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In June 2024, the EU AI Act came into force. The AI Act includes obligations for the provider of an AI system. Article 10 of the AI Act includes a new obligation for providers to evaluate whether their training, validation and testing…
This chapter provides a comprehensive discussion on AI regulation in the European Union, contrasting it with the more sectoral and self-regulatory approach in the UK. It argues for a hybrid regulatory strategy that combines elements from…
The EU Artificial Intelligence Act (AI Act) came into force in the European Union (EU) on 1 August 2024. It is a key piece of legislation both for the citizens at the heart of AI technologies and for the industry active in the internal…
The EU AI Act provides a rulebook for all AI systems being put on the market or into service in the European Union. This article investigates the requirement under the AI Act that Member States establish national AI regulatory sandboxes for…
The EU AI Act represents the world's first transnational AI regulation with concrete enforcement measures. It builds on existing EU mechanisms for regulating health and safety of products but extends them to protect fundamental rights and…
As artificial intelligence (AI) regulations evolve and the regulatory landscape develops and becomes more complex, ensuring compliance with ethical guidelines and legal frameworks remains a challenge for AI developers. This paper introduces…
The lack of explainability of Artificial Intelligence (AI) is one of the first obstacles that the industry and regulators must overcome to mitigate the risks associated with the technology. The need for eXplainable AI (XAI) is evident in…
This article provides a critical overview of the recently approved Artificial Intelligence Act. It starts by presenting the main structure, objectives, and approach of Regulation (EU) 2024/1689. A definition of key concepts follows, and…
The EU Artificial Intelligence Act (AIA) establishes different legal principles for different types of AI systems. While prior work has sought to clarify some of these principles, little attention has been paid to robustness and…
The proposed European Artificial Intelligence Act (AIA) is the first attempt to elaborate a general legal framework for AI carried out by any major global economy. As such, the AIA is likely to become a point of reference in the larger…
The EU Artificial Intelligence Act (AIA) establishes a lifecycle governance regime for high-risk AI systems built around ex-ante conformity assessment, post-market monitoring, and re-assessment upon "substantial modification." These…
As deep learning (DL) technologies advance, their application in automated visual inspection for Class III medical devices offers significant potential to enhance quality assurance and reduce human error. However, the adoption of such…
The rapid rollout of AI in heterogeneous public and societal sectors has subsequently escalated the need for compliance with regulatory standards and frameworks. The EU AI Act has emerged as a landmark in the regulatory landscape. The…
AI agents -- systems that can independently take actions to pursue complex goals with only limited human oversight -- have entered the mainstream. These systems are now being widely used to produce software, conduct business activities, and…
As AI technology advances rapidly, concerns over the risks of bigness in digital markets are also growing. The EU's Digital Markets Act (DMA) aims to address these risks. Still, the current framework may not adequately cover generative AI…
The EU AI Act was created to ensure ethical and safe Artificial Intelligence (AI) development and deployment across the EU. This study aims to identify key challenges and strategies for helping enterprises focus on resources effectively. To…
In August 2024, the EU Artificial Intelligence Act (AIA) came into force, marking the world's first large-scale regulatory framework for AI. Central to the AIA is a risk-based approach, aligning regulatory obligations with the potential…
The EU's Artificial Intelligence Act (AI Act) is a significant step towards responsible AI development, but lacks clear technical interpretation, making it difficult to assess models' compliance. This work presents COMPL-AI, a comprehensive…
The introduction of the AI Act in the European Union presents the AI research and practice community with a set of new challenges related to compliance. While it is certain that AI practitioners will require additional guidance and tools to…
The proposed EU AI Act is the first comprehensive attempt to regulate AI in a major jurisdiction. This article analyses Article 9, the key risk management provision in the AI Act. It gives an overview of the regulatory concept behind…