Department of Health and Human Services

National Committee on Vital and Health Statistics

Subcommittee on Standards Hearing

February 24, 2009

Hubert H. Humphrey Building
Washington, D.C.

Purpose of the Four-Day Hearing Initiative:
How Do We Improve the Processes for Health IT Standards Development, Selection and Implementation?

Theme of Day One Hearing:
Setting the Context for the Evolution of Health IT Standards

Meeting Minutes

The Subcommittee on Standards of the National Committee on Vital and Health Statistics was convened on February 24, 2009 at the Hubert Humphrey Building in Washington, D.C. for the first of four days of hearings planned for the coming months. The meeting was open to the public. Present:

Subcommittee on Standards members

  • Jeffrey Blair, M.B.A., Co-Chair
  • Judith Warren, Ph.D., R.N., Co-Chair
  • Harry Reynolds, NCVHS Chair
  • Walter Suarez, M.D.

Staff and liaisons

  • Marjorie Greenberg, NCHS/CDC, Executive Secretary
  • Denise Buenning, CMS, Subcommittee lead staff
  • Jorge Ferrer, M.D., VA liaison
  • J. Michael Fitzmaurice, Ph.D., AHRQ liaison
  • Debbie Jackson, NCHS
  • James Sorace, M.D., ASPE
  • Marietta Squire, NCHS
  • Karen Trudel, CMS liaison

Others

  • Larry Green, M.D., NCVHS member
  • Charles Friedman, M.D., ONC
  • Allison Viola, AHIMA
  • Carol Bickford, PhD, American Nurses Assn.
  • Stanton Park, Capitol Associates
  • Maria Friedman, SureScripts-RxHub
  • Steven Zigtkus, CAQH
  • Miriam Halimi, RN, Holy Cross Hospital
  • Charles Jaffe, MD, HL7
  • Adam Birnbaum, BlueCross BlueShield
  • Claudia Williams, Markle Foundation
  • Virginia Saba, EdD, CCC
  • Alan Mertz, American Clinical Laboratory Assn.
  • Melvyn Greberman, MD, Public Health Resources, LLC
  • Catherine Schenk-Yglesias, Johns Hopkins Univ.

Panelists

  • Douglas Bell, MD, PhD, Rand Corporation
  • Don Detmer, MD, AMIA
  • Carol Diamond, MD, Markle Foundation
  • Linda Fischetti, RN, MS, Veterans Health Administration/ONC
  • Rosemary Kennedy, MBA, RN, Alliance for Nursing Informatics
  • Robert Kolodner, M.D., ONC
  • Gilad Kuperman, MD, New York-Presbyterian
  • Alan Mertz, American Clinical Laboratory Association
  • Rod Piechowski, American Hospital Association
  • William Stead, MD, Vanderbilt University/National Research Council
  • John Tooker, MD, National eHealth Collaborative/Amer. College of Physicians
  • Steven Waldren, MD, American Academy of Family Physicians

Hearing Day One:

Setting the Context for the Evolution of Health IT Standards

THEMATIC SUMMARY

This NCVHS hearing was the first in a series planned by the Subcommittee on Standards to assess the processes for health care information technology (IT) standards development, selection, implementation and adoption and to engage stakeholders in a continuous improvement process for the future. The recent passage of the American Recovery and Reinvestment Act (ARRA) made this a timely opportunity to take a broad look at standards and consider what has been accomplished, what perspectives may be missing, and how processes could be improved. A dozen speakers gave informative and thought-provoking presentations that stimulated lively discussion. The proceedings are summarized briefly in the next section, starting on page 4. This section summarizes the major themes of the meeting. (The full transcript and speakers’ slides and prepared statements, when available, are posted on the NCVHS Website.)

The day began with an update on the Office of the National Coordinator (ONC) by the Coordinator, Dr. Rob Kolodner. His comments helped frame the day’s discussion and anticipated many of its themes. This was followed by presentations by three panels—the first composed of thought leaders, the second composed of a diversity of standards users, and the third addressing the role of standards in national IT initiatives. The final presenter, Dr. William Stead, echoed other thought leaders in a call for outside-the-box thinking. He based his comments on the recent National Research Council report, Computational Technology for Effective Healthcare: Immediate Steps and Strategic Directions.

Three Questions

The Standards Subcommittee had asked the panelists to respond to the following questions:

  1. What are the major recent achievements for health IT standards development, selection, and/or implementation? Describe the processes that enabled these achievements.
  2. What health IT standards, development, selection, and/or implementation challenges remain?
  3. What should the model be for the development, adoption, and implementation of health IT standards for the nation as a whole? Who are the players and who should be involved?

Although their responses reflected their varied experiences and viewpoints, most panelists agreed that standards activities have produced positive results, especially during the last four to five years. The success of the Nationwide Health Information Network (NHIN) Trial Implementation was noted as especially significant. There was also a good deal of agreement about the nature of the remaining challenges for standards development, selection and/or implementation. One of the important meeting themes concerned the need to broaden participation in the standards development process. In addition, several presenters noted the disappointing adoption record for some standards. Besides a number of technical and process issues, panelists pointed out challenges related to enforcement, the need for a more compelling value case for adoption, and the importance of building a better interface between standards and clinical care. In addition to broader participation, many commented on the need for strong, visionary leadership, notably from government.

In response to the third question, about a model, some panelists offered actual models and others commented on what such a model should include. Dr. Detmer asserted that to reach desired societal values and provide the kind of health care envisioned for Americans, the IT standards model should be broadened beyond information to include health communication, and it should be framed in terms of desired outcomes. The NRC report recommends a portfolio approach to enabling interoperability, one that encompasses standard practices, terminology frameworks, standard product identifiers and vocabulary, data interchange, metrics, and appropriate tools and services.

Major Themes and Messages

The key message that emerged from the hearing was the importance of clarifying the health outcomes that standards are intended to help achieve, and thus of evaluating them on that basis. This principle was expressed early on by Dr. Green, who asked, What do we want to accomplish for the American people?  Both Drs. Detmer and Diamond emphasized health outcomes in their remarks, and both called for new thinking about standards and health IT. In his concluding remarks, Dr. Stead stressed the gravity of the current starting-point. His NRC committee found that the health care information systems they saw “fall far short of what would be needed to achieve the IOM’s vision for 21st century health care.” He cautioned that “current efforts aimed at nationwide deployment of healthcare IT will not be sufficient to achieve the vision… and may even set back the cause.” A key to the solution, he said, is to “embrace measurable health care quality improvement as the driving rationale for HCIT adoption efforts.”

The day’s discussions generated a sense of a dynamic approach to standards, built on but moving beyond the existing foundation. The envisioned approach begins with clarified goals, as discussed above. It includes an awareness of the “ecosystem” for standards as well as a broader view of what the standards encompass; expanded participation; and understanding of the process as a feedback loop, with refinements in every cycle of innovation.

Several presenters stressed that with the large infusion of Federal money into health information and communications technology, the American people will hold government accountable for results, measured in terms of better health outcomes. In addition, evolving standards must provide demonstrable value to physicians. Looking at the ecosystem for standards, panelists called attention to the enormous social problems to be solved, and stressed the need to expand participation in the standards process and show people how they can contribute. Several offered suggestions for how to do this. Some panelists pointed to the risk of burn-out among the “passionate volunteers” responsible for existing standards achievements as another reason to broaden participation. Establishing the clinical relevance and utility of health IT standards was another strong theme of the discussion. Regarding the standards themselves and what they encompass, two messages in addition to satisfying clinical need concerned keeping them simple and incorporating communication.

The group discussed a variety of process issues. There was broad agreement about the need for strong Federal leadership and closer collaboration. Many panelists stressed the importance of testing. For the Markle Foundation, Dr. Diamond recommended an open, market-based approach to validating the standards. She and others also stressed the merits of incrementalism—aiming for early, easy wins and learning and modifying along the way. Dr. Diamond also emphasized that technology must implement new privacy policies, because trust is a critical aspect of information sharing. Finally, many presenters discussed evaluation as part of the feedback loop, based on the desired outcomes identified at the beginning of the process.

SUMMARY OF PRESENTATIONS

Following introductions, Mr. Blair, who co-chaired the hearing with Dr. Warren, explained that the NCVHS Standards Subcommittee is conducting these hearings, with cooperation from ONC, to enable NCVHS to hear from as many parts of the health care delivery system as possible so that both mainstream and diverse viewpoints are represented. To accomplish this broad input, written testimony from many other industry stakeholders also will be solicited. The next hearings, on April 28-29, will feature HITSP, standards development organizations, health IT vendors and standards users. The final day of in-person testimony will be in June. As background, Mr. Blair briefly reviewed the history of standards development over the past decade or more, noting the major milestones since 1996 and the role played by NCVHS throughout. The National Committee’s contributions include the recommendations in its 2001 report. Information for Health: A Strategy for Building the National Health Information Infrastructure, with its call for Federal leadership. The pace quickened under the subsequent leadership of ONC; and now the ARRA will intensify the pace and greatly expand the resources available. For the next phase, NCVHS will continue to serve its traditional role as a forum to engage stakeholders in a continuous improvement process that builds on the foundation laid in recent years.

Panel One: ONC UPDATE AND STRATEGIES

Rob Kolodner, MD, National Coordinator for Health Information Technology (slides)

Noting that “the timing is just right for getting started,” Dr. Kolodner offered his comments as a frame for this and future hearings. He began by reviewing developments over the past four years, then looked at what lies ahead in the light of the ARRA. He also noted the questions that ONC would like feedback on as it moves forward.

The National Coordinator described the ONC process of identifying high priority health/health care use cases, identifying the interoperability standards to support the use cases, and then harmonizing them into implementable products. He likened each step to “the turn of a crank.”  These products have been incorporated into a library of implementable, interoperable standards packages that can be used nationwide to accelerate the implementation of a national health information infrastructure. To support this process, ONC established an organizational infrastructure that included AHIC to identify and define high-priority use cases, the Healthcare IT Standards Panel (HITSP) to identify and harmonize the standards to support the use cases, and the Certification Commission for Healthcare IT (CCHIT) to certify health IT products that meet the functionality, interoperability and privacy requirements that health care providers will need for the future. There were executive orders for Federal entities to build standards into their products. Use cases have been approved annually, starting in 2006. Dr. Kolodner briefed the hearing attendees on the status of various use cases and Interoperability Specifications.

In June 2008, ONC assessed the adoption of standards and their incorporation into products, and concluded that they were not as robust as had been anticipated. This was attributed to a lack of incentives for moving the standards forward and exchanging information. On a more positive note, the NHIN reached a new level of maturity by late 2008. The NHIN, which Dr. Kolodner noted is a collaboration of local, state and regional health information exchange networks and “not top-down,” provides a critical neutral platform where the best solutions can compete and be tested. He described trials of the NHIN, the first of which (in August 2008) revealed problems that were then resolved, demonstrating an essential “feedback loop for refining the standards” like that called for by Dr. Diamond (see below). The September trial implementation demonstrated the NHIN’s technical capability and was “a very powerful first step.” The goal for 2009 is to foster wider adoption and acceptance of standards and move into “a path to production.”

The new phase is intensified and supported by aspects of the ARRA, which reflects the new administration’s support for health IT and its interest in building on the existing foundation. Dr. Kolodner discussed aspects of the bill, including the creation of two new FACAs and establishment of “very aggressive” goals; and he noted that the NHIN provides “a place where entities can begin to work together…a venue or crucible.” Given the pace and objectives, the goal for standards is “to get good-enough standards” to enable the process to go forward, refining along the way. He observed that the incentives for adoption and sharing information are more positive under the new law. The “bottom line” is incremental advancement and learning using the network enabled by the NHIN. While the $2 billion in the HITECH portion of the ARRA are significant, they will not cover all costs, so the government must find ways to “get $10 worth of impact for each dollar spent.” Finally, the system created must be upgradeable and allow evolution.

In the discussion period, Mr. Reynolds commented on the need to make the standards “real” and to show all who want to contribute how they can do so. Asked whether government will need to push harder to ensure adoption, Dr. Friedman of ONC said the hope is that the standards will be good enough that people will want to adopt them. Dr. Kolodner noted the need to be aware of the entire “ecosystem” for health IT standards— a concept that resonated with NCVHS members. Dr. Fitzmaurice commented on the importance of evaluation to assess the value achieved by these investments, and Dr. Friedman said ONC welcomed suggestions on how to do that.

Dr. Green called for “a galvanizing focus that takes us all the way to human beings.” He posed a question that became a touchstone for the day’s discussions: What do we want to accomplish for the American people? Another participant asked how local providers would be engaged and educated. An ONC representative reported that ARRAproposed “regional extension offices” are expected to be instrumental.

PANEL 2: IT THOUGHT LEADERS

Don Detmer, MD, AMIA (slides)

Dr. Detmer, a former NCVHS Chair, used his slides to list recent health IT standards achievements and remaining challenges. He noted that the overall process is shifting from a bottom-up to a top-down one, each of which has plusses and minuses. The major advantage of a top-down process, he said, is that “actual standards can be set.”

He moved quickly to talking about the third question posed by the Subcommittee—the best model for development, adoption and implementation of health IT standards. He stressed that communication, which is different from and as important as information, should be added to the picture. He encouraged NCVHS to “develop an outcomes model that uses complementary health IT and health communications technology (HICT) standards…to reach desired societal values.”

He pointed out that standards influence thinking and lead toward particular measures; and we need standards that reflect “what we choose to recognize and value.” Returning to the perspective offered by Dr. Green, he asked, “What vision does America seek to achieve for its people?” and answered, “Healthy people living in an altruistic society.” To achieve that, we need standards that “create a better balance among competing social goods” (including altruism, freedom, health, personal privacy, and useful knowledge). Value-driven standards could help bring about value-driven care—standards that are compatible with care based on the criteria set by the Institute of Medicine (including those set by the IOM Education Summit in 2003: evidence based, delivered by a team, patient-centered, continuously improving quality, and utilizing informatics). Such an approach would enhance standards across the domains of equity, patient-centeredness and timeliness as well as effectiveness, efficiency and safety.

On that basis, Dr. Detmer asserted that an outcome model that reflects important national and international reports (listed in his slides) can help bring about relevant health IT and HCT standards that reflect American values, and can create global markets for product adoption. He wondered if NCVHS needs “a new working group to take on this new, robust HICT Standards model.” Finally, he offered the support and assistance of AMIA’s Board, staff and members to help with this “fairly substantial mandate,” if the Committee decides to accept it.

In the discussion period, Dr. Detmer agreed that the communications standards of other industries should be looked to as models. He observed that physicians are interested in “communication, not records,” and patient-centeredness is all about communication. Ms. Greenberg picked up on his idea of value-driven standards, noting that it aligns with recent NCVHS thinking and with plans for the observation of its forthcoming 60th anniversary. To other questions, Dr. Detmer stressed the importance of keeping the desired ends in mind, along with a societal perspective, when thinking about standards. Dr. Kolodner observed that the “C” (communication) is implicit in current work on health IT, but it needs to be made more explicit as the process evolves. Dr. Detmer pointed to the magnitude of social problems to be addressed, and said we need to use the Internet and technology more “directively” to help solve them than we have in the past.

John Tooker, MD, MBA, National eHealth Collaborative (slides)

Dr. Tooker said his organization, the American College of Physicians, sees a strategic role for health IT and standards in its efforts to reshape the health care delivery system. Thus he has been active in the transition from AHIC to the National eHealth Collaborative (NeHC), chairing the Governance Committee. NeHC embodies Dr. Detmer’s emphasis on communication and Dr. Kolodner’s on the ecosystem, he said. He focused his remarks on the importance of involving a broad range of stakeholders to improve the standards harmonization process and accelerate interoperable health IT, and called special attention to consumers and vendors. Value cases are a device for involving the market, including standards harmonization, model processes, best practices, and frameworks. The strategy for all value cases will be developed by NeHC; Dr. Tang of NCVHS is chairing a value case steering committee.

Dr. Tooker talked about the new FACAs (on policy and standards) established by the ARRA in terms of the oversight that will be necessary. Next steps involve strengthening the relationships with ONC, HITSP, CCHIT, and the NHIN collaborative; convening stakeholders; setting priorities; addressing barriers to progress; and increasing the cohesion of the health care world. Dr. Tooker emphasized the importance of coordination, both among the stakeholders and among all those engaged in health information exchange.

Carol Diamond, MD, MPH, Markle Foundation and Connecting for Health (testimony; Health Affairs article)

Dr. Diamond began by aligning herself with Dr. Green’s question about goals for Americans, and with Dr. Detmer’s “widening of the aperture.” She stressed that the ARRA “portends profound changes to health care and health IT”; government will be held accountable for “getting health IT right,” and these times call for new thinking. The purpose of health information sharing must be to support better decisions, and standards must support measurable health improvements, the basis on which Americans will judge the success of the enterprise. Thus, government and others need to set objectives based on the understanding that better health outcomes (such as lower blood-pressure, better cost-effectiveness, fewer avoidable hospital readmissions, and fewer medication errors) are the measure of success. Government should identify high-value health improvement goals against which health IT solutions should compete.

Regarding standards for information-sharing, Dr. Diamond recommended simplicity: “We need to start with just a basic set of standards for interoperability using the Internet, and other standards will evolve as products and software using them provide value and mature.” Furthermore, the process should be incremental and focus first on the most basic issues—specifically, making it easier to share data in its current form while protecting privacy and security. Once health objectives are set, the focus should be on standards adoption, which will in turn generate cycles of innovation and refinement. And incremental standards that solve one problem well are better than complex standards that are constructed to solve all problems at the same time.

Dr. Diamond cautioned against striving for perfection instead of keeping the focus on enabling data sharing, motivated by health improvement goals. She emphasized trust as a critical component, and thus the need for new privacy policies for technology. She noted that Markle’s Connecting for Health Common Framework articulates the need for comprehensive privacy policies, implemented together. The establishment of new policy and standards Committees offers an unprecedented chance to marry policy and technology implementation.

Finally, Dr. Diamond returned to the importance of accountability, noting that the criteria for it have never been higher, and it is government that will be held accountable for results. As a next step, she urged that the Secretary establish measurable health goals that health IT standards can be designed to help achieve. The standards should be validated through an open, market-based approach. A plurality of certification bodies, including CCHIT, should be allowed to compete for public and private sector business.

In the discussion, Dr. Diamond agreed with Mr. Blair that this is an evolutionary process, and Dr. Kolodner expressed ONC’s alignment with the perspectives she expressed. In response to a question from Mr. Reynolds, she observed that health IT work needs to shift the focus away from its present emphasis on transactions and to health goals, which will clarify what health IT is needed for. Dr. Tooker agreed that this is “the cardinal question.” He referenced the Wagner Chronic Care Model, and Dr. Diamond mentioned the need to reengineer processes of care.

PANEL 3: ENHANCING STANDARDS ADOPTION BY USERS

Steven  Waldren, MD, American Academy of Family Physicians (testimony)

Dr. Waldren reinforced the point made by earlier speakers, that standards are a means to an end. Based on AAFP’s experience with the market adoption of the Continuity of Care Record standard, he outlined five predictors of success in the adoption and use of standards: market demand, keeping it simple, strong and early clinician involvement, real-world testing, and understanding that standardization is not the end goal.

On the first of these, he commented that aligning incentives to create business models that drive demand for standards is the greatest lever to accelerate adoption. On the second, he said, “a strategy of building on early, easy wins that can be built upon will go much farther than creating a more complex, comprehensive standard at the beginning.” On the third point, he observed that a standard must satisfy clinical need for the clinician and take into account the delivery of care process and work flows. On the fourth, he noted the huge percentage of medical visits that take place in very small practices and said, “Testing standards in these environments is very difficult and challenging, but one cannot and should not assume that the standards tested in the large group practices or hospitals will necessarily function at the same level of efficiency in much smaller settings or in the community.” On his final point, he reiterated the need to focus on desired outcomes. He concluded by encouraging ONC and NeHC to coordinate closely with NCVHS, as directed in the new law.

Alan Mertz, American Clinical Laboratory Association (ACLA) (testimony)

Mr. Mertz said standards adoption is very important to his organization, whose members have a great deal invested in electronic records and long experience with connectivity. Regarding the “promise and pitfalls” of past efforts, he focused on the ELINCS project and HITSP specifications. The California HealthCare Foundation funded an initiative, requested by Dr. Brailer, to develop a national standard for real-time reporting of lab data to EHRs. The process involved broad stakeholder involvement and an incremental, real-world approach that produced a usable standard, ELINCS.

Mr. Mertz contrasted this with the process and outcome of HITSP, which he said produced an “ideal” standard that cannot be feasibly implemented in the short term. He attributed this “futuristic outcome” to HITSP’s governance model, which enabled vendors (because they are more able to participate) to dominate the process. In contrast, CCHIT ensures a more equitable representation among stakeholders that has resulted in a more practical, incremental approach to certification criteria.

Turning to the remaining challenges, he focused on “two fundamental issues”: standard laboratory order codes, and updating the Clinical Laboratory Improvement Amendment (CLIA) regulations to accommodate and promote the transmission of laboratory data. He predicted that developing standard order codes will be far more difficult than ELINCS was, and he stressed the need for incremental efforts and for ensuring that those most directly affected, laboratories, have an equal voice in a standard’s creation and also confirm its operational feasibility. Regarding CLIA, he offered specific suggestions from ACLA for easing the regulatory burden.

Finally, Mr. Mertz called attention to the risk that providers could be overwhelmed in the coming years by the demands on them to update their practice management and health IT systems. To prevent this, he called for greater Federal coordination of health IT efforts.

Rosemary Kennedy, MBA, RN, Alliance for Nursing Informatics (slides)

The Alliance for Nursing Informatics (ANI) is a collaboration of organizations that provides a unified voice for nursing informatics. Ms. Kennedy described the broad and active role of nursing representatives in standards activities, and shared several “success stories.” Through ANI’s efforts, nurses are on NeHC boards and committees and represented on the NHIN Governance Workgroup as well as on HITSP committees, HL7, and other bodies. She pointed out that nurses are at strategic places in the health care and health information arenas, and in a good position to assess and contribute to the usability of standards. Among other things, ANI has worked on education and outreach throughout the nursing community “to infuse standards into day-to-day implementation.”

Ms. Kennedy discussed the remaining challenges in these four areas, with examples: the complexity of information exchange; implementation of standards in provider organizations; standards development and testing; and the points of intersection between standards and care delivery. She noted that exchange of a discharge document from an acute to an ambulatory setting is complicated, and that educational programs are needed for all levels of provider organizations to facilitate adoption. She enumerated many challenges related to standards development and testing and noted the need for better communication between standards committees.  She offered several suggestions to improve the intersection between standards and care delivery, a major emphasis of her remarks.

Finally, she offered a possible model for future standards work that connects information with decision support and workflow, all in the context of care delivery. The model illustrates the interaction of standards development, testing, adoption, implementation and evaluation with the following dimensions: educational curricula, professional practice, measurement of impact, collaboration, and input from all stakeholders. Regarding players, she highlighted the importance of “pulling in the consumer.”

Rod Piechowski, American Hospital Association (slides)

Mr. Piechowski began by observing that AHIC/NeHC’s use cases provide a way to move beyond the multiplicity of standards that has been a barrier to HIT adoption. Previously conflicting standards are being harmonized, and missing standards are being created. He noted that the existing process has a downside: even though hundreds of people have been involved, some organizations and interests have been left out of the process, as Mr. Mertz pointed out. Mr. Piechowski added that at the same time, those who have been participating are suffering from burnout. He observed, “we cannot burn out the same people nor can we have the same people making all of the decisions all of the time on this; … we need to work to broaden the engagement of different groups of people.”

Standards development and adoption, he observed, are at a nascent stage. So far, the accomplishments include workflow and structure, stakeholder engagement, a foundation and leadership, technical harmonization, and trust. Processes need to be created now to “manage evolution.” The remaining challenges include the need for visionary leadership and closer links between technology and policy. At this juncture, he said, it is time to look beyond the EHR to “the overall ability to function in a health information technology-enabled world.” He called attention to challenges in the areas of quality metrics, supply-chain standards, DEA issues, and the unique patient identifier with its attendant privacy concerns. He noted that privacy concerns are best addressed by policy, not technology. Finally, he stressed the ongoing and increasing need for government leadership.

In the discussion period, Dr. Suarez asked the panelists to comment on how they would change the standards process. One observed that while the initial work was on technical standards, the stimulus funding for information technology offers “a perfect opportunity to reassess and to adjust the system.” Another commented that this is an opportunity to candidly assess what is working and should be accelerated, and what is not working. The panelists’ suggestions, reiterating their previous remarks, were:

  • Broad stakeholder involvement; portray it as a national project that all healthcare stakeholders can participate in.
  • Explicit goal setting; make sure it is outcomes based; start with the outcomes and back in.
  • Use an incremental process.
  • Provide methods and tools for quick-cycle turnaround time to get feedback.
  • Make sure the standards work in the real world; assess them in terms of “What can I actually do with those that adds value?”
  • Look at impact in terms of the outcomes defined up front.

Mr. Reynolds asked for suggestions on how to broaden stakeholder involvement, and participants offered these approaches:

  • Regional education; implementation of the idea of regional health extension centers
  • Using remote technology as an alternative to face-to-face meetings
  • Closing the gap between those working on developing the standards and those implementing technology and providing patient care; prioritizing around “pain points”

Dr. Kolodner affirmed ONC’s intention to broaden stakeholder participation, and he queried the ACLA representatives on how to ease the burden on laboratories. They stressed the need for incremental change rather than “making the leap in one step.”

PANEL 4: NATIONAL IT INITIATIVES — ROLE OF STANDARDS

Douglas Bell, MD, PhD, Rand Corporation (slides)

Dr. Bell described a pilot test of RxNorm and NCPDP SCRIPT 10.5, which CMS is sponsoring and Rand is carrying out. He said e-prescribing may be a model for understanding how other kinds of health IT get implemented and how the effects of the information drive value. He characterized it as a domain with a better chance to connect specific information to specific clinical value derived from it.

He outlined the many challenges related to e-prescribing adoption, and use, noting that today, only 10% of prescriptions are transmitted electronically. He enumerated the reasons for this low adoption and usage rate, which relate to system integration issues among other things. The hope is that RxNorm will “come to the rescue,” but that remains to be seen, as a number of barriers and problems have been identified. The Rand study is looking at whether vocabularies and code sets can communicate information unequivocally, and at how the standards interoperate with existing standards. Then there will be a live pilot test, after which a Delphi expert panel will look at the results and help CMS interpret the readiness for adoption of each of these standards.

Gilad Kuperman, MD, PhD, New York Presbyterian Hospital (slides)

Dr. Kuperman served with Mr. Blair as Co-chairs of the core content working group on the NHIN Trial Implementation Project. Regarding the recent standards achievements (he lists 12 on his slide), he highlighted the NHIN trial implementation as particularly important. He identified three categories of reasons for the recent successes: building on decades of experience and iterative process improvement; the culture and style of SDOs and related organizations (e.g., they are open to all, and powered by “passionate volunteers”); and many processes are working well (e.g., solicitation of broad input, articulation of plans, and good interaction between groups).

The remaining challenges relate to managing the success of the SDOs and aligning national and international activities, as well as various process issues (e.g., parochial interests) and technical issues (multiple terminology standards, overlaps and gaps). Regarding enforcement, Dr. Kuperman noted that the CCHIT model is “good but heavy” (expensive), and it needs to be lightened. There also is work to be done in specific domains such as personal identifiers and medications (he called medication standards “the most egregious gap”), and there are a number of technical challenges including the need for a “library of converters” and for robust testing approaches. In addition, adoption is still not compelling for system vendors; the value cases are not well enough articulated.

Dr. Kuperman called for a broader model that goes beyond selection, adoption and implementation. He proposed a set of “value-added activities,” with toolkits that include implementation guides, profiles, quick-start guides, and how-to guides. Another key part of the model is profile enforcement and testing to assure that implementation conforms to a profile; and selection of standards for particular use cases is critical. His other suggestions included ensuring adequate and rapid feedback from implementers and providing “instigation,” as ONC does for the NHIN.

He called attention to the struggles of large organizations such as his with “intra-institutional interoperability,” as the nation and regions struggle with the inter-institutional version. Finally, his list of players included, besides the usual ones, “instigators” (i.e., ONC) and “deciders” (i.e., governance). He concluded with detailed recommendations in five areas: support for the standards development process, support for implementation and testing, encouraging completion of medication standards, certification of ancillary systems, and continued support for standards-related research topics.

Linda Fischetti, RN, MS, Veterans Health Administration (for ONC) (slides)

Ms. Fischetti said she was presenting on behalf of Vish Sankaran, Program Director for Federal Health Architecture (FHA). She noted that a benefit of her FHA activities has been the chance to learn about all the people in Federal government “doing the exact same thing” that she was. FHA has facilitated a significant level of collaboration across government, and provided leadership in that sector.

She explained that “SDOs do the development; HITSP does the selection and harmonization; and then implementation of course is NHIN”—distinctions, she noted approvingly, that are made in this hearing. As she discussed the achievements at each stage, she called attention to the time it took to achieve a standard for role-based access control, from the initial idea in 2001 and workgroup creation in 2003 to the HL7 re-balloting scheduled for September 2009. She stressed that such processes must be streamlined in the future: “This type of timeline will no longer be acceptable.” FHA is working on how the process can be accelerated, as well as on aligning Federal standards activities with the NHIN.

On the remaining challenges, Ms. Fischetti said FHA decided to focus on the underlying problems that create “a plethora of issues for HIT standards.” It identified two major challenges: First, tooling is absent that would enable programmers to operationalize developed standards, and as a result, operationalization varies as programmers “interpret what they see.” Second, there is a lack of common components across SDOs, such as a reference information model, a reference terminology model, and a security/trust framework.

Regarding a model, she shared FHA’s view of the Federal role with respect to national standards activities. It is concentrating on achieving a coordinated Federal voice for its roles in communication, collaboration and coordination. She identified standards players in the categories of creators, harmonizers, enforcers/profilers, and users. She then described the purpose and work of the Federal HIT Standards Organization Participation (FHITSOP), which provides resources for standards work. She concluded with four recommendations, among which she highlighted supporting the implementation and maintenance of a national testing facility and associated equipment.

William Stead, MD, Vanderbilt University (testimony)

Dr. Stead chaired a National Research Council (NRC) committee that recently released the report, “Computational Technology for Effective Healthcare: Immediate Steps and Strategic Directions.” He focused his remarks on the committee’s observations from its site visits and its recommendations.

The following “information-intensive aspects” of the IOM’s vision for 21st century health care and wellness outline what is expected from our information systems:

  • The foundation: comprehensive data on patients’ conditions, treatments and outcomes
  • Cognitive support for healthcare professionals and patients to help integrate patient-specific data and evidence-based practice guidelines and research results
  • The tools to manage a portfolio of patients and highlight problems as they arise
  • Rapid integration of new instrumentation, biological knowledge, treatment modalities, etc., into the learning healthcare system
  • Accommodation for a growing heterogeneity of locales for provision of care
  • Ability to empower patients and their families in effective management of healthcare decisions and their implementation

The NRC committee visited eight health systems, representing a broad spectrum, to assess “the gap between the best of what is deployed today and what would be needed to achieve that vision.” What it found, despite “a lot of successes,” was that the information systems, even in aggregate, “fall far short of what would be needed to achieve the IOM’s vision for healthcare.” The “problematic aspects” included fragmented records, poorly integrated biomedical devices, and little integration of clinical research into clinical care. The NRC report presents three central conclusions:

  • Current efforts aimed at nationwide deployment of this technology will not be sufficient to achieve the vision for better healthcare, and they may even set back the cause.
  • Success will require much greater emphasis on cognitive support—i.e., assistance for thinking about and solving problems.
  • In the near term, to deal with this, it is very important to embrace measurable healthcare quality improvement as the driving rationale for health care IT adoption efforts.

The NRC committee discovered during the site visits that health care mainly uses IT for automation and transaction processes, neglecting the potential uses for other purposes such as connectivity and decision support. It believes health care needs to achieve more balance in its uses of IT. The committee made three large recommendations, each with several sub-parts:

  • Redefine the objective of standards initiatives to reflect the challenges identified in the NRC report. This would involve a redefinition of interoperable data, ensuring the separability of data from applications, and limiting the use of “standard data” that can have only one interpretation.
  • Take a portfolio approach to enabling interoperable health information. The portfolio would include standard practices, terminology frameworks, product identifiers and vocabulary, data interchange, metrics, and tools and services to facilitate adoption and effective use.
  • Drive to value, using three management approaches: bringing developers and users together for multiple activities, developing test beds, and creating and maintaining a roadmap showing what needs to be done, with deadlines.

Dr. Stead illustrated what could be achieved through a coordinated effort, using the example of “end-to-end” medication knowledge management.

For the long term, the NRC report recommends support for research into computable knowledge structures and models to make sense of available patient data, and their integration into a library for a given patient, along with systems that can infer clinical conditions from raw data.

In the discussion period, Mr. Reynolds pointed out that Dr. Stead’s concluding comments and Dr. Detmer’s that began the day provide “bookends” for this hearing that call for thinking outside the box. He invited the panelists to comment on how they saw “the box” in the light of these comments. The responses noted the importance of communication, of purpose and the need to keep goals in mind, and of prioritization and monitoring.

Dr. Stead emphasized that it is possible to “move extremely quickly” to achieve some of the goals he outlined; for example, he estimated that his medication scenario could be achieved in six months, at relatively little expense. The most important action would be to create test beds. “If we can begin to actually set these different approaches side by side and drive them to targeted improvement goals, I think we can make a difference in the very short term. I think it would be a different way of looking at the problem.”

In response to a question from Dr. Kolodner about how to involve more stakeholders, Ms. Fischetti endorsed the idea of funding some stakeholders (e.g., physicians) to participate. Asked how to expedite the processes recommended by the NRC, Dr. Stead emphasized the government’s role in a national “convening effort”—on a scale that could require Presidential involvement—to persuade stakeholders that they can benefit from something that also supports the common good.

In conclusion, Mr. Blair noted the diversity among the presenters and their viewpoints, which the Standards Subcommittee intended in its planning. He urged the participants not to draw premature conclusions from the day’s proceedings, but instead to reserve judgment until the entire series of hearings is completed and all the learning is accumulated. He thanked the presenters for their contributions.

Note: See also the February 25 testimony of Professor Martin Severs to the full Committee on the UK and IHTSDO perspective on standards implementation. (Posted on the NCVHS Website as part of the full Committee minutes; slides accessible via the agenda.)