Cybersecurity In Medical Devices Part 2: General Principles

Did our previous update on the FDA's draft guidance leave you craving more information? If so, you're in luck!

Published on January 15, 2016, the FDA's draft guidance titled "Postmarket Management of Cybersecurity in Medical Devices" provides a comprehensive list of recommendations aimed at helping medical device manufacturers safeguard patients from cybersecurity vulnerabilities.

The FDA underscores that cybersecurity in medical devices is a collective responsibility involving various stakeholders, including healthcare facilities, patients, providers, and manufacturers. Neglecting cybersecurity measures can lead to compromised device functionality, data loss, or exposure to security threats, potentially resulting in patient harm.

The draft guidance emphasizes the importance of effective risk management to mitigate patient risks associated with cybersecurity vulnerabilities. Manufacturers are advised to establish robust cybersecurity risk management programs covering both premarket and postmarket lifecycle phases, ensuring comprehensive coverage from device inception to obsolescence.