Related papers: On Medical Device Cybersecurity Compliance in EU
In today's rapidly evolving digital landscape, organisations face escalating cyber threats that can disrupt operations, compromise sensitive data, and inflict financial and reputational harm. A key reason for this lies in the organisations'…
The cybersecurity threat landscape is constantly actively making it imperative to develop sound frameworks to protect the IT structures. Based on this introduction, this paper aims to discuss the application of cybersecurity frameworks into…
The world is currently strongly connected through both the internet at large, but also the very supply chains which provide everything from food to infrastructure and technology. The supply chains are themselves vulnerable to adversarial…
This paper examines the European Union's emerging regulatory landscape - focusing on the AI Act, corporate sustainability reporting and due diligence regimes (CSRD and CSDDD), and data center regulation - to assess whether it can…
The Smart4Health (S4H) software application will empower EU citizens to manage, analyze, and exchange their aggregated electronic health data. In order to provide such a service, basic features are needed to ensure usability, reliability,…
With the everlasting development of technology and society, data privacy has proven to grow into a pressing issue. The bureaucratic state system seems to expand the number of personal documents required for any kind of request. Therefore,…
The European General Data Protection Regulation (GDPR) brings new challenges for companies who must ensure they have an appropriate legal basis for processing personal data and must provide transparency with respect to personal data…
The use of connected surgical robotics to automate medical procedures presents new privacy challenges. We argue that conventional patient consent protocols no longer work. Indeed robots that replace human surgeons take on an extraordinary…
Background: Electronic health records (EHRs) enable machine learning for diagnosis, prognosis, and clinical decision support. However, EHR standards vary by country and hospital, making records often incompatible. This limits large-scale…
Security is a hot issue to be discussed, ranging from business activities, correspondence, banking and financial activities; it requires prudence and high precision. Since information security has a very important role in supporting…
This note is intended to provide an overview of the implications of regulations and standards on the safety of mechanical equipment, with a focus on accelerator components. Each research facility has different internal rules and standards…
When developing devices, architectures and services for the Internet of Medical Things (IoMT) world, manufacturers or integrators must be aware of the security requirements expressed by both laws and specifications. To provide tools guiding…
Thanks to new technologies and communication paradigms, such as the Internet of Things (IoT) and the Robotic Operating System (ROS), modern robots can be built by combining heterogeneous standard devices in a single embodiment. Although…
Conceptions of privacy differ by culture. In the Internet age, digital tools continuously challenge the way users, technologists, and governments define, value, and protect privacy. National and supranational entities attempt to regulate…
The General Data Protection Regulation (GDPR) came into effect in May 2018 and is designed to safeguard EU citizens' data privacy. The benefits of the regulation to consumers' rights and to regulators' powers are well known. The benefits to…
While the applications and demands of Machine learning (ML) systems in mental health are growing, there is little discussion nor consensus regarding a uniquely challenging aspect: building security methods and requirements into these ML…
The maritime industry stands at a critical juncture, where the imperative for technological advancement intersects with the pressing need for robust cybersecurity measures. Maritime cybersecurity refers to the protection of computer systems…
Machine Learning on Big Data gets more and more attention in various fields. Even so privacy-preserving techniques become more important, even necessary due to legal regulations such as the General Data Protection Regulation (GDPR). On the…
Teaching industry staff on cybersecurity issues is a fundamental activity that must be undertaken in order to guarantee the delivery of successful and robust products to market. Much research attention has been devoted to this topic over…
In our data-centric world, most services rely on collecting and using personal data. The EU's General Data Protection Regulation (GDPR) aims to enhance individuals' control over their data, but its practical impact is not well understood.…