Im Rahmen des ULME Forschungsseminars referiert Fr. Prof. Dr. iur. Claudia Seitz (Private University  in the Principality of Liechtenstein) zu dem 

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

Datum: 16.07.2026 um 16:15 Uhr

Ort: Helmholtzstrasse 18, Raum 1.20

Fr. Seitz wird am Nachmittag anwesend sein. Gerne kann ein Treffen vereinbart werden. E-Mail an Fr. 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, personalized 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 of 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 medical devices legislation, data protection law and emerging health data governance, highlighting the need for coherent, integrated and future-oriented regulatory approaches.

Building on selected examples from medical AI, the lecture discusses key governance challenges, including algorithmic bias, explainability, transparency, human oversight and the role of risk 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 while ensuring legal certainty, patient safety and the protection of fundamental rights.