BEST IM Program: Accelerating the Automation of Adverse Event Reporting

The FDA Center for Biologics Evaluation and Research(CBER) is expanding its pilot program for health systems participating in automated reporting of potential adverse events (AEs) of vaccines, blood products, gene therapies and other biologics. The Biologics Effectiveness and Safety (BEST) Innovative Methods (IM) Program enables health systems to transfer data from electronic health records to the FDA using Fast Healthcare Interoperability Resources standards through the national eHealth Exchange. Electronic phenotypes specify electronic health record data elements needed to identify and report potential adverse events such as anaphylaxis, hypogammaglobulinemia, myocarditis/pericarditis and aseptic meningitis. FDA studies from 2024 and 2025 demonstrate the use of AI, large language models and logic tools using Clinical Quality Language to greatly accelerate the systematic approach to evaluating AEs and improving patient safety surveillance. The FDA is expanding the program to cover additional phenotypes and many more healthcare systems across the United States.