FHIR IG analytics

Resources that use this resource

No resources found

Resources that this resource uses

No resources found

Narrative

Note: links and images are rebased to the (stated) source

Source1

{
  "resourceType": "CodeSystem",
  "id": "fda-add-seriousness-criteria-cs",
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
      "valueCode": "informative",
      "_valueCode": {
        "extension": [
          {
            "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
            "valueCanonical": "http://hl7.org/fhir/uv/ae-research-backport-ig/ImplementationGuide/hl7.fhir.uv.ae-research-backport-ig"
          }
        ]
      }
    }
  ],
  "url": "http://hl7.org/fhir/uv/ae-research-backport-ig/CodeSystem/fda-add-seriousness-criteria-cs",
  "version": "1.0.0-ballot",
  "name": "FDAaddSeriousnessCriteriaCS",
  "title": "FDA Additional Seriousness Criteria CodeSystem",
  "status": "draft",
  "experimental": true,
  "date": "2023-07-28T19:53:38+00:00",
  "publisher": "HL7 International - Biomedical Research and Regulation, Vulcan AdverseEvent groups",
  "contact": [
    {
      "name": "Biomedical Research and Regulation WG",
      "telecom": [
        {
          "system": "url",
          "value": "http://hl7.org/Special/committees/rcrim"
        }
      ]
    }
  ],
  "description": "Additional codes found on https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event#:~:text=Required%20Intervention%20to%20Prevent%20Permanent%20Impairment%20or%20Damage%20(Devices),use%20of%20a%20medical%20product. Typically used in reporting for Clinical Research, post-market surveillance (e.g. Form FDA 3500A MedWatch).",
  "jurisdiction": [
    {
      "coding": [
        {
          "system": "http://unstats.un.org/unsd/methods/m49/m49.htm",
          "code": "001"
        }
      ]
    }
  ],
  "caseSensitive": true,
  "content": "complete",
  "count": 1,
  "concept": [
    {
      "code": "requiresPreventImpairment",
      "display": "Required Intervention to Prevent Permanent Impairment or Damage (Devices)",
      "definition": "Report if you believe that medical or surgical intervention was necessary to preclude permanent impairment of a body function, or prevent permanent damage to a body structure, either situation suspected to be due to the use of a medical product"
    }
  ]
}