The ODPD participates in the 1st International Meeting on Digital Rights to analyse the impact of the European Health Data Space Regulation on biomedical research

The Foundation’s Data Protection Office (DPO) took part in the session “Biomedical research after the European Health Data Space Regulation. A new world?”, held the 1st International Meeting on Digital Rights. The event focused on analysing the new legal, technological and social challenges linked to data governance and digital rights.

The session, organised by Professor Iñigo de Miguel Beriain, Ikerbasque Research Professor at the University of the Basque Country / Euskal Herriko Unibertsitatea, brought together professionals from the legal, research and data protection fields to discuss the implications of the European Health Data Space Regulation (EHDS) for biomedical research and healthcare innovation.

Challenges posed by the new regulation

Maria Esteban, research technician at the Health Data Protection Delegate’s Office, participated in an expert panel focused on the legal and operational challenges arising from the implementation of the EHDS.

During her intervention, she presented the main new features introduced by the regulation. She highlighted the reuse of personal health data for scientific research, innovation and artificial intelligence development purposes. She also explained why organisations with access to health data will be responsible for authorising, supervising and controlling the secondary use of information, as well as the obligations that hospitals, public administrations and other health data holders will assume.

The session provided further insight into the procedures through which researchers, universities, companies and public bodies may access health data for projects of public interest, including clinical, genetic and administrative data, as well as data from medical devices. Legal limitations on access were also discussed to ensure safe and controlled use.

Another key topic addressed during the session concerned the safeguards established by the regulation to protect fundamental rights, particularly regarding privacy, security, data pseudonymisation and supervision mechanisms for authorised uses.

From the ODPD perspective, several unresolved issues concerning the interaction between the EHDS and the General Data Protection Regulation (GDPR) were also raised. Among the main points discussed were the consideration of pseudonymised data as personal data, the processing of health data belonging to deceased persons — since the EHDS does not explicitly mention them, it remains unclear whether such data will be included and, if so, how it will be regulated. The discussion also covered the compatibility of the Spanish research system with the new European regulation, as well as the principles of data minimisation and accuracy and citizens’ right to opt out.

The session concluded with a reflection on the practical impact that this new regulatory framework will have on both citizens and healthcare and research centres, in a context marked by the growing importance of data sharing for biomedical research and technological innovation. It also opened a debate on balancing the promotion of scientific research and healthcare innovation with the effective protection of fundamental rights, privacy and citizens’ control over their personal data.

Transparency and safeguards in the use of health data

During the debate, participants stressed the importance of ensuring that citizens receive clear and transparent information regarding the use of their health data and that they can exercise their rights in an agile and effective manner.

The need to process such sensitive data with the highest guarantees was also highlighted, ensuring that the development of the EHDS achieves a balance between promoting research and innovation and effectively protecting fundamental rights.

Experts in data protection and research ethics

The panel also included Anna Boix, Head of the Legal Area at the Vall d’Hebron Research Institute, who provided a practical perspective on how research institutions are preparing for the implementation of the EHDS, and Sergi Morales Fernández, Head of the Data Protection Unit at Vall d’Hebron, who analysed the regulation’s impact from the perspective of Research Ethics Committees.

One of the conclusions of the debate was that the EHDS represents a key opportunity to boost biomedical research and technological innovation in healthcare across Europe. However, its effective implementation will require resolving significant legal challenges and ensuring clear coordination with the GDPR.