HIT Standards Committee 9 21 2010 Presentation Materials


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HIT Standards Committee 9 21 2010 Presentation Materials

  1. 1. HIT Standards Committee __________ September 21, 2010
  2. 2. AGENDA HIT Standards Committee September 21, 2010 9:00 a.m. to 2:15 p.m. [Eastern Time] Washington Marriott Wardman Park Hotel 2660 Woodley Road, NW, Washington, DC 202-328-2000 9:00 a.m. CALL TO ORDER – Judy Sparrow Office of the National Coordinator for Health Information Technology 9:05 a.m. Opening Remarks – David Blumenthal, National Coordinator for Health IT 9:15 a.m. Review of the Agenda – Jonathan Perlin, Chair 9:30 a.m. Vocabulary Task Force Briefing on Hearing Jamie Ferguson, Chair Betsy Humphreys, Co-Chair 10:15 a.m. Implementation Workgroup Update Judy Murphy, Chair Liz Johnson, Co-Chair 10:30 a.m. Standards & Interoperability Framework Doug Fridsma, Office of the National Coordinator 12:30 p.m. LUNCH 1:15 p.m. Setting Priorities Jonathan Perlin, Chair Doug Fridsma, ONC 2:00 p.m. Public Comment 2:15 p.m. Adjourn
  3. 3. HEALTH INFORMATION TECHNOLOGY (HIT) STANDARDS COMMITTEE Member Organization Chair Jonathan Perlin Hospital Corporation of America Vice Chair John Halamka Harvard Medical School Members Dixie Baker Science Applications International Corporation Anne Castro BlueCross BlueShield of South Carolina Christopher Chute Mayo Clinic College of Medicine Janet Corrigan National Quality Forum John Derr Golden Living, LLC Linda Dillman Wal-Mart Stores, Inc. James Ferguson Kaiser Permanente Steven Findlay Consumers Union Linda Fischetti Department of Veterans Affairs Douglas Fridsma Arizona State University C. Martin Harris Cleveland Clinic Foundation Stanley M. Huff Intermountain Healthcare Kevin Hutchinson Prematics, Inc. Elizabeth Johnson Tenet Healthcare Corporation John Klimek National Council for Prescription Drug Programs David McCallie, Jr. Cerner Corporation Judy Murphy Aurora Health Care J. Marc Overhage Regenstrief Institute Gina Perez Delaware Health Information Network Wes Rishel Gartner, Inc. Richard Stephens The Boeing Company Sharon Terry Genetic Alliance James Walker Geisinger Health System Nancy J. Orvis Director, Health Standards Participation, Department of Defense Aneesh Chopra Chief Technology Officer, OSTP Cita Furlani National Institutes of Standards and Technology
  4. 4. Health Information Technology Standards Committee DRAFT Summary of the August 30, 2010, Meeting KEY TOPICS 1. Call to Order Judy Sparrow, Office of the National Coordinator (ONC), welcomed participants to the 16th meeting of the HIT Standards Committee (HITSC), which was being conducted virtually. She reminded the participants that this was a Federal Advisory Committee meeting, with an opportunity for the public to make comments. Following her opening remarks, she conducted roll call. 2. Opening Remarks and Review of the Agenda HITSC Chair Jonathan Perlin also welcomed participants to the meeting and reviewed the agenda. In his opening remarks, Committee Co-Chair John Halamka noted that the final rule still stands up well after 2 months of intense inspection. There is one mistake in the rule—the incorrect version of the syndromic surveillance implementation guide was referenced. He asked that any Committee members who identify or learn of any inconsistencies or questions about the final rule to forward these to him, and he will collect and deliver this information. Action Item #1: Minutes from the last HITSC meeting, held on July 28, 2010, were approved by consensus. 3. Enrollment Workgroup Update Enrollment Workgroup Co-Chair Sam Karp updated the Committee on the progress of the Enrollment Workgroup and presented final recommendations for approval. During its last meeting (held the week prior to this meeting), the HIT Policy Committee (HITPC) reviewed and approved these recommendations. The Enrollment Workgroup has held five meetings and established four tiger teams to develop these recommendations. Doug Fridsma of ONC led an internal team of staff and consultants to examine the standards development at the state level. The Workgroup held a series of public hearings and maintained a blog, from which it received public input. Sam Karp presented the Workgroup’s first recommendation: Recommendation 1.1: We recommend that federal and state entities administering health and human services programs use the National Information Exchange Model (NIEM) guidelines to develop, disseminate, and support standards and processes that enable the consistent, efficient, and transparent exchange of data elements between programs and states. HIT Standards Committee 8-30-2010 DRAFT Meeting Summary Page 1
  5. 5. In response to a question from Wes Rishel, Sam Karp explained that the group’s review of the data elements has led it to believe that it is possible to conduct verification without states having to change their systems, provided that the output of the 10-12 core data elements conforms with NIEM exchange guidelines. Doug Fridsma noted that there was fairly good consistency across all of the agencies with regard to collecting the required data. Some of the variability that was identified related to business rules. It was noted that there will be local autonomy for deciding how to use this system to exchange. The next set of Enrollment Workgroup recommendations were as follows: Recommendation 2.1: We recommend that federal agencies required by Section 1411 of the Affordable Care Act (ACA) to share data with states and other entities for verification of an individual’s initial eligibility, re-certification, and change in circumstances for ACA health insurance coverage options (including Medicaid and CHIP), use a set of standardized Web services that could also be used to support such eligibility determinations in other health and human services programs such as SNAP and TANF. To accomplish this recommendation, federal and state agencies should provide data by individual, as opposed to household, to ensure the data can be used in a consumer- mediated approach. Recommendation 2.2: We recommend development of a federal reference software model, implementing standards for obtaining verification of an individual’s initial eligibility, re- certification and change in circumstances information from federal and state agencies, to ensure a consistent, cost-effective, and streamlined approach across programs, states, and community partners. The initial build of this toolset should include interfaces to the federal agencies referenced in Recommendation 2.1. In order to ensure comprehensive and timely verification, additional interfaces to other Federal, State or other widely-available data sources and tools should be added, including the National Directory of New Hires, the Electronic Verification of Vital Events Record (EVVE) system, State Income and Eligibility Verification (IEVS) systems, Public Assistance Reporting Information System (PARIS), and the U.S. Postal Service Address Standardization API tool. In discussion, Wes Rishel noted that a key aspect of this tooling is that it must work with legacy systems. Most of what is done now is based on JAVA, .net, and other modern systems, and it will be important for the Committee to determine how to represent the legacy system implementers. Sam Karp noted that new systems developed in the large states potentially will have the ability to more easily interface with the exchange being discussed. Workgroup Chair Aneesh Chopra then presented the next set of recommendations: Recommendation 3.1: Federal and state agencies should express business rules using a consistent, technology-neutral standard (e.g., OMG’s SBVR, WC3’s RIF, etc.). Upon HIT Standards Committee 8-30-2010 DRAFT Meeting Summary Page 2
  6. 6. identification of a consistent standard, federal and state agencies should clearly and unambiguously express their business rules (outside of the transactional systems). Recommendation 3.2: To allow for the open and collaborative exchange of information and innovation, we recommend that the federal government maintain a repository of business rules needed to administer ACA health insurance programs coverage options (including Medicaid and CHIP), which may include an open source forum for documenting and displaying eligibility, entitlement and enrollment business rules to developers who build systems and the public in standards-based and human-readable formats. To allow for seamless integration of all health and human services programs, business rules for other health and human services programs such as SNAP and TANF should be added to the repository over time. The Committee’s discussion on these recommendations included the following points: David McCallie noted that if the NIEM is managing the data element issue in a different format or system, some of these elements do not have tools available as of yet. This could lead to multiple independent repositories of information. Aneesh Chopra acknowledged that this policy issue demonstrates the fact that a common language for this has not yet been developed. Doug Fridsma noted that the NIEM process works well with data, but it does not capture such behavioral aspects as business rules and what happens with the data. Work has been ongoing to expand the functionality of the NIEM process to describe the service and behavioral aspects for which the rules are going to be a part. Chris Chute noted that the Business Rules Tiger Team has discussed this issue at length, and the core view is that business rules cannot exist abstract from a data domain. The expectation is that the business rules would have a clear cross-representation to the data model. However, if the data, the program rules, and the deployment were consistent across states, then there would be no need for business rules. The tiger team was trying to document a set of rules once for deployment, such that those rules can be used everywhere. Wes Rishel said that any process that leads an organization to state their business rules in a way that others can understand would be beneficial. David McCallie explained that if the goal is to develop a system that is deployable to multiple environments, then expressing the rules in terms of deployment would mean there would be almost infinite variations when program differences and state-to-state differences are layered on. Aneesh Chopra presented the Enrollment Workgroup’s fourth series of recommendations: Recommendation 4.1: We recommend using existing Health Insurance Portability and Accountability Act (HIPAA) standards (e.g., 834, 270, 271) to facilitate transfer of applicant eligibility, enrollment, and disenrollment information between ACA health insurance programs, coverage options (including Medicaid and CHIP), public/private health plans, and other health and human service programs such as SNAP and TANF. HIT Standards Committee 8-30-2010 DRAFT Meeting Summary Page 3
  7. 7. Recommendation 4.2: We recommend further investigation of existing standards to acknowledge a health plan’s receipt of an HIPAA 834 transaction and, if necessary, development of new standards. Nancy Orvis asked whether there has been a resolution of the issue of key code sets on identifying a person. Farzad Mostashari replied that this issue has not yet been completely resolved. Nancy Orvis noted that this represents a significant challenge; if there is still no compatibility on what the set will be, then some of the hardest work is still to be done. There cannot be common business rules if there is not a common understanding of what the data is. Therefore, she suggested, Recommendation 4.2 needs to be stronger than it is, and needs to push for more work to harmonize the code sets. Aneesh Chopra then presented the Workgroup’s final set of recommendations, as follows: Recommendation 5.1: We recommend that consumers have: (1) timely, electronic access to their eligibility and enrollment data in a format they can use and reuse; (2) knowledge of how their eligibility and enrollment information will be used, including sharing across programs to facilitate additional enrollments, and to the extent practicable, control over such uses; and (3) the ability to request a correction and/or update to such data. This recommendation builds upon the Health Information Technology for Economic and Clinical Health (HITECH) Act, which gave consumers the right to obtain an electronic copy of their protected health information from HIPAA-covered entities, including health plans and clearinghouses. Additional investigation into format and content of such disclosures is needed. Recommendation 5.2: We recommend that the consumer’s ability to designate third-party access be as specific as feasible regarding authorization to data (e.g., read-only, write-only, read/write, or read/write/edit), access to data types, access to functions, role permissions, and ability to further designate third parties. If third-party access is allowed, access should be: Subject to the granting of separate authentication and/or login processes for third parties; Tracked in immutable audit logs designating each specific proxy access and major activities; and Time-limited and easily revocable. Recommendation 5.3: We recommend that state or other entities administering health and human services programs implement strong security safeguards to ensure the privacy and security of personally identifiable information. Specifically, we recommend the following safeguards: Data in motion should be encrypted. Valid encryption processes for data in motion are those which comply, as appropriate, with NIST SP 800-52, 800-77, or 800-113, or others which are Federal Information Processing Standards (FIPS) 140-2 validated. Automated eligibility systems should have the capability to:  Record actions related to the PII provided for determining eligibility. The date, time, client identification, and user identification must be recorded when HIT Standards Committee 8-30-2010 DRAFT Meeting Summary Page 4
  8. 8. electronic eligibility information is created, modified, deleted, or printed; and an indication of which action(s) occurred must also be recorded.  Generate audit logs. Enable a user to generate an audit log for a specific time period and to sort entries in the audit log. In Committee discussion, the following points were raised: Kevin Hutchinson asked for clarification on the definition of a third party as referenced in Recommendation 5.2. Would a provider of medical care be considered a third party? Aneesh Chopra provided an example of the type of entity that these recommendations are considering. The example was a non-profit organization advocating on behalf of a provider to make sure that it is getting all of the benefits it is entitled to. The intent of Recommendation 5.2 is that this arrangement be separately maintained, versus having the organization simply use the provider’s log-in and password. If the Workgroup’s recommendations are approved, the group will follow up with the supporting material that is going to be provided in the appendices. The deadline for completing this work is September 17, to move the material through the internal clearance process to determine whether the recommendations will be accepted in full or in part and then promulgated by the Secretary for states to use. The Workgroup recognizes that it is far from being able to give the definitive implementation guidance that they would like to provide. In response to a question about the core data elements, Farzad Mostashari pointed Committee members to Appendix B, which discusses this topic. Wes Rishel suggested a line edit to Recommendation 3.1. After the first sentence, he suggested the wording, “consistent with data standards developed under other recommendations.” Dixie Baker suggesting adding a reference to Fair Information Practices in Recommendation 5.1 Carol Diamond commented that it would be beneficial if all of the privacy and security recommendations were organized within the context of the ONC framework (i.e., the Fair Information Practices). Farzad Mostashari said that, in terms of practical edits, this might translate to having a header section for the privacy and security recommendations that discusses the overall privacy and security framework and the Fair Information Practices, prior to the specific recommendations. Action Item #2: The recommendations of the Enrollment Workgroup were approved by consensus, with line edits as described (i.e., adding “consistent with data standards developed under other recommendations” HIT Standards Committee 8-30-2010 DRAFT Meeting Summary Page 5
  9. 9. to the end of the first sentence in Recommendation 3.1, and adding a reference to Fair Information Practices in Recommendation 5.1). 4. Privacy and Security Tiger Team Recommendations Deven McGraw and Paul Egerman presented the Privacy and Security Tiger Team’s recommendations to the Committee, noting that last week the HITPC accepted these without modifications. The team has been presenting various components of these recommendations to the HITSC during previous meetings, and Committee member feedback has been incorporated into the final product. The Committee received the team’s letter outlining the complete set of recommendations. Some of the more salient recommendations were discussed during the meeting. The team’s overarching recommendation is that all entities involved in health information exchange—including providers (individual and institutional) and third-party service providers such as health information organizations (HIOs) and other intermediaries—should follow the full complement of Fair Information Practices when handling personally identifiable health information. Each set of recommendations is mapped to applicable Fair Information Practices Principles. Deven McGraw and Paul Egerman presented recommendations dealing with intermediaries and third-party service providers, the trust framework to allow exchange among providers for the purpose of treating patients, triggers for additional consent, meaningful consent attributes, consent implementation guidance, and provider choice about participation in exchange models. In discussion, the following points were made: On the subject of granularity, Carol Diamond clarified that the team’s previous recommendations were not necessarily “all or nothing.” If the provider is in control of the exchange, then the provider and the patient can share some control over which information is shared. This relates to what technology is used in the sharing. John Halamka proposed an operational example involving e-prescribing. Checking a patient’s eligibility is a non-persistent transaction: nothing is deposited in a repository. There is nothing persistent in a check against the formulary. Then, there is a drug interaction check, which would imply that the e-prescribing entity had a list of previous transactions. Medication reconciliation is part of meaningful use, and that crosses the line into persistence. The challenge here is the notion of achieving consent. There is participation in the transaction but not the maintenance of history. Kevin Hutchinson asked about which model would apply to e-prescribing, an HIO model or a direct exchange model. The information used is not aggregated at a single point and then delivered. Paul Egerman explained that the trigger for consent would be a place where the medication profile from multiple providers is kept. If the information can be obtained from other sources through direct exchange, then there would be no trigger. David McCallie HIT Standards Committee 8-30-2010 DRAFT Meeting Summary Page 6
  10. 10. added that it is an issue of information control, and not where the information sits. The issue is what controls are in place to guarantee that the access is appropriate. Wes Rishel referenced a previous Veterans Health Administration hearing and explained that one theme that arose from those discussions was that there is a tradeoff between how granular the consent is and how difficult it is to explain options to the patient. This is part of the difference between what is technically possible and what is practical. Jonathan Perlin acknowledged that this is a complex dialog, including new forums that defy traditional categorization. Additional work may be needed in standards classification of the entities that are involved in these complex relationships. 5. Standards and Interoperability Framework John Halamka noted that a series of Requests for Proposals (RFPs) were issued by the ONC, and this Committee will provide some oversight for the work of the contract winners. Doug Fridsma said that as they plan their work going forward, continued emphasis on standardization and need to move towards increasingly computational specification implementation are needed. Also, a mechanism so that standards can be manipulated by tools is required. These tools need to be stored in repositories that can be used by those interested in information exchange. Rather than a set of descriptions that would be difficult to harmonize, it is important that they are linked from inception all the way through certification, implementation specifications, and standards that can be tested for certification. This necessitates involving the National Institute of Standards and Technology (NIST) and other entities early in the process. The Standards and Interoperability (S&I) Framework is the framework by which the ONC will manage this work, to promote interoperability and meaningful use. The S&I Framework is not intended to develop new standards in and of itself, but it will help the ONC to work with health care organizations throughout the health care community. In a series of slides, Doug Fridsma explained the S&I Framework, and reviewed the following characterizations of the Framework: Managing the lifecycle: There needs to be a controlled way to manage all the activities within the standards and interoperability activities from identification of a needed capability to implementation and operations. Reuse: Standards development and harmonization efforts need to accommodate multiple stakeholders and business scenarios so as to ensure reuse across many communities. Semantic discipline: The work products need to be developed in a way to ensure computability and traceability throughout the entire lifecycle. Human consensus: Achieving human consensus is a prerequisite for computable interoperability HIT Standards Committee 8-30-2010 DRAFT Meeting Summary Page 7
  11. 11. Within a few weeks, all of the contracts will be in place. Doug Fridsma showed a timeline illustrating the contracts supporting the network. Contractors awarded so far include Deloitte, Lockheed, and Stanley. The government will serve as a platform to support the work, creating a neutral ground. As part of this effort, there is a need to leverage the HIT community, to take professional organizations, government agencies, and standards organizations, and ensure that all of their work comes down to a harmonized set of standards and implementable specifications. The goal is to solve real problems around meaningful use. The contractors will develop content exchange standards, transportation standards, nomenclature and value sets, and throughout the process will ensure that there are privacy and security standards to support the implementation specifications. The S&I Framework will provide coordination across strategic, operational, and technical issues. A top-down approach is needed to establish goals and an acceptance process. A bottom-up method is necessary to involve the standards community. Committee discussion followed, during which these points were raised: John Halamka said that previous uses of NIEM framework have been in different kinds of environments. He raised the possibility that this strategy may not fit into the health care framework, with its existing infrastructures and platforms. Doug Fridsma acknowledged that vigilant monitoring will be necessary. The process that NIEM undergoes to develop data specifications is similar to the processes within other standards organizations, including CDIP, HL7, and also the National Cancer Institute. Stan Huff commented that he likes the overall approach and its collaborative nature. He indicated that he did not have a clear picture of how the interoperability framework interacts with the formal processes in the other standards development organizations. When a new standard is needed, it may be possible to rapidly make a new prototype, but does that need to go to ballot somewhere? Will existing standards organizations be used for this, or will ONC become an “uber-standards” organization? Doug Fridsma explained that the goal is to coordinate across all of the different standards- development organizations (SDOs). The ONC will not serve as an “uber-standards” organization, and it will not replace the work of SDOs. When impossibly tight timeframes for standards development occur, it would be useful to have an organization that could come up with a potential standard and then develop the transfer method, content, vocabulary, etc. Then, that whole package can be handed to SDOs to make sure that they are appropriately balloted. As it relates to this work, the government’s job is not to create standards, but to identify the need for them. Wes Rishel described a continuum, between SDOs and profiler and enforcer organizations. The current NHIN Direct operation, for example, is a profiler. It did not define new standards; rather, it decided how to pick among standards and create interfaces between them. The Healthcare Information Technology Standards Panel (HITSP) is a profiler. One of the advantages of the NIEM approach is that it can solve some of the problems that HIT Standards Committee 8-30-2010 DRAFT Meeting Summary Page 8
  12. 12. profiler organizations can have, but it can only do so if it acquires the right intellectual property from the SDOs. He suggested that there be some sort of visioning process looking downstream for standards that will be needed when there is time to actually use the benefits of an SDO consensus process to obtain a broad perspective on the requirements and possible solutions. Doug Fridsma acknowledged that one unresolved issue involves intellectual property and engagement with SDOs. He hopes that the Committee can provide some guidance in this area. If solving problems requires multiple different groups to be able to come together and bring their expertise to the table, it will be important for there to be a comprehensive policy regarding the engagement of SDOs. They must be able to can contribute to those packages and still have business models that are able to support the work in which they are engaged. Nancy Orvis pointed to the business model and financing the maintenance of standards as the underlying issue. For those who are trying to help as organizational providers or as government agencies, it can be extremely complicated to determine all of the different levels to which resources need to be assigned. Carol Diamond suggested that it is time to operationalize this process. She reminded the Committee that she has often discussed the interplay between policy and technology in the formation of standards and implementation guides. Policy needs to be present in a visible and required manner. Her sense now is that because there has been some progress on information exchange, and because the ONC framework is in place, that those policies have to be a part of the contracts that are active. They need to be integrated into the approach in a very operational way. She commented that it would be detrimental if a situation arose in which the implementation guide or other items have to be reworked, or the policy objectives cannot be fulfilled, because the technical work was done out of sync. Dixie Baker asked whether milestones and metrics have been established for measuring the process. Doug Fridsma explained that this is one of the first charges of those who are working on the contracts. Most of the contracts have been awarded within the last 3 weeks, and there is still time to submit feedback and suggestions. 6. Vocabulary Task Force Update Vocabulary Task Force Chair Jamie Ferguson shared information about the upcoming September 1 hearing that will be held by the Vocabulary Task Force. He explained that in March, the Task Force held public hearings to answer questions about the national governance of terminology and subsets related to meaningful use. A set of resultant recommendations was forwarded to the National Coordinator. One of the themes that arose during those hearings was the desire for “one-stop shopping,” to make it easy for implementers to have access to the required vocabulary value sets and subsets. Therefore, the overall framing of the September 1 hearing is to gain input and understand what would constitute the right set of requirements for infrastructure that would provide this one-stop shopping. HIT Standards Committee 8-30-2010 DRAFT Meeting Summary Page 9
  13. 13. Which of these requirements would have the highest priority for achieving meaningful use? Other overarching questions guiding the hearing include: what do you think a one-stop shop means? Which requirements are urgent? What would be a staged approach to creating such an environment? Each of the 23 panelists will be asked a series of questions relating to their unique experiences and perspectives. The panelists are divided into four sets: (1) value set developers; (2) end users, with a focus on clinicians, hospitals, and medical centers; (3) EHR vendors; and (4) vendors, developers, and implementers of technical services from the commercial and government sectors. Jamie Ferguson also noted that the Vocabulary Task Force’s parent group, the Clinical Operations Workgroup, has been in discussions with Aneesh Chopra regarding the need for better understanding in terms of standards for remote sensing. Examples include collecting data on vital statistics in hospital and clinical settings and remote sensor data for home and other remote settings. The Clinical Operations Workgroup will plan a hearing on this topic. 7. Implementation Workgroup Update Implementation Workgroup Chair Judy Murphy noted that the group is in transition. The Workgroup is developing a new member list and expanding its membership to draw in additional experts who have implementation experience. The Implementation Workgroup has rewritten its broad charge as follows: “To bring forward real-world implementation experience into the HIT Standards Committee recommendations, with emphasis on strategies to accelerate the adoption of proposed standards or mitigate barriers, if any.” The Implementation Workgroup’s next meeting is scheduled for September 15 and will include an orientation for new members. 8. Public Comment David Tau of Siemen explained that his understanding is that the document being prepared by the ONC to tie together the S&I Framework will explain how the public and vendors can be engaged. He asked when that document will be made available. Doug Fridsma explained that it will be difficult to finalize this until all of the contracts have been awarded. SUMMARY OF ACTION ITEMS Action Item #1: Minutes from the last HITSC meeting, held on July 28, 2010, were approved by consensus. Action Item #2: The recommendations of the Enrollment Workgroup were approved by consensus, with line edits as described (i.e., adding “consistent with data standards developed under other recommendations” to the end of the first sentence in Recommendation 3.1, and adding a reference to Fair Information Practices in Recommendation 5.1). HIT Standards Committee 8-30-2010 DRAFT Meeting Summary Page 10
  14. 14. HIT Standards Committee Vocabulary Task Force Report From Task Force Hearing Sept. 1-2, 2010 Jamie Ferguson Kaiser Permanente Betsy Humphreys National Library of Medicine 21 September, 2010 Vocabulary Task Force Members Chair Organization Co-Chair Organization Jamie Ferguson Kaiser Permanente Betsy Humphreys National Library of Medicine Members Donald Bechtel Accredited Standards Organization X12 Chris Brancato HHS/ONC Lisa Carnahan NIST Christopher Chute Mayo Clinic Bob Dolin HL7 Greg Downing HHS Floyd Eisenberg National Quality Forum Doug Fridsma HHS/ONC Marjorie Greenberg HHS/CDC Patricia Greim Veterans Affairs Amy Gruber CMS John Halamka Harvard Medical School Stan Huff Intermountain Healthcare John Klimek NCPDP Clem McDonald National Library of Medicine Stuart Nelson National Library of Medicine Marc Overhage Regenstrief Institute Marjorie Rallins American Medical Association Dan Vreeman Regenstrief Institute Jim Walker Geisinger Andrew Wiesenthal IHTSDO (SNOMED) 2 1
  15. 15. Review: Subject of Hearing • General questions: 1. What are the requirements for a centralized infrastructure to implement “one-stop shopping” for obtaining value sets, subsets, and vocabularies for meaningful use? 2. Which requirements or functionalities are urgent, i.e., absolutely required to support “meaningful use”? Which would be most useful immediately? What would be a staged approach over time to get to the desired end state? • Detailed questions: – 15 detailed questions addressed the panelists’ operational experience and views in support of the general questions 3 Review: Structure of Hearing • Panel 1, Value Set Publishers • Panel 2, End User Implementers of EHR technology • Panel 3, EHR Vendors and Canadian Perspectives • Panel 4, Providers of Terminology Services • 24 Panelists represented a mix of the public and private sectors including developers of health measures, standards organizations, academic researchers, small office providers, large health systems, EHR vendors and terminological specialists • Format: Short introductory presentations by panelists, followed by one hour to two hours Task Force Q&A discussion with the panel 4 2
  16. 16. Hearing Results: Major Themes 1 • Clarity is more important than simplicity and harmony (but not by much) – Government must provide clarity, stability and predictability for vocabularies – Clarity about what is required, of whom, for what intended purpose – Clarity of future direction and vision is important – Simplicity for users should be an overriding goal of the infrastructure – Simplicity must be balanced by mechanisms for handling exceptions • A comprehensive plan does not mean it should be done all at once – Prioritize the most immediately useful content sets (value sets, subsets and cross-maps) including maps of SNOMED CT to ICD-9-CM & ICD-10-CM – Providing an enumerated list of codes is not enough for any value set implementation, but not everything is needed at first because attributes may be added over time to cultivate a more complete system – Prioritize establishment of a US extension to SNOMED CT for rapid additions needed by value set developers • Intellectual property (IP) issues can be a significant barrier to adoption and use of vocabulary content sets – More on this later, hold discussion for now 5 Hearing Results: Major Themes 2 • Strong version management is absolutely critical for distribution of vocabulary content sets, and expiration dates should be considered • System performance, uptime, and security characteristics must define infrastructure requirements – Explore the possible uses of cloud technology and distributed solutions • Value set context is important and unique – controls may be needed – The intended use of a value set establishes suitability for a specific purpose – “Off-label” use of value sets is sometimes highly problematic – Information about “off-label” uses may be helpful – Value set context and intent must be documented consistently • Multi-stakeholder, cross-functional involvement in the development and review of content sets should be facilitated by the one-stop shop 6 3
  17. 17. Hearing Results: Focus on IP (1 of 2) • Despite a diversity of individual views, every panel cited Intellectual Property (IP) restrictions and licensing as a barrier to vocabulary implementation in MU • The scope of vocabulary IP issues in MU encompasses all uses of vocabulary IP that may be involved in complying with MU regulations: – Vocabulary standards and extensions to standard vocabularies – Derivative works including crossmaps and value sets – Messaging standards that specify vocabularies, including HIPAA and MU • Alternative solutions suggested by panelists were all over the map: – Don’t allow monopolies for vocabularies/code sets that charge fees – Government should pay national license fees for all standards it adopts – Provider fees should recover a portion “X%” of national license costs • Plea from hospitals and clinicians: “Make this simple for us.” 7 Hearing Results: Focus on IP (2 of 2) • For IP issues, simplicity appears to trump both cost and mere clarity • “I understand the need to pay for the standards I use in my EHR but I am not in the business of tracking IP in my [medical office] practice.” • “Of course free is better …[but] we do not mind mind a reasonable fee for IP – we are used to that model – but you have to make it simple.” • “Just tell me how much it costs but it has to be one check made out to one place. Don’t make me figure it out [the IP] or I’ll never do it, it’s not worth it.” • Panelist comments suggest a possible alternative solution: – The Government or its agent could centrally administer license payments for intellectual property it adopts and uses in MU. Separate from the question of national licenses, this could potentially involve federal negotiation of license fees on behalf of regulated entities and federal payment processing. Each meaningful user would know his or her obligation and where to send their one single payment for all MU-related IP. 8 4
  18. 18. Next Steps • HITSC discussion, input and guidance for the Task Force • Task Force meetings are scheduled to develop our recommendations and next steps • HITSC may make recommendations to ONC 9 5
  19. 19. HIT Standards Committee Implementation Workgroup Judy Murphy, Aurora Health Care, Co-Chair Liz Johnson, Tenet Healthcare, Co-Chair September 21, 2010 Implementation Workgroup Member List Co-Chairs Judy Murphy Aurora Health Care Liz Johnson Tenet Healthcare Corporation Members Rob Anthony Centers for Medicare & Medicaid/CMS [new] Lisa Carnahan National Institute of Standards and Technology/NIST Anne Castro BlueCross BlueShield of South Carolina Simon P. Cohn Kaiser Permanente [new] John Derr Golden Living, LLC Carol Diamond Markle Foundation Timothy Gutshall Iowa HIT Regional Extension Center [new] Joseph Heyman Whittier IPA [new] Kevin Hutchinson Prematics, Inc. Lisa McDermott Cerner Corporation [new] Nancy Orvis Dept. of Defense Wes Rishel Gartner, Inc. Cris Ross Lab Hub Kenneth Tarkoff RelayHealth [new] Micky Tripathi MA eHealth Collaborative TBD Veterans Affairs/VA (Gregg Seppala will monitor) [new] TBD Office of the National Coordinator/ONC [new] Ex Officio Aneesh Chopra Chief Technology Officer, OSPT 1
  20. 20. Broad Charge To bring forward “real-world” implementation experience into the HIT Standards Committee recommendations, with a special emphasis on strategies to accelerate the adoption of proposed standards, or mitigate barriers, if any. Meeting held: September 15, 2010, 12:00 to 2:00 pm/ET Future Meetings – first Thursday of the month, 2-3:30pm ET October 7, 2010, 2:00 to 3:30 pm/ET November 4, 2010, 2:00 to 3:30 pm/ET December 2, 2010, 2:00 to 3:30 pm/ET Preliminary List of Potential Activities • Recommend that ONC create a publicly accessible online report/dashboard to track implementation progress (MU qualification, Regional Extension Centers, State Programs, Beacon Communities, and NHIN) – Don’t duplicate existing; post in one place what is already being done through the various programs – Specifically for MU, provide access to lists of: • Vendors who completed certification • Providers/hospitals who have registered with CMS • Providers/hospitals who have attested to MU with CMS • Providers/hospitals who have successfully achieved MU qualification and will be receiving incentive payments – Goal is to provide situational awareness and transparency, as well as access to potential resources 2
  21. 21. Preliminary List of Potential Activities • Provide feedback/”reality test” to HITPC and HITSC’s recommendations – does this make sense from an implementation standpoint? – Synergies – Concerns • Encourage/advertise use of existing resources such as – Health IT Buzz Blog – Federal Advisory Committee Blog – Health IT Journey - Stories from the Road – ONC FAQ’s – CMS FAQ’s Preliminary List of Potential Activities • Evaluate and consider use of social networking tools to connect people and learn form each others’ implementation efforts • Provide clarity on MU specifications and resolve any confusion on available resources (source of truth) – Create a “Playbook” for MU – Provide guidance on NHIN and NHIN Direct – Help providers/hospitals determine how to bridge efforts re: MU performance, quality measures and NHIN • Clarify consumer expectations of EHR vendor certification – what can they actually expect from a “certified EHR product”? 3
  22. 22. Preliminary List of Potential Activities • Consider a home for the questions that NIST is not able to answer and a place to publish “lessons learned” • Ascertain if it would make sense to create a version of the NIST test scenarios for consumers to use in evaluating their implementation/adoption of the EHR • Determine what drives our Workgroup agenda – Our understanding – Input from others – HITPC and HITSC’s policies and programs feedback Next Steps • Find out what ONC and CMS already have planned and what they need our input or feedback on • Prioritize activities • Create a roadmap to begin work on the highest priority items • Add a member from public health to the Workgroup • Determine metrics to measure our success as a Workgroup - are we helpful / successful ? 4
  23. 23. HIT STANDARDS COMMITTEE DRAFT: S&I Framework Principles and Processes 1 1 S&I Framework KICK-OFF 2 1
  24. 24. S&I Mission » Promote a sustainable ecosystem that drives increasing interoperability and standards adoption » Create a collaborative, coordinated, incremental standards process that is led by the industry in solving real world problems » Leverage “government as a platform” – provide tools, coordination, and harmonization that will support interested parties as they develop solutions to interoperability and standards adoption. 3 ONC Standards and Interoperability Framework Standards Pilot Demonstration Development Projects (TBD) (Lockheed Martin) Use Case Development Harmonization of Implementation Reference Certification and Functional Core Concepts Specifications Implementation and Testing Requirements (Deloitte) (Deloitte) (Lockheed Martin) (Stanley/Deloitte) (Accenture) Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc) (Stanley) 4 2
  25. 25. Standards and Interoperability Organizational Structure Standards and Interoperability Standards National Health Certification FHA Information Network and Testing Standards NHIN Teams Certification FHA Teams Teams Team CONNECT Use Cases Architecture Certification (TBD) (Accenture) (Stanley/Deloitte) Reference Standards Implementations Development (Lockheed Martin) Test Infrastructure (TBD) (Stanley/Deloitte) Emergent Pilots (Lockheed Martin) Harmonization (Deloitte) Tools (Stanley) Spec Factory (Deloitte) Operations (Stanley) 5 What is an IEPD? » An Information Exchange Package Documentation (IEPD) is a collection of artifacts that describe the construction and content of an information exchange • Developed to provide the business, functional, and technical details of the information exchange through predefined artifacts • Created with a core set of artifacts in a prescribed format and organizational structure to allow for consistency • Designed to be shared and reused in the development of new information exchanges through publication in IEPD repositories • IEPDs contain design specifications for an information exchange but may not include supplementary information such as implementation decisions. 6 3
  26. 26. The IEPD Artifacts • Sequence IEPDs contain both Scenario • Business Process Diagrams Planning • Use Cases required and recommended • Business Rules • Business artifacts Analyze Requirements Requirements Required : Bold • Exchange Content • Mapping Map & Model Model Document Recommended : Italic • Subset Schema • XML Wantlist Note: Best Build & • Exchange •Constraint Schema Validate practices for most Schema •Extension Schema organizations •Main Document •Sample XML include many of the Assemble & •IEPD Catalog Instances Document optional artifacts •IEPD Metadata •XML Stylesheets listed here No required artifacts. Publish the IEPD Publish & to a repository and implement the Implement exchange 7 S&I NIEM Harmonization Strategy Human Services Human Services » ONC’s Office of Interoperability and Standards is building a Health Information Exchange Model (NIEM Health) that is harmonized with NIEM » Health and Human Services petal to serve as bridge between NIEM 8 and NIEM Health 4
  27. 27. S&I NIEM Process Harmonized Participants S&I Development Phases Capability Capability Construction Release & Formulation Elaboration Publication Analyze Build & Assemble & Pub. & NIEM Lifecycle Scenario Planning Requirements Map & Model Validate Document Impl. Use Case Development Harmonization Spec Development Reference Impl Cert &Testing Health Community S&I Governance 9 Addressing Challenges for the Health Information Exchange Model Challenge Approach Existence of disparate health information Map exchange requirements to existing exchange standards and specifications standards & specifications and address any and implementation approaches gaps, duplications, or overlaps Harmonization and management of Leverage existing vocabulary repositories (e.g. several well-established, large PHIN VADS), coordinate with Unified Medical vocabularies for semantic interoperability Language System (UMLS), and collaborate with standards development organizations Usability of existing HIT exchange Use NIEM processes and adapt supporting protocols and specifications tools to create computable, useable implementation specifications NIEM only addresses data content, but Adapt structure and content of S&I IEPD to transaction behavior and security incorporate transport and security aspects of provisions are necessary for health exchange information exchange Compatibility of S&I IEPDs with existing Develop and adapt NIEM and health NIEM infrastructure and tools, as well as information technology tools and framework to existing health information exchange support NHIN goals 10 protocols 5
  28. 28. Requirements for a Model Centric Approach » The modeling approach used by the S&I Framework must • Provide traceability from Use Case and Requirements through to one or more implementations • Provide semantic and syntactic modeling constructs to support defining the information and behavior that are part of exchanges • Support the need to harmonize with existing standards defined at different levels of abstraction • Be adoptable by different organizations • Be able to integrate into NIEM process 11 Model-Centric Solution - MDA » Base S&I Framework modeling on the 3 OMG/MDA model abstractions. • Computational Independent Model (CIM) • Platform Independent Model (PIM) • Platform Specific Model (PSM) » Define a mechanism to show traceability from Use Cases and Functional Requirements through to technical bindings defined in a PSM. » Define a flexible modeling foundation by which different types of specifications can be defined. » Provides ability for multiple technology bindings for the same set of logical specifications (multiple PSMs) 12 6
  29. 29. Model Centric Solution - NIEM S&I Activities NIEM Processes and Artifacts Specification Models Use Case Development Business Processes, Vision Document, Scenario Planning and Functional Use Cases Process Model Requirements CIM Business Rules, Use Case Model, Harmonization of Analyze Business Interaction Model, Core Concepts Requirements Requirements Domain Model Map and Model Exchange Content Implementation Model, Mapping Behavior Model Specifications Document Domain Model PIM Reference Exchange Schema, Build and Validate Implementation Subset/Constraint and Pilots Schema, Web Services PSM Schema and WSDL Assemble and Main Document, Certification and Document IEPD Catalog, IEPD Testing Metadata, Sample XML Publish and Implement 13 Prioritization and Backlog Lists Strategic Priorities Operational Priorities “Day to Day” Priorities within each functional team 14 7
  30. 30. What’s Next Pilot Standards Demonstration Development Projects Use Case Harmonization of Development Implementation Reference Certification Core Concepts and Functional Specifications Implementation and Testing (NIEM framework) Requirements Scenario Map & Assemble & Planning Model Document Analyze Build & Publish & NIEM IEPD Lifecycle Requirements Validate Implement » Create a NIEM Health standards harmonization process and governance framework » Establish roadmap for existing NHIN standards, MU harmonization, and non-MU health information exchange specifications » Establishes a repeatable, iterative process for developing widely reusable, computable implementation specifications » Establishing the tooling and repositories needed » Establishing the practices and guidelines for modeling » Enables semantic traceability so that useable code can be traced back to original requirements and definitions 15 » Promotes transparency and collaboration from broad range of health stakeholders S&I Framework CURRENT LESSONS 16 8
  31. 31. Lessons Learned: NHIN Direct High » Consensus Driven Process Focused » Open Collaboration Command Collaboration and Control » Established core guiding principles Focus » Driven by business needs and elaborated use cases A Thousand » Real world pilot Flowers Bloom implementation » Establish executive Low Low High sponsorship and workgroup leads Participation 17 Lessons Learned: Eligibility and Enrollment High » Dedicated resource(s) to drive Focused project and decision making Command Collaboration and Control » Clearly defined problem statement at project initiation Focus » Define expectations for desired artifacts A Thousand » Promote community Flowers Bloom enthusiasm » Leverage tools to increase Low Low High efficiencies Participation 18 9
  32. 32. S&I Framework ISSUES TO DISCUSS 19 Issues and Challenges (1) Issues and Challenges HITSC HITPC » How and when do we get input from other stakeholders including those Coordination outside of meaningful use? Priority Setting » VLER Evaluating Artifacts » Federal partners » Other stakeholders » How do we foster multiple working S&I Framework groups and create a unified view of Sustainable Operations priorities? Shared Infrastructure 20 10
  33. 33. S&I Framework Challenges (2) How do we create simple, easy to implement specifications that will drive adoption? » How do we facilitate access to SDO standards for providers and support sustainable business models? • Engaging the SDO community • Developing a “one stop shop” for implementation specifications » How do we foster community and industrial participation to support balanced representation and diverse priorities? • Identifying champions for S&I lifecycle initiatives • Engage communities throughout S&I Framework • Identifying demonstrable pilot programs • Engaging and incentivizing volunteers from existing community 21 S&I Framework Open Questions cont. » What are the appropriate interface points with HITSC through S&I Framework lifecycle? • Establish priorities, approve implementation specifications, • Identifying appropriate decision makers at S&I control points • Identifying appropriate roles and participants in the governance of S&I Framework » How do we identify and select tools as shared resources that foster collaboration? • Establishing and adhering to agreed upon modeling conventions • Tools to support artifact lifecycle management and dissemination » How do we extend NIEM to accommodate needs of health care domain? 22 11
  34. 34. S&I Framework Priorities Prioritization needs to accommodate broad stakeholder needs, account for breadth and depth of available expertise, and support a long term growth strategy » What should our priorities be for the next six months, twelve months, twenty-four months? From among… • Meaningful Use Stage 1 • Meaningful Use Stage 2 & 3 • NHIN Exchange • NHIN Direct • Health Care Reform • VLER • New use cases (lab, pharmacy, content specifications) 23 12