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  1. Project Scope Statements/Proposals
  2. PSS-1656

FHIR Implementation Guide for ICSR Transfusion and Vaccination Submissions

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    • Type: Project Proposal
    • Status: Accepted
    • Priority: Medium
    • Resolution: Done
    • Labels:
      None
    • Sponsoring Work Groups:
      Biomedical Research & Regulation
    • Ballot Cycle Target:
      May 2021
    • Project Description:
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      The FHIR Implementation Guide provides a set of profiles for detection, validation, reporting, and ultimately recording/persisting Adverse Events associated with blood transfusions and vaccinations. There are two sets of profiles with the first set intended to enable the detection, validation, and recording of 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 Individual Care Study Report (ICSR) specifications, specifically FDA’s FAERS (FDA Adverse Event Reporting System) and VAERS (Vaccine Adverse Event Reporting System) implementations of those specifications, for the purposes of allowing the submission of Adverse Event Case Reports to FDA using the FHIR profiles after they have been transformed into the current XML specifications.
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      The FHIR Implementation Guide provides a set of profiles for detection, validation, reporting, and ultimately recording/persisting Adverse Events associated with blood transfusions and vaccinations. There are two sets of profiles with the first set intended to enable the detection, validation, and recording of 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 Individual Care Study Report (ICSR) specifications, specifically FDA’s FAERS (FDA Adverse Event Reporting System) and VAERS (Vaccine Adverse Event Reporting System) implementations of those specifications, for the purposes of allowing the submission of Adverse Event Case Reports to FDA using the FHIR profiles after they have been transformed into the current XML specifications.

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            Unassigned Unassigned
            Reporter:
            jduteau Jean Duteau
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