This paper examines in what way providers of specialized Large Language Models (LLM) pre-trained and/or fine-tuned on medical data, conduct risk management, define, estimate, mitigate and monitor safety risks under the EU Medical Device Regulation (MDR). Using the example of an Artificial Intelligence (AI)-based medical device for lung cancer detection, we review the current risk management process in the MDR entailing a “forward-walking” approach for providers articulating the medical device’s clear intended use, and moving on sequentially along the definition, mitigation, and monitoring of risks. We note that the forward-walking approach clashes with the MDR requirement for articulating an intended use, as well as circumvents providers reasoning around the risks of specialised LLMs. The forward-walking approach inadvertently introduces different intended users, new hazards for risk control and use cases, producing unclear and incomplete risk management for the safety of LLMs. Our contribution is that the MDR risk management framework requires a backward-walking logic. This concept, similar to the notion of “backward-reasoning” in computer science, entails sub-goals for providers to examine a system’s intended user(s), risks of new hazards and different use cases and then reason around the task-specific options, inherent risks at scale and trade-offs for risk management.

Almost 10 years ago, the Ordonnance of 10 February 2016 reforming the French Civil Code (CC) removed the cause from the conditions for validity of the obligation. Thus, it broke with the tradition of the Code Napoléon, and a large number of civil codifications followed. Since 2016, French scholars have argued that, notwithstanding its conceptual implications, the disappearance of the formula of the cause has resulted in semantic rather than substantial changes. Whereas, in one opinion, the cause is still found underlying ‘contenu litice et certain’ (Article 1128), its various forms and functions today appear in several CC provisions.

The numerous scandals that have marred the world of football suggest that reform is badly needed. As governing bodies like FIFA and UEFA fail to make meaningful improvements, calls for public regulation are gaining ground. This article explores what the European Union (EU) could do to effect change. Although long hailed as a powerful sports regulator, there is a widespread feeling that the EU’s regulatory potential remains unfulfilled. The article argues that the Union is in a unique position to leave a positive mark on football governance if it decides to regulate the sport more extensively. Three options are outlined: increasing the intensity of scrutiny exercised under the internal market rules, changing the approach towards cooperation with football stakeholders, or enacting a European Sports Act. After examining the benefits and drawbacks of each route, it will be claimed that, on balance, the most promising avenue is EU legislation which sets out minimum governance standards as well as substantive requirements, including on human rights, gender equality, and athlete welfare. The conclusion will offer some reflections on what would need to happen for the proposal to materialize, discussing the role of advocacy coalitions and crises in bringing about regulatory change.

Energy has been a fundamental precondition for human survival, economic development, and preserving dignity throughout history. At the same time, the increasing digitalisation of energy systems, especially in the EU’s energy transition, creates new challenges, especially concerning rights such as data protection and privacy. Although European Law restricts the right to energy as a consumer right, it expressly recognises data protection and privacy as fundamental rights. This article outlines the theoretical, historical and legal foundations of the right to energy and analyses the implications of digitalisation for its realisation while also addressing emerging concerns about data protection and privacy rights. Furthermore, it identifies the tension points between the Recast Electricity Directive (RED) and the General Data Protection Regulation (GDPR) and provides recommendations for a legal framework that harmonises the abovementioned rights.

This paper discusses how epistemic and ontological commitments shape different understandings of European Union (EU) law and why it matters. Many key debates on EU law—and some of the fiercest disagreements in European legal scholarship—go back to divergent epistemic and ontological commitments. While these philosophical commitments usually operate in the background, this paper foregrounds them. A core aim of the paper is to denaturalise the epistemic and ontological groundings of mainstream approaches to EU law and, thus, to demarginalise approaches more peripheral to the centres of power in EU law-making and in EU legal academia.

This article considers the application of the precautionary principle as understood in EU law to EU decision-making on geoengineering, in particular solar geoengineering. It finds that the situation is riddled with more complexities than first appears; (i) the principle is used to argue against research, even though more research is usually itself seen as precautionary response; (ii) the risks of research are claimed to lie in its political impact, whereas the principle is traditionally applied to direct physical risks; (iii) while there are legitimate precautionary arguments against geoengineering, it is itself put forward as a precautionary measure and there are precautionary arguments in favour too. Drawing on case law and scholarship we conclude that the precautionary principle can nevertheless be applied and will lead to a procedural requirement to do comprehensive reviews of relevant scientific knowledge before decision-making. This leaves wide – but not unbounded – discretion but may still be valuable in providing a frame for reasoned public debate. We also apply our findings to the recent expert reports on Solar Radiation Modification and show that they have failed to apply precaution correctly.

As the EU is positioned, and positions itself, as a global leader in digital regulation, it is more important than ever to challenge narratives that flatten disparities within the bloc. In this paper, I seek to problematise the perception of the European Union as the homogenous bloc sometimes alluded to, and even outwardly projected, in discussions about a ‘Brussels Effect’ in digital regulation. Using the EU Digital Services Act as a prism, I draw attention to the legal, political, social, and cultural variation within the EU and, crucially, the inter-state power dynamics and disparities that shape the development and implementation of EU digital regulation. Building on scholarship related to core-periphery dependencies within the EU and extending burgeoning critical methods in EU legal studies, leaning on decolonial approaches, I offer a foundational analysis of the DSA’s preliminary stages of the implementation of the EU Digital Services Act.

Calling for different comparative counterpoints to those routinely used in EU legal studies and digital regulation, this article presents a rare insight into the process from the perspective of the EU’s smallest member state, Malta, a former British colony considered part of the EU’s southern periphery that acceded in 2004. In this paper, I argue that, within the EU’s borders, the belief that we are moving toward increased harmonisation and standardisation in the realm of digital rights is, in practice, questionable. I underline that any meaningful assessment of the Digital Services Act’s overall success must pay close attention to the regulation’s tangible impacts (and shortcomings) from the perspective of ‘peripheral’ EU states.

This introductory article outlines three fundamental regulatory developments in the EU’s legislation addressing digitalization and automation of decision-making: One is that across many acts we see a move towards more complex multi-level composite procedures, involving not only public structures with agencies, EU bodies, national agencies, but also co-regulation through standardisation in combination with – in several areas – audited self-regulation. A second feature of much of the current legislation in digital matters is that obligations imposed therein require an increased attention to information management – from sourcing to use, dissemination, sharing. This is a requirement for both public and private actors imposing ever more ‘granular’ knowledge and reporting of information flows in economic operators. A third is the growing role of interoperability which is being firmly established as a tool to create data exchange possibilities The diverse regulatory tools and methods are creating complex networks of legal relations and obligations which appear difficult to submit to oversight and compliance without strong protection of individual rights and procedural structures ensuring their enforcement.

Strategic litigation plays a crucial role in advancing human rights in the digital age, particularly in cases where data subjects, such as migrants and protection seekers, experience significant power imbalances. In this Article, we consider strategic litigation as part of broader legal mobilization efforts. Although some emerging studies have examined contestation against digital rights and migrant rights separately using legal mobilization frameworks, scholarship on legal mobilization concerning the use of automated systems on migrants and asylum seekers is scarce. This Article aims to address this gap by investigating the extent to which EU law empowers strategic litigants working at the intersection of technology and migration. Through an analysis of five specific cases of contestation and in-depth interviews, we explore how EU data protection law is leveraged to protect the digital rights of migrants and asylum seekers. This analysis takes a socio-legal perspective, analyzing the opportunities presented by EU data protection law and how civil society organizations (CSOs) utilize them in practice. Our findings reveal that the pre-litigation phase is particularly onerous for strategic litigants in this field, requiring a considerable investment of resources and time before even reaching the litigation stage. We illustrate this phase as akin to “climbing a wall,” characterized by numerous hurdles that CSOs face and the strategies they employ to overcome them.

Strategic litigation is a form of legal mobilization, where actors bring cases before judges not only to win in court, but also to pursue broader political, social or economic ends. Various actors can use the law strategically – big corporations, specialized non-governmental organizations or individual academics. The ends can range from resisting market regulation or a political advocacy campaign to simply “testing the law”. The results of strategic litigation maintain or change power relations in society, economy or politics.

This article provides an analytical framework for the Special Issue on Strategic Litigation in EU Law. This framework can be used to study strategic litigation mobilizing EU law. A contextual and normatively open definition of strategic litigation, recognizes that strategic litigation as a practice operates within specific social, institutional, and economic contexts while accommodating a spectrum of agendas from progressive to conservative. The framework encompasses three dimensions: the actors involved, the unique legal structures of EU law, and its effects—both in terms of strictly legal outcomes and of broader socio-political consequences. Ultimately, this framework aims to illuminate the dynamics of (dis)empowerment characterizing strategic litigation, paving the way for a comprehensive exploration of its implications within the EU legal landscape.

This Article explores, from a participatory perspective of an engaged legal scholar, the case of homeless EU citizens in the Netherlands and the mobilization of their rights. By marking them as so-called niet-rechthebbenden (“non-rightholders”), Dutch municipalities have systematically denied homeless EU citizens access to overnight shelters and general homelessness services on equal footing as Dutch citizens. This legal and practical deadlock—a classic case of non-compliance through “law in action”—has most probably led to a denial of rights to EU citizens entitled to shelter as permanent residents, (former) workers, or otherwise legally residing EU citizens. The contribution explores the context and motivations that led a broad coalition of actors—ranging from homelessness organizations, advocacy groups, a public interest litigation organization and legal experts—to join efforts and consider strategic litigation a credible avenue to protect the interests of the most vulnerable under EU law within a national and local context. The case demonstrates, however, how strategic litigation is not considered the most effective or preferred strategy when other avenues for legal mobilization open up.

The present contribution seeks to provide an empirical overview of how the amended internal review mechanism established under the EU Aarhus Regulation is currently being deployed by civil society organizations to mobilize EU climate change law. This Article argues that the 2021 reform of the Aarhus Regulation has broadened the legal opportunity structure available to environmental organizations, which can now challenge a much broader set of EU administrative acts. However, this contribution holds that the internal review mechanism is being used strategically by environmental NGOs with the intention to contest - even before the EU judiciary - not only EU administrative acts, but also broader policy arrangements, representing the legal infrastructure of the EU ecological transition. In this regard, the Aarhus internal review mechanism can now be considered a real scientific dispute settlement forum, where NGOs and EU institutions can confront each other and disagree on the way scientific evidence is taken into account in the EU policymaking. Finally, the new specific features of the internal review mechanism are truly empowering only those organizations owning the necessary legal and technical expertise, allowing such NGOs to act as credible scientific interlocutors of the EU institutions on behalf of the wider public.

This paper traces the legislative process of the EU Artificial Intelligence Act (AI Act) to provide an empirical and critical account of the choices made in its formation. It specifically focuses on the dynamics that led to increasing or lowering fundamental rights protection in the final text and their implications for fundamental rights. Adopting process-tracing methods, the paper sheds light on the institutional differences and agreements behind this landmark legislation. It then analyses the implications of political compromise for fundamental rights protection. The core message it aims to convey is to read the AI Act with its institutional setting and political context in mind. As this paper shows, the different policy aims and mandates of the three EU institutions, compounded by the unprecedented level of redrafting and the short time needed to reach a political agreement, influenced the formulation of the AI Act. Looking forward, the paper points to the role of implementation, enforcement and judicial interpretation in enhancing the protection of fundamental rights in the age of AI.