Governing AI in the European Union: Emerging Infrastructures and Regulatory Ecosystems in Health

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This article examines and discusses recent European developments in AI governance and regulation. It considers their implications for health in the EU in four sections. Following an introduction to recent EU initiatives that have resultet in a complex regulatory eco-system, section 2 outlines the AI-related policies and guidelines that have developed in the EU. Section 3 examines the AI Act, the AILD and the PLD, highlighting their potential impact on AI in health. Within that examination it also considers how the Medical Device Regulation (MDR) operates alongside the AI Act for AI medical devices, and how generative AI (GenAI) will be regulated. Section 4 explores the European data architecture that intersects with the laws in this area, particularly highlighting the GDPR’s intersection with the AI Act, and further examines the sector-specific European Health Data Space (EHDS) Regulation.
Original languageEnglish
Title of host publicationResearch Handbook on Health, AI and the Law
EditorsBarry Solaiman, Glenn Cohen
PublisherEdward Elgar Publishing
Publication date20 Jul 2024
Pages311-331
Chapter18
DOIs
Publication statusPublished - 20 Jul 2024

ID: 312852174