A Blanket That Leaves the Feet Cold: Exploring the AI Act Safety Framework for Medical AI.

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.

De Jure and De Facto: An Overview on the Italian Measures on Compulsory Vaccination.

The outbreak of the Covid-19 pandemic has forced States to take restrictive measures to contain the growing number of infections. Among these measures, after the approval of vaccines by the EMA, the possibility of introducing a compulsory vaccination has become a plausible and attractive prospect. In Italy, Covid-19 compulsory vaccination is implemented by a succession of Decrees concerning specific categories of workers and, only recently, a section of the population with the recent Decree of 7 January, 2022, no. 1. However, if we look back at the most critical restrictions implemented in the country, we realise that a de facto obligation was already in place before establishing a de jure obligation. The following article traces the most important profiles of the vaccination obligation implemented de jure and de facto by the Italian government.

Inevitable Influences: AI-Based Medical Devices at the Intersection of Medical Devices Regulation and the Proposal for AI Regulation.

In recent years, the use of Artificial Intelligence (AI) in the medical field has attracted increased attention. Due to their impressive advantages, AI systems offer excellent prospects for medical device manufacturers using these systems to upgrade their products. Such AI-based medical devices are already subject to partial regulation within the lines of Medical device regulation 745/2017. However, following the proposal for a regulation on artificial intelligence published by the European Commission, the regulatory landscape for these devices has partially changed. This article aims to clarify the influences that this regulatory intervention by the European Commission brings to the path towards the use and marketing of AI-based medical devices.

The physician's right to conscientious objection: an evolving recognition in Europe.

Due to the growing number of medical treatments, physicians--who are also human beings with their own conscience and beliefs--are increasingly confronted with treatments that may conflict with their principles and convictions. Although several human rights documents recognize the freedom of conscience and belief, we could not locate the recognition of an explicit right to conscientious objection. Furthermore, a direct application of the right to freedom of thought, conscience and religion, as recognized by article 9 of the ECHR, does not include such a right due to the narrow interpretation of this right by the European Court of Human Rights. However, the Court seems to have taken steps away from this narrow interpretation in Pichon and Sajous v. France. Notwithstanding these steps, no general right to conscientious objection exists. Physicians therefore are dependent on a judgment if they refuse a certain treatment because of conscientious objections.

Reporting, recording, and communication of COVID-19 cases in workplace: data protection as a moving target.

In response to concerns related to privacy in the context of coronavirus disease 2019 (COVID-19), recently European and national Data Protection Authorities (DPAs) issued guidelines and recommendations addressing a variety of issues related to the processing of personal data for preventive purposes. One of the recurring questions in these guidelines is related to the rights and responsibilities of employers and employees in reporting, recording, and communicating COVID-19 cases in workplace. National DPAs in some cases adopted different approaches regarding duties in reporting and communicating the COVID-19 cases; however, they unanimously stressed the importance of adopting privacy-preserving approaches to avoid raising concerns about surveillance and stigmatization. We stress that in view of the increasing use of new data collection and sharing tools such as 'tracing and warning' apps, the associated privacy-related risks should be evaluated on an ongoing manner. In addition, the intricacies of different settings where such apps may be used should be taken into consideration when assessing the associated risks and benefits.

Attitudes regarding predictive genetic testing in minors: a survey of European clinical geneticists.

The aim of this study is to gather information from European clinical geneticists about their practices and attitudes with regard to presymptomatic and predictive genetic testing in minors. European clinical institutes where genetic counseling is offered to patients were contacted. One hundred seventy-seven of the 287 eligible respondents (63%) answered a questionnaire. There was strongest support for testing young children when it provides a clear medical benefit, such as in the case of FAP and MEN2A. However, there is disagreement about when to provide predictive genetic testing for childhood-onset disorders for which therapeutic or preventive measures exist with some supporting the rule of earliest onset and others giving parents wider discretion. However, for childhood-onset disorders that do not have therapeutic measures, the majority of the respondents is unwilling to provide a presymptomatic or predictive genetic test. With respect to adolescents, many held a cautious position regarding presymptomatic and predictive genetic testing. Most clinical geneticists were unwilling to provide a presymptomatic or predictive genetic test for adult-onset diseases, except if it might provide a medical benefit. Although adolescents might be legally in the position to request a presymptomatic or predictive genetic test personally, the clinical geneticists are significantly more willing to provide a test if this request is made together with the minor's parents. This variability demonstrates the need for clinical geneticists to discuss their contradicting views and to develop harmonized practices throughout Europe.

Why eight EU Member States signed, but not yet ratified the Convention for Human Rights and Biomedicine.

The European Convention on Human Rights and Biomedicine was adopted by the Committee of Ministers of the Council of Europe on 19 November 1996 and opened for signature on 4 April 1997. At the moment 21 of the 33 countries that signed the Convention are EU Member States. Signing the Convention implies the obligation to put the Convention before the national Parliament within a reasonable period of time with a view to ratification. Eight of the 21 EU Member States--namely Finland, France, Italy, Latvia, Luxembourg, The Netherlands, Poland and Sweden - still have to complete the ratification. In this article the reasons why eight Member States have not yet ratified the Convention, but only signed it, are mapped and analyzed. Because of the concrete list of patient rights provided for in the Convention, we focus on the question whether the reasons for not ratifying are related to these patient rights provisions.