Summary of Article 61
- Provider Responsibilities for Consent Procedures: Providers must obtain freely-given informed consent from subjects prior to testing, ensuring they are fully informed of the testing objectives, conditions, their rights, and relevant procedural details.
- Provider Obligations for Documenting Consent: Providers are required to date, document, and provide a copy of the informed consent to the subjects or their legal representatives.
Provider Responsibilities for Consent Procedures
1. For the purpose of testing in real world conditions under Article 60, freely-given informed consent shall be obtained from the subjects of testing prior to their participation in such testing and after their having been duly informed with concise, clear, relevant, and understandable information regarding:
(a) the nature and objectives of the testing in real world conditions and the possible inconvenience that may be linked to their participation;
(b) the conditions under which the testing in real world conditions is to be conducted, including the expected duration of the subject or subjects’ participation;
(c) 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;
(d) the arrangements for requesting the reversal or the disregarding of the predictions, recommendations or decisions of the AI system;
(e) 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 or its legal representative from whom further information can be obtained.
Provider Obligations for Documenting Consent
2. The informed consent shall be dated and documented and a copy shall be given to the subjects of testing or their legal representative.
