IBM FHIR Implementation Guide: Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting
0.1.0 - CI Build

IBM FHIR Implementation Guide: Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting - Local Development build (v0.1.0). See the Directory of published versions

Home

Overview

This FHIR Implementation Guide provides a set of profiles for generating Adverse Event case reports related to biologic products, such as vaccines and blood products. There are two sets of profiles. The first set of profiles are intended to provide value sets of codes for detecting specific conditions and observations on a patient’s record that would indicate the occurrence of an Adverse Event. The second set of profiles provides mappings to the ICH ICSR specifications, specifically FDA’s FAERS and VAERS implementations of those specifications.

Authors

The development of this Implementation Guide was funded by FDA Center for Biologic Evaluation and Research (CBER) as part of the Biologic Effectiveness and Safety (BEST) initiative.

  • FDA CBER BEST IBM Project Team
  • Jean Duteau (mailto: jean@duteaudesign.com)
  • Shayan Hobbi (mailto: shayan.hobbi@ibm.com)
  • Will Rosenfeld (mailto: will.rosenfeld@ibm.com)