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Content of Premarket Submissions for Management of Cybersecurity in Medical Devices January 29-30, 2019 FDA White Oak Campus Silver Spring, MD

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Content of Premarket Submissions for Management of Cybersecurity in Medical Devices January 29-30, 2019 FDA White Oak Campus Silver Spring, MD FDA CENTER FOR DEVICES & RADIOLOGICAL HEALTH (CDRH) PRESENTS A PUBLIC WORKSHOP: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices January 29-30, 2019 FDA White Oak Campus Silver Spring, MD VerDate Sep<11>2014 17:28 Oct 17, 2018 Jkt 247001 PO 00000 Fmt 4703 Sfmt 4703 E:\FR\FM\18OCN1.SGM 18OCN1 2 WELCOME January 29, 2019 Dear Colleagues, On behalf of the FDA, it is with great enthusiasm that I welcome you to our 2-day public workshop, ‘Content of Premarket Submissions for Management of Cybersecurity in Medical Devices’. Advancing and safeguarding the nation’s public health warrants attentiveness to the total product life cycle (TPLC) of medical devices, from design to obsolescence. FDA has leveraged this holistic view in its approach to medical device cybersecurity. In 2014, we issued final premarket guidance describing factors that manufacturers should consider in the design and development of medical devices to assure cybersecurity, maintain functionality, and reduce potential risk to patients. To keep apace with the rapidly evolving nature of cyber threats, we’ve recently updated our guidance so that manufacturers can be in the best position to proactively address cybersecurity when they are designing and developing their devices – helping to protect against different types of cybersecurity risks, from ransomware to potential catastrophic attacks on health systems and/or on multiple patients. The updated guidance released as DRAFT in October 2018 includes new considerations for device design, labeling and documentation that the FDA recommends be included in premarket submissions for medical devices with cybersecurity risk. As we reflected on the current landscape during guidance drafting sessions, three cornerstone principles emerged that, in turn, have become the themes of this workshop – trustworthiness, transparency and resilience. When established appropriately in the premarket (design/build) phase, they are, in our view, critical anchors to medical device cybersecurity that set the course for stronger security and improved resilience throughout the product’s use life. While this public meeting builds on the foundational work of prior FDA medical device cybersecurity workshops showcasing collaborative efforts, discussing standards and risk assessment tools and engaging the multi-stakeholder community in focused dialogue on unresolved gaps and challenges, we are especially interested in seeking your input on novel concepts introduced in the guidance. These include: tiering of cybersecurity risk; cybersecurity bill of materials (CBOM); threat modeling and designing for increased resilience, since even with the most robust ‘built in’ protections, incidents and exploits cannot be entirely eliminated. We express overwhelming appreciation to all that made this public meeting possible. Much gratitude goes to FDA’s Center for Devices and Radiological Health Cybersecurity Working Group, the Emergency Preparedness/Operations & Medical Countermeasures Program, Office of Communications and Education staff, and Center Science Council staff. Planning, organizing and executing a meeting of this size and magnitude is a massive undertaking and today’s workshop would not have occurred without their herculean efforts. We would also like to recognize our speakers, moderators, panelists, and facilitators for taking time out of their hectic schedules to partner with us in strengthening cybersecurity within the healthcare and public health sector. Today we are seeing early fruits of our collective labor, achieved through a “whole of community” approach, and we look forward to your ongoing participation. We may approach cybersecurity from different vantage points, but we all have one common goal and that is to protect patients. Sincerely, Suzanne B. Schwartz, MD, MBA 3 Workshop Themes: Trustworthiness, Transparency, and Resilience Workshop Objectives 1. Catalyze critical discussion to help inform finalization of the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices guidance. 2. Foster dialogue on cross-stakeholder efforts to address current and emerging medical device cybersecurity gaps and challenges. 3. Spur collaborations to enable trustworthiness, transparency, and resilience in medical device cybersecurity. 4. Examine considerations for integrating principles of threat modeling and cyber safety into the design of resilient medical devices. 5. Facilitate discussion on Cybersecurity Bill of Materials. 4 FDA Disclaimer The views expressed in this Public Workshop are those of the authors and do not necessarily reflect the official policy or position of the U.S. Food and Drug Administration, the Department of Health and Human Services, or the United States Government, and should not be used for advertising or product endorsement purposes. Reference to any specific commercial products, process, or service by trade name, trademark, manufacturer, or otherwise, does not constitute or imply its approval, endorsement, recommendation, or favoring by the United States Government or any department, agency, office, or branch thereof. 5 Contents Contents Content of Premarket Submissions for Management of Cybersecurity in Medical Devices ........................ 1 WELCOME ..................................................................................................................................................... 3 Workshop Themes: ....................................................................................................................................... 4 Trustworthiness, Transparency, and Resilience ........................................................................................... 4 Workshop Objectives .................................................................................................................................... 4 FDA Disclaimer .............................................................................................................................................. 5 Contents ........................................................................................................................................................ 6 Agenda at a Glance ..................................................................................................................................... 10 Cybersecurity Public Workshop Session Descriptions, Objectives and Questions for Consideration ........ 12 Speaker Biographies .................................................................................................................................... 25 Laura M. Alfredo ..................................................................................................................................... 25 Nina Alli ................................................................................................................................................... 26 Denise Anderson, MBA, BA, EMT, NIMS ................................................................................................. 27 Jennings R. Aske, JD, CISSP, CIPP/US....................................................................................................... 28 Daniel Beard ............................................................................................................................................ 29 Chris Bitza, GSLC, GSIF, GSEC .................................................................................................................. 30 Seth D. Carmody, Ph.D. ........................................................................................................................... 31 Joseph Chapman, MS .............................................................................................................................. 32 Penny Chase, S.M. ................................................................................................................................... 33 Steve Christey Coley ................................................................................................................................ 34 Julie Chua, PMP, CISSP ............................................................................................................................ 35 Julie Connolly, CISSP ............................................................................................................................... 36 Joshua Corman ........................................................................................................................................ 37 6 Christian Dameff, MD.............................................................................................................................. 38 Reid W. D’Amico, Ph.D. ........................................................................................................................... 39 Erik Decker .............................................................................................................................................. 40 Phil Englert .............................................................................................................................................. 41 Anura Fernando, MSE ............................................................................................................................. 42 Christoph Fischer, Dipl.-Ing. .................................................................................................................... 43 Brian J. Fitzgerald ..................................................................................................................................
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