Article 9Chapter III — High-Risk AI Systems
Risk Management System
High-Risk
Summary
Requires providers of high-risk AI systems to establish, implement, document, and maintain a risk management system throughout the entire lifecycle of the AI system.
Keywords
risk managementlifecycleresidual risktestingmitigation
Legal Text
Article 9 — Risk Management System 1. A risk management system shall be established, implemented, documented and maintained in relation to high-risk AI systems. 2. The risk management system shall be understood as a continuous iterative process run throughout the entire lifecycle of a high-risk AI system, requiring regular systematic review and updating. It shall comprise the following steps: (a) the identification and analysis of the known and reasonably foreseeable risks that the high-risk AI system can pose to health, safety or fundamental rights when the high-risk AI system is used in accordance with its intended purpose; (b) the estimation and evaluation of the risks that may emerge when the high-risk AI system is used in accordance with its intended purpose, and under conditions of reasonably foreseeable misuse; (c) the evaluation of other risks possibly arising, based on the analysis of data gathered from the post-market monitoring system referred to in Article 72; (d) the adoption of appropriate and targeted risk management measures in accordance with the provisions of the following paragraphs.
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