FDA Aims to Shore Up Medical Device Cybersecurity

The Food and Drug Administration last week released long-awaited recommendations aimed at better managing cybersecurity risks to protect patient health and information in a document titled "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." The new standards recommend manufacturers take into account cybersecurity risks as part of the design and development of a medical device. They require device makers to submit documentation to the FDA about identified risks and existing controls to mitigate those risks.