Uploaded image for project: 'FHIR Specification Feedback'
  1. FHIR Specification Feedback
  2. FHIR-34358

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

    XMLWordPrintableJSON

Details

    • Icon: Change Request Change Request
    • Resolution: Not Persuasive
    • Icon: Highest Highest
    • Personal Healthcare Devices (FHIR)
    • 0.3.0
    • Devices
    • (NA)
    • 1.1.4 Scope
    • Hide

      Question is out of scope for this PHD IG. No change required.

      Show
      Question is out of scope for this PHD IG. No change required.
    • John Rhoads/Javier Espina: 8-0-1

    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)

      Attachments

        Activity

          People

            Unassigned Unassigned
            jrhoads John Rhoads
            Watchers:
            2 Start watching this issue

            Dates

              Created:
              Updated:
              Resolved: