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  1. FHIR Specification Feedback
  2. FHIR-22147

Devices producing Observation / DiagnosticReport

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    • Icon: Change Request Change Request
    • Resolution: Persuasive with Modification
    • Icon: Medium Medium
    • FHIR Core (FHIR)
    • STU3
    • Orders & Observations
    • DiagnosticReport
      Observation
    • Hide

      We will add Device to DiagnosticReport.performer and include the following guidance: 

      1. In the regulated context of diagnostic laboratory work on humans, it is extremely likely that regulation requires a human performer.
      2. Point of care testing, veterinary testing, drug screens, and environmental surveillance are common cases where the device is the performer with no additional human interaction or direct oversight. 
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      We will add Device to DiagnosticReport.performer and include the following guidance:  In the regulated context of diagnostic laboratory work on humans, it is extremely likely that regulation requires a human performer. Point of care testing, veterinary testing, drug screens, and environmental surveillance are common cases where the device is the performer with no additional human interaction or direct oversight. 
    • Grahame Grieve / Bas van den Heuvel : 12-0-1
    • Enhancement
    • Compatible, substantive
    • R6

      Neither Observation or DiagnosticReport allows for a device to be the performer. Presumably for Observation this is because device is a separate element - but is it the case that the device is assumed to be asserting that the result is true? or that a device is known to not be able to do that? Either seems an odd conclusion to me, and I think that OO should at least document their intent here.

      As for diagnostic report- is it not possble for a device to issue a diagnostic report? surely not?

            rhausam Robert Hausam
            GrahameGrieve Grahame Grieve
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              Created:
              Updated:
              Resolved: