On 15 December 2020, the European Commission published its proposal for the Digital Services Act, which is expected to be adopted before summer 2022. It carries out a regulatory overhaul of the twenty-one-year-old horizontal rules on intermediary liability in the e-Commerce Directive and introduces new due diligence obligations for intermediary services. Our analysis illuminates an important point that has so far received little attention: how would the Digital Services Act’s rules interact with existing sector-specific lex specialis rules? In this article, we look specifically at the intersection of the Digital Services Act with the regime for online content-sharing service providers (OCSSPs) set forth in Article 17 of Directive (EU) 2019/790 on Copyright in the Digital Single Market (CDSM Directive). At first glance, these regimes do not appear to overlap, as the rules on copyright are lex specialis to the Digital Services Act. A closer look shows a more complex and nuanced picture. Our analysis concludes that the Digital Services Act will apply to OCSSPs insofar as it contains rules that regulate matters not covered by Article 17 CDSM Directive, as well as specific rules on matters where Article 17 leaves a margin of discretion to Member States. This includes, to varying degrees, rules in the Digital Services Act relating to the liability of intermediary providers and to due diligence obligations for online platforms of different sizes. Importantly, we consider that such rules apply even where Article 17 CDSM Directive contains specific (but less precise) regulation on the matter. From a normative perspective, this might be a desirable outcome, to the extent that the Digital Services Act aims to establish “uniform rules for a safe, predictable and trusted online environment, where fundamental rights enshrined in the Charter are effectively protected”. Based on our analysis, we suggest a number of clarifications that might help us to achieve that goal.

What type of enforcement is the most effective to punish violations of food law or to prevent them from occurring in the first place? This article examines the question of which mix of private and public enforcement exists in European Union (EU) food law and whether this mix corresponds to the recommendations of existing social science research. Based on this research, we contend that EU-determined enforcement mechanisms differ in effectiveness across Member States. New technologies have the potential to stimulate a novel mix of public and private enforcement tools at the EU and national levels.

Under what conditions can artificial intelligence contribute to political processes without undermining their legitimacy? Thanks to the ever-growing availability of data and the increasing power of decision-making algorithms, the future of political institutions is unlikely to be anything similar to what we have known throughout the last century, possibly with parliaments deprived of their traditional authority and public decision-making processes largely unaccountable. This paper discusses and challenges these concerns by suggesting a theoretical framework under which algorithmic decision-making is compatible with democracy and, most relevantly, can offer a viable solution to counter the rise of populist rhetoric in the governance arena. Such a framework is based on three pillars: (1) understanding the civic issues that are subjected to automated decision-making; (2) controlling the issues that are assigned to AI; and (3) evaluating and challenging the outputs of algorithmic decision-making.

In this article, we argue that the design and timing of regulatory responses, as well as the adherence of the population to the relevant rules, have a critical impact on the progression and public health consequences of the COVID-19 pandemic. This hypothesis is empirically tested using the example of Poland, a country that experienced, compared to its Western European neighbours, a relatively mild first phase of the pandemic. In this context, we compare Poland with selected countries, including France, Germany, Spain and the UK, and we supplement them with examples from other Visegrad Four (V4) countries – Czechia, Slovakia and Hungary. On that basis, we conclude that while the observed differences between the countries in the progression of the COVID-19 pandemic are the result of a multitude of complex and interrelated reasons (such as demographic structure, population density and connectivity or cultural factors), well-designed public health measures, which are implemented early as a part of the proactive strategy that anticipates and reacts quickly to changing circumstances, can effectively decrease the number of COVID-19 infections and related deaths, provided that the adherence of the relevant population is high.

This paper argues for a sandbox approach to regulating artificial intelligence (AI) to complement a strict liability regime. The authors argue that sandbox regulation is an appropriate complement to a strict liability approach, given the need to maintain a balance between a regulatory approach that aims to protect people and society on the one hand and to foster innovation due to the constant and rapid developments in the AI field on the other. The authors analyse the benefits of sandbox regulation when used as a supplement to a strict liability regime, which by itself creates a chilling effect on AI innovation, especially for small and medium-sized enterprises. The authors propose a regulatory safe space in the AI sector through sandbox regulation, an idea already embraced by European Union regulators and where AI products and services can be tested within safeguards.

While nudging has garnered plenty of interdisciplinary attention, the ethics of applying it to climate policy has been little discussed. However, not all ethical considerations surrounding nudging are straightforward to apply to climate nudges. In this article, we overview the state of the debate on the ethics of nudging and highlight themes that are either specific to or particularly important for climate nudges. These include: the justification of nudges that are not self-regarding; how to account for climate change denialists; transparency; knowing the right or best behaviours; justice concerns; and whether the efficacy of nudges is sufficient for nudges to be justified as a response to the climate crisis. We conclude that climate nudges raise distinct ethical questions that ought to be considered in developing climate nudges.

The role of software in society has changed drastically since the start of the twenty-first century. Software can now partially or fully facilitate diagnosis and treatment of a disease, regardless of whether it is psychological or pathological. Consequently, software plays a role comparable to medical equipment with a physical footprint. Understanding when software as a medical device must comply with applicable rules is vital for both manufacturers and regulators. We therefore examine the Medical Device Regulation to expand on the notion of intention, as this is the key basis for the classification of medical devices. Finally, we develop objective criteria that software must fulfil to be considered a medical device under European Union law.

This article contributes to the discussion about managing the risks and uncertainties of emerging technologies through increased stakeholder participation. Authorities have increasingly invited stakeholders from high-technology sectors to participate in assessing the risks of, and designing responses to, new technologies. Yet authorities often struggle to attract stakeholders from such sectors to participate; a critical challenge identified but still undertheorised in the literature. Responding to this gap, this article presents a case study of the UK’s regulatory sandbox for financial technologies, applying a document study, questionnaire and interviews to explore fintech firm motivations and apprehensions about participation. Drawing on the bureaucratic reputation literature, the study finds that fintech firms have a range of practical, reputational and normative motivations to participate, and these motivations are inextricably tied to the regulator’s strong reputation with the sector as procedurally correct, high-performing and morally committed to facilitating innovation. On this basis, recommendations for practitioners and hypotheses for future research into the drivers of stakeholder participation in regulatory decision-making surrounding emerging technologies are proposed.

Under the notion of human rights due diligence (HRDD), firms are under a responsibility to account for the social and environmental impact connected to their operations across global value chains. This responsibility intersects with the sphere of operation of voluntary sustainability standards (VSS), which certify production against certain social and environmental criteria. With mandatory European rules on HRDD in the making, the question arises regarding the extent of alignment of VSS with HRDD notions and, consequently, the possibility for this form of transnational private regulation to complement European Union (EU) HRDD legislation. After presenting the regulatory effects of HRDD in global value chains and its current transposition in EU instruments, this contribution examines the relationship between private standards and HRDD. By delving into the substantive requirements and policies of several schemes certifying agricultural commodities, this paper studies the extent to which they manage social and environmental risks in global value chains and the possible support they provide to firms subject to the upcoming HRDD obligations.

Digital vaccination certification involves making many promises, few of which can realistically be kept. In this paper, we demonstrate how this phenomenon constitutes various forms of theatre – immunity theatre, border theatre, behavioural theatre and equality theatre – doing so by drawing on perspectives from technology regulation, migration studies and critical geopolitics. Technological theatre and political theatre often serve valid functions, but these forms are problematic for several reasons. First, they involve real-world infrastructures that, while unlikely to accomplish the task at hand, will nevertheless last a long time and be repurposed. They therefore constitute governance by data infrastructure, diverting action and control away from elected legislators to for-profit contractors. Second, vaccine certification effectively legitimises inequalities between countries and people by formalising ways to distinguish between the vaccinated and non-vaccinated and to exclude the latter, thus reinforcing both mobility and connectivity divides. It serves as a way to (further) close borders and to regulate, through code and infrastructure, access to public goods such as employment and public space. Finally, the project of certification displaces a more important action, namely addressing the radical inequality in countries’ ability to combat the pandemic.

This article further develops the concept of algorithmic vulnerability. The analysis is built on empirical evidence of the Chinese Health Code System (HCS), compared to similar plans for the “COVID-19 Certificate” in the European Union (EU). Implementing the HCS has shown two-sided regulatory implications: improving social protection (a national strategy, a common mutual-recognition standard, scaled-up public–private cooperation) and increasing risks of social exclusion (non-digital and digital forms of vulnerability). This article argues that algorithmic vulnerability is caused by mismatches between biased databases, unfairly pre-designed algorithms and dynamically changed risk groups in reality in the context of COVID-19 vaccination. It contributes a framework for deploying plans for digital certificates in the EU concerning minimising the social risks associated with algorithmic vulnerability. The framework consists of (1) reinforcing existing vulnerability inherited from non-digital society (eg caused by intersectional factors of race/ethnicity, gender, age and health) and (2) introducing new forms of vulnerability generated by algorithm design and implementation (eg excluding the risk groups of individuals who are un/mis/overrepresented in the databases, such as those defined by nationality plus COVID-19 status).

In the World Trade Organization (WTO), the US approach to science-based risks and trade restrictions prevailed over that of the European Union (EU). The EU, dissatisfied with the margin of action available when “relevant scientific evidence is insufficient”, largely kept intact its internal practice on marketing and importing genetically modified (GM) crops and GM-containing products. The goal of this article is to ascertain whether these regulatory preferences of the US and the EU translate into their post-Biotech external trade efforts. US and EU preferential trade agreements are scanned for rules on trade in biotechnology goods or the use of precautionary elements in regulation. It transpires that neither bloc systematically tries (or manages) to bend trade agreements to accommodate its defensive or offensive trade interests in this field. Among the possible reasons for this apparent inertia are the US confidence in the WTO baseline and the EU preference for a “don’t ask, don’t tell” approach to its trade-restrictive policy in this area.

The Digital Green Certificate (DGC) proposed by the European Commission on the basis of facilitating the free movement rights of European Union (EU) citizens will be capable of effectively serving as a COVID-19 passport. In this contribution, we cast doubt on whether the DGC is fit for purpose, highlighting in particular the potential for the DGC to in fact facilitate greater free movement restrictions for a large number of EU citizens, in particular those who have received non- European Medicines Agency (EMA)-approved vaccines such as Sputnik V in compliance with EU law. Under the proposal as amended by the European Parliament, any destination Member State that accepts proof of vaccination “in order to waive restrictions to free movement” must apply the same waiver to any DGC-holder that has received an EMA-approved vaccine and has the option of doing so for vaccines added to the World Health Organization (WHO) Emergency Use Listing; however, such equal treatment is not available for DGC-holders who have received non-EMA/WHO vaccines. While this measure was alleged to be taken on grounds of public health, a convincing public health case has not been put forward. Instead, the DGC proposal as it stands disregards the promise of the internal market and sets the stage for its fragmentation through geopolitics and bilateralism.

At the international level, proof of vaccination against SARS-CoV-2 offers an enticing promise to the return of normality, particularly for the much-desired reopening of national borders. At the same time, vaccination passports could be a false hope: the requirement of vaccine passports could adversely embed social and economic inequalities that reflect the power dynamics in international relations. Specifically, the ability to secure vaccines relates to the varying market and economic power across countries. This paper focuses on Taiwan as a case study to explore ways in which the use of COVID-19 certifications, if used as a precondition for international travel, would further exacerbate a binary of exclusion and inclusion as a function of geopolitics. With its relative success in containing the COVID-19 pandemic within its borders, Taiwan represents a low priority for vaccine distribution in the COVAX initiative. Furthermore, due to Taiwan’s contentious political status and its exclusion from the World Health Organization regime, if vaccination passports are required as a precondition for international travel, then outbound passengers from Taiwan potentially could be subjected to restriction of movement absent wide availability of vaccines domestically. This paper argues that insofar as sustainable pandemic control requires a global concerted effort, vaccination passports could further polarise a global response. This paper suggests that equitable access to effective vaccines worldwide and governance reform of global health would help to rebuild global solidarity and mitigate the unimaginable human, social and economic suffering arising from the pandemic.

On 20 May 2021, the European Commission, Council and Parliament announced a breakthrough in the trialogue negotiations to establish the European Union (EU) Digital COVID Certificate. Originally, this standardisation effort was labelled as “Digital Green Certificate” and – “[i]n view of the urgency” – presented without a data protection impact assessment. It should allow citizens and residents of Member States to prove that they are either vaccinated against COVID-19, have recently tested negative or are currently immune against the virus. This article considers the proposal from a privacy perspective, taking into account the opinion of EU data protection authorities, ongoing negotiations in the EU institutions and relevant developments on the national and international level. While the European Parliament and others tried to improve the original Commission proposal, questions around the appropriateness and effectiveness of the framework remain. The technological and organisational implementation is essentially left to Member States, who already have started to develop their own tracing and identification systems.

This article offers a critical discussion of the “Report on Liability for Artificial Intelligence and Other Emerging Digital Technologies” released by the Expert Group on Liability and New Technologies. In particular, the authors consider: the excessive diversity of applications encompassed through the notion of “artificial intelligence and other emerging technologies”; the distinction between high- and low-risk applications as a potential source of legal uncertainty; the primary reliance on evidentiary rules over substantive ones; the problematic role attributed to safety rules; the unclear relationship between the Product Liability Directive and other ad hoc liability regimes; the radical exclusion of electronic personhood as a way of addressing liability issues; and the limited contextualisation of compulsory insurance and no-compensation funds.

Many of today’s products and services fall into the category of products and services that are, as such, legal but still unhealthy. Think of smoking as an example. This paper deals with the question of which mix of legal instruments should ideally be used in the light of such products and services. It distinguishes between products and services that predominantly lead to “harm to oneself” or “harm to others”. In the end, most law and economics arguments point in the direction of ex ante safety regulation. However, when there are concerns about the quality of regulation (eg due to lobbying efforts), liability has important added value. In the “harm to others” scenario, safety regulation is even more warranted because the larger number of victims and the increased difficulty to prove the causal link render litigation burdensome. Strict liability has several advantages over negligence and is, therefore, generally preferred. A strong point of negligence, however, is that it enables the court to conduct its own weighing of costs and benefits, which in specific circumstances may be better than that of the regulator or the producer. Furthermore, it enables the judge to consider not only the harm to the user, but also the harm to others in setting the due care standard.

On 16 December 2020, the European Commission delivered on the plans proposed in the European Digital Strategy by publishing two proposals related to the governance of digital services in the European Union: the Digital Services Act (DSA) and the Digital Markets Act (DMA). The much-awaited regulatory reform is often mentioned in the context of content moderation and freedom of expression, market power and competition. It is, however, important to bear in mind the contractual nature of the relationship between users and platforms and the additional contracts concluded on the platform between the users, in particular traders and consumers. Moreover, the monetisation offered by digital platforms has led to new dynamics and economic interests. This paper explores the reform proposed by the European Commission by means of the DSA by touching upon four main themes that will be addressed from the perspective of consumer protection: (1) the internal coherence of European Union law; (2) intermediary liability; (3) the outsourcing of solutions to private parties; and (4) digital enforcement.