Regulation (EU) 2025/327, the legislative act that establishes the European health data space (EHDS), is a landmark regulation for the healthcare, technology and digital innovation sectors, and ultimately for every individual whose health data is processed.
Through its architecture, the regulation sets out a unified legal framework for the access, use and sharing of health data across the European Union, with direct implications for healthcare providers, digital health solution developers, public authorities and end users alike.
Formally adopted on 11 February 2025 and in force since March 2025, this regulation is not a theoretical exercise. It represents an ongoing digital transformation process that will become fully applicable as of 26 March 2027.
But beyond articles and technical definitions, what does this actually mean in practice?
A revolution in access: health data without borders
Until recently, medical data across Europe was fragmented, locked inside clinics, hospitals and IT systems that did not communicate with one another. Regulation (EU) 2025/327 aims to break down these silos through what it defines as the primary use of health data.
The core principle is simple and familiar from the GDPR: your health data belongs to you, and you can exercise your rights over it.
In concrete terms, this means:
- Immediate and free access – Individuals have the right to access their electronic health records, including summaries, prescriptions and laboratory results, instantly, free of charge, in a clear and user-friendly digital format.
- True data portability – If you choose to receive medical care in another city or another EU member state, your data can follow you seamlessly through the MyHealth@EU infrastructure.
- Full control and transparency – You can restrict healthcare professionals’ access to sensitive parts of your medical record, such as mental or sexual health data, and see exactly who accessed your data and when.
The science of tomorrow: when health data saves lives, safely
The most ambitious pillar of the EHDS is the secondary use of health data. Instead of remaining unused in isolated databases, health data can become a powerful engine for research, innovation and public health through the HealthData@EU infrastructure.
Crucially, this does not mean unrestricted access to personal information:
- data is anonymised or pseudonymised
- data can only be processed in highly secure environments
- data cannot be downloaded or reused freely
Researchers may use this data to train medical AI systems, improve diagnostics or develop new treatments, but never for marketing purposes or discriminatory decision-making.
The balance is deliberate: unlocking innovation without compromising privacy.
Between promise and reality
While the vision of the EHDS is compelling, its implementation will be gradual, with phased deadlines running from 2027 to 2035. Several realities deserve attention:
- The bureaucracy challenge – Over-regulation could risk becoming an obstacle to innovation, particularly for smaller start-ups that lack the financial and legal resources to navigate the combined complexity of the EHDS, GDPR and the AI Act.
- This is not just about technology, it is about culture – Moving from paper files to a pan-European digital health ecosystem is as much an issue of medical and digital education as it is of IT infrastructure.
- The real success metric – Regulation (EU) 2025/327 provides the tools for more efficient, data-driven and personalised healthcare. Its true success will not be measured in terabytes of shared data, but in how well it protects patient privacy while genuinely improving access to better care, wherever patients are in Europe.