Regulatory sandboxes in the AI Act: reconciling innovation and safety?

Author(s)

Thomas Buocz, Sebastian Pfotenhauer, Iris Eisenberger

Abstract

This paper explores the regulatory sandbox regime under the EU’s draft Artificial Intelligence (AI) Act. It investigates how useful the sandbox regime is for testing an AI-based skin cancer detection systems in an EU member state. The paper focuses on whether the proposed AI regulatory sandbox regime can resolve tensions between innovation and safety. Although we find considerable potential for the sandbox regime, the proposal also creates several legal issues. It blurs jurisdictional boundaries between the EU and member states, raises concerns of legality and equal treatment, creates liability risks for innovators, and fails to require informed consent from testing subjects. To address these problems, the paper suggests adopting a more targeted legal basis for the sandbox regime that takes inspiration from conventional testing mechanisms such as clinical investigations for medical devices.

Organisation(s)

Department of Innovation and Digitalisation in Law

External organisation(s)

Universität für Bodenkultur Wien, Technische Universität München

Journal

Law, Innovation and Technology

Volume

15

Pages

357-389

No. of pages

33

ISSN

1757-9961

DOI

https://doi.org/10.1080/17579961.2023.2245678

Publication date

08-2023

Peer reviewed

Yes

Austrian Fields of Science 2012

505012 Public law

Keywords

ASJC Scopus subject areas

Computer Science (miscellaneous), Artificial Intelligence, Law, Biotechnology, Computer Science Applications

Portal url

https://ucris.univie.ac.at/portal/en/publications/regulatory-sandboxes-in-the-ai-act-reconciling-innovation-and-safety(5ea669a5-5445-4737-a0b9-929ce688ee95).html