Cybersecurity In Medical Devices Part 1: Networked Medical Devices & Cybersecurity Vulnerabilities

On January 15, 2016, the FDA released a draft guidance offering medical device manufacturers several recommendations to safeguard patients against cybersecurity threats in their devices.

Specifically, "Postmarket Management of Cybersecurity in Medical Devices" urges manufacturers to integrate cybersecurity measures across the entire product life cycle, from design and development to distribution, deployment, and maintenance. The recommendations outlined in the document apply to:

• Medical devices containing software (including firmware) or programmable logic
• Software classified as medical devices

Furthermore, the draft guidance includes an extensive list of definitions, encompassing terms such as Compensating Controls and Controlled Risk, in addition to providing recommendations for medical device manufacturers.