Suzanne B. Schwartz
US Food and Drug Administration
Abstract:
Medical devices from insulin pumps to implantable cardiac pacemakers are becoming more interconnected, which can lead to safer, more effective technologies. However, like computers and the networks they operate in, these devices may have vulnerabilities that if exploited could threaten the health and safety of patients.
FDA’s approach to medical device cybersecurity is grounded in fostering collaboration and engagement across the broad community of stakeholders. FDA’s Center for Devices and Radiological Health (CDRH) work has involved assessing the landscape; convening stakeholders to understand the challenges and barriers that hinder advances in security; and then working together to identify incentives and solutions. These efforts have necessitated a significant change in culture within the health care sector and the medical device ecosystem.
In this presentation, key milestones will be covered including: publication of premarket and postmarket guidances for management of medical device cybersecurity; three public workshops convened with both government and non-government partners; a memorandum of understanding with NH-ISAC; and federally funded research and development center support, via the Mitre Corporation (MITRE), for CDRH’s medical device cybersecurity strategic initiative. In addition, advances in medical device cybersecurity as described in the recent (April 2018) release of the “FDA Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health” will be highlighted.
View the full USENIX Security '18 program at [ Ссылка ]
