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Electronic Product Information (ePI)

ePI (Electronic Product Information) is a digital document standardized in FHIR format (FHIR ePI IG) that contains regulated and scientifically validated medicinal product information.

Content​

The ePI includes the Patient Information Leaflet (PIL), providing:

  • Medicinal product description
  • Indications and contraindications
  • Dosage and administration instructions
  • Side effects and warnings
  • Storage and handling information

Standardization​

ePI follows the HL7 FHIR ePI Implementation Guide:

  • Structured as ePI Bundles
  • Uses Composition resource for narrative content
  • Contains embedded HTML for rendering

Regulatory Nature​

ePI content is:

  • Highly regulated: Approved by authorities
  • Legally binding: Considered legal text
  • Immutable: Cannot be removed or altered by Focusing

Processing States​

Raw ePI​

Original ePI as retrieved from Trusted Sources via Connectors.

Preprocessed ePI (p(ePI))​

ePI after semantic annotation by Preprocessors, with standard terminologies embedded.

Focused ePI (f(ePI))​

Final personalized output after Lens execution, adapted for specific patient context.

Access​

ePIs are: