Endpoint Device

This document describes the syntax and semantics of querying FHIR Device resources via the standard FHIR RESTful API. A Device resources represent individual Personal Health Devices (medical aids and implants) of a patient, such as glucometers, CGM sensors, and pace makers.

To be compliant with § 374a SGB V, a Device Data Recorder MUST implement interactions for reading and searching Device resources:

• reading individual Device resources that are referenced by Observation or DeviceMetric resources,
• version specific reading individual Device resources that are referenced by Observation or DeviceMetric resources. This interaction MAY be omitted by a Device Data Recorder if it does not support versioning of Device resources (see Retrieving Data for a discussion on how to implement versioning of Device resources).
• searching for Device resources linked with the current patient and an authorised MIV

Returned resources MUST conform to the HDDT Personal Health Device Device profile.

Endpoints

Device - READ

Device - VREAD

Remark: A Device Data Recorder MAY omit the version specific read interaction if it does not support versioning of Device resources (see Retrieving Data for a discussion on how to express changes of device properties).

Device - SEARCH

Profile - HDDT Personal Health Device

Profile: Device – Personal Health Device

This structure is derived from Device

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Device		0..*	Device	Personal Health Device
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
definition		1..1	Reference(DeviceDefinition)	Definition of the Personal health device
status	?!SΣ	0..1	code	active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device.
expirationDate	S	0..1	dateTime	Date and time of expiry of this Personal health device (if applicable)
serialNumber	S	0..1	string	Serial number of the Personal health device
deviceName	S	0..*	BackboneElement	Name of the Personal health device
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
name		1..1	string	The name of the device
type		1..1	code	udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other Binding: DeviceNameType (required): The type of name the device is referred by.
type		0..1	CodeableConcept	The machine-readable type of the Personal health device Binding: Device Type of personal health devices (required)
Documentation for this format

Example: Glucometer

In this example the patient uses a glucometer that is connected to the Device Data Recorder via Bluetooth. The glucometer is used to perform blood glucose measurements that are stored as Observation resources in the Device Data Recorder. Each Observation references the Device resource that represents the glucometer (either directly or through a DeviceMetric resource).

The glucometer used in this example is the product GlukkCheck plus mg/dl from Glukko Inc.. The glucometer performs “bloody” measurements from capillary blood. The vendor-defined model number of this type of devices is CGPA987654 and the serial number of the patient’s individual device is SN123456. Both identifiers are printed on the back of the device and allow the patient to validate the authenticity of this Personal Health Device resource.

Remarks:

• As glucometers do not expire (that is just the case for the test stripes), the expirationDate is not set, even though this element is set to Must Support in the profile.
• The text element is omitted in this example to keep the example small. Nevertheless, as all HDDT resources are intended for sole machine processing, the text element MAY be omitted.

Device - READ

Request: GET /Device/example-glucometer

Response:

{
  "resourceType" : "Device",
  "id" : "example-glucometer",
  "meta" : {
    "profile" : [
      🔗 "https://gematik.de/fhir/hddt/StructureDefinition/hddt-personal-health-device"
    ]
  },
  "definition" : {
    🔗 "reference" : "DeviceDefinition/example-glucometer-def"
  },
  "status" : "active",
  "manufacturer" : "Glukko Inc.",
  "serialNumber" : "SN123456",
  "deviceName" : [
    {
      "name" : "GlukkoCheck plus mg/dL",
      "type" : "user-friendly-name"
    }
  ],
  "modelNumber" : "CGPA987654",
  "type" : {
    "coding" : [
      {
        "system" : "urn:iso:std:iso:11073:10101",
        "version" : "20250520",
        "code" : "528401",
        "display" : "Glucose Monitor"
      }
    ]
  }
}

Device - SEARCH

Request: GET /Device

Response:

{
    "resourceType": "Bundle",
    "type": "searchset",
    "entry": [
        {
            "fullUrl": "https://example.com/fhir/Device/example-glucometer",
            "resource": {
                "resourceType": "Device",
                "id": "example-glucometer",
                "meta": {
                    "profile": [
                        "https://gematik.de/fhir/hddt/StructureDefinition/hddt-personal-health-device"
                    ]
                },
                "type": {
                    "coding": [
                        {
                            "code": "528401",
                            "system": "urn:iso:std:iso:11073:10101",
                            "version": "20250520",
                            "display": "Glucose Monitor"
                        }
                    ]
                },
                "status": "active",
                "deviceName": [
                    {
                        "name": "GlukkoCheck plus mg/dL",
                        "type": "user-friendly-name"
                    }
                ],
                "manufacturer": "Glukko Inc.",
                "serialNumber": "SN123456",
                "modelNumber": "CGPA987654",
                "definition": {
                    "reference": "DeviceDefinition/example-glucometer-def"
                }
            },
            "search": {
                "mode": "match"
            }
        }
    ]
}

Example: rtCGM Sensor

This example describes a real-time Continuous Glucose Monitoring sensor (rtCGM) as a personal health device.

The example sensor is the product GlukkoCGM 18 from Glukko Inc. that performs continuous glucose measurements from interstitial fluid. The sensor in the example will stop transmitting data on September 10, 2025, and MUST be replaced by the patient at that date. The vendor-defined model number of this type of devices is GCGMA98765 and the serial number of the patient’s individual device is CGM1234567890. Both identifiers are printed on the package of the device and allow the patient to validate the authenticity of this Personal Health Device resource.

Remarks:

• The text element is omitted in this example to keep the example small. Nevertheless, as all HDDT resources are intended for sole machine processing, the text element MAY be omitted.

Instance of the HDDT Personal Health Device profile

{
  "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"
      }
    ]
  }
}