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Risk level: high Title III — High-Risk AI Systems Requirements

Article 13 — Transparency and Provision of Information to Deployers

Transparency and provision of information to deployers 1. High-risk AI systems shall be designed and developed in such a way as to ensure that their operation is sufficiently transparent to enable deployers to interpret a system’s output and use it appropriately. An appropriate type and degree of transparency shall be ensured with a view to...

Article 13
Transparency and provision of information to deployers
1. High-risk AI systems shall be designed and developed in such a way as to ensure that their operation is sufficiently
transparent to enable deployers to interpret a system’s output and use it appropriately. An appropriate type and degree of
transparency shall be ensured with a view to achieving compliance with the relevant obligations of the provider and
deployer set out in Section 3.
2. High-risk AI systems shall be accompanied by instructions for use in an appropriate digital format or otherwise that
include concise, complete, correct and clear information that is relevant, accessible and comprehensible to deployers.
3. The instructions for use shall contain at least the following information:
(a) the identity and the contact details of the provider and, where applicable, of its authorised representative;
(b) the characteristics, capabilities and limitations of performance of the high-risk AI system, including:
(i) its intended purpose;
(ii) the level of accuracy, including its metrics, robustness and cybersecurity referred to in Article 15 against which the
high-risk AI system has been tested and validated and which can be expected, and any known and foreseeable
circumstances that may have an impact on that expected level of accuracy, robustness and cybersecurity;
(iii) any known or foreseeable circumstance, related to the use of the high-risk AI system in accordance with its
intended purpose or under conditions of reasonably foreseeable misuse, which may lead to risks to the health and
safety or fundamental rights referred to in Article 9(2);
(iv) where applicable, the technical capabilities and characteristics of the high-risk AI system to provide information
that is relevant to explain its output;
ELI: http://data.europa.eu/eli/reg/2024/1689/oj 59/144
EN OJ L, 12.7.2024
(v) when appropriate, its performance regarding specific persons or groups of persons on which the system is
intended to be used;
(vi) when appropriate, specifications for the input data, or any other relevant information in terms of the training,
validation and testing data sets used, taking into account the intended purpose of the high-risk AI system;
(vii) where applicable, information to enable deployers to interpret the output of the high-risk AI system and use it
appropriately;
(c) the changes to the high-risk AI system and its performance which have been pre-determined by the provider at the
moment of the initial conformity assessment, if any;
(d) the human oversight measures referred to in Article 14, including the technical measures put in place to facilitate the
interpretation of the outputs of the high-risk AI systems by the deployers;
(e) the computational and hardware resources needed, the expected lifetime of the high-risk AI system and any necessary
maintenance and care measures, including their frequency, to ensure the proper functioning of that AI system, including
as regards software updates;
(f) where relevant, a description of the mechanisms included within the high-risk AI system that allows deployers to
properly collect, store and interpret the logs in accordance with Article 12.

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