EUROPEAN JOURNAL OF HEALTH LAW最新文献

Wastewater surveillance (WWS) is a non-invasive and privacy friendly method for providing close to real time data on public health impact of, spread of epidemics, environmental pollutants and new health threats. Updated EU legislation covers the full potential of WWS as a platform for monitoring public health related issues. Special attention is given to vulnerable groups in the society. EHDS Regulation enables the ECDC, governments and researchers to link WWS data with other types of health data, related socio-economic data and environmental data for EU wide datasets. Primarily the data sets would be anonymised, but EDHS will make it possible to use also pseudonymised data in a secure processing environment. Extensive information requirements are included in each statutory instrument ensuring that the public is informed of pathogens, viruses, bacteria and environmental pollutants contained in the wastewater and their impact on health. Use of personal data is subject to detailed information requirements.

This paper inquires whether performing euthanasia in accordance with an advance directive is acceptable in the case of individuals with severe dementia. Specifically, the Convention on the rights of persons with disabilities is examined to determine whether it provides the basis to perform euthanasia in these cases. The meaning of certain values in particular is analysed, namely, equality, (legal) personhood, autonomy, freedom, dignity and physical and mental integrity. The intricate aspect of the identity of individuals with severe dementia merits special attention.

This paper examines how privacy-enhancing technologies such as synthetic data, federated learning and 'Secure Data Environments' can be integrated into artificial intelligence (AI) development processes to uphold key data protection principles in the UK GDPR, like storage limitation, data minimisation, purpose limitation, security, and fairness. The analysis highlights how privacy-enhancing technologies offer benefits beyond anonymisation by embedding privacy-by-design values to support responsible innovation and protect sensitive patient data throughout the design, training, and validation of medical AI systems. The paper uses the 2015 DeepMind and Royal Free case as a practical study to realise the practical and legal benefits of privacy-enhancing technologies in medical AI development, particularly involving public-private collaborations. While grounded in the UK context, the findings have broader relevance to the European Union and other international jurisdictions grappling with tensions between data protection and AI development in the healthcare context.

The regulation of advanced therapy medicinal products in the European Union relies on a definition-driven architecture designed to ensure legal certainty and a high level of patient protection. While effective for established technologies, this model increasingly struggles to accommodate emerging and hybrid therapeutic modalities that do not fit easily into existing legal categories. By contrast, EU veterinary pharmaceutical law has adopted a more flexible regulatory logic through the notion of novel therapy veterinary medicinal products. This article examines the normative divergence between these two frameworks and assesses whether elements of the veterinary approach could inform the future evolution of human medicines regulation. It argues that regulatory sandboxes should be understood not as ad-hoc legal experiments, but as a structured and reusable regulatory instrument, enabling selected veterinary-derived regulatory approaches to be assessed within EU human pharmaceutical law through controlled regulatory experimentation, while preserving legal certainty and patient protection.

The paper primarily examines the interpretation of the right to health protection of migrants in health pandemics under the law of the Council of Europe (CoE). The study analyses the CoE's right to health legal framework, vis-à-vis pandemic response. The paper focuses on the provisions of the European Convention on Human Rights (ECHR) and the European Social Charter (ESC), which are the two most important human rights treaties adopted by the CoE under the authority of the European Council and their interpretations by their monitoring bodies. It finds that there exist legal impediments to migrants' right to health under the law of the CoE. The paper asserts that these legal impediments may negatively impact pandemic response and offers recommendations to address them.

Clinical practice guidelines are frequently considered a source of medical knowledge and guidance on how medical interventions should be conducted. The relevance of such guidelines was recognised by the Council of Europe, which perceives them not only as a tool for safeguarding the appropriate quality of healthcare but also as a measure that can be used to strengthen the protection of fundamental rights. Because the use of the guidelines' potential depends on their quality and authority, the Council of Europe explores the conditions that should be met to recognise guidelines as an appropriate model of conduct for healthcare professionals. Conclusions resulting from Council recommendations may be used to highlight the consequences of the interaction between medical standards and fundamental rights, and to ascertain whether and on what conditions it is possible to use clinical guidelines as a determinant of medical standards and benchmarks for assessing the acts of healthcare professionals.

The European Health Data Space (EHDS) Regulation establishes a governance framework for secondary health data use, yet its material scope remains contested. A dichotomy has emerged between 'dualists', who interpret Article 1(8) as granting health data users a permanent choice between the EHDS and national regimes, and 'monists', who view the Regulation as exhaustive maximum harmonisation. This research collects and groups the arguments supporting the two interpretations, in line with the textual, systemic, and teleological methods of the EU Court of Justice. As a result, the article analyses legislative evolution, the implications of the introduced 'permit power', and the effet utile of the Regulation. While legal ambiguity persists pending CJEU clarification, the article recommends pragmatic implementation strategies to prevent administrative bottlenecks and ensure future-proof compliance.