EUROPEAN JOURNAL OF HEALTH LAW最新文献

The rapid development of information technology has made the sharing and utilization of medical and health data a key factor in promoting medical innovation and improving public health levels. However, China still faces many challenges in the field of medical and health data sharing, including an imperfect legislative system, unclear data ownership, lack of incentive mechanisms, and lagging construction of data sharing platforms. This paper analyzes the current status of medical and health data sharing in China and the existing problems, pointing out that the decentralization and low level of legislation restrict the rational flow and effective utilization of health data. Through comparative analysis with the European Health Data Space, the deficiencies in China's data sharing are revealed, and drawing on the experience of the EU, corresponding improvement paths are proposed. This paper suggests that measures such as establishing a medical data ownership and authorization mechanism, constructing a diversified benefit distribution mechanism, and building a secure and trustworthy dual-track sharing platform should be taken to promote the efficient utilization and circulation of medical and health data in China. These measures will facilitate the implementation of medical informatization and the medical data sharing strategy.

This article examines the expanding role of Artificial Intelligence (AI) in healthcare and associated human rights concerns, including whether new EU legislation takes all relevant human rights concerns into account. AI presents promising ways to fulfil the right to health through improving diagnostics, treatments, and resource allocation, but its use also comes with risks concerning privacy, bias, discrimination, and human dignity. Existing literature often relies on the rather vague FATE (Fairness, Accountability, Transparency, Ethics) principles, but recent calls have been made for a human-rights-based approach more broadly to ensure the legality and ethics of AI applications. This article responds to that call by proposing a structured methodology for reconciling rights, considering both the different structures of civil and political versus economic, social and cultural human rights, the negative and positive obligations of the state, and the interplay with different AI design choices.

Modern ethics and law understand the human embryo as a value deserving special protection. This protection is ensured by legal systems and until recently was based on a generally accepted understanding of what we mean by 'embryo'. With the technological innovations of the last decades, this perception has begun to be challenged, as new embryonic entities have been artificially created. These entities are not derived from a gamete union and may develop in a biologically similar way to the natural embryo, at least in their early stages. To what extent should these new biological forms be protected, given their similarities and differences with the latter? This article argues that from an ethical and legal point of view, the sole criterion justifying the protection of the human embryo is its potential to fully develop into a complete organism. It is on the basis of this criterion that we should assess the protection of 'synthetic' embryonic entities and proceed to adopt specific regulations for their treatment, particularly in research.

This contribution explores the implications of the EU legal framework for the use of AI in health care, with a focus on the EU Artificial Intelligence Act. The AI Act, currently the most specific legal AI document, is not tailored to health care and the provisions that focus on the deployer (in this case the physician) lack specificity. Ultimately, we identify five elements for responsible AI usage in medical decision-making that, in our view, should be included in practical guidance, established by the medical profession.

In the future, the European Health Data Space (EHDS) Regulation will enhance the secondary use of electronic health data in the EU, including for scientific research purposes. From the data subjects' perspective, the EHDS introduces a significant change, a new opt-out mechanism for the secondary use of data, in which data subjects shall have the right to opt out at any time without stating reasons. However, not all scientific research with health data will be covered by the opt-out rules of the EHDS. This article aims to clarify the effects of the EHDS' opt-out mechanism and its scope of application. It also suggests a balanced approach for Member States to implement the EHDS opt-out mechanism and reassess the implementation of the GDPR's right to object that remains relevant in the future in addition to the opt-out introduced by the EHDS.

According to Italian Law on informed consent and advance directives claims regarding parents' refusal of treatment in favor of a child must be referred to Protection Courts. This paper described some recent decree by District Appeal Courts called to settle the conflict of jurisdiction between Family Courts and Protection Courts in claims regarding the refusal of medical treatment in favor of minors. The decrees by the Court of Appeal confirmed that Protection Courts are entitled to manage claims regarding refusal of medical treatment by parents except when elements of neglect or maltreatment rise. They also established that the refusal of a medical treatment is not sufficient to override parental responsibility when there are no proofs of neglect. The new Italian law marks a difference between the Italian jurisdiction and the ones of other European countries and significantly limited the cases when overriding parents' responsibility is legal.