The Food & Drug Administration (FDA) issued draft guidelines since all IoT “medical devices that use software and are connected to hospital and health care organizations’ networks have vulnerabilities—some we can proactively protect against, while others require vigilant monitoring and timely remediation.” On January 15, 2016 the FDA announced:
Cybersecurity threats to medical devices are a growing concern.
The exploitation of cybersecurity vulnerabilities presents a potential risk to the safety and effectiveness of medical devices.
While manufacturers can incorporate controls in the design of a product to help prevent these risks, it is essential that manufacturers also consider improvements during maintenance of devices, as the evolving nature of cyber threats means risks may arise throughout a device’s entire lifecycle.
The FDA draft guidelines outlined “…important steps medical device manufacturers should take to continually address cybersecurity risks to keep patients safe and better protect the public health.”
Given the scope of IoT medical devices it is imperative that cybersecurity protections be included and well managed.