Health Device Data Transfer
Version 1.0.0-rc2 - release

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

BfArM Registries and ZTS

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In order to authenticate with each other and to share device data after successful authorization for the processing of defined Mandatory Interoperable Values (MIVs), a DiGA and a Device Data Recorder

  • need to discover relevant information about each other, including the MIVs the other party is eligible to process
  • must obtain information about the other party’s X.509 certificates from a trusted third party
  • must be able to expand MIV-defining FHIR ValueSets and other ValueSets used by the HDDT-specific resource definitions

These services are usable through the DiGA Verzeichnis (DiGA VZ: BfArM DiGA Registry) and the Verzeichnis der Hilfsmittel- und Implantat-Schnittstellen (HIIS-VZ: BfArM Device Registry) and the Zentraler Terminologieserver (ZTS: German Central Terminology Service). This section summarizes the functionalities of these services which are relevant for the rest of this specification. More details on the managed data is given in the section HDDT information model.

HIIS-VZ

The HIIS-VZ (BfArM Device Registry) is operated by BfArM and provides access to definitions of registered Personal Health Devices and Device Data Recorders. For HDDT the HIIS-VZ provides the following functions:

  • providing HiisPersonalHealthDeviceDefinition resources as FHIR DeviceDefinitions for Personal Health Devices that are registered as HDDT certification relevant systems. These DeviceDefinitions include information such as:
    • device information (name, version, etc.)
    • manufacturer and contact data
    • static properties (e.g. amount of measured data that can temporarily be stored on the device)
  • providing HiisDeviceDataRecorderDefinition resources as FHIR DeviceDefinitions for Device Data Recorders that successfully implemented § 374a SGB V HDDT interfaces. These DeviceDefinitions include information such as:
    • product information (name, version, etc.)
    • manufacturer and contact data
    • supported Personal Health Devices
    • endpoint addresses of the provided FHIR Resource Server and OAuth2 Authorization Server
    • information for verifying the authenticity of the Device Data Recorder in electronic communications
    • versioning of information about registered Device Data Recorders

Extensions on these DeviceDefinitions allow DiGA manufacturers to discover the relationships between Device Data Recorders, Personal Health Devices and MIVS (e.g. to discover Personal Health Devices and Device Data Recorders that support a certain MIV). The full information model of the named DeviceDefinition types together with all extensions can be found at https://fhir.bfarm.de/guide/hiis-information-model-en.html.

The HIIS-VZ and the processes for registering Personal Health Devices and Device Data Recorders are recently being built up by BfArM. Further information on this is provided on the BfArM website.

DiGA Verzeichnis

The DiGA Verzeichnis (DiGA VZ: BfArM DiGA Registry) is operated by BfArM and provides access to definitions of registered DiGA (Digital Health Applications acc. § 33a SGB V). For HDDT the DiGA Verzeichnis provides the following functions:

  • providing information about registered DiGA
    • a unique 5-digit identifier assigned by BfArM known as DiGA-ID
    • product information (name, version, etc.)
    • manufacturer and contact data
    • information for verifying the authenticity of the DiGA in electronic communications
  • listing the MIVs a defined DiGA is eligible to process
  • listing all DiGA that are eligible to process a defined MIV
  • providing feeds for monitoring changes in the DiGA Verzeichnis (e.g. new DiGA registrations, changes in eligible MIVs, changes in certificate status, etc.)

The DiGA Verzeichnis can be reached at the URL https://diga.bfarm.de/de/verzeichnis, and its API documentation is available at https://fhir.bfarm.de/guide/diga-overview-en.html. The documentation contains information models and query examples for generic use-cases like retrieving different trust attributes (i.e. certificates, clientId, redirectUri). How to gain access for medical aid and implant manufacturers to the DiGA API is described on the BfArM website.

Zentraler Terminologieserver

The Zentraler Terminologieserver (ZTS: German Central Terminology Server) is operated by BfArM and gematik. It provides access to medical terminologies and classification systems in FHIR package format. These packages include CodeSystems, ValueSets, and ConceptMaps and serve as the foundation for semantic interoperability in the German healthcare ecosystem.

In the ZTS, all terminology artifacts relevant to a specific domain or application (e.g., active ingredients of drugs or dosages, classification of diseases and - in the future - HDDT MIV definitions) are bundled and provided as FHIR packages. This ensures that implementers always receive a complete set of logically related ValueSets, CodeSystems, and ConceptMaps in one package – simplifying integration and guaranteeing consistency.

The ZTS can be reached at the URL https://terminologien.bfarm.de. This site allows navigation through the provided FHIR CodeSystems and ValueSets and allows users to manually download these as FHIR packages.

For HDDT the ZTS will provide the following functions:

In addition to the GUI the ZTS provides several APIs which are designed for automation and integration into IT systems. The ones relevant for HDDT are:

  • Packages API: Search and retrieve FHIR Packages (openAPi)
  • Feeds API: Stay informed about new or updated releases (openAPI)

Detailed descriptions of these APIs are available as part of the ZTS documentation (German only).

Remark: The FHIR ValueSets for MIV definitions will be made available on ZTS after the end of the public review of the HDDT specification. Until then, all FHIR ValueSets for MIV definitions can be found in the ValueSets section of the Artifact Summary.