The U.S. Food and Drug Administration (FDA) received a 2024 FORUM Innovation Award for their Biologics Effectiveness and Safety (BEST) initiative using Fast Healthcare Interoperability Resources® (FHIR®) nationwide for next-generation electronic exchange of rich clinical patient data involving validation of adverse events between healthcare providers and the FDA.
The FDA is a government agency responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.
Current Biologic-products adverse events (AEs) reporting system has multiple challenges related to the burden of manual reporting, no direct data connection, under-reporting for certain products, and inconsistences in the quality of reports. The Center for Biologics Evaluation and Research (CBER) launched the BEST initiative and established the BEST Platform to address some of these challenges. The BEST Platform is a HL7® FHIR-based infrastructure leveraging automation and innovative technologies to advance and improve the post-market adverse events reporting and ensure biologic-products safety and effectiveness, while minimizing the reporting burden.
In collaboration with eHealth Exchange, the BEST Pilot commenced, conducting two studies with twelve eHealth Exchange member providers, including the Veterans Health Administration (46 states) and 11 large integrated delivery networks (IDNs). This “Networked FHIR” solution provides one connection and one trust agreement to facilitate exchange with the FDA to review and confirm post-vaccination adverse events. It is the largest and most important successful use of FHIR in the US. While this project was not absent of challenges, it proved that Networked FHIR can be a national solution that will promote public health use cases and reduce burden on providers. Learn more
