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  1. FHIR Specification Feedback
  2. FHIR-38909

Adverse Event Definition

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    • Icon: Comment Comment
    • Resolution: Considered - No action required
    • Icon: Medium Medium
    • FHIR Core (FHIR)
    • R5
    • Patient Care
    • AdverseEvent
    • 9.9.7. Detailed Descriptions
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      No Change needed since 

      • AdverseEvents are encountered and reported in clinical care processes, so no change to wording needed,
      • Mishaps and near misses are known as AdverseEvents.
      • Clinical care describes the context in which the AdverseEvent occurs.
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      No Change needed since  AdverseEvents are encountered and reported in clinical care processes, so no change to wording needed, Mishaps and near misses are known as AdverseEvents. Clinical care describes the context in which the AdverseEvent occurs.

    Description

      Suggest using the term "patient safety events" for the clinical care domain. (AHRQ patient safety events)
      Adverse event is defined as: is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product (source: GCP, ICH E6, E2A)

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            Unassigned Unassigned
            mrocca Mitra Rocca
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