FDA to Hold Public Workshop on Cybersecurity and Regulatory Science

By MedTech Intelligence Staff
April 25, 2017


• Categories: 04-Product Design & Development, 05-Quality/Regulatory

Next month FDA, in partnership with the National Science Foundation and the Department of Homeland Security, Science and Technology will hold a public workshop to look at opportunities to strengthen medical device cybersecurity. The event, “Cybersecurity of Medical Devices: A Regulatory Science Gap Analysis”, which will be held May 18–19, will assess FDA engagement with new and ongoing research, collaboration with Healthcare and Public Health, and stakeholders to pinpoint challenges in regulatory science and discuss strategies to address the hurdles. The workshop will also promote proactive development of analytical tools, process and best practices that can be used in cybersecurity.  Cybersecurity has been identified as one of the top 10 regulatory science gaps by the agency.

“FDA, NSF and DHS, S&T are therefore seeking input to create a framework to address the cybersecurity regulatory science gaps. The scope and nature of this cybersecurity regulatory science research framework is designed to be broad to foster collaboration across all interested stakeholders. The domain is defined by the intersection of safety and security in the design and evolution of medical devices. The objective of the workshop is to facilitate a discussion on the current state of regulatory science in the field of cybersecurity of medical devices, with a focus on patient safety.” – FDA

The meeting will be held at the FDA White Oak Campus in Silver Spring, MD. The event is unavailable via webcast, but a transcript and slides will be posted on FDA’s website in early June, according to the agency.