Implementation Guide
Health Device Data Transfer
Version 0.1.0 - ballot

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

Resource Profile: Device – Personal Health Device

Official URL: https://gematik.de/fhir/hddt/StructureDefinition/hddt-personal-health-device Version: 0.1.0
Draft as of 2025-10-27 Computable Name: HddtPersonalHealthDevice

Copyright/Legal: Copyright (c) 2025 gematik GmbH

This profile defines a Personal Health Device within the context of § 374a SGB V. A Personal Health Device acc. to this profile is any medical aid or implant that

  • is distributed to patients at the expense of the statutory health insurance and
  • transmits the data about the patient electronically to the device manufacturer or third parties, which make the data available to patients and/or physicians via publicly accessible networks.

Personal Health Devices that fulfill the criteria of this regulation MUST be able to pass on data to authorized Digital Health Applications (DiGA acc. § 374a SGB V) using the protocols and interfaces as defined in the HDDT specification.

This profile helps a device data consuming DiGA to

  • increase patient safety by comparing the serial number of a Personal Health Device as presented with this profile with the serial number the patient may have provided to the DiGA
  • increase data quality by getting information about the current status of the end-to-end communication flow from the Personal Health Device to the device backend and thus being able to detect if there may be more data available for the requested period
  • optimize its interactions with the device data providing resource server by getting access to the DeviceDefinition resource that holds static attributes about the device and its connected backend (e.g. minimum delay between data measurement and data availability)

Obligations and Conventions:

The Personal Health Device’s backend regularely synchronizes with the device hardware through a gateway (Personal Health Gateway). The maximum delay that the concrete end-to-end synchronization from the Personal Health Device to the FHIR resource server imposes is provided by the BfArM HIIS-VZ (Device Registry) through the static attribute Delay-From-Real-Time. If a resource server has not synchronized with the connected Personal Health Device for a time span longer than Delay-From-Real-Time(e.g. due to temporarely lost Bluetooth or internet connectivity), the status of the Device resource that represents the Personal Health Device MUST be set to unknown.

Constraints applied:

  • status is set to Must Support in order to allow a DiGA to detect missing data (e.g. due to connection issues)
  • deviceName and serialNumber are set to Must Support to allow a validation of the source of device data by comparing this information with information printed on the Personal Health Device
  • definition is constrained as a mandatory element in order to enable a DiGA to obtain static device attributes through this reference
  • expirationDate is set to Must Support to allow a DiGA to be aware of regular sensor changes (e.g. for patient wearing a rtCGM)

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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
... 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)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Device.status Base required FHIRDeviceStatus 📍4.0.1 FHIR Std.
Device.deviceName.type Base required DeviceNameType 📍4.0.1 FHIR Std.
Device.type Base required Device Type of personal health devices 📦0.1.0 This IG

Constraints

Id Grade Path(s) Description Expression
dom-2 error Device If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Device If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error Device If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error Device If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Device A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

This structure is derived from Device

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device 0..* Device Personal Health Device
... definition 1..1 Reference(DeviceDefinition) Definition of the Personal health device
... status S 0..1 code active | inactive | entered-in-error | unknown
... expirationDate S 0..1 dateTime Date and time of expiry of this Personal health device (if applicable)
... deviceName S 0..* BackboneElement Name of the Personal health device
... type 0..1 CodeableConcept The machine-readable type of the Personal health device
Binding: Device Type of personal health devices (required)

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Device.type Base required Device Type of personal health devices 📦0.1.0 This IG
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device 0..* Device Personal Health Device
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.
Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier 0..* Identifier Instance identifier
... definition 1..1 Reference(DeviceDefinition) Definition of the Personal health device
... udiCarrier Σ 0..* BackboneElement Unique Device Identifier (UDI) Barcode string
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... deviceIdentifier Σ 0..1 string Mandatory fixed portion of UDI
.... issuer 0..1 uri UDI Issuing Organization
.... jurisdiction 0..1 uri Regional UDI authority
.... carrierAIDC Σ 0..1 base64Binary UDI Machine Readable Barcode String
.... carrierHRF Σ 0..1 string UDI Human Readable Barcode String
.... entryType 0..1 code barcode | rfid | manual +
Binding: UDIEntryType (required): Codes to identify how UDI data was entered.
... status ?!SΣ 0..1 code active | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required): The availability status of the device.
... statusReason 0..* CodeableConcept online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device.
... distinctIdentifier 0..1 string The distinct identification string
... manufacturer 0..1 string Name of device manufacturer
... manufactureDate 0..1 dateTime Date when the device was made
... expirationDate S 0..1 dateTime Date and time of expiry of this Personal health device (if applicable)
... lotNumber 0..1 string Lot number of manufacture
... serialNumber S 0..1 string Serial number of the Personal health device
... deviceName S 0..* BackboneElement Name of the Personal health device
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... 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.
... modelNumber 0..1 string The model number for the device
... partNumber 0..1 string The part number of the device
... type 0..1 CodeableConcept The machine-readable type of the Personal health device
Binding: Device Type of personal health devices (required)
... specialization 0..* BackboneElement The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... systemType 1..1 CodeableConcept The standard that is used to operate and communicate
.... version 0..1 string The version of the standard that is used to operate and communicate
... version 0..* BackboneElement The actual design of the device or software version running on the device
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type 0..1 CodeableConcept The type of the device version
.... component 0..1 Identifier A single component of the device version
.... value 1..1 string The version text
... property 0..* BackboneElement The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type 1..1 CodeableConcept Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
.... valueQuantity 0..* Quantity Property value as a quantity
.... valueCode 0..* CodeableConcept Property value as a code, e.g., NTP4 (synced to NTP)
... patient 0..1 Reference(Patient) Patient to whom Device is affixed
... owner 0..1 Reference(Organization) Organization responsible for device
... contact 0..* ContactPoint Details for human/organization for support
... location 0..1 Reference(Location) Where the device is found
... url 0..1 uri Network address to contact device
... note 0..* Annotation Device notes and comments
... safety Σ 0..* CodeableConcept Safety Characteristics of Device
... parent 0..1 Reference(Device) The parent device

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Device.language Base preferred Common Languages 📍4.0.1 FHIR Std.
Device.udiCarrier.entryType Base required UDIEntryType 📍4.0.1 FHIR Std.
Device.status Base required FHIRDeviceStatus 📍4.0.1 FHIR Std.
Device.statusReason Base extensible FHIRDeviceStatusReason 📍4.0.1 FHIR Std.
Device.deviceName.type Base required DeviceNameType 📍4.0.1 FHIR Std.
Device.type Base required Device Type of personal health devices 📦0.1.0 This IG

Constraints

Id Grade Path(s) Description Expression
dom-2 error Device If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Device If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error Device If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error Device If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Device A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

This structure is derived from Device

Summary

Mandatory: 1 element
Must-Support: 4 elements

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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
... 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)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Device.status Base required FHIRDeviceStatus 📍4.0.1 FHIR Std.
Device.deviceName.type Base required DeviceNameType 📍4.0.1 FHIR Std.
Device.type Base required Device Type of personal health devices 📦0.1.0 This IG

Constraints

Id Grade Path(s) Description Expression
dom-2 error Device If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Device If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error Device If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error Device If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Device A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Differential View

This structure is derived from Device

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device 0..* Device Personal Health Device
... definition 1..1 Reference(DeviceDefinition) Definition of the Personal health device
... status S 0..1 code active | inactive | entered-in-error | unknown
... expirationDate S 0..1 dateTime Date and time of expiry of this Personal health device (if applicable)
... deviceName S 0..* BackboneElement Name of the Personal health device
... type 0..1 CodeableConcept The machine-readable type of the Personal health device
Binding: Device Type of personal health devices (required)

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Device.type Base required Device Type of personal health devices 📦0.1.0 This IG

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device 0..* Device Personal Health Device
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.
Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier 0..* Identifier Instance identifier
... definition 1..1 Reference(DeviceDefinition) Definition of the Personal health device
... udiCarrier Σ 0..* BackboneElement Unique Device Identifier (UDI) Barcode string
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... deviceIdentifier Σ 0..1 string Mandatory fixed portion of UDI
.... issuer 0..1 uri UDI Issuing Organization
.... jurisdiction 0..1 uri Regional UDI authority
.... carrierAIDC Σ 0..1 base64Binary UDI Machine Readable Barcode String
.... carrierHRF Σ 0..1 string UDI Human Readable Barcode String
.... entryType 0..1 code barcode | rfid | manual +
Binding: UDIEntryType (required): Codes to identify how UDI data was entered.
... status ?!SΣ 0..1 code active | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required): The availability status of the device.
... statusReason 0..* CodeableConcept online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device.
... distinctIdentifier 0..1 string The distinct identification string
... manufacturer 0..1 string Name of device manufacturer
... manufactureDate 0..1 dateTime Date when the device was made
... expirationDate S 0..1 dateTime Date and time of expiry of this Personal health device (if applicable)
... lotNumber 0..1 string Lot number of manufacture
... serialNumber S 0..1 string Serial number of the Personal health device
... deviceName S 0..* BackboneElement Name of the Personal health device
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... 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.
... modelNumber 0..1 string The model number for the device
... partNumber 0..1 string The part number of the device
... type 0..1 CodeableConcept The machine-readable type of the Personal health device
Binding: Device Type of personal health devices (required)
... specialization 0..* BackboneElement The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... systemType 1..1 CodeableConcept The standard that is used to operate and communicate
.... version 0..1 string The version of the standard that is used to operate and communicate
... version 0..* BackboneElement The actual design of the device or software version running on the device
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type 0..1 CodeableConcept The type of the device version
.... component 0..1 Identifier A single component of the device version
.... value 1..1 string The version text
... property 0..* BackboneElement The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type 1..1 CodeableConcept Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
.... valueQuantity 0..* Quantity Property value as a quantity
.... valueCode 0..* CodeableConcept Property value as a code, e.g., NTP4 (synced to NTP)
... patient 0..1 Reference(Patient) Patient to whom Device is affixed
... owner 0..1 Reference(Organization) Organization responsible for device
... contact 0..* ContactPoint Details for human/organization for support
... location 0..1 Reference(Location) Where the device is found
... url 0..1 uri Network address to contact device
... note 0..* Annotation Device notes and comments
... safety Σ 0..* CodeableConcept Safety Characteristics of Device
... parent 0..1 Reference(Device) The parent device

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Device.language Base preferred Common Languages 📍4.0.1 FHIR Std.
Device.udiCarrier.entryType Base required UDIEntryType 📍4.0.1 FHIR Std.
Device.status Base required FHIRDeviceStatus 📍4.0.1 FHIR Std.
Device.statusReason Base extensible FHIRDeviceStatusReason 📍4.0.1 FHIR Std.
Device.deviceName.type Base required DeviceNameType 📍4.0.1 FHIR Std.
Device.type Base required Device Type of personal health devices 📦0.1.0 This IG

Constraints

Id Grade Path(s) Description Expression
dom-2 error Device If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Device If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error Device If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error Device If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Device A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

This structure is derived from Device

Summary

Mandatory: 1 element
Must-Support: 4 elements

 

Other representations of profile: CSV, Excel, Schematron