Cybersecurity signal

Signals come from complaints, investigations and security sources alike. Post-market processes need a route to collect and assess them, including those that never arrive as a customer complaint.

A cybersecurity signal is any information which indicates the potential for, or confirmation of, a cybersecurity vulnerability or exploit that affects, or could affect a medical device. A cybersecurity signal could originate from traditional information sources such as internal investigations, postmarket surveillance, or complaints, and/or security-centric sources such as CERTS (Computer/Cyber, Emergency Response/Readiness Teams), such as ICS-CERT, ISAOs, threat indicators, and security researchers. Signals may be identified within the HPH Sector. They may also originate in another critical infrastructure sector (e.g., defense, financial) but have the potential to impact medical device cybersecurity.

FDA guidance: Postmarket Management of Cybersecurity in Medical Devices (December 2016), Section IV.D, Definitions