Cardiac implantable electronic devices (CIED) are vulnerable to radio frequency (RF) cyber-attacks. Besides, CIED communicate with medical equipment whose telemetry capabilities and IP connectivity are creating new entry points that may be used by attackers. Therefore, it remains crucial to perform a cybersecurity risk assessment of CIED and the systems they rely on to determine the gravity of threats, address the riskiest ones on a priority basis, and develop effective risk management plans. In this study, we carry out such risk assessment according to the ISO/IEC 27005 standard and the NIST SP 800-30 guide. We employed a threat-oriented analytical approach and divided the analysis into three parts, an actor-based analysis to determine the impact of the attacks, a scenario-based analysis to measure the probability of occurrence of threats, and a combined analysis to identify the riskiest attack outcomes. The results show that vulnerabilities on the RF interface of CIED represent an acceptable risk, whereas the network and Internet connectivity of the systems they rely on represent an important potential risk. Further analysis reveals that the damages of these cyber-attacks could spread further to affect manufacturers through intellectual property theft or physicians by affecting their reputation.

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