Implementation Guide
Health Device Data Transfer
Version 0.1.0 - ballot

Specification of health data transfer from devices to DiGA (§ 374a SGB V)

: HL7 CGM Summary: Example Bundle - XML Representation

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<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>