FDA Paving the Way in Medical Device Cybersecurity Leadership

Smart medical devices are designed to improve health care and increase access to health care for patients and medical professionals. The benefits that come with connected networks and smart devices also increase the risk of cybersecurity threats and vulnerabilities.

The FDA has recognized this potential danger and is taking steps to advance the safety of these devices by creating a new position in 2021. Last month, the FDA appointed Kevin Fu as the first acting director of medical device cybersecurity at the agency’s Center for Devices and Radiological Health. 

Experts are projecting 2021 to be a major year for FDA cybersecurity initiative, especially after this past year with the rise of the COVID-19 pandemic. Cyber professionals claim the coronavirus public health crisis has created even greater opportunities for hackers to exploit medical device vulnerabilities, which can be targeted as entry points into hospital networks. 

Fu, a longtime security advocate and researcher, will serve a one-year term for the FDA where he will enhance the growth of research and guidance on the regulatory front of medical device cybersecurity. He has a versatile background in both small embedded ‘resource constrained’ devices as well as PC-based devices. Director of the CDRH’s Office of Strategic Partnerships and Technology Innovation, Suzanne Schwartz, noted Fu’s academic background and experience will make a “potent combination” towards their efforts to advance medical device cybersecurity.

Medical device cybersecurity will be an ever-evolving effort and experts say Fu’s addition to the FDA is a great step toward mitigating the risks and providing safe steps and guidelines for the future. 

About the Author