Ensuring the Trustworthy Use of Medical AI: a legal perspective

Korte beschrijving

This thesis explores the essential building blocks for a legal framework necessary to ensure the trustworthy use of artificial intelligence (AI) in healthcare. It examines the interplay between these elements and identifies gaps in the current EU legal framework. Part I provides a foundational legal and conceptual analysis, focusing on the concept of trust within the doctor-patient relationship and how AI in healthcare may challenge this trust. This section presents a comprehensive overview of regulations designed to ensure trust in both healthcare and AI. Part II applies these regulatory building blocks to three key aspects of AI integration in healthcare: the safety of medical AI, the competencies of doctors regarding AI, and patient-centered communication. The thesis advocates for a new patient-centric approach that fosters trust through a robust legal framework encompassing the safety and clinical efficacy of medical AI, healthcare professional proficiency in AI, and enhanced patient digital literacy.