Article 59 Further processing of personal data for developing certain AI systems in the public interest in the AI regulatory sandbox

1. AI systems 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; shall be developed for safeguarding substantial public interest by a public authority or another natural or legal person and in one or more of the following areas:

   1. public safety and public health, including disease detection, diagnosis prevention, control and treatment and improvement of health care systems;

   2. a high level of protection and improvement of the quality of the environment, protection of biodiversity, protection against pollution, green transition measures, climate change mitigation and adaptation measures;

   3. energy sustainability;

   4. safety and resilience of transport systems and mobility, critical infrastructure means critical infrastructure as defined in Article 2, point (4), of Directive (EU) 2022/2557; and networks;

   5. efficiency and quality of public administration and public services;

2. the data processed are necessary for complying with one or more of the requirements referred to in Chapter III, Section 2 where those requirements cannot effectively be fulfilled by processing anonymised, synthetic or other non-personal data means data other than personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679;;

3. there are effective monitoring mechanisms to identify if any high risks means the combination of the probability of an occurrence of harm and the severity of that harm; to the rights and freedoms of the data subjects, for the purpose of real-world testing, means a natural person who participates in testing in real-world conditions;, as referred to in Article 35 of Regulation (EU) 2016/679 and in Article 39 of Regulation (EU) 2018/1725, may arise during the sandbox experimentation, as well as response mechanisms to promptly mitigate those risks means the combination of the probability of an occurrence of harm and the severity of that harm; and, where necessary, stop the processing;

4. any personal data means personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679; to be processed in the context of the sandbox are in a functionally separate, isolated and protected data processing environment under the control of the prospective 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; and only authorised persons have access to those data;

5. providers 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; can further share the originally collected data only in accordance with Union data protection law; any personal data means personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679; created in the sandbox cannot be shared outside the sandbox;

6. any processing of personal data means personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679; in the context of the sandbox neither leads to measures or decisions affecting the data subjects, for the purpose of real-world testing, means a natural person who participates in testing in real-world conditions; nor does it affect the application of their rights laid down in Union law on the protection of personal data means personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679;;

7. any personal data means personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679; processed in the context of the sandbox are protected by means of appropriate technical and organisational measures and deleted once the participation in the sandbox has terminated or the personal data means personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679; has reached the end of its retention period;

8. the logs of the processing of personal data means personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679; in the context of the sandbox are kept for the duration of the participation in the sandbox, unless provided otherwise by Union or national law;

9. a complete and detailed description of the process and rationale behind the training, testing and validation 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; is kept together with the testing results as part of the technical documentation referred to in Annex IV;

10. a short summary of the AI project developed in the sandbox, its objectives and expected results is published on the website of the competent authorities; this obligation shall not cover sensitive operational data means operational data related to activities of prevention, detection, investigation or prosecution of criminal offences, the disclosure of which could jeopardise the integrity of criminal proceedings; in relation to the activities of law enforcement means activities carried out by law enforcement authorities or on their behalf for the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including safeguarding against and preventing threats to public security;, border control, immigration or asylum authorities.

For the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including safeguarding against and preventing threats to public security, under the control and responsibility of law enforcement authorities means: any public authority competent for the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to public security; or any other body or entity entrusted by Member State law to exercise public authority and public powers for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to public security;, the processing of personal data means personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679; in AI regulatory sandboxes shall be based on a specific Union or national law and subject, for the purpose of real-world testing, means a natural person who participates in testing in real-world conditions; to the same cumulative conditions as referred to in paragraph 1.

Paragraph 1 is without prejudice to Union or national law which excludes processing of personal data means personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679; for other purposes than those explicitly mentioned in that law, as well as to Union or national law laying down the basis for the processing of personal data means personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679; which is necessary for the purpose of developing, testing or training of innovative AI systems 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; or any other legal basis, in compliance with Union law on the protection of personal data means personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679;.