- By Doreen Witt
GeDIG at a glance: Why modern image management is the key to data exchange
Pre-recorded images on CD, an import that fails due to format incompatibility, an examination that must therefore be repeated: This is still an everyday occurrence in hospitals and radiology departments. With the Law on Data and Digital Innovation in Healthcare (GeDIG), however, the requirements for data exchange will increase significantly. On July 15, 2026, the Federal Cabinet approved the draft; the parliamentary process is still ongoing. It is already becoming clear that hospitals and radiology practices must take action to be prepared for these requirements.
What is GeDIG – and what does it have to do with image data?
The GeDIG is a wide-ranging digitalisation package: it introduces the electronic referral, creates a nationwide digital entry point to healthcare, gives the gematik greater responsibility for the operational stability of the telematics infrastructure and expands the use of health data for research and care.
For imaging, three main areas are relevant:
- the interoperability obligation,
- the further development of EHR and
- the implementation of the EHDS Regulation.
Whether a facility can meet the requirements will be decided, amongst other things, in medical image data management, where large volumes of data meet long retention periods.
Interoperability is becoming mandatory
The draft GeDIG bill obliges service providers to process the health-related data of their patients in future in an interoperable format to be maintained. Mirror-imaged, manufacturers of information technology systems must enable this interoperable data storage.
The Federal Ministry has in its FAQ on the GeDIG draft bill makes concrete what this means for manufacturers:
- Health data must be made available quickly, free of charge and in a standardised format upon request. This is due to the regulations of the European Health Data Space EHDS – the GeDIG implements the EU-wide statutory entitlement to it.
- Access must not be restricted by technical, contractual or organisational measures.
- The explicit goal is also to facilitate the switching of systems.
For GeDIG implementation in the clinic, this means that decision-makers will in future have to evaluate the choice of image archive from compliance and interoperability perspectives too. An archive that hinders smooth data exchange through proprietary interfaces or a rigid tie-in to a specific primary system is likely to be difficult to reconcile with the GeDIG guiding principle on interoperable data storage. A vendor-neutral long-term archive (VNA) that consistently relies on open standards, on the other hand, creates the necessary flexibility. Telepaxx achieves this with the TMD Cloud Image data can be saved to the archive from all standard PACS via a DICOM interface and requested and viewed from any standard PACS, RIS or HIS using a DICOM query/retrieve service.
The GeDIG requirements apply to all image data in a hospital, not just radiological images. Images and videos from modalities in cardiology, endoscopy, or pathology are covered just as much as radiological PACS, even if they currently reside in department-specific isolated solutions and partly outside the DICOM standard.
The EHR transports the image report - the archive supplies the image
The GeDIG is also building the EHR furthermore - with new applications and binding deadlines for their implementation. Currently, only the inspection report is stored in EHR, but not the associated image data. These are only attached or linked.
For hospitals and radiology departments, this already means: the medical report in the patient file is only as valuable as the accessibility of the images it refers to. These must therefore be retrievable on a permanent basis, including from outside the facility and regardless of the system that generated them.
With the EHDS, medical images will be part of the European exchange from March 2031
The EU regulation on the European Health Data Space, which implements the GeDIG at national level, makes cross-border data exchange mandatory – phased according to data type. The following key dates have already been set:
- 26th March 2029: Patient summaries and electronic prescriptions
- 26th March 2031: Medical images, laboratory results and discharge summaries
By then, the image data must be available in such a way that a standardised exchange is technically possible – not just for new captures, but also for the existing archive.
The solution for the GeDIG requirements: image management as infrastructure
The GeDIG calls for seamless, digital data exchange across institutional boundaries. This is precisely where hospitals often encounter technical limitations when it comes to medical image data: the massive amounts of data are frequently trapped in proprietary PACS silos. To meet the new legal requirements, image data management must therefore be viewed as a standalone, interoperable infrastructure. Three key aspects are central to this, which hospitals and medical practices must consider when selecting systems: interoperable data formats, immediate digital accessibility, and verifiable security.
Hospitals, MVZs or medical practices can implement this, for example, with the TMD Cloud from Telepaxx, which is designed for secure, vendor-neutral and interoperable data exchange.
Aspect 1: Liberating image data from proprietary silos for true interoperability
To achieve GeDIG-compliant interoperability, hospitals and radiology departments should decouple their image data from the reporting system to ensure that it is archived independently and in accordance with standards that are readable by other systems. This is the only way to enable standards-based, seamless communication of image data. In practice, this is achieved through a vendor-neutral long-term archive (VNA). This allows images to be retrieved via any standard PACS, PVS, RIS, or HIS - without any system limitations.
The example of how cross-sector collaboration works brilliantly even with growing data volumes is demonstrated by Radiology at the Questerhof: to overcome time-consuming processes and system boundaries in data exchange with referrers and patients, the practice has previously bundled separate image workflows in the TMD Cloud.
The result is a central, future-proof image management software that enables fast, flexible data access from different locations – the ideal starting point for the growing interoperability requirements due to the GeDIG.
Aspect 2: Media-free exchange of medical images for immediate image retrieval
The digital data exchange targeted by GeDIG marks the end of physical data media such as the patient CD. Instead, a modern patient or referrer portal provides some of the enormously large image data and reports immediately and digitally via QR code or weblink. A central role is played here by the DIN standard DLX, which helped develop Telepaxx within the DIN working group. This standardises the image exchange and allows patient images to be read regardless of the system that generated the QR code.
Aspect 3: Verifiable legal certainty regarding sensitive health data
Medical images are among the most sensitive data of all. Anyone who outsources these massive volumes of data to the cloud for flexible data exchange – in the sense of the GeDIG – must be able to prove watertight IT security to regulatory authorities and data protection officers. For cloud services in the healthcare sector, Section 393(3) No. 2 of the German Social Security Code, Book V (SGB V) strictly requires an up-to-date C5 attestation from the BSI (C5 criteria catalogue).
The Telepaxx TMD Cloud features one such thing BSI C5 Certificate and thereby ensures that the external image management is based on an audit-proof foundation, not only technically but also legally. In addition, Telepaxx is according to ISO/IEC 27001:2022 certified.
Conclusion: GeDIG demands a rethink in image management
The GeDIG makes interoperable data exchange mandatory. Image data plays a special role here: due to the high storage volumes, medical institutions require an image archive for this that is available long-term, standards-compliant and accessible from the outside.
The technical setup of image management thus plays a decisive role in whether a hospital or radiology department can practically meet the requirements of EHR, interoperability obligations and the EHDS. This applies to both new scans and existing archives.
Therefore, the first step is to take stock: where are your image data located today, in what format - and how do you access them if the generating system is no longer on site? Let us tackle this inventory together. The experts at Telepaxx will gladly support you in this. Together with you, we will analyse what gaps arise with regard to GeDIG, EHR and EHDS and what a vendor-neutral, legally compliant solution for your organisation could look like. Contact Us.