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  1. FHIR Specification Feedback
  2. FHIR-42040

Scope (premaket or postmarket)

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    • Icon: Change Request Change Request
    • Resolution: Persuasive
    • Icon: Highest Highest
    • Adverse Event Clinical Research (FHIR)
    • current
    • Biomedical Research & Regulation
    • Withdrawn
    • AdverseEvents for Clinical Research Home Page
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    • Peter Bomberg / Rebecca Baker : 16 - 0 - 2
    • Clarification
    • Non-substantive

    Description

      The Scope section is not as clear as it should be. Perhaps the Scope is meant to be the collection/representation of AEs in EHRs for both premarket and postmarket safety reporting to support patient safety protection and regulatory review and evaluation. Anyway, a clearer description of the Scope would be desirable.

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            bheale Bret Heale
            mrocca Mitra Rocca
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              Updated:
              Resolved: