相关论文: On Medical Device Cybersecurity Compliance in EU

Cybersecurity in robotics stands out as a key aspect within Regulation (EU) 2024/1689, also known as the Artificial Intelligence Act, which establishes specific guidelines for intelligent and automated systems. A fundamental distinction in…

Implantable and wearable medical devices (IWMDs) are widely used for the monitoring and therapy of an increasing range of medical conditions. Improvements in medical devices, enabled by advances in low-power processors, more complex…

The Internet of Medical Things (IoMT) has transformed the healthcare industry by connecting medical devices in monitoring treatment outcomes of patients. This increased connectivity has resulted to significant security vulnerabilities in…

The Directorate General for Parliamentary Research Services of the European Parliament has prepared a report to the Members of the European Parliament where they enumerate seven main risks of Artificial Intelligence (AI) in medicine and…

This chapter explores the essential role of Binding Corporate Rules (BCRs) in managing and facilitating secure health data transfers within corporate groups under the EU General Data Protection Regulation (GDPR). BCRs are tailored to ensure…

In recent years, our society is being plagued by unprecedented levels of privacy and security breaches. To rein in this trend, the European Union, in 2018, introduced a comprehensive legislation called the General Data Protection Regulation…

The onward development of information and communication technology has led to a new industrial revolution called Industry 4.0. This revolution involves Cyber-Physical Production Systems (CPPS), which consist of intelligent Cyber-Physical…

The General Data Protection Regulation (GDPR) is considered as the benchmark in the European Union (EU) for privacy and data protection standards. Since before its entry into force in 2018, substantial research has been conducted in the…

Unlocking the potential of Industry 5.0 hinges on robust cybersecurity measures. This new Industrial Revolution prioritises human-centric values while addressing pressing societal issues such as resource conservation, climate change, and…

The data revolution continues to transform every sector of science, industry and government. Due to the incredible impact of data-driven technology on society, we are becoming increasingly aware of the imperative to use data and algorithms…

Context: Continuous Software Engineering is increasingly adopted in highly regulated domains, raising the need for continuous compliance. Adherence to especially security regulations -- a major concern in highly regulated domains -- renders…

The rapid evolutions in micro-computing, mini-hardware manufacturing, and machine to machine (M2M) communications have enabled novel Internet of Things (IoT) solutions to reshape many networking applications. Healthcare systems are among…

As cloud services become central in an increasing number of applications, they process and store more personal and business-critical data. At the same time, privacy and compliance regulations such as GDPR, the EU ePrivacy regulation, PCI,…

Cybersecurity issues in medical devices threaten patient safety and can cause harm if exploited. Standards and regulations therefore require vendors of such devices to provide an assessment of the cybersecurity risks as well as a…

In this work, we analyze the legal requirements on how cookie banners are supposed to be implemented to be fully compliant with the e-Privacy Directive and the General Data Protection Regulation. Our contribution resides in the definition…

Ample research has demonstrated that compliance with data protection principles remains limited on the web and mobile. For example, almost none of the apps on the Google Play Store fulfil the minimum requirements regarding consent under EU…

Over the past decade, focus on the security and privacy aspects of implantable medical devices (IMDs) has intensified, driven by the multitude of cybersecurity vulnerabilities found in various existing devices. However, due to their strict…

The European Union's General Data Protection Regulation (GDPR) went into effect on May 25, 2018. Its privacy regulations apply to any service and company collecting or processing personal data in Europe. Many companies had to adjust their…

To facilitate monitoring and management, modern Implantable Medical Devices (IMDs) are often equipped with wireless capabilities, which raise the risk of malicious access to IMDs. Although schemes are proposed to secure the IMD access, some…

The rapid growth of the Internet of Things technology in healthcare domain led to the appearance of many security threats and risks. It became very challenging to provide full protection with the expansion in using sensor objects in medical…