This book chapter assesses the EU medical devices legal framework in light of the EU
cybersecurity policy objectives and the complexity aspects inherently characterizing the …

Medical devices and artificial intelligence systems rapidly transform healthcare provisions.
At the same time, due to their nature, AI in or as medical devices might get exposed to …

Cyberattacks on the IT infrastructure of hospitals, electronic health records or medical
devices that have taken place during the COVID-19 pandemic reaffirmed how crucial it is to …

Cybersecurity in medical devices has become a pressing issue in modern times.
Technological progress has simultaneously benefited health care and created new risks …

Medical devices are becoming increasingly more sophisticated in a variety of ways. This
includes having increasingly complex digital functionalities assisted by software systems. 2 …

New digital technologies and systems, such as the Internet of Things (IoT) or Artificial
Intelligence (AI) tools that are typically implemented as software in medical devices or as …

Abstract 2020 marks a crucial year for the EU agenda on critical infrastructure protection and
cybersecurity, as EU policy-makers which will have to re-consider key pieces of legislation …

Nov. The Healthcare Information and Management Systems Society (HIMSS) releases the
Manufacturers Disclosure Statement for Medical Device Security (MDS2) form, which …

The US Food and Drug Administration's (FDA) latest draft guidelines for post-market
management of cybersecurity risks in medical devices are a good start, but need to be given …

As healthcare is increasingly digitized and interconnected, medical systems are exposed to
cybersecurity threats that can endanger patient health and safety. This paper examines how …