Cybersecurity of AI medical devices: risks, legislation, and challenges

Excerpt

Medical devices and artificial intelligence (AI) systems are rapidly transforming healthcare. Due to their nature, AI in or as medical devices might be exposed to cyberattacks, leading to patient safety and security risks. In this chapter, we explore the new aspects AI systems bring to medical device cybersecurity and explain through examples (the poisoning of datasets, social engineering and data or source code extraction) the related cyber threats. As new cybersecurity legislation is drafted by the European Union legislator, we discuss the challenges that two legislative proposals (the AI Act and NIS2 Directive) may imply for the existing legislation concerning AI medical device cybersecurity.