相关论文: On Medical Device Cybersecurity Compliance in EU

Privacy is a key challenge for continued digitalization of health. The forthcoming European General Data Protection Regulation (GDPR) is transforming this challenge into regulatory directives. User consent provisioning and coordinating…

Many modern consumer devices rely on network connections and cloud services to perform their core functions. This dependency is especially present in Internet of Things (IoT) devices, which combine hardware and software with network…

The ultimate goal in the pharmaceutical sector is product quality. However this quality can be altered by the use of a number of heterogeneous information systems with different business structures and concepts along the lifecycle of the…

The goal of this paper is to propose a blockchain-based platform to enhance transparency and traceability of cybersecurity certification information motivated by the recently adopted EU Cybersecurity Act. The proposed platform is generic…

The Industry 4.0 concept promotes a digital manufacturing (DM) paradigm that can enhance quality and productivity, that reduces inventory and the lead-time for delivering custom, batch-of-one products based on achieving convergence of…

The European General Data Protection Regulation (GDPR) calls for technical and organizational measures to support its implementation. Towards this end, the SPECIAL H2020 project aims to provide a set of tools that can be used by data…

The present paper deals with the elucidation and implementation of the Data Protection by Design (DPbD) principle as recently introduced in the European Union data protection law, specifically with regards to cybersecurity systems in a…

Safety and efficacy are the paramount objectives of medical device regulation. And in line with the medical ethos of non-maleficence, first do no harm, safety is the primary goal of regulation also. As such, risk management is the…

Modern software has been an integral part of everyday activities in many disciplines and application contexts. Introducing intelligent automation by leveraging artificial intelligence (AI) led to break-throughs in many fields. The…

In December 2023, the European Parliament provisionally agreed on the EU AI Act. This unprecedented regulatory framework for AI systems lays out guidelines to ensure the safety, legality, and trustworthiness of AI products. This paper…

With the arrival of the European Union's General Data Protection Regulation (GDPR), several companies are making significant changes to their systems to achieve compliance. The changes range from modifying privacy policies to redesigning…

The EU Artificial Intelligence Act (AIA) establishes different legal principles for different types of AI systems. While prior work has sought to clarify some of these principles, little attention has been paid to robustness and…

The General Data Protection Regulation (GDPR) forces IT companies to comply with a number of principles when dealing with European citizens' personal data. Non-compliant companies are exposed to penalties which may represent up to 4% of…

The General Data Protection Regulation (GDPR) is a European Union regulation that will replace the existing Data Protection Directive on 25 May 2018. The most significant change is a huge increase in the maximum fine that can be levied for…

Purpose: The introduction of artificial intelligence / machine learning (AI/ML) products to the regulated fields of pharmaceutical research and development (R&D) and drug manufacture, and medical devices (MD) and in-vitro diagnostics (IVD),…

This paper introduces the strategic approach to regulating personal data and the normative foundations of the European Union's General Data Protection Regulation ('GDPR'). We explain the genesis of the GDPR, which is best understood as an…

The synthesis of technology and the medical industry has partly contributed to the increasing interest in Medical Cyber-Physical Systems (MCPS). While these systems provide benefits to patients and professionals, they also introduce new…

The General Data Protection Regulation (GDPR) provides new rights and protections to European people concerning their personal data. We analyze GDPR from a systems perspective, translating its legal articles into a set of capabilities and…

The proliferation of Large Language Models (LLMs) has demonstrated remarkable capabilities, elevating the critical importance of LLM safety. However, existing safety methods rely on ad-hoc taxonomy and lack a rigorous, systematic…

Digital medical imaging laboratories contain many distinct types of equipment provided by different manufacturers. Interoperability is a critical issue and the DICOM protocol is a de facto standard in those environments. However,…