Connected Medical Devices (CMD) are redefining care within the NHS but exposing it to bi-directional cyber-physical threats that traverse physical, network and cloud layers. These vulnerabilities blur the boundary between technology and patient safety. This Comment argues that the MHRA should elevate cybersecurity to a clinical-safety mandate, enforcing a unified socio-technical framework with security-by-design, cross-layer risk assessment and continuous post-market vigilance.
Toparti et al. (Tue,) studied this question.