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Cybersecurity of AI medical devices: risks, legislation, and challenges by Biasin, Elisabetta; Kamenjasevic, Erik; Ludvigsen, Kaspar Rosager is a scholarly article available to read on EtoBox.

What is Cybersecurity of AI medical devices: risks, legislation, and challenges about?

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, leading to patient safety and security risks. This book chapter is divided into three parts. The first part starts by setting the scene where we explain the role of cybersecurity in healthcare. Then, we briefly define what we refer to when we talk about AI that is considered a medical device by itself or supports one. To illustrate the risks such medical devices pose, we provide three examples: the poisoning of datasets, social engineering, and data or source code extraction. In the second part, the paper provides an overview of the European Union's regulatory framework relevant for ensuring the cybersecurity of AI as or in medical devices (MDR, NIS Directive, Cybersecurity Act, GDPR, the AI Act proposal and the NIS 2 Directive proposal). Finally, the third part of the paper examines possible challenges stemming from the EU regulatory framework. In particular, we look toward the challenges deriving from the two legislative proposals and their interaction with the existing legislation concer

Author

Biasin, Elisabetta; Kamenjasevic, Erik; Ludvigsen, Kaspar Rosager

Published

2023

Language

EN