Securing Connected Medical Devices to Ensure Regulatory Compliance and Customer Safety (Part Two of Two)

“The risks of cybersecurity are being felt more in healthcare-related companies,” Abhishek Agarwal, chief privacy officer for legal and compliance at a major global healthcare company, told Cybersecurity Law Report, particularly in the area of connected medical devices. Government, industry and outside counsel experts agree that it is essential to evaluate and monitor cybersecurity vulnerabilities and the potential impacts on patient health and safety from the beginning and throughout a product’s lifecycle to mitigate those risks. This second article in our two-part series explores operational best practices and post-market considerations to address medical device cybersecurity, including the new proposed FDA post-market guidance and adding connectivity to existing devices. Part one examined the development and risks of connected devices and recommended pre-market steps companies should take. See also “Tackling Privacy and Cybersecurity Challenges While Fostering Innovation in the Internet of Things” (May 20, 2015).

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