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npj Digital Medicine, Published online: 10 March 2026; doi:10.1038/s41746-026-02534-4

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.

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