Health IT Standards Committee A Public Advisory Body on Health Information Technology to the National Coordinator for Health IT 2017 Interoperability Standards Advisory Task Force Kim Nolen, co-chair Richard Elmore, co-chair May 23, 2016

Health IT Standards Committee Work Product Agenda 2 Welcome and Opening Remarks Task Force Charge Discussion Discuss Public Comments Related to ISA Scope, Structure, the Six Characteristics, and “Best Available” Discuss Next Steps

Membership MemberOrganizationRole Kim NolenPfizer, Inc.Co-Chair Richard ElmoreAllscriptsCo-Chair Mark RocheAvanti iHealthMember David McCallie, Jr.Cerner CorporationMember Dan VreemanRegenstrief InstituteMember Christina CaraballoGet Real HealthMember Michael IbaraMichael Ibara, LLCMember Russ LeftwichInterSystemsMember Dale NordenbergNovasano Health and ScienceMember Michael BuckNew York City Department of Health and Mental Hygiene Member Eric HeflinThe Sequoia Project/HIETexasMember Tone SoutherlandReady ComputingMember Susan MatneyIntermountain HealthcareMember Robert IrwinRobert Wood Johnson University HospitalMember Health IT Standards Committee Work Product 3

Membership MemberOrganizationRole Clem McDonaldNational Library of MedicineFederal Ex Officio Kin Wah FungNational Library of MedicineFederal Ex Officio Christopher HillsDoD/VA Interagency Program OfficeFederal Ex Officio Brett AndriesenOffice of the National Coordinator-Health and Human Services ONC Lead Health IT Standards Committee Work Product 4

Draft Workplan Health IT Standards Committee Work Product Meeting DatesTask Fri, Apr 15, :00pm ETTask Force Kickoff Fri, May 6, :00pm ETReview Purpose and Assign Task Force Workgroups  Mon, May 23, 2016 – 2:00pm ETISA Framing & Structural Improvements Thu, Jun 2, :00pm ETBest Available Standards Tue, Jun 14, :00pm ETUpdates from Public Comments Mon, Jun 20, :00pm ETUpdates from Public Comments Jun 23, :30am - Joint CommitteeDraft Findings / Recommendations to HITSC Tue, Jun 28, :00pm ETAdditional Updates from Public Comments Tue, Jul 26, :00pm ETRefine Recommendations Jul 27, :30am - Joint CommitteePresent Findings / Recommendations to HITSC 5

Health IT Standards Committee Work Product Original Task Force Charge 6 By the July 2016 HITSC meeting, submit recommendations to the Health IT Standards Committee regarding revisions and enhancements ONC should consider as it creates the Draft 2017 Interoperability Standards Advisory (ISA), taking into account feedback from the public comment process.

Health IT Standards Committee Work Product Next Generation ISA 7 Next generation ISA (and its formative process) would be used in the following ways: Provide an open and transparent process for the industry to vet standards and attribute them to particular interoperability needs (with appropriate implementation context); Facilitate greater standards use consistency (level playing field expectations) among established health IT developers and new entrants to health care; Enable executives leading procurements to point to vetted ISA standards; Lead industry dialogue around standards implementation and use such that government agencies could use the ISA as a strong basis from which to propose regulatory requirements/changes (e.g., when an “emerging” standard becomes ready for prime time).

Health IT Standards Committee Work Product New Task Force Charge 8 Over the course of two phases, the 2017 ISA Taskforce is charged to develop recommendations for the HITSC on the following: Phase 1 (Now ->July) Updates to the ISA based on an analysis of public comments; Structural and framing improvements to the ISA, including elements that could provide additional clarity and context for stakeholders that would use and consult the ISA; Limited set of new “interoperability needs” that should be included in the ISA along with attributed standards and implementation specifications; The explicit “best available” designation to a standard or implementation specification, where appropriate (and in consideration of available implementation experience). Phase 2 (July ->Nov 1) Discussion and recommendations around the TF’s priority list for inclusion in the 2017 ISA’s “Projected Additions” section.

PUBLIC COMMENTS OVERVIEW 9

Health IT Standards Committee Work Product ISA Scope 10 Revise the Advisory to include advice for “best available” standards for both primary and secondary use, making the reference to each designated standard explicit as to whether it supports one or both uses. Include in scope, patient identity matching as this is a huge barrier to interoperability. The Advisory should concentrate on such promising standards with significant potential to be finalized, moved into production, and widely adopted in the near future (balloted standards), rather than duplicating the list of fully mature standards, already in production and widely implemented, which are specified in regulations or which could be published in a separate document.. Revise the Advisory to make explicit which “best available” standards are designed and capable to deliver intact vital clinical context/content relationships from source health data/records (especially for primary uses and users). Recommend that ONC incorporate any lessons learned, outcomes or other benefits obtained from the ONC Tech Lab into the Best Available Specifications section. It is short sided not to include administrative standards because clinical and administrative data are so closely entwined. The Advisory should over time become a predictor of what will be endorsed for national adoption and should consider adding standards that did not make it into the 2015 Edition Certification, or clarify that they are no longer being considered.

Health IT Standards Committee Work Product ISA Structure 11 Where ONC has identified gaps in available standards or implementation specifications for specific use cases, list these in a separate section to highlight where further focus is required, or to recognize projects in progress to fill that gap. Add a category of “Ballot in Development” and create a section for emerging standards to point stakeholders to initiatives that they may want to be aware of, if not join. This could be a summary of some of the entries on ONC’s Interoperability Proofing Ground. Organizing the standards and implementation specifications based on Use Case and Interoperability Needs must provide more helpful context to assess fit-for-purpose and maturity. Suggest rewording/restructuring to say "the standards for services, or the infrastructure components..." As defined here, it would not include standards such as FHIR but only would include actual instantiations of services via infrastructure.

Health IT Standards Committee Work Product The Six Characteristics 12 "Production" vs "Pilot" for Implementation Maturity is too coarse grained ONC modify the “Standards Process Maturity” levels to reflect one of the following: Final, Standard for Trial Use (“STU”), or Ballot in Development. Including actual cost data in the Cost field (if known) would be extremely helpful to implementers evaluating the standards in the ISA As new interoperability needs and standards are identified for mobile/consumer use cases, additional ratings should be given to cater for newer classes of Adoption and Maturity in mobile and consumer settings Should there be a nuance that accounts for inclusion in other established certification programs, e.g., Surescripts, states, or industry (e.g., Concert by HIMSS)? Recommend adding a characteristic for who owns the standard. Adoption Level: »Needs more detail to ascertain whether used in production vs large numbers of pilots. Also should show a “slope” of the adoption curve as well as whether it is increasing or decreasing in adoption. »Be more transparent in data sets used and organizations polled to determine adoption level and whether it represents the extent to which software developers have adopted a standard or implementation specification in their products or whether it is actually being used by providers.

Health IT Standards Committee Work Product “Best Available” Concept 13 Add a definition of what an emerging standard is to distinguish between the terms final, balloted draft, production and pilot. Need to better distinguish between pilots and emerging standards. Important to clarify “the best standard for what?” This issue remains a challenge with this version of the Advisory. The new organization and section titles are a step in the right direction, but it remains a challenge to understand the specific use cases for standards listed. Each “interoperability need” should be better described to prevent unintended consequence of developers investing in the wrong solutions or hampering innovation by focusing on the wrong problems. Make more explicit that developers should consider the ISA and its standards to be a starting point, while assessing the level of maturity and whether the needs of their clients dictate that they adopt early in the lifecycle and help mature the standard, or wait until standards have matured and/or are included in regulatory programs.

Next Meeting Thursday, June 2 2:00pm-3:30pm ET Full text of public comments will be provided to task force members and the focus will be on the criteria for how the “best available” designation is determined. Health IT Standards Committee Work Product 14

Health IT Standards Committee A Public Advisory Body on Health Information Technology to the National Coordinator for Health IT