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FHIR IG Statistics: Requirements/EHRSFMR2-CP.1.9

Packagehl7.ehrs.uv.ehrsfmr2
TypeRequirements
IdEHRSFMR2-CP.1.9
FHIR VersionR5
Sourcehttp://hl7.org/ehrs/uv/ehrsfmr2/https://build.fhir.org/ig/mvdzel/ehrsfm-fhir-r5/Requirements-EHRSFMR2-CP.1.9.html
URLhttp://hl7.org/ehrs/uv/ehrsfmr2/Requirements/EHRSFMR2-CP.1.9
Version2.1.1-ballot
Statusactive
Date2025-05-13T15:11:00+00:00
NameCP_1_9_Manage_Adverse_Events
TitleCP.1.9 Manage Adverse Events (Function)
Realmuv
Authorityhl7
DescriptionCapture and maintain adverse events.
PurposeThis function is focused on the capture and maintenance of adverse events that have occurred to the patient. The system should capture discrete information about the adverse event to enable the rendering Serious Adverse Event (SAE) reports according to organizational policy, and or jurisdictional law. Reporting may conform to the HL7 Individual Case Safety Reporting (ICSR).

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Narrative

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

Statement N:

Capture and maintain adverse events.

Description I:

This function is focused on the capture and maintenance of adverse events that have occurred to the patient. The system should capture discrete information about the adverse event to enable the rendering Serious Adverse Event (SAE) reports according to organizational policy, and or jurisdictional law. Reporting may conform to the HL7 Individual Case Safety Reporting (ICSR).

Actors:
ehr
Criteria N:
CP.1.9#01 SHALL

The system SHALL provide the ability to manage adverse events associated with a patient.

CP.1.9#02 dependent SHALL

The system SHALL capture and maintain as discrete data an adverse event. For example:a) Patient identificationb) Event date/timec) Event descriptiond) Event severitye) Event category (e.g., medication error, fall)f) Care providers associated with the eventaccording to scope of practice, organizational policy, and/or jurisdictional law.

CP.1.9#03 dependent SHALL

The system SHALL provide the ability to capture and render a Serious Adverse Event (SAE) report according to organizational policy, and/or jurisditional law.

CP.1.9#04 MAY

The system MAY provide the ability to render a set of Serious Adverse Event (SAE) data as modeled by the current release of HL7 ICSR (Individual Case Safety Reporting).


Source

{
  "resourceType": "Requirements",
  "id": "EHRSFMR2-CP.1.9",
  "meta": {
    "profile": [
      "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/FMFunction"
    ]
  },
  "text": {
    "status": "extensions",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
      "valueCode": "ehr"
    }
  ],
  "url": "http://hl7.org/ehrs/uv/ehrsfmr2/Requirements/EHRSFMR2-CP.1.9",
  "version": "2.1.1-ballot",
  "name": "CP_1_9_Manage_Adverse_Events",
  "title": "CP.1.9 Manage Adverse Events (Function)",
  "status": "active",
  "date": "2025-05-13T15:11:00+00:00",
  "publisher": "HL7 International / Electronic Health Records",
  "contact": [
    {
      "telecom": [
        {
          "system": "url",
          "value": "http://www.hl7.org/Special/committees/ehr"
        }
      ]
    }
  ],
  "description": "Capture and maintain adverse events.",
  "jurisdiction": [
    {
      "coding": [
        {
          "system": "http://unstats.un.org/unsd/methods/m49/m49.htm",
          "code": "001",
          "display": "World"
        }
      ]
    }
  ],
  "purpose": "This function is focused on the capture and maintenance of adverse events that have occurred to the patient. The system should capture discrete information about the adverse event to enable the rendering Serious Adverse Event (SAE) reports according to organizational policy, and or jurisdictional law. Reporting may conform to the HL7 Individual Case Safety Reporting (ICSR).",
  "statement": [
    {
      "extension": [
        {
          "url": "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "EHRSFMR2-CP.1.9-01",
      "label": "CP.1.9#01",
      "conformance": [
        "SHALL"
      ],
      "conditionality": false,
      "requirement": "The system SHALL provide the ability to manage adverse events associated with a patient.",
      "derivedFrom": "EHR-S_FM_R1.1 DC.1.3.1#1"
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent",
          "valueBoolean": true
        }
      ],
      "key": "EHRSFMR2-CP.1.9-02",
      "label": "CP.1.9#02",
      "conformance": [
        "SHALL"
      ],
      "conditionality": false,
      "requirement": "The system SHALL capture and maintain as discrete data an adverse event. For example:a) Patient identificationb) Event date/timec) Event descriptiond) Event severitye) Event category (e.g., medication error, fall)f) Care providers associated with the eventaccording to scope of practice, organizational policy, and/or jurisdictional law.",
      "derivedFrom": "EHR-S_FM_R1.1 DC.1.3.1#2"
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent",
          "valueBoolean": true
        }
      ],
      "key": "EHRSFMR2-CP.1.9-03",
      "label": "CP.1.9#03",
      "conformance": [
        "SHALL"
      ],
      "conditionality": false,
      "requirement": "The system SHALL provide the ability to capture and render a Serious Adverse Event (SAE) report according to organizational policy, and/or jurisditional law.",
      "derivedFrom": "EHR-S_FM_R1.1 DC.1.3.1#2"
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/ehrs/uv/ehrsfmr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "EHRSFMR2-CP.1.9-04",
      "label": "CP.1.9#04",
      "conformance": [
        "MAY"
      ],
      "conditionality": false,
      "requirement": "The system MAY provide the ability to render a set of Serious Adverse Event (SAE) data as modeled by the current release of HL7 ICSR (Individual Case Safety Reporting).",
      "derivedFrom": "EHR-S_FM_R1.1 DC.1.3.1#3"
    }
  ]
}