Network-connected Medical Devices: In the Cyber Crosshairs, Pharmaceutical Compliance Monitor by Marc S. Moses and Chang Liu
On March 16th, Pharmaceutical Compliance Monitor published an article written by Marc S. Voses, Esq. and Chang Liu on network-connected medical devices and cyber concerns.
In a growing market for network-connected medical devices such as health monitoring devices, remote-controlled infusion pumping systems, and network-connected pacemakers, these devices could potentially implicate serious cybersecurity liability to manufacturers under both federal regulations and state common law. This article will explore the FDA’s recommendations for premarket and postmarket cybersecurity risk management, potential liability for manufacturers under federal and state rules, and solutions manufacturers can implement to minimize such risks.