<status value="active" /> <description value="Extension for information about the medical device." /> <fhirVersion value="4.0.1" /> <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="Medical device" /> <definition value="Information about the medical device." /> <mustSupport value="true" /> </element> <element id="Extension.extension"> <path value="Extension.extension" /> <mustSupport value="true" /> </element> <element id="Extension.extension:intendedPurpose"> <path value="Extension.extension" /> <sliceName value="intendedPurpose" /> <short value="Intended purpose" /> <definition value="The (medical) intended purpose according to the manufacturer's information on labeling, instructions for use, advertising material, sales material, or sales information." /> <min value="0" /> <max value="1" /> <mustSupport value="true" /> </element> <element id="Extension.extension:intendedPurpose.extension"> <path value="Extension.extension.extension" /> <max value="0" /> </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]" /> <slicing> <discriminator> <type value="type" /> <path value="$this" /> </discriminator> <ordered value="false" /> <rules value="open" /> </slicing> <min value="1" /> </element> <element id="Extension.extension:intendedPurpose.value[x]:valueString"> <path value="Extension.extension.value[x]" /> <sliceName value="valueString" /> <min value="1" /> <max value="1" /> <type> <code value="string" /> </type> <mustSupport value="true" /> </element> <element id="Extension.extension:isMedicalDevice"> <path value="Extension.extension" /> <sliceName value="isMedicalDevice" /> <short value="Medical device" /> <definition value="Indicates whether the digital application module is a medical device." /> <min value="0" /> <max value="1" /> <mustSupport value="true" /> </element> <element id="Extension.extension:isMedicalDevice.extension"> <path value="Extension.extension.extension" /> <max value="0" /> </element> <element id="Extension.extension:isMedicalDevice.url"> <path value="Extension.extension.url" /> <fixedUri value="isMedicalDevice" /> </element> <element id="Extension.extension:isMedicalDevice.value[x]"> <path value="Extension.extension.value[x]" /> <slicing> <discriminator> <type value="type" /> <path value="$this" /> </discriminator> <ordered value="false" /> <rules value="open" /> </slicing> <min value="1" /> </element> <element id="Extension.extension:isMedicalDevice.value[x]:valueBoolean"> <path value="Extension.extension.value[x]" /> <sliceName value="valueBoolean" /> <min value="1" /> <max value="1" /> <type> <code value="boolean" /> </type> <mustSupport value="true" /> </element> <element id="Extension.extension:notifiedBody"> <path value="Extension.extension" /> <sliceName value="notifiedBody" /> <short value="Notified body" /> <definition value="Information about the notified body." /> <min value="0" /> <max value="1" /> <mustSupport value="true" /> </element> <element id="Extension.extension:notifiedBody.extension"> <path value="Extension.extension.extension" /> <mustSupport value="true" /> </element> <element id="Extension.extension:notifiedBody.extension:code"> <path value="Extension.extension.extension" /> <sliceName value="code" /> <short value="Identification number" /> <definition value="Identification number of the notified body." /> <min value="0" /> <max value="1" /> <mustSupport value="true" /> </element> <element id="Extension.extension:notifiedBody.extension:code.extension"> <path value="Extension.extension.extension.extension" /> <max value="0" /> </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]" /> <slicing> <discriminator> <type value="type" /> <path value="$this" /> </discriminator> <ordered value="false" /> <rules value="open" /> </slicing> <min value="1" /> </element> <element id="Extension.extension:notifiedBody.extension:code.value[x]:valueString"> <path value="Extension.extension.extension.value[x]" /> <sliceName value="valueString" /> <min value="1" /> <max value="1" /> <type> <code value="string" /> </type> <mustSupport value="true" /> </element> <element id="Extension.extension:notifiedBody.extension:name"> <path value="Extension.extension.extension" /> <sliceName value="name" /> <short value="Name" /> <definition value="Name of the notified body." /> <min value="0" /> <max value="1" /> <mustSupport value="true" /> </element> <element id="Extension.extension:notifiedBody.extension:name.extension"> <path value="Extension.extension.extension.extension" /> <max value="0" /> </element> <element id="Extension.extension:notifiedBody.extension:name.url"> <path value="Extension.extension.extension.url" /> <fixedUri value="name" /> </element> <element id="Extension.extension:notifiedBody.extension:name.value[x]"> <path value="Extension.extension.extension.value[x]" /> <slicing> <discriminator> <type value="type" /> <path value="$this" /> </discriminator> <ordered value="false" /> <rules value="open" /> </slicing> <min value="1" /> </element> <element id="Extension.extension:notifiedBody.extension:name.value[x]:valueString"> <path value="Extension.extension.extension.value[x]" /> <sliceName value="valueString" /> <min value="1" /> <max 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="Nursing benefit" /> <definition value="DiPA only: Description of the nursing benefit according to § 9 DiPAV." /> <min value="0" /> <max value="1" /> <mustSupport value="true" /> </element> <element id="Extension.extension:nursingBenefit.extension"> <path value="Extension.extension.extension" /> <max value="0" /> </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]" /> <slicing> <discriminator> <type value="type" /> <path value="$this" /> </discriminator> <ordered value="false" /> <rules value="open" /> </slicing> <min value="1" /> </element> <element id="Extension.extension:nursingBenefit.value[x]:valueString"> <path value="Extension.extension.value[x]" /> <sliceName value="valueString" /> <min value="1" /> <max value="1" /> <type> <code value="string" /> </type> <mustSupport value="true" /> </element> <element id="Extension.extension:regulatoryBasis"> <path value="Extension.extension" /> <sliceName value="regulatoryBasis" /> <short value="Regulatory basis" /> <definition value="Specifies the regulatory basis." /> <min value="0" /> <max value="1" /> <mustSupport value="true" /> </element> <element id="Extension.extension:regulatoryBasis.extension"> <path value="Extension.extension.extension" /> <max value="0" /> </element> <element id="Extension.extension:regulatoryBasis.url"> <path value="Extension.extension.url" /> <fixedUri value="regulatoryBasis" /> </element> <element id="Extension.extension:regulatoryBasis.value[x]"> <path value="Extension.extension.value[x]" /> <slicing> <discriminator> <type value="type" /> <path value="$this" /> </discriminator> <ordered value="false" /> <rules value="open" /> </slicing> <min value="1" /> </element> <element id="Extension.extension:regulatoryBasis.value[x]:valueCode"> <path value="Extension.extension.value[x]" /> <sliceName value="valueCode" /> <min value="1" /> <max 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="Risk class" /> <definition value="Specifies the risk class." /> <min value="0" /> <max value="1" /> <mustSupport value="true" /> </element> <element id="Extension.extension:riskClass.extension"> <path value="Extension.extension.extension" /> <max value="0" /> </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]" /> <slicing> <discriminator> <type value="type" /> <path value="$this" /> </discriminator> <ordered value="false" /> <rules value="open" /> </slicing> <min value="1" /> </element> <element id="Extension.extension:riskClass.value[x]:valueCode"> <path value="Extension.extension.value[x]" /> <sliceName value="valueCode" /> <min value="1" /> <max 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>