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.

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.

Alzheimer's disease and driving: review of the literature and consensus guideline from Belgian dementia experts and the Belgian road safety institute endorsed by the Belgian Medical Association.

Alzheimer's disease (AD) is a highly prevalent condition and its prevalence is expected to further increase due to the aging of the general population. It is obvious that the diagnosis of AD has implications for driving. Finally, driving discussions are also emotionally charged because driving is associated with independence and personal identity. However, it is not clear how to implement this in clinical practice and the Belgian law on driving is rather vague in its referral to neurodegenerative brain diseases in general nor does it provide clear-cut instructions for dementia or AD compared to for example driving for patients with epilepsy and as such does not prove to be very helpful. The present article reviews what is known from both literature and existing guidelines and proposes a consensus recommendation tailored to the Belgian situation agreed by both AD experts and the Belgian Road Safety Institute endorsed by the Belgian Medical Association. It is concluded that the decision about driving fitness should be considered as a dynamic process where the driving fitness is assessed and discussed early after diagnosis and closely monitored by the treating physician. The diagnosis of AD on itself definitely does not imply the immediate and full revocation of a driving license nor does it implicate a necessary referral for a formal on-road driving assessment. There is no evidence to recommend a reduced exposure or a mandatory co-pilot. A MMSE-based framework to trichotomise AD patients as safe, indeterminate or unsafe is presented. The final decision on driving fitness can only be made after careful history taking and clinical examination, neuropsychological, functional and behavioral evaluation and, only for selected cases, a formal assessment of driving performance.