HL7® FHIR® (Fast Healthcare Interoperability Resources)
What is HL7® FHIR®?
HL7® FHIR® (Fast Healthcare Interoperability Resources) is a modern, web-based standard for exchanging healthcare information electronically.
Developed by Health Level Seven International (HL7), FHIR defines a set of modular “resources” — such as Patient, Medication, Observation, or Organization — that can be combined and exchanged via standard internet protocols (RESTful APIs, JSON, XML) to ensure interoperability between diverse health IT systems.
FHIR supports the structured, secure exchange of both clinical and administrative data, making it a critical enabler for structured content authoring and regulatory submissions in the pharmaceutical and life sciences sectors.
Why it Matters in Pharma Today
- Interoperability — Enables consistent, machine-readable data exchange between sponsor systems, CROs, regulators, EHRs, and safety databases.
- Structured data foundation — FHIR’s resource model maps directly to component-based authoring, supporting fact-level traceability from data to documents.
- Regulatory alignment — Supports structured product information initiatives such as EU ePI, FDA Structured Product Labeling (SPL), and ISO IDMP.
- Automation & efficiency — Reduces manual data entry by allowing automated population of regulatory documents and submissions from validated data sources.
- Global adoption momentum — Widely adopted in healthcare IT, increasingly used in clinical research, safety reporting, and regulatory data exchange.
Global Landscape
| Region/Body | Governing Entity | Adoption Status / Timeline |
| Global | HL7 International | Publishes FHIR specification; current release is R4, with R5 in draft. |
| US | Office of the National Coordinator for Health IT (ONC) | FHIR APIs mandated for certified EHRs under the Cures Act. |
| EU | National Health Authorities | National and cross-border FHIR implementation guides in use; alignment with ePI and IDMP. |
| EMA | EMA & HL7 Europe | Pilots FHIR for structured product data exchange and regulatory submissions. |
| Canada, Australia, Japan | National Standards Bodies | Multiple implementation pilots for healthcare and research data sharing. |
How HL7 FHIR Works in a Component-Based Authoring Model
Source — Authoritative product, safety, and clinical trial data stored in FHIR resources (e.g., Medication, Substance, Organization, Observation).
Normalize — Apply profiles and implementation guides to constrain FHIR resources to regulatory-ready formats (e.g., EMA ePI profile, IDMP profile).
Map — Bind specific FHIR elements to metadata fields in component-based authoring systems.
Govern — Validate data provenance, integrity, and compliance with regulatory standards.
Publish — Generate documents (CCDS, SmPC, USPI, ePI) and structured data packages (eCTD 4.0) directly from FHIR-sourced components.
Update — When source FHIR resources change, propagate targeted updates to all dependent documents and submissions.
Example: HL7 FHIR in Practice
- ePI production — Structured product data pulled from FHIR Medication and Ingredient resources into EMA’s ePI XML format.
- Safety signal update — Adverse events stored as AdverseEvent resources trigger updates to safety sections in CCDS, SmPC, and USPI.
- Clinical trial integration — ResearchStudy and Observation resources feed directly into CSR and DSUR templates.