Article 59

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

1.   In the AI regulatory sandbox, personal data lawfully collected for other purposes may be processed solely for the purpose of developing, training and testing certain AI systems in the sandbox when all of the following conditions are met:

(a)

AI systems 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:

(i)

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

(ii)

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;

(iii)

energy sustainability;

(iv)

safety and resilience of transport systems and mobility, critical infrastructure and networks;

(v)

efficiency and quality of public administration and public services;

(b)

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;

(c)

there are effective monitoring mechanisms to identify if any high risks to the rights and freedoms of the data subjects, 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 and, where necessary, stop the processing;

(d)

any personal data 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 and only authorised persons have access to those data;

(e)

providers can further share the originally collected data only in accordance with Union data protection law; any personal data created in the sandbox cannot be shared outside the sandbox;

(f)

any processing of personal data in the context of the sandbox neither leads to measures or decisions affecting the data subjects nor does it affect the application of their rights laid down in Union law on the protection of personal data;

(g)

any personal data 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 has reached the end of its retention period;

(h)

the logs of the processing of personal data 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;

(i)

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

(j)

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 in relation to the activities of law enforcement, border control, immigration or asylum authorities.

2.   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, the processing of personal data in AI regulatory sandboxes shall be based on a specific Union or national law and subject to the same cumulative conditions as referred to in paragraph 1.

3.   Paragraph 1 is without prejudice to Union or national law which excludes processing of personal data 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 which is necessary for the purpose of developing, testing or training of innovative AI systems or any other legal basis, in compliance with Union law on the protection of personal data.

Frequently Asked Questions

The AI regulatory sandbox is a protected environment where AI systems created for important public needs, like healthcare or environmental protection, can be safely developed and tested; personal data processed within the sandbox is used only to build and improve these specific systems under strict data safety and privacy rules, ensuring people’s rights remain fully protected.
Personal data can only be processed if it meets strict guidelines, including use for substantial public interest, necessity where anonymous data won’t suffice, effective monitoring of risks, limiting data access strictly to authorized individuals, ensuring no harm or decisions affect individuals involved, and properly deleting data after the sandbox activity ends.
Personal data in the sandbox must be processed separately and securely, access is restricted, sharing of any personal data created there is confined strictly to the sandbox, there are required technical safeguards against unauthorized use, and it is promptly deleted after use to minimize risks to people’s data protection rights and freedoms.
When using personal data in an AI sandbox for law enforcement, purposes such as crime prevention or investigation, it must follow specific European Union or national laws and satisfy all the same strict protective conditions concerning personal data set forth clearly in this article.

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