{
  "description": null,
  "_filename": "Extension-HealthAppMedicalDevice.json",
  "package_name": "fhir.trustedhealthapps.org",
  "date": null,
  "derivation": "constraint",
  "publisher": null,
  "fhirVersion": "4.0.1",
  "name": "HealthAppMedicalDevice",
  "mapping": [ {
    "uri": "http://hl7.org/v3",
    "name": "RIM Mapping",
    "identity": "rim"
  } ],
  "abstract": false,
  "type": "Extension",
  "experimental": null,
  "resourceType": "StructureDefinition",
  "title": "MedicalDevice on HealthApp",
  "package_version": "1.1.0",
  "status": "active",
  "id": "4d0d48af-b112-4fc2-8704-626ded239c01",
  "kind": "complex-type",
  "url": "https://fhir.trustedhealthapps.org/StructureDefinition/HealthAppMedicalDevice",
  "context": [ {
    "type": "element",
    "expression": "DeviceDefinition"
  } ],
  "version": "1.1.0",
  "differential": {
    "element": [ {
      "id": "Extension",
      "max": "1",
      "path": "Extension",
      "short": "Medizinprodukt",
      "definition": "Angaben zum Medizinprodukt",
      "mustSupport": true
    }, {
      "id": "Extension.extension",
      "path": "Extension.extension",
      "slicing": {
        "rules": "open",
        "discriminator": [ {
          "path": "url",
          "type": "value"
        } ]
      }
    }, {
      "id": "Extension.extension:ce",
      "max": "1",
      "path": "Extension.extension",
      "short": "CE-Kennzeichnung",
      "sliceName": "ce",
      "definition": "Angaben zur CE-Kennzeichnung",
      "mustSupport": true
    }, {
      "id": "Extension.extension:ce.extension",
      "path": "Extension.extension.extension",
      "slicing": {
        "rules": "open",
        "discriminator": [ {
          "path": "url",
          "type": "value"
        } ]
      }
    }, {
      "id": "Extension.extension:ce.extension:attachment",
      "max": "1",
      "path": "Extension.extension.extension",
      "short": "Anhang",
      "sliceName": "attachment",
      "definition": "Angehangene CE-Kennzeichnung",
      "mustSupport": true
    }, {
      "id": "Extension.extension:ce.extension:attachment.url",
      "path": "Extension.extension.extension.url",
      "fixedUri": "attachment"
    }, {
      "id": "Extension.extension:ce.extension:attachment.value[x]",
      "min": 1,
      "path": "Extension.extension.extension.value[x]",
      "type": [ {
        "code": "Attachment",
        "profile": [ "https://fhir.trustedhealthapps.org/StructureDefinition/AttachmentHealthApp" ]
      } ],
      "mustSupport": true
    }, {
      "id": "Extension.extension:ce.extension:url",
      "max": "1",
      "path": "Extension.extension.extension",
      "short": "URL",
      "sliceName": "url",
      "definition": "URL zur CE-Kennzeichnung",
      "mustSupport": true
    }, {
      "id": "Extension.extension:ce.extension:url.url",
      "path": "Extension.extension.extension.url",
      "fixedUri": "url"
    }, {
      "id": "Extension.extension:ce.extension:url.value[x]",
      "min": 1,
      "path": "Extension.extension.extension.value[x]",
      "type": [ {
        "code": "url"
      } ],
      "mustSupport": true
    }, {
      "id": "Extension.extension:ce.extension:status",
      "max": "1",
      "path": "Extension.extension.extension",
      "short": "Status der CE-Kennzeichnung",
      "sliceName": "status",
      "definition": "+ available: Vorhanden\r\n+ intended: Angestrebt\r\n+ unavailable: Nicht vorhanden\r\n+ unknown: Unbekannt",
      "mustSupport": true
    }, {
      "id": "Extension.extension:ce.extension:status.url",
      "path": "Extension.extension.extension.url",
      "fixedUri": "status"
    }, {
      "id": "Extension.extension:ce.extension:status.value[x]",
      "min": 1,
      "path": "Extension.extension.extension.value[x]",
      "type": [ {
        "code": "code"
      } ],
      "binding": {
        "strength": "required",
        "valueSet": "https://fhir.trustedhealthapps.org/ValueSet/HealthAppCeStatus"
      },
      "mustSupport": true
    }, {
      "id": "Extension.extension:ce.url",
      "path": "Extension.extension.url",
      "fixedUri": "ce"
    }, {
      "id": "Extension.extension:ce.value[x]",
      "max": "0",
      "path": "Extension.extension.value[x]"
    }, {
      "id": "Extension.extension:intendedPurpose",
      "max": "1",
      "path": "Extension.extension",
      "short": "Medizinische Zweckbestimmung",
      "sliceName": "intendedPurpose",
      "definition": "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:notifiedBody",
      "max": "1",
      "path": "Extension.extension",
      "short": "Benannte Stelle",
      "sliceName": "notifiedBody",
      "definition": "Angaben zur benannten Stelle.",
      "mustSupport": true
    }, {
      "id": "Extension.extension:notifiedBody.extension",
      "path": "Extension.extension.extension",
      "slicing": {
        "rules": "open",
        "discriminator": [ {
          "path": "url",
          "type": "value"
        } ]
      }
    }, {
      "id": "Extension.extension:notifiedBody.extension:code",
      "max": "1",
      "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",
      "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:regulatoryBasis",
      "max": "1",
      "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.trustedhealthapps.org/ValueSet/HealthAppRegulatoryBasis"
      },
      "mustSupport": true
    }, {
      "id": "Extension.extension:riskClass",
      "max": "1",
      "path": "Extension.extension",
      "short": "Risikoklasse",
      "sliceName": "riskClass",
      "definition": "+ unknown: Unbekannt\r\n+ 1: Risikoklasse 1\r\n+ 2a: Risikoklasse IIa\r\n+ 2b: Risikoklasse IIb\r\n+ 3: Risikoklasse III",
      "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.trustedhealthapps.org/ValueSet/HealthAppRiskClass"
      },
      "mustSupport": true
    }, {
      "id": "Extension.url",
      "path": "Extension.url",
      "fixedUri": "https://fhir.trustedhealthapps.org/StructureDefinition/HealthAppMedicalDevice"
    }, {
      "id": "Extension.value[x]",
      "max": "0",
      "path": "Extension.value[x]"
    } ]
  },
  "baseDefinition": "http://hl7.org/fhir/StructureDefinition/Extension"
}