Biomedical Research and Regulation
Biomedical Research Integrated Domain Group (Archived)Project Summary for FHIR Implementation Guide: Migrate from Structured Product Labeling V3 to a FHIR-based submission (PSS in Confluence)
Visit Project Insight to see the full project details.
Project Details
Number | 1704 View Ballot Items List (with NIBs) |
---|---|
Name | FHIR Implementation Guide: Migrate from Structured Product Labeling V3 to a FHIR-based submission (PSS in Confluence) |
Sponsor(s) | Biomedical Research and Regulation Work Group |
Co-Sponsor(s) | |
Steering Division | Clinical |
Description | 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. |
Project Facilitator | Jean Duteau |
Status | Active Project (Resources assigned to pjt) |
SD Approval Date | Apr 19, 2021 |
TSC Approval Date | Apr 26, 2021 |
Project Type | Ballot - STU to Normative |
Objectives / Deliverables | Connectathon: Target - September 2021 Initial ballot: Target - January 2022 Publishing: Target - May 2022 |
Next Milestone Date | 2023 May WGM |
Project End Date | 2023 September WGM |
Project Intent | Implementation Guide |
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. |
Success Criteria | |
Dependancies | |
Collaboration Efforts | |
Ballot Cycle Info | |
Misc Notes | |
Product Type | FHIR Implementation Guide |
Project Document Repository |
https://confluence.hl7.org/display/BRR/FHIR+IG+Project+Space%3A+Migrate+from+SPL+V3+to+a+FHIR-based+submission PSS: https://confluence.hl7.org/display/BRR/FHIR+Implementation+Guide%3A+Migrate+from+Structured+Product+Labeling+V3+to+a+FHIR-based+submission... |
Backwards Compatibility | No |
Stakeholders | Regulatory Agency |
Vendors | Pharmaceutical |
Providers | |
SDO/Profilers | |
Realms | Realm Specific - Enter "U.S." or name of HL7 Affiliate below |
HL7 Affiliate | U.S. |
Roadmap Reference | |
Start Date | Nov 24, 2020 |
* A Project Insight User ID and password is required to access Project Insight. Contact the HL7 PMO at pmo@HL7.org for more information.
Visit the Projects, Ballots and Standards Metrics Excel Report to view projects that are behind 120+ days along with other ballots and standards requiring a Work Group's attention.
Visit the Projects, Ballots and Standards Metrics Excel Report to view projects that are behind 120+ days along with other ballots and standards requiring a Work Group's attention.