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Recital 142

Real-world testing outside regulatory sandboxes

Regulation (EU) 2024/1689 - Artificial Intelligence Act · Preamble

In order to accelerate the process of development and the placing on the market of the high-risk AI systems listed in an annex to this Regulation, it is important that providers or prospective providers of such systems may also benefit from a specific regime for testing those systems in real world conditions, without participating in an AI regulatory sandbox. However, in such cases, and taking into account the potential consequences of such testing on individuals, it should be ensured that appropriate and sufficient guarantees and conditions are established by this Regulation for providers or prospective providers. Such guarantees should include, inter alia, requesting informed consent of natural persons to participate in testing in real world conditions, with the exception of law enforcement where the seeking of informed consent would prevent the AI system from being tested. Consent of subjects to participate in such testing under this Regulation is distinct from and without prejudice to consent of data subjects for the processing of their personal data under the relevant data protection law. It is also important to minimise the risks and enable oversight by competent authorities and therefore to require prospective providers to have a real-world testing plan submitted to competent market surveillance authority, to register the testing in dedicated sections in the EU database subject to some limited exceptions, to set limitations on the period during which the testing can be done and to require additional safeguards for persons belonging to certain vulnerable groups, as well as a written agreement defining the terms, conditions and responsibilities of prospective providers and deployers and effective oversight by competent staff involved in the real world testing. Furthermore, it is appropriate to require specific additional safeguards to ensure that the predictions, recommendations or decisions of the AI system can be effectively reversed and disregarded and that personal data is protected and is deleted when the subjects have withdrawn their consent to participate in the testing without affecting the rights they enjoy as data subjects under Union data protection law. As regards transfer of data, it is also appropriate to envisage safeguards that data that has been collected and processed for the purpose of testing in real world conditions should not be transferred to third parties outside the framework of the real world testing and subject to appropriate safeguards, and that data is deleted after the testing period has ended. It is appropriate to provide that testing in real world conditions is supervised directly by the prospective provider, while closely involving the deployer. Providers or prospective providers wishing to conduct testing in real world conditions should register themselves and the testing in the EU database, subject to a few listed exceptions. It is also appropriate to ensure that financial institutions or other entities under financial services Union law testing innovative AI systems can participate in testing in real world conditions, with the involvement of financial supervisory authorities.