EU Law and the Use of Artificial Intelligence Tools in Health and Wellbeing

“EU Law and the Use of Artificial Intelligence Tools in Health and Wellbeing” course is part of the Digital Transformations in Health and Wellbeing micro-programme within the CIVIS HUB5, focusing on the European legal frameworks shaping the development of AI for health and wellbeing and the key legal risks associated with such a technology.

The whole micro-programme will be available starting with the running academic year (2025/2026) and will consist of a set of 5 courses as follows:

C1: Digital and Technological Transformation: Social Challenges Across Domains offered by Universidad Autónoma de Madrid

C2: EU Law and the Use of Artificial Intelligence Tools in Health and Wellbeing offered by Eberhard Karls Universität Tübingen

C3: Artificial Intelligence Tools in Health and Wellbeing offered by Aix-Marseille Université

C4: Digital Transformations in Oncology offered by University of Bucharest

C5: New Technologies in the Diagnostic and Treatment of Cancer offered by Aix-Marseille Université

The objective of the course is to introduce the students to the key legal frameworks regulating AI for Health and Wellbeing and how they should be taken into account in the development of the technology. The students will develop an understanding of how data protection law, data law, the regulation of AI and medical devices as well as intellectual property law and consumer protection law shape the development, marketing and use of AI for health and wellbeing. Through practical case examples, the students will learn to explain which fields of law should be considered and what their key regulatory objectives are with respect to AI for Health and Wellbeing. The students will also learn to reflect on different regulatory and governance objectives for AI. The long-term aim of the course is to familiarize and sensitize students to the legal landscape and legal and ethical risks associated with working on or using AI applications for health and wellbeing.

Main topics addressed

The course will introduce to the students to the key fields of EU law regulating digital health and wellbeing:

• Data protection law
• Artificial Intelligence Act
• Medical Device Regulation
• Private and Consumer Protection Law
• Intellectual Property Law

In addition the course will discuss the broader topics of regulating the ecosystems of health data and international AI governance, including future trends.

The course consists of 12 lectures that presuppose familiarization with preparatory reading material. Throughout the course, the participants develop a descriptive, integrative case study on an AI application for AI for Health or Wellbeing and an analysis of how the relevant legal frameworks shape its development. The case study will be accompanied by a reflection on the challenges of applying the EU law to the particular case and the broader challenges of regulating AI in highly interdisciplinary application contexts.

Learning outcomes

• Through reading material, lectures and case examples of AI applications for digital health and well being, the students will learn to identify key EU law obligations shaping the development and the technology.
• The students shall learn the objectives of EU regulations for AI and medical devices, data protection law, intellectual property law and consumer protection law.
• On a more abstract level, the students will recognize possible conflicts and uncertainties related to the application of the laws discussed in the context of AI for digital health and wellbeing.
•  Finally, they will also learn to reflect critically on the trade-offs between different regulatory approaches to AI in the context of health and wellbeing.

Read more about the micro - programme