Improving and Expediting Biologics Adverse Event Surveillance Using FHIR®

Event Time

Thursday, March 14 11:30 AM - 12:30 PM Eastern Time (US & Canada)

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Event Location

Location: W330A

Event Information

Type: General Education

Session ID: 207

Title: Improving and Expediting Biologics Adverse Event Surveillance Using FHIR®

Description: Current reporting systems for biologic products’ adverse events (AEs) have 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) established the Biologics Effectiveness and Safety (BEST) Platform to address some of these challenges. The BEST Platform is an HL7®® FHIR® (FHIR®® )-based infrastructure to enhance post-market AEs reporting, while minimizing the burden. BEST partnered with eHealth Exchange (eHx) to conduct two pilot studies with eHx member providers, exploring validation and automated detection of AEs. The BEST pilot assesses the status of the FHIR® ® implementation in the U.S. healthcare system and its fitness-for-purpose for public health use cases. The BEST team will describe the platform’s components and share a summary of results from the pilot. The eHx team will present the development and implementations on the eHx FHIR® Hub to enable these studies. Cedars-Sinai’s team will present the experience from the provider perspective, specifically the automation of AE detection. We will share the challenges, the short-term implemented solutions and the potential long-term solutions to enable a national implementation that will promote public health use cases and reduce burden on providers.

Level: Intermediate

Format: 60-Minute Lecture

Learning Objective #1: Describe the CBER BEST Platform, its component, current capabilities, current and potential use cases to establish an innovative surveillance reporting system for validation and detection of biologics-related adverse events

Learning Objective #2: Evaluate the quality of the data obtained from FHIR®-based platforms and assess its fitness for AE surveillance use case for public health

Learning Objective #3: Outline how the retrieval of FHIR®-based data from clinical data repositories (CDRs) was implemented and refined to meet the needs of CBER BEST

Learning Objective #4: Discuss the technical implementation to deliver and write CDR data to the BEST Platform so that it may be used for AE validation

Learning Objective #5: Explain the efforts by trailblazers in the interoperability ecosystem to streamline the process of recognizing and reporting of biologic-products AEs


Continuing Education Credits

  • ACPE – 1 Credit(s)
  • CAHIMS – 1 Credit(s)
  • CME – 1 Credit(s)
  • CNE – 1 Credit(s)
  • CPD UK – 1 Credit(s)
  • CPHIMS – 1 Credit(s)

  • Tracks



    • Public Health and Population Health


    • Data Scientist
    • Government or Public Policy Professional
    • Public Health Practitioner