§ 374a SGB V – and what it means for medical aid manufacturers
Background: Section 374a SGB V aims to improve digital and hybrid healthcare in Germany by enabling interoperable data exchange between eligible medical aids and implants and Digital Health Applications (DiGA). Manufacturers of medical aids and implants must provide relevant health data from devices through open, interoperable interfaces.
The draft Act on Data and Digital Innovation in Healthcare (GeDIG) proposes to strengthen enforcement, including sanctions for non-compliance. By 1 January 2028, affected platforms and backend systems must implement open interfaces in accordance with the gematik Health Device Data Transfer (HDDT) specifications and register them in the BfArM’s HIIS directory. For manufacturers of medical aid and implants, HDDT marks a shift from isolated, manufacturer-specific ecosystems towards connected digital healthcare. Beyond regulatory compliance, interoperability offers opportunities to integrate with DiGA and clinical IT, improve care processes, and unlock new value for their products.
Who is impacted?
The regulation impacts manufacturers of medical aids, implants and the respective backend systems that
- provide devices which are reimbursed by statutory health insurance and/or provide backend systems that process data from such devices, and
- provide apps to patients for visualizing device data and/or configuring the device.
These manufacturers are required to provide device-generated data (including aggregated data) for use by DiGA, insofar as such use is consistent with the intended purpose of the DiGA.
The data must be provided to DiGA in interoperable data formats following gematik’s Health Device Data Transfer (HDDT) specification which also covers the secure pairing of the involved backend systems. The medical aids, implants and backend systems must also be registered with the electronic HIIS device registry provided by BfArM.
Example use cases
The measures planned by § 374a SGB V could enhance multiple healthcare use cases, such as:
- Telemonitoring via a DiGA – For example, in the context of a digital disease management program (dDMP), a patient’s condition can be continuously monitored using medical device data and patient‑reported outcome measures (PROMs).
- AI-based analysis of a patient’s condition – DiGA could use data from electronic medical devices to support AI-based analysis of a patient’s condition, resulting in therapy recommendations and adjustments, and helping patients better manage their own health.
- Providing medical device data directly to healthcare providers – Data can be transferred via ePA or KIM, used to generate standardized reports (e.g. an ambulatory glucose profile), and used to trigger notifications to healthcare providers once thresholds are exceeded.
From HDDT requirements to production
Implementing HDDT involves more than providing an interoperable interface. Requirements need to be translated into the existing system architecture, device data needs to be made available in the required formats and service levels, DiGA connections need to be tested, and the infrastructure needs to remain reliable as specifications evolve.
_fbeta combines regulatory and technical expertise with its own HDDT infrastructure and tools to support manufacturers from initial assessment through implementation and validation to ongoing operation.
01 – UNDERSTAND. Regulation · Requirements · Market
Determine which regulatory requirements apply to your products and translate them into concrete technical and organizational requirements.
02 – DESIGN. Strategy · Architecture · Interoperability
Define the implementation approach and target architecture for integrating HDDT into your existing device and backend infrastructure.
03 – IMPLEMENT. Software · Interfaces · Integration
Implement the required HDDT components and connect existing systems, data sources and interfaces.
04 – VALIDATE. Security · Compliance · Testing
Validate the implementation, security and interoperability and prepare to connect to eligible DiGA.
05 – OPERATE. Support · Governance · Evolution
Operate and monitor the HDDT infrastructure and keep it aligned with evolving technical specifications and regulatory requirements.
Our HDDT solutions
HDDT support tailored to your starting point
Whether you are still assessing the implications of § 374a SGB V, preparing your technical implementation or looking for a solution that can be integrated into your existing infrastructure: _fbeta provides modular HDDT services from initial assessment to ongoing operation.
HDDT Readiness & Advisory
Clarify what HDDT means for your products and organization.
We assess which products, systems and data flows are affected, translate regulatory and technical requirements into concrete implementation needs and define the appropriate target architecture. This also includes the processes, technical resources and support manufacturers need to provide for connecting DiGA.
Key topics:
Applicability · Requirements · DiGA enablement · Target architecture · Make-or-buy
HDDT Gateway
Add HDDT capabilities to your existing device infrastructure.
The _fbeta HDDT Gateway provides the technical components required to make device data available to eligible DiGA through standardized and secure interfaces. It is 100% HDDT compliant and integrates with existing manufacturer backends rather than requiring a new device infrastructure.
Key capabilities:
FHIR & MIVs · Pairing & authorization · mTLS connectivity · Data validation · Backend integration
HDDT Test Platform
Test HDDT integration in a standardized environment.
_fbeta runs a dedicated testing environment that enables manufacturers and DiGA providers to validate HDDT connectivity before production. It includes a separate test environment for each DiGA, synthesized test data and the technical setup required for integration testing.
Key capabilities:
Dedicated test environments · Test data · Certificates · DiGA onboarding · Integration testing
Managed HDDT
Keep your HDDT infrastructure operational and up to date.
_fbeta supports the ongoing operation of the HDDT infrastructure, including monitoring, technical support and updates as HDDT specifications and FHIR profiles for HDDT mandatory interoperable values (MIVs) evolve.
Key capabilities:
Operation · Monitoring · Support · Specification updates · New MIVs
What is HDDT?
Mandatory Interoperable Values (MIVs)
The specification is centered around Mandatory Interoperable Values (MIVs). During the creation of the specification, a thorough analysis was conducted to identify which types of data should initially be required for transfer from medical aid manufacturers to DiGA. The analysis focused on medical domains with a high number of prescriptions for electronic medical aids and implants, and then examined common use cases within each domain to understand:
- in which constellations devices are used,
- what data is transferred, and
- how this data is used and medically interpreted.
Collections of measured values that represent a common use case were grouped under the same MIV.
Currently, the specification defines four MIVs, with more expected in the future:
- Blood Glucose Monitoring
- Continuous Glucose Monitoring
- Lung Function Testing
- Blood Pressure Monitoring
Manufacturers of electronic medical aids and implants that measure any of these MIVs are required to implement and operate the interface in order to make the measurements available to DiGA.
Pairing
The HDDT specification also defines a comprehensive pairing procedure, which serves the following purposes:
- It ensures secure communication between the DiGA and the medical aid manufacturer’s interface.
- It produces a Pairing ID, which ensures that the DiGA and the medical aid manufacturer “agree” that they are exchanging data for the same patient, without revealing the patient’s identity to either party.
- It ensures that the patient’s consent regarding which data the DiGA is allowed to access is properly recorded.
FHIR Interface
The HDDT specification relies on the HL7 FHIR standard for interoperability. It defines normative requirements for a REST FHIR API, through which DiGA can access patient data from medical aids and implants. In addition, each MIV defines a set of FHIR profiles that specify how the data must be structured in order to be transferred to DiGA. Medical aid manufacturers must provide the data in this format, and DiGA must be able to interpret it.
The specification also includes additional requirements for security (e.g. usage of mutual TLS), error handling, and operation (e.g. availability, logging, and the provision of a test environment) of the interface.
The _fbeta HDDT Gateway & HDDT Test Platform
_fbeta HDDT Gateway
_fbeta offers a HDDT Gateway – a collection of infrastructure components designed to minimize the complexity of implementing the HDDT interface and its regulatory requirements. The HDDT Gateway provides the following functionality:
- Management of mTLS connectivity with eligible DiGA
- Authorization server that implements the HDDT pairing procedure and manages SMART OAuth scopes based on patient consent
- FHIR server supporting all endpoints, search parameters, and operations required for a given MIV, with data access restricted by SMART scopes
- FHIR-native storage and validation to ensure data integrity and minimize processing overhead during data exchange
- Integration adapter that minimizes integration effort by transforming data from existing databases, APIs, and proprietary formats into the FHIR resources required by HDDT
_fbeta HDDT Test Platform
In addition, _fbeta offers a Test Platform for manufacturers of medical aids, which can be integrated with the HDDT Gateway to provide a test environment for DiGA. It includes:
- Creation or upload of mTLS certificates for DiGA
- Automatic provisioning of a private test environment per device and DiGA
- Automatic generation of test data (patients, measurements) for every MIV defined by HDDT
- A graphical user interface that allows all of the above features to be managed with just a few clicks
Talk to our HDDT Experts
_fbeta combines regulatory and interoperability expertise with hands-on technical implementation –
from assessing your requirements to integrating and operating the HDDT infrastructure.
Dr. Jörg Caumanns
Regulatory & Interoperability
Jie Wu
Interoperability & Technology
Sergej Reiser
Architecture & Technology
