Minutes of the April 9, 2004 NCVHS Workgroup on National Health Information Infrastructure (NHII) Meeting

Department of Health and Human Services

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

National Health Information Infrastructure (NHII) Workgroup

April 9, 2004

Washington , D.C.

Meeting Minutes

The NHII Workgroup of the NCVHS was convened on April 9, 2004, at the Hubert
H. Humphrey Building in Washington, D.C. The meeting was open to the public.

Workgroup members present:

John R. Lumpkin, M.D., M.P.H., Chair
Jeffrey Blair, M.B.A.
Simon P. Cohn, M.D., M.P.H.
Richard K. Harding, M.D.
John Paul Houston, Esq.
Stanley M. Huff, M.D.
C. Gene Steuerle, Ph.D.

Workgroup members absent:

Robert W. Hungate
Harry Reynolds
Kevin C. Vigilante, M.D., M.P.H.

Staff and liaisons:

Marjorie Greenberg; NCHS/CDC Executive Secretary, NCVHS
Mary Jo Deering, Ph.D., OPHS, Lead Staff
Jorge Ferrer, M.D., M.B.A., CMS
Kathleen Fyffe, ASPE
Steven J. Steindel, Ph.D., CDC
William A. Yasnoff, M.D., Ph.D., OS/APSE

Others:

Jackie Lee Adler, NCHS
Bill Alfano, BlueCross BlueShield
Suzie Burke–Bebee, HHS/ASPE
Carol Bickford, Amer. Nurses Assn.
Brian J. Baum, Duke U.
Cynthia Baur, HHS
Ken Beutow, NIH, NCI
Kelly Cronin, CAHIT
Carol C. Diamond, Markle Foundation
John Dumoulin, Amer. College of Physicians
Emily Graham, ASCRS
Robert Hogan, Permanente Medical Group
Debbie Jackson, NCVHS
Trisha Kurtz, SCAHU
J. Marc Overhage, Ind. U. School of Medicine
Dan Rode, AHIMA
Clay Shirky, NYU

EXECUTIVE SUMMARY

WELCOME, INTRODUCTIONS, AND RECAP OF NHII WORKGROUP WORK PLANS—DR. LUMPKIN

Dr. Lumpkin welcomed NHII Workgroup members and guests, everyone introduced themselves, and then Dr. Lumpkin recapped the four-part agenda for the day. He asked the Workgroup to focus on defining the new dimensions for the NHII, and looking at the areas of overlap between the current dimensions and any new dimensions.

UPDATE ON NHII CONFERENCE PLANS—DR. YASNOFF

Dr. Yasnoff summarized the Workgroup activities under the six-point strategic plan: inform, collaborate, convene, standardize, demonstrate, and evaluate. His summary emphasized the importance of agreement on the requirements being accomplished before architecture decisions are made, because the architecture must meet those requirements.

There are eight topic areas at this year’s meeting and sessions for 10 stakeholder groups. Concern expressed at the last meeting that one breakout group by stakeholders was not sufficient was remedied by changing the lunch that followed that breakout group to a box lunch, extend the stakeholder discussions to almost three hours.

ASPE is working very closely with the Veterans Administration on the EHR standard.

On April 13, the full details of a solicitation for state demonstration projects of health information infrastructures will be announced by AHRQ.

ASPE is also working to bring together the stakeholders in the National Capital Area to create an LHII here; the first large stakeholder meeting is April 26. This effort will show senior government policymakers how this type of improved information flow can affect the quality of care that they and their families receive.

In the question period following Dr. Yasnoff’s presentation, the Workgroup discussed Workgroup attendance at the July NHII conference; recommendations for topic leaders at the conference; security and the NHII; regulatory issues; confidentiality issues related to state law; improved language for descriptions of the Personal Health, Governance, and Clinical Research sessions (which Dr. Deering agreed to write and send to Dr. Yasnoff); patient safety; use of the term “ emerging LHIIs” to distinguish the ones that exist from complete LHIIs; and metrics (an area of limited progress, according to Dr. Yasnoff). The Workgroup also discussed conference preparatory work (which should be completed by mid-June) for the following breakout groups: Personal Health; Governance; Incentives, in particular, incentives for quality and models for incentives; Standards and Architecture, which were combined in the hope that the breakout group will produce recommendations regarding gaps in standards development; Confidentiality; Population Health; and Clinical Research. Workgroup members also suggested particular organizations and individuals to contact about the conference and NHII effort.

UPDATE ON CONNECTING FOR HEALTH INITIATIVE

Carol C. Diamond, managing director of the Markle Foundation’s Healthcare Program, presented an update on the initiative, whose activities in many ways complement the Workgroup’s. Dr. Diamond emphasized that her report to the Workgroup is a work in progress and does not represent official recommendations of Connecting for Health. J. Marc Overhage, assistant professor of medicine at the Indiana University School of Medicine, contributed to the presentation to the Workgroup, as did Clay Shirky, adjunct professor in NYU’s graduate Interactive Telecommunications Program.

Every Connecting for Health committee and leadership group involves a combination of public and private-sector stakeholders. Phase One was completed in June 2003. Phase Two efforts are devoted to trying to bring together a broad set of healthcare leaders to establish a shared view of how to improve the healthcare system for patients and consumers through connectivity and information sharing. The two main components of this phase are the incremental roadmap or shared path (referring to things public and private stakeholders agree need to be done), and issues that remain barriers to the information infrastructure. Upon Dr. Yasnoff’s request, Dr. Diamond agreed to have reports on the topics of her presentation available to the NHII Workgroup by mid-June so they could be discussed at the July conference. She also said she will make interim postings on the Web site (http://www.connectingforhealth.org/).

UPDATE ON THE HHS COUNCIL ON THE APPLICATIONS OF HEALTH INFORMATION TECHNOLOGY (CAHIT)

Kelly Cronin, executive director of HHS’ Council on the Applications of Health Information Technology, presented an update on CAHIT. Created in June 2003, CAHIT promotes timely exchange of information about different activities going on across federal agencies and sharing information about opportunities. CAHIT also makes recommendations to the Secretary regarding opportunities related to adopting health information technology and serves as the primary forum for identifying and evaluating activities and investments that complement what is going on in the private sector.

CAHIT has established several working groups, including one on data standards that has built consensus on the electronic health record functional standard that HL7 has developed over the last six months; one on e-prescribing that requires close collaboration with the Office of HIPAA Standards at CMS; and one related to access to drugs.

CAHIT is drafting a policy principles document that supports emerging LHIIs and NHII and that can be used to guide HHS activities. In its Council meetings, CAHIT reviews high-priority projects across agencies to be sure these activities are coordinated.

In a follow-up discussion, Mr. Blair discussed three ways to approach standards: the incremental approach, the long-term approach, and convergence. “We need to converge to our long-term strategy, but in the short term, we can accommodate multiple different incremental [approaches] as long as they will converge to the long-term goal.”

WORKGROUP DISCUSSION

Dr. Lumpkin called for discussion to identify new domains the Workgroup would like to talk about as well as which areas of overlap the Workgroup would like to focus on for the next committee meeting. (He asked Ms. Greenberg for a slot of two hours or more at the next full committee meeting.)

He also said he is looking for volunteers to create an outline of what might be a descriptor of that domain or the issues that need to be discussed within that domain before the next meeting. He identified “research” as the first new dimension.

The Workgroup considered amending “research” to “clinical research and developing health policy,” and discussion ensued about the definition of terms—including clinical research, population research, public health, policy, population health, community health—and what each term encompasses. Mr. Blair suggested another new dimension—payers, and Dr. Lumpkin suggested adding purchasers. Dr. Deering asked whether the technology industry, and particularly vendors, would be a new domain.

Regarding the report that NHII will be writing at the end of the year, Dr. Yasnoff suggested that rather than trying to tweak the prior framework, the Workgroup instead take all the new information and acknowledge the additional complexity and try to communicate clearly that complexity in laying out a long-term vision.

Dr. Lumpkin proposed that at its next meeting, the Workgroup look at the list of stakeholders the Workgroup has identified and answer such questions as: What do they have to offer? What do they have to gain from this vision of interconnectivity interchange of data? What are their rights? The Workgroup should also flesh out some of the materials that will go in the end-of-the-year report, and identify areas on which to conduct hearings. Dr. Yasnoff suggested developing a comprehensive set of requirements or capabilities that will be in place when NHII is completed that do not now exist.

The suggestion to take a stab at creating a model or models was dismissed because the Workgroup felt the requirements have to be defined before the models can be built.

For each of three areas (Research, Policy, and Purchasers/Payers), the Workgroup members agreed that staff would draft bullets defining the requirements for users within this dimension. These would be circulated to Workgroup members for their comments. Dr. Yasnoff said he would take the results of the requirements meeting that he held, try to organize it by dimension, and distribute that well before June.

Dr. Lumpkin adjourned the meeting.

DETAILED MEETING SUMMARY

AGENDA ITEM: WELCOME, INTRODUCTIONS AND RECAP OF NHII WORKGROUP WORK PLANS—Dr. Lumpkin

Dr. Lumpkin welcomed NHII Workgroup members and guests, everyone introduced themselves, and then Dr. Lumpkin recapped the agenda for the day: conference plans; Connecting for Health Initiative; CAHIT, the Council for Application Health Information Technology; and discussion. He asked those gathered to focus on two issues: defining the new dimensions that might be added to the three initially mapped out for the NHII, and looking at the areas of overlap between the current dimensions and any new dimensions that may be defined.

AGENDA ITEM: UPDATE ON NHII CONFERENCE PLANS – DR. YASNOFF

Dr. Yasnoff said that the Assistant Secretary for Planning and Evaluation (ASPE) NHII staff’s activities fall under the six-point strategic plan to inform, collaborate, convene, standardize, demonstrate, and evaluate.

Under inform, collaborate and convene:

ASPE is making presentations at multiple places and doing ongoing educational seminars. Dr. Yasnoff met with stakeholders on March 29 to talk about NHII requirements. Everyone must agree on the requirements before there can be detailed discussions about architecture, because the architecture must meet those requirements. At the next meeting he plans to present preliminary information on the requirements, based on the stakeholders’ input. The Workgroup will comment on those, and then they will be widely circulated for comment.

ASPE has been collaborating with a number of outside organizations, including Connecting for Health, and it has been planning for the NHII 2004 meeting. Also, the Web site is up and running.

The eight topic areas at this year’s meeting are personal health; governance; incentives; standards and architecture; confidentiality; measuring progress; population health; and clinical research. There will also be a tutorial evening before the meeting, so that new attendees can get up to speed on NHII.

Also, there will be sessions for 10 stakeholder groups: consumers, healthcare providers, healthcare organizations, employers, public health, payers, system developers, researchers, long-term care, and health plans. To remedy concern expressed at the last meeting that one breakout group by stakeholders was not sufficient, a lunch period that followed that breakout session has been changed to a box lunch to extend the stakeholder discussions to almost three hours.

More than 40 organizations have already endorsed the NHII 2004 meeting, with more expected.

Under standardize, demonstrate, and evaluate:

There is a set of functional standards for the electronic health record, which is currently in ballot by HL7, but expected to be successful. In addition, ASPE is tasking HL7 to develop an EHR interchange standard that will allow easy transmission of electronic health records in total from one place to another in standardized form.

ASPE is working very closely with the Veterans Administration on the EHR standard. The VA anticipates using this standard to connect with local health information infrastructures (LHIIs) all over the country, since 40 percent of the people who seek treatment from VA facilities also are being treated elsewhere.

On April 13, the full details of a solicitation for state demonstration projects of health information infrastructures will be announced by AHRQ. The intent is to encourage state governments to develop infrastructures within the state or regional infrastructures that involve multiple states.

ASPE is also working hard to bring together the stakeholders in the National Capital Area to create an LHII here; the first large stakeholder meeting is April 26. This effort will show senior government policymakers how this type of improved information flow can affect the quality of care that they and their families receive. ASPE is also evaluating financial and other potential incentives for accelerating NHII.

Questions:

Dr. Steindel expressed pleasure with the expanded stakeholder session. He noted that the HIMSS (Healthcare Information and Management Systems Society) survey is now out (there is a link off the first page on the Web site: www.himss.org), and he invited members of the NHII Workgroup to participate in the survey.

The group then discussed whether members and staff to the NHII Workgroup who attend the NHII meeting have to pay the registration fee. Dr. Greenberg and Dr. Yasnoff said though the decision is not up to them, the NCVHS budget will cover the registration, and it would be appropriate for it to also pay for travel expenses for members, while staff members’ travel is covered by their own agencies. In response to a question by Dr. Steuerle, Dr. Greenberg explained that Workgroup members can attend whichever sessions they like at the conference unless Dr. Yasnoff asks them to serve as an expert.

Dr. Deering suggested everyone indicate which sessions they plan to attend to see if there are gaps in attendance at any of the sessions, though Dr. Yasnoff does not expect Workgroup members to be able to cover every one of the 16 simultaneous topic breakout sessions.

In response to a question from Mr. Houston about who selects topic leaders and topic experts for the July conference, Dr. Yasnoff explained that the decision is made by the ASPE staff, and that they welcome recommendations. Last year, the topic leaders also did the facilitation at the meeting. This year, ASPE instead is asking the topic leaders to cull material for background information for attendees, so that the discussions of the topics can begin at a higher level, with the recommendations that grew out of last year’s conference. There will be separate facilitators.

In response to a question from Mr. Houston about whether security will be considered an architectural issue or whether it will fall under confidentiality, Dr. Yasnoff said security is primarily an architectural issue. The real issue, he said, is what policies need to be set in the area of privacy and confidentiality. Once those policies are set, an architecture has to be created that allows for security implementation and a security regimen that provides a level of protection that is consistent with the policies. At Dr. Yasnoff’s request, Mr. Houston agreed to work on the confidentiality issue.

Responding to Mr. Houston’s question about regulatory issues, Dr. Yasnoff highlighted what has been done in response to a strong recommendation from last year’s meeting as a major positive development. Essentially, a safe harbor has been established under the Stark Rules for investment in information technology. He also noted that he cannot say anything about what HHS is doing on regulatory activities until they are announced.

Confidentiality issues related to state law are more complex, Mr. Houston noted, and some states’ laws will be a definite barrier to establishing LHIIs. Pinning down the actual state laws that are barriers to LHIIs has proved elusive, Dr. Yasnoff said. “I have literally not been able to document, even in an email, a single legal opinion related to this.” Research on these state laws shows that “the issue is not that the regulations prevent the proposed action, but that the counsel involved misinterpreted the regulations and was being overly conservative.”

AHRQ and CDC should be listed as part of the Department of Health and Human Services under conference endorsers, Dr. Deering noted. She then referred the Workgroup to the breakout process on Dr. Yasnoff’s conference overview and commented on the personal health bullet, the governance bullet, and the clinical bullet. Characterizing the personal health breakout session as focusing on inviting consumers and patients to participate in discussions “is extraordinarily condescending,” she said. Under governance, she encouraged Dr. Yasnoff to expand that language as well. Under clinical research, she again thought the topic was framed too narrowly, and she agreed to suggest alternate language in writing to Dr. Yasnoff on all three areas.

In response to Ms. Cronin’s suggestion that quality or patient safety be referenced in the context of measuring progress, Dr. Yasnoff noted that one of the most important goals of NHII is, in fact, to enhance the quality and safety of patient care. And since a health information infrastructure is needed to improve quality and safety, “we did not feel that any more discussion of that was worthwhile,” he said. He does not want to include quality and safety measures in terms of measuring progress because that is up to the folks in the breakout group. When Ms. Cronin pointed out that improvements in quality and safety could help with sustainability and be a key factor in spurring a decision to even initiate LHIIs, Dr. Yasnoff responded that, “It’s precisely because everyone agrees on that that it is not here, because it does not need to be discussed.”

To avoid the problem of disenchantment with the NHII and LHIIs due to unrealistic expectations, Mr. Blair suggested distinguishing emerging LHIIs from complete LHIIs. Dr. Yasnoff agreed to try using the term “emerging LHIIs” for the LHIIs that now exist.

Dr. Diamond asked the Workgroup whether the IT investments in quality and safety projects could be considered part of building the NHII, rather than always thinking that the NHII is there first, and those are built as derivative outputs. The same opportunity is there for public health, she said.

Since none of the existing LHIIs can communicate with each other, and that is an important aspect of the NHII, Dr. Steindel supports the term “emerging LHIIs” for the LHIIs that currently exist. He suggested that the NHII conference should answer the questions: Why do I need all these point-of-care systems that are handling quality? Why do I need them linked together nationally?

Dr. Yasnoff noted that, “It certainly would be easy to miss the bulk of the quality and safety benefits if you are not careful about implementation.” He asked how those points might be emphasized within the framework of the meeting or whether some changes need to be made to the framework.

In response to Dr. Lumpkin’s suggestion that a plenary speaker could make the case for the NHII and the potential increase in quality, Dr. Yasnoff said one of the few plenary sessions is devoted to NHII benefits—quality, safety, and efficiency. “The idea that we have to build the NHII in such a way that we do not miss these benefits I believe is very important … at a minimum, we can make sure that, in the materials that are prepared for the topic discussions, those kind of overarching points are made to each group.”

Although Dr. Yasnoff agreed with Dr. Steuerle’s comment that the metrics group should discuss measuring how disseminating better healthcare is facilitated through the NHII, he said that the place for that is in the background material for that session. That way, conference organizers do not influence in advance what the metrics group talks about.

Dr. Deering pointed out that the metrics she has seen are still mostly bean counting, and observed that “the discussions are about which beans to count.” She asked whether there is any thinking about what kinds of connections and links between projects and efforts could be valuable from a policy point of view.

“I am very dissatisfied with the progress that we have been able to make in terms of defining even what the universe of metrics to choose from should be,” Dr. Yasnoff responded. He noted that the whole area of relationships is very important and that “we ought to, if possible, try to measure those relationships, because, clearly, I can tell you, in communities, that you don’t get health information infrastructure until you first build strong and numerous relationships among all the stakeholders in the community.”

This is a challenge for HHS, even within its funding efforts, Dr. Deering said. Defining what to ask the groups that receive funding to do together is a bit of an intellectual challenge that people should be equal to, and it has huge policy implications.

Dr. Ken Buetow said the National Cancer Institute is looking at metrics that look at how people actually go about sharing tools, and sharing infrastructures. Rather than looking at how many lives or dollars have been saved, they are asking: What is the sharing ratio of important biomedical research tools? How commonly does a wrapper for a particular infrastructure get deployed at multiple locations? How commonly can a data set that is generated in one location be communicated and utilized by another community? Clearly there are parallels to NHII.

Dr. Lumpkin asked the Workgroup to discuss the preparatory work (which should be completed by mid-June) for the breakout groups, starting off with Personal Health because it has been the slowest-developing dimension.

That group is now moving forward, Dr. Rippen reported. Dr. Deering suggested the Personal Health group consult with a provider or payer who is fairly far ahead with patient-centered care, such as Blue Cross/Blue Shield or Kaiser, to make sure lessons learned are being incorporated for the provider domain.

Dr. Yasnoff said he would like to expand the Governance area, but is looking for specific suggestions of issues to consider. Dr. Lumpkin would like the Governance group to get input from the organizations (such as United Health Care or Kaiser) that span multiple regions of the country. Rather than trying to influence an early draft of background materials, he suggested having a select group of responders willing to prepare a page-long piece that could be sent to the participants. Participants would not only see what the group leaders are thinking, but provide some initial response, and allow the discussion to move forward rather than retread familiar ground.

Dr. Buetow pointed out that besides what is happening in the private sector, national activities by NIH and CDC and others are going on. Figuring out how to coordinate or govern all of those to a common setup of standards would be very important.

Dr. Yasnoff noted that if an LHII is built in any area in the country, then living on the boundaries of that area will be people who are going to get their care in the next LHII over in every direction. To be able to deliver complete patient information at the point of care, it has to be possible—at a minimum—to communicate patient information to the adjacent LHIIs. “If we do that, with a set of standards and a set of standard functions, the same standard functions will then allow you to communicate with the VA, DoD, CDC, NIH, other national organizations.” The issue then becomes how to define the set of functions needed to communicate between LHIIs, and that is a Governance issue.

Someone should be designated to address how to put incentives in place—whether financial, regulatory, or other types of incentives—that tilt the balance towards the adoption of standards for interoperability, Mr. Blair said. Otherwise, several years from now there could be two major groups of LHIIs, those that are interoperable and those that have very high function and have been able to develop quickly because they ignored standards for interoperability with others. Dr. Steuerle agreed, and pointed out that legal and contractual issues about forming LHIIs are important, especially for boundary cities between two states, such as Chattanooga or Washington, D.C.

Dr. Lumpkin observed that whatever the NHII does in terms of governance, it has to balance local needs and desires with regional and national needs and desires, and so that tension will be presented to the breakout sessions, so that they can see the interplay.

After comments from Mr. Houston and Dr. Steuerle about whether those points are more related to architectural standards or law than governance, Dr. Yasnoff said that how the LHIIs relate to each other ought to be brought to the attention of all the different groups to consider as part of their deliberations. “Obviously, if there is no measure of progress that relates to how LHIIs link to each other in any way, we are not measuring the right thing, or we are missing a big piece.”

Governance issues should be reserved for those things that inhibit all the other pieces from coming together—an overarching framework that has to be in place for the NHII to work, said Mr. Houston. With regard to privacy, are there other models out there (what is the EU doing?) that might be helpful, or is the Workgroup charting new territory, he asked.

Dr. Yasnoff said there are lessons to be learned from other countries, but there is no solution any other group or country has used that is easily importable. He noted that there have been preliminary discussions of convening a conference to talk about the developing health information infrastructures around the world and to facilitate sharing that information.

Dr. Lumpkin asked the Workgroup to discuss Incentives, in particular, incentives for quality and models for incentives. Dr. Steuerle, an economist, volunteered to work on the backgrounder for this area. Dr. Steuerle said he would like both private-sector and public-sector people in the Incentives group to think freely and talk openly at the NHII conference about the disincentives within their own structure that disincline them to move toward the NHII as well as what possible incentives might make things move.

Removing current disincentives could be equally or even more important than putting in place good incentives, said Dr. Yasnoff. For example, the current U.S. healthcare system is designed to produce expensive, inefficient care, of inconsistent quality, and those who practice quality care are not only not paid more, their income is likely to decrease. Clearly, that is not a good incentive, he said. HHS is already sponsoring some specific research looking at “what kind of incentives and what amount of incentive is required to move the adoption of electronic health records and to facilitate the adoption of LHIIs.”

A substantial number of experiments in pay-for-performance for physicians have yielded disappointing results, Dr. Yasnoff said, so HHS concludes that they have been not been giving physicians the tools they need to perform what is being asked of them. He compared it to giving people a financial incentive to travel at 25 miles an hour, but not giving any of them bicycles or automobiles to do it. If a financial incentive is necessary, what level is necessary? Will removing the disincentive work as well or better, he asked.

Dr. Lumpkin noted that most incentives are tied into a capital-intensive conversion to electronic health records, which refers to buying the equipment and software initially and buying upgrades as needed. But another model to consider is “back-office electronic health systems” where vendors sell, on a per-transaction basis, the ability to use their system. Those models may lend themselves to different kinds of incentives or reimbursements, because there is no up-front capital cost for the users.

Mr. Blair said he was puzzled by the conversation on incentives, because he thought there was already agreement that pay-for-performance was the model for incentives.

Dr. Lumpkin responded that “we don’t know quite how to do pay-for-performance yet, and we are not sure which of those models for pay-for-performance will work, and … the economics—the micro-economics in the office as well as the overall system economics—are different for quality than they are for the use of electronic health record, and we need to understand those differences.”

When outcomes can be measured, then quality improvements can be made based on those results, Dr. Steuerle said. But many times, measuring outcomes is so complex that rather than subsidizing outcomes, which is the ideal, money has to be spent on inputs.

Dr. Deering made two comments, the first about the model where a vendor might provide a utility. “Clearly, then, you are looking at incentives for the payers, because, under any scenario, they benefit.” She concluded that incentives that do not just look to the individual physician at the point of care or office practice or the provider organization would be another issue to keep on the table. Her second comment suggested Dr. Yasnoff’s report omit reference to the 1946 Hill–Burton Act (a federal program that provided federal money to healthcare facilities for reconstruction or modernization). People in healthcare policy insist Hill–Burton was responsible for the overdevelopment of capacity that created significant problems later, she said.

Figuring out the proper incentives to spur change is tricky, Dr. Lumpkin said, since it is possible that even if the individual incentive can be determined, when it is applied to the whole system, it may cost individuals more than doing nothing. The CDC found, according to Dr. Steindel, that having incentives alone (in the form of grant money) is not enough. The tools have to exist to augment the incentives.

Dr. Lumpkin asked the Workgroup to talk about Standards and Architecture, and Dr. Yasnoff asked Dr. Huff, as a co-lead in that area, to begin the discussion.

Dr. Huff and his co-leader have talked about the need to set up a process for adopting architecture: “that is, if you are adopting architecture, you are adopting standards, and, actually, in implementing, how does that happen?” He pointed out that the two emerging LHIIs (in Santa Barbara and Indianapolis) have very different models about how data is put into repositories and how it is shared. A second thing to work on is what are the options for architectures. A third topic was the special problems related to decision support, sharing decision support, and being able to execute decision support within this framework. They also discussed what other ways exist to implement standards, such as open-source consortiums to share software, implementations, and applications; tool kits; or other business models for sharing tools and architecture. Architecture at the boundaries of LHIIs to the national NHII was also a topic.

He noted that they are creating a standard to exchange a whole EMR, and an alternative strategy for handling requests for parts of the record needed when care is provided. Creating a system for tracking versions and maintaining a master record is also important, as well as finding out what lessons have been learned about healthcare system architecture in the United Kingdom and the European Union and ways to certify or validate whether a system meets the standards.

The Architecture and Standards discussions were combined into one group. By combining them, it is hoped that the group will produce some recommendations regarding gaps in standards development, and, in particular, for example, the need for a standard for computable guideline exchange. Mr. Blair expressed his support for combining Standards and Architecture. Dr. Lumpkin suggested adding the concept of being “incrementable” to the Standards and Architecture heading. What is needed is a standard that can be incrementally put in place, that is robust enough to support what the Workgroup ultimately thinks will be done.

Mr. Houston thought it would be valuable to explicitly recommend that NHII defer entirely on support of specific standards to another group such as NCVHS, but Dr. Yasnoff said that though the NCVHS activity is obviously very important and helpful in terms of standards, NCVHS does not develop standards.

Dr. Lumpkin agreed with Dr. Yasnoff, saying that “we need to really invest in the standard development process to make sure that there are standards available when there is a demand for them.” Dr. Cohn concurred, saying the idea of combining Standards and Architecture sounded like a very reasonable way to put together an agenda for a set of breakout sessions at a major plenary session, a yearly meeting. He then asked Dr. Huff if he was planning to have business cases or priorities help focus the discussion, noting that perhaps the breakout session should consider decision support at the point of care a high priority issue, since it begins to order a lot of the architectural discussions.

The intent of this meeting is not to figure out what that standard should be, but, perhaps, there may be some recommendations for an ongoing process, said Dr. Yasnoff. This is an important gap, and it is important to hear the stakeholder view on it because it is a serious productivity impediment in the implementation of electronic health record systems and in deriving the desired benefits. Dr. Cohn agreed but questioned whether a standard for guideline exchange is necessarily the solution.

What are the categories of needs to support the development of the personal health dimension and to support other kinds of exchanges between the dimensions that are not purely related to clinical data exchange, Dr. Deering asked.

Dr. Steindel noted that everybody accepts the idea there should be a standardized way of exchanging information in the form of a message. He suggested there should also be standardized terminology that people are using and that he hopes the discussion at the July conference can move one step beyond that.

When Dr. Steuerle expressed hope that the stakeholders discussing architectural standards would pinpoint where they are liable to serve as obstacles to an NHII, Dr. Huff agreed, saying that commercial vendors are going to be asking whether there is a new business opportunity for them and in what way can they participate profitably.

Dr. Lumpkin asked the Workgroup to discuss Confidentiality, and whether there were any items to add to that breakout session. When no one had any new points to suggest, the discussion moved on toPopulation Health. E. Andrew Balas, dean of the School of Public Health at St. Louis University, and Scott Williams, executive director of the Utah Health Department, are taking the lead on the advance work for the breakout session. Since the NCVHS has a Population Health Subcommittee and a workgroup on quality is part of that subcommittee, Dr. Deering suggested they might facilitate that.

Moving to Clinical Research, Dr. Lumpkin suggested Alex Ommaya, director of the IOM’s Clinical Research Roundtable.

To get across the idea to the public and anyone who feels threatened by the NHII that those putting together the NHII are sensitive to consumer concerns, Mr. Blair suggested listing consumer health and privacy at the top of the breakout sessions and list of topics. As a followup, Dr. Deering asked that wherever appropriate, consumers and patients be represented in breakout groups, not just in the personal health dimension. She suggested turning to NIH to help identify anyone who could help represent the patient perspective in clinical research within this workgroup.

In response to Mr. Blair’s suggestion that the Workgroup contact privacy advocacy groups in healthcare to be sure they know they are welcome at the July meeting, Dr. Rippen said they are making aggressive efforts to reach out, and that they welcome suggestions of organizations or individuals to contact.

Dr. Deering suggested reaching out to the executive directors and presidents of all the major constituency groups—such as the Heart Association, the Cancer Society, the Diabetes Association, associations for those with chronic diseases, and the National Caregivers Alliance. Caregivers is such an important category that she added it to the personal health dimension; now it includes consumers, patients, and caregivers.

Consumers Union and Consumer Web Watch were also suggested. Dr. Yasnoff reported already contacting the American Association of College Nursing, meeting with a representative of the Consumer Federation, and having regular representation from AARP, but, “the more the better. … the last thing we want is for some important group to feel slighted because we haven’t reached out to them.”

If as small number of attendees shows up for one session, that session will likely merge that group with another group, and if a large number of people show up, he would like to split it into more groups, although that will be logistically challenging.

AGENDA ITEM: UPDATE ON CONNECTING FOR HEALTH INITIATIVE

Dr. Lumpkin introduced Dr. Carol C. Diamond, managing director of the Markle Foundation’s Healthcare Program, who is now actively engaged in the second round of Connecting for Health, whose activities in many ways complement the Workgroup’s. Dr. Diamond emphasized that her report to the Workgroup is a work in progress and does not represent official recommendations of Connecting for Health.

The purpose of the first phase of Connecting for Health was to spur an interconnected health information infrastructure. The assumption is the network is worthwhile, that it provides value, and the future base is for high-quality care. The information needs to be able to move when it needs to move, and move in a private and secure manner.

A premise of the Initiative and its participants is that achieving this goal requires public and private-sector collaboration, so every Connecting for Health committee and leadership group involves a combination of public and private-sector stakeholders.

Dr. J. Marc Overhage, assistant professor of medicine at the Indiana University School of Medicine has been working on the Connecting for Health Project since it began. He contributed to the presentation to the Workgroup, as did Clay Shirky, adjunct professor in NYU’s graduate Interactive Telecommunications Program.

Connecting for Health completed Phase One in June 2003. Phase Two efforts are devoted to trying to bring together a broad set of leaders within healthcare to establish a shared view of how to improve the healthcare system for patients and consumers through connectivity and information sharing. The two main components of Phase Two are the incremental roadmap or shared path (referring to the things public and private stakeholders can agree need to be done), and issues that remain big barriers to the information infrastructure. To address the second component, four new workgroups were set up: the business and organizational aspects of health information exchange; policies of information sharing between doctors and patients; technical and policy aspects of accurately linking health information; and additional technical aspects of health information exchange that go above and beyond the initial set of standards.

Input and outreach in Phase Two began in February 2004 with a series of informational interviews designed to create a foundation for focus. Dr. Diamond conducted most of the 60 interviews with healthcare leaders; Kelly Cronin conducted many of the interviews with public sector leaders. The interview responses revealed diverging views about near-term priorities for creating the NHII. Seven primary areas were identified: incremental infrastructure; funding; data standards; incremental applications; the IT exemption for Stark; linking health information (or the identifier issue); and federal leadership.

Dr. Diamond elaborated on the areas where disagreement exists, especially about what the most important areas for the near-term—the next one to three years. (See transcript at http://ncvhs.hhs.gov/040409tr.htm.) She also gave a progress report about the shared path for four of the seven issues she mentioned.

Dr. Overhage presented the five technical specifications of the common framework, which include a common, well-established infrastructure underlying framework for communications, which has to be ubiquitous, built upon the Internet for communication, with agreed-to and consistent security standards. There also should be an authorization infrastructure to deal with who is allowed to do what, and a minimum level of system functionality in terms of response time and length of retention of data. And the NHII should be built upon messaging standards, leveraging existing standards with common connectivity parameters in order to facilitate the communications.

Regarding linking health information, Dr. Diamond noted that the relevant Connecting for Health workgroup had great success putting healthcare folks and non-healthcare folks together to try to solve some of these problems, and generating learning from other industries. This group had early consensus for a decentralized system that needs to be federated—some organizational structure that provides a shared policy framework for safe and appropriate data sharing.

Mr. Blair expressed how impressed he was with Dr. Diamond’s presentation and what it reflected about respect for divergent views and efforts to reconcile those divergent views with trying to build consensus. Dr. Cohn appreciated the fresh thinking presented in some areas, in particular bringing people outside of healthcare in for some of these discussions.

In response to a question from Dr. Cohn, Dr. Diamond said that by June or July, written reports on the topics of her presentation will be available and that she will make interim postings on the Web site (http://www.connectingforhealth.org/).

In response to a comment from Mr. Blair that he appreciated the discussion about whether an incremental approach or long-term change is appropriate (Mr. Blair feels they are complementary rather than opposing views), Dr. Overhage noted that the long-term strategy and plan probably cannot be absolutely crystallized yet, so it will by necessity remain “a little bit fuzzy” for a while. Meantime, they need to “accept that fuzziness for now, but know that we are headed in the right direction, and then the fuzziness will get resolved over some of this early time.”

AGENDA ITEM: UPDATE ON THE HHS COUNCIL ON THE APPLICATIONS OF HEALTH INFORMATION TECHNOLOGY (CAHIT)

CAHIT has established several working groups, including one on data standards that has built consensus on the electronic health record functional standard that has been developed over the last six months; one on e-prescribing that requires close collaboration with the Office of HIPAA Standards at CMS; and one related to access to drugs.

Among the short-term opportunities Ms. Cronin cited were incremental applications, for example going forward with e-prescribing on a national basis even if all the standards are not in place yet, and acceleration of electronic health record. CAHIT is drafting a policy principles document that supports the emerging LHIIs and NHII and that can be used to guide HHS activities.

CAHIT is also working closely with the consolidated health informatics effort and thinking creatively and strategically about “how can we work together to make sure we have a systematic, reasonable policy that will encourage the adoption of standards, particularly as it pertains to data exchange with the government,” Ms. Cronin said.

In its Council meetings, CAHIT reviews high-priority projects across agencies to be sure these opportunities and activities are coordinated

After Dr. Lumpkin disclosed his professional affiliations to both Connecting for Health and CAHIT, and called for questions and comments, Dr. Deering offered her thanks to Dr. Diamond for helping the government identify and thus avoid funding dead ends. When Dr. Ferrer asked Dr. Diamond to share the barriers between the private sector and federal government initiative and what recommendations she has for continuing private–federal collaboration, she responded that Connecting for Health experienced few barriers, and that “there is a role for, I think, both public and private sectors to play.”

Two parallel processes happening now relate to developing the next iteration of recommendations on the development of the NHII, Dr. Lumpkin said. These are the NHII conference in July and the Connecting for Health initiative. Connecting for Health is an elite process, because it goes out to all the leaders in the federal government, the vendor community, and the provider community. The NHII conference of 1,000 represents the breadth of those interested in