CYLCOMED

Cyber security toolbox for connected medical devices

Challenge

Accelerated digitalization in the health sector brings opportunities for cost-effective and efficient delivery of personalized care, through medical devices (including software) connected to IT networks and increasingly combined with novel technologies (AI, cloud computing, blockchain, or 5G networks) and simultaneously Europe is witnessing an increase in the complexity and sophistication of attacks threatening such critical infrastructure.

Objective

CYLCOMED addresses the overall ambitious goal of strengthening the cybersecurity of connected, in vitro diagnostic and software as medical devices (CMDs, IVDs, SaMD), maintaining their performance and safety for patients, and preserving or enhancing the confidentiality, integrity, and availability of private data they exchange or allow to be remotely accessed and focusing on humans operating the technology as the weakest link in the chain for security and privacy, with training and awareness measures tailored to healthcare staff needs. It does so by enabling adoption by all ecosystem stakeholders of technologically sovereign and trustworthy cybersecurity methodologies and toolboxes for connected medical devices and the environments in which they are managed and operate (platforms), complemented with fit-for-purpose guidance covering identified risks and gaps.