EU-funded projects contributing to the implementation of the European Health Data Space

26 March 2025 marked the entry into force of the European Health Data Space (EHDS) Regulation, and the beginning of the transition phase towards its application.  

The EHDS Regulation aims to establish a common framework for the use and exchange of electronic health data across the EU.  

The EHDS will: 

• Empower individuals to access, control and share their electronic health data across borders for the healthcare delivery (primary use of data);  
• Enable the secure and trustworthy reuse of health data for research, innovation, policy-making, and regulatory activities (secondary use of data); 
• Foster a single market for electronic health record (EHR) systems, supporting both primary and secondary use. 

HaDEA manages projects and initiatives under the EU4Health, Horizon Europe and Digital Europe programmes to support the implementation of the EHDS.  

EU4Health  

Under EU4Health, HaDEA manages 68 projects supporting the implementation of the EHDS, amounting to a total EU funding of €105 206 061. This includes three key projects preparing the groundwork for the EHDS implementation: 

• The Xt-EHR Joint Action is developing implementation guides and technical specifications for a comprehensive, interoperable and secure Electronic Health Records (EHR) system, promoting seamless healthcare data flows across Europe. The aim is to help healthcare providers with the diagnoses and treatments, to improve patient care and to allow citizens to control their own health data.  
• The TEHDAS2 Joint Action is developing technical specifications and guidelines to ensure health data can be accessed in a secure manner across borders and enable the secondary use of such data for research, innovation or policy making. The project regularly collects input from stakeholders through public consultations and EU countries can use its results to prepare the implementation of the EHDS regulation. TEHDAS2 builds on the work of the TEHDAS Joint Action and the EHDS2 pilot project. 
• The EHDS2 Pilot project, which ran until December 2024, piloted an infrastructure to share health data within the future EHDS, testing how health data can be reused safely and securely across different EU countries by connecting national data platforms. 

In addition, HaDEA is currently managing 65 EU4Health direct grants to EU countries and associated countries to support the setup of a trustworthy system to exchange and reuse health data in EU countries and implement the EHDS:  

• 32 grants (9 from 2021 and 23 from 2022) are helping EU countries launch and expand electronic health services via MyHealth@EU . This platform includes services such as e-prescriptions, patient summaries, medical images, laboratory results and clinical documents. 
• 21 grants are supporting the set-up of national infrastructures and services that enable the secure and ethical re-use of health data for purposes such as research, innovation, personalised medicine and policy making. 
• 12 grants focus on enhancing semantic interoperability, ensuring that health data can be understood and reused across borders and systems.  

Moreover, 3 ongoing procurement contracts managed by HaDEA are supporting the EHDS, for the total amount of over €3.8 Million, with actions focusing on: 

• Capacity building on primary use of health data; 
• Capacity building for secondary uses of health data for the European Health Data Space (EHDS); 
• Communication and information activities to support the rollout and use of the planned European Health Data Space (EHDS) and related services. 

4 other contracts are currently under preparation under the Annual Work Programme 2024.  

Horizon Europe ‘Health’ 

• The Quantum project is developing a label mechanism to facilitate the access of researchers, innovators and policymakers to high-quality datasets within the HealthData@EU Framework, where datasets are used for secondary purposes.  

Digital Europe Programme 

• The SHAIPED project supports the Health Data Access Bodies (HDABs) by establishing Artificial Intelligence (AI) pathways for the development, testing and deployment of medical devices. By optimising the collaboration between the HDABs across Europe, it leverages the EHDS Regulation and AI Act to improve patient outcomes, reduces time-to-market for AI medical devices, and strengthens the EU’s leadership in digital healthcare innovation.  

Background 

Publication of the European Health Data Space Regulation  

Frequently Asked Questions on the European Health Data Space 

EU4Health is the fourth and largest of the EU health programmes. The EU4Health programme goes beyond an ambitious response to the COVID-19 crisis to address the resilience of European healthcare systems. The programme provides funding to national authorities, health organisations and other bodies through grants and public procurement, contributing to a healthier Europe. HaDEA manages the vast majority of the total EU4Health budget and implements the programme by managing calls for proposals and calls for tenders.   

Horizon Europe is the research and innovation programme of the EU for the period 2021-2027. The aims of Cluster 1 ‘Health’ include improving and protecting the health and well-being of citizens of all ages by generating new knowledge, developing innovative solutions and integrating where relevant a gender perspective to prevent, diagnose, monitor, treat and cure diseases. 

The Digital Europe Programme (DEP) aims to build the strategic digital capacities of the EU and to facilitate the wide deployment of digital technologies. With an overall budget of €7.5 billion, out of which €0.8 billion is managed by HaDEA, the programme will support investments in the following sectors:

• High Performance Computing
• Cloud, data and Artificial Intelligence
• Cybersecurity
• Advanced digital skills
• Accelerating best use of technologies

HaDEA manages actions under Cloud, data and Artificial Intelligence, Advanced Digital Skills and Accelerating best use of technologies.