CSIAC Webinar - Update on Current FDA Cybersecurity Efforts

Over the past several years, FDA has undertaken a significant and diverse set of efforts aimed at improving not only medical device cybersecurity, but cybersecurity across the healthcare sector. The agency has worked internally on efforts such as updated guidance with respect to satisfying regulatory requirements for cybersecurity within medical devices, the development of a playbook related to regional response, “boot camps” for threat modeling, and others. FDA has also supported the development of a vulnerability scoring system specifically targeted at medical devices. At the same time, FDA has been working closely with its government and private sector partners, patients, security researchers, and more. This includes groups like the International Medical Device Regulators Forum, the Healthcare Sector Coordinating Council, and the National Telecommunications and Information Administration’s multistakeholder process on software transparency. This talk will provide an update and overview of these efforts.


Presenter: 

Jessica Wilkerson is a Cyber Policy Advisor with the All Hazards Readiness, Response, and Cybersecurity (ARC) team in the Center for Devices and Radiological Health (CDRH) within the Food and Drug Administration (FDA). As part of ARC, she examines issues and develops policy related to the safety and effectiveness of connected medical devices. Previously, she worked as the Cybersecurity Research Director for the Linux Foundation, and spent over five years as a congressional staffer with the House Committee on Energy and Commerce, covering cybersecurity issues in the telecommunications, commercial, energy, and health sectors. As part of that work, she examined issues related to coordinated vulnerability disclosure, software supply-chain transparency, legacy technology risks, and cybersecurity governance models, among others. She received a B.A. in Policy Studies and minors in Computer Science and Mathematics from Syracuse University, and is currently pursuing a J.D. from the Catholic University of America’s Columbus School of Law.

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