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  1. FHIR Specification Feedback
  2. FHIR-26636

Differentiation of implantable Vs patient-use and "non-implantable" devices unclear

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    • Icon: Change Request Change Request
    • Resolution: Persuasive with Modification
    • Icon: Medium Medium
    • FHIR Core (FHIR)
    • R4
    • Orders & Observations
    • Device
      DeviceDefinition
      DeviceMetric
      DeviceRequest (was DeviceUseRequest)
      DeviceUsage (DeviceUseStatement)
    • Hide

      Proposed motion to include these definition/scope clarifications on general types of devices covered into both Device and Device Definition.

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      Proposed motion to include these definition/scope clarifications on general types of devices covered into both Device and Device Definition.
    • Marti Velezis/Jose Costa-Teixeira: 4-0-7
    • Clarification
    • Non-substantive
    • R5

    Description

      Neither FHIR Core nor US Core clearly define "implantable device" without ambiguity. All existing definitions assume the reader/user already understands the meaning of both "implantable" device, "patient-use" device, what might (by exclusion) be considered a non-patient-use and non-implantable device.  To assist with clarity perhaps these three references may add more specification for users to understand how to use various resources:

      Implantable device:

      Patient-use device:

       

      Greater clarity in definitions is essential.  Trying to navigate through the various FHIR device-related resources is highly problematic without clear definitions (Device, DeviceRequest, DeviceUseStatement, DeviceDefinition, and when to differentiate between DeviceRequest and ServiceRequest). AND US Core inherits the definition of implantable device from FHIR Core leading the user into endless circular loops to find there really is no clear definition.  

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            jdlnolen John D.L. Nolen
            feisenberg Floyd Eisenberg
            Floyd Eisenberg
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              Created:
              Updated:
              Resolved: