Biomedical Research and Regulation
Biomedical Research Integrated Domain Group (Archived)Project Summary for Electronic Product Information FHIR Implementation Guide (Jira PSS-2102)
Visit Project Insight to see the full project details.
Project Details
Number | 1773 View Ballot Items List (with NIBs) |
---|---|
Name | Electronic Product Information FHIR Implementation Guide (Jira PSS-2102) |
Sponsor(s) | Biomedical Research and Regulation Work Group |
Co-Sponsor(s) | Structured Documents Work Group |
Steering Division | N/A |
Description | Electronic Product Information (ePI) is the online version of the "product label" or "package insert" or "patient information" that is supplied with every medication package. By expressing this in FHIR the information can be structured which in turn allows selection of information most relevant to a specific patient. A FHIR representation also facilitates presentation of the material in multiple languages.
The Implementation Guide will document how the ePI is represented as a FHIR document and will include instructions on how to create and exchange FHIR ePI documents; a common core profile for international use; region specific sub?profiles to accommodate unique local requirements; and recommendations for in-scope terminologies. This project is supported by FDA, EMA and other regulators. The project is run within the Vulcan Accelerator and IMI Gravitate Health. |
Project Facilitator | Craig Anderson |
Status | STU - Test Period/Accepting Comments |
SD Approval Date | Awaiting Approval |
TSC Approval Date | Aug 16, 2023 |
Project Type | Ballot - STU to Normative |
Objectives / Deliverables | Ballot IG STU - Target: Jan 2023 Ballot Cycle |
Next Milestone Date | 2025 September WGM |
Project End Date | 2025 September WGM |
Project Intent | Create New Standard |
Project Need | |
Success Criteria | |
Dependancies | None |
Collaboration Efforts | |
Ballot Cycle Info | 2023 Jan Ballot Cycle Info: STU Ballot results: Met basic vote requirements. 4 Negatives to reconcile Document Name: HL7 FHIR Implementation Guide: Electronic Medicinal Product Information, Release 1 |
Misc Notes | 2023 July: STU Publication Request for HL7 FHIR Implementation Guide: Electronic Medicinal Product Information, Release 1 |
Product Type | FHIR Implementation Guide |
Project Document Repository |
TBD PSS: https://jira.hl7.org/browse/PSS-2102 |
Backwards Compatibility | |
Stakeholders | |
Vendors | |
Providers | |
SDO/Profilers | |
Realms | Universal |
HL7 Affiliate | |
Roadmap Reference | |
Start Date | May 27, 2022 |
* 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.