FHIR Implementation Guide: Migrate from Structured Product Labeling V3 to a FHIR-based submission

1a. Project Name FHIR Implementation Guide: Migrate from Structured Product Labeling V3 to a FHIR-based submission 1b. Project ID 1704 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 2d. Project Facilitator Jean Duteau 2e. Other Interested Parties (and roles) Vocabulary WG Structured Documents WG Clinical Decision Support WG 2f. Modeling Facilitator 2g. Publishing Facilitator Jean Duteau 2h. Vocabulary Facilitator 2i. Domain Expert Representative 2j. Business Requirements Analyst 2k. Conformance Facilitator Jean Duteau 2l. Other Facilitators 2m. Implementers IBM FDA 3a. Project Scope IBM and FDA are partnering to produce a FHIR Implementation Guide that will allow stakeholders to migrate from the current Structured Product Labeling (SPL) V3 document architecture to a FHIR-based submission architecture. The Implementation Guide will provide profiles on FHIR resources as well as a mapping to and from the existing SPL V3 specification. Additionally, it will document an initial FHIR-based architecture for handling existing FDA SPL use cases in parallel with the current SPL-based architecture. The initial scope will be focused on the pharmaceutical submissions along with the associated SPL use cases that are needed for those label submissions. As the project goes on, we will look at expanding beyond the pharmaceutical use case. Since this is a US Realm project, we have analyzed US-Core and there is no overlap with the profiles and use cases covered by US-Core. Therefore there is no dependency on US-Core by this project. Attachments 3b. Project Need The existing SPL submission process at FDA uses the existing V3 models. As part of a project that is looking at how the V3 submission could be enhanced or replaced with a FHIR-based submission, this Implementation Guide is needed to provide the guidance on how to use the FHIR artifacts. 3c. Security Risk No 3d. External Drivers 3e. Objectives/Deliverables and Target Dates Connectathon: September 2021 Initial ballot: January 2022 Publishing May 2022 3f. Common Names / Keywords / Aliases: 3g. Lineage 3h. Project Dependencies 3i. HL7-Managed Project Document Repository URL: https://confluence.hl7.org/display/BRR/FHIR+IG+Project+Space%3A+Migrate+from+SPL+V3+to+a+FHIR-based+submission 3j. Backwards Compatibility No 3k. Additional Backwards Compatibility Information (if applicable) We are mapping from the existing V3 SPL standard into FHIR and are trying to remain as backwards-compatible in terms of the data elements needed, although obviously not their representation. 3l. Using Current V3 Data Types? No 3l. Reason for not using current V3 data types? This is a FHIR Implementation Guide. 3m. External Vocabularies Yes 3n. List of Vocabularies NCI Thesaurus contains a number of terminologies used in the current SPL submission process and we will be reusing these in our implementation guide. 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? FHIR R4B, FHIR R5 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 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 6b. Content Already Developed 0% 6c. Content externally developed? 6d. List Developers of Externally Developed Content 6e. Is this a hosted (externally funded) project? 6f. Stakeholders Regulatory Agency 6f. Other Stakeholders 6g. Vendors Pharmaceutical 6g. Other Vendors 6h. Providers 6h. Other Providers 6i. Realm U.S. Realm Specific 7d. US Realm Approval Date Dec 01, 2020 7a. Management Group(s) to Review PSS FHIR 7b. Sponsoring WG Approval Date Nov 24, 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 Nov 25, 2020 7g. V2 MG Approval Date 7h. Architecture Review Board Approval Date 7i. Steering Division Approval Date Apr 19, 2021 7j. TSC Approval Date Apr 26, 2021