Implementing Regulation on AI Regulatory Sandboxes

It is vital for start-ups to work directly with the regulatory Office over the AI regulatory sandboxes. Although the solution would require additional resources on the side of the regulatory such approach would stimulate greater operational flexibility of the start-ups (and SMEs in general) and assure scalability of their businesses in the long run. Therefore point 4.5 would provide more clarity on this issue.

Please find attached detailed comments, and below our key observations and recommendations on the draft implementing act on AI regulatory sandboxes: - Regulatory sandboxes should operate with harmonised processes, uniform treatment and predictable outcomes across the EU. The European AI Board should receive a clear mandate to coordinate sandboxes and issue EU-wide guidelines, in partnership with industry.

AI has the potential to deliver a significant contribution to accelerating the EUs energy transition. The upcoming Strategic Roadmap for digitalization and AI in the energy sector will accelerate deployment of AI solutions in the energy system and stimulate research.

Aena encourages the Commission to ensure that the final wording of the Regulation is sufficiently ambitious to maximise the impact of sandboxes as real catalysts for innovation. This means ensuring that sandboxes are not limited to experimental spaces, but act as effective platforms for validation, technology transfer and scaling of innovative solutions in the European market.

Platformable welcomes the opportunity to respond to the consultation process on AI regulatory sandboxes rules for their set-up and operation. We work with enterprises, SMEs, startups, industry associations, standards bodies, and non-profit organisations on open digital ecosystems in which everyone can participate and co-create their own value.

Access VetMed welcomes the Commissions initiative to establish harmonised rules for AI regulatory sandboxes as a useful framework for the development, testing and validation of AI-based solutions in health, including animal health. Our feedback to the consultation on the Draft Implementing Regulation is attached.

This response addresses six areas where the draft implementing act would benefit from strengthening: a new chapter on establishment; access and selection criteria; sandbox plan; mandatory dissemination of learnings; structured cooperation with EU initiatives; and timely availability of standardised templates. First, the draft lacks concrete provisions on establishment of AI Regulatory Sandboxes.

Pharma Deutschland welcomes the establishment of common rules governing the creation, development, implementation, operation and supervision of AI regulatory sandboxes. We particularly support the objectives of these sandboxes, namely to enhance legal certainty for innovators, facilitate regulatory compliance with Regulation (EU) 2024/1689, promote responsible innovation and competitiveness, and accelerate the…

The AI Act offers providers the possibility to develop, train, validate and test their innovative AI systems for a limited period of time under regulatory supervision in a controlled framework established by a competent authority. AI regulatory sandboxes help achieve the AI Act’s objective of fostering innovation and compliance.

Filed in Italian · English published by the European Commission

Regulatory sandboxes have evolved into pivotal governance instruments designed to bridge the gap between accelerating innovation and legal stability. While the draft successfully establishes a harmonized framework for AI experimentation within the Union, it can be further strengthened by adopting "second-generation" sandbox tools - such as accelerated entry mechanisms and digital synthetic testing - to better align…

This opinion is the result of joint work involving: * Arnault Ioualalen, Numalis, AI SMEs and standardisation expert (the tenderer for this opinion on behalf of the group) * Anne Laurent, Professor and Vice-President of the University of Montpellier * Romaric Redon, Director of the ANITI programme * Pierre Trilles, Director of Mission in the Occitanie Region.

Filed in French · English published by the European Commission

The comments reflect the practical experience of members of the Latvian Association of Artificial Intelligence in developing, deploying and ensuring compliance with AI solutions. The proposals aim to promote responsible innovation and effective application of regulation in practice.

Filed in Latvian · English published by the European Commission

While welcoming the objective of AI regulatory sandboxes to enhance legal certainty and support innovation, it will be important to ensure that their practical operation does not inadvertently favor larger players or more resource-intensive ecosystems.

AI regulatory sandboxes should be framed as more than a safe test environment for innovators. They are also an institutional learning instrument. As argued in the Cambridge Forum paper AI: Law and Governance - Regulatory sandboxes for AI in the majority world: A learning-centric approach to legal adaptation, the value is two-sided: providers learn how to achieve compliance and manage risks, while authorities learn…

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Germanys media authorities expressly welcome the fact that AI regulatory sandboxes can be established not only horizontally, but also in specific sectors, particularly in the media sector, as well as at regional and local level. It is crucial that these structures are integrated in and interoperable to the existing independent system of media regulation.

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