Implementation Guide
Health Device Data Transfer
Version 0.1.0 - ballot

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

Example Bundle: HL7 CGM Summary: Example Bundle

Bundle example-cgm-summary-bundle of type collection


Entry 1 - fullUrl = https://gematik.de/fhir/hddt/Observation/cgmSummaryExample

Resource Observation:

status: Final

category: Laboratory

code: Continuous glucose monitoring summary panel - Reporting Period

subject: Anonymous Patient (no stated gender), DoB Unknown

effective: 2025-09-01 --> 2025-09-30

hasMember:


Entry 2 - fullUrl = https://gematik.de/fhir/hddt/Observation/cgmSummaryMeanGlucoseMassPerVolumeExample

Resource Observation:

status: Final

category: Laboratory

code: Average glucose [Mass/volume] in Interstitial fluid during Reporting Period

subject: Anonymous Patient (no stated gender), DoB Unknown

effective: 2025-09-01 --> 2025-09-30

value: 145 mg/dl (Details: UCUM codemg/dL = 'mg/dL')


Entry 3 - fullUrl = https://gematik.de/fhir/hddt/Observation/cgmSummaryMeanGlucoseMolesPerVolumeExample

Resource Observation:

status: Final

category: Laboratory

code: Glucose [Moles/volume] in Reporting Period mean Interstitial fluid by calculation

subject: Anonymous Patient (no stated gender), DoB Unknown

effective: 2025-09-01 --> 2025-09-30

value: 8.1 mmol/l (Details: UCUM codemmol/L = 'mmol/L')


Entry 4 - fullUrl = https://gematik.de/fhir/hddt/Observation/cgmSummaryTimesInRangesExample

Resource Observation:

status: Final

category: Laboratory

code: Continuous glucose monitoring time in ranges panel

subject: Anonymous Patient (no stated gender), DoB Unknown

effective: 2025-09-01 --> 2025-09-30

component

code: Time below range, very low in Reporting Period Interstitial fluid by calculation

value: 3 % (Details: UCUM code% = '%')

component

code: Time below range, low in Reporting Period Interstitial fluid by calculation

value: 8 % (Details: UCUM code% = '%')

component

code: Glucose measurements in range out of Total glucose measurements during reporting period

value: 65 % (Details: UCUM code% = '%')

component

code: Time above range, high in Reporting Period Interstitial fluid by calculation

value: 20 % (Details: UCUM code% = '%')

component

code: Time above range, very high in Reporting Period Interstitial fluid by calculation

value: 4 % (Details: UCUM code% = '%')


Entry 5 - fullUrl = https://gematik.de/fhir/hddt/Observation/cgmSummaryGMIExample

Resource Observation:

status: Final

category: Laboratory

code: Glucose management indicator

subject: Anonymous Patient (no stated gender), DoB Unknown

effective: 2025-09-01 --> 2025-09-30

value: 6.8 % (Details: UCUM code% = '%')


Entry 6 - fullUrl = https://gematik.de/fhir/hddt/Observation/cgmSummaryCoefficientOfVariationExample

Resource Observation:

status: Final

category: Laboratory

code: Glucose standard deviation/Glucose mean in Reporting Period Interstitial fluid by calculation

subject: Anonymous Patient (no stated gender), DoB Unknown

effective: 2025-09-01 --> 2025-09-30

value: 34 % (Details: UCUM code% = '%')


Entry 7 - fullUrl = https://gematik.de/fhir/hddt/Observation/cgmSummaryDaysOfWearExample

Resource Observation:

Profile: Days of Wear

status: Final

category: Laboratory

code: Days continuous glucose monitor device worn [#] Reporting Period Estimated

subject: Anonymous Patient (no stated gender), DoB Unknown

effective: 2025-09-01 --> 2025-09-30

value: 28 days (Details: UCUM coded = 'd')


Entry 8 - fullUrl = https://gematik.de/fhir/hddt/Observation/cgmSummarySensorActivePercentageExample

Resource Observation:

status: Final

category: Laboratory

code: Percentage of time continuous glucose monitor device worn Reporting Period Calculated

subject: Anonymous Patient (no stated gender), DoB Unknown

effective: 2025-09-01 --> 2025-09-30

value: 95 % (Details: UCUM code% = '%')


Entry 9 - fullUrl = https://gematik.de/fhir/hddt/Device/example-device-cgm

Resource Device:

definition: No display for Device.definition (reference: ->DeviceDefinition: identifier = https://hilfsmittelverzeichnis.de#30.29.05.2004; manufacturer[x] = rtCGM Manufacturer Inc.; modelNumber = CGM Model mg/dL; type = Point-of-care blood glucose continuous monitoring system (physical object))

status: Active

manufacturer: Glukko Inc.

expirationDate: 2025-09-10

serialNumber: CGM1234567890

modelNumber: GCGMA98765

type: MDC_DEV_SPEC_PROFILE_CGM