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

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

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

Develop FHIR Profiles 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 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. 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. 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.

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

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

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

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.

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

 March27 Form Design Form Instances Transactions FHIR Baseline Assessment Execute Phase Community feedback and revision Draft resources are reviewed with community Support team drafts FHIR resources Community feedback and revision Draft resources are reviewed with community Support team drafts FHIR resources Community feedback and revision Transactions are reviewed with community Support team drafts transactions FHIR Resource Identification for SDC by support team Community feedback and revision Draft IG sections are reviewed with community Support team drafts sections FHIR Profile IG Development and Consensus  July 5

Jan- Feb ‘14Mar- Apr 4May- Jun ‘14Jul- Aug ‘14Sept- Oct ‘14Nov- Dec ‘14 Milestones HL7 Ballot (Aug 8- Sept 8) SDC HL7 Project Scope Statement (May 18) SDC FHIR Profile IG Development and Consensus/ End-to-end Review HL7 Rest/OAuth Ballot Preview Period HL7 HL7 Notification of Intent to Ballot (June 29) HL7 Initial Content Deadline (Jul 13) HL7 WG Meeting (Sept 14-19) HL7 Final Content Due (Aug 3) FHIR Baseline Assessment for SDC SDC FHIR Profile Timeline Feb 2014 – Dec 2015 FHIR Resource Identification (March 15) SDC FHIR Profile IG (July 5) HL7 Ballot Package Development HL7 Ballot Reconciliation FHIR Connectathon (May 2-May 3)

FHIR Connectathon Goal: Testing of Connectathon Track 2 Usecases Date: Saturday May 2 and Sunday May 3, 2014 Location: Phoenix, Arizona Track 2 - Questionnaire 1.Retrieve a completed Questionnaire 2.Retrieve a template 3.Save a Questionnaire 4.Generate resources 5.Pre-populate a questionnaire

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

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

FORM DESIGN Package

APPENDIX

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

Tasks ProgressTask CompleteIn ProgressNot Started HighMediumLow DecNovOctSep Aug TBD