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The European Union is on the brink of an artificial intelligence (AI) revolution in the health sector. AI holds the promise of saving billions of lives by improving the quality of healthcare, reducing costs, increasing accessibility of healthcare, and anticipating health emergency threats. At the same time, AI can bring about serious risks to patients’ rights, such as medical privacy, self-determination, and equal access to healthcare. As technology is preceding legal developments, it is doubtful whether the current framework for patients’ rights protection in Europe is sufficiently adapted to the impact of AI technology on patients. Creating an EU regulatory and legislative framework in the field of AI is complex: the EU is faced with the difficult task of striking a balance between innovation and individual interests, rights, and values. This PhD research project, conducted by Hannah van Kolfschooten, examines the ways in which health AI is and will be regulated at the EU level and explores legal challenges through a patients’ rights lens.

Part of this research project was conducted at Harvard Law School as part of a visiting fellowship. Kristina Irion from the Institute for Information Law (IViR) is involved in this project as a co-supervisor.

Researchers involved

Mr. H.B. (Hannah) van Kolfschooten LLM

Main researcher

Prof. dr. mr. A. (Anniek) de Ruijter


Prof. J. (Johan) Legemaate


Dr K. (Kristina) Irion