As part of the ULME seminar, Prof. Dr. iur. Claudia Seitz (Private University in the Principality of Liechtenstein) will be talking about

 “The EU AI Act and Medical AI: Regulatory Architecture, Risk Classification and Governance Challenges”.

Date: 16 July 2026 at 4.15 pm

Venue: Helmholtzstrasse 18, Room 1.20

Prof. Seitz will be around in the afternoon. You are welcome to arrange a meeting. Please email Prof. Dr Sandra Ludwig (sandra.ludwig(at)uni-ulm.de)

Abstract:

Artificial intelligence (AI) is rapidly transforming healthcare and medicine, creating significant opportunities for improving diagnostics, treatment planning, personalised medicine and healthcare management. At the same time, the increasing integration of AI into clinical practice raises complex legal, regulatory and governance challenges relating to patient safety, transparency, accountability, data governance and the effective protection of fundamental rights.

This lecture examines the European Union’s regulatory approach to AI in healthcare, with a particular focus on the EU AI Act. It explains the underlying regulatory architecture of the AI Act and the rationale behind its risk-based approach, including the classification and governance of high-risk AI systems used in medical contexts. The lecture further explores the interaction between the AI Act and the broader European regulatory framework, including legislation on medical devices, data protection law and emerging health data governance, highlighting the need for coherent, integrated and forward-looking regulatory approaches.

Drawing on selected examples from medical AI, the lecture discusses key governance challenges, including algorithmic bias, explainability, transparency, human oversight and the role of risk-based regulation in balancing technological innovation with the effective protection of patients and fundamental rights. Rather than analysing the AI Act as an isolated legal instrument, the lecture situates it within the evolving European regulatory ecosystem and examines how an integrated European AI governance framework can contribute to fostering trustworthy innovation whilst ensuring legal certainty, patient safety and the protection of fundamental rights.