1. Standards and Interoperability Framework esMD Primer of S&I Phases, Procedures, and Functions S&I F2F Thursday, April 12 th, 2012 8:00 AM

2. S&I Framework Process We Are Here

3. S&I Framework Functions DISCOVERY IMPLEMENTATIONPILOTS EVALUATION

4. Standards Development Support Team “Building Blocks” Successfully implement developed standards Extend, modify, or develop a standard and develop implementation guidance Align initiative with SDO balloting or development priorities Engage SDOs through initiative awareness Scan the standards & implementation environment Develop a “Candidate Standards” list Support standards analysis against requirements Confirm Gaps Work with WG and SDOs to create plan and recommendations to address gaps Foundation Contribution Action Result Initiative Progress 4

5. *denotes potential artifact Use Case & Functional Requirements (UCR) Candidate Standards SDO Communication Plan Standards Analysis Mapping Gap Mitigation Plan Initiative CEDD* Implementation Guide* Standards modification* New standard* Artifacts S&I Framework Harmonization of Standards 5 Candidate Standards Selected Standards Draft Harmonized Standard Recommended Standard Evaluate Use Case and functional requirements determine candidate standards Applicable standards evaluated on HITSC-outlined criteria Further evaluation may be conducted relying on environmental scans of real- world implementations for factors such as Deployment/Operational Complexity, Market Adoption and Past Performance (Pilots) Analyze Assess support of detailed interoperability requirements for required CEDD data elements, including value sets Identify standards harmonization gaps and redundancies Determine most implementer-friendly approach to implementation Harmonize Work with SDOs to develop, extend or modify required standards artifacts and follow-up with appropriate balloting process alignment Develop implementation guidance that meets functional and technical requirements using current standard(s) Feedback on the implementation guidance is received from pilots, RI, and SDO balloting, and is then incorporated to result in a standard suitable for inclusion in regulation

6. The S&I Framework Harmonization Process Reference Implementation, Pilots, SDO Balloting Development of Draft Standard Development of Draft Standard Validation of Standard Harmonized Standard Recommended to HITSC Provides detailed analysis of candidate standards to determine “fitness for use” in support of workgroup/initiative interoperability requirements Activities lead to a selected draft standard to be supported and validated through Reference Implementation and Pilots Gap mitigation results and lessons learned are incorporated into an SDO-balloted artifact to be proposed as implementation guidance for Recommendation Depending on the workgroup/initiative, Activities may not lead to the development of a new standard Provides detailed analysis of candidate standards to determine “fitness for use” in support of workgroup/initiative interoperability requirements Activities lead to a selected draft standard to be supported and validated through Reference Implementation and Pilots Gap mitigation results and lessons learned are incorporated into an SDO-balloted artifact to be proposed as implementation guidance for Recommendation Depending on the workgroup/initiative, Activities may not lead to the development of a new standard 6

7. esMD Initiative: Harmonization Process Harmonization for Use Case 1 may include the following steps: 1.Expand dataset requirements into a full data model Reuse elements from PD Data Model and CEDD 2.Review and select standards identified by SDS Choose standards based on use case, data model requirements, and community expertise 3.Map data model to select standards Identify gaps and work with SDS to communicate needs with SDOs 4.Develop registration processes for CMS and commercial payers Expand on Section 10 in Use Case 1 document to prepare detailed process guidance for Implementation Guide(s) 5.Develop Implementation Guide(s) for CMS and commercial payers Guide should enable implementation of data model and registration request processes 7

8. In order to align Use Case 1 and Use Case 2 to the same standards, we will focus on steps 1 and 4 while Use Case 2 is under development. We will continue with steps 2, 3, and 5 when Use Case 2 is complete. 1.Expand dataset requirements into a full data model Reuse elements from PD Data Model and CEDD 2.Review and select standards identified by SDS Choose standards based on use case and data model requirements and community expertise 3.Map data model to select standards Identify gaps and work with SDS to communicate needs with SDOs 4.Develop registration processes for CMS and commercial payers Expand on Section 10 in Use Case 1 document to prepare detailed process guidance for Implementation Guide(s) 5.Develop Implementation Guide(s) for CMS and commercial payers Guide should enable implementation of data model and registration request processes esMD Initiative: Harmonization Process 8

9. S&I Framework Functions DISCOVERY IMPLEMENTATIONPILOTS EVALUATION We Are Here

10. esMD Initiative Timeline 10 Author of Record WG Use Case and Requirements Pilots (TBD) Harmonization SDS Structured Content WG Use Case #2: Sending eMDR Outline Use Cases & Stories Harmonization/ Standards Analysis of Registration (Use Case #1) Harmonization/ Standards Analysis of eMDR (Use Case #2) Use Case #1: Registration Discovery Implementation Pilot Combined Registration/ eMDR Pilots 11/30-12/7 Charter Consensus Pre-Discovery Initiative Charter/Scope Today (4/11/12) Oct ‘11 Kick-Off/ F2F Oct ‘12 Jan ‘12April ‘12 July ‘12 PPA Workgroup Target Initiative Completion: Oct ‘12

11. esMD Building Blocks Vocabulary & Code Sets Content Structure Transport Security Transformation Eventually, we’ll be able to fill in this diagram with esMD-specific content, further building the S&I Tools and References Repository