Conformance, Guidance and Best Practices for FHIR Implementation Guides PSS

1a. Project Name Conformance, Guidance and Best Practices for FHIR Implementation Guides 1b. Project ID 1544 1c. Is Your Project an Investigative Project (aka PSS-Lite)? No 1d. Is your Project Artifact being Reaffirmed or proceeding to Normative directly after being either Informative or STU? No 1e. Today's Date 1f. Name of standard being reaffirmed 1g. Project Artifact Information 1h. ISO/IEC Standard to Adopt 1i. Does the standard include excerpted text from one or more ISO, IEC or ISO/IEC standards, but is not an identical or modified adoption? 1j. Unit of Measure 2a. Primary/Sponsor WG Conformance 2b. Co-Sponsor WG Architecture Review Board 2c. Co-Sponsor Level of Involvement Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.) 2c. Co-Sponsor Update Periods Ballot 2b. Co-Sponsor WG 2 FHIR Infrastructure 2c. Co-Sponsor Level of Involvement Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.) 2b. Co-Sponsor WG 3 Vocabulary 2c. Co-Sponsor Level of Involvement Request periodic project updates; specify period in text box below (e.g. 'Monthly', 'At WGMs', etc.) 2d. Project Facilitator Ioana Singureanu 2e. Other Interested Parties (and roles) NIST (Rob Snelick), Sequoia Project (Did Davis), Department of Veterans Affairs 2f. Modeling Facilitator Ioana Singureanu 2g. Publishing Facilitator NA 2h. Vocabulary Facilitator NA 2i. Domain Expert Representative Matt Greene (VA), Daniel Rutz(?), Hans Buitendijk(?), Frank Oemig 2j. Business Requirements Analyst 2k. Conformance Facilitator NA 2l. Other Facilitators 2m. Implementers Department of Veterans Affairs, MITRE/Inferno Project ( Sequoia Project 3a. Project Scope • This specification has to two major objectives: to provide rules that lead to consistency across implementation guides, across the US realm and implementers with clear guidance and best-practices to implement FHIR IGs successfully • Where appropriate, this specification clarifies how extensions and "must support" data elements should be used improve patient outcomes and safety. Test cases may also be produced by this project, if needed. • This specification will provide testing guidance across US-Realm specifications (implementation guides -see "Project Dependencies) such that provider, payers, public health, and research organization can make effective use of FHIR APIs to meet national policy objectives (see "External Drivers"). • This project will leverage successful testing approaches developed by implementers using other APIs (e.g. SOAP, ebXML) and HL7 standards (e.g. HL7 V2, CDA). It includes best-practices for data quality, first principles for effective testing, and testing guidance. • The purpose of this project is to enable effective use of FHIR conformance constructs to test both application/clients and FHR server that use FHIR resources and FHIR-related specifications (e.g. SMART, CDS Hooks, etc.). This project is intended to bridge the gap between implementation guides and test case development and assist early adopters of FHIR APIs in the US. • Even though the guidance is intended to assist US early adopters in the short term, it will be applicable worldwide. Attachments 3b. Project Need FHIR-based APIs are a new paradigm in health IT that will require expanded conformance and testing capabilities. Other industries have had a great of experience with APIs but healthcare is new to this approach. Until now, vendors have been using self-attestation to claim conformance to FHIR and FHIR-related specifications. As FHR-related APIs become ubiquitous, the importance of consistency across implementations will be crucial. Rather than conforming with a specific FHIR implementation, systems will have to conform to a common set of data and service specifications. The future success of such an environment depends on using best-practices to test and validate implementation against national specifications and local enterprise needs. 3c. Security Risk No 3d. External Drivers Notice of Proposed Rulemaking to Improve the Interoperability of Health Information https://www.healthit.gov/topic/laws-regulation-and-policy/notice-proposed-rulemaking-improve-interoperability-health 3e. Objectives/Deliverables and Target Dates Informative Ballot : September 2020 -- Publication : December 2020 3f. Common Names / Keywords / Aliases: 3g. Lineage 3h. Project Dependencies US-realm IGs including: • US Core R4 IG Da Vinci Projects: • Coverage Requirements Discovery (CRD) • Documentation Templates and Rules ( DTR) CAIRN Alliance 3i. HL7-Managed Project Document Repository URL: https://confluence.hl7.org/display/CONF/Conformance%2C+Guidance+and+Best+Practices+for+FHIR+Implementation+Guides+Project 3j. Backwards Compatibility No 3k. Additional Backwards Compatibility Information (if applicable) 3l. Using Current V3 Data Types? N/A 3l. Reason for not using current V3 data types? 3m. External Vocabularies N/A 3n. List of Vocabularies 3o. Earliest prior release and/or version to which the compatibility applies NA 4a. Products FHIR Resources, Guidance (e.g. Companion Guide, Cookbook, etc) 4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to? 4c. FHIR Profiles Version 4d. Please define your New Product Definition 4d. Please define your New Product Family 5a. Project Intent Supplement to a current standard, Implementation Guide (IG) will be created/modified 5a. White Paper Type 5a. Is the project adopting/endorsing an externally developed IG? No 5a. Externally developed IG is to be (select one) 5a. Specify external organization 5a. Revising Current Standard Info 5b. Project Ballot Type Informative 5c. Additional Ballot Info 5d. Joint Copyright No 5e. I understand I must submit a Joint Copyright Letter of Agreement to the TSC in order for the PSS to receive TSC approval. no 6a. External Project Collaboration 6b. Content Already Developed 6c. Content externally developed? No 6d. List Developers of Externally Developed Content 6e. Is this a hosted (externally funded) project? No 6f. Stakeholders 6f. Other Stakeholders 6g. Vendors EHR, PHR, Health Care IT, Lab, HIS, Other 6g. Other Vendors Payers 6h. Providers Healthcare Institutions (hospitals, long term care, home care, mental health) 6h. Other Providers 6i. Realm U.S. Realm Specific 7d. US Realm Approval Date Aug 06, 2019 7a. Management Group(s) to Review PSS FHIR 7b. Sponsoring WG Approval Date May 21, 2019 7c. Co-Sponsor Approval Date Aug 15, 2019 7c. Co-Sponsor 2 Approval Date 7c. Co-Sponsor 3 Approval Date 7c. Co-Sponsor 4 Approval Date 7c. Co-Sponsor 5 Approval Date 7c. Co-Sponsor 6 Approval Date 7c. Co-Sponsor 7 Approval Date 7c. Co-Sponsor 8 Approval Date 7c. Co-Sponsor 9 Approval Date 7c. Co-Sponsor 10 Approval Date 7e. CDA MG Approval Date 7f. FMG Approval Date 7g. V2 MG Approval Date 7h. Architecture Review Board Approval Date 7i. Steering Division Approval Date 7j. TSC Approval Date