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Source1

{
  "resourceType": "Requirements",
  "id": "CMHAFFR2-AIG.5",
  "meta": {
    "profile": [
      "http://hl7.org/ehrs/uv/cmhaffr2/StructureDefinition/FMFunction"
    ]
  },
  "text": {
    "status": "extensions",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
      "valueCode": "mobile"
    }
  ],
  "url": "http://hl7.org/ehrs/uv/cmhaffr2/Requirements/CMHAFFR2-AIG.5",
  "version": "2.0.1",
  "name": "AIG_5_Human_Factors__Explainability__and_Human_Oversight",
  "title": "AIG.5 Human Factors, Explainability, and Human Oversight (Function)",
  "status": "active",
  "date": "2026-10-27T09:40:49+00:00",
  "publisher": "HL7 International / Mobile Health",
  "contact": [
    {
      "telecom": [
        {
          "system": "url",
          "value": "http://www.hl7.org/Special/committees/mobile"
        }
      ]
    }
  ],
  "description": "This category is about what the consumer can see, correct, question, and override. It covers review and escalation pathways before high-impact or irreversible actions, correction of faulty input data, and explanation at a level appropriate to the consumer and the risk of the intended use.",
  "jurisdiction": [
    {
      "coding": [
        {
          "system": "http://unstats.un.org/unsd/methods/m49/m49.htm",
          "code": "001",
          "display": "World"
        }
      ]
    }
  ],
  "statement": [
    {
      "extension": [
        {
          "url": "http://hl7.org/ehrs/uv/cmhaffr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "CMHAFFR2-AIG.5-01",
      "label": "AIG.5#01",
      "conformance": [
        "SHALL"
      ],
      "conditionality": true,
      "requirement": "IF an AI function can influence a high-impact health, safety, access, or financial decision THEN the system SHALL provide a risk-appropriate human or consumer review, correction, override, or escalation pathway before an irreversible or high-impact action is taken, unless a documented exception is required for immediate safety and is permitted by applicable rules."
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/ehrs/uv/cmhaffr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "CMHAFFR2-AIG.5-02",
      "label": "AIG.5#02",
      "conformance": [
        "SHALL"
      ],
      "conditionality": true,
      "requirement": "IF the system uses AI functionality THEN the system SHALL enable a consumer to view or correct material input data that the consumer provided or that the system attributes to the consumer when incorrect input could materially affect the AI output."
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/ehrs/uv/cmhaffr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "CMHAFFR2-AIG.5-03",
      "label": "AIG.5#03",
      "conformance": [
        "SHOULD"
      ],
      "conditionality": true,
      "requirement": "IF the system displays AI output THEN the system SHOULD provide a meaningful explanation of the primary factors, data limitations, or evidence sources relevant to the output, at a level appropriate to the consumer and the risk of the intended use."
    },
    {
      "extension": [
        {
          "url": "http://hl7.org/ehrs/uv/cmhaffr2/StructureDefinition/requirements-dependent",
          "valueBoolean": false
        }
      ],
      "key": "CMHAFFR2-AIG.5-04",
      "label": "AIG.5#04",
      "conformance": [
        "MAY"
      ],
      "conditionality": true,
      "requirement": "IF the system uses AI functionality THEN the system MAY offer alternative explanation formats, such as plain-language summaries, detailed technical explanations, visual context, or translated content."
    }
  ]
}