Article 61 Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes

1. the nature and objectives of the testing in real world conditions and the possible inconvenience that may be linked to their participation;

2. the conditions under which the testing in real world conditions is to be conducted, including the expected duration of the subject, for the purpose of real-world testing, means a natural person who participates in testing in real-world conditions; or subjects, for the purpose of real-world testing, means a natural person who participates in testing in real-world conditions;’ participation;

3. their rights, and the guarantees regarding their participation, in particular their right to refuse to participate in, and the right to withdraw from, testing in real world conditions at any time without any resulting detriment and without having to provide any justification;

4. the arrangements for requesting the reversal or the disregarding of the predictions, recommendations or decisions of the 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;;

5. the Union-wide unique single identification number of the testing in real world conditions in accordance with Article 60(4) point (c), and the contact details of the provider 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; or its legal representative from whom further information can be obtained.

The informed consent means a subject’s freely given, specific, unambiguous and voluntary expression of his or her willingness to participate in a particular testing in real-world conditions, after having been informed of all aspects of the testing that are relevant to the subject’s decision to participate; shall be dated and documented and a copy shall be given to the subjects, for the purpose of real-world testing, means a natural person who participates in testing in real-world conditions; of testing or their legal representative.