HL7 FHIR FHIR4FAIR IG PSS

1a. Project Name FAIRness for FHIR 1b. Project ID 1651 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 Service Oriented Architecture 2d. Project Facilitator Giorgio Cangioli 2e. Other Interested Parties (and roles) BR&R would like to be kept informed of progress, particularly to ensure the relevance of FAIR principles in Clinical Research are taken account of. CDS wishes to be an Interested Party, given that we are interested in applying the same FAIR principles to the creation, management, and access of knowledge artifacts. FHIR-I would like to be kept informed of progresses. ArB would like to be kept informed of progresses. 2f. Modeling Facilitator 2g. Publishing Facilitator Giorgio Cangioli 2h. Vocabulary Facilitator 2i. Domain Expert Representative Oya Beyan (Fraunhofer, RDA DE; EOSC FAIR WG); Carlos Luis Parra Calderón (EOSC; FAIR4Health coordinator; Andalusian Health); Catherine Chronaki (HL7 Europe); ALICIA MARTINEZ GARCIA (Andalusian Health Service); Anthony Juehne (RDA Reproducible Health Services WG ); Matthias Löbe (IMISE Leipzig) 2j. Business Requirements Analyst 2k. Conformance Facilitator Giorgio Cangioli 2l. Other Facilitators 2m. Implementers 1) FAIR4Health Project 2) SRDC 3) ATOS 3a. Project Scope Develop a FHIR4FAIR FHIR Implementation Guide aiming to (FAIR Principles https://www.go-fair.org/fair-principles): 1) Identify how HL7 FHIR standard fulfills data FAIRness maturity indicators a) analyse relationship between FAIR data object conceptual components (e.g. data, metadata, provenance, identifiers) and HL7 FHIR resources b) analyze how RDA FAIR Maturity indicators are supported by specific HL7 FHIR resources c) analyze how RDA Reproducible Health Data Services recommendations can be supported by HL7 FHIR d) identify a minimum set of metadata to be fulfilled for specific sets of RDA FAIRness maturity indicators extended of health-related research data sets. e) provide examples of best practices from EOSC (European Open Science Cloud https://www.eosc-portal.eu/) or NIH (https://www.nih.gov/) 2) Suggest an assessment methodology/checklist, exploring machine readable and manual assessment methods. This guide should contain a large informative part addressing the above mentioned points and a set of FHIR conformance resources and examples that provide, for selected case(s), a practical example of how FAIRness can be realized and assessed by using HL7 FHIR. This project is intended to be the result of an active collaboration between RDA and HL7, the plan is to consult the Health care communities to comment and endorse the resulting HL7 FHIR IG taking into account relevant RDA group input. Attachments 3b. Project Need Provide guidance on supporting FAIRness by using HL7 and specifically: - the FAIR (Findability, Accessibility, Interoperability and Reusability) principles (https://www.go-fair.org/fair-principles/) - the proposed RDA (Research Data Alliance) - https://www.rd-alliance.org/ -recommendations on FAIR data maturity model, providing indicators for assessing adherence to the FAIR principles. - the recommendations of RDA Reproducible Health Services Working Group for describing, documenting, and sharing metadata for health data curation workflows 3c. Security Risk Unknown 3d. External Drivers 3e. Objectives/Deliverables and Target Dates Connect-a-thon [Jan 2021] Connect-a-thon [May 2021] STU ballot [May 2021] Publication as STU IG (2 years) [Oct 2021] Normative ballot [May 2023] Publication as Normative IG [Oct 2023] 3f. Common Names / Keywords / Aliases: FHIR4FAIR; FAIR; 3g. Lineage 3h. Project Dependencies 3i. HL7-Managed Project Document Repository URL: . 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 Unknown 3n. List of Vocabularies 3o. Earliest prior release and/or version to which the compatibility applies 4a. Products FHIR Implementation Guide 4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to? 4.0.1 4c. FHIR Profiles Version 4d. Please define your New Product Definition 4d. Please define your New Product Family 5a. Project Intent 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 RDA 5a. Revising Current Standard Info 5b. Project Ballot Type STU to Normative 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 RDA 6b. Content Already Developed 0% 6c. Content externally developed? No 6d. List Developers of Externally Developed Content 6e. Is this a hosted (externally funded) project? No 6f. Stakeholders Clinical and Public Health Laboratories, Quality Reporting Agencies, Regulatory Agency, Standards Development Organizations (SDOs) 6f. Other Stakeholders 6g. Vendors EHR, PHR, Health Care IT 6g. Other Vendors 6h. Providers Clinical and Public Health Laboratories, Healthcare Institutions (hospitals, long term care, home care, mental health) 6h. Other Providers 6i. Realm Universal 7d. US Realm Approval Date 7a. Management Group(s) to Review PSS FHIR 7b. Sponsoring WG Approval Date Sep 22, 2020 7c. Co-Sponsor Approval Date 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 Sep 30, 2020 7g. V2 MG Approval Date 7h. Architecture Review Board Approval Date 7i. Steering Division Approval Date Nov 08, 2020 7j. TSC Approval Date Nov 16, 2020