Recent hacking and data breach incidents have shown that as technology continues to advance, there is an ever-increasing need for effective cybersecurity. This need extends beyond protecting individuals' private information on the internet and on their smartphones. On October 2, the U.S. Food and Drug Administration released an industry guidance document entitled "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."
According to the FDA, "Effective cybersecurity management
is intended to reduce the risk to patients by decreasing the
likelihood that device functionality is intentionally or
unintentionally compromised by inadequate cybersecurity."
Cybersecurity is defined in the industry guidance as "the
process of preventing unauthorized access, modification, misuse or
denial of use, or the unauthorized use of information that is
stored, accessed, or transferred from a medical device to an
external recipient."
The FDA recommends that manufacturers develop controls to ensure
medical device cybersecurity and to maintain the functionality and
safety of their devices. Failure to do so, the FDA warns, may
result in compromised functionality, loss of data, and exposure to
network and security threats to connected medical devices. The FDA
further recommends that medical device manufacturers implement a
cybersecurity framework consistent with the framework established by the National
Institute of Standards and Technology.
The industry guidance outlines the FDA's recommendations to the
medical device industry regarding information to include in
premarket submissions in order to achieve effective cybersecurity
management. The FDA's recommendations apply to the following
premarket submissions for medical devices that contain software or
programmable logic and software that meets the definition of
"medical device":
- 510(k) Premarket Notifications
- De novo submissions
- Premarket Approval Applications
- Product Development Protocols
- Humanitarian Device Exemption submissions
The FDA further recommends that device manufacturers provide the following cybersecurity-related information as part of their premarket submissions:
- Hazard analysis, mitigation, and design considerations related to security risks associated with the medical device;
- Links between cybersecurity controls and risks associated with the medical device;
- Summary of the plan to provide validated software updates to the medical device throughout its lifecycle;
- Summary of the controls to ensure software integrity; and
- Instructions for use and product specifications related to cybersecurity controls.
The industry guidance sets forth the FDA's suggestions to the industry but is not legally enforceable.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.