WASP-HS Webinar on "Standardisation and the Regulation of Intelligent Medical Devices"

Abstract: The webinar will focus on the role of standardisation in the regulation of intelligent medical devices within the European Union, focusing on its interaction with product safety law and emerging AI governance. It highlights how harmonised standards function as a key regulatory instrument, while also raising concerns related to transparency, accountability, and fundamental rights. The analysis is complemented by brief comparative remarks on the United States, where AI governance relies more heavily on voluntary standards in the absence of a comprehensive federal regulatory framework.

Speaker: Vittoria Trifiletti, University of Turin

Discussant: Professor Michele Graziadei, University of Turin

Chair: Professor Martin Ebers, Örebro University

Bios:  

Vittoria Trifiletti is a PhD candidate at the University of Turin. Her research focuses on the standardisation of smart medical devices, with a comparative analysis between the EU and the US.

Michele Graziadei is a full professor of Comparative Private Law at the University of Turin, where he teaches comparative legal systems and comparative private law.   

This webinar forms part of the WASP-HS research project "Private Rule-Making and European Governance of AI & Robotics" and the WASP-HS Research Cluster "The Rule of AI: AI, Regulation and Society".

A Zoom link will be sent to you by email upon registration.