Definition Edit

Medical device Edit

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), ISAOs 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.[1]

References Edit

  1. Postmarket Management of Cybersecurity in Medical Devices: Draft Guidance for Industry and Food and Drug Administration Staff, at 8-9.

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