Related papers: On Medical Device Cybersecurity Compliance in EU
This report summarizes the European Union's series of data and AI regulations and analyzes them for managers in automotive vehicle manufacturing organizations. In particular, we highlight the relevant ideas of the regulations, including how…
The recent advancements in computing systems and wireless communications have made healthcare systems more efficient than before. Modern healthcare devices can monitor and manage different health conditions of the patients automatically…
The explosion in the performance of Machine Learning (ML) and the potential of its applications are strongly encouraging us to consider its use in industrial systems, including for critical functions such as decision-making in autonomous…
There is a growing demand for the use of Artificial Intelligence (AI) and Machine Learning (ML) in healthcare, particularly as clinical decision support systems to assist medical professionals. However, the complexity of many of these…
The dawn of the digital medicine era, ushered in by increasingly powerful embedded systems and Internet of Things (IoT) computing devices, is creating new therapies and biomedical solutions that promise to positively transform our quality…
Regulatory compliance is a well-studied area, including research on how to model, check, analyse, enact, and verify compliance of software. However, while the theoretical body of knowledge is vast, empirical evidence on challenges with…
Mobile devices and technologies offer a tremendous amount of benefits to users, although it is also understood that it introduces a set of challenges when it comes to security, compliance, and risks. More and more healthcare organizations…
Cyber assurance, which is the ability to operate under the onslaught of cyber attacks and other unexpected events, is essential for organizations facing inundating security threats on a daily basis. Organizations usually employ multiple…
As wearable health technologies have grown more sophisticated, the distinction between "wellness" and "medical" devices has become increasingly blurred. While some features undergo formal U.S. Food and Drug Administration (FDA) review, many…
The abundance of data has transformed the world in every aspect. It has become the core element in decision making, problem solving, and innovation in almost all areas of life, including business, science, healthcare, education, and many…
Software security has been an important research topic over the years. The community has proposed processes and tools for secure software development and security analysis. However, a significant number of vulnerabilities remains in…
With the rapid development of online technologies and the widespread usage of mobile phones among children, it is crucial to protect their online safety. Some studies reported that online abuse and incidents negatively affect children's…
As technology advances towards more connected and digital environments, medical devices are becoming increasingly connected to hospital networks and to the Internet, which exposes them, and thus the patients using them, to new cybersecurity…
Advanced medical devices exploit the advantages of embedded software whose development is subject to compliance with stringent requirements of standardization and certification regimes due to the critical nature of such systems. This paper…
Cybersecurity governance influences the quality of strategic decision-making to ensure cyber risks are managed effectively. Board of Directors are the decisions-makers held accountable for managing this risk; however, they lack adequate and…
"Safety" and "Risk" are key concepts for the design and development of automated vehicles. For the market introduction or large-scale field tests, both concepts are not only relevant for engineers developing the vehicles, but for all…
With the ongoing adoption of 5G for communication in industrial systems and critical infrastructure, the security of industrial UEs such as 5G-enabled industrial robots becomes an increasingly important topic. Most notably, to meet the…
Specifying legal requirements for software systems to ensure their compliance with the applicable regulations is a major concern to requirements engineering (RE). Personal data which is collected by an organization is often shared with…
Medical device regulators in the United States(FDA), China (NMPA), and Europe (EU MDR) all use the language of risk, but classify devices through structurally different mechanisms. Whether these apparently shared concepts carry transferable…
The Accountability Principle of the GDPR requires that an organisation can demonstrate compliance with the regulations. A survey of GDPR compliance software solutions shows significant gaps in their ability to demonstrate compliance. In…