APIX - API Exchange for Medicinal Products (Jira PSS-2675)

Description

This FHIR IG will define a global standard for real-time, API-based exchange of medicinal product information. The guide promotes the use of a common international exchange framework that is modern and offers lightweight interoperability across organizations and jurisdictions.

This IG will look at three use cases:

1) Medicinal product information is exchanged between pharma, regulators, contractors, academia and healthcare institutions using a mix of technologies (e.g., AS2, FTP, email, secure email, https portals, physical media). As a result, information exchange is inconstant, requires higher manual effort than is necessary, slow, relatively expensive, and incurs extra costs to sustain redundant systems. The problem is amplified on an international scale for any organization operating across international jurisdictions.

2) Vulcan and BR&R developed FHIR standards defining how to structure regulatory content (e.g., ePI, UDP, PQI, PQ/CMC, AE). However, these projects do not define how to exchange this FHIR compliant content. If we do not define a common standard for API exchange, all stakeholders will adopt differing approaches which does not resolve problem #1 mentioned above; and could make it worse.

3) Recommended supporting infrastructure. Even with a well-defined API standard, stakeholders need practical guidance on implementing it efficiently. This IG will provide recommendations for supporting infrastructure, including guidance on open-source tools and frameworks that organizations can use to quickly adopt the standard.

In summary, there is no common framework for exchanging medicinal product information. Particularly not one that leverages modern best practices.

Misc Notes
Accelerators: Vulcan Stakeholders: Academic/Research, Pharmaceutical/Biotech, Regulatory Agencies, Medicinal product regulators; structured content authoring developers; pharma industry; research hospitals; academia. Other Interested Parties: Representatives from the following will contribute throughout the life of the project: EMA, Gravitate Health, Global IDMP Working Group (GIDWG), Uppsala Monitoring Centre (UMC), Pfizer, Amgen, Johnson and Johnson, Boehringer Ingelheim, i4i, Docuvera, Glemser, national drug compendia (Felleskatalogen, EMC).