The European Health Data Space (EHDS): A Legal Breakthrough in Digital Health Governance

Introduction: Why Health Data Needs Its Own Legal Space

The COVID-19 pandemic exposed both the power and fragility of digital health systems in Europe. Data silos, incompatible records, and legal uncertainty about sharing health data across borders hampered public health responses, research, and patient care.

In response, the European Commission unveiled the European Health Data Space (EHDS) proposal in May 2022—now moving toward final adoption in 2025. The EHDS will be the first sector-specific data space under the broader European Strategy for Data. It aims to establish a legal and technical framework for the secure, interoperable, and rights-based use of health data across the EU.

It’s a bold attempt to transform Europe's fragmented e-health landscape into a coherent, rights-respecting digital infrastructure.

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The Dual Purpose of the EHDS

The EHDS has two main pillars—each targeting different uses of health data:

1. Primary Use of Health Data

This covers individual access and sharing of electronic health data for care purposes.

Key features include:

EU citizens will have free, real-time access to their electronic health records (EHRs),

Health professionals can access a patient’s data regardless of the Member State, improving cross-border healthcare,

Common data formats for prescriptions, lab results, imaging, discharge summaries, and more.

2. Secondary Use of Health Data

This allows for regulated access to anonymized or pseudonymized health data for:

Research, innovation, and public health,

Policy development and regulatory use (e.g., pharmacovigilance),

AI training and medical device evaluation.

Use for commercial advertising, discrimination, or other non-health purposes will be strictly prohibited.

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Who Will Govern and Access the Data?

National Health Data Access Bodies

Each Member State must designate a national body to:

Grant or deny data access permits,

Monitor compliance,

Coordinate with the central EHDS infrastructure.

These bodies act as gatekeepers, ensuring that only legitimate, ethical, and legally compliant data uses are allowed.

HealthData@EU Infrastructure

At the EU level, the EHDS will be supported by HealthData@EU, a decentralized digital infrastructure that connects national systems while respecting data sovereignty.

This system will enable cross-border queries without centralizing sensitive data, using federated learning and secure processing environments.

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Legal Basis and Alignment with Existing Law

The EHDS is grounded in Article 168 TFEU (public health) and aligns with:

GDPR, particularly Articles 6, 9, and 89 (processing of health data for public interest and scientific research),

Data Governance Act (DGA) and Data Act, for broader data sharing principles,

Medical Devices Regulation and AI Act, which will govern technologies accessing EHDS data.

It also builds on MyHealth@EU, an eHealth interoperability system already in limited use for cross-border e-prescriptions and patient summaries.

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What It Means for Patients and Citizens

EHDS empowers individuals by:

Giving full digital access to their health data via national portals,

Enabling them to control access and set permissions (e.g., deny access to certain doctors),

Providing transparency on how their data is used for research and policy.

Digital health literacy campaigns will also accompany rollout to avoid digital exclusion, especially among elderly and marginalized populations.

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Implications for Health Professionals, Industry, and Researchers

The EHDS creates new opportunities and responsibilities for:

Healthcare providers, who must adopt interoperable EHR systems,

Pharmaceutical and MedTech companies, who may access EHDS data for clinical trials, AI development, and regulatory filings,

Academic and public health researchers, who gain structured access to high-quality real-world data.

However, all actors must adhere to strict cybersecurity, ethics, and data protection standards, and use secure processing environments.

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Challenges: Interoperability, Consent, and Trust

While ambitious, the EHDS faces key implementation challenges:

Technical interoperability remains patchy across Member States; standardizing health data formats and semantics is complex,

Differing interpretations of GDPR among national authorities may cause legal uncertainty,

Building public trust is essential—especially around secondary data use and AI-driven diagnostics.

The Commission plans a phased implementation from 2025 through 2030, with real-world testing and national alignment underway.

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Conclusion: The EHDS as a New Legal Model for Sectoral Data Spaces

The European Health Data Space is not just a healthcare reform—it is a new paradigm for how the EU treats data in critical sectors. By combining digital innovation, patient empowerment, and legal safeguards, the EHDS could:

Improve diagnoses and outcomes,

Accelerate medical research,

Enhance pandemic preparedness,

Set global standards for digital health governance.

As the EU builds sectoral data spaces in energy, finance, agriculture, and beyond, the EHDS may become the template for future data-driven regulation—balancing innovation with rights and trust.