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  1. FHIR Specification Feedback
  2. FHIR-33648

Approved Jurisdiction clarification

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    • Icon: Change Request Change Request
    • Resolution: Persuasive with Modification
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    • Point of Care Devices (FHIR)
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      This has the same meaning and intention as DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction. 

      If marketPeriod is not needed, the extension may be as follows:

      Extension

      --subJurisdiction 1..1 uri (with a valueSet binding to Jurisdiction valueSet)

      OR

      If the marketPeriod is needed - follow the DeviceDefinition pattern below (with changes to cardinality:

      Extension       approved-jurisdictions
      url       "http://hl7.org/fhir/uv/pocd/StructureDefinition/approved-jurisdictions"
      marketPeriod   0..1 Period Begin and end dates for the commercial distribution of the device
      subJurisdiction   1..1 uri National state or territory where the device is commercialized

       

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      This has the same meaning and intention as DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction.  If marketPeriod is not needed, the extension may be as follows: Extension --subJurisdiction 1..1 uri (with a valueSet binding to Jurisdiction valueSet) OR If the marketPeriod is needed - follow the DeviceDefinition pattern below (with changes to cardinality: Extension       approved-jurisdiction s url       "http://hl7.org/fhir/uv/pocd/StructureDefinition/approved-jurisdiction s " marketPeriod   0..1 Period Begin and end dates for the commercial distribution of the device subJurisdiction   1..1 uri National state or territory where the device is commercialized  

      Describe how this is different than the UDICarrier.jurisdiction, and why the country codes will be sufficient for its use (i.e., this is not the regulatory authority aligned with the UDI). 

            Unassigned Unassigned
            marti_velezis Marti Velezis
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              Created:
              Updated:
              Resolved: