The European Health Data Space (EHDS) is a transformative EU initiative that sets out a new framework for the use and sharing of health data across member states. Introduced under EHDS Regulation (EU) 2025/327, the aim is to foster a single market for digital health services in Europe, promoting innovation, patient rights, and public health while ensuring robust data protection and security.
Understanding EHDS and its impact on health data platforms
At its core, EHDS requires digital health platforms and healthcare providers to adhere to strict compliance measures, not only around data privacy but also interoperability, data quality, and streamlined access for both primary and secondary uses of health data.
Key objectives of the European Health Data Space include:
- empowering individuals with greater control over their personal health data,
- enhancing the continuity of care across borders,
- and enabling the secure reuse of anonymized data for research, innovation, and policymaking.
EHDS standards make it mandatory for digital health solutions to implement mechanisms that allow individuals to access, manage, and, where necessary, restrict access to their health records. For secondary use (such as scientific research) EHDS obligates platforms to operate within a tightly regulated environment, ensuring that all data is appropriately pseudonymized or anonymized, and accessed only under clear, lawful conditions.
For digital health platforms operating in the EU, EHDS compliance is now a central regulatory requirement. Organizations must align their data architecture and consent management systems to fit the new EU health data regulation, which may involve adopting common data models, certification standards, and interoperable APIs as outlined by the European Union. Failure to meet EHDS standards can limit market access and subject platforms to penalties, making proactive adaptation essential for continued operation and growth in the European digital health ecosystem.
MEDrecord’s approach: Aligning FHIR backend with EHDS standards as a MedMij member
To proactively address Fast Healthcare Interoperability Resources (FHIR) backend EHDS preparation, MEDrecord is executing a structured strategy that ensures full compliance with both the EHDS technical standards and MedMij certification requirements. MEDrecord’s engineering team has initiated a comprehensive review of EHDS specifications, identifying areas where their current FHIR backend must evolve to support enhanced FHIR interoperability and secure health data access across European borders. Key actions include versioning updates, implementing required EHDS profiles, and meticulous documentation to ensure smooth audits and certifications.
Central to this process is the harmonization of MedMij’s guidelines with the evolving EHDS mandates. MEDrecord regularly engages with MedMij, actively participating in technical workgroups and standardization initiatives to anticipate and respond to regulatory shifts. By doing so, MEDrecord maintains its MedMij certification while extending its FHIR backend’s interoperability, enabling seamless and secure information exchange between healthcare systems, patients, and authorized providers, in line with the EHDS vision for connected, patient-centric healthcare.
Strengthening data security is another pillar of MEDrecord’s FHIR backend EHDS preparation. The organization has heightened its security protocols through advanced authentication measures, continuous penetration testing, and rigorous data access controls. All updates are not only aimed at regulatory compliance but also at building trust among users and stakeholders, reaffirming MEDrecord’s role as a leader in secure, standards-driven health data solutions aligned with both MedMij and EHDS technical frameworks.
Building an Agentic framework for personalized health advice using FHIR and EHDS data
MEDrecord is pioneering the development of an Agentic framework for health data, aiming to transform the way individuals receive and interact with personalized healthcare advice. By embracing a data-driven approach, MEDrecord integrates Fast Healthcare Interoperability Resources (a globally recognized standard for exchanging electronic health information) with the European Health Data Space (a regulatory initiative designed to harmonize health data access across Europe). This fusion allows the Agentic framework to draw upon a comprehensive range of user health records in a secure and interoperable manner.
The core of MEDrecord’s Agentic framework health data model is its ability to provide AI-powered, highly personalized advice. Leveraging advanced algorithms, the framework analyzes a user’s EHDS and FHIR health data (including medical history, lab results, and treatment plans) to generate tailored, evidence-based health recommendations. With this level of individualized insight, users can receive guidance uniquely relevant to their needs, preferences, and clinical context, advancing the concept of truly personalized healthcare advice.
MEDrecord’s innovative application of AI in healthcare not only empowers individuals but also supports care providers and the broader healthcare system. Through secure, consent-driven data integration, the framework delivers EHDS-based advice while maintaining strict privacy standards. This positions MEDrecord’s Agentic framework as a transformative solution in the movement toward data-driven health recommendations, paving the way for more proactive and patient-centered care.
Collaborating on secure, multilingual LLM and PET research for healthcare innovation
Across Europe, the landscape for Horizon proposals in digital health is rapidly evolving, with transformative research initiatives focusing on privacy-enhancing technologies (PET) and secure large language model (LLM) pipelines. MEDrecord, in collaboration with leading stakeholders, is actively exploring innovative solutions that leverage PET infrastructure to unlock the full potential of health data while maintaining stringent security and ethical standards.
Harnessing these emerging technologies within the framework of Horizon Europe proposals, our mission is to bridge the gaps between technical innovation, clinical application, and robust data governance. But any collaboration we have and projects we are contributing to, meets all the requirements for privacy and security. For example, one of the projects we are involved in regarding the EHDS standards is the Secur-e-Health project with ITEA.
The recent DIGITAL-EUROHPC-2025-LLM-01 call presents a unique opportunity to advance multilingual LLM research tailored for healthcare, with a strong emphasis on privacy, performance, and interoperability. The integration of EuroHPC resources (an initiative established to improve Europe’s supercomputing capabilities, including the LUMI Supercomputer, one of the most powerful computing platforms worldwide) provides the computational foundation necessary to develop, validate, and scale secure LLM pipelines for multilingual medical data.
Join us
We believe that true breakthroughs in digital health will come through vibrant collaboration – uniting researchers, clinicians, technology providers, and patient organizations. If you are developing solutions in multilingual LLM, PET, or EuroHPC integration, we warmly invite you to partner with us in crafting joint Horizon Europe proposals.
By combining our expertise and resources, we can co-create innovations that redefine secure and multilingual healthcare while ensuring trust, scalability, and real-world impact for all stakeholders. If you wish to join a proposal, please contact us and we will get back to you shortly.