Working with other agencies, the U.S. Food and Drug Administration (FDA) will kick off 2016 by bringing together a diverse group of stakeholders for a public workshop focused on the complex cybersecurity challenges that impact the medical device ecosystem.
The workshop, Moving Forward: Collaborative Approaches to Medical Device Cybersecurity, will be co-hosted by the Department of Homeland Security, along with the National Health Information Sharing Analysis Center and the Department of Health and Human Services.
During the event, the agencies plan to highlight past collaborative efforts; increase awareness of standards, existing frameworks to evaluate cybersecurity, and tools in development; and promote discussion about issues that have hampered progress in advancing medical device cybersecurity.
This workshop comes five 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. In October, the FDA released final guidance calling for manufacturers to “develop a set of cybersecurity controls to assure medical device cybersecurity and maintain medical device functionality and safety.”
According to the FDA, “Addressing cybersecurity threats, and thus reducing information security risks, is especially challenging. Because cybersecurity threats cannot be completely eliminated, manufacturers, hospitals, and facilities must work to manage them.”
The public cybersecurity workshop will be held Jan. 20–21, 2016, from 9:00 a.m. – 5:30 p.m. at the FDA’s White Oak Campus in Silver Spring, MD, and will be streamed online. To attend the workshop in person, online registration must be completed by 4:00 p.m. on Jan. 13.