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