On October 21-22 the U.S. Food and Drug Administration (FDA), in collaboration with the U.S. Departments of Health and Human Services and Homeland Security, conducted a public workshop entitled “Collaborative Approaches for Medical Device and Healthcare Cybersecurity.”  The FDA held this public workshop in order to bring together stakeholders in the field to obtain information on medical device cybersecurity.  Cyber vulnerabilities can result in unauthorized access to patient information; device malfunction; disruption of health care; or compromised health record data integrity.

At the outset, the FDA made clear to attendees that the meeting was intended to serve as a springboard for future work and to initiate what they expected to be an ongoing dialogue.  The FDA expects the discussions initiated during this workshop to continue and is soliciting input from interested stakeholders.  This public workshop came shortly after the FDA’s final guidance regarding mobile medical device cybersecurity which we discussed here.  It has also been reported that the Department of Homeland Security is currently investigating at least a dozen cases of possible cybersecurity flaws in medical devices.  It is clear from this recent activity in the field that cybersecurity in mobile medical devices is an area that the government intends to continue to scrutinize.