相关论文: On Medical Device Cybersecurity Compliance in EU
As deep learning (DL) technologies advance, their application in automated visual inspection for Class III medical devices offers significant potential to enhance quality assurance and reduce human error. However, the adoption of such…
Over the last decade, surgical robots have risen in prominence and usage. For surgical robots, connectivity is necessary to accept software updates, accept instructions, and transfer sensory data, but it also exposes the robot to…
The growing adoption of IT solutions in the healthcare sector is leading to a steady increase in the number of cybersecurity incidents. As a result, organizations worldwide have introduced regulations, standards, and best practices to…
Data-driven applications and services have been increasingly deployed in all aspects of life including healthcare and medical services in which a huge amount of personal data is collected, aggregated, and processed in a centralised server…
Incident management is a classical topic in cyber security. Recently, the European Union (EU) has started to consider also the relation between cyber security incidents and cyber security crises. These considerations and preparations,…
The General Data Protection Regulation (GDPR) in the European Union is the most famous recently enacted privacy regulation. Despite of the regulation's legal, political, and technological ramifications, relatively little research has been…
Recent years have witnessed a boom of connected medical devices, which brings security issues in the meantime. Medical imaging devices, an essential part of medical cyber-physical systems, play a vital role in modern hospitals and are often…
The integration of AI/ML into medical devices is rapidly transforming healthcare by enhancing diagnostic and treatment facilities. However, this advancement also introduces serious cybersecurity risks due to the use of complex and often…
Integrating Internet of Things (IoT) devices in healthcare has revolutionized patient care, offering improved monitoring, diagnostics, and treatment. However, the proliferation of these devices has also introduced significant cybersecurity…
Machine learning is expected to fuel significant improvements in medical care. To ensure that fundamental principles such as beneficence, respect for human autonomy, prevention of harm, justice, privacy, and transparency are respected,…
In Europe and indeed worldwide, the General Data Protection Regulation (GDPR) provides protection to individuals regarding their personal data in the face of new technological developments. GDPR is widely viewed as the benchmark for data…
Ensuring data quality in machine learning (ML) systems has become increasingly complex as regulatory requirements expand. In the European Union (EU), frameworks such as the General Data Protection Regulation (GDPR) and the Artificial…
Electronic Health Records (EHR) are crucial for the success of digital healthcare, with a focus on putting consumers at the center of this transformation. However, the digitalization of healthcare records brings along security and privacy…
The increasing integration of artificial intelligence (AI) systems in various fields requires solid concepts to ensure compliance with upcoming legislation. This paper systematically examines the compliance of AI systems with relevant…
The transparent and decentralized characteristics associated with blockchain can be both appealing and problematic when applied to a healthcare use-case. As health data is highly sensitive, it is also highly regulated to ensure the privacy…
Over time, the distribution of medical image data drifts due to factors such as shifts in patient demographics, acquisition devices, and disease manifestations. While human radiologists can adjust their expertise to accommodate such…
This chapter introduces the Accountability Principle and its role in data protection governance. We focus on what accountability means in the context of cybersecurity management in smart homes, considering the EU General Data Protection Law…
Implantable Medical Devices (IMD) is a fast pace growing medical field and continues to grow in the foreseeable future. Advancement in science and technology has led to the IMD devices offering advanced medical treatments. Modern IMDs can…
The healthcare sector is increasingly vulnerable to cyberattacks due to its growing digitalization. Patient data, including medical records and financial information, are at risk, potentially leading to identity theft and patient safety…
The Cyber Resilience Act (CRA) of the European Union (EU) imposes many new cyber security requirements practically to all network-enabled information technology products, whether hardware or software. The paper examines and elaborates the…