Can FHIR Support Standardization in Post-Market Safety Surveillance?

ABSTRACT

The Fast Healthcare Interoperability Resources (FHIR) contain multiple data-exchange standards that aim at optimizing healthcare information exchange. One of them, the FHIR AdverseEvent, may support post-market safety surveillance. We examined its readiness using the Food and Drug Administration's (FDA) Adverse Event Reporting System (FAERS). Our methodology focused on mapping the public FAERS data fields to the FHIR AdverseEvent Resource elements and developing a software tool to automate this process. We mapped directly nine and indirectly two of the twenty-six FAERS elements, while six elements were assigned default values. This exploration further revealed opportunities for adding extra elements to the FHIR standard, based on critical FAERS pieces of information reviewed at the FDA. The existing version of the FHIR AdverseEvent Resource may standardize some of the FAERS information but has to be modified and extended to maximize its value in post-market safety surveillance.