相关论文: On Medical Device Cybersecurity Compliance in EU
The integration of the Internet of Medical Things (IoMT) into healthcare systems has transformed patient care by enabling real-time monitoring, enhanced diagnostics, and enhanced operational efficiency. However, this increased connectivity…
The growing availability and use of deepfake technologies increases risks for democratic societies, e.g., for political communication on online platforms. The EU has responded with transparency obligations for providers and deployers of…
Interoperability is increasingly recognised as a foundational principle for fostering innovation, competition, and user autonomy in the evolving digital ecosystem. Existing research on interoperability predominantly focuses either on…
This systematic literature review analyzes the current state of compliance with Regulation (EU) 2024/1689 in autonomous robotic systems, focusing on cybersecurity frameworks and methodologies. Using the PRISMA protocol, 22 studies were…
The Internet of Medical Things (IoMT) has the potential to revolutionize healthcare by reducing human error and improving patient health. For instance, wearable smart infusion pumps can accurately administer medication and integrate with…
The efficiency and service quality in a medical environment can be improved by using electronic documents (or e-docs) and digital signatures to speed up both doctors' activity and to provide in the same time easy retrieval and use of needed…
The focus in this paper is placed on shared responsibility and ethics in health policy, specific to Internet of Things (IoT) devices in healthcare systems. The article assesses how the introduction of IoT brings risks to the security of…
The focus of this paper is on wearable technologies which are increasingly being employed in the medical field. From smart watches to smart glasses, from electronic textile to data gloves; several gadgets are playing important roles in…
Supporting e-Science in the EGI e-Infrastructure requires extensive and reliable software, for advanced computing use, deployed across over approximately 300 European and worldwide data centers. The Unified Middleware Distribution (UMD) and…
Digital Embedded Devices of next-generation safety-critical industrial automation systems require high levels of survivability and resilience against the hardware and software failure. One of the concepts for achieving this requirement is…
In today's age of digital technology, ethical concerns regarding computing systems are increasing. While the focus of such concerns currently is on requirements for software, this article spotlights the hardware domain, specifically…
Information protection is becoming a focal point for designing, creating and implementing software applications within highly integrated technology environments. The use of a safe coding technique in the software development process is…
The many initiatives on trustworthy AI result in a confusing and multipolar landscape that organizations operating within the fluid and complex international value chains must navigate in pursuing trustworthy AI. The EU's AI Act will now…
This paper explores the importance of accountability to data protection, and how it can be built into the Internet of Things (IoT). The need to build accountability into the IoT is motivated by the opaque nature of distributed data flows,…
Under the current regulatory framework for data protections, the protection of human rights writ large and the corresponding outcomes are regulated largely independently from the data and tools that both threaten those rights and are needed…
The General Data Protection Regulation (GDPR) came into force in 2018. After this enforcement, many fines have already been imposed by national data protection authorities in Europe. This paper examines the individual GDPR articles…
Though the sharing of medical data has the potential to lead to breakthroughs in health care, the sharing process itself exposes patients and health care providers to various risks. Patients face risks due to the possible loss in privacy or…
Despite large progress in Explainable and Safe AI, practitioners suffer from a lack of regulation and standards for AI safety. In this work we merge recent regulation efforts by the European Union and first proposals for AI guidelines with…
Industrial standards for developing medical device software provide requirements that conforming devices must meet. A number of reference software architectures have been proposed to develop such software. The ISO/IEC 25010:2011 family of…
Regulatory compliance is increasingly being addressed in the practice of requirements engineering as a main stream concern. This paper points out a gap in the theoretical foundations of regulatory compliance, and presents a theory that…