Article 12 Record-keeping


    1. 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 technically allow for the automatic recording of events (logs) over the lifetime of the system.

    1. In order to ensure a level of traceability of the functioning of a 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; that is 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 system, logging capabilities shall enable the recording of events relevant for:

      1. identifying situations that may result in 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; presenting a risk means the combination of the probability of an occurrence of harm and the severity of that harm; within the meaning of Article 79(1) or in a substantial modification means a change to an AI system after its placing on the market or putting into service which is not foreseen or planned in the initial conformity assessment carried out by the provider and as a result of which the compliance of the AI system with the requirements set out in Chapter III, Section 2 is affected or results in a modification to the intended purpose for which the AI system has been assessed;;

      2. facilitating the post-market monitoring referred to in Article 72; and

      3. monitoring the operation 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; referred to in Article 26(5).

    1. For 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; referred to in point 1 (a), of Annex III, the logging capabilities shall provide, at a minimum:

      1. recording of the period of each use of the system (start date and time and end date and time of each use);

      2. the reference database against which input data means data provided to or directly acquired by an AI system on the basis of which the system produces an output; has been checked by the system;

      3. the input data means data provided to or directly acquired by an AI system on the basis of which the system produces an output; for which the search has led to a match;

      4. the identification of the natural persons involved in the verification of the results, as referred to in Article 14(5).

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