On 6 December 2022, the Council of the European Union adopted its general approach on the Artificial Intelligence Act (AI Act), which 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.
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