FDA Medical Device Cyber Guidance Protects Patients, Cos.

By Brenda Sharton, Emily Van Tuyl and Kathleen Fay (June 9, 2022, 5:15 PM EDT) — Medical devices that rely on software or the internet — such as wearable or implantable devices that are monitored remotely by health care providers[1] — can improve patient care and outcomes, reduce the number of in-person medical visits and associated costs, and promote patient safety.

But the same features that make these devices valuable may make them vulnerable to cybersecurity threats, potentially impacting device safety or effectiveness, and giving rise to product liability claims.

As discussed below, by anticipating, monitoring for and remediating cybersecurity vulnerabilities, manufacturers can reduce the risks to devices and patients — as well as their own risk…

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