The Medical Product Information found in most medication boxes offer a wealth of information, including terms of active ingredients, excipients, indications, dosage, route of administration, risks, and safety information. Digital health services that help patients, their care givers, and health professionals to manage medication, can be improved with tailored information based on user profile, the patient's Electronic Health Record (EHR) summary, and Medicinal Product Information. The electronic Product information (ePI) comprises the summary of product characteristics, package leaflet, and product label. The European Medicines Agency released in 2021 the first version of the EU proof-of-concept ePI standard based on HL7 FHIR. The Gravitate-Health project uses this common standard as a springboard to implement a federated open-source platform and services that helps advance access, understanding, and adherence by providing trusted medicinal information in an interoperable and scalable way. In this paper, we present the agile technical approach and co-creation process to design, test, and progressively mature interoperability working with the HL7 Vulcan Accelerator and FHIR connectathons.
Keywords: Citizen Empowerment; HL7 FHIR; International Patient Summary; electronic product information; interoperability; regulatory science.