Electronic Product Information (ePI) is the online version of the "product label" or "package insert" or "patient information" that is supplied with every medication package. By expressing this in FHIR the information can be structured which in turn allows selection of information most relevant to a specific patient. A FHIR representation also facilitates presentation of the material in multiple languages.
The Implementation Guide will document how the ePI is represented as a FHIR document and will include instructions on how to create and exchange FHIR ePI documents; a common core profile for international use; region specific sub‑profiles to accommodate unique local requirements; and recommendations for in-scope terminologies.
This project is supported by FDA, EMA and other regulators.
The project is run within the Vulcan Accelerator and IMI Gravitate Health.