European Journal of Risk Regulation最新文献

The proposal for a European Health Data Space aims at creating a common space where individuals may control their health data in a trusted and secure way. The objective is not only improving healthcare delivery, but also enhancing the opportunities to use health data for research and innovation. To achieve these results, the proposal implements a mandatory self-certification scheme for European health records systems as well as for wellness devices and applications, setting up essential requirements related to interoperability and security. Although this is the first intervention that sets a horizontal framework that is mandatory for all Member States, the security requirements that are included in the legislative proposal are not sufficiently detailed and comprehensive. Given that cyberthreats are increasing and security incidents affecting health data may potentially have an impact on the lives of patients, it is important that cybersecurity measures are adopted and implemented in the most effective way. The paper will analyse the European Health Data Space proposal pointing to the open issues and doubts that may be emerging and it will compare them with the proposed Cyber Resilience Act, identifying the issues that may be solved thanks to this horizontal regulation and the ones that instead remain open.

The development of the precautionary principle by the EU Courts has often been interpreted by scholars as inconsistent with another trend in EU risk regulation: one that is evidence-based and relies on impact assessment. This article argues that the two trends – precaution and regulatory impact assessment – are not mutually exclusive. Together they may, in fact, act as a procedural safeguard against discretionary decisions that have an impact on fundamental rights, especially under conditions of epistemic uncertainty. The article illustrates this claim by looking at the decisions to close schools in Ireland during the pandemic.

This article explores the proposed amendments to the AI Act, which introduce the concept of “groups of persons”. The inclusion of this notion has the potential to broaden the traditional individual-centric approach in data protection. The analysis explores the context and the challenges posed by the rapid evolution of technology, with an emphasis on the role of artificial intelligence (AI) systems. It discusses both the potential benefits and challenges of recognising groups of people, including issues such as discrimination prevention, public trust and redress mechanisms. The analysis also identifies key challenges, including the lack of a clear definition for “group”, the difficulty in explaining AI architecture concerning groups and the need for well-defined redress mechanisms. The article also puts forward recommendations aimed at addressing these challenges in order to enhance the effectiveness and clarity of the proposed amendments.

This paper describes how the development of texts on regulatory deference by the Codex Alimentarius Commission (CAC) addresses relevant recommendations of the World Trade Organization (WTO) and supports Member countries of CAC in their negotiation and implementation of equivalence agreements. We consider the role and function of CAC within a rules-based multilateral framework, particularly in relation to the development and implementation of equivalence concepts. We then consider whether, through use of equivalence agreements, trade facilitation outcomes have been realised. Our hypothesis is that international standards on regulatory deference promote fair but aspirational standards and support fair practices in the trade of safe food – both vital outcomes for global food security and the achievement of many of the United Nations Sustainable Development Goals. We test this hypothesis against the framework provided by decisions of the WTO Sanitary and Phytosanitary Committee. We argue that the equivalence concepts and guidelines developed by CAC are appropriate but underutilised tools available for Member countries to strike a balance between their right to regulate to protect human, animal or plant life and health and to fulfil legitimate objectives whilst meeting their WTO obligations to avoid measures that constitute unnecessary barriers to trade.