EU AI法

Paul Voigt, Axel von dem Bussche

Hannah van Kolfschooten, J. van Oirschot

In August 2024, the EU Artificial Intelligence Act (AI Act) entered into force. This legally binding instrument sets rules for the development, the placing on the market, the putting into service, and the use of AI systems in the European Union. As the world's first extensive legal framework on AI, it aims to boost innovation while protecting individuals against the harms of AI. Since healthcare is one of the top sectors for AI deployment, the new rules will significantly reform national policies and practices on health technology. In this article, we highlight the implications of the AI Act for the healthcare sector. We give a comprehensive overview of the new legal obligations for various healthcare stakeholders (tech developers; healthcare professionals; public health authorities). We conclude that, due to its horizontal approach, it is necessary to adopt further guidelines to address the unique needs of the healthcare sector. To this end, we make recommendations for the upcoming implementation and standardization phase.

M. Aboy, Timo Minssen, E. Vayena

The newly adopted EU AI Act represents a pivotal milestone that heralds a new era of AI regulation across industries. With its broad territorial scope and applicability, this comprehensive legislation establishes stringent requirements for AI systems. In this article, we analyze the AI Act’s impact on digital medical products, such as medical devices: How does the AI Act apply to AI/ML-enabled medical devices? How are they classified? What are the compliance requirements? And, what are the obligations of ‘providers’ of these AI systems? After addressing these foundational questions, we discuss the AI Act’s broader implications for the future of regulated digital medical products.

Nathalie A. Smuha

Artificial intelligence (AI) systems are permeating all domains of our lives. Aside from the many opportunities they raise, their deployment can also hamper individual and societal interests. To counter these risks, regulators across the globe are therefore adopting normative initiatives to govern the technology. While these mostly consist of the promulgation of ethics guidelines and non-binding recommendations, the European Union (EU) opted for binding rules instead. In Spring 2024, it adopted a landmark regulation titled the Artificial Intelligence Act. The Act entered into force on August 1, 2024, and most of its provisions become applicable after two years. Since it systematically and punctiliously regulates the use of AI across sectors rather than focusing on a specific application domain, the AI Act is heralded as the first legal instrument of its kind. Its trendsetter status in the global AI regulatory landscape, coupled with its extraterritorial scope, means the Act is likely to shape the course of AI's uptake in Europe and beyond.

M. Almada, N. Petit

p class="MsoNormal" style="margin-bottom:0cm;margin-bottom:.0001pt;line-height: normal;mso-layout-grid-align:none;text-autospace:none"font face="TimesNewRomanPS-ItalicMT, serif"The European Union (EU) Artificial Intelligence Act (the AI Act) sets out a hybrid regulatory framework. The AI Act combines two classic traditions of EU law, namely product safety and fundamental rights protection. However, the proposed combination can fail if it does not account for the structural differences between the two legal traditions. This article uses three classical themes of the law and technology literature – the pacing problem, the regulatory lens, and institutional path dependence – to show why the AI Act’s design creates practical and theoretical challenges that will need to be addressed during the Act’s implementation and in future EU legislation. /font