Interoperability Roadmap Implementation, Certification, and Testing Workgroup Liz Johnson, Co-Chair Christopher Ross, Co-Chair February 13, 2015

Workgroup Charge Review implementation challenges with existing standards and provide recommendations for how to improve existing standards and testing Recommend testing process that support the goals of interoperability and information exchange Evaluate sustainable and inclusive approaches to certification and test method development Identify the necessary health IT functions and standards that must be tested Recommend stages of maturity in a certification testing model 2

Current Member list 3 NameOrganization Cris Ross, co-chairMayo Liz Johnson, co-chairTenet Healthcare Corporation Sarah CorleyNext Gen Udayan MandaviaiPatientCare Rick MooreNational Committee for Quality Assurance Andrey OstrovskyCare at Hand Danny RosenthalInova Health System John TravisCerner Corp. Steve WaldrenAmerican Academy of Family Physicians Zabrina GonzagaLantana Kyle MeadorsDrummond Group Inc. Brett Andriesen, staff leadOffice of the National Coordinator for Health IT

2014 Q42015 Q12015 Q22015 Q3 DecJanFebMarAprMayJunJulAugSep FACA Milestones 4 Kick-off Federal Milestone Federal HIT Strategic Plan Posted for Comment HITPC Interoperability Roadmap Recommendations FACA HIT Strategic Plan Comments Interoperability Roadmap V1 Posted for Comment HITPC comments on MU3 NPRM HITSC comments on Certification NPRM All workgroups kicked off FACA Milestone FACA Interoperability Roadmap Comments (estimate)

MeetingsTask February 10, 2015 – Joint Committee Meeting Charged by HITSC with responding to the Interoperability Roadmap V.1  February, :00 ET  Discuss how ONC can consider modifying community-driven process to enhance the value it delivers and provide recommendations  Overview of Interoperability Roadmap V.1 and prepare to comment February, :00 ET Discuss testing criteria that could be used to address multiple testing requirements and provide recommendations Comment on Interoperability Roadmap V.1 March 13, :00pm ET Review alternative testing tools and testing simplification recommendations Comment on Interoperability Roadmap V.1 March 18, 2015 – HITSC Meeting Anticipated date to be charged by HITSC with commenting on Certification NPRM March 23, :30 – 5:00pm ET Overview of Certification NPRM and prepare to comment (anticipated date for planning purposes) April 9, :30pm ET Finalize comments on Interoperability Roadmap V.1 April 22, 2015 – HITSC meeting Interoperability Roadmap V.1 comments to the HITSC April 27, 2015, 2:00pm ET Comment on Certification NPRM (anticipated date for planning purposes) May 8, 2015 – 12:00- 1:30pm ET Comment on Certification NPRM (anticipated date for planning purposes) May 14, 2015 – 2:00pm ET Finalize comments on Certification NPRM (anticipated date for planning purposes) May 20, 2015 – HITSC Meeting Anticipated date to present Certification NPRM Comments to the HITSC Implementation Certification & Testing Draft Work plan

HITSC - Implementation, Certification & Testing WorkgroupImplementation, Certification & Testing ONC FACA WG Lead(s)Brett Andriesen ONC SMEsAlicia Morton, Scott Purnell-Sanders, Michael Lipinski Chair / Co-Chairs Elizabeth Johnson, Co-Chair, Tenet Healthcare Corporation Christopher Ross, Co-Chair, Mayo Clinic General Questions (as they apply to the assigned Roadmap section) Are the actions proposed in the draft interoperability Roadmap the right actions to improve interoperability nationwide in the near term while working toward a learning health system in the long term? What, if any, gaps need to be addressed? Is the timing of specific actions appropriate? Are the right actors/stakeholders associated with critical actions? Roadmap Sections I. Stakeholder assurance that technology can interoperate Charge / Question(s) In what ways can semantic interoperability be best tested? (e.g., CCDA content and semantics) 6

Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap – DRAFT Version 1.0 Joint FACA Meeting February 10, 2015

Shared Nationwide Interoperability Roadmap Overview of the Process and Timeline Initial roadmap development FACA review and recommendations Roadmap released for public comment Nationwide Interoperability Roadmap Version 1.0 Q2/Q

Why Interoperability? Significant progress in digitizing the care experience Consumers increasingly expect and demand real-time access to their electronic health information Evolving delivery and payment models are not only driving appropriate data sharing, but depend on it Successes and promising practices exist and can be built on Technology is rapidly evolving Opportunities to improve care and advance science in a learning health system environment demand rapid action 9

10 DRAFT Shared Nationwide Interoperability Roadmap - Version 0.5 The Vision Broad-scale learning health system Expand interoperable data, users, sophistication, scale Nationwide ability to send, receive, find, use a common clinical data set

Principle-based Interoperability 11 ONC Guiding Principles ONC Working to establish a floor, not a ceiling (allow room for innovation) Working to create a system that allows data to move around a person (not just at the encounter) Tried to be as parsimonious as possible for a learning health system that allow the kinds of research that we want This is Version 1.0, we will continue to iterate – just the beginning of the journey Hoping to identify opportunities to allow the private sector be at the forefront (e.g. Argonaut project). How can the federal government work in partnership?

Functional and Business Requirements for a Learning Health System 12 Core technical standards and functions 1.Consistent data formats and semantics 2.Consistent, secure transport technique(s) 3.Standard, secure services 4.Accurate identity matching 5.Reliable resource location Certification to support adoption and optimization of health IT products and services 6. Stakeholder assurance that health IT is interoperable Privacy and security protections for health information 7. Ubiquitous, secure network infrastructure 8. Verifiable identity and authentication of all participants 9. Consistent representation of permission to collect, share, and use identifiable health information 10. Consistent representation of authorization to access health information Supportive business, clinical, cultural, and regulatory environments 11. A supportive business and regulatory environment that encourages interoperability 12. Individuals are empowered to be active managers of their health 13. Care providers partner with individuals to deliver high value care Rules of engagement and governance 14. Shared governance of policy and standards that enable interoperability

13 Certification and Testing to Support Adoption and Optimization of Health IT Products and Services

Stakeholders who purchase and use health IT need reasonable assurance that what they are purchasing is interoperable with other systems. Certification is designed to provide confidence to stakeholders without the expertise to individually evaluate whether a product meets specific requirements.  Topics addressed in this section of the roadmap:  Certification  Ongoing testing Certification and Testing to Support Adoption and Optimization of Health IT Products and Services 14 DRAFT Shared Nationwide Interoperability Roadmap - Version 0.5 Building Blocks

 ONC: improve rigor of certification program and reach to health IT used in additional care settings  ONC and federal partners: Continue to develop and provide testing tools for ONC HIT certification program  Stakeholders broadly:  Accelerate suite of testing tools that can be used pre and post- implementation  Help identify gaps and provide feedback to ONC regarding certification criteria 15 Certification and Testing to Support Adoption and Optimization of Health IT Products and Services DRAFT Shared Nationwide Interoperability Roadmap - Version 0.5 Critical Actions for Near Term Wins

Today’s Workgroup Discussion Interoperability Roadmap Building Block: Certification and Testing to Support Adoption and Optimization of Health IT Products and Services Section I. Stakeholder Assurance that Health IT is Interoperable 16

Interoperability Roadmap Section I Stakeholder Assurance that Health IT is Interoperable Learning Health System Requirement Stakeholders that purchase and use health IT must have a reasonable assurance that what they are purchasing can interoperate with other system Federal Health IT Strategic Plan Objectives Supported Increase HIT – Adoption – Effective use of products, systems and services Increase user / market confidence in: – Safety – Safe use of HIT products, systems and services Accelerate – Development – Commercialization of innovative technologies and solutions Technical Standards – Identify – Prioritize – Advance to support secure and interoperable health information 17

Section I: Stakeholder Assurance that Health IT is Interoperable 18 Charge Question In what ways can semantic interoperability be best tested? (e.g., CCDA content and semantics) General Questions for Workgroup Discussion Are the actions the right actions to improve interoperability nationwide in the near term while working toward a learning health system in the long term? What, if any, gaps need to be addressed? Is the timing of specific actions appropriate? Are the right actors/stakeholders associated with critical actions? Category Send, receive, find and use a common clinical data set Expand interoperable health IT and users Achieve nationwide LHS I1. Testing Tools Workgroup Member(s): (to be assigned) 1.ONC, NIST and other HIT stakeholders will provide testing tools to support ONC certification criteria 2.HIT developers, SDOs and government will accelerate testing tools suite for use by implementers post-implementation to ensure continued interoperability 3.SDOs begin to develop and maintain additional testing tools to support more stringent testing of standards 4. ONC, NIST and other health IT stakeholders will update testing tools 5. HIT Developers, SDOs and government will maintain a suite of testing tools 6. HIT developers will regularly use testing tools to maintain interoperability 7. ONC, NIST and other HIT stakeholders will provide updated testing tools 8. HIT developers. SDOs and government will maintain a suite of testing tools

Section I: Stakeholder Assurance that Health IT is Interoperable 19 Charge Question In what ways can semantic interoperability be best tested? (e.g., CCDA content and semantics) Questions for Workgroup Discussion Are the actions the right actions to improve interoperability nationwide in the near term while working toward a learning health system in the long term? What, if any, gaps need to be addressed? Is the timing of specific actions appropriate? Are the right actors/stakeholders associated with critical actions? Category Send, receive, find and use a common clinical data set Expand interoperable health IT and users Achieve nationwide LHS I2. Certification programs Workgroup Member(s): 1.HIT Developers, ACBs, ATLs and other stakeholders will recommend certification criteria to add to ONC HIT Certification Program. Examples: Criteria for accessibility and usability Criteria to expand HIT in more health care settings (e.g., long-term and post- acute care, home and community based services in non-institutional settings and behavioral health settings. 4.HIT Developers, ACBs, ATLs and other stakeholders will continue to provide these types of feedback

Section I: Stakeholder Assurance that Health IT is Interoperable 20 Charge Question In what ways can semantic interoperability be best tested? (e.g., CCDA content and semantics) Questions for Workgroup Discussion Are the actions the right actions to improve interoperability nationwide in the near term while working toward a learning health system in the long term? What, if any, gaps need to be addressed? Is the timing of specific actions appropriate? Are the right actors/stakeholders associated with critical actions? Category Send, receive, find and use a common clinical data set Expand interoperable health IT and users Achieve nationwide LHS I2. Certification programs (cont’d) Workgroup Member(s): 2.Other existing industry certification programs will continue to complement ONC's certification program to ensure that different aspects of health IT conform to the technical standards necessary for interoperability 3.FACAs recommend standards and certification criteria for ONC’s program 5.ONC and other industry certification programs will include more stringent testing Examples: Scenario-based Post-implementation testing 6.ONC and other certification programs will update criteria as needed to support: Learning health system needs New standards Expanded program's scope

Process for Responding Review Interoperability Roadmap Comment Develop Consensus Submit Comments to HITSC 21 Roadmap Overview Discuss assigned section and questions Volunteer to draft sub-section comments Members draft comments offline & submit comments to ONC staff ONC staff aggregates comments Workgroup meets to refine and finalize comments Co-chairs to brief HITSC on final comments Today’s Discussion Feb 13, 2015Feb 19, 2015 (due to ONC) Feb 27, 2015 Mar 13, 2015 Apr 9, 2015 Apr 22, 2015 (HITSC)

Assignments SubsectionWorkgroup Members In what ways can semantic interoperability be best tested? (e.g., CCDA content and semantics) I1. Testing Tools I2. Certification programs 22

Next Steps Workgroup members to draft comments on assigned sections Deliver comments to ONC February 18, 2015 ONC staff synthesize comments Discuss comments on upcoming workgroup calls to reach consensus Deliver final comments to HITSC April 22,

24 Charge QuestionComments In what ways can semantic interoperability be tested? (e.g., CCDA content semantics) Interoperability Roadmap Charge Question

1. Are the actions the right actions to improve interoperability nationwide in the near term while working toward a learning health system in the long term? 2. What, if any, gaps need to be addressed? 3. Is the timing of specific actions appropriate? 4. Are the right actors/stakeholders associated with critical actions? Send, receive, find and use a common clinical data set Comments 1.ONC, NIST and other health IT stakeholders will provide testing tools necessary to support the criteria in ONC's certification program. 2.Health IT developers, SDOs and government will explore and accelerate a suite of testing tools that can be used by implementers post-implementation to ensure continued interoperability while health IT is in use.