Adverse Events

Support standardizing the reporting and format of an adverse event.  Improve the maturity of the relevant FHIR resources

Adverse Event (AE) data capture and standardization is a challenge. There are variations in the definitions, workflows, and data requirements across the use cases for patient monitoring, clinical intervention, FDA safety reporting requirements and clinical trials monitoring.

The project has published a profile of the FHIR AdverseEvent resource that is specific to Clinical Research using FHIR R5 and a separate profile as a backport to R4. They have also drafted a profile for use in clinical care.

The project is now looking for partners to pilot the profiles.

Follow the link to Confluence for more detail.