assure you that they prepared long and hard.

I'd like to make one comment. Four of them are full certifications. That means it was an existing product. It's in the market. It's in use. Two of them are what we call premarket certifications. That means it's new. There is nothing wrong with that, in fact we like the transparency. The people buying the product know that it's new.

But vendors said if we create something new, and we can't get certified until it's in the market, how will we ever get it in the market? We'll have a chicken or an egg kind of deadlock. So we let them certify, and then we wait until they've had at least one customer live for 45 days verify it. Then they become fully certified. So we had two in that category; one a well-established vendor with a new product, and the other was a brand new vendor.

And I want to just share a comment. We've spoken to the vendors, and we learned that actually, this entire initiative and certification was a primary driver in the decision to invest in this development and come into the marketplace, which was -- kind of made my head spin around for a moment. So we're actually encouraging capital investment in health information technology, which I think is one of our goals. We've been slow to adopt, now we're at least, to some extent, bringing capital in to invest in products. So I was really excited to hear that. So that's stimulating competition.

As far as the market acceptance of certification, just looking from the side of the vendor and the marketplace, as you know, in the ambulatory sector, in the first four quarters, we reached 44 percent of the vendors who basically deliver the product that is used by over 75 percent of the doctors that have an EHR. It was about ten percent per quarter on the average, penetration of the vendor marketplace. There were about 200 ambulatory vendors.

In the hospital market, there is only about 25 vendors, so six actually represents 24 percent of the vendors. So in the first quarter, we're actually ahead of the pace we set in ambulatory, in terms of the percentage of vendors involved. And applications are now open. If there is [sic] any vendors out there in Web-land, you have today and tomorrow to get your application in this quarter. But we already have several in place. So we know we'll be doing some testing this quarter.

We also, in the ambulatory sector, you know, we updated the criteria in 2007. In particular, we require e-prescribing, standards based e-prescribing, and we have nine products certified, and we have about half a dozen in process, so we're getting a good show. We did raise the bar, so it's a little tougher, and the vendors are having to work harder and prepare. The total number of products now certified is 98, I think, it's almost a hundred. So there is lots of choice out there.

I'd like to update you on our development work of the standards for 2008. As you know, we'll update the ambulatory and inpatient criteria. A little earlier, Kerry Weems talked about the Medicare standards being extended now. In e-prescribing, it's also going to include medication history and formulary checking. We're ready for that. Those requirements are being added to our criteria for July, 2008. We started with simple prescribing and refill, and we add the additional ones this year, so we're nicely in sync there.

We are adding four new domains this year. We are adding the health information exchanges or networks, as you know, and then three areas which we were basically asked to come to by the marketplace, emergency department systems, criteria for child health and cardiovascular medicine, and that's all under way. And we published the environmental scans, which was their first step. It's just surveying the standards out there in September, for public comment. Received about a thousand public comments, which indicates we still have very strong industry engagement. It also indicates we have a lot of work to go through those, basically, and we are almost through the comments, and our first draft of the criteria will be released after the Commission meeting. The Commission meets next Monday. We expect to release the first draft November 21st. That will, again, have a 30 day comment period.

I wanted to comment on interoperability testing. One of the most important things that we can do for end users is make sure that these systems are interoperable. And when I say interoperable, I mean not just the systems claim to be interoperable, but the experience when you buy it, is not having to hire a consultant or spend six months trying to make these darn interoperable things actually work. We've had that experience with our personal computers in days gone by. You know how much better it is now, trying to do that in health IT, from the days gone by to what it could be. It will never be perfect, but it can be better.

So we actually need to test. We can't just ask the vendor, are you interoperable. We actually want to test, and so we need some tools. And we need some technical help, because we're a small organization. So we announced a collaboration with the MITRE Corporation, which is a nonprofit, federally funded research and development organization, and they're basically the technical leaders on this project with us to develop testing tools. And we made the decision to do this in open source. The reason is we don't want to -- to create a proprietary advantage to anyone who helps us with it, so it's open source which means anyone can get the testing tool and the source code. It's freely and publicly available.

And we think this is going to really reduce -- get rid of one of the barriers to interoperability, which is how do you figure out the standards, and how are you going to test me? Basically, the vendor can go and practice whenever they want, and refine their product before they bring it to us. We've had a lot interest.

I want to just speak to NIST in particular, Cita here is aware. The engineers basically didn't even wait for the announcement. The engineers are burning up the phone lines, talking to NIST, and MITRE and CCHIT on all the work that NIST has already done on this. We want to be able to leverage that, work together, so they're all excited. We'll have a kickoff teleconference on November 15th for that.

And then as a final slide, just to comment on accelerating HIT adoption, which is really the goal here, we've heard about payers and their incentives, not necessarily new monies. Oftentimes, this is a realignment of existing payment, but I like to -- it's still incentives. And we've seen what was a phenomenal announcement from CMS about the pilot project with 1,200 practices, and also the broader inclusion of EHRs, as a quality -- structural quality criterion.

And we've also seen private payers. Just last Thursday I was speaking at the Blue Cross symposium for all the blue plans. Their IT leaders go to this, and they were not only interested but actually heard about more plans that are going to offer health IT incentives that haven't been announced yet. So we're seeing good progress there.

You've heard about the state and regional initiatives. They're working closely with us. We're trying to help them. And just a kind of a -- one more thing. We were asked to look into the possibility of malpractice premium discounts for physicians whose use EHRs. And Karen Bell at ONC and others in ONC have been working on that, and we worked with them to create an analysis. We had a physician attorney expert consultant draft a white paper. He analyzed the situation, pointed out how EHRs help reduce risk, but also, what you need to do to make sure it doesn't increase risk. Because implemented poorly, it could increase risk.

So looking at both sides, we'll put the white papers out there, we'll be -- he'll be speaking before the organization of malpractice insurers. So, you know, a three or five percent discount on malpractice, for some doctors that's a modest amount. For others, it's actually a pretty big amount that could help cover these EHRs, too. So we're excited to see that.

And really, just to sum up, before I take questions, sometimes CCHIT, because we're at the intersection with the private sector marketplace, we get a lot of attention, and we often have these milestones. But every time we hit a milestone, it's because of these integrated efforts. It's because of, you know, basically the beginnings with federal leadership, and leadership from the private sector, the harmonization of standards, the development of standards that we need, the use cases, the -- talking about networks, and finally defining them.

This all comes together, and we're sort of where it meets the road in the private sector. So we really think everyone, all of our contractors, and all of the Workgroups, and all the initiatives are volunteers for helping us. And thank you for your attention. I look forward to your questions.

SECRETARY LEAVITT: Mark, tell us about volunteer fatigue. How are we doing on that?

MR. LEAVITT: We're actually doing okay on it. We became aware of the issue fairly early on, because so many initiatives started and they all depended on volunteers. So what we did is we structured -- we added staff this year, last July, so that the volunteers didn't have to do quite as much homework. And we also added new areas so that people could focus on what they cared about most. A new privacy and compliance group, for example.

So we actually -- volunteers are the key resource of CCHIT, and you really have to monitor how happy they are. It's just like your employees. How are they feeling, what's the morale, how well are they coordinated? It's not easy, but we're not hearing that they're fatigued. What you'll be hearing is that there is lots of debate, and it will bounce out into the press sometimes. I think that's perfectly healthy. Because that's actually what keeps them engaged, is that they heard there is an open process, and then when you're finished, you're having an impact. So last year, we had twice as many applications as we could accept for volunteers. So I'm hoping that we'll see something similar next April when we go to refresh the group. So I think we're doing okay on that.

SECRETARY LEAVITT: Years ago I used to watch my grandmother take certain materials and she'd put it in the top of a thing and she would turn this crank and it would all get ground through this process. And that's where we came up with the analogy of turns of the crank.

Our goal has been to get through three complete turns of the crank from use case all the way to your place where it comes together. Could you give us -- give just an assessment of where you think we are right now? Can we get the three turns of the crank if we just keeping turning? Are we pushing too much material through it? What about our pace and productivity?

MR. LEAVITT: I think actually the pace now is right. The start was lumpy, because we tried to start things in parallel that people thought should be sequential, but you couldn't make them sequential. But actually it's lined up very much now. So the use cases coming out of the community now are the ones that are real practical things that we can drive a standard into the HIT systems about. And so I think that 2008 is the year that you'll actually see all the pieces.

Networks will be new. It will be interesting and challenging. We were supposed to launch in July. We're still looking at that July date, but we know that this parallel project finishes in October, so it's going to be interesting coordinating times next year, but I think this is the first turn of the crank that engages all the ingredients.

SECRETARY LEAVITT: One last -- this is not right in the heart of your mission, but you see a lot, and I'm interested in your opinion. I asked the NHIN panel about the number of new large technology players who are seeing an opportunity in the personal health records space. In my judgment, that will be the energy that ultimately drives this whole thing. But they have to have the ability to populate those electronic health records, or personal health records with data coming from the 98 systems that you have now certified.

Could you elaborate some on just how much work are you seeing between those systems and those large technology providers, and the extent to which this system of standards is necessary to enable that?

MR. LEAVITT: That's a really good question. The system of standards is needed, not only to enable it, but to make sure that patients have freedom of choice. So we wanted to actually energize competition between providers for not just quality and safety, but could I mention convenience? And so you really want it now. You really want those standards now, because you don't want it to evolve into a proprietary world, where it's not as competitive. So I think we need them very much.

We were -- this group basically suggested we certify PHRs, but with some caution. They said you might want to wait. The market's very embryonic now. The companies in it are small. That seems to have changed. The size of the companies that are in it are no longer small. And so I think now the time probably may be coming that it would be helpful to begin certifying at least the security and the connectivity of those systems with the networks, the doctor's systems, the hospital systems, and I think that will further encourage innovation, competition, and growth in the marketplace.

SECRETARY LEAVITT: That's a very important statement. Lastly, may I just say, with the caveat that to the extent that we have been able to -- Mark and I are not related. [laughter] But I would just like to say with that caveat, how much I appreciate CCHIT and your leadership, and what a pleasure it is to be periodically updated on your progress. We are making serious progress here, and I think in large measure, it's because of you, CCHIT and the thousands of volunteers who just continually turn the crank. And I'd like you to know that I believe that, and it's good to have you here again, today.

MR. LEAVITT: Thank you.

DR. KOLODNER: Do we have time --

MR. LEAVITT: Oh, sorry, questions. Other questions.

DR. KOLODNER: Can't get away quite that easily. We have time for a few questions. We'll start with Nancy, Craig.

MS. DAVENPORT-ENNIS: Mark, I would like to just reiterate ditto to all that Secretary Leavitt just said, with regard to your reports to this group. I find them to be energetic, refreshing, insightful, succinct, and I leave feeling that there is a huge degree of momentum.

I have to say to you that it is very exciting to consider that, indeed, you may be able to work with insurers to incent providers, through a reduction in the cost of malpractice premium discounts. I would certainly defer to the leaders on AHIC or in the insurance community, but from our point of view, that would suggest that, indeed, we are reducing medical errors, and we are improving the likelihood that patients are going to be served in a manner that is going to be improved through the use of information technology. So continue to stay the course. Thank you for keeping the patient in the center of your universe. Thank you.

MR. LEAVITT: Thank you.

DR. KOLODNER: Okay, next. Craig?

MR. BARRETT: I have a question that may turn into a comment. And the question really is for Kerry and Mark. I heard a lot this morning about the safety and well being of our patients as our highest priority. And Kerry, if I understood what CMS is doing about electronic prescriptions, it's you're creating a standard without requiring usage. And I'm still looking at all of the data that suggests that thousands or tens of thousands of people in this country are impacted each year because we don't have 100 percent e-prescription. And so my question is, this is the 17th meeting of this august body. We've discussed this at meeting number one, two, three, four, then we went dark, and now we're back at 17. Where are we?

MR. LEAVITT: There may come a time when we require -- right now we don't require it as a condition of writing a prescription, but if you write an electronic prescription, then you must use our standards. And certainly, there is a considerable push out there to do that. I believe Mr. Serota wrote us last week or the week before about that. We are not, you know, completely deaf to those exhortations, but we're not yet in a position to require it.

DR. KOLODNER: But it will happen.

MR. BARRETT: What meeting number do I have to come back to to get there?

MR. LEAVITT: I can't predict that number for you.

DR. KOLODNER: One of the things, Craig, for those of us who have been in healthcare systems, especially large healthcare systems, what we found is that as good as something might be as an idea, that until you have a base in there that in some cases may be up at the 30 or 40 percent range, you haven't worked through all the issues. And if you put an arbitrary date in before having that, at least in the healthcare arena, it has sometimes caused a problem. Now, the question is how you put incentives in, so you can get to that more quickly rather than starting with the stick.

MR. BARRETT: You ought to talk to your friends in the IRS or the EPA. They don't seem to hesitate to put requirements in without the necessary base involved. I'm just -- I go back continually to the issue of patient safety as our highest priority. This is an obvious issue, and we seem to just be moving ever so cautiously and slowly on it when we could make a giant leap and perhaps facilitate the movement of the infrastructure and the capability. I knew I'd get to my comment. I had to give you a question to get started, though. [laughter] And I did.

DR. KOLODNER: Okay. Chip.

MR. KAHN: I'd just like to reinforce what Craig said. I think in the case of an institution like a hospital, where you've got computerized prescription order entry, you have an institution that can bring people along. And I agree with the sort of reaching the 40 percent. But I think in terms of individual physicians, you're not going to get to 40 percent in this century unless you acquire it, frankly. You're not going to get to 50 percent. You're not going to get to 20 percent. So I think it's really the only way to go. You're going to have some use, but it's not going to happen until you just tell people. And I think this is one area where if you tell them, I think they're going to have to do it.

SECRETARY LEAVITT: So I appreciate hearing this. This is very helpful. May I -- it's clear to me that at some point, you reach the point where you tip this, and the issue is, when do you get to the tip where you're being constructive and when are you -- when are you pushing more into the top than you can turn at the crank? And Chip, I mean I'm really interested to hear you reflect that.

MR. KAHN: I just don't think there is anything happening out there that's going to get you to the tipping point. Having standards is great, important, it sends a signal. But there is not anything sort of promoting -- pushing you to the tipping point. There is some vendors out there that are pushing products, but it's not going to happen, I don't think. I mean in the hospital situation, whether it's Leap Frog or some payers are compelling hospitals, and so the hospitals are beginning to work with the doctors; but in terms of individual practices -- you know, just look at the numbers. They're pitiful, and they're not growing that rapidly. They're growing by the hundreds. They're not growing by the thousands. And so I just think if you look at the trend line, it ain't going to happen unless something forces it.

MR. BARRETT: Let the record show that this is probably the first time Chip and I really agreed on a topic. [laughter]

DR. KOLODNER: Mitch, you have e-prescribing. I do want to get back to you, but I think Kevin has a comment along these lines.

MR. HUTCHINSON: I'm just sitting here itching to speak, so I appreciate that, and I enormously appreciate all the focus on electronic prescribing, especially at this meeting, and to the administrator and Secretary for making the advancements of the standards. That has been a major help in getting the infrastructure necessary in place to do that.

The elimination of the facts exemption and eliminating the ability to send prescriptions by fax, even though they're generated inside of computer, is also enormously important, so that there is a stronger value proposition for adopting these levels of technologies on both sides.

I will tell you that, you know, we stand today with 40,000 of the 55,000 pharmacies in the United States, are live on the network and ready to do electronic prescribing, and that continues to grow. There are an average of about 100 physicians a day that are logging on to the network and registering to get the network to do electronic prescribing. That's 100 per business day.

But we're not seeing the utilization that we would expect to see. It's still very much in a pilot mode. Even those physicians that are coming onto the network are processing maybe 10 to 15 percent of their total prescriptions electrically, and still picking up the pad. And we go back to this issue of the DEA. We have to solve this DEA issue. It's only one of the issues. There is a lot that we have solved over the last several years with your help, but we need to solve this DEA issue on controlled substances for schedule two through fives, because it causes physicians confusion and concern about when they can write electrically and when they can't.

The one number I would remind everyone, and I've said this in meetings past, but when we get to the tipping point, it is about, you know, a 30 or 40 percent range, but it's not about 30, 40 percent of physicians. It's about 30, 40 percent of the volume. And 30 percent of the physicians of the United States write 80 percent of the prescriptions. So if you've automated 80 percent of the prescriptions of the United States going electrically, you have, in fact, improved enormously patient safety, and it's those 30 percent of physicians writing 80 percent of the volume that we really need to get to.

SECRETARY LEAVITT: I'd like to continue this conversation. I'd like to continue it after we've listened to the next on adoption, and so if we could -- there may be some other -- I think it -- that conversation so informs this discussion, that it would be helpful to continue the conversation. This is about advice to the Secretary. This is a very important piece of advice that I could and am willing to receive. This is about when do you reach the tipping point that you can begin to require the use of this technology? I believe we will ultimately and must get to that point. There will be a point where we have to go across that divide. I'd be interested to get your view on where we are. Let's have this next panel, and then have the further conversation.

DR. KOLODNER: Okay. So if we can have the next panel come up, and it will -- this is, as the Secretary said, report on the adoption survey, actually two surveys. And we have Karen Bell, Jane Sisk, and David Blumenthal joining us. So welcome. Karen?

DR. BELL: Thank you very much, Rob. And greetings to you, Mr. Secretary, and everyone on the panel. I'm sorry. Everyone on the Community. You may recall that just about a year ago, Dr. David Blumenthal and Dr. Jane Sisk were here as well, and at that point in time, Dr. Blumenthal, along with his colleagues from Harvard and George Washington University, reported on a standardized methodology for measuring the adoption of EHRs in physicians' offices. He also reported a rate fairly close to 10 percent using that methodology. Actually it was 9.2 percent, to be exact, when that particular methodology was applied to existing data. Today, he'll be presenting the 2007 rate that is the result of a survey that was fielded this year using that methodology. It's preliminary data, and he'll be describing how that transpired very shortly.

But I also want to point out that in a converging effort, Dr. Jane Sisk of the CDC's National Center for Health Statistics, continues to oversee an annual survey that monitors multiple factors in clinician's offices, as well as other parts of the delivery system. In 2006, that survey incorporated the standardized questions that were developed by Dr. Blumenthal's group. And in 2008, that survey will, in fact, encompass the entire methodology. So next year at this time, Dr. Sisk will be here presenting the annual adoption rate in physical offices while Dr. Blumenthal will move into the hospital sector.

But without further ado, then, I'd like to then turn this over to Dr. Sisk, who will now talk about the 2006 rate.

DR. SISK: Good afternoon Secretary Leavitt, Dr. Kolodner, and members of the Community. I'm going to share with you the -- as Dr. Bell just said, the most up-to-date statistics that we have about adoption in physician's offices.

Just a little background context of what the National Ambulatory Medical Care survey and the National Hospital Ambulatory Medical Care surveys are. They're both annual nationally representative surveys, the so-called NAMCS of physicians in office based settings, starts out with a sample of three -- well, in 2006, 3,350 physicians. Those exclude non -- those exclude federal physicians as well as radiologists, anesthesiologists, and pathologists.

In this coming year, 2008, we're going to add a mail survey, starting with 2,000 additional physicians at the request of the Office of the National Coordinator. In addition to those physicians surveyed in NAMCS, HAMCS, the hospital one, surveys emergency departments and outpatient clinics in 500 hospitals, and I'll have a little bit to say about that as well.

In both cases, in both surveys, our representatives literally go into the organizations and conduct, in person, interviews, and that's the source. Those are the source of the data that I'm going to share with you.

There was about a 63 percent response rate in 2006, and a 92 percent response rate in -- among hospitals. And the data that I'm going to share with you about NAMCS, just came out in the report a couple weeks ago. For 2006, as you can see, the trend line there, as you've just mentioned in the last session, has been on the increase, and in 2006, was an estimated 29 percent of physicians who reported using either full or partial electronic medical record systems. We don't have the data from HAMCS, from the hospital side for 2006 yet, but all of those trend lines, including what I just reported for office based physicians from '05 to '06, are significant differences.

This shows the percent of physicians who reported using selected features of their systems, and we've circled the ones that David Blumenthal's group a year ago summer identified as being necessary for so-called minimally functional systems, namely, clinician notes, prescription orders, test orders, including lab and imaging and test results, including lab and imaging. And those in '06, again, keying to the term minimally functional over in the far right column there, this busy table, of all physicians, about 12 percent reported that they had those minimally functional selected features from the previous slide.

These categories on this slide report on areas where there were significant differences among the kinds of physicians that -- and the level that they were reporting. It was pretty much the same for whether it was full or partial systems, or the minimally functional more comprehensive systems. The more physicians that were in a practice, the greater the adoption rate was reported to be. Physicians in health maintenance organizations reported a significantly higher rate. Physicians in the west reported a significantly higher rate than those in other regions of the country.

And note, this also harkens back to some of the discussion in the previous session. Solo physicians account for about 34 percent of all physicians. It's not on this slide, but that's about two-thirds -- a little more than two-thirds of the practices in the country. Their reported rate of any use is 24 percent, and of the minimally functional features, about seven percent.

And you go down the chart there, and the high numbers in the adoption category, for example, among HMOs are among physicians in practices, practice settings that account for a fairly small percent of all practices, and vice versa. Those who have lower rates of use tend to be in the practice settings that have the greatest numbers of physicians. So this by way of saying we're on the go, but still have a ways to go.

These data are from 2005, but I thought you might be interested in some of these relationships. These data come from both the survey of physicians in offices as well as hospital emergency department and outpatient clinic -- well, it's mostly outpatient clinic in this slide.

Physicians whose primary care providers reported using electronic medical record systems that had these minimal features that I mentioned before. Urban was significantly higher than rural. Privately insured, significantly higher than Medicaid or Medicare. Hispanic, significantly lower -- these were Hispanic patients, significantly lower than non Hispanic black or non Hispanic white. There was no significant difference between the two non Hispanic categories, whether black or white.

And just to conclude with some information that was gathered from the physician office one about the plans that physicians who did and did not have systems in place, or the minimally functional here on the slide called comprehensive features, and perhaps not surprisingly, physicians were more likely to be planning to adopt new systems, if they didn't have them already.

DR. BELL: Thank you very much, Jane. David.

DR. BLUMENTHAL: Thank you, Karen. Mr. Secretary, Dr. Kolodner, members of the community, it's a pleasure to join you, and we've -- I speak on behalf of a large team at George Washington University and at Mass General Hospital in saying that we greatly appreciated the opportunity to work on this very important project with you all.

I'm going to talk about a survey that is very much in progress. And I'm going to start by describing to you what the survey will look like when it's completed. We're going to be mailing a survey, which is just about health information technology, to about 5,000 currently practicing physicians that are randomly selected from the American Medical Association master file. We expect to get responses from about 3,000, which would be a target response rate of about 60 percent.

We are in the field or coming out of the field, have just come out of the field, and we began in July, 2007. Physicians were sent two questionnaires. They were directed to fill out the physician instrument and also to give the second questionnaire to the person who is most knowledgeable about their practice characteristics and HIT use, because we want to get a sense of what practices are doing, not just individual physicians.

And the current analysis is very preliminary. We have completed and analyzed responses from only about 400 of our ultimate 3,000 responses, so this is a sneak preview, and may not be typical of what our final numbers represent. But I think you'll get a sense of the ballpark.

Before I go on, I want to see if I can provide you some guidance through the thicket of alternative definitions of an electronic health record. What you find when you measure the prevalence of a record depends very much on how you define a record. It's not a single item, but as you know from your certification work, what you -- it's very much up to the observer to define it.

There is a historical definition that the national inventory medical care survey has used, has allowed providers, basically, to say in their own terms whether or not they had an electronic health record. It places no restrictions at all around what that record consisted of. And some of the information that's been presented to you uses that definition.

Then there is another definition that we created with input from an expert advisory group, which we call the minimally functional, and has been also termed the selectively -- a selective EHR, and that encompasses a set of minimal functionalities, which I'll describe for you in a moment. It's geared to a framework that the Institute of Medicine created, but it doesn't capture all the functionalities that the Institute of Medicine suggested were typical of an electronic health record.

And then there is something which we are calling a functional electronic health record, and that's a definition that is -- fully encompasses the basic functionalities that our expert panel thought should characterize an electronic health record.

Now, what does this mean in practice? I don't want to take you through each of these items, but it gives you a sense of how, what we are calling a minimally functional or selective EHR compares to a functional EHR. The minimally functional EHR has six of the 17 functionalities that a fully functional EHR would have. These are not, and I realize this is complicated. These may not be a fully functional EHR in five years from now, but as of the current time, this is what our expert panel thought these technologies ought to have to be fully functional. There are four categories of functionalities. These track on the Institute of Medicine's domains of functionality. And I'd be happy to come back to these to clarify as we go forward.

So if you compared these three definitions, the historical NAMCS electronic health record definition, the minimally functional EHR definition, or the functional EHR, and you look at the data that we've gotten back, the 400 responses in the year 2007, this July to -- the summer and fall of 2007, what you see is that we would -- we are seeing that about 39 percent of physicians answer positively to the historical NAMCS definition. They say they have an electronic health record, without our defining it for them. If you, then, ask them if they had the functionalities that we call minimal, we get to about 14 percent. That number is analogous to the 12 percent that was shown to you by Dr. Sisk just a moment ago.

If you push on, then, to a more elaborate electronic health record, the functional electronic health record, the number goes down to five percent. So you've got three -- and you can define these -- the more rigorously you define it, obviously, the fewer respondents will tell you that they have that kind of record in place.

We've also, as part of our survey, been asking about barriers to adoption, and I'm sure these won't surprise you, but in order of importance, comparing those who have the functional electronic health record to those who don't, you can see the ranking of important barriers. And we've ranked these from left to right, according to the prevalence with which those who do not have an EHR report that these are barriers. So these are the non-adopters that we're emphasizing here, the purple bars.

The most important, 70 percent, is lack of capital. Fifty-six percent say they're concerned about finding a system that will meet their needs. Fifty-five percent say they're uncertain about getting a return on investment. Forty-seven percent say that they're worried about their system becoming obsolete. Thirty-nine percent, that they are worried about losing productivity. Thirty-seven percent -- sorry, that was 39 percent. Thirty-seven percent talk about capacity to implement, worrying about it, and 33 percent are concerned about physician resistance, presumably among colleagues.

So that's a peek at our initial results, and I'd be happy to answer any questions that you may have.

DR. KOLODNER: Okay. We're open for questions, and obviously picking up on the -- on the conversation from before, I do want to point out that as we engaged in this conversation from the last presentation, we're now going to be changing the break a little bit, but we'll deal with that after a little more conversation. So first Mitch, then Lillee.

MR. ROOB: Thank you. Before we get to e-prescribing, can I draw an inference? I want to make sure that I'm drawing the inference correctly from the data, two different datasets that you've presented.

Jane, you presented a dataset that says that HMOs have an enormously higher uptake of EMR usage than anybody else, right? And -- that's correct?

DR. SISK: Yes, that's correct.

MR. ROOB: Hugely off the chart difference. Not even in the same ballpark different.

DR. SISK: These data, just to put a fine point on it, are about physicians who are in HMOs. The information, the calculation about the HMOs, themselves, would be slightly different, in the same ball park, but the one is about the individual -- from the individual physician's perspective, the other is the perspective of the practice.

MR. ROOB: In HMOs, there is correlation between the economic -- between the payer and the provider. Right? An enormous -- I mean what I'm trying to get at --

DR. SISK: Deliver as well as insure --

MR. ROOB: Correct, is that the insurer -- it must be that the marketplace has spoken here that, the insurer is getting value out of that record in a way that the provider doesn't, from an economic standpoint. Or you wouldn't see that enormous difference.

And David, I think that correlates to some of the -- to the concerns that the EHR adoptions have raised here with a lack of capital issue. And so I mean I think that the market here is saying that the place that an EHR is valuable is at the -- on the provider side, rather on the insurer side, as opposed to necessarily on the provider side.

DR. SISK: I wouldn't necessarily make -- take that implication. Health maintenance organizations, as you know, are characterized as organizations that both insure and deliver care in exchange for a per capita -- a capitation payment for comprehensive services. It's been -- I'm going offline now from MCHS statistics, but just in general, as far as the history and the literature, et cetera.

It's interesting that organizations, including the veterans administration hospitals and system, that are responsible financially for a more comprehensive set of services, delivering a more comprehensive set of services, and have the more comprehensive set in their organization, are more likely to undertake the adoption of these systems.

I don't know that one can say that it's necessarily the insurance function versus the delivery function. I guess I would -- I would speculate that it's probably the delivery side of things, but I have no information about that.

MR. ROOB: I'm -- this is the second year in a row that this data has been presented, and they're hugely different uptake rates with those HMOs, as opposed to everybody else. And I think that as we postulate who ought to be paying for that in the future, we might learn something from what you just said.

DR. BLUMENTHAL: I think that the information -- the best information available suggests that there are some gains to physicians, but they are very small compared to the gains that are realized by other parties that participate in the healthcare system. And the parties that gain most are insurers and ultimately, employers. And payers of all kinds. And so there is -- there are some things that physicians, once they get really well working EHRs, can gain. But if you're looking for rapid adoption, the major incentives will be felt by groups that have internalized the financial gains.

DR. KOLODNER: Lillee, then Chip, and then I want to make sure we get back to the conversation that we had before. Lillee?

MS. GELINAS: And I'm not addressing e-prescribing at this point, but I want to come back to that as well. The Electronic Health Records Workgroup, as you know, has been dealing with this very topic, hours and hours and hours. And what Mitch has teed up here just cannot be lost in the conversation around the employer and the insurer reaping the benefit. And how are we going to overcome that? I just want to speak for the many voices that volunteer hours of the Electronic Health Records Workgroup.

And I really appreciated your presentation, Karen. You've sat in all of our Workgroup meetings, so I hope this isn't going to be a surprise to you, but we've talked about barriers here, which is the negative aspect. I prefer to be on the positive side of the equation, and that's around the incentives. And we've said, at least in our Workgroup and here more than once, that monetary incentives are pay for adoption, is clearly a key component, and I would just like to hear a little bit about that, why it's not a part of this conversation here.

I've got hours and hours of transcript for you, if you'd like to read through it. But this notion of incentive for adoption -- and Mitch, what you brought up is a slightly different angle than what we've talked about in our Workgroup meetings. And that is that benefit goes to those that would not adopt. We've got to overcome this. We absolutely have to overcome this particular aspect, so I would love to hear what the survey said in terms around incentives, and what this work might be able to do to recommend to the Secretary.

You know, this meeting so far has been great. Excellence is breaking out everywhere, as we say. So how do we get these incentives where they need to be to get going in a rapid way? I'm struck with the fact that we're not going to be around here much longer, I don't think. The new successor will come in and the work that we've begun, we want to see come to fruition before the next turn of the crank, so to speak. So where were the incentives in the report? Thank you.

DR. BLUMENTHAL: Well, we have some information that wasn't presented here that looks at incentives reported by physicians that we queried. And the top two are financial. One is the availability of capital. The other is compensation -- additional compensation for care rendered. So it's pay for performance or pay for use of the electronic health record. And a third, which has also come to light here, and been mentioned, is relief from fear of liability. It's not quite discount. It's concerns that something about the use of the record will make physicians more vulnerable to legal -- to torts about the care they provide.

And additional things -- after that, there is a considerable falloff. All those are in the 70 to 80 percent prevalence of reporting that those are important barriers -- important incentives, I'm sorry. After that, standards, and some guaranty that the records that they will use will be the records they should be using, would be -- are considered -- would be very helpful.

MS. GELINAS: And just one structural question about the survey process. Are physician’s assistants and nurse practitioners broken out in the survey process, or do these results only apply to physicians?

DR. BLUMENTHAL: It's only physicians.

DR. BELL: And I would just like to add one thing as well, if I may. As Dr. Blumenthal indicated, this was a -- results of the survey, the first 400 respondents of the survey. There will be another report that's coming to this group after the first of the year, based on the 3,000, and at that point in time, there will be far more ability to get down to some of the specifics and some more of the details on the survey at that point in time, so this group will hear, in great detail, all of the results of the survey at that point. So thank you.

DR. KOLODNER: Chip?

MR. KAHN: [low audio] It's interesting what Mitch was asking about, because I think it's pretty clear what [low audio] lump together here different columns, and one side [low audio] it's not somebody else's money. It's their money. When you say capital, [low audio] the question is, is it going to be a cost to them personally. [low audio]. Great, I want to use it. But it seems to me that's one of the key ingredients here.

And second, this issue of [low audio] is really an issue of certainty, also [low audio] in fear of disrupting the business model and the work flow. [Low audio] And it seems to me that it's going to have to be something big that's going to change that dynamic. In the case of [low audio] I'm a little bit less hesitant about being more aggressive there, because I have no knowledge what the costs are there. I don't think it's that big a deal, although workflow should be an issue. But [low audio]. I don't think we found the secret weapon yet. The dilemma [low audio] that you can't put enough money on the table, unless [low audio] 1 percent, 1.5 percent, we know from just problem solving. On individual physician it's meaningless, particularly when you're looking at a 10 percent cut that Congress may or may not make.

So I think that we really -- the survey shows the obvious, which is that the individual physician, unless this is equivalent to whatever [low audio]. I'm not sure I would be [low audio] It ain't going to happen unless the government or the payers or [low audio] are going to want to pay for it. Because it just doesn't fit in terms of the way [low audio]

DR. KOLODNER: Scott, and then if -- if Scott doesn't take us into there, I think we do want to --

SECRETARY LEAVITT: Let's go to Craig and then to me, because I'm going to have to leave in a minute.

MR. SEROTA: I could take you into there, but I promise I won't. [laughter] My only comment on the access to capital issue is it's not as clear as it appears on this issue, because we, in the blues, have tried on numerous occasions to give away practice management technology to physicians, and they won't take it. So it's not simply that they can't afford to pay for it, it's more like they don't want to change the practice -- the pattern of practice that they have in order to adopt the technologies that are required.

And I also raise a little bit of concern, as you might expect, to the comment that insurers and employers are the ultimate beneficiaries. Patients are the ultimate beneficiaries of this. The objective of the electronic health record is to improve the quality of care. If the -- the economics will follow, because high quality care is more cost effective. So the economics will follow, but the ultimate beneficiary of an electronic record will be the patient who will get a more integrated care experience.

And so, you know, I think we need to kind of put it in that context. If we build the model of an electronic health record around economics, around it will be less expensive, I think two things will occur. One, it will never get adopted. Because it won't be less expensive to the practicing physician, initially. It will be over time, but there is a hurdle. And second, we'll be missing a lot of uses of that electronic record, because it will focus on the wrong things. We will not focus on informatics. We will not focus on gathering data and information. And it will miss a whole big piece of that puzzle. And I'll stop and not go into e-prescribing until after everybody else does.

MR. BARRETT: Simple question. Was it a hard copy a mail survey?

DR. BLUMENTHAL: Yes.

MR. BARRETT: That has got to be the biggest statement about what we're talking about here. When was the last time anybody in this room filled out a hard copy survey on any topic? [laughter]

SECRETARY LEAVITT: I'm just trying to think, when was the last time? Look. This whole discussion really is about how do you motivate change? Do we motivate change by paying more for process or do we motivate change by paying more for results?

And we've just announced the -- this new electronic health record demo, where we're going to take 12 different regions and we're going to engage in this discussion, in a very practical way, with a hundred practices in each region. 1,200 practices. 3.6 million patients.

This is exactly what we need to find out, is what -- how do we construct a business model that will motivate change, or at least complement our need to change in other ways? I mean we may have to say society demands this occur, and we're going to demand that it occur in the following ways. But somehow we've got to make this business model transition so that some of the savings that comes from quality find its -- finds its way into the pocket of the physician.

And how do we change the macroeconomics of this? It's easy and evident, I think, to all of us that that's the reason they're not buying. It isn't -- I think Scott's absolutely right. Part of the -- but that's economics, too. They don't want to change, because of the economics and the disruption.

And anybody who has been through this process of bringing an enterprise through this transition knows that it's very difficult. So I mean this is not an easy proposition, but it's an absolutely essential one, and it will -- and we're going to have to learn how we do it.

You know, this whole business of pay for use. That means we pay for process. If we pay for results, we're paying -- if we pay for reporting, or we pay for quality, or we pay for value, then we're getting results. My guess is it has to be some combination of these. We have to stimulate it early on with something, but easily and quickly trans -- not easily, but quickly transition.

Our model -- rather our demo pays the first year for some very basic reporting. And we're talking basic here. The second year, it begins to require some compensation or provides compensation for reporting of some quality measures. That's leaving pay for -- that's leaving the -- paying for showing up into the paying for providing information.

And then the third year it gets into pay for performance, where we're paying more for results. That's, I think, a good example of how that transitions. Now, we'll do in this 1,200 practices around the country. And I think we'll learn a great deal that will help us figure out how to do this.

I am anxious to have the conversation or have the -- on pharmacy. Regrettably, I have -- I have this very special deal with the airlines. If I'm not there, they just leave anyway. [laughter] And they're just about -- I've got to exercise that special provision. I would like to ask that you have the conversation. I'd like to hear a full report on it. Because I think this -- the advice is very important to me.

I know that at some point, we need to use the purchasing power of the federal government. And I expect that it's at a point where it's done, that the private insurers will begin to do the same thing, where we say it's now an expectation if you're going to do business with us, that you use these. Where we are on this process of tipping is an important thing that this group could give me some advice on. I don't expect that your advice would be conclusive, but I would like to have you follow on the conversation.

I'm going to excuse myself so as to make that, but again, may I just say in closing how much I appreciate what's going on here. We're making progress. It's not as fast or as neat as any of us would like it to be, but it's progress.

I also want to emphasize the discussion we had earlier about 2.0. That is still very much a priority, and I'd hope we could accomplish that at this meeting. We'll have accomplished it before the next meeting, I predict, and we got to begin this handshake of making certain that this can be perpetuated on in a meaningful way. So -- thanks.

DR. KOLODNER: So Ward, did you want to take us into the e-prescribing?

DR. CASSCELLS: Thank you. Dr. Blumenthal, thanks for that. And Dr. Sisk, thank you. I think people got the idea that the NHINs data was 2005, and much of that was collected in '04, so I hope -- I just want to say that to make sure we understand that we're doing better than we were in '04, and Dr. Blumenthal's data brings us up to speed nicely on that.

As somebody who is struggling to get 10 million people's electronic records fully utilized by themselves and their providers, military, where everybody has access and training time and, you know, good equipment, and reasonably up-to-date software. We still encounter some of these same issues, but the -- the rationales we get for resistance are different, are couched in different terms than the providers that I dealt with in Texas, when we were trying to get these systems adopted there.

One thing they have in common is the -- is the -- the challenge of speed and everybody finds these current systems, all the commercial available systems still frustratingly slow. It still interrupts the doctor/patient relationship. And you've mentioned that in productivity, I think, here, but I want to mention it. The speed of the systems are still frustrating.

The second thing that comes up, if you really have a second cup of coffee with the person, or know them well, is that it's challenging to your ego, when the system gives you unsolicited advice or corrects you, and that's not so hard to take, if you think it through cerebrally, you know that -- and maybe you have some deeper knowledge about this, Dr. Blumenthal, but you know that it's going to improve your quality of care, and the patient is going to benefit, and you, as the doctor, are going to look better and less chance for malpractice lawsuit.

But somehow, it just still grates on doctors to have a machine telling them -- questioning their judgment. And talking to my brother about this the other day, who is private practice. He's -- he's had several turnovers in electronic systems over the past decade, maybe 18 or so, a lot of -- he says one of the big problems is that when you document things, which we all -- you and I think is critical for quality of care.

I know Dr. Kolodner agrees, you ought to be immunizing yourself against some of the risks. But the fact is that the legal risk -- the malpractice risk is still overwhelming weighted towards things that you do, rather than things that you fail to do. So a lot of these people just feel safer by not documenting -- the less they put down, the better they feel. And it's going to take the kinds of -- I think Secretary Leavitt had his finger right on it. You have to be reimbursed, you know, that week for the notation that the colonoscopy was, you know, scheduled or was declined, because we still -- we still are so underpaying for preventive care and paying for -- we're still paying for procedures to a large extent. Mr. Weems doesn't have that completely solved yet.

And as a consequence, this -- these incentives that we -- this body can suggest -- have to take these issues into account. I'm not sure how to do it. I'm speaking as a provider now, an administrator, but until six months ago, an every day provider, and we're having trouble in the -- at the University of Texas, and at the Texas Heart Institute and at the Department of Defense, in getting docs to use these systems. So if you have more -- what I'm saying, Dr. Blumenthal, is if you have more data on physician resistance, and on this question of loss of productivity, if you can give us more breakdown, maybe not today, maybe at another session, that would be very helpful. Because we're redrafting policies for our 10 million beneficiaries now in defense. And that alone would be a big service to us.

Sorry for the long explanation, but I think every practicing doctor feels a little bit tortured by this, so I hope you'll forgive me.

DR. BLUMENTHAL: If I can take my research hat off and put on my practitioner's hat, I converted to an electronic record when I tried to prescribe a sulfa drug to a patient who was allergic to it, and the record said, you can't. And that was, to me, a kind of seminal moment in my use of the record. It didn't endear me -- the record to me when it also prevented me from ordering a stress test on a patient who wanted it, because it said the indications weren't there, but I think you take the good with the bad in these things.

We will be able to get you additional data, perhaps not all the data you'd like in terms of motivation, and psychology, and physician attitudes, but we will be able to get you more data about some of these barriers and incentives in our next presentation.

DR. CASSCELLS: One follow up, if I may. If there are any DOD or VA docs and nurses in there, could you analyze them separately?

DR. BLUMENTHAL: I don't think we're going to be including DOD and VA docs.

DR. KOLODNER: Craig, then, Kevin, then Gail, and we'll have a decision as to what we do about the rest of the conversation.

MR. BARRETT: There may be some parallels in some other aspects of business. For example, Congress, in its infinite wisdom, passed something called Sarbanes-Oxley. Every public corporation in the United States had to immediately change the way it did business, had somebody looking over its shoulder, public auditors, public reports about how you did this, how you did not do it.

It cost us all millions of dollars. I think it cost my corporation something like 25 or $30 million a year for the first three years or so. And documenting every aspect of our doing business, and every decision we made. And how every internal control operated.

This is not a new issue. Every other business in the United States has done this. As I keep trying to remind this audience, I know that medical care is different. Everybody says their industry is different, but there are innumerable instances where massive changes have taken place almost overnight in the way we do business. Somehow, we're more resistant in this area than every other business that I know of.

MR. HUTCHINSON: I don't know if we want to take this topic on before the break, but going back to this e-prescribing conversation about the benefit incentives and how do you drive it and should it be mandated. You know, there's -- we don't need any more studies. There's plenty of data out there that suggests the value and the benefit that comes out. Most recent ones that came out from Henry Ford Medical Center that spent well over a year looking at this issue, and where the benefit lies. And the fact is, all the participants in the prescribing process benefit by automating this process.

Physicians benefit because they're not reimbursed for their time to manage medications, to take phone call for refill requests, to handle patient calls for those refill requests and pharmacy calls for illegible scripts and things like that. But they have to take the time to do it, and they lose money through that process.

The patients obviously benefit from a safety standpoint and from a convenience standpoint of having those medications ready when they show up at the pharmacy, and from a safety standpoint, obviously, of avoiding drug interactions and avoiding contraindications of medications.

Pharmacies benefit because now the recent studies show that they're actually dispensing more new medications when sent electronically, because there is more compliance with physician's orders on initial medications that are ordered electronically versus ones that are handed to the patient that actually never make it to the pharmacy, but they only make it to the glove box of the car.

And the employers and plans benefit because what Henry Ford has seen, and we all assume this is the case, there is more generic utilization when prescriptions are written electronically. They've even analyzed and they look at how many drug interaction avoidance they had last year with over 1 million medications that were ordered electronically and analyzed, and the percentage of those medications that because they were written electronically, found drug to drug interaction issue problems or allergic problems. It ended up saving them a lot of money, because they're obviously the health plan as well, in avoidance of emergency room visits and hospitalizations.

So all of the data is there that suggests that all of the parties that are participants in this process benefit from it. Some would say, well, then why are the physicians bearing all of the cost of this? And that's not true. The physicians aren't bearing all the cost of this. The pharmacies have borne a lot of cost in implementing and upgrading all of their systems to support these standards that have been required by HHS with NCPDP script standards.

And the pairs, obviously, are in the game and are starting to work with physicians and health plans to try to incentivize to drive the adoption of electronic prescribing. There is going to be a cost to the physicians that has to be dealt with. Is it something that the physicians can absorb, or is there some way to cover the cost to allow the physicians to adopt the prescriptions electronically?

But I guess the point I want to make is before we go too far down the road and say, well, let's go analyze it or look at it, I don't think we need to do that. I think there is recognition that all parties benefit from the process. The question becomes where should -- how we should incentivize the physicians to adopt, whether it be through positive incentives or negative?

DR. KOLODNER: Gail Graham?

MS. GRAHAM: Gail Graham, Department of Veterans Affairs. I want to thank you all, and we had some involvement in the early stages of the definition, and this has been something we have long struggled with, when talking about ourselves, comparing VA to others, is what do people say when they mean EHR adoption, implementation. So I think that really goes a long way to set a baseline and into the future.

In regard to just the VA experience, certainly there were quality drivers, and that's been written about extensively. And I think an offshoot that we did see were economic drivers for this, because we are a closed system. But then there is also that expectation today, where we serve a large rural population, and in order to serve that rural population, the electronic health records for us were really a must, and not a luxury, to provide primary care locally, but tertiary specialized care in larger urban areas, and make that a seamless transition. It was really the only way that we could do it, and maybe we didn't know otherwise, at the time. So it's a matter that was a benefit.

Our clinicians are still clinicians whether they work for VA or DOD or the private sector. And it did have to go hand in hand with administration, locally doing things like adjusting exam rooms to facilitate the flow, adjusting appointment time, duration, to facilitate the initial implementation of the electronic health record. So there was certainly a balancing act between those things. But I want to thank you again for this.

DR. KOLODNER: Lillee, and then I think that -- I'm sensing the energy, at least on the e-prescribing that we had a little while ago isn't there to go in depth on that. So Lillee, why don't you make your comment, and then I'll --

MS. GELINAS: And would you be sensing the iron bladders are giving way?

DR. KOLODNER: Lots of biological --

MS. GELINAS: I have to just call out the obvious here. I'm the nurse on the panel. [laughter] I was intrigued when Kevin said that 30 percent of physicians represent 80 percent of the prescriptions. Did I hear that right? Okay. So if 30 percent have the large majority, what's the cost to get the 30 percent automated? And I don't think we've ever approached it that way before, because then you're really reaching the tipping point. Do we have a handle on that number or not?

[low audio] E-prescribing, I'm sorry. I mean that's what I think he was saying.

DR. KOLODNER: Count for 80 percent of the prescriptions.

[low audio]

MR. KAHN: ... minimal cost to the physician. [low audio]

DR. KOLODNER: What I'd like to suggest is I think we need to get into this, but I don't think we're going to -- for a variety of biological reasons or whatever, including hunger, we're going to be able to continue this right now. Nancy, did you have a brief comment that you want --

MS. DAVENPORT-ENNIS: Two points of observation. If we're going to go back and look at more specifically what is driving the physician resistance, I would like to suggest that we have more of an analysis of how many of the physicians that responded to the survey are actually specialists in their field. And I think it's also quite relative to look at what is a composition at the professional work force within the practice, because indeed, we know that work force transition to electronic health records is a major piece of opposition. So I think we may want to see the practices that -- what they look like. So I would encourage that we consider both of those as we analyze it.

DR. KOLODNER: Okay. Chip, you want to --

MR. KAHN: [low audio] in terms of both quality and savings [low audio] and I would say that the model is not exact, and who says [low audio]. I don't think it's clear. So I'm not saying it shouldn't be done. It should be applied. I'm just saying the business case around EHR in terms of actual savings is a lot different and not as well understood as it is in e-prescribing, where literally generics and buying brand formulary can make a difference on the bottom line of whoever is paying for the drugs.

DR. KOLODNER: Let me bring us to a close at this point. I think there are a couple of things that we know of. First of all, the Secretary wanted us to engage in a further conversation about e-prescribing, and we, I think, don't have the energy to do that today. But what I would like to do is to, in fact, make sure that we do that in January. Lillee, maybe the EHR Workgroup can spend a little time helping to frame that. It will align with David coming back with the full report, and not based on 400, but based on 3,000 responses. And yes, Craig, they are mail survey, and the problem is, did we --

MR. BARRETT: We've discussed this on and off for 17 meetings. The issue is, if you believe Kevin's numbers, and he's quoted those numbers every damn time, they haven't changed. I have to believe they're right. Thirty percent of the doctors do 80 percent of the work. You want a tipping point. Go up to 30 percent of the doctors. By the way, what we do here means nothing.

It's what you guys do that means something. You have the purchasing power. You have the control to say -- not these are the standards, but these are the standards and you will be reimbursed if you do it this way. Period. I mean seems to me this is the simplest possible decision that somebody has to make. It's not a discussion topic. We've discussed this painfully several times.

If I sound like I'm frustrated, yeah, I'm frustrated. In the business world, this would have been a done deal 17 meetings ago. Slam dunk. Get on with it. Falls in your guys' court.

DR. KOLODNER: I think one of the things, and Kevin, maybe you can work with the EHR Workgroup and I'm not sure who else. But one of the issues about the 30 percent is how many actually are Medicare versus pediatrics and versus other chronic illnesses. Because they may or may not be the federal Medicare dollars, and it may be more widespread. But if we -- I think if we can begin to tee up the data to have this discussion continue in January, I think that we -- hopefully, we'll put it at the beginning of the -- or near the beginning, because we're also going to have AHIC 2.0, but to have it when we have the energy and we can have more data that we can see about driving forward, as you'd like to drive forward, Craig.

Ward, last comment before we take a break.

DR. CASSCELLS: I think Craig Barrett's comment deserves a real answer. I share his frustration. I'm looking for ideas for a kind of demo we can do to -- and it may be that the -- it may be that a year from now, the Navy doctor or Air Force doctor doesn't get their check on time, until they get their certain percent of prescriptions done electronically. I don't know what we're going to do, but we have a dutiful bunch, and we have really complete control. I don't want to suggest anything we do is really going to be very instructive to the larger group of physicians.

But I do think a clear demonstration of these kinds of microeconomic incentives that the secretary mentioned is necessary, and we -- I don't want to put Kerry Weems on the spot, but gosh, this is the place to discuss this. And the Secretary's posited some things, and Mr. Barrett has expressed the frustration that the business community feels.

I know the hour is late, but can't we do something? Can't -- Kerry, can you take the pledge on this, and answer this -- [laughter]

MR. WEEMS: I did take the liberty of checking with counsel and that points to one of the great differences between business and government, and why we have government and why we have business. And that is that it would require a change in the statute for us to compel this. So it's not within our means. Certainly it is within our means to ask the legislature for that change, but it's not within our means just to do the slam dunk.

DR. KOLODNER: Scott, did you want to make a final comment and test the --

MR. SEROTA: I'm always willing to make a final comment. I was going to do two things. One was, I was going to say what Kerry just said, that before we put too much pressure on Kerry and his organization, recognize that they can't do it unless Congress allows them to do it.

But I want to support Craig's position. I don't need to see any more data. I've got data everywhere. I don't need to have people waste more time, doing more research, doing more surveys. We know the answer. And maybe we, as AHIC, need to collectively put pressure on Congress through a letter to the Secretary, to -- through a letter to the leadership and Congress to say look, we have studied this until we're blue in the face, and there is only one solution, and that is to mandate compliance with electronic prescribing.

I mean the data is overwhelming. Our blue data, a third of the prescriptions -- when people get electronic, a third of them have drug interactions. You'd save the money alone, forget generic substitution. I mean if you don't want to get into the dollars, just talk about the quality implications. It doesn't matter what measure you look at. The case is compelling.

And I am very sensitive to the physician's practice disruptions. I resisted e-mail and all those things, too, but eventually you got to do it. And now I don't know how I existed without it. And I suspect once we get over the hump of I didn't really want to do it, once the practices go electronic, they'll wonder how the heck they ever operated with paper and pencil before. So --

DR. KOLODNER: With that comment, and with us teeing up for the conversation at the next AHIC, and for you to be thinking about what you might -- how we might move this forward, let me bring -- start the break. We will be back in 30 minutes. I know that's tight for the audience, given some of the choices here, but I think we need to move forward. So if you check your watch, we'll start at what I think will be five of the hour. For members of the AHIC, we do have some sandwiches for you, so if you'll stay.

[break]

DR. KOLODNER: Looks like we were able to get a pretty good part of the AHIC back in time. The audience is still trying to find some sandwiches in the area, so I'm sure they'll join us as we go forward. We have two more presentations. And what I'd ask is that we cut them down to about 35 minutes for each of the panels, and that should help us to get out on time. But I know that they have some important information, and look forward to the discussions.

What we're going to have are two presentations that are complementary to one another. The first one being by AMIA on the report that they have of advancing the framework for uses of health data. And here to make the presentation and to engage in the discussions are Don Detmer and Charlie Safran. So gentlemen, thank you for joining us.

DR. DETMER: Thank you, Dr. Kolodner. The way Charles -- Charlie and I will do this, we'll sort of tag team it. So I'm going to set the stage a bit, and then he was really involved more in the details of the study, and then I'll come back in near the end of the report.

So we're delighted to be here. We're very appreciative, both of the opportunity to tell you about this, and I think also to tell the AHIC how pleased we were that the Secretary addressed our meeting this morning, and obviously, did a wonderful job and was extremely well received by the audience. So we want to thank him for that.

I don't -- yes, I wanted that slide up. AMIA may or may not be known to all of you. It's the American Medical Informatics Association, and it really represents not just medical people. It has nursing, pharmacists, dentists, computer scientists, a variety of health professionals and other scientists who work together to make essentially IT work the way you want it to.

And so we're approximately 4,000 members from 53 nations, so we're quite international. Those areas of interest, about two-thirds of our population of our members are what we'd call clinical people involved in healthcare, but are also very involved in informatics. About a quarter of the population, in our membership, are in public health or population health, and the rest are in what we call bioinformatics or translational bioinformatics, taking the human genome data and moving it toward patient care.

What we plan to cover today are the uses of clinical data and why that is important, and then go into the studies that we've done, and give an overview of the findings of our report, and then talk, perhaps, about next steps. And we'll try to do that in a timely fashion to leave plenty of time for discussion.

I had the pleasure and honor of chairing the Institute of Medicine report on the computer based patient study that went from 1989 to 1991, and Don Berwick at that time, chaired the part of that study that related to data users and date uses. And even then, it was something like either 130 users with 150 uses, or the other way around. But the point was, at that point, it hardly mattered. There is a lot of users and a lot of uses. And everyone thinks that their users -- that they're important as a user, and that the use is important. So this is obviously a big space and place.

Since that time, I also chaired the National Committee of Vital and Health Statistics under Secretary Shalala and had an opportunity to look through these issues when I was chairing that, as we went through the HIPAA exercises, as it got under way. So I had quite a bit of experience in this.

When we approached this study with our two conferences, we really looked at it from the perspective of, well, what is the core of this all? And it's that clinician patient relationship, the doctor patient relationship, the nurse patient -- it's really looking after a health problem. So we started there thinking, well, we ought to look at that first. But then all other uses, in a way, are secondary to that.

Well, obviously, if you're in public health, the patient's the whole country or the whole city. So the point is, we got under way with that kind of a definition. And we didn't want to give the impression that secondary was different from tertiary or something. We were really starting to just say, we better start at the start and work this out, and see what are the issues and what makes most sense. So with that, I'm now going to turn the floor over to Charlie Safran, Dr. Safran, to take it from there.

DR. SAFRAN: So I'd like to thank the Secretary and the members of the AHIC Community for inviting us here today. I'm a primary care internist by background. I run an informatics -- an academic informatics research division at one of the Harvard hospitals, and I spend about half of my time at the Center for Disease Control in the National Center for Public Health Informatics.

I want to just give you a little bit of motivation for -- in addition to some of the points Don made, as to why we were interested in this topic. Just give you a very quick overview of the processes since 2005 to today, of the work that we've done and the deliverables. Then talk about the most recent deliverables, specifically consumer awareness, check lists, a taxonomy that -- of uses of health data. And then talk about the concept of stewardship as it's evolved in our conferences.

So we start from the premise that use of data is a good thing, use of health data is a good thing. And that more of it would be better, under appropriate conditions. And so when we've talked about the uses, the secondary uses of health data, we begin by just trying to remind everybody why it is that we want to facilitate more and better use of this information to enhance experiences for individual citizens, to expand the knowledge about disease and treatment, to strengthen the understanding and effectiveness and efficiency of our health system or health sector, to support public health and homeland security, and to help businesses meet the needs of their customers.

As I mentioned, we started with some colleagues from Pfizer Pharmaceuticals back in 1985 and enlisted support from a variety of corporate supporters. And we convened in 2006, a -- our first conference of about 30 experts. And I'll describe those findings in a second.

We published the framework which I believe has been provided to you all in January of '07, and convened a second conference in June of this year. We've presented to the Consumer Empowerment Working Group of AHIC, of which I also sit as a member. We've testified, Dr. Labcoff [spelled phonetically] and Meryl Bloomrosen from AMIA have testified in NCVHS in July. We have submitted our taxonomy to NCVHS in September. We have also submitted our consumer checklist, which I'll talk about in a second, to Dr. Kolodner and the Office of the National Coordinator. And I'm here today to talk a little bit more.

So as Don said, we started off by talking about secondary, and as you'll see, as I progress, we've dropped the term secondary as being not productive to the discussions, the further discussion of the issues before us. But at the time, we defined primary as being for reasons of patient care, so information that was collected in the context of a clinician patient relationship. And secondary was everything else. I'm just mentioning that to give you the context of 2006, when we held our first expert meeting. Today we believe that it's just appropriate to talk about uses of healthcare data in an appropriate framework.

What we found was that the uses of health data broadly were very widespread, and some beyond the framework or the policy and legal framework that existed. Second, that privacy dominates the public policy to date. I thought we saw that today when Secretary Leavitt talked his first three principles of how we would move forward, which were privacy, privacy and privacy.

Thirdly, we were -- in talking to a variety of experts, both in business and in computer science, we realized that the pace of development outpaced policy and practice. And we were uncovering businesses whose basic business case was that they were out beyond the HIPAA framework, that that was their fundamental business case. We were also concerned at the time that the emerging RHIOs had, as their -- would eventually discover, as a business case, that perhaps they might be able to resell their data, that that might be a part of their evolving business model.

Fourthly, we felt that it was not productive to talk about data ownership, and that to forward a policy discussion, that it was perhaps important to put forward the idea of stewardship. And intuitively, we sort of had a feeling for what that was, but no precise definition. As I'll talk about the work in 2007, we added further definition to what we meant by stewardship.

And lastly, we identified in 2006 the need for more leadership at the national and state levels, and I commend the Secretary, Dr. Kolodner, Julie Gerberding, Dr. Lenert, Dr. Solomon at CDC, for helping us and putting forward on a national basis this issue.

So when we talk about the use of health data, just for purposes of today's discussion, and I'm -- I include secondary just for anchoring effect, we're talking about data that's collected for -- or used for reasons for other than which they were originally collected.

And, again, I just want to state that this data is valuable for reasons of quality, safety, public health, payment, business operations, research, provider certification, accreditation, post marketing surveillance, and a variety of business uses that we felt were appropriate. But that also left open the question, what was questionable or inappropriate uses of data?

The work, then, proceeded to define a framework in six dimensions. These are accountability. That would be the levels of sanctions or penalties for disclosure or inappropriate use of patient health data, transparency, the extent to which the practices governing the use of patient’s health data are known and understood by those who disclose or use patient data, and to the patients whose data are subject to use.

Patient consent notification. The opportunity offered to patients to allow, permit, allow or permit the use of their health data. Notification refers to the mechanism by which patients are informed of their right to consent.

We were very concerned about the concept of deidentification, and we talk more about the cost and complexity of reidentifying data. So there is some important scientific work to basically let us believe that data can be reidentified by publicly available databases. And there was a general feeling that if that could not be done today, technology and data available tomorrow might allow for the reidentification of an anonymized database. So we thought that one of the dimensions was really the cost or complexity of reidentification.

Fifthly, oversight, the extent to which the entity is subject to governance or supervision, including the ability to impose remedies for breaches. And lastly, the regularity and law that existed that is a framework for regulations and law that governs the use of health data, including penalties and enforcement guidelines. So within that framework we, then, put forward a consumer checklist for, or awareness about personal health information, and how it was being used, or how a policy might be devised. Particularly for non-HIPAA covered entities, which was a large part of our concern. This is a broader issue, in terms of consumer education, that we felt was important to be addressed.

So data reuse policy or data use policy needs to be prominently posted on a website or elsewhere with an effective date written in a clear, understandable language, identify that the contact to resolve privacy issues be identified, that any and all use of health data be described, and any sharing of data with other organizations be made explicit to -- we felt the policy should describe how personal health data are protected. And lastly, that we ought to tell patients whether they could have a free report of who's accessed their data and when.

In addition, we thought that the policy should describe permission of how a permission should be obtained to share data with others, and whether decisions to opt out of data sharing would result in denial of services. So we weren't saying whether they should or shouldn't, but if there was that ability to opt out, that we wanted to make sure denial of services wasn't a consequence. We wanted to assure that citizens were provided notification and advance of any changes, and that one could terminate the agreement that you had with a -- someone that had your data, without penalty, if you didn't agree to the changes in policy.

Two more points. We wanted to describe whether upon termination of the agreement, you were able to remove your data from that dataset. Now, we weren't saying that we thought, as a matter of policy, you should be able to do that, but we at least wanted to educate patients that perhaps they might consider that. And lastly, what happens to a variety of these web-based companies when they're sold, merged, with another organization or filed for bankruptcy? What happens to your data in that event?

So one of the things that we think was important to begin the dialogue, and to really drill down on a policy, was that the language that we all use around this table, and in any discussion, that we meant the same thing by the words that were being used. And so one of the things that we did was we assembled members of AMIA, who are among the countries and worlds brain trust in figuring out taxonomy sort of a codification. So in some sense, without going into great detail of what actually transpired in the taxonomy, which is available on the AMIA website, it's the who, what, when, where, why; the terms that we use and the meaning associated with those terms of how we're using the data, for what purpose, who's using it. So that policy needs to be evolved around a common language that we all use. We've contributed that to NCVHS, who I believe has adopted that, and we'll make a recommendation to the Secretary to adopt that.

I think the point that I'll make right now, and I'm sure Dr. Detmer may say more about this, it's a beginning, not a destination, that taxonomies, the words we use are basically dynamic, and as uses evolve over time, and users and a variety of other things, these kind of taxonomies can't just be done and left to age. They need to be maintained and evolve.

So as I mentioned, we thought that the concept of ownership got in the way of discussion, and that trying to understand what was meant by data stewardship and building and maintaining a chain of trust of data. Basically, the idea is that if you're a certified data steward, and whatever that means, that you can transact with other certified data stewards without -- under the same umbrella, that the citizen would have trust that the person or the entity that you are handing the data to would abide by the same rules and understandings and philosophy and policy of the original entity for which they contributed their data. So that's sort of the concept of a data steward. And we wanted to drill down on that a little bit.

So I think I mentioned, the benefits are that they provide a rationale for safeguards and legitimate use. It carries with it enforcement mechanisms, and it enhances the trust that we would have in -- as citizens in contributing our data to stewards.

One principle of data stewardship is that we use the data appropriately. One of our colleagues from the pharmaceutical industry said yesterday at a panel on this topic, don't torture the data until it gives you a false confession. And so that's what we mean by data analytic principles. That they are statistically sound or appropriate. If not statistically sound, use appropriate techniques, that we use standard principles for analysis, that the principles mitigate the risk of false positives, and that provides a grounding for multiple parties that analyze such data so that the data can be compared from one entity to the next.

We're currently working on a refinement of these seven principles that we're putting forward, which do look a little similar to the broader framework. They include accountability, including governance, oversight, and extent and level of applicable regulations. Openness and transparency including structure, processing, and delivery of data plus business processes and outcomes. The idea of notification to patients as being essential to the concept of stewardship. Obviously, privacy and security are included as a principle in data stewardship.

Some level of granularity of consent is one of the principles, and we -- that is an area that in the group of experts that we have convened is still struggling with, is to what level of granularity would both facilitate the principles and adoption of stewardship, and yet not be too onerous from a business process point of view, or a clinical process point of view. The data analysis, principles, and enforcement and remedies.

DR. DETMER: So our next steps. We seek to differentiate really appropriate from inappropriate uses. That seems to be where the crux of this really is, and what kinds of rules, if you will, the road should be in that, and what level of granularity as said, really is appropriate, particularly for this commercial use category.

I think the general sense is that the HIPAA piece of this is quite clear, and actually in place. Where do we go, though, on these places where we're not that certain about? And then how do we develop recommendations to assure the maintenance of the use taxonomy? We're pretty pleased, frankly, not smug, because this is work still underway. But I think we're pretty pleased with the taxonomy and its potential value. But also, it's going to need to be maintained. And how do you maintain that and even refine it as well, but then also cross track to the back as things change over time, so you don't lose meaning as the world does continue to evolve.

And we really do think that stewardship is really the way to look at this. What are the stewardship principles that should really drive this? And that should include data analytic principles. If you're really not doing work that's going to have value, you shouldn't be doing the work, and it's not really a proper use of anybody's data. So there should be also, we think, the science, if you will, of all of this underpinning that should be reasonable. So there are issues there that we clearly still need to refine and define.

We've published these things as white papers. They go through quite a bit of review, because we like to think that we're creating a sort of a story over time, and we obviously like the participation, although we had funding from some private corporate sources and others. We really were able to reach out to quite a wide community and get a lot of input, from essentially a variety of sectors. And obviously, the opportunity to relate to the Office of the National Coordinator and this group. And I sit, for example, on the AHIC Privacy, Confidentiality and Security. You heard that Charlie is involved in that, too. I think a number of us have different roles as it relates to that. We're very interested as well in looking at the issue of the negative impact, if we don't do this right, that it could have on biomedical and health related research. Obviously, that's an issue of huge importance as well.

So with that, we thank you for this opportunity. If you do have questions that you'd like to ask me offline or something, my e-mail address is there. I'd be happy to pass them along to Charlie as well. AMIA really does thank also the sponsors and all the people that put work in this. We're sitting in front of you, but actually, there is a lot of people sitting behind us, and I think in your handouts, you have -- oh, he's also scrolling through those. You have the conference steering committee, they put a lot of work into this. The taxonomy group, the conference sponsors. So you can see, as you look through this, really quite a bit of involvement was there. And I think continuing interest is involved going forward.

And last, the slide is my board, and they also have been very involved and engaged with this. So thank you again, Mr. Kolodner, for the chance to be here, and Secretary Leavitt, for letting us present these.

DR. KOLODNER: Well, thank you very much for your report, for your presentation, and opening up now for a conversation and discussion about this important report. As Charlie Safron mentioned, it actually is forming the basis of some of the NCVHS thinking and report that we'll hear shortly from Dr. Simon Cohn. Kevin?

MR. HUTCHINSON: This is more kind of a process question. Is this also [low audio] having presented to the Privacy Security Groups that are working on some areas around confidentiality of information? The Security, Privacy, Confidentiality Workgroup that's part of AHIC?

DR. DETMER: Yes. I sit on that Workgroup. We haven't made a formal presentation of these data to them. I think we, on the other hand, do have a number of other people who are in the nix of it. But that's a thought, actually. I hadn't thought about it, but I can raise that with the chair and see where that --

MR. HUTCHINSON: I think -- this is very good work, so I think it would be great to share that with the Workgroup who's trying to struggle with where to start on some of these very issues that you've done a lot of work on already. No sense in recreating the wheel.

DR. KOLODNER: Lillee?

MS. GELINAS: Just great work. I just want to commend you, because I know there is a lot of hard work behind the scenes. Industry alignment along this, and when I look -- I don't know who attended the conference, and is behind the scenes from other organizational standpoint, but, you know, industry alignment across a number of organizations, is just as important as the depth. So breadth and depth. How would you ascertain industry alignment of other major groups, in getting behind this work and endorsing it, and vetting it, so that we know that it's one voice, one work, you know, multiple recipients?

DR. DETMER: Excellent question. I'd like to think that the opportunity to present this here certainly is a major piece of that and also to the National Committee on Vital and Health Statistics. As I say, this is still a work in progress, and we will be doing as much as we can to try to get a balanced representation, if you will. We have also talked about this to other groups. And we have published it certainly. But Charlie Safran, do you have other thoughts --

DR. SAFRAN: Yeah. So I'm guessing you'd have to tell me what you meant by industry, but we've reached out to the health information technology industry. Some of them are corporate members, many of them participated in the meeting as -- and also sponsored this. They -- as well as the pharmaceutical industry, which was very interested in promoting the principles, and standards and a framework for a variety of reasons.

Quite a few -- and subsequent to our publishing, we've had a number of groups reach out to us and asked if they could participate in further evolution of this. So we're in process of trying to think about how to drill down on the one very hard part that we had -- I shouldn't say the one very hard part, but the part that was hardest for us, was getting any sort of alignment around what was a use of data where there was an exchange of money. So we sort of abandoned the term commercial use of data, because what it meant to be a commercial entity was a sticking point.

But if you look at the uses of data around where there is an exchange of money, so sometimes companies, for profit companies do work for the government to develop quality databases, for instance. And so we are needing to sort of refine the framework as it might apply to that specific area. So I think that, you know, of the area that perhaps -- our next iteration of this, after we finish further defining the principles of stewardship, I think, then, we need to test this framework and the stewardship principles in this one very important area where we seem to get the most lively discussion, to be kind, which is when data moves from one entity to another, and there is an exchange of money as a part of the transaction.

DR. DETMER: I might take a follow on to that, and try my own words, and see if that may help. I think your question is really a good one, and I think as we got into it, it was more, what's an appropriate use and what's an inappropriate use. Because in fact, if you're running business operations or quality, in a lot of these circumstances, some of those are done in a not for profit, or some of them in a for profit. But again, the use and the rules, if you will, guiding the work, are totally appropriate and already safeguarded, if you will, according to the principles.

The issue is, when is it inappropriate, is particularly I think -- now, again, how do you reach those communities and deal with that? If you have ideas for us, we would be open to it, because I think in our kind of really complex, huge complicated society, it's really important, but it's also not a simple -- simple answer to give.

DR. KOLODNER: Nancy?

MS. DAVENPORT-ENNIS: [low audio] Thank you. I appreciate that. But there are a couple of questions that I have. And certainly, Charlie, this will not be a surprise, since we've talked about this a lot at the Consumer Empowerment Working Group meeting. But as you're looking at your framework and stewardship principles that you were trying to develop, and when we look on slide number two, and we talk about the dimensions of use of framework, and we talk about accountability, and it begs the question that perhaps within the principles, there needs to be some identification of what relief would be available to consumers if, indeed, the secondary use of data did become a matter of public information concerning them.

So as we look at principles, I read throughout the notes here, there is a lot of patient consent and patient will be notified and informed, but I'd like to challenge you to look a bit at what is going to be available to patients in the event that their information is breached and becomes public.

The second observation I'd like to share with you concerning patients and the public, is the issue of opting out with any denial of services. I'm so delighted to hear that that is an issue that you're looking at, and one that continues to probably need discussion and review. I think it is also the final point I would like to make relative to the principles, and what can be done to ensure some form of safety for consumers, if there is a breach, is the definition of how is the data going to be used correctly? How does that happen? And what will the definition look like?

And the final question that I would have that you may need to answer at a later date, but what are the steps that data stewards will go through in order to become certified, so that as we move to assist them, where perhaps we don't own data, but we become stewards of data, there is an accountability.

DR. SAFRAN: So your questions are well taken and right at the heart of the discussions that went on at length over the two conferences and the endless number of smaller Working Group meetings and telephone calls, and -- over the past two years. And I don't know that there is a simple answer for any one of those four questions.

Needless to say, that's really the heart of the debate, which is in order to build a system where there is a chain of trust, we clearly need to bring the citizen -- the citizen needs to believe that the steward is, in fact, doing the things, as you suggest, that will protect the citizen, and at the same time, that there is remedy and recourse.

So, you know -- and I think on the other hand, there is a concern among health service researchers and others about issues of opt in versus opt out, and the quality of data, and what we're going to be able to do to protect the public health and a variety of other issues. If the data are basically censored for certain kinds of uses, meaning that the citizen has control and decides that I just don't want my data to be used for any purpose.

So it's a -- it's an important -- it's a really important part of that issue of stewardship and our attempt, at least, to address that in the slightly less controversial way, to move the dialogue forward, was to put forward this consumer awareness checklist, which is, at a minimum, where should we start educating the citizens around the use of their health data? So we think until citizens are better informed, it's going to be hard to really find the right set point is for policy along several of these dimensions. And so at least in that -- I don't know whether I'm really answering your question.

I think part of the answer is that we need to begin to address consumer awareness, before we get to, you know, regulatory or punitive or other environment. We ought to spend some effort to make people part -- citizens more broadly part of the dialogue that you've invited us here to talk about today.

DR. DETMER: I'd like to add as well to that. You know, AMIA is -- it really doesn't have all the legal expertise. We're more on the medical data side, and some of -- there's definitely a legal dimension to almost every question that you asked, and not, in my experience, unfortunately -- I also chaired the board on Healthcare Services for the Institute of Medicine for eight years, gave rise to the errors report and chasm report.

It's possible that actually the Office of National Coordinator, or perhaps somebody else should be actually asking the Institute of Medicine to take on some of these. These are very, very tough issues, and there is not necessarily a clean right answer, particularly. But you do need the best legal minds, I think, and the data minds, as well as the society more broadly. And really, the Institute of Medicine is probably in the best position to take on some of those kinds of questions. I think we still can go a ways. But as I'm saying, I think you really have touched on some things that have been challenges, actually, for us.

MS. DAVENPORT-ENNIS: I think that to know that you're sensitive to the issues of the consumer and to acknowledge the importance that these issues are to all of us, because ultimately, we are all consumers of healthcare, and to move the ball as far as you can within AMIA, and certainly within AHIC and the leadership of ONCHIT and CCHIT, we do continue to collaborate with many other organizations to get some of the very difficult legal questions answered. Thank you.

DR. KOLODNER: Dr. Safran and Dr. Detmer, thank you very, very much for presenting your report. And moving the conversation along, that clearly is a critically important one, and one that we need to keep advancing and working together on. Appreciate it.

DR. SAFRAN: Thank you. Best wishes.

DR. KOLODNER: And Simon, Dr. Simon Cohn can come up for the next panel, but Scott, you have something you want to bring up?

MR. SEROTA: Rob, if it's -- I don't know if it's in order or out of order, but in following up on our discussion prior to the break, I'd like to suggest that AHIC adopt a resolution suggesting to the Secretary or requesting the Secretary, go to Congress or recommend to Congress aggressively granting CMS the statutory authority to mandate e-prescribing through the Medicare program. Perhaps somebody more eloquent than I can put it in the right terminology, and I know there is a protocol for posting and all that good stuff, but I'd like to recommend, before we start losing members of the panel, that we take an action like that.

DR. KOLODNER: Kerry.

MR. WEEMS: I had occasion to speak to the Secretary, knowing that this might come up. He would be anxious to receive that recommendation, so I think the way that we'd like to proceed is to take this and have Lillee's EHR Committee very quickly draft what that recommendation would be. We'll share it with the panel, and then as quickly as we can, within the rules of public notice and all that, we would schedule a meeting of the AHIC, but do it by voice so that we can accomplish it quickly.

There is a notification period, some of which can be overcome in exigent circumstances. We just need to look at those exigent circumstances. But Lillee, if you could have something for us by maybe the end of --

MS. GELINAS: Tomorrow.

MR. WEEMS: Tomorrow? Fine. That we could -- [laughter]. We could even --

DR. KOLODNER: Actually, under the FACA rules --

MALE SPEAKER: Paper and pencil, I think we have to -- [laughter]

MR. WEEMS: We can -- there are public requirements. Having e-mail isn't quite public enough, or at least most of yours aren't. So if we could have something quickly, and then we'll work with the ONC staff to set up the required notification and then the meeting to get that recommendation to the Secretary.

MR. SEROTA: I assume that that means that my recommendation or resolution passes AHIC?

MS. GELINAS: Did you see the energy just go up in the room big time?

MR. SEROTA: [low audio] Thank you. That's what I was --

DR. KOLODNER: Let the voice record show that all hands went up.

MS. GELINAS: Right. And Rob, I don't know exactly -- Karen, maybe you know the date of the next EHR Workgroup meeting, but the meeting, itself, may be out of alignment. It's December? Just want to make sure that it's aggressive enough in terms of the timeframe, when that Group means --

MR. SEROTA: I mean I'd like to see it get done before year end.

MR. WEEMS: Right. The Secretary's schedule is even more aggressive than that. If we could get something together within the next -- within the next -- within the next couple of weeks, would be --

MR. ROOB: I had to step out during a portion of the conversation, I'm sorry I missed it. But it's for Medicare and Medicaid, or just Medicare?

MR. SEROTA: The original recommendation is just for Medicare. Again, that's a nuance we could discuss when we have an actual resolution in front of s.

MALE SPEAKER: My suggestion would be to give CMS the authority to implement -- let CMS decide which programs, which protocols, and in what sequence.

DR. KOLODNER: Okay. So sounds like we've finished with that brief action, and have a couple of steps to take. And now we'll go to the next panel, as we mentioned. It really is very complementary to the panel that you just heard; whereas the first was a study and report done by a professional organization, AMIA, whose meeting we're at, this next panel is really the report from a subcommittee of another federal advisory committee, National Committee for Vital and Health Statistics.

And because of the close alliance, as you may know, and may recall, we have at times -- ONC has gone to NCVHS for some advice, study and input. So we're really working together. And this is meant to be bringing it back so that we're informed about it. But the actual recommendations that you'll hear about, we'll go back to NCVHS, as that's the Committee that they're actually under. But this is so we can make sure we have wide open communication and also some discussion about the report. So Dr. Simon Cohn will start.

DR. COHN: Okay. Well, thank you for the introduction, Dr. Kolodner, members of AHIC, Administrator Weems. I'm Simon Cohn. I'm an associate executive director for Health Information Policy for Kaiser Permanente, and Chair of the National Committee on Vital and Health Statistics.

I also want to take a minute to introduce Justine Carr, who is senior director for Clinical Resource Management for Beth Israel Deaconess Medical Center in Boston; and Harry Reynolds, who is the vice-president for Blue Cross and Blue Shield of North Carolina. They are both members of the NCVHS, have co-chaired, co-vice chaired the ad hoc Workgroup that we're going to be talking about in just a minute. And we appreciate their participation in this presentation.

As you know, the NCVHS is a statutory public advisory commit to the US Department of Health and Human Services, and the Secretary. We have a 58 year history of advising on a variety of health information policy areas and issues, including health data, health statistics, and health information privacy.

I should also comment, given your discussions about e-prescribing today, this part of MMA, we were actually asked to work with CMS to identify the e-prescribing standards that were additionally identified for [unintelligent] as of today, now going out to regulation. I think we all recognize that that's necessary, but I do applaud the AHIC for recognizing that it's not a sufficient condition to move e-prescribing forward. So obviously, we're happy to be here at this time to hear your thoughts on next steps.

We met with you about a year ago to talk about another effort that we had been involved with, which had to do with initial functional requirements for the definition of a nationwide health information network. To date, we are pleased to have the opportunity to brief you on another set of activities that we have, or are actually just in the process of completing. This was also at the request of the Office of National Coordinator, and looks at benefits and concerns related to expanded uses of health data, as we move from paper to electronic, and from point to point communication, to this vision of a nationwide health information network.

This report is clearly complementary to what you just heard from AMIA, but has really taken the next steps, which some of you were asking about, which includes, number one, hearing from a wider audience, as well as, number two, beginning to contemplate possible HHS next steps in this area. We're obviously delighted that AMIA has done much of the groundwork and advance work for this, and we really do appreciate their leadership, and expertise and thought in all of this.

Now, for today, and obviously, we'll try to go somewhat rapidly, knowing this is your last presentation, between you and airplanes. I'll be talking briefly about scope of work and process, as well as a brief comment on terminology. There is a lot of what Charlie Safran was describing.

Justine will talk about the timing and urgency issues, why now, as well as I think our view about a data stewardship framework and principles. And then finally, Harry Reynolds will be talking about what we'll describe as draft observations, recommendations and next steps.

Now, the NCVHS was asked by the Office of the National Coordinator, in late spring, to begin this work. We began by developing an overall conceptual and policy framework to balance risks, benefits, obligations and protections of various uses of health data.

Then we moved to develop recommendations to HHS on possible next steps. This has included recommendations on data stewardship, principles, and approaches and other measures to enable optimal use of health data while respecting individual privacy. And in all of this, we were asked to make sure to pay particular attention to uses of health data for quality measurement, reporting and improvement as referenced in the AHIC quality use case.

And we were asked to report back in six months. So this has been a pretty fast effort. You have to be aware that this is still sort of final draft documents. As commented, we formed an ad hoc Workgroup of the full committee for this effort, and I think as you can see, it had multiple meetings since the beginning of the summer. The Workgroup membership was designed to reflect diversity of expertise and perspectives of the Committee. Membership is noted in the appendix. Obviously, we also want to thank our excellent staff as well as key consultants in this activity.

Now, this has been a very open and inclusive process. NCVHS held four meetings, eight days of hearings in all, at which expert testimony was taken. We heard from a wide variety of organizations and testifiers representing a wide variety of perspectives. And I want to thank the many that have testified before us. I think as you see, its 58 expert testifiers before our post comments.

We have also appreciated the opportunity to discuss earlier versions of this work with a couple of the AHIC Workgroups. Additionally, in late October, recognizing the fact that this is an important and somewhat contentious area generally, we released a draft document for public comment. This has been circulated. It's also been posted on the NCVHS website. We also held an open public conference call, and have encouraged additional written comments. We are, of course, also discussing it with you, and will be considering all of this input as we finalize our document and recommendations. And in addition, of course, we've leveraged your work as well as that of AHRQ, AMIA, and of course work that we've developed on our own from previous recommendations to the Secretary on many of the issues that we're discussing here.

Now, before I hand it over to Justine, and I think Harry sort of -- Charlie discussed this also, just a word about terminology. We started out and we were asked by ONC to look at secondary uses. As we began to hear testimony, many of the testifiers became very concerned about the use of this term. And we kept coming up with other terms and nothing else seemed to quite fit.

The terms are -- the term is difficult to define. Some people believe primary uses is direct patient care. Others consider primary uses to include primary direct patient care as well as payment and healthcare operations. So clearly, there is no standard definition.

The other point, of course, is that when you start talking about primary and secondary, you start, well, which one is most important? Is primary most important? Clearly, this is a whole connotation that we wanted to get away from. Finally, there is a tendency that when you group everything together like this, that you wind up in a situation where people think that one solution will fit all. And clearly, there is a great heterogeneity of uses within this concept, however we decide to frame it.

Indeed, I think the conclusion that we have come to is that we're really trying to avoid the uses of such terms as secondary, reuse, or other terms like this, and instead, trying to be very precise about what use we're talking about; be it direct patient care, data for submission to public health and communicable diseases, information for quality improvement, et cetera. And I think when you get to that level of specificity, it really moves the debate and discussion along.

Now, with that, I'll turn this over to Justine for other comments.

DR. CARR: And I, too, thank you for the invitation to bring this forward, this work forward today. What I'm going to do is present six slides to you. One is why now, and what were the major themes of our testimony. Then a little background on HIPAA and the privacy rule. And then an overview of our stewardship framework and our principles.

So why address the use of health data now? Basically, the landscape is changing. Electronically available health data are no longer just claims data, but they include very clinically rich data, including problems, problem lists, lab results, medications.

The second point is that electronic data can be linked more readily with other data bases, and this is a good thing in terms of affording the opportunity to assess clinical outcomes, longitudinally. But it also creates the risk of data being linked to databases that might jeopardize privacy, employment, or insurance eligibility.

A third point is that sources of electronic health information are expanding beyond HIPAA protections of covered entities and their business associates. So for example, providers who do not file claims electronically are not covered by HIPAA. Also, as Charlie referred to, programs that provide personal health record services may not be all -- also may not be covered by HIPAA.

And the final point about why to address uses of health data now is that electronic solutions to protect and secure data continue to evolve, including the emergence of approaches to allow individual consent to follow the data. Okay.

So the recurring themes that we heard in the testimony basically boil down to two. The first recognized the great benefit that can be achieved by using electronic health data. And this includes enhancements of quality measurement and reporting with more real-time quality improvement cycle. Also acceleration of accrual of cases for timely identification of complications that may occur from new medications or new procedures, new technologies and devices.

The other theme that we heard is the concern about the potential for harm, and that took on two aspects. One is that there can be erosion of trust in the healthcare system with potential compromise to healthcare, when individuals don't trust that their privacy can be protected. And the second concern is the potential or actual discrimination or confidentiality violations that occur with increased ability to collect longitudinal data and coupled with sophisticated methods to reidentify data.

In the next two slides, I want to talk about HIPAA and the privacy rule, to lay the groundwork of where we are today, and where we perceive gaps to be. Our analysis began with the review of HIPAA. HIPAA's focus was the promotion of electronic exchange of data for administrative simplification. Therefore, HIPAA regulates entities that electronically transmit health information, and this includes healthcare payers, providers and clearing houses. And HIPAA also regulates business associates and their agents.

A key concern is the fact that there are a growing number of entities that are not covered by HIPAA as mentioned, some vendors of personal health records. Another concern is the lack of detail on the expectations of business associations and their agents with regard to the ongoing uses of health information.

As part of HIPAA, Congress required HHS to adopt regulations safeguarding the privacy of individually identifiable health information, and this is called the HIPAA privacy rule. This covers individual identifiable health information in any form; paper, electronic, spoken, any form held or transmitted by the covered entity. So this -- as I mentioned, this is protected health information, but it does not cover personal health information held by any organization outside of HIPAA.

HIPAA requires authorization for disclosures of protected health information except for uses -- uses for treatment, payment or healthcare operations. Or when required by law such as in public health. So healthcare operations is -- it includes an array of activities, such as quality assessment, competence and review, compliance activities, business planning, et cetera.

And the fourth point we want to make is that HIPAA privacy does not protect deidentified data. And CBHS heard concerns related to the sale of deidentified data. So my next two slides will shape or help you understand how we were thinking about the observations and the recommendations that Harry is going to present.

So in this slide, you see the health data stewardship conceptual framework. This framework is intended to outline how an organization may approach evaluation of intended uses of data, and recognize where it may elect to enhance data stewardship processes.

For example, a business associate of a payer that is covered by HIPAA, who wishes to use identifiable data for quality measurement under healthcare operations, would describe the benefits of the use and consider the potential risks for harm, and then consider how it would address each of the data stewardship considerations identified in the boxes at the bottom. In some areas, the user may believe it provides appropriate stewardship, but in other areas, it might see an opportunity for improvement, such as improved transparency or stronger security controls.

We want to point out, as was alluded -- as was spoken about earlier by Charlie, that stewardship addresses not just data collection at transmission, but it also includes data aggregation and use of the data. And focus is needed on completeness and accuracy of data, and processes to assure correct application of methodologic rules. And also valid application of the rules related to statistical significance.

Use of health data is a very challenging area. Despite ongoing evaluation and study of some materials, thought leaders differ on the optimal courses of action. The complexity of this topic is further compounded by the evolving landscape. We are still in early stages of our understanding of the NHIN, and as Harry will describe, NCVHS has put forward some preliminary recommendations that are still under consideration.

In the development of the recommendations, we have identified guiding principles, which each -- against which each of the recommendations is evaluated. So I'll go through these principles now. Protections should maintain or strengthen an individual's health information privacy. Protections should enable improvements in the health of Americans and the healthcare delivery system of the nation. Protections should facilitate uses of electronic health information. Protections should not place an undue administrative burden on healthcare industry. It should increase the clarity and uniform understanding of laws and regulations pertaining to privacy and security of health information. And finally, should build upon existing legislation and regulations whenever possible.

MR. REYNOLDS: Thank you, Justine. I also want to also echo our appreciation for being included today. And now let's move into our observations and recommendations.

First slide, as we transition to health information exchanges, NHIN and beyond, transformation is needed. Our recommendations call for enhanced HIPAA protections and data stewardship for all uses of health data by all users, independent of whether an organization is covered by HIPAA. It is -- whether an organization is covered under HIPAA.

Most of our recommendations don't require legislation, and take the form of guidance, such as was just issued in December for security, requirements for federal agency adoption, you just discussed that a little bit ago in your earlier discussion on e-prescribing; inclusion and requirements for contractors, incentives, conditions of participation, interagency collaboration and others.

Our categories of recommendations, and we have broken those into four, is; one is the principles of data stewardship which will address the areas and the framework having to do with accountability and chain of trust, transparency, individual participation and control, deidentification, security, and data integrity, data quality.

Since our recommendations also -- are also to focus on uses of health data for quality measurement, reporting and improvement, we are including recommendations relating to monitoring such uses and enhancing oversight as appropriate.

Third, as the industry makes a transition to HIE and NHIN, there needs to be evaluation of new tools and technologies, and we'll talk more about those later also. And then last, additional legislation to broaden the scope of privacy coverage to all who may have access to personal health information and to address antidiscrimination consequences that may arise out of the wrongful uses of health data, as we transition to this new world.

So our draft principles on data stewardship and on this page is broken into accountability and chain of trust, and then transparency. Specifically, NCVHS is recommending that covered entities strengthen the terms of their business associate contracts to be more specific about what data will be used, how the data will be used, and by whom the data will be used. Included in the recommendation -- included is a recommendation that covered entities and their business associates regularly confirm compliance with those contracts.

Transparency is very important to consumers, and the notice of privacy practices needs to be more meaningful, and individuals should be able to request and be supplied additional information about what specific uses and users there are of their data, drawn from greater specificity in the business associate contracts.

Next slide. The next, as we continue data stewardship, we have four items; individual participation and control over personal health, deidentification, security safeguards and controls, and data integrity and quality.

Principles of data stewardship also need to expand to personal health data and deidentified data. Today, as Justine mentioned, HIPAA only protects -- protected health information held by covered entities, yet personal health information is being collected by many other organizations outside of HIPAA's jurisdiction, such as web based vendors.

NCVHS is recommending that authorization for uses of personal health information be assured. Further, when PHI is deidentified, the HIPAA definition of deidentified should be used. And CVHS recommends on business associate -- recommendations on business associate -- associate contracts included that uses of deidentified data can we described in the contract. NCVHS will further investigate uses of deidentified data and offer recommendations, if warranted. Turned out to be a larger subject that we originally thought it was. Also, within organizations, there are also more readily available security safeguards and controls that could be applied and data integrity, and data quality need to be assured.

Under oversight of specific -- next slide, please. Under oversight for specific uses of health data, two items we want to discuss there is quality measurement, reporting and improvement, and the next is research. For specific uses of health data, NCVHS believes there should be recognition that quality measurement reporting and improvement are within the scope of HIPAA healthcare operations. However, there may be increased risk as health data for quality measurement reporting and improvement cross more organizational lines. So NCVHS is recommending that organizations institute a more proactive oversight process to ensure compliance with HIPAA.

In the area of research, the Office of Human Rights Protections, OHRP, is already working to clarify definitions within the common rule, but there needs to be a harmonization of research regulations among the common rule, FDA, VA and HIPAA, all of which cover research, but each only in specific instances with some variations.

Guidance on research should also be disseminated beyond the research community to others who may not typically conduct research, but who may find, for example, that a quality study is evolving into research. As finding from a quality study become generalizable to a broader population than the focus of a quality study, organizations are at risk of not meeting the HIPAA privacy rule requirements for privacy board or institutional review board oversight.

Transitioning to the NHIN. And we have two categories there. NCVHS has been very active in the area of envisioning a nationwide health information infrastructure and recommending functional requirements for a NHIM. In follow-up, specific tools and technologies, such as means to attach individual choices to data, improve deidentification techniques, and safeguards for selling -- for the selling of data should be evaluated. So as these new pilots come along, include some of these things in there to make sure that as this transition continues, those things are considered as the world changes.

And our last set of recommendations is having to do with additional privacy protections for health data. NCVHS recognizes that HIPAA has limits. Other protections beyond data stewardship are needed. NCVHS recommends more inclusive federal privacy legislation to cover all organizations that have access to personal health data. And as it says under the second bullet of number one, in the absence of the comprehensive federal legislation, expand the definition of covered entity under HIPAA to include those groups that are not covered currently. NCVHS also believes that legislative or regulatory measures on anti discrimination need to be stronger, and to promote interoperability differences, and state laws need to be understood by all.

So our next steps. We plan to address additional public comment to finalize recommendations of which you are part of that today. NCVHS, we have our full committee meeting November 27th and 28th, and everything will be sent to the Secretary. It does, in fact, go back through our full Committee in public view for further consideration. And then an ongoing analysis and subsequent recommendations will be anticipated.

So in conclusion, we welcome your comments. We know that in some areas, further analysis needs to be made, and we'll continue to do so. With that, I thank you and Simon, I'll turn it back over to you.

DR. COHN: Harry and Justine, thank you very much for doing the bulk of the presentation. I think we're open to questions or comments.

DR. KOLODNER: Craig?

MR. BARRETT: I'm always struck by parallels and other aspects of society, and it seems to me the scenario where a relatively small number of absolute principles trumps all else, and that you can worry infinitely about the process by which things happen. But if you have certain things which are illegal, like disclosing of information, discrimination, et cetera, et cetera, if you engage in any of those activities, you're breaking the law and the law should be enforced, and that should be the ultimate guardian of the individual's rights.

The parallel I was thinking of is if you look at the Enron, WorldCom, those business scandals, it turns out that the executives involved broke existing law, which was not being enforced. And yet what we came down with was a complex set of new processes to try to control the behavior people, as opposed to monitoring the law and monitoring whether they were breaking the law or not.

So I love the approach I think you're taking which is here is a small number of absolute principles. Those should trump all else. And if you effectively implement the principles, then you don't have to effectively go after every minute process within the system. Am I understanding correctly the direction you're taking?

DR. COHN: Yes. I think we're all nodding our head yes, and we're obviously trying to make this along the lines of best practices, model agreements, and contracts with the idea that hopefully it will lessen the administration burden. So thank you.

DR. KOLODNER: Other comments? Questions? Gail?

MS. GRAHAM: What we found through a lot of experience over the last couple of years with data, and we use the data by those that are working on behalf of the government, in this case, but in any other case, is that we've really had to not only strengthen our business associate agreements, but also augment them with data use agreements, or data transfer agreements. And maybe that's too operationally down the weeds here, but it's really been something that at least our general counsel has advised us to do, to be very cognizant. And I really like the aspects of your recommending the follow up with these groups. One thing we've started to do is really going onsite to see if these -- how they're protecting the data, what their security systems are and the disposal of the data at the end of the agreement, for example.

DR. KOLODNER: Nancy.

MS. DAVENPORT-ENNIS: I would like to compliment, particularly, the guiding principles for making recommendations on enhanced protections for use of health data. The bulletin which you do cite the need to increase clarity and uniform understanding of laws and regulations pertaining to privacy and security of health information. Certainly that is a topic that AHIC and the Consumer Empowerment Working Group, as well as Privacy and Security Workgroup have spent a great deal of time on. It is also interesting to note that you are making recommendations that perhaps we need to look at, and explore the need for additional legislation in this area, at the federal level.

I'm also very pleased to see under the individual participation, the control over personal health data, that you are requiring that you assure authorization for personal health information uses not protected under HIPAA.

So I thank you and commend the thorough approach that you have taken to your task, and I think it will certainly benefit us as we make decisions moving forward. Thank you.

DR. KOLODNER: Other questions or comments? Panel, thank you, very, very much for your presentation. We look forward as the report goes back to NCVHS, and as we start to be able to work together on a number of the things that you've recommended.

Okay. With that, we've finished the formal agenda. We have time for public comment. For those who want to make public comment, please come to the microphone that we have, and remind you to keep your remarks relatively brief and no commercial advertisements or promotions.

DR. ZUCKERMAN: Secretary Leavitt, Dr. Kolodner, esteemed members of the AHIC, it's a pleasure and a privilege to return to this microphone where I appeared at your second meeting two years ago, and to thank you, again, for your efforts.

I'm Alan Zuckerman, a pediatrician, who also teaches informatics, Georgetown University. I represent the American Academy of Pediatrics, with its 60,000 pediatricians and represents America's children to the Health Information Standards Panel. And at CCHIT, I co-chair the interoperability expert panel with a representative from industry.

Two years ago I mentioned the importance of reciprocal registration where providers would register with patients. This is the interoperability with personal health records we're still seeking. I mentioned the importance of including children, and I want to point out that the EHR pilot that you've so enthusiastically embraced will not include children. I can't change the legislative mandate of CMS, but, of course, we are going to bring this to the state alliance.

I feel it's important for the AHIC to make a statement on the importance of including children in health information technology so we don't have a repeat of what happened at the FDA regarding the certification of use of drugs for children.

As Mark Leavitt mentioned to you, on Monday, we begin the home stretch of that first turn of the crank with the use cases that you adopted two years ago. And I fear that there may be some surprises in store, in that we've perhaps missed an opportunity to build adoption and enthusiasm for many of these use cases.

Fortunately, the medication history and the formulary transactions I think will make it in. But when it comes to things like the registration summary and medication history, the 200 comments -- over 200 comments we got on our environmental scan show that the industry isn't quite ready to embrace some of the things we've put forward. In fact, we may propose some of these as provisional, where people who fail to meet them this year won't fail, but will need to come back next year and be sure to include them.

And I mention this because I think it's important for the third turn of the crank for you to begin right now building acceptance, adoption, and demonstration of things like a portable family history, like the immunization and response management. It takes a long time to build acceptance of the need to exchange information, and standards alone won't get us there.

Regarding the e-prescribing issues that you mentioned, I do want to point out that this use case you adopted two years ago, with the registration summary, could be a huge enabler of e-prescribing by facilitating work flow, enabling a patient's usual pharmacy, their insurance, their existing medications to move seamlessly into physician's systems. Yet there is very little awareness of this, and I think we need to focus on that work flow facilitation.

And finally, two years ago, I raised the issue at the DEA and the importance of controlled substances to children with attention deficit disorder. And I think it remains a tremendous challenge to align our standards with the needs of our system. And I thank you for your attention, and I hope that you'll continue your fine work towards these challenging issues.

DR. KOLODNER: Thank you very much.

MR. ZETTEL: Good afternoon Dr. Kolodner, and members of the AHIC panel. I'm Hugh Zettel, GE Healthcare. And I'm pleased to speak to you on behalf of my role as the vice chair of the HIMSS EHR Vendor Association, a leading trade association of the over 40 EHR providers, both inpatient and ambulatory space.

Recognizing the benefits of interoperability -- and I'll make these comments available for the public record. Recognizing the benefits of interoperability in healthcare, the HIMSS EHRVA is pleased to announce that it has released a quick start guide for the ASTM HL7 continuity of care document standard. The association developed the guide which is available at no charge at www.HIMSSEHRVA.org on the EHRVA website, as a resource to help hasten interoperability in healthcare.

We developed the quick start guide as a resource to expedite further adoption of the CCD standard because our members recognized interoperability as both an EHRVA and an industry goal. In addition to the resources that are available on that website, along with HIMSS, EHRVA will be developing other resources such as web-x's [spelled phonetically] and tee cons [spelled phonetically] and other materials to help implement this as we introduce this into our products. Thank you.

DR. KOLODNER: Thank you very much. Are there any comments -- any other comments that anybody has to offer?

MR. JACAMATHAN: This is the first time I've come and seen this august body in action, but I always wondered about -- I saw --

DR. KOLODNER: Could you introduce yourself, please?

MR. JACAMATHAN: -- the Secretary's comment, during the convention. And it occurred to me that there doesn't seem to be a focus on removing some regulatory barriers for practice across states. He mentioned about the system, the healthcare system, and he mentioned that if you look at your driver's license, it would be pretty ridiculous for me to say that I can only drive in West Virginia, I'm from West Virginia, and I cannot drive in California. But that is the case for physicians. And it removes an area of competition from the whole mix of things, and it removes the ability to price, and quality, and the cost to play into the mix.

And I was wondering if there is any effort at all to remove the regulatory barriers for practice. I'm not a physician, but I'm sure that other physicians probably kill me, but --

DR. KOLODNER: Could you identify yourself, please?

MR. JACAMATHAN: My name is Jackie Jacamathan [spelled phonetically]. I work for a transcription service company.

DR. KOLODNER: Seeing no one else moving to the microphone, I declare this 17th meeting of the AHIC officially adjourned. I look forward to seeing you all again in Washington in January. Thank you.

[Whereupon, the meeting was adjourned at 3:17 pm CST]