EUROPEAN JOURNAL OF HEALTH LAW最新文献

In the post-pandemic world, the ability of researchers to reuse, for the purposes of scientific research, data that had been collected by others and for different purposes has rightfully become a policy priority. At the same time, new technologies with tremendous capacity in data aggregation and computation open new horizons and possibilities for scientific research. It is in this context that the European Commission published in May 2022 its proposal for a sector-specific regulation aiming at establishing the legal landscape and governance mechanisms for the secondary use of health data within the European Union. The ambitious project is centred on administrative efficiency and aspires to unleash the potential of new technologies. However, the quest for efficiency usually comes with privacy compromises and power asymmetries and the case of the European Health Data Space Regulation is no different. This paper draws attention to some of these compromises and suggests specific amendments.

The role of the Council of Europe (CoE) in tobacco control remains largely unexplored. This paper aims to fill this gap, focusing on the CoE's European Social Charter. Article 11 of the Charter protects the right to health, and adequate tobacco control measures are necessary to respect this article. This paper examines the potential and limits of the Collective Complaints procedure, one of the two monitoring mechanisms of the Charter, as a means to evaluate the compliance of national tobacco control measures with Article 11. It demonstrates that, so far, this mechanism has never been used in this way. However, although the Collective Complaints procedure presents several drawbacks, it should not be underestimated. Indeed, it possesses certain features, such as the collective nature of the complaint and the lack of the requirement of the exhaustion of domestic remedies, which might make it a particularly suitable tool for the abovementioned purpose.

The use and disclosure of patient information is subject to multiple legal and ethical obligations. Within European human rights law the differences relating to consent are reflected in the separate requirements of data protection law, the common law, and professional ethics. The GDPR requires explicit consent. This contrasts with the ethical and common law availability of reliance on implied consent for the use of patient information for that patient's care and treatment. For any proposed use of patient information for healthcare purposes other than direct care, even where GDPR may be satisfied if the patient refuses to consent to disclosure, the information should not normally be disclosed. For any proposed use or disclosure outside healthcare the justification should normally be consent. However, consent is often not possible or appropriate and an overriding public interest can be relied upon to justify the use or disclosure, both legally and ethically.

One approach to stimulating patient safety and health care quality is through holding health care professionals legally responsible for their performance. Law and health care variation across countries, however, makes it difficult to get an overview and make comparisons of the personal legal responsibility of health care providers. This article describes health care professional liability and complaint measures in some European countries (UK, The Netherlands, Sweden and Denmark) and US. Countries all have established a public authority to assess complaints about health professional performance and opportunities for economic compensation. The assessment of health professional legal responsibility generally relies on comparisons to supposedly "objective" standards predominantly dictated by the health profession. In line with the aim of ensuring acceptable care for all, health ethics principles on justice, respect for patients' autonomy, and the duty to do good and prevent harm may provide an attractive supplement in the description of legal responsibility in the health professions.

Assisted dying is subject to markedly different laws in different European countries, and the legislation is rapidly changing in many of them. This article seeks to enhance our understanding of how public and health-care professionals' opinions shape assisted dying legislation in Europe. To that end, data on the attitudes of the general public as well as health-care professionals was systematically collected, analysed and compared to the legal situation in seven European countries, covering the period from 1990 until 2021.

In 2021, the European Commission published its Assessment of the EU Member States' rules on health data in the light of General Data Protection Regulation. The Commission concluded that the GDPR has been interpreted in many ways in the EU as regards health research, and national implementation legislation has resulted in a fragmented legal landscape. Several lawful bases are used as a legitimation for the secondary use of health data. I address the Dutch legislation on the re-use, or secondary use of health data for scientific research where explicit consent is the general rule. However, both the GDPR, the Dutch GDPR Implementation Act and sectoral health legislation leave room for alternatives. I conclude that a further review of these alternatives is required to enhance scientific health research with the secondary use of health data, and I sketch a few avenues for further exploration.

Contemporary biomedical research heavily relies on secondary use of personal health data that were obtained in a different clinical or research setting. Under the European Union’s General Data Protection Regulation (GDPR), data controllers processing personal data must comply with the principle of purpose limitation, which restricts further processing of personal data beyond the purpose for which the data were initially collected. However, “further processing” is not explicitly defined, resulting in considerable interpretive ambiguities as to whether “secondary use” of data by researchers constitutes “further processing” under the GDPR. This ambiguity is problematic as it exposes researchers to potential non-compliance risks. In this article, we analyse the term “further processing” within the meaning of the GDPR, elucidate important aspects in which it differs from “secondary use”, and discuss the implications for data controllers’ GDPR compliance obligations. Subsequently, we contextualise this analysis within a broader discussion of regulating scientific research under the GDPR.