1. HIT Steering Committee 6/20/2102 Doug Fridsma, MD, PhD, FACMI Chief Science Officer Director, Office of Science & Technology

2. Future Direction of S&I Framework ONC's commitment to enabling rapid standards develop is not diminished with the end of ARRA funding. The HITECH Act has given ONC the responsibility to support standards and certification criteria now and in the future. While we will not have the ARRA resources after 2013, funding for the S&I framework will continue to support coordination around key initiatives We are working with the community to find ways to make the federal investment go even further. For example, we are working with CHCF to develop a new standard for lab ordering interfaces, in which we provide additional coordination resources. The S&I framework will continue to support and coordinate high priority initiatives. We can anticipate additional discussion in the HITSC, and within the S&I framework. 2

3. Application of S&I Framework process to standards challenges High Low Availability of Empirically-Validated Standards Required Approach To Standards Development Degree of Consensus Low High Incremental Innovative Shaded Area = Good Alignment with S&I Framework Process 3

4. How do we operationalize standards analysis and harmonization? ModHigh Low Mod High Track and encourage SDOs, Agencies, Coalitions, Community-Driven Pilots Recommend as Priority for (di novo) Innovation Project Recommend as Priority for S&I Framework Delegate to HITSC WG or Power Team Enable Public Comments Low Degree of Consensus Degree to which an Incremental approach will solve the challenge 4

5. Examples ModHigh Low Mod High Track and encourage SDOs, Agencies, Coalitions, Community-Driven Pilots Recommend as Priority for S&I Framework Delegate to HITSC WG or Power Team Enable Public Comments Low Degree of Consensus Availability of Empirically-Validated Standards federated provider directories lab results care transitions distributed queries immunization reporting FBCA cross- certification lab orders 5

6. How do we support S&I initiatives? ModHigh Low Mod High Low Alignment with ONC Priorities (i.e., Value Created) Unique Impact of S&I Framework (i.e., Degree of Platform Reuse) Limited Support Self-ServiceFull Support Use of the S&I wiki Use of paid-for WebEx and meeting recording facilities, if available Periodic touch points with S&I Framework Coordination Team Self-Service Resources + Facilitator to guide meetings and report back to S&I Framework Coordination Team Strategic Resources + Full resources to complete deliverables in timely manner Strategic Support Hybrid Resources + Targeted investment in specific components in line with ONC/partner objectives 6

7. NPRM 2014 Edition Standards 7 Vocabulary & Code Sets Content Structure Transport Security Other Consolidated CDA (Sum. Record) Consolidated CDA (Sum. Record) NCPDP SCRIPT 10.6 (e-Rx) NCPDP SCRIPT 10.6 (e-Rx) HL7 2.5.1 (Pub. Health) HL7 CDA R2 (cancer rept’n) DICOM (Imaging) DICOM (Imaging) Direct Specifications SOAP – Secure Transport (NwHIN Exchange Spec) SOAP – Secure Transport (NwHIN Exchange Spec) More Comprehensive Auditable Events FIPS 140-2 Annex A (Encryption/ Hashing) FIPS 140-2 Annex A (Encryption/ Hashing) Synchronized Clocks WCAG 2.0, Level AA (accessibility) WCAG 2.0, Level AA (accessibility) HL7 Infobutton (knowledge requests) HL7 Infobutton (knowledge requests) NQF Quality Data Model (CQM data capture) NQF Quality Data Model (CQM data capture) CVX (Immunization) CVX (Immunization) OMB Race/Ethnicity SNOMED CT (Problems) SNOMED CT (Problems) ISO 639-1 (Pref. Lang) ISO 639-1 (Pref. Lang) ICD-10-PCS/ HCPCS & CPT-4 (Procedures) ICD-10-PCS/ HCPCS & CPT-4 (Procedures) ICD-10-CM (Prelim Cause of Death & Encounter Diagnoses) ICD-10-CM (Prelim Cause of Death & Encounter Diagnoses) LOINC Smoking status RxNorm (Medications) RxNorm (Medications) IG e-Lab Rept’n IG e-Lab Rept’n IG Syndromic Surv IG Syndromic Surv IG Immz Rept’n IG Immz Rept’n IG Cancer Registry Rept’n IG Cancer Registry Rept’n HL7 2.5.1 (Incorp Lab Results) IG – Lab Result Interface

8. S&I Initiative Portfolio Snapshot Transitions of Care Provider Directories Query Health Pre- Discovery Use Case Harmonization RI, Test & Pilot Evaluation Lab Results Interface Data Segmentation for Privacy esMD Longitudinal Coordination of Care Public Health Reporting Laboratory Orders Interface Targeting completion of pilot(s) and initial evaluation by September 2012 2 nd IG Ballot Publication (4/9/12) Pilots Underway 1 st (of 3) use cases consensus-approved; Targeting completion of pilot(s) and initial evaluation by October 2012 Working on Extension of the ToC Use Case for LCC (reuse); Limited Support Initiative Community-Led initiative Finalizing Initiative Charter and drafting Use Case; S&I Community Launched 3/30 Plan to begin piloting in April 2012 Direct Project (S&I Archetype) Looking at potential pilots and reference implementation Health eDecisions S&I Community launching early June 2012 8

9. Direct Project Initiative Coordinator: John Hall Initiative Purpose: –The Direct Project develops specifications for a secure, scalable, standards-based way to establish universal health addressing and transport for participants (including providers, laboratories, hospitals, pharmacies and patients) to send encrypted health information directly to known, trusted recipients over the Internet. 9

10. Direct Project: Recently Achieved Milestones Implementation Geographies WG released draft guidance for labs looking to transport lab reports using Direct (included CLIA and CAP approval) Kicked-off planning for pilots of lab report delivery via Direct Direct Project Virtual Connect-A-Thon held and new release candidate of Java software implementation issued Vetted proposed changes to Applicability Statement addressing typos/errors and certificate discovery with Project workgroups 10

11. Direct Project: Planned Milestones Call to committed members for consensus around certificate discovery Publish updated Applicability Statement addressing typos/errors and certificate discovery Finalize guidance to labs using Direct to transport lab reports Incorporate functionality in reference software implementations related to lab guidance 11

12. Transitions of Care Initiative Coordinator: John Feikema Initiative Purpose: –Improve the electronic exchange of core clinical information among patients and providers of care in support of Meaningful Use and IOM-identified needs –Enable care transitions with an unambiguously-defined core set of high- quality clinical data to inform complete reconciled medications lists, medication reactions, laboratory results, etc. Standards Related: –Consolidated CDA Analyzed NPRMs against Consolidated CDA S&I developing Consolidated-CDA Companion Guide with best practice examples –Forum and knowledgebase for questions: collaboration with HL7 SDWG for expert advice to the nation 12

13. Transitions of Care: Recently Completed Milestones Redirected Pilots work group to other initiatives (no pilot activity necessary at this time) Developed the foundation for a set of Consolidated CDA clinical examples, aligned with 2014 Edition MU Transition of Care objectives 13

14. Transitions of Care: Planned Milestones Finalize clinical scenarios used to exhibit each 2014 Edition MU Transition of Care objective. Recommend “best fit” Document Templates from Consolidated CDA for each 2014 Edition MU Transition of Care objective. 14

15. Query Health Initiative Coordinator: John Feikema Initiative Purpose: –Establish standards and services for distributed population queries –Improve access to data for purposes of disease outbreak monitoring, comparative effectiveness research, quality and performance measures, all while maintaining a strong focus on patient privacy and security Standards Related: –Focus on wrapping up our work on specifications and executing pilots to obtain real world feedback on selected standards and implementation guidance. –Standard for questions: “new” HQMF –Standard for results: “new” QRDA Categories 2 & 3 –Presented to SDWG at HL7. –Ballot in September 15

16. Query Health: Recently Completed Milestones Completion of CEDD Consensus on Version 2 of Query Health CEDD. This version will be pilot tested by Allscripts and by the State of New York using the greenCEDD ontology developed by New York to support key query data elements. Completion of HQMF Implementation Guide and formation of a joint HL7/S&I Framework workgroup to prepare implementation guide for formal HL7 ballot Completion of QRDA Category 2/3 Implementation Guide to also be reviewed and finalized by joint HL7/S&I Framework workgroup Completion of HQMF Sample Query code for review and discussion in Query Health Technical Workgroup, and to support initial piloting efforts 16

17. Query Health: Planned Milestones Initial pilot results for Query Health Reference Implementation discussed and reviewed Finalize updated June 2012 Quality Data Model (QDM) alignment to Query Health CEDD Complete final HQMF Implementation Guide Review with joint HL7/SDWG workgroup and prepare for balloting by HL7 in September Complete final QRDA Category 2/3 Review and incorporate with QRDA Category 1 into QRDA Implementation Guide for balloting by HL7 in September Complete QRDA Translator to support pilots who are planning to use native formats such as SQL for query results 17

18. Data Segmentation for Privacy Initiative Coordinator: Johnathan Coleman Initiative Purpose: –Build on the PCAST vision and recommendations from the HITSC for the development of metadata tags to be used for exchanging data across organizational structures while maintaining the privacy and security of the information. –Goal is to enable appropriate sharing of data which is given heightened protection under the law, such as substance abuse treatment information. Standards Related: –Reviewing for comment several documents including: HL7 EHR-System Functional Profile for HIE Metadata HL7 Implementation Guide for CDA R2 Consent Directives, DSTU –Referencing or including in the DS4P Implementation Guide several HL7 Vocabulary Codeset standards and reference material such as: Confidentiality Codes, Refrain Policy, Obligation Policy, Purpose of Use, and HL7 Security & Privacy Ontology –Recognize the support and leadership of various HL7 participants and co-chairs including: John Moehrke, Richard Thoreson, Mike Davis, Ioana Singureanu, Kathleen Connor, Walter Suarez, Allen Hobbs 18

19. Data Segmentation for Privacy: Recently Achieved Milestones Completed development of the Implementation Guide Analyzed HITSC standards recommendations for privacy metadata Launched RI/Pilot phase and confirmed VA/SAMHSA as approved pilot Received update from SSA on use of NwHIN Exchange to convey patient authorizations 19

20. Data Segmentation for Privacy: Planned Milestones Reach consensus on the Implementation Guide Provide detailed update to the HITSC Security and Privacy WG on the HITSC recommendations for privacy metadata (scheduled for June 29 th ) Develop and approve test cases for demonstrating data segmentation in the VA/SAMHSA environment 20

21. Electronic Submission of Medical Documentation (esMD) Initiative Coordinator: Sam Elias Initiative Purpose: –The purpose of the S&I Framework esMD initiative is to enable the electronic sending of medical document request letters to providers, and identify author- level signature solutions needed to enable acceptance of electronic claims attachments. –Define the requirements and select the electronic standards necessary to replace current paper processes for medical documentation requests with an electronic alternative. Standards Related: Author of Record and Digital Authentication – Standards for Author of Record and Digital Authentication related to clinical and administrative content and their associated transactions. Structured Medical Documentation (CDA) – Standard for structured medical documentation to be submitted through esMD in future. Claims Attachments – Standard for claims attachments to the structured medical documentation submitted through esMD in future. 21

22. esMD: Recently Completed Milestones Achieved consensus on Use Case 2 pertaining to the Electronic Medical Documentation Request (eMDR) Structured Content and Transport Initiated Harmonization and Standards Development engagement for Use Case 2 and Use Case 1 pertaining to Provider Profile Authentication to register to receive an eMDR Initiated an environmental scan of current industry practices in the realm of Author of Record with regards to the scope established in the pre-discovery activity (identity proofing, digital identity management, encryption, digital signatures, delegation of rights, and author of record) Received presentations from NSTIC/NIST and the Direct Project 22

23. esMD: Planned Milestones Continue and finalize Harmonization and Standards work for Use Case 1 and 2, to include mapping data set requirements to existing standards (X12 277 and 274, CDA, etc) Achieve consensus on the Author of Record Charter Continue the environmental scan of current industry practices for the Author of Record scope –Planned presentations include HL7 RM-ES, Certificate Authorities, VeriSign, SAFE Bio-Pharma, HL7 Security and Privacy Committee, OASIS, IHE Begin Use Case development and review for Author of Record Phase 1 23

24. Laboratory Orders Interface (LOI) Initiative Coordinator: John Feikema Initiative Purpose: –The goal of the initiative is an IG for electronic ordering of laboratory tests in an ambulatory setting that can serve as a foundation for eventual use in in-patient and public health settings. Further, the design will incorporate vocabulary consistent with the above mentioned guides as well as support for use of the Electronic Directory of Service (eDOS) IG. Standards Related: –Lab Results Interface HL7 Version 2.5.1 Implementation Guide: Laboratory Results Interface for US Realm, Release 1 –Laboratory Orders Interface Aligning the ELINCS Orders interface to LRI 2.5.1 –eDOS (electronic Directory of Services) Aligning HL7 Laboratory Test Compendium Framework Implementation Guide Release 1 to LRI and LOI 24

25. LRI/LOI/eDOS: Recently Completed Milestones LRI – 175 of 228 ballot issues resolved (16 minor and 16 major negatives remain). On track. eDOS formally launched LOI use case (aligned with LRI) 90% complete Unified LRI/LOI/eDOS pilot program launched 25

26. LRI/LOI/eDOS: Planned Milestones Complete LRI ballot reconciliation LOI end-to-end use case review –consensus review expected in less than 30 days. eDOS use case analysis launched – planned completion end of July. 26

27. Longitudinal Coordination of Care (LCC) Initiative Coordinator: Victor Palli LCC/LTPAC activities will be covered in next presentation 27

28. New Initiatives Coming PCOR (Coordinator: Jamie Skipper) –Establish standard data elements for EHRs to capture that will support Patient Centered Outcomes Research Blue Button (Coordinator: Pierce Graham Jones) –Establish tools (use cases, standards, and services) to automate the blue button: “Automated directed exchange of patient health information” and “Publication and subscription of patient health information” Health eDecisions (Coordinator: Alicia Morton) –To identify, define and harmonize standards that facilitate the emergence of systems and services whereby shareable and/or interoperable CDS intervention artifacts can be implemented in a system by any healthcare stakeholder via: Standards for the importable computable biomedical knowledge format and Standards to access a CDS Web service to provide actionable interventions 28

29. Value of the S&I Framework platform –A public platform where the community can build consensus around a solution to a standards gap that must be addressed to support the exchange of health data. –The ideal use of the S&I Framework (the “sweet spot”) is to build consensus around a standards solution when there is 2 or more standards that fail to address the needs of the community. –The functions of the S&I Framework will be to: Help identify standards gaps for health information exchange Provide a flexible process and dynamic tools that can support a community to create consensus around solutions for priority standards gap areas Evaluate the solutions emerging from the Framework and improve the Framework’s processes and tools and refine the criteria for a successful S&I Framework initiative. Serve as a repository for standards products that have been developed using the S&I Framework platform. 29

30. Cross S&I Framework Activities Current efforts are underway to create: A clear public facing vision for the S&I framework that allows it to be a platform with a purpose A standards gaps analysis for crucial health data exchange among primary healthcare stakeholders A governance process for the S&I Framework Initiative criteria to help determine whether an initiative would be appropriate for the S&I Framework Multiple tracks through which an initiative can achieve its goals A dynamic data dictionary that serves as a communication tool for users to understand the semantics behind the terms used within S&I framework products. (Terms within the data dictionary would be reused and extended in future S&I initiatives) A standardized S&I Framework wiki workspace for the community that allows community members to easily participate in multiple initiatives without having to relearn new wiki page structures. 30

31. Questions for HITSC What are the criteria for a successful S&I initiative? What does the HITSC see as their role within S&I governance? How does the HITSC wish to convey their prioritization of standards gap areas? What supportive information would the HITSC need to identify and prioritize standards gap areas? What kinds of flexibilities should be built into the Framework’s initiative life cycle/process? How should a multi-track option for initiatives look like? What steps should be taken to properly evaluate the success of S&I Framework initiatives? 31