Project Information
Active
25 September, 2025
Project Introduction
Electronic Product Information (ePI)
The Electronic Product Information (ePI) project is developing a global FHIR standard for medicinal product information. By moving beyond static PDF formats, ePI makes product information more accessible, interoperable, and patient-friendly, supporting both healthcare professionals and consumers with timely, trustworthy data.
What is ePI?
A medicine’s product information is a regulated and validated resource that explains how a medicine should be used safely and effectively. Today, most ePI is published as PDFs (e.g., USPI in the US, SmPC/Package Leaflet in the EU, JPI in Japan), which are hard to search, update, or adapt for patient needs.
By structuring this information in FHIR, ePI becomes searchable, accessible in multiple formats and languages, and interoperable across systems. This enables better patient engagement and creates new opportunities for integration with EHRs, apps, wearables, and other health data sources.
The ePI Implementation Guide (IG) defines:
- A common global core profile for medicinal product information.
- Region-specific sub-profiles to meet unique regulatory requirements.
- Guidance on data elements, code systems, and value sets commonly used in ePI.
- Recommendations for in-scope terminologies and business rules.
The project is closely aligned with the EU Gravitate-Health initiative and contributes to international harmonization of medicinal product information standards.
Project Status
- Version 1 of the ePI IG is published and available for adoption.
- Version 2 is under development, informed by real-world feedback and more complex scenarios tested at HL7 Connectathons.
- Adoption is encouraged by regulators, industry, and vendors to improve accessibility and accelerate harmonization.
Vulcan projects, including ePI, are open to participation. Vulcan is a member-based initiative where anyone with an interest in digital clinical research can join project teams, contribute expertise, and shape future standards.
Electronic Product Information (ePI)
Project Resources
Confluence
Project workspace with meeting notes, documentation, and collaboration materials.
FHIR IG
The evolving technical specification that defines how FHIR is used for this project.
SharePoint Resources
Central repository for project artifacts, reference materials, and shared files.
Electronic Product Information (ePI)
Get Involved
The ePI project is now seeking adopters to implement the published IG and help develop or provide feedback for Version 2. You can:
- Pilot ePI profiles in regulatory or vendor systems.
- Explore integration opportunities with EHRs, apps, and patient-facing solutions.
- Join HL7 Connectathons to test implementations and share lessons learned.
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