HL7 FHIR Implementation Guide: Profiles for Transfusion and Vaccination Adverse Event Detection and Reporting
1.0.1 - STU 1 Technical Correction
HL7 FHIR Implementation Guide: Profiles for Transfusion and Vaccination Adverse Event Detection and Reporting
1.0.1 - STU 1 Technical Correction
This page is part of the Profiles for ICSR Transfusion and Vaccination Adverse Event Detection and Reporting (v1.0.1: STU 1 Update) based on FHIR R4. This is the current published version. For a full list of available versions, see the Directory of published versions 
Two sets of mappings were created from the FDA ICSR Specifications. The FAERS mappings were done using FDA's FAERS R2 Implementation Guide and mapping the specified elements to the FHIR Profiles in this guide. The VAERS mappings where done using both the ICH ICSR R3 Implementation Guide and FDA's VAERS Regional Guide.
The mappings were expressed in an Excel spreadsheet.
Samples used at the January 2021 Connectathon provide the FAERS and VAERS XML formats as well as the converted FHIR Bundles that correspond to those samples (Transfusion FHIR Bundle and Vaccination FHIR Bundle).
IG © 2020+ Biomedical Research & Regulation WG. Package hl7.fhir.us.icsr-ae-reporting#1.0.1 based on FHIR 4.0.1. Generated 2023-08-29
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