CDISC recommends the data element "Serious Adverse Event" be considered for promotion in USCDI v5.
The rationale is that it will aid in drug safety, patient safety and clinical research. HL7 Vulcan Adverse Event working group is close to publishing two implementation guides to clarify how the data element would be used: http://hl7.org/fhir/uv/ae-research-ig/2023Sep/StructureDefinition-AdverseEvent-clinical-research.html https://build.fhir.org/ig/HL7/fhir-ae-research-backport-ig/index.html
The FHIR AdverseEvent Resource is Maturity Level 2 http://build.fhir.org/adverseevent.html
Submitted by rbaker@cdisc.org on
CDISC recommends Serious Adverse Event promotion in v5
CDISC recommends the data element "Serious Adverse Event" be considered for promotion in USCDI v5.
The rationale is that it will aid in drug safety, patient safety and clinical research. HL7 Vulcan Adverse Event working group is close to publishing two implementation guides to clarify how the data element would be used:
http://hl7.org/fhir/uv/ae-research-ig/2023Sep/StructureDefinition-AdverseEvent-clinical-research.html
https://build.fhir.org/ig/HL7/fhir-ae-research-backport-ig/index.html
The FHIR AdverseEvent Resource is Maturity Level 2
http://build.fhir.org/adverseevent.html
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