Project Information
Adoption
25 September, 2025
Project Introduction
Adverse Events (AE)
The Adverse Events (AE) project is working to standardize how adverse events are reported and exchanged using FHIR. By creating common profiles and guidance, the project addresses the challenge of inconsistent definitions, workflows, and reporting requirements across clinical care, clinical research, and regulatory settings.
Why AE Standardization Matters
Adverse event reporting is central to patient safety, regulatory compliance, and clinical research quality. Today, AE capture varies widely, from EHR-based documentation to clinical trial case report forms and FDA MedWatch submissions. Without standardization, the same event often needs to be re-entered in multiple formats, creating inefficiency and risk of error.
By developing a shared FHIR-based approach, the AE project enables consistent data capture that can be shared seamlessly across systems, from healthcare providers to sponsors, CROs, and regulators.
The AE project has published:
- A Clinical Research Adverse Event profile based on FHIR R5, with a backport available for R4.
- Draft profiles for clinical care use cases, expanding interoperability across care and research.
- Guidance on terminology bindings, data elements, and cardinality for consistent implementation.
The project has been tested at multiple HL7 Connectathons and refined with expert input. Current priorities include piloting the profiles in real-world systems and expanding support for both pre-market clinical research and post-market surveillance scenarios.
Adverse Events (AE)
Project Resources
Confluence
Project workspace with meeting notes, documentation, and collaboration materials.
FHIR IG
The evolving technical specification that defines how FHIR is used for this project.
SharePoint Resources
Central repository for project artifacts, reference materials, and shared files.
Adverse Events (AE)
Get Involved
The project is published and is seeking adopters and partners to pilot AE profiles in real-world environments. You can:
- Implement AE capture and exchange in EHRs, ePROs, or safety reporting workflows.
- Test profile adoption in clinical trial or regulatory reporting pipelines.
- Join HL7 Connectathons to validate implementation and share feedback.
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