European Union: Reached Council and Parliament agreement on AI Act including monitoring requirements for "high-risk AI systems"

On 9 December 2023, the Parliament and the Council of the European Union adopted a provisional agreement on the proposal on harmonised rules on artificial intelligence (AI Act). The compromise agreement clarifies the definition of an AI system by aligning it with the OECD's proposed approach, seeking to differentiate AI from simpler software systems. The AI Act specifically exempts systems exclusively utilised for military or defence purposes and those employed solely for research, innovation, or non-professional personal use. The Act includes post-deployment performance monitoring requirements for "high-risk" AI systems. The Regulation would require 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 Regulation 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. Following the provisional agreement, the next steps involve finalising the document and submitting it to the European Union Parliament and Council for adoption.