No abstract

Cyberattacks on the IT infrastructure of hospitals, electronic health records or medical devices that have taken place during the COVID-19 pandemic reaffirmed how crucial it is to ensure cybersecurity in the healthcare sector. Medical devices are regulated in the European Union (EU) through vertical product-specific legislation, such as the Medical Device Regulation (MDR), among others. The MDR foresees safety requirements implying cybersecurity obligations for medical device manufacturers. In 2021, the EU legislator put forward the Network and Information Security System Directive reform (NIS 2) and the Artificial Intelligence Act (AIA) proposal, containing additional cybersecurity requirements applicable to medical devices. This article analyses how the new reforms interact with the existing legislation from a cybersecurity perspective. The research finds that parallel provision of analogous cybersecurity requirements (especially on notification requirements) could lead to regulatory overlapping, fragmentation, and uneven levels of protection of individuals in the EU internal market. In the “Recommendations and conclusions”, the article provides policy recommendations to the EU legislator to help mitigate these risks.

In this paper, we attempt to provide starting points for a discussion on immediate and longer term consequences of COVID-19 induced uses of digital technologies for the distinction of the public and the private spheres. We start with clarifying definitions of the public and the private spheres in relation to the concept of privacy. What is considered private is at least in part contextually determined by conventions and social, political, economic and technological developments. From this perspective, we set out to critically evaluate the COVID-19 induced large-scale introduction of new digital tools in two essential areas of life: the workplace and education. We discuss the role of technology and its immediate concomitant legal or ethical challenges. The paper concludes with reflections on the possible longer-term normative effects of the use of digital tools in the context of the COVID-19 containment on the demarcation of the public and private spheres. 1 We leave typically philosophical uses of the notion, such as Habermas' reference to the public primarily as a societal forum for social and political debate undiscussed here. Habermas J. Strukturwandel der Öffentlichkeit: Untersuchungen zu einer Kategorie der bürgerlichen Gesellschaft: Untersuchungen zu einer Kategorie der bürgerlichen Gesellschaft. Berlin: Suhrkamp, 1990Suhrkamp, (originally published 1962.