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 - JSON Representation

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