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Type:
Change Request
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Resolution: Unresolved
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Priority:
Medium
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FHIR Core (FHIR)
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R5
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Biomedical Research & Regulation
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ClinicalUseDefinition (was ClinicalUseIssue)
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15.7.4
ClinicalUseIssue may convey information of 5 distinct types, as announced by the value set ClinicalUseIssueType attached to the "type" element.
However, only 4 of these 5 are explicitly supported by a dedicated backbone: indication, contraindication, interaction and undesirableEffect. The fith one "warning" is not represented in the resource. At the minimum, it should be possible to convey a warning as a CodeableConcept (either one or more coding, or only the text).
Hence this suggested change:
1) Add this element to the resource:
warning
- CodeableConcept
- summary
- 0..1
- Definition: "Specifics for when this is a warning"
2) In the Boundaries & Relationships section, add one fith bullet to the bullet list:
- Warning: A warning or precaution for use of a medicinal product, medical device or procedure.