This track is Phase 5 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, as well as potential UNICOM scenario’s for IDMP implementation.
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, including consistent identification by IDMP standards, that improves the patient experience and supports interoperability across the international healthcare clinical and regulatory environment.
ePI Track Phase 5 builds towards this vision by incorporating lessons learned from the previous 4 connectathons 28-29-30-31. 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 apart from the core ePI, there are additional risk minimization measures like a patient card, videos, pictures, etc. that can act in support of the ePI to support patient understanding and safe use. IDMP-standards are crucial to ensure that any medicinal product can be accurately identified anywhere in the world to improve patient safety.
These documents are currently mostly based on PDF and they are section-formatted, but basically unstructured electronic paper content. As a result, they are difficult to search, difficult to find, and the content does not always meet patient needs as it lacks e.g., large fonts, accessibility support, multimedia, multiple languages, UpToDate (not including latest 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 with an ongoing SPLtoFHIR project; Japan’s PMDA uses custom XML; EU’s EMA is developing a FHIR XML ePI and authoring tool. Without harmonization, alignment and exchange of ideas, there is a high risk of divergence. This divergence won’t allow us to reap the benefits of the digital transformation.
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 and review ballot comments.
|IPS track, various accelerator tracks.|
Call for participants
Gravitate Health members; HL7 Vulcan Members; FDA; EMA; Project UNICOM; adopters; implementers; ePI and IPS data consumers, HELIOS and Gravity accelerators
Catherine Chronaki, Craig Anderson, Jens Villadsen
|Gravitate Health Team|
Patricia Arbil, Cecilia Vera, Alvaro Belmar, Joao Almeida, Giorgio Cangioli, Erol Hoffman, Evinn Drusys, Adam Kover, Bente Jensen, Alejandro M. Medrano
Track Lead Email(s)
|Supporting Documents||Concept scenario: 2022-0630-PPT-UNICOM-Demonstrator-FINAL.pdf|
Track Kick off Call
LinkedIn Event on Tuesday January 10, 2023, 07:00 to 08:00 EDT
Sample data for use with the testing scenarios noted below
Electronic Product Information (ePI)
International Patient Summary (IPS)
Other Testing Scenarios to be considered as we move closer to FCAT32