The current state of product information exchange is like printing PDFs of streaming content—static, disconnected, and quickly outdated.
Labeling remains locked in documents that are costly to maintain, difficult to reuse, and impossible to integrate in real time.
ePI Type 4 represents the streaming era of product information.
It transforms labeling into a fully structured, FHIR-based model where narrative text is decomposed into atomic components, coded with controlled terminologies (e.g., SNOMED CT, MedDRA), and linked directly to machine-readable resources.
Result: labeling that systems can interpret, query, and consume automatically, enabling healthcare interoperability, personalization, content reuse, and dynamic content generation.
ePI Maturity Model
Type 1 – Digital Label
Digitized version of the label document with structured text, tables, and images
Type 2 – Product Information
Structured product data enabling search and reuse
Type 3 – Clinical Information
Structured clinical content (e.g., coded indications, contraindications, dosing)
Type 4 – Dynamic Digital Label
Personalized, granular content with direct links between text and FHIR resources
Value
For Regulators
- Data-driven oversight and automated validation
- Real-time updates and dissemination
For Industry
- Reduced duplication across markets
- Real-time updates and interoperability with healthcare systems
For Patients
- More accessible, up-to-date product information
- Personalized and context-relevant content within digital health tools
Join us for a virtual session on the significance and value of ePI Type 4.
Date: 16th June 2026
Time: 11.00 EST
Format: Virtual (Free)
Register: [Insert Link]
Link to the Vulcan ePI Project Page: https://hl7vulcan.org/projects/electronic-product-information-epi/
In 90 minutes, you will see
- From Documents to Data: Atomic, coded labeling linked to FHIR
- Maturity in Practice: Type 1 → Type 4 capabilities
- Use Cases: Healthcare interoperability, personalization, granular reuse, and encoded components
Agenda
Kim Sherwood and Markus Forslund (Swedish MPA), Craig Anderson (J&J), Ádám Kövér (Felleskatalogen), Niklas Jaenich (Boehringer Ingelheim), Jenny Sage (Pfizer), Esther Mapletoft (Pfizer) and Philippe Michiels (Datapharm)
15 min – Introduction and evolution
60 min – Overview how to build ePI type 4 IG by words, IG by Build ePI 4
– Definitions and structure, IG by code
– Best practice, use of IDMP
15 min – Q&A + next steps
Audience
Regulators · RA Leaders · Labeling & Submissions · Digital/IT · Clinical Informatics · Solution Providers
