Secondary use of data under the European Health Data Space: some relevant issues

  • Panel
  • Class Room
  • Thursday 21.05 — 08:45 - 10:00

Organising Institution

University of the Basque Country

Spain

Research Group on Social and Legal Sciences Applied to New Technosciences - Chair in Law and Human Genome Network
  • Academic 1
  • Business 2
  • Policy 3
The main objective of this panel is to analyse some of the main legal issues raised by the implementation of the EHDS in the EU context. These include: the issue of standardisation and quality labels; the role of the European Commission in the overall system; how issues relating to the allocation of fees and the protection of industrial property will be resolved; the distribution of roles between ethics committees, data protection agencies and access bodies, etc. Funded by project GODAS (PID2022-137140OB-I00, financed by MCIN/AEI/10.13039/501100011033/FEDER, UE)

Questions to be answered

  1. What exactly is the role of the European Commission in the secondary use of data? And how will it be organised?
  2. How will access fees be determined? How will the preservation of intellectual property be determined? Could there be forum shopping?
  3. What role will standards play in the EHDS?
  4. How are we going to ensure that supervision is not repetitive and contradictory with so many bodies involved in the case of AI medical devices?

Moderator

Pablo TRIGO KRAMCSÁK

Vrije Universiteit Brussels (VUB) - Belgium

Pablo Trigo Kramcsák is a PhD candidate at the Faculty of Law and Criminology of the Vrije Universiteit Brussel (VUB). He is a researcher at the Research Group on Law, Science, Technology & Society (LSTS), where he is affiliated with the Cyber and Data Security Lab (CDSL). His research examines how the GDPR's legal bases for personal data processing interact with the regulatory frameworks taking shape around data spaces.

Speaker

Francesca Tassinari

University of the Basque Country - Spain

Dr Francesca Tassinari, lawyer, is research fellow at the Department of Public Law of the University of Basque Country (UPV/EHU). She got her Ph.D. in Public International Law and International Relations at the University of Granada (UGR) and in EU law and national legal orders at the University of Ferrara (UNIFE) in 2022. She was the first candidate for the UNIFE/UGR Double Degree in Law in 2016 and received several awards throughout her career. She worked for the European Commission between 2020/2021 and 2022/2023.

Speaker

Albena KUYUMDZHIEVA

European Commission - Europe

Dr Albena Kuyumdzhieva is the Head of the Sector for Health Biotechnology at the Directorate-General for Research and Innovation. The Sector oversees policy and funding initiatives related to health biotechnology and guides research policy developments in this field. Albena has over 20 years of international experience advising policymakers on data protection, ethics of new and emerging technologies, innovation, and good governance. Over the years, she has contributed to the development of EU health data research and innovation policies, as well as the legal drafting of major data frameworks, policy guidelines, and recommendations. Albena holds a Doctor of Philosophy degree and master’s degrees in law and in finance. She is a certified Data Protection Officer and possesses a Privacy Management Professional Diploma.

Speaker

Anastasiya Kiseleva

Vrije Universiteit Brussel - Belgium

Dr Anastasiya Kiseleva is a Postdoctoral Researcher in Health Law and Technologies at Vrije Universiteit Brussel (VUB), Faculty of Law, affiliated with the Law, Science, Technology and Society (LSTS) Research Group and the Health and Ageing Law Lab (HALL). She holds dual doctoral degrees in Law (Belgium) and Computer Science (France), where her research developed an interdisciplinary framework for ensuring transparency of AI in healthcare that is both legally compliant and technically feasible. Her work lies at the intersection of AI regulation, health law, transparency, accountability, and socio-technical governance of emerging technologies.

Speaker

Owe Langfeldt

European Commission - Belgium

Owe Langfeldt is a policy officer in the Digital Health unit of the European Commission’s Directorate-General for Health and Food Safety, focussing on the European Health Data Space. Earlier, he worked in the Directorate-General for Justice and Consumers, in the data protection unit, particularly on digital single market files, health, and home affairs. Before joining the Commission, Owe was a legal officer in the Supervision and Enforcement unit of the European Data Protection Supervisor.