EUROPEAN JOURNAL OF HEALTH LAW最新文献

This article asks whether and how law matters in ethics advisory work in the fields of health, medicine and science, and whether it is law or legal knowledge, or both, that matters. Written from the perspective of four law professors, each with first-hand experience of ethics advisory groups, it examines the framing of academic legal expertise on ethics advisory groups and explains why this framing requires ongoing negotiation.

The rapid integration of high-risk Artificial Intelligence (AI) into healthcare promises efficiency gains but also raises pressing questions about safety, accountability, and human agency. The European Union's AI Act classifies healthcare AI as high-risk and imposes strict human oversight requirements under Articles 14 and 26. Yet, translating this principle into practice exposes significant legal and operational ambiguity. The Act does not clearly identify who - among providers, deployers, or individual clinicians - bears the ongoing responsibility for oversight, risking fragmented accountability and potential harm through automation bias or misuse. This paper argues that effective oversight requires more than procedural compliance: it demands a systemic, institution-wide governance model. Analogous to an editor-in-chief coordinating an editorial team, hospitals must establish formal AI governance structures that ensure oversight is informed, continuous, and empowered. Deployers must create clear roles, policies, and training programs to equip human overseers with AI literacy and authority to challenge algorithmic outputs. Reconciling these duties with professional autonomy and regulatory constraints requires a shift from the narrow "Human-in-the-Loop" model toward a multidisciplinary AI Governance Committee. Such committees are essential to balance legal compliance with ethical responsibility, ensuring that AI enhances rather than undermines clinical judgment and patient advocacy.

This article is inspired by Herman Nys's tireless academic insistence on the importance of human rights and fundamental ethical principles in biomedicine. It examines the evolving landscape of data-driven health research in Europe, using a recent Danish case involving large-scale access to electronic health records as a point of departure. The article explores whether existing European regulatory frameworks adequately safeguard the rights and freedoms of data subjects in contemporary research contexts. The article argues that while data-driven research is often justified by public interest, this concept remains underdefined and insufficiently aligned with patients' and citizens' expectations. It concludes that current legal instruments may not fully reflect the broader catalogue of human rights at stake, including dignity, integrity, and protection against discrimination. The article calls for a recalibration of safeguards and governance mechanisms, including stronger ethical review and participatory structures, to ensure that health data research respects both individual rights and collective imaginaries of technological development.

This article honours Herman Nys' foundational contributions to European Union (EU) health law and, based on his oeuvre, strives to answer the question of who serves as the field's 'editor-in-chief': the EU or its Member States. It first clarifies the concept and boundaries of EU health law within a normative space also linked to national law, while excluding Council of Europe standards and other international instruments. It then analyses cross-border healthcare as a paradigmatic site in which the Court of Justice of the EU has shaped the balance between limited EU treaty competences and Member States' autonomy, notwithstanding modest levels of patient mobility. Finally, the article situates these legal dynamics within the EU's ethical framework, focusing on EU values and the role of the European Group on Ethics in Science and New Technologies, where Herman served as First Vice-Chair. It concludes that 'editor-in-chief' authority has increasingly shifted from the Member States to the EU, while individuals continue to play an important role.

During the COVID-19 pandemic, government-to-business (G2B) data sharing became a vital practice, exemplified by the 2021 Israeli Ministry of Health-Pfizer agreement. This established a large-scale data sharing operation outside of research and data protection regulations and oversight. This paper explores two related questions: (i) whether an EU Member State could replicate this scenario, and (ii) whether EU data legislation provides sufficient protection against excessive G2B data sharing. The analysis of the General Data Protection Regulation, Data Governance Act, and European Health Data Space shows that (i) despite the uncertain definitions of research and personal data, it would be difficult for an EU Member State to replicate this scenario; and (ii) despite its many grey areas and flexibilities, EU data legislation offers protection against excessive G2B data sharing. This highlights the need to explore alternative strategies to facilitate data sharing that can address public health emergencies promptly while safeguarding fundamental rights.

This article examines the legal nature and enforcement of insurance contracts in Ukraine amid martial law and ongoing military aggression. Special attention is given to the challenges of insuring life and health for borrowers, particularly military personnel and residents of frontline or temporarily occupied territories. The analysis highlights systemic problems such as the exclusion of war-related risks, ambiguity in contract terms, and unjustified refusals to pay insurance claims. Using case law and legislative developments, the article identifies gaps in the legal framework and proposes targeted reforms to enhance law enforcement, protect policyholders' rights, and stabilize the insurance market. Emphasis is placed on the need to incorporate war risks into insurance coverage, strengthen regulatory oversight, promote judicial consistency, and introduce digital and alternative dispute resolution mechanisms. The article also outlines prospects for legislative and institutional reform, taking into account international legal standards and Ukraine's evolving socio-economic conditions.