Navigating Cybersecurity Challenges in Healthcare: Challenges, Innovations, and EU Legal Framework for Connected Medical Devices

As healthcare technologies advance, their increasing interconnectivity and integration into more extensive IT networks and systems offer numerous ad-vantages, such as real-time remote monitoring, early prevention and cost reduc-tion. However, this heightened interconnectedness also presents significant chal-lenges, with cyberattacks targeting medical devices and hospital networks emerg-ing as prominent issues. Understandably, the cybersecurity of connected medical devices has gained paramount importance and urgency.

This paper outlines the principal cybersecurity challenges confronting the healthcare sector and introduces insights from the EU-funded CYLCOMED pro-ject, which aims to provide the latest technological solutions to address these challenges. Mainly, the paper seeks to identify the primary challenges encoun-tered by the healthcare sector concerning cyber threats. Subsequently, it outlines the high-level architecture of the EU-funded CYLCOMED project (Cyber secu-ritY tooLbox for COnnected MEdical Devices) and its principal objectives, which aim to enhance the cybersecurity of connected, in vitro diagnostic, and software as medical devices (CMDs, IVDs, SaMD). Lastly, it provides a brief overview of the applicable EU legal framework governing the cybersecurity of medical devices.