In collaboration with other agencies, the US Food and Drug Administration (FDA) will offer a public workshop early next year that addresses the complex cybersecurity challenges of medical devices. According to the agency, the workshop will reexamine past collaborative efforts, increase awareness of existing frameworks to evaluate cybersecurity, and encourage discussion about issues that have slowed cybersecurity progress.
The public workshop, “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity,” will be held January 20–21, 2016, from 9:00 AM – 5:30 PM at the FDA’s White Oak Campus in Silver Spring, Md, and will be streamed online. The session will be cohosted by the Department of Homeland Security, the National Health Information Sharing Analysis Center, and the Department of Health and Human Services.
This workshop will take place 5 months after the FDA issued an alert regarding the cybersecurity of Hospira’s Symbiq infusion system—the agency’s first safety communication related to an approved device’s cybersecurity. The workshop also follows up on the FDA’s October 2015 release of its final guidance calling for manufacturers to “develop a set of cybersecurity controls to assure medical device cybersecurity and maintain medical device functionality and safety.”
The FDA reports that addressing cybersecurity threats to reduce information security risks is especially challenging, and emphasizes that cybersecurity threats cannot be completely eliminated, so manufacturers, hospitals, and facilities must work together to manage them.
To attend this workshop in person, online registration must be completed by 4:00 PM on January 13, 2016.
