Article 9 Risk management system

A risk means the combination of the probability of an occurrence of harm and the severity of that harm; management system shall be established, implemented, documented and maintained in relation to high-risk AI systems means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments;.

1. the identification and analysis of the known and the reasonably foreseeable risks means the combination of the probability of an occurrence of harm and the severity of that harm; that the high-risk AI system means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; can pose to health, safety or fundamental rights when the high-risk AI system means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; is used in accordance with its intended purpose means the use for which an AI system is intended by the provider, including the specific context and conditions of use, as specified in the information supplied by the provider in the instructions for use, promotional or sales materials and statements, as well as in the technical documentation;;

2. the estimation and evaluation of the risks means the combination of the probability of an occurrence of harm and the severity of that harm; that may emerge when the high-risk AI system means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; is used in accordance with its intended purpose means the use for which an AI system is intended by the provider, including the specific context and conditions of use, as specified in the information supplied by the provider in the instructions for use, promotional or sales materials and statements, as well as in the technical documentation;, and under conditions of reasonably foreseeable misuse means the use of an AI system in a way that is not in accordance with its intended purpose, but which may result from reasonably foreseeable human behaviour or interaction with other systems, including other AI systems;;

3. the evaluation of other risks means the combination of the probability of an occurrence of harm and the severity of that harm; possibly arising, based on the analysis of data gathered from the post-market monitoring system means all activities carried out by providers of AI systems to collect and review experience gained from the use of AI systems they place on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions; referred to in Article 72;

4. the adoption of appropriate and targeted risk means the combination of the probability of an occurrence of harm and the severity of that harm; management measures designed to address the risks means the combination of the probability of an occurrence of harm and the severity of that harm; identified pursuant to point (a).

The risks means the combination of the probability of an occurrence of harm and the severity of that harm; referred to in this Article shall concern only those which may be reasonably mitigated or eliminated through the development or design of the high-risk AI system means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments;, or the provision of adequate technical information.

The risk means the combination of the probability of an occurrence of harm and the severity of that harm; management measures referred to in paragraph 2, point (d), shall give due consideration to the effects and possible interaction resulting from the combined application of the requirements set out in this Section, with a view to minimising risks means the combination of the probability of an occurrence of harm and the severity of that harm; more effectively while achieving an appropriate balance in implementing the measures to fulfil those requirements.

The risk means the combination of the probability of an occurrence of harm and the severity of that harm; management measures referred to in paragraph 2, point (d), shall be such that the relevant residual risk means the combination of the probability of an occurrence of harm and the severity of that harm; associated with each hazard, as well as the overall residual risk means the combination of the probability of an occurrence of harm and the severity of that harm; of the high-risk AI systems means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; is judged to be acceptable.

1. elimination or reduction of risks means the combination of the probability of an occurrence of harm and the severity of that harm; identified and evaluated pursuant to paragraph 2 in as far as technically feasible through adequate design and development of the high-risk AI system means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments;;

2. where appropriate, implementation of adequate mitigation and control measures addressing risks means the combination of the probability of an occurrence of harm and the severity of that harm; that cannot be eliminated;

3. provision of information required pursuant to Article 13 and, where appropriate, training to deployers means a natural or legal person, public authority, agency or other body using an AI system under its authority except where the AI system is used in the course of a personal non-professional activity;.

With a view to eliminating or reducing risks means the combination of the probability of an occurrence of harm and the severity of that harm; related to the use of the high-risk AI system means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments;, due consideration shall be given to the technical knowledge, experience, education, the training to be expected by the deployer means a natural or legal person, public authority, agency or other body using an AI system under its authority except where the AI system is used in the course of a personal non-professional activity;, and the presumable context in which the system is intended to be used.

High-risk AI systems means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; shall be tested for the purpose of identifying the most appropriate and targeted risk means the combination of the probability of an occurrence of harm and the severity of that harm; management measures. Testing shall ensure that high-risk AI systems means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; perform consistently for their intended purpose means the use for which an AI system is intended by the provider, including the specific context and conditions of use, as specified in the information supplied by the provider in the instructions for use, promotional or sales materials and statements, as well as in the technical documentation; and that they are in compliance with the requirements set out in this Section.

Testing procedures may include testing in real-world conditions means the temporary testing of an AI system for its intended purpose in real-world conditions outside a laboratory or otherwise simulated environment, with a view to gathering reliable and robust data and to assessing and verifying the conformity of the AI system with the requirements of this Regulation and it does not qualify as placing the AI system on the market or putting it into service within the meaning of this Regulation, provided that all the conditions laid down in Article 57 or 60 are fulfilled; in accordance with Article 60.

The testing of high-risk AI systems means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; shall be performed, as appropriate, at any time throughout the development process, and, in any event, prior to their being placed on the market or put into service. Testing shall be carried out against prior defined metrics and probabilistic thresholds that are appropriate to the intended purpose means the use for which an AI system is intended by the provider, including the specific context and conditions of use, as specified in the information supplied by the provider in the instructions for use, promotional or sales materials and statements, as well as in the technical documentation; of the high-risk AI system means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments;.

When implementing the risk means the combination of the probability of an occurrence of harm and the severity of that harm; management system as provided for in paragraphs 1 to 7, providers means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; shall give consideration to whether in view of its intended purpose means the use for which an AI system is intended by the provider, including the specific context and conditions of use, as specified in the information supplied by the provider in the instructions for use, promotional or sales materials and statements, as well as in the technical documentation; the high-risk AI system means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; is likely to have an adverse impact on persons under the age of 18 and, as appropriate, other vulnerable groups.

For providers means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; of high-risk AI systems means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; that are subject, for the purpose of real-world testing, means a natural person who participates in testing in real-world conditions; to requirements regarding internal risk means the combination of the probability of an occurrence of harm and the severity of that harm; management processes under other relevant provisions of Union law, the aspects provided in paragraphs 1 to 9 may be part of, or combined with, the risk means the combination of the probability of an occurrence of harm and the severity of that harm; management procedures established pursuant to that law.