- Created by Craig C. Anderson, last modified on Sep 12, 2022
This track is Phase 4 of an ongoing series, spanning multiple Connectathons, to test the creation, exchange and display of electronic Product information (ePI) and the International Patient Summary (IPS) as FHIR Documents.
Each phase will include increased numbers of product information and increasingly complex healthcare/life scenarios.
Track Objective is to test and gather feedback on the following:
The track is supported by the EU IMI Project Gravitate Health, the EU funded project UNICOM and supports the ePI pilot project at the European Medicines Agency.
The vision of the Gravitate Health ePI /Vulcan accelerator ePI/ eLabeling project is to define a common structure for medicinal product information that improves the patient experience and supports interoperability across the international healthcare clinical and regulatory environment.
ePI Track Phase 4 builds towards this vision by incorporating lessons learned from the previous 4 connectathons 28-29-30. Also, by testing more complex real-world scenarios; additional FHIR resources; and more advanced product label data we expect the IG to be more mature and effective in covering a wider range of products.
A medicine’s product information is a pivotal source of regulated and scientifically validated information that assists healthcare professionals in prescribing and dispensing the medicine and informs consumers about its safe use.
ePI includes two primary forms of Information adapted for healthcare professionals and patients/consumers. Frequently there are additional risk minimization measures like a patient card, videos, pictures, etc.
These documents are currently mostly based on PDF and they are unstructured electronic paper. As a result, they are difficult to search, difficult to find, and the content does not always meet patient needs lacking e.g., large fonts, accessibility support, multimedia, multiple languages, uptodate.
Only a few regions/countries have XML ePI’s, but the number and interest is growing. For example, US FDA uses HL7’s SPL; Japan’s PMDA uses custom XML; EU’s EMA is developing a FHIR XML ePI. Without harmonization, there is a high risk of divergence.
Hence the need to transition to a dynamic structured format that can be used as an international standard; i.e., FHIR documents with the added benefit of tailoring to individual patient/consumer needs.
Test an Implementation Guide
Craig Anderson, Catherine Chronaki, Jens Villadsen
Track Lead Email(s)
Craig.Anderson2@pfizer.com; email@example.com; firstname.lastname@example.org
Vulcan/Gravitate Health Core ePI IG
Github Repository with sample instances (in FSH)
Call for participants
Gravitate Health members; HL7 Vulcan Members; FDA; EMA; Project UNICOM; adopters; implementers; ePI and IPS data consumers
Concept scenario: 2022-0630-PPT-UNICOM-Demonstrator-FINAL.pdf
|Track Kick off Call|
LinkedIn Event on September 15, 2022, 07:00 to 08:00 EDT
|Clinical Input Required?||No|
|Related Tracks?||2022 - 09 SPL to FHIR and Back - FHIR - Confluence (hl7.org)|
Sample data for use with the testing scenarios noted below
HTML, XML and JSON versions of the samples can be found in the Implementation Guide or the FHIR Shorthand (FSH) source files can be found in GitHub.
Electronic Product Information (ePI)
International Patient Summary (IPS)
Test Scenarios (Details to be shared closer to September)