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Against the backdrop of interconnected devices, people, and processes in the Internet of Everything (IoE) an examination of the MDR (Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EE), data protection and cybersecurity rules are carried out with respect to medical devices’ privacy and security. The legal analysis therefore investigates how and to what extent the MDR could cope with the copious challenges of cybersecurity and data protection in the IoE of medical devices. The article sheds light on how the MDR sets a minimal standard of requirements for medical device safety and security. In this respect, an unexpected and complicated regulatory interplay is discussed providing for a well-coordinated approach for digital health technologies. Finally, the article discusses several key points of the proposed EU AI Regulation considering digital health technologies.
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On 20 September 2022, the European Court of Human Rights (ECtHR) delivered its judgment in a remarkable case on sterilisation without the patient’s consent, Y.P. v Russian Federation (ECtHR, application no. 43399/13, 20 September 2022). According to the Court, there is no inhuman and degrading treatment, but it was a justified medical procedure. However, the Court did conclude a violation of the right to private life, under Article 8 ECHR. This outcome is at odds with an earlier sterilisation case without consent, V.C. v Slovakia (V.C. v. Slovakia, ECtHR application no. 18968/07, 8 November 2011). The question is how both rulings can be understood, especially the legal consideration regarding the prohibition of torture. After all, both cases lacked the patient’s consent.
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Abstract
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.
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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.
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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 Significance of ELSPI Perspectives
This edited collection examines the ethical, legal, social and policy implications of genome editing technologies. Moreover, it offers a broad spectrum of timely legal analysis related to bringing genome editing to the market and making it available to patients, including addressing genome editing technology regulation through procedures for regulatory approval, patent law and competition law.
In twelve chapters, this volume offers persuasive arguments for justifying transformative regulatory interventions regarding human genome editing, as well as the various legal venues for introducing necessary or desirable changes needed to create an environment for realizing the potential of genome editing technology for the benefit of patients and society.
In twelve chapters, this volume offers persuasive arguments for justifying transformative regulatory interventions regarding human genome editing, as well as the various legal venues for introducing necessary or desirable changes needed to create an environment for realizing the potential of genome editing technology for the benefit of patients and society.
The Significance of ELSPI Perspectives
This edited collection examines the ethical, legal, social and policy implications of genome editing technologies. Moreover, it offers a broad spectrum of timely legal analysis related to bringing genome editing to the market and making it available to patients, including addressing genome editing technology regulation through procedures for regulatory approval, patent law and competition law.
In twelve chapters, this volume offers persuasive arguments for justifying transformative regulatory interventions regarding human genome editing, as well as the various legal venues for introducing necessary or desirable changes needed to create an environment for realizing the potential of genome editing technology for the benefit of patients and society.
In twelve chapters, this volume offers persuasive arguments for justifying transformative regulatory interventions regarding human genome editing, as well as the various legal venues for introducing necessary or desirable changes needed to create an environment for realizing the potential of genome editing technology for the benefit of patients and society.