EUROPEAN JOURNAL OF HEALTH LAW最新文献

The AI presence in healthcare (e.g., telemedicine platforms and Software as Medical Devices) is uncontroversial by now. Beyond the Big Tech already for some time large investors in this field, the States, repeatedly accused to be unable keeping pace with the exponential technological development, are growingly called upon to deal with it. Taking the distance from those who perceive the US as a regulatory model to oppose in order to assert the EU digital sovereignty, the present analysis will prove that a glimpse across the Atlantic could only help the EU legislator. With a specific focus on the SaMD regulation, it will be shown how the choices made in the US appear to be grounded on a fair balance between patient and economic operators' rights. Building on it, a new balancing formula needs to be put forward to guide the EU intensive legislative activity for the digital world.

Informed consent (IC), following the Supreme Court judgment in Montgomery v Lanarkshire Health Board, [2015] UKSC 11, constitutes a key patients' right. There is a vast literature exploring the significance of this right, while an analysis of the role that this has played in England during the COVID-19 vaccine distribution has been under-explored. Using England as a case study, this paper argues that IC has received limited protection in the COVID-19 vaccination context of the adult population, upholding at its best only a minimalistic approach where mere 'consent' has been safeguarded. It suggests that new approaches should be brainstormed so as to more properly safeguard IC in a Montgomery-compliant-approach, namely in a way that enhances patients' autonomy and medical partnership, and also to better prepare and respond to future pandemics.

The case Mortier v. Belgium is the first case where the Court comments on the figure of euthanasia. The area of euthanasia in particular raises the issue of finding a balance between the protection of the patients' right to life in Article 2 of the Convention and that of the right to respect for his or her private life and personal autonomy in Article 8 of the Convention. The Court confirmed the States must be afforded a margin of appreciation in finding this balance. However, it does not concern an unlimited margin as the Court reserved its power to review the States fulfilment of its obligations under Article 2. After deciding that there had been no breach of article 8 in the performing of euthanasia as such, the Court examined the positive obligation of Belgium to foresee in sufficient safeguards to protect the right to life.

The AI Act is based on, and at the same time aims to protect fundamental rights, implying their protection, while fulfilling the safety requirement prescribed by the AI Act within the whole lifecycle of AI systems. Based on a risk classification, the AI Act provides a set of requirements that each risk class must meet in order for AI to be legitimately offered on the EU market and be considered safe. However, despite their classification, some minimal risk AI systems may still be prone to cause risks to fundamental rights and user safety, and therefore require attention. In this paper we explore the assumption that despite the fact that the AI Act can find broad ex litteris coverage, the significance of this applicability is limited.

The duty of ensuring epidemiological safety, including the duty to ensure vaccination against SARS-CoV-2 to people, is included in the framework of the national constitutional rights. The healthcare institutions providing vaccination and medical practitioners performing vaccination are one of the key assets of the national health care system, to whom the duty in the field of public health and protection of lives that is a part of human rights have been delegated. Violation of the epidemiological safety requirements in the Republic of Latvia, if it may cause a risk to human health, is subject to a fine. In this study, the authors have analysed the administrative offence cases, in which administrative liability has been imposed on medical institutions for performing vaccination with age-inappropriate vaccine, explain separation of administrative liability from criminal liability in such cases, reveal compensation mechanisms in the event of consequences, when inappropriate vaccination has caused harm to persons' life or health. The results of the research show that no appropriate security measures have been introduced in the medical institutions to prevent or avoid administrative offences in particular cases, as the result medical institutions were subject to first-time application of administrative liability. Besides, there are lack sufficiently secure system for the examination and registration of patients in the medical institutions. The minor patients were unsecured and have been vaccinated with an inappropriate vaccine, because a specific (non appropriate) vaccine has been requested by the minors' parents or the minors themselves.

Telehealth enables equal, high-quality, and efficient provision of health services, but it also poses serious risks in the absence of a legal basis. Despite its increasing use and promising potential, there has been no specific legal framework for telehealth in Turkey until recently. A new by-law governing the procedures and principles of telehealth services has been introduced by the Ministry of Health. As repeatedly referred to in the regulation, the most important issue is the positioning of telehealth in the data protection context. This article, therefore, aims to map telehealth services within the frame of the Turkish data protection regime. In this regard, we show how the category of personal data and the purpose of the processing should be determined. Thereafter we argue how relevant actors should be identified and present the rights and obligations of these actors in the light of basic principles regarding data processing, security, and transfer.