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  1. FHIR Specification Feedback
  2. FHIR-33469

Does FDA certify PHDs? What standards are required for that certification?

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    • Icon: Change Request Change Request
    • Resolution: Not Persuasive
    • Icon: Highest Highest
    • Point of Care Devices (FHIR)
    • 0.3.0
    • Devices
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      Incorrectly submitted for the Point-of-Care IG (FHIR) Specification (PoCD), but it is clear from the content and the references that they are actually about the Personal Health Devices (FHIR) Implementation Guide (PHD) Specification, which is a distinct Specification not included in the 2021Sep ballot. The issue has been cloned and transferred to the correct Specification, and the original, incorrectly submitted issue will be rejected as unpersuasive because unrelated.

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      Incorrectly submitted for the Point-of-Care IG (FHIR) Specification (PoCD), but it is clear from the content and the references that they are actually about the Personal Health Devices (FHIR) Implementation Guide (PHD) Specification, which is a distinct Specification not included in the 2021Sep ballot. The issue has been cloned and transferred to the correct Specification, and the original, incorrectly submitted issue will be rejected as unpersuasive because unrelated.
    • Martin Rosner / Todd Cooper : 4-0-1

    Description

      Does FDA certify PHDs? What standards are required for that certification?

      Existing Wording:

      Furthermore, these PHDs must communicate a sufficient amount of information in a manner that guarantees the generation of reliable measurement time stamps .

      (Comment 5 - imported by: Chris Shawn)

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            s_mitchell Sandi Mitchell (Inactive)
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