FDA | Biologics Effectiveness and Safety (BEST)

The Exchange Pilot

The Biologics Effectiveness and Safety (BEST) Innovative Methods (IM) Exchange Platform is an HL7 (Fast Healthcare Interoperability Resources) FHIR-based interoperable platform. The BEST team developed the Exchange Platform to facilitate the detection, validation, and reporting of post-market adverse events (AEs) of biologics to the FDA. This Platform is designed to automate parts of the current manual AE reporting process, manual detection, clinical review, and submission of AE reports. In addition, the BEST Platform aims to obtain quality, fit-for-purpose, data to guide regulatory decisions as part of the FDA’s post-marketing safety and effectiveness surveillance mission.

The BEST IM team has partnered with eHealth Exchange to pilot the Exchange Platform. To become an early adopter, or If you are interested to learn more about the BEST IM Pilot, please see these slides, or contact administrator@ehealthexchange.org.

The below figure illustrates one of the two Use Cases of the Platform, the Pull Use Case, where a reported AE could be validated via the BEST IM platform.

The BEST IM Platform is the culmination of different workstreams such as data standards, data quality, detection and reporting. Here we share some of the artifacts and work products of these efforts.

Data Standards

The BEST IM team developed and balloted a FHIR IG to detail the process of extracting the relevant data and mapping it into the corresponding vaccine and transfusion AE report. In addition, the BEST IM team submitted and has been working on promoting the needed data elements to become part of the United States Core Data for Interoperability (USCDI).

• HL7 FHIR Implementation Guide: Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting
• Biologically Derived Product USCDI ONDEC