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Title-v-Measures-in-Support-of-Innovations

Article 53: AI Regulatory Sandboxes

1. Member States shall ensure that their competent authorities establish at least one AI regulatory sandbox at national level, which shall be operational 24 months after entry into force. This sandbox may also be established jointly with one or several other Member States’ competent authorities. The Commission may provide technical support, advice and tools for the establishment and operation of AI regulatory sandboxes. The obligation established in previous paragraph can also be fulfilled by participation in an existing sandbox insofar as this participation provides equivalent level of national coverage for the participating Member States.

Article 54: 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 purposes 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 governed by public law or by private law and in one or more of the following areas:

Article 54a: Testing of High-Risk AI Systems in Real World Conditions Outside AI Regulatory Sandboxes

1. Testing of AI systems in real world conditions outside AI regulatory sandboxes may be conducted by providers or prospective providers of high-risk AI systems listed in Annex III, in accordance with the provisions of this Article and the real world testing plan referred to in this Article, without prejudice to the prohibitions under Article 5. The detailed elements of the real world testing plan shall be specified in implementing acts adopted by the Commission in accordance with the examination procedure referred to in Article 74(2).

Article 54b: 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;

Article 55: Measures for Providers and Deployers, in Particular SMEs, Including Start-Ups

1. Member States shall undertake the following actions: (a) provide SMEs, including start-ups, having a registered office or a branch in the Union, with priority access to the AI regulatory sandboxes, to the extent that they fulfil the eligibility conditions and selection criteria. The priority access shall not preclude other SMEs including start-ups other than those referred to in the first subparagraph to access to the AI regulatory sandbox, provided that they fulfil the eligibility conditions and selection criteria;

Suitable Recitals for article 1

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