Abstract:
Medical devices, from insulin pumps to implantable pacemakers, are becoming increasingly interconnected, which could lead to safer, more effective technologies. But like computers and the networks they operate in, these devices may contain vulnerabilities that, if exploited, could compromise the health and safety of patients.

The FDA's approach to medical device cybersecurity is based on fostering collaboration and engagement across the broad stakeholder community. The work of the FDA's Center for Devices and Radiological Health (CDRH) included assessing the landscape; bringing together stakeholders to understand the challenges and barriers hindering progress in security; and then work together to identify incentives and solutions. These efforts have necessitated significant cultural change within the healthcare industry and the medical device ecosystem.

This presentation will cover key milestones including: publication of pre- and post-market guidance for medical device cybersecurity management; three public workshops with both government and non-government partners; a memorandum of understanding with NH-ISAC; and federally funded research and development center support, through the Miter Corporation (MITRE), for CDRH's strategic medical device cybersecurity initiative. In addition, an emphasis will be placed on advances in medical device cybersecurity, as outlined in the recent (April 2018) release of the “FDA Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health.”

View the full USENIX Security '18 program at https://www.usenix.org/usenixsecurity18/technical-sessions

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