New Rules, New Opportunities

On 5 March 2025, the European Union adopted the European Health Data Space (EHDS) through Regulation (EU) 2025/327. This marks the EU’s most ambitious attempt yet to unlock the potential of health data – while safeguarding fundamental rights.

The EHDS introduces a unified legal framework for the use of electronic health data across Member States. It sets out two core pillars:

• Primary use: patients’ data will be better structured and accessible across borders for treatment purposes.
• Secondary use: health data may be reused for research, innovation, public health, and policy – under strict conditions.

This includes individual rights, such as access to data, transparency regarding who accesses it, and (in some cases) opt-out rights for secondary use.

The EHDS Regulation entered into force on 26 March 2025, but its practical application will be gradual. The key milestones are:

• 2025–2027: Adoption of implementing acts by the European Commission, defining technical standards, procedures for data access permits, and interoperability requirements.
• 2025 onward: Establishment and designation of national health data access bodies and digital health authorities in each Member State.
• 2026–2027: Development and alignment of EHR systems and infrastructure across the EU.
• From 2027: Gradual application and enforcement of the EHDS provisions, including mandatory documentation, cross-border access, and secondary use.

For pharmaceutical companies, the EHDS opens the door to unprecedented access to real-world health data under a clear and harmonized legal regime. Potential benefits include:

• Accelerated research and development through access to structured, high-quality, cross-border data
• Improved feasibility of real-world evidence (RWE) studies and AI-based drug development
• Legal certainty around data reuse, replacing fragmented national rules

At the same time, compliance challenges remain: companies will need to obtain permits from national health data access bodies, demonstrate ethical and responsible data use, and address national deviations regarding opt-out regimes.

To stay ahead, pharmaceutical companies should:

• Track the implementing acts and engage in consultations to help shape practical and science-compatible frameworks.
• Start internal EHDS readiness assessments, covering legal, technical, and ethical aspects of secondary data use.
• Set up engagement strategies with national access bodies and digital health authorities to anticipate application procedures.
• Invest in data infrastructure to meet new interoperability and documentation requirements.
• Develop opt-out handling processes to comply with national rules on patient consent and data sovereignty.

The EHDS will reshape the European data landscape for health. The EHDS will fundamentally reshape the legal landscape of health data in Europe. Pharmaceutical companies that act early will be best positioned to navigate this shift and harness its potential.