The European adoption of FHIR for electronic Product Information is a progressive step towards introducing structured content authoring and scientific assessment for the European network. Under the EU ePI Common Standard, medicinal product information (SmPCs, package leaflets, labeling annexes) must conform to defined HL7 FHIR profiles (structured data templates governed by the HL7 standards body) before dissemination to patients and healthcare professionals. The transformation from traditional document base to structured content, involves structural validation against profile constraints, terminology bindings, mandatory element cardinality, and alignment with SPOR master data domains. The practical consequence is that product information authored in one form must survive mechanical interrogation in another, and the distance between those two forms determines the organization’s exposure.
Authors:
- Anjana Pindoria-Rettenberger, EXTEDO
- Kenneth Gutiérrez, Docuvera
