{
  "description": null,
  "_filename": "Extension-HealthAppModuleMedicalDevice.json",
  "package_name": "fhir.bfarm.de",
  "date": null,
  "derivation": "constraint",
  "publisher": null,
  "fhirVersion": "4.0.1",
  "name": "HealthAppModuleMedicalDevice",
  "mapping": [ {
    "uri": "http://hl7.org/v3",
    "name": "RIM Mapping",
    "identity": "rim"
  } ],
  "abstract": false,
  "type": "Extension",
  "experimental": null,
  "resourceType": "StructureDefinition",
  "title": "MedicalDevice on HealthAppModule",
  "package_version": "2.0.0",
  "status": "active",
  "id": "497b7dd7-d836-418d-828c-0868522ffc4b",
  "kind": "complex-type",
  "url": "https://fhir.bfarm.de/StructureDefinition/HealthAppModuleMedicalDevice",
  "context": [ {
    "type": "element",
    "expression": "DeviceDefinition"
  } ],
  "version": "2.0.0",
  "differential": {
    "element": [ {
      "id": "Extension",
      "max": "1",
      "path": "Extension",
      "short": "Medizinprodukt",
      "definition": "Angaben zum (Medizin-)produkt",
      "mustSupport": true
    }, {
      "id": "Extension.extension",
      "min": 0,
      "path": "Extension.extension",
      "slicing": {
        "rules": "open",
        "discriminator": [ {
          "path": "url",
          "type": "value"
        } ]
      }
    }, {
      "id": "Extension.extension:intendedPurpose",
      "max": "1",
      "min": 0,
      "path": "Extension.extension",
      "short": "Zweckbestimmung",
      "sliceName": "intendedPurpose",
      "definition": "Die (medizinische) Zweckbestimmung entsprechend den Angaben des Herstellers auf der Kennzeichnung, in der Gebrauchsanweisung oder dem Werbe- oder Verkaufsmaterial bzw. den Werbe- oder Verkaufsangaben.",
      "mustSupport": true
    }, {
      "id": "Extension.extension:intendedPurpose.url",
      "path": "Extension.extension.url",
      "fixedUri": "intendedPurpose"
    }, {
      "id": "Extension.extension:intendedPurpose.value[x]",
      "min": 1,
      "path": "Extension.extension.value[x]",
      "type": [ {
        "code": "string"
      } ],
      "mustSupport": true
    }, {
      "id": "Extension.extension:isMedicalDevice",
      "max": "1",
      "min": 0,
      "path": "Extension.extension",
      "short": "Medizinprodukt",
      "sliceName": "isMedicalDevice",
      "definition": "Gibt an ob es sich beim Modul der digitalen Anwendung um ein Medizinprodukt handelt.",
      "mustSupport": true
    }, {
      "id": "Extension.extension:isMedicalDevice.url",
      "path": "Extension.extension.url",
      "fixedUri": "isMedicalDevice"
    }, {
      "id": "Extension.extension:isMedicalDevice.value[x]",
      "path": "Extension.extension.value[x]",
      "type": [ {
        "code": "boolean"
      } ],
      "mustSupport": true
    }, {
      "id": "Extension.extension:notifiedBody",
      "max": "1",
      "min": 0,
      "path": "Extension.extension",
      "short": "Benannte Stelle",
      "sliceName": "notifiedBody",
      "definition": "Angaben zur benannten Stelle.",
      "mustSupport": true
    }, {
      "id": "Extension.extension:notifiedBody.extension",
      "min": 0,
      "path": "Extension.extension.extension",
      "slicing": {
        "rules": "open",
        "discriminator": [ {
          "path": "url",
          "type": "value"
        } ]
      }
    }, {
      "id": "Extension.extension:notifiedBody.extension:code",
      "max": "1",
      "min": 0,
      "path": "Extension.extension.extension",
      "short": "Kennnummer",
      "sliceName": "code",
      "definition": "Kennnummer der benannten Stelle.",
      "mustSupport": true
    }, {
      "id": "Extension.extension:notifiedBody.extension:code.url",
      "path": "Extension.extension.extension.url",
      "fixedUri": "code"
    }, {
      "id": "Extension.extension:notifiedBody.extension:code.value[x]",
      "min": 1,
      "path": "Extension.extension.extension.value[x]",
      "type": [ {
        "code": "string"
      } ],
      "mustSupport": true
    }, {
      "id": "Extension.extension:notifiedBody.extension:name",
      "max": "1",
      "min": 0,
      "path": "Extension.extension.extension",
      "short": "Name",
      "sliceName": "name",
      "definition": "Name der benannten Stelle.",
      "mustSupport": true
    }, {
      "id": "Extension.extension:notifiedBody.extension:name.url",
      "path": "Extension.extension.extension.url",
      "fixedUri": "name"
    }, {
      "id": "Extension.extension:notifiedBody.extension:name.value[x]",
      "min": 1,
      "path": "Extension.extension.extension.value[x]",
      "type": [ {
        "code": "string"
      } ],
      "mustSupport": true
    }, {
      "id": "Extension.extension:notifiedBody.url",
      "path": "Extension.extension.url",
      "fixedUri": "notifiedBody"
    }, {
      "id": "Extension.extension:notifiedBody.value[x]",
      "max": "0",
      "path": "Extension.extension.value[x]"
    }, {
      "id": "Extension.extension:nursingBenefit",
      "max": "1",
      "min": 0,
      "path": "Extension.extension",
      "short": "Pflegerischer Nutzen",
      "sliceName": "nursingBenefit",
      "definition": "Nur DiPA: Die Beschreibung des pflegerischen Nutzens nach § 9 DiPAV.",
      "mustSupport": true
    }, {
      "id": "Extension.extension:nursingBenefit.url",
      "path": "Extension.extension.url",
      "fixedUri": "nursingBenefit"
    }, {
      "id": "Extension.extension:nursingBenefit.value[x]",
      "min": 1,
      "path": "Extension.extension.value[x]",
      "type": [ {
        "code": "string"
      } ],
      "mustSupport": true
    }, {
      "id": "Extension.extension:regulatoryBasis",
      "max": "1",
      "min": 0,
      "path": "Extension.extension",
      "short": "Regulatorische Grundlage",
      "sliceName": "regulatoryBasis",
      "definition": "+ mdd: Medical Device Directive\r\n+ mdr: Medical Device Regulation",
      "mustSupport": true
    }, {
      "id": "Extension.extension:regulatoryBasis.url",
      "path": "Extension.extension.url",
      "fixedUri": "regulatoryBasis"
    }, {
      "id": "Extension.extension:regulatoryBasis.value[x]",
      "min": 1,
      "path": "Extension.extension.value[x]",
      "type": [ {
        "code": "code"
      } ],
      "binding": {
        "strength": "required",
        "valueSet": "https://fhir.bfarm.de/ValueSet/HealthAppRegulatoryBasis"
      },
      "mustSupport": true
    }, {
      "id": "Extension.extension:riskClass",
      "max": "1",
      "min": 0,
      "path": "Extension.extension",
      "short": "Risikoklasse",
      "sliceName": "riskClass",
      "definition": "Die Angabe der Risikoklasse.",
      "mustSupport": true
    }, {
      "id": "Extension.extension:riskClass.url",
      "path": "Extension.extension.url",
      "fixedUri": "riskClass"
    }, {
      "id": "Extension.extension:riskClass.value[x]",
      "min": 1,
      "path": "Extension.extension.value[x]",
      "type": [ {
        "code": "code"
      } ],
      "binding": {
        "strength": "required",
        "valueSet": "https://fhir.bfarm.de/ValueSet/HealthAppRiskClass"
      },
      "mustSupport": true
    }, {
      "id": "Extension.url",
      "path": "Extension.url",
      "fixedUri": "https://fhir.bfarm.de/StructureDefinition/HealthAppModuleMedicalDevice"
    }, {
      "id": "Extension.value[x]",
      "max": "0",
      "path": "Extension.value[x]"
    } ]
  },
  "baseDefinition": "http://hl7.org/fhir/StructureDefinition/Extension"
}