Figure 1.

FDA BEST pilot platform. This FDA Biologics Effectiveness and Safety (BEST) Pilot Platform allows an FDA reviewer to query for additional clinical information for a patient with a probable AE. Listed below are the steps of the process: (1) FDA identifies AE case: an FDA reviewer, using VAERS adverse event case report, identify case of interest that requires additional data. (2) BEST Platform provides UI to query case: the FDA reviewer uses patient demographics provided in the VAERS report to send request for additional data. (3) BEST Platform request case data from eHealth Exchange. (4) eHealth Exchange requests additional data from providers: eHealth Exchange requests additional data for patient case from all participating health provider partners. (5) Provider EHR systems respond to request for patient: all health provider partners check their EHR databases for patients that match the queried demographics. If there is a match, the provider will send a FHIR bundle of agreed upon resource types for the patient case to eHealth exchange. (6) eHealth Exchange routes data to BEST Platform. (7) BEST Platform displays data to FDA: data are displayed in a custom chart review application. The left-hand side (blue) components are representative of the contractor-managed FDA BEST Platform, which includes several BEST-developed applications and services. This section also includes review of data by the FDA. The center (orange) cloud is representative of the eHealth Exchange, which serves as an intermediary between the FDA BEST Platform and any providers exchanging data. The right-hand side (green) components are representative of providers that are members of the eHealth Exchange. These are the sites where vaccinations/other biologic treatments occur and where any adverse event data would be queried for and sent back to FDA. Dotted arrows represent data flowing internally to one of the three systems described above while the solid arrows represent communication between systems. Adapted from “Validation of a Computable Phenotype for Myocarditis/Pericarditis Following COVID-19 Vaccinations Using a Pilot Active Surveillance Electronic Healthcare Data Exchange Platform” JMIR Preprints.