Standards & Interoperability (S&I) Structured Data Capture (SDC ) FHIR Profile IG SWG

1. Standards & Interoperability (S&I)Structured Data Capture (SDC)FHIR Profile IG SWG

2. Meeting Reminders Tentative Ad-Hoc working session to be scheduled for this Friday 4:00PM-6PM

3. Objectives • To create HL7 content profile for SDC using FHIR • Create FHIR content profiles to represent SDC content including • Form Design • Form Instances • Completed Forms • CDEs • To define FHIR Rest based transactions required for SDC • Retrieve form including support for transmission of pre-pop data • Submit completed forms

4. Develop FHIR Profiles Business Justification • FHIR is an upcoming standard that is getting noticed and adopted widely across vendors • Developing FHIR based forms may increase adoption of SDC • FHIR already has a Questionnaire resource. Currently the authors intend to develop profiles to address similar use cases as SDC. Early alignment while FHIR is in DSTU will reduce risk of multiple Form Model Standards. Assumption • The FHIR content profiles and FHIR REST interactions will conform to/meet all requirements identified by the conformance statements in the SOAP SAML IG. Concerns • For implementers, multiple options to create SDC/MFI conformant forms creates the conflict of: “Which do I choose?” • S&I core group comment: We provide for multiple options as well as the ability to transform between forms designed using one option into the other. • Could create a shift of momentum on current SDC work • S&I core group comment: Any open items related to ongoing SDC work including pilots will keep moving forward. Description Develop FHIR Content Profile(s) based on SDC-MFI model Develop bi-directional transformation from FHIR based SDC forms and native SDC XML forms based on MFI-13 Utilize FHIR Exchange Framework to retrieve and submit Forms

5. FHIR Content Profiles-Scope • Develop Normative FHIR Content Profiles for • Form Design Package Normative • SDC Conformant MFI-13 Form Design • SDC Conformant MDR Mapping along with SDC Content Model Extension • SDC Form Design MFI- 13 Administrative Information • Form Instance Informative • HTML rendered instance of Form • Completed Form Normative • FHIR CCDA – CCD Profile re-use only** • FHIR Profile for Consent Directive • Based on HL7 v3 CDA R2 Implementation Guide for Consent Directives re-use only** ** These are not in scope for development as part of SDC

6. FHIR Content Profiles-Assumptions Profiles / Identified resources Must conform to MFI-13 and Must conform to SDC extensions to MFI-13 Since MFI-13 is technology agnostic, actual element / attribute names are not required to be the same as the XML based SDC Form Design. As long as the structure and semantic meaning of the class is not changed MFI-13 is our primary guide, SDC extensions are added requirements As a part of Q/A, a reference implementation, realizing one of the user stories described in the SDC charter, will need to be part of the Implementation Guide package

7. SDC FHIR Transactions- Scope • Re-use/Extend FHIR Exchange Framework to • Retrieve a Form Design from a Form Repository • Retrieve a Form Instance from a Form Repository • Provide Patient Data- CCD or its FHIR equivalent as part of the Query to the Form Repository. • The Retrieved form should be a fully/partially filled form instance • Submit a Completed Form to an Intended recipient

8. FHIR SDC Interactions- Assumptions Security Considerations including Authentication, Auditing, as described in the SDC SOAP SAML IG must be met. Transmission of Consent Directives when Pre-population data is transmitted to a Form repository as part of the Retrieve Form Query, must be supported. Support for transmission of digital signature of a completed Form , along with the Form, must be supported. Currently we use the XAdES profile for this purpose. If FHIR profiles for CCDA- CCD and /or CDA based Consent Directives are not available in time for the release of the FHIR SDC profile, then we have the option to transmit the CDA as binary Resources.

9. Timeline Aug Feb Mar Apr May Jun Jul Socialization • March 13 • SDC FHIR Profile Introduction • March 14 • FHIR Introduction • March 27 • FHIR Resource Identification for SDC Execute • March 27 • Assess FHIR Baseline • Build FHIR Profile for Form Design • Build FHIR Profile for Form Instance • Define FHIR based SDC transactions • Jul 5 • Develop IG and Consensus voting Control • Manage plan • Conduct reviews • Manage comment log HL7 • May 2 • FHIR Connectathon • May 18 • Project Scope Statement • Notification of intent to ballot • Jun 29 • Final Content • Aug 3 • Ballot

10. Execute Phase FHIR Baseline Assessment FHIR Resource Identification for SDC by support team • March27 FormDesign Support team drafts FHIR resources Community feedback and revision Draft resources are reviewed with community FormInstances Support team drafts FHIR resources Community feedback and revision Draft resources are reviewed with community Transactions Support team drafts transactions Community feedback and revision Transactions are reviewed with community FHIR Profile IG Development and Consensus Draft IG sections are reviewed with community Support team drafts sections Community feedback and revision • July 5

11. SDC FHIR Profile Timeline Feb 2014 – Dec 2015 FHIR Baseline Assessment for SDC SDC SDC FHIR Profile IG Development and Consensus/ End-to-end Review FHIR Connectathon (May 2-May 3) HL7 Ballot Package Development HL7 Project Scope Statement (May 18) HL7 Notification of Intent to Ballot (June 29) HL7 Rest/OAuth Ballot Preview Period HL7 Ballot (Aug 8- Sept 8) HL7 HL7 WG Meeting (Sept 14-19) HL7 Ballot Reconciliation SDC FHIR Profile IG (July 5) FHIR Resource Identification (March 15) Milestones HL7 Initial Content Deadline (Jul 13) HL7 Final Content Due (Aug 3)

12. FHIR Connectathon • Goal: Testing of Connectathon Track 2 Usecases • Date: Saturday May 2 and Sunday May 3, 2014 • Location: Phoenix, Arizona • Track 2 - Questionnaire • Retrieve a completed Questionnaire • Retrieve a template • Save a Questionnaire • Generate resources • Pre-populate a questionnaire

13. Approach • Manage in iterations • Initial iteration: • Broad identification of Resources/ Gaps across all key SDC classes and interactionsMARCH 27 • 1st iteration is Content: • Form Design Package (including MDR Mapping) • CDEs ? • 2nd iteration is Content: • Form instance • Completed Form • 3rd iteration is Transport: • Retrieve Form (no pre-pop) • 4th iteration is Transport: • Submit Form • 5th iteration is Transport: • Retrieve Form (with pre-pop)

14. Approach (cont’d) • Iteration Phases: • IDENTIFY • Identify candidate resources for key SDC classes • Classify as: • Complete match • Extensions required • New FHIR resource required • Community review/approval • ANALYZE • Generate attribute level map between SDC Class and FHIR resource • Include value set maps • DESIGN • Define new resource • Design extensions to existing resource • FINALIZE • Community review

15. FORM DESIGN Package

17. APPENDIX

18. Form/Template Exchange without Patient Data Form/Template Exchange with Patient Data EHR System Form/Template Repository EHR System Form/Template Repository A A TLS v 1.0 or higher TLS v 1.0 or higher OAuth REST OAuth REST Get Query for Pre-pop Get Query FHIR Questionnaire Profile FHIR SDC Query for pre-pop data Privacy Consent Directive Document* FHIR Questionnaire Profile TBD TLS v 1.0 or higher B B FHIR Questionnaire TLS v 1.0 or higher TLS v 1.0 or higher Query response REST OAuth REST OAuth Query response FHIR Query response Myserver/message/header/bundle of resources FHIR Questionnaire Profile representing an instance of a SDC Form Completed Form/Template Structured Data EHR System External Data Repository Legend Transport Items Metadata C OAuth Security Item Payload REST TBD Authentication & Authorization 1. Form Data [XML Name-Value pairs]2. Privacy Consent Directive Document* Service * Optional

19. Tasks Task Progress Aug Sep Oct Nov Dec TBD TBD High Medium Low Complete In Progress Not Started