UNPACKING THE AI ACT : - GAINS AND GAPS IN THE

UNPACKING THE AI ACT: GAINS AND GAPS IN THE PROTECTION OF HEALTH April 2024 The Artificial Intelligence (AI) Act is a much-discussed piece of innovative European Union (EU) legislation that is generating global interest. [...] Fundamental Rights Public deployers of high-risk AI systems, such In many European health systems, the majority of as municipalities and the Ministry of Health (or deployers of high-risk AI are private entities (e.g., private operators providing public services), need to privatised hospitals or insurance companies), and conduct a fundamental rights impact assessment therefore will not have to cond. [...] registration of all high-risk AI systems in healthcare, including medical devices, by providers and public and private deployers, would improve oversight and assist in assessing the scope, implementation and potential gaps of the AI Act. [...] Health Specificity The Act aims to protect the health, safety and The AI Act does not define health or health fundamental rights of individuals. [...] The sole responsibility for the project lies with the organiser(s) and the content may not necessarily reflect the positions of EAISF, NEF or European AI Fund’s Partner Foundations.