相关论文: On Medical Device Cybersecurity Compliance in EU

Biometric systems involve security assurance to make our system highly secured and robust. Nowadays, biometric technology has been fixed into new systems with the aim of enforcing strong privacy and security. Several innovative system have…

Background: Governments worldwide are considering data privacy regulations. These laws, e.g. the European Union's General Data Protection Regulation (GDPR), require software developers to meet privacy-related requirements when interacting…

The integration of medical devices in the patient treatment process becomes increasingly important due to the efficiency of the technology. On the one hand, medical devices hardware is more powerful and its integration with the software…

Product safety has been a concern in Europe ever since the early 1960s. Despite the long and relatively stable historical lineage of product safety regulations, new technologies, changes in the world economy, and other major transformations…

Artificial Intelligence (AI) plays an essential role in healthcare and is pervasively incorporated into medical software and equipment. In the European Union, healthcare is a high-risk application domain for AI, and providers must prepare…

The GDPR, or the Datenschutz Grundverordnung (DSGVO) in German, is an EU Law which addresses the subject of safeguarding privacy of personal data of the citizens of the EU and EEA. It also specifies how data the collected data might be…

Cybersecurity is a big challenge as hackers are always trying to find new methods to attack and exploit system vulnerabilities. Cybersecurity threats and risks have increased in recent years, due to the increasing number of devices and…

Cyber Security plays an important role in the field of information technology .Securing the information have become one of the biggest challenges in the present day. When ever we think about the cyber security the first thing that comes to…

The Internet of Medical Things (IoMT) offers a promising solution to improve patient health and reduce human error. Wearable smart infusion pumps that accurately administer medication and integrate with electronic health records are an…

The management of data and digital assets poses various challenges, including the need to adhere to legal requirements with respect to personal data protection and copyright. Usage control technologies could be used by software platform…

The Cyber Security and Resilience (Network and Information Systems) Bill, introduced to Parliament in November 2025, represents the most significant reform of UK cyber security legislation in nearly a decade. This paper provides a…

How do healthcare organizations (from small Practices to large HDOs) evaluate adherence to the cybersecurity and privacy protection of Medical Internet of Things (MIoT) used in clinical settings? This paper suggests an approach for such…

The Internet of Medical Things (IoMT) has the potential to radically improve healthcare by enabling real-time monitoring, remote diagnostics, and AI-driven decision making. However, the connectivity, embedded intelligence, and inclusion of…

Purpose: Used extensively in the diagnosis, treatment, and prevention of disease, Medical Imaging Devices (MIDs), such as Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) machines, play an important role in medicine today. MIDs…

This report provides a detailed comparison between the Safety and Security measures proposed in the EU AI Act's General-Purpose AI (GPAI) Code of Practice (Third Draft) and the current commitments and practices voluntarily adopted by…

Secure robotics is a multi-disciplinary endeavour for improving the cybersecurity posture of robotic and embodied Artificial Intelligence systems. The article surveys emerging concepts and ideas encapsulating the notion of secure robotics…

The automotive industry has evolved significantly since the introduction of the Ford Model T in 1908. Today's vehicles are not merely mechanical constructs; they are integral components of a complex digital ecosystem, equipped with advanced…

Context: Privacy legislation has impacted the way software systems are developed, prompting practitioners to update their implementations. Specifically, the EU General Data Protection Regulation (GDPR) and the California Consumer Privacy…

Security incidents such as targeted distributed denial of service (DDoS) attacks on power grids and hacking of factory industrial control systems (ICS) are on the increase. This paper unpacks where emerging security risks lie for the…

The use of embedded software is advancing in modern medical devices, so does its capabilities and complexity. This paradigm shift brings many challenges such as an increased rate of medical device failures due to software faults. In this…