In the engine room of the EHDS
The European Health Data Space has come into force. Now the clock is ticking for its implementation. Our expert Dr. Marc Kämmerer is involved in developing the guidelines for the exchange of image data.
Policymakers were immediately jubilant. “For me, this was the most important decision for protecting health in the European Union in many years, perhaps ever,” stated CDU MEP Peter Liese, as quoted in the German medical journal, the "Ärzteblatt". This refers to the EHDS, European Health Data Space. It is intended to enable both the cross-border primary use of data and their reuse “for research, innovation, policy-making, and regulatory activities.”
The EHDS entered into force on March 26, 2025. And the clock is ticking. The reason being that March 2027 is the deadline for the Commission to adopt several important implementing acts, and two years later, in March 2029, the key elements of the EHDS Regulation are scheduled to enter into force.
“The schedule is very tight”
With regard to this regulation, the EU Commission is supported by the Xt-EHR Joint Action. This involves more than 50 partner organizations from 26 European countries. “The time frame is very tight,” says Dr. Marc Kämmerer, our Head of Innovation Management. He is co-leader of the joint working group "EU Imaging Report “ of HL7 Europe and IHE Europe, which contributes to the Xt-EHR work package 7.2.
In this committee, representatives from various providers, user groups, and standards organizations work together to develop the technical specifications and implementation guidelines for the exchange of medical image data and the associated diagnostic reports. One of Dr. Marc Kämmerer's objectives is to define the exchange as closely as possible to the national standards for image and diagnostic exchange, which he is co-developing as head of the German MIO-X project. “Such extensive harmonization would keep the application processes lean overall and avoid suppliers having to implement duplicate systems.”
DICOM to be the standard for image Exchange
The National Contact Points (NCPs) which act as gateways between countries and also translate findings from one language into another – in the literal sense – play a key technological role in EU-wide data exchange. Here, the FIHR standard will be mandatory for the exchange of document data. Marc Kämmerer explains: "Image data are special. Here, it is the DICOM standard which will determine the representation of studies in diagnostic imaging and their transport."
Various committees from the responsible organizations are working together to ensure the seamless integration of HL7-FHIR, DICOM, and existing IHE profiles. The joint objective is to develop a solution that is ultimately applicable, interoperable, and technically feasible for the EU-wide exchange of image studies and the associated diagnostic reports.
The organization of data storage is the competence of the EU member states. The NCP must only be able to provide the relevant data in response to legitimate requests, regardless of where the data are stored. For a number of reasons, decentralized data storage is primarily being considered for image data in the EHDS. For example, sustainability, practical enforceability, and reliable operation are arguments in favor of this approach. However, this does not rule out a centralized solution in the individual member states.
What are the implications for the target groups of the EHDS?
From 2031 onwards, imaging processes will become a serious matter. Then the systems supporting this area must possess the interfaces described for the EHDS to be able to provide images and image findings. For example, this means that PACS systems must make stored data accessible to authorized persons within the scope of EHDS use cases.
What does this now imply for the target groups of the EHDS? Patients will have solutions that allow them to authenticate themselves abroad and authorize the doctor to access their data - possibly similar to the German e-prescription app, but possibly also different: a challenge for the envisaged interoperability. Health professionals, for their part, must have a software infrastructure for contacting their country's NCP, for which providers must in turn implement the necessary interfaces. The draft specifying which use cases are to be mapped was submitted to the Xt-EHR Consortium at the end of September for forwarding to the EU Commission for further consideration.
To find out more about the Xt-EHR Joint Action please visit: www.xt-ehr.eu