This track is the latest in an ongoing series, spanning multiple Connectathons, to test the creation, exchange and display of electronic Product information (ePI) and the International Patient Summary (IPS).
Each phase strives to make a more robust and implementable FHIR solution for electronic medicinal product information.
In this series, SPL on FHIR, UNICOM, and GIDWG scenarios for the implementation of the ISO IDMP standards for the Identification of Medicinal Product (IDMP) will be incorporated into the testing plan.
Track Objective is to test and gather feedback on the following:
The track is supported by the Innovative Medicines Initiative (IMI) Gravitate-Health Project; HL7’s Vulcan Accelerator; and the EU’s funded project UNICOM. The track also supports the European Medicines Agency’s ePI pilot project, the GIDWG initiative, and HL7 BR&R’s SPL on FHIR project.
The lack of international harmonization on the adoption and implementation of the ISO IDMP standards for the unique identification of medicinal products is leading to a divergence of approaches for structured product and substance information and the related terminologies. Differing standards are developing internationally, e.g., HL7 SPL in North America, FHIR in HL7, FHIR in the European Union; and multiple custom XML standards developing in Asia and the Middle East.
The vision of the Gravitate-Health/Vulcan ePI project is to define a common structure for medicinal product information that improves the patient experience and supports semantic interoperability across the international healthcare clinical and regulatory environment.
ePI Track Phase 7 builds towards this vision by incorporating lessons learned from the previous connectathons. Also, by testing more complex real-world scenarios and more advanced product label data, we expect to make FHIR a more robust solution for medicinal product information.
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 three primary forms:
These documents are currently mostly based on PDF. 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, up-to-date information.
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.
FHIR Design, FHIR Testing, Test Implementation Guides
Call for participants
Gravitate Health members; HL7 Vulcan Members; FDA; EMA; PMDA; GIDWG members; Project UNICOM; adopters; implementers; ePI and IPS data consumers
Gravitate-Health/Vulcan: Craig Anderson, Catherine Chronaki
US FDA: Scott Gordon
US FDA: Ron Fitzmartin, TJ Chen
EMA (Europe): Panagiotis Telonis, Rik Smithies, Robert Stegwee, Giorgio Cangioli, Achilleas Voutsas, and Andrei Idu
UMC: Magnus Wallberg, Malin Fladvad
Track Lead Email(s)
Track Kick off Call
Virtual kick-off event on the 34th HL7 FHIR CONNECTATHON - ePI Track
Date and Time: Sep 5, 2023 13:00 (CEST) or 07:00 (EST)
Follow this link to register for the event: 05.09.2023 | Gravitate Health Webinar Ahead of HL7 FHIR Connecthathon 34 in Phoenix | | REGISTER NOW! - Gravitate Health
Servers (ePI/IPS and SPL-FHIR Repositories)
Sample data for use with the testing scenarios:
Scenario #1: Connections between ePI to SPL-FHIR
Scenario #2: Patient travels from Europe to US
Scenario #3: Patient travels from Japan to US
Scenario #4: Incorporate IDMP’s identifiers into the ePIs and, where possible, into the SPL-FHIR
Goal: Demonstrate how substance identifiers and PhPID (for ePI) can facilitate cross-border search and prescriptions.
Action-1: MP look-up
Action-2: PhPID look-up
Action-3: Decode PhPID
Action-4: Translate PhPID (out of scope for this FCAT)
Slide reference #3 - Test scenario 2 and 3
Slide reference #4 - Test scenario 4
Slide reference #5 - Test scenario summary
This zip file contains the html and json files that are the result of the calls documented in the Scenario Details PDF.