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Article 54b


Removed on May 8th 2024 based on the version and article numbering in the EU Parliament's 'Corrigendum' version dated April 19th 2024.

[Previous version]

Removed on April 10th 2024 based on the version and article numbering approved by the EU Parliament on March 13th 2024.

Updated on Feb 6th 2024 based on the version endorsed by the Coreper I on Feb 2nd

Informed Consent to Participate in Testing in Real World Conditions Outside AI Regulatory Sandboxes

1. For the purpose of testing in real world conditions under Article 54a, informed consent shall be freely given by the subject of testing prior to his or her participation in such testing and after having been duly informed with concise, clear, relevant, and understandable information regarding:

(i) the nature and objectives of the testing in real world conditions and the possible inconvenience that may be linked to his or her participation;

(ii) the conditions under which the testing in real world conditions is to be conducted, including the expected duration of the subject's participation;

(iii) the subject's rights and guarantees regarding participation, in particular his or her 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;

(iv) the modalities for requesting the reversal or the disregard of the predictions, recommendations or decisions of the AI system;

(v) the Union-wide unique single identification number of the testing in real world conditions in accordance with Article 54a(4c) and the contact details of the provider or its legal representative from whom further information can be obtained.

2. The informed consent shall be dated and documented, and a copy shall be given to the subject or his or her legal representative.

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