European Union: Adopted AI Act including monitoring requirements for "high-risk AI systems" by Council

On 21 May 2024, the Council of the European Union adopted the regulation laying down harmonised rules on Artificial Intelligence (Artificial Intelligence Act). The Act includes post-deployment performance monitoring requirements for "high-risk" AI systems. The Act requires providers of high-risk AI systems to establish and document a post-marketing monitoring system, through which it actively collects data on the performance of high-risk AI systems in order to evaluate their compliance with the Regulation's requirements. Further, the Act would require providers of high-risk AI systems to report serious incidents to the market authorities of their respective member states. In general, providers are required to report a serious incident as soon as they establish a causal link between a high-risk system and a serious incident and, in any case, within 15 days of becoming aware of such an incident. The Act will come into effect 20 days following its publication in the Official Journal and will be implemented 24 months after it enters into force. Chapters I and II will apply 6 months after the Act's effective date. Chapter III Section 4, Chapter V, Chapter VII, Chapter XII, and Article 78 will be implemented 12 months after the Act comes into effect.