Specification of health data transfer from devices to DiGA (§ 374a SGB V)
<Bundle xmlns="http://hl7.org/fhir">
<id value="example-cgm-summary-bundle"/>
<meta>
<profile
value="https://gematik.de/fhir/hddt/StructureDefinition/hddt-cgm-summary"/>
</meta>
<type value="collection"/>
<timestamp value="2025-10-01T09:15:00Z"/>
<entry>
<fullUrl
value="https://gematik.de/fhir/hddt/Observation/cgmSummaryExample"/>
<resource>
<Observation>
<id value="cgmSummaryExample"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/cgm/StructureDefinition/cgm-summary"/>
</meta>
<status value="final"/>
<category>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/observation-category"/>
<code value="laboratory"/>
</coding>
</category>
<code>
<coding>
<system value="http://loinc.org"/>
<code value="107931-8"/>
</coding>
</code>
<subject>🔗
<reference value="Patient/patientExample"/>
</subject>
<effectivePeriod>
<start value="2025-09-01"/>
<end value="2025-09-30"/>
</effectivePeriod>
<hasMember>🔗
<reference
value="Observation/cgmSummaryMeanGlucoseMassPerVolumeExample"/>
</hasMember>
<hasMember>🔗
<reference value="Observation/cgmSummaryTimesInRangesExample"/>
</hasMember>
<hasMember>🔗
<reference value="Observation/cgmSummaryGMIExample"/>
</hasMember>
<hasMember>🔗
<reference
value="Observation/cgmSummaryCoefficientOfVariationExample"/>
</hasMember>
<hasMember>🔗
<reference value="Observation/cgmSummaryDaysOfWearExample"/>
</hasMember>
<hasMember>🔗
<reference
value="Observation/cgmSummarySensorActivePercentageExample"/>
</hasMember>
</Observation>
</resource>
</entry>
<entry>
<fullUrl
value="https://gematik.de/fhir/hddt/Observation/cgmSummaryMeanGlucoseMassPerVolumeExample"/>
<resource>
<Observation>
<id value="cgmSummaryMeanGlucoseMassPerVolumeExample"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/cgm/StructureDefinition/cgm-summary-mean-glucose-mass-per-volume"/>
</meta>
<status value="final"/>
<category>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/observation-category"/>
<code value="laboratory"/>
</coding>
</category>
<code>
<coding>
<system value="http://loinc.org"/>
<code value="97507-8"/>
</coding>
</code>
<subject>🔗
<reference value="Patient/patientExample"/>
</subject>
<effectivePeriod>
<start value="2025-09-01"/>
<end value="2025-09-30"/>
</effectivePeriod>
<valueQuantity>
<value value="145"/>
<unit value="mg/dl"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg/dL"/>
</valueQuantity>
</Observation>
</resource>
</entry>
<entry>
<fullUrl
value="https://gematik.de/fhir/hddt/Observation/cgmSummaryMeanGlucoseMolesPerVolumeExample"/>
<resource>
<Observation>
<id value="cgmSummaryMeanGlucoseMolesPerVolumeExample"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/cgm/StructureDefinition/cgm-summary-mean-glucose-moles-per-volume"/>
</meta>
<status value="final"/>
<category>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/observation-category"/>
<code value="laboratory"/>
</coding>
</category>
<code>
<coding>
<system value="http://loinc.org"/>
<code value="105273-7"/>
</coding>
</code>
<subject>🔗
<reference value="Patient/patientExample"/>
</subject>
<effectivePeriod>
<start value="2025-09-01"/>
<end value="2025-09-30"/>
</effectivePeriod>
<valueQuantity>
<value value="8.1"/>
<unit value="mmol/l"/>
<system value="http://unitsofmeasure.org"/>
<code value="mmol/L"/>
</valueQuantity>
</Observation>
</resource>
</entry>
<entry>
<fullUrl
value="https://gematik.de/fhir/hddt/Observation/cgmSummaryTimesInRangesExample"/>
<resource>
<Observation>
<id value="cgmSummaryTimesInRangesExample"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/cgm/StructureDefinition/cgm-summary-times-in-ranges"/>
</meta>
<status value="final"/>
<category>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/observation-category"/>
<code value="laboratory"/>
</coding>
</category>
<code>
<coding>
<system value="http://loinc.org"/>
<code value="106793-3"/>
</coding>
</code>
<subject>🔗
<reference value="Patient/patientExample"/>
</subject>
<effectivePeriod>
<start value="2025-09-01"/>
<end value="2025-09-30"/>
</effectivePeriod>
<component>
<code>
<coding>
<system value="http://loinc.org"/>
<code value="104642-4"/>
</coding>
</code>
<valueQuantity>
<value value="3"/>
<unit value="%"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
</component>
<component>
<code>
<coding>
<system value="http://loinc.org"/>
<code value="104641-6"/>
</coding>
</code>
<valueQuantity>
<value value="8"/>
<unit value="%"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
</component>
<component>
<code>
<coding>
<system value="http://loinc.org"/>
<code value="97510-2"/>
</coding>
</code>
<valueQuantity>
<value value="65"/>
<unit value="%"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
</component>
<component>
<code>
<coding>
<system value="http://loinc.org"/>
<code value="104640-8"/>
</coding>
</code>
<valueQuantity>
<value value="20"/>
<unit value="%"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
</component>
<component>
<code>
<coding>
<system value="http://loinc.org"/>
<code value="104639-0"/>
</coding>
</code>
<valueQuantity>
<value value="4"/>
<unit value="%"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
</component>
</Observation>
</resource>
</entry>
<entry>
<fullUrl
value="https://gematik.de/fhir/hddt/Observation/cgmSummaryGMIExample"/>
<resource>
<Observation>
<id value="cgmSummaryGMIExample"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/cgm/StructureDefinition/cgm-summary-gmi"/>
</meta>
<status value="final"/>
<category>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/observation-category"/>
<code value="laboratory"/>
</coding>
</category>
<code>
<coding>
<system value="http://loinc.org"/>
<code value="97506-0"/>
</coding>
</code>
<subject>🔗
<reference value="Patient/patientExample"/>
</subject>
<effectivePeriod>
<start value="2025-09-01"/>
<end value="2025-09-30"/>
</effectivePeriod>
<valueQuantity>
<value value="6.8"/>
<unit value="%"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
</Observation>
</resource>
</entry>
<entry>
<fullUrl
value="https://gematik.de/fhir/hddt/Observation/cgmSummaryCoefficientOfVariationExample"/>
<resource>
<Observation>
<id value="cgmSummaryCoefficientOfVariationExample"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/cgm/StructureDefinition/cgm-summary-coefficient-of-variation"/>
</meta>
<status value="final"/>
<category>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/observation-category"/>
<code value="laboratory"/>
</coding>
</category>
<code>
<coding>
<system value="http://loinc.org"/>
<code value="104638-2"/>
</coding>
</code>
<subject>🔗
<reference value="Patient/patientExample"/>
</subject>
<effectivePeriod>
<start value="2025-09-01"/>
<end value="2025-09-30"/>
</effectivePeriod>
<valueQuantity>
<value value="34"/>
<unit value="%"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
</Observation>
</resource>
</entry>
<entry>
<fullUrl
value="https://gematik.de/fhir/hddt/Observation/cgmSummaryDaysOfWearExample"/>
<resource>
<Observation>
<id value="cgmSummaryDaysOfWearExample"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/cgm/StructureDefinition/cgm-summary-days-of-wear"/>
</meta>
<status value="final"/>
<category>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/observation-category"/>
<code value="laboratory"/>
</coding>
</category>
<code>
<coding>
<system value="http://loinc.org"/>
<code value="104636-6"/>
</coding>
</code>
<subject>🔗
<reference value="Patient/patientExample"/>
</subject>
<effectivePeriod>
<start value="2025-09-01"/>
<end value="2025-09-30"/>
</effectivePeriod>
<valueQuantity>
<value value="28"/>
<unit value="days"/>
<system value="http://unitsofmeasure.org"/>
<code value="d"/>
</valueQuantity>
</Observation>
</resource>
</entry>
<entry>
<fullUrl
value="https://gematik.de/fhir/hddt/Observation/cgmSummarySensorActivePercentageExample"/>
<resource>
<Observation>
<id value="cgmSummarySensorActivePercentageExample"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/cgm/StructureDefinition/cgm-summary-sensor-active-percentage"/>
</meta>
<status value="final"/>
<category>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/observation-category"/>
<code value="laboratory"/>
</coding>
</category>
<code>
<coding>
<system value="http://loinc.org"/>
<code value="104637-4"/>
</coding>
</code>
<subject>🔗
<reference value="Patient/patientExample"/>
</subject>
<effectivePeriod>
<start value="2025-09-01"/>
<end value="2025-09-30"/>
</effectivePeriod>
<valueQuantity>
<value value="95"/>
<unit value="%"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</valueQuantity>
</Observation>
</resource>
</entry>
<entry>
<fullUrl value="https://gematik.de/fhir/hddt/Device/example-device-cgm"/>
<resource>
<Device>
<id value="example-device-cgm"/>
<definition>🔗
<reference value="DeviceDefinition/device-definition-cgm-001"/>
</definition>
<status value="active"/>
<manufacturer value="Glukko Inc."/>
<expirationDate value="2025-09-10"/>
<serialNumber value="CGM1234567890"/>
<deviceName>
<name value="GlukkoCGM 18"/>
<type value="user-friendly-name"/>
</deviceName>
<modelNumber value="GCGMA98765"/>
<type>
<coding>
<system value="urn:iso:std:iso:11073:10101"/>
<version value="20250520"/>
<code value="528409"/>
<display value="MDC_DEV_SPEC_PROFILE_CGM"/>
</coding>
</type>
</Device>
</resource>
</entry>
</Bundle>