The European Health Data Space (EHDS) enables the secure secondary use of health data across Europe, supporting research, innovation, AI and more effective healthcare policies.
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Over the last few years, Europe has taken significant steps towards building an interoperable digital healthcare ecosystem.
While MyHealth@EU represents the pillar dedicated to the use of health data for patient care (primary use), the European Health Data Space (EHDS) introduces a second, equally strategic dimension: the secondary use of health data, namely the reuse of electronic health data for purposes beyond the direct care of individual patients, including research, innovation, public health planning and policymaking.
The ambition is clear: to transform the vast amount of health information generated every day across European healthcare systems into a shared strategic asset that can be accessed securely and under harmonised rules. By enabling the responsible reuse of health data, the EHDS aims to accelerate scientific research, foster the development of innovative therapies and medical technologies, support personalised medicine, and improve the efficiency and resilience of healthcare systems across Europe.
The EHDS Regulation establishes a common framework for all Member States, defining which categories of health data may be reused, who can access them, for which purposes, and under which safeguards. Permitted uses include scientific research, the development of medicines and medical devices, the training and validation of artificial intelligence systems, epidemiological surveillance, statistical analysis, health system performance assessment and evidence-based policymaking.
Access to health data will not be unrestricted. Each Member State will establish a Health Data Access Body (HDAB) responsible for assessing data access requests and issuing Data Permits where the proposed use complies with the Regulation. In most cases, authorised users will analyse data within Secure Processing Environments, controlled infrastructures that enable data processing without allowing raw datasets to be freely downloaded, thereby significantly reducing privacy and security risks.
At European level, these national infrastructures will be connected through HealthData@EU, the cross-border infrastructure designed to support the secondary use of health data across the Union. By providing harmonised access procedures and common governance mechanisms, HealthData@EU will help overcome the current fragmentation of health data and create a truly European data ecosystem for research and innovation.
The organisational impact will be substantial. All Member States, including Italy, will need to progressively adapt their governance models, technical infrastructures and data management processes in line with the implementation timeline established by the EHDS Regulation. This includes establishing national Health Data Access Bodies, deploying secure processing environments, ensuring interoperability with HealthData@EU, and making the required categories of electronic health data available according to the regulatory roadmap. For Italy, as for the other Member States, the EHDS represents not only a regulatory obligation but also an important opportunity to enhance the value of the National Health Service's data assets and strengthen the country's capacity for research, innovation and digital healthcare.
The EHDS also opens new opportunities for companies operating in digital health, healthcare ICT and artificial intelligence. Implementing the Regulation will require advanced expertise in health data interoperability, standardisation, privacy protection, cybersecurity, secure cloud infrastructures, data governance and advanced analytics platforms capable of supporting trusted data sharing across organisational and national boundaries.
In this context, Maggioli Group has already developed significant expertise through its participation in major European initiatives focused on the value of health data. In particular, the EUCAIM (European Cancer Imaging Initiative) and INCISIVE projects have enabled the Group to consolidate its knowledge of several technological building blocks that underpin the secondary use of health data, including data federation, interoperability, large-scale management of clinical imaging repositories, secure health data sharing and distributed infrastructures supporting artificial intelligence-driven research.
The EHDS is therefore much more than a new regulatory framework. It completes Europe's broader digital health strategy: while MyHealth@EU strengthens cross-border continuity of care for citizens, the secondary use framework creates the conditions for health data to generate value for society as a whole by supporting research, innovation and more effective public health policies.
Over the coming years, Europe will progressively build a healthcare ecosystem in which health data becomes a strategic infrastructure serving patients, researchers, healthcare providers and policymakers alike. For public administrations, research organisations and technology providers, preparing today means being ready to play an active role in one of the most significant transformations of European digital healthcare.