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Medical devices and artificial intelligence systems rapidly transformhealthcare provisions. At the same time, due to their nature, AI in or asmedical devices might get exposed to cyberattacks, leading to patient safetyand security risks. This book chapter is divided into three parts. The firstpart starts by setting the scene where we explain the role of cybersecurity inhealthcare. Then, we briefly define what we refer to when we talk about AI thatis considered a medical device by itself or supports one. To illustrate therisks such medical devices pose, we provide three examples: the poisoning ofdatasets, social engineering, and data or source code extraction. In the secondpart, the paper provides an overview of the European Union's regulatoryframework relevant for ensuring the cybersecurity of AI as or in medicaldevices (MDR, NIS Directive, Cybersecurity Act, GDPR, the AI Act proposal andthe NIS 2 Directive proposal). Finally, the third part of the paper examinespossible challenges stemming from the EU regulatory framework. In particular,we look toward the challenges deriving from the two legislative proposals andtheir interaction with the existing legislation concerning AI medical devices'cybersecurity. They are structured as answers to the following questions: (1)how will the AI Act interact with the MDR regarding the cybersecurity andsafety requirements?; (2) how should we interpret incident notificationrequirements from the NIS 2 Directive proposal and MDR?; and (3) what are theconsequences of the evolving term of critical infrastructures?  [This is a draft chapter. The final version will be available in ResearchHandbook on Health, AI and the Law edited by Barry Solaiman & I. Glenn Cohen,forthcoming 2023, Edward Elgar Publishing Ltd]

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