BR&R FHIR Resource Maintenance

1a. Project Name BR&R FHIR Resource Maintenance 1b. Project ID 1702 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 Biomedical Research & Regulation 2b. Co-Sponsor WG Orders & Observations 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 WGMs 2b. Co-Sponsor WG 2 Pharmacy 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 2 Update Periods WGMs 2d. Project Facilitator BR&R Co-chairs 2e. Other Interested Parties (and roles) CQI WG 2f. Modeling Facilitator BR&R WG Members 2g. Publishing Facilitator Rik Smithes, Hugh Glover, TBD 2h. Vocabulary Facilitator 2i. Domain Expert Representative BR&R WG Members 2j. Business Requirements Analyst BR&R WG Members 2k. Conformance Facilitator N/A 2l. Other Facilitators 2m. Implementers For Medication Definition Resources -- EMA, FDA, Health Canada, Others For Research related Resources - US National Institute of Health (NIH), FDA, Vulcan projects, Software vendors, others 3a. Project Scope This is an umbrella project for the maintenance and development work to be done on all current and future FHIR Resources in the BR&R WG. As of Q1 2021, there are 16 FHIR resources that are in active development. The list and status of each is managed by BR&R here: https://confluence.hl7.org/pages/viewpage.action?pageId=97476291 Below is the list of current BR&R Resources - Two (2) in Clinical Research: ResearchStudy, ResearchSubject Fourteen (14) in Medication Definition: MedicinalProductDefinition, AdministrableProductDefinition, ClinicalUseIssue, Ingredient, ManufacturedItemDefinition, PackagedProductDefinition, RegulatedAuthorization, Substance, SubstanceDefinition, SubstanceNucleicAcid, SubstancePolymer, SubstanceProtein, SubstanceReferenceInformation, SubstanceSourceMaterial The above list of resources may grow as BR&R explores and begins to further use cases associated with our scope of Biomedical Research and Regulation. Attachments 3b. Project Need This is larger BR&R FHIR Resource development project and not specific to any one particular project use case or implementation needs. The larger need is to support development of FHIR specifications for research and regulatory driven use cases. 3c. Security Risk No 3d. External Drivers Regulatory entities -- EMA, US FDA, Health Canada; HL7 Accelerators -- Vulcan, CODEx; Pharmaceutical Manufacturers and Vendors; Other Research entities: US NIH 3e. Objectives/Deliverables and Target Dates Objectives: 1. Develop FHIR Resources and related artifacts in support of research and regulatory requirements for data exchange. 2. Maintain the FHIR Resources 3. Support the FHIR Resources thru each balloting process 3f. Common Names / Keywords / Aliases: Medication Definition, Research Resources, BR&R Resources 3g. Lineage Partial lineage of Medication Definition resources -- Project # 1367, #1416 3h. Project Dependencies None 3i. HL7-Managed Project Document Repository URL: https://confluence.hl7.org/pages/viewpage.action?pageId=97476291 3j. Backwards Compatibility No 3k. Additional Backwards Compatibility Information (if applicable) 3l. Using Current V3 Data Types? No 3l. Reason for not using current V3 data types? Using FHIR data types 3m. External Vocabularies N/A 3n. List of Vocabularies 3o. Earliest prior release and/or version to which the compatibility applies None 4a. Products FHIR Extensions, FHIR Profiles, FHIR Resources 4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to? This project will not build FHIR IGs. It is an umbrella project to manage and maintain all BR&R FHIR Resources. 4c. FHIR Profiles Version N/A 4d. Please define your New Product Definition 4d. Please define your New Product Family 5a. Project Intent Revise current standard, Supplement to a current standard 5a. White Paper Type 5a. Is the project adopting/endorsing an externally developed IG? 5a. Externally developed IG is to be (select one) 5a. Specify external organization 5a. Revising Current Standard Info 8 of the 16 BR&R FHIR resources were balloted in R4B in March/April 2021. These are the Medication definition resources. 2 more resources (ResearchStudy and ResearchSubject) were balloted in the May 2021 R5 ballot. 5b. Project Ballot Type N/A (project won’t go through ballot) 5c. Additional Ballot Info This project will not go thru ballot as such, sets of resources that fall under this project will be balloted over the next few years. 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 70% 6c. Content externally developed? No 6d. List Developers of Externally Developed Content 6e. Is this a hosted (externally funded) project? No 6f. Stakeholders Regulatory Agency, Standards Development Organizations (SDOs), Other 6f. Other Stakeholders BR&R WG members representing -- FDA, EMA, Health Canada, Vulcan, CODEx, NIH, CDISC, Implementation vendors, others, etc. Pharmacy, O&O and CQI WGs 6g. Vendors Pharmaceutical, EHR, PHR, Equipment, Health Care IT, Clinical Decision Support Systems, Lab, HIS, Other 6g. Other Vendors 6h. Providers N/A 6h. Other Providers 6i. Realm Universal 7d. US Realm Approval Date 7a. Management Group(s) to Review PSS FHIR 7b. Sponsoring WG Approval Date Apr 13, 2021 7c. Co-Sponsor Approval Date Mar 10, 2022 7c. Co-Sponsor 2 Approval Date Apr 26, 2021 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 Mar 09, 2022 7g. V2 MG Approval Date 7h. Architecture Review Board Approval Date 7i. Steering Division Approval Date 7j. TSC Approval Date