1. Candidate Standards Analysis by Transaction 0 SDC Solution Diagram

2. Outputs 1.Validate candidate standards list 2.Draft Solution diagram 3.Analyze candidate standards per HITSC criteria to narrow list of standards 4.Perform technical feasibility analysis 5.Map UCR to standards 6.Develop gap mitigation plan 7.Review with community Gap mitigation plan Requirements Traceability Matrix 1.Validate solution plan 2.Confirm data model approach 3.Modify/harmonize existing standard(s) to produce final standards 4.Achieve community consensus or agreement Final standards 1.Using final standards, develop Implementation Guide document 2.Document IG Conformance Statements in RTM 3.Develop Examples to inform implementers 4.Validate examples 5.Achieve community consensus or agreement Implementation Guidance 1.Survey SDO or standards organization options 2.Select balloting approach 3.Align timeline with ballot cycles 4.Submit PSS (HL7) 5.Submit NIB (HL7) 6.Submit Content (HL7) 7.Conduct balloting cycle & reconciliation per SDO guidelines Balloted standards Standards Development & Harmonization: Workflow

3. Week Target Date All Hands WG Meeting Tasks Homework due Tuesday COB Evaluate Standards 15/2 Standards & Harmonization Overview Introduce: S&H Processes, Candidate Standards List, Solution Diagram 25/9Solution DiagramReview: Solution Diagram 35/16 Solution Diagram, Standards Evaluation Criteria Finalize: Solution Diagram Review: Standards Evaluation Process Review: Standards Evaluation Template 45/23Standards EvaluationReview: Standards Evaluation ProcessReview: Standards Evaluation Template 55/30 Standards Evaluation, Technical Feasibility Analysis Finalize: Standards Evaluation Review: In-scope Requirements, Information Interchange Functions 66/6 Technical Feasibility, UCR to Standards Mapping Review: UCR to Standards Mapping Review: UCR to Standards Mapping Template, In-scope Requirements, Information Interchange Functions 76/13 Technical Feasibility, UCR to Standards Mapping, Gap Mitigation Plan Finalize: In-scope Requirements, Information Interchange Functions, UCR to Standards Mapping Review: Gap Mitigation Plan template Review: Gap Mitigation Plan Template 86/20Gap Mitigation PlanReview: Gap Mitigation Plan 96/27Gap Mitigation Plan ReviewFinalize: Gap Mitigation Plan Plan for Solution and Final standards Develop Implementation Guidance Structured Data Capture Initiative Proposed Standards & Harmonization Timeline

4. Discussed current understanding of four standards for SDC (slide 6) Provided inputs on SDC Solution Diagram (slide 7) Reviewed interoperability standards for Use Case transactions and discussed items to remove or add to each category (slide 8) –Goal was to narrow down the list to 8-10 standards for each category to increase the efficiency of downstream Harmonization activities 3 Tiger Team Review Summary

5. 5 2 xx John Doe x x x x x 6 1 4 Selects form/template Inputs data Stores/ transmits data Finds form/template Caches data 3 Converts, populates & displays form 7 Extract, Transform, & Load Data by form/ template EHR System Provider/ End User Actor Key Structured Data Capture Conceptual Workflow

6. 5 2 xx John Doe x x x x x 6 1 4 Selects form/template Inputs data Stores/ transmits data Finds form/template Caches data 3 Converts, populates & displays form 7 Extract, Transform, & Load Data by form/ template EHR System Provider/ End User Actor Key Structured Data Capture – Standards Overlay 1. CDE Standard 2. Structure Standard 4. Pre-populate Standard 3. EHR Interaction Standard: Find, display, cache, store/transmit

7. 6 SDC’s 4 Standards (Working Definition) StandardDetailsWG Responsible 1. CDE Standard Standard for the CDEs that will be used to fill the specified forms or templates Includes: data representations that are consistent and reusable across forms Form SWG 2. Form / Template Container Structure Standard Standard for the structure or design of the form or template (container) Includes: Form / Template Information – what is being sent back to the EHR System? Examples: Name, Type of Data, Ranges, Codes, Other Optional: Population of EHR-System derived patient data Standard to define the structure of the data sent from EHR System for storage in External Data Repository Form SWG 3. EHR- Interaction Standard Standard for how EHR Systems interact with the form or template: Includes: two components How form is queried for and retrieved by EHR System from Form/Template Repository How incorporated into EHR workflow Standards SWG 4. Auto- populate Standard Standard to auto-populate form or template Includes: Auto-populate by EHR-derived patient data sent to an external system EHR System population of relevant patient data Standards SWG

8. 7 SDC Sequence Diagram: SDC’s 4 Components by Transaction A CDE B Container (including structured data) C EHR interaction D Auto-populate A B C D BC D BCA B AB AB AB AB A A AB

9. 8 #TransactionContent and Structure Vocabulary and Code Set Transport and Security Cross-Category 1 Request for form/template CDA R2 C-CDA ICSR RFD XUA RPE CAP 135 CTS2 ODM XD* ISO/IEC 11179 Common Formats CPT CVX MVX PHIN-VADS HCPCS ICD-9-CM ICD-10-CM ICD-10-PCS LOINC UCUM Multilex DDF NDC C80 C154 SNOMED-CT MEDCIN UMLS RxNORM MedDRA VSAC ODM (T) XD* (T) SOAP (T) REST (T) Direct (T) HTTPS (S) TLS (S) ATNA (S) XUA (S) BPPC (S) SAML (S) XACML (S) HL7 IG for CDA, R2: Consent Directives, R1 Healthcare Privacy and Security Classification System esMD Author of Record Level 1 IG XAdES CDEs CDASH USHIK SHARE CIMI FHIM vMR caDSR XMI MDMI FHIR HL7 IG for CDA R2: Form Definition Document, R1 HL7 IG for CDA R2: Questionnaire Response 1(a) Optionally with Patient Data CDA R2 C-CDA ICSR RFD ISO/IEC 11179 RPE CAP 135 CTS2 CDASH vMR 3 Sends requested form/template CDA R2 C-CDA ICSR ISO/IEC 19763-13 ISO/IEC 11179 XHTML Javascript RFD RPE CAP 135 CTS2 CDS Knowledge Sharing IG 7 Sends completed form/template structured data CDA R2 C-CDA HL7 V2.x HL7 V3 ICSR ISO/IEC 19763-13 RFD SDC Use Case: Interoperability Standards

10. Week Target Date All Hands WG Meeting Tasks Homework due Tuesday COB Evaluate Standards 15/2 Standards & Harmonization Overview Introduce: S&H Processes, Candidate Standards List, Solution Diagram 25/9Solution DiagramReview: Solution Diagram 35/16 Solution Diagram, Standards Evaluation Criteria Finalize: Solution Diagram Review: Standards Evaluation Process Review: Standards Evaluation Template 45/23Standards EvaluationReview: Standards Evaluation ProcessReview: Standards Evaluation Template 55/30 Standards Evaluation, Technical Feasibility Analysis Finalize: Standards Evaluation Review: In-scope Requirements, Information Interchange Functions 66/6 Technical Feasibility, UCR to Standards Mapping Review: UCR to Standards Mapping Review: UCR to Standards Mapping Template, In-scope Requirements, Information Interchange Functions 76/13 Technical Feasibility, UCR to Standards Mapping, Gap Mitigation Plan Finalize: In-scope Requirements, Information Interchange Functions, UCR to Standards Mapping Review: Gap Mitigation Plan template Review: Gap Mitigation Plan Template 86/20Gap Mitigation PlanReview: Gap Mitigation Plan 96/27Gap Mitigation Plan ReviewFinalize: Gap Mitigation Plan Plan for Solution and Final standards Develop Implementation Guidance Structured Data Capture Initiative: Activities Planned for Next Week