The new European Health Data Regulation: Legal implications for businesses and professionals
Regulation (EU) 2025/327 of the European Parliament and of the Council on the European Health Data Space (EEDS) came into force on 25 March 2025 and represents a radical change in the way health data is managed and shared within the European Union.
Its aim is to ensure that electronic health data can circulate securely and in a standardised manner across all Member States, both for healthcare purposes (direct patient care) and for secondary purposes (scientific research, health policy development, technological innovation).
Main obligations for healthcare and technology entities
- Mandatory interoperability: electronic health records must be adapted to common formats that are accessible throughout the EU from March 2027.
- Governance and security: robust cybersecurity systems, regular audits and access traceability mechanisms must be implemented.
- Secondary use of data: public institutions may authorise the use of health data for research purposes without prior consent, unless the patient exercises their right to opt out.
- Enhanced transparency: entities must clearly inform patients about the processing of their data and facilitate the exercise of digital rights (access, rectification, restriction, objection).
Legal challenges and risks
- Need to carry out enhanced Data Protection Impact Assessments (DPIAs), given the sensitivity of the information processed.
- Review of contracts with technology providers and cloud storage platforms to define responsibilities.
- Risk of significant financial penalties in the event of non-compliance, especially for international data transfers.
- Possible claims by patients in the event of unauthorised access, lack of transparency or defects in anonymisation.
Applicable legislation
- Regulation (EU) 2025/327 of 13 March 2025 on the European Health Data Space.
- Regulation (EU) 2016/679 (GDPR) on the protection of personal data.
- Organic Law 3/2018 of 5 December on the Protection of Personal Data and Guarantee of Digital Rights (LOPDGDD).
- Charter of Fundamental Rights of the EU, Articles 7 and 8 (respect for private life and protection of personal data).
Opportunities for clients and law firms
The new legal framework requires adaptation, but it also opens up opportunities:
- For healthcare and technology companies: advice on regulatory compliance, drafting privacy policies and reviewing contracts.
- For patients and citizens: greater control over their data and greater legal certainty in accessing and managing their health records.
- For law firms: a new field of specialisation in digital, healthcare and data protection law.
At SF Abogados, we offer specialised advice on privacy, healthcare law and regulatory compliance, helping companies and professionals to adapt to the new European Health Data Regulation and protect the rights of patients and users.
| Reglamento UE Datos de Salud 20250211 | 2078 KB |
