Abstract & Bio
Abstract:
This panel will provide valuable perspectives and practical knowledge for anyone involved in the healthcare and cybersecurity sectors. Attendees will leave with a deeper understanding of the collaborative efforts needed to protect healthcare technologies and the vital role cybersecurity plays in safeguarding patient health and safety.
Panel Highlights:
Innovative Collaborations: Explore how interdisciplinary collaborations between government agencies, regulatory bodies, and private companies are essential for advancing cybersecurity in healthcare.
Regulatory Landscape: Gain insights into the current and future regulatory landscape, and how it impacts the development and deployment of secure medical devices.
Real-World Applications: Hear firsthand accounts of the challenges and successes in implementing cybersecurity measures within healthcare environments.
Ethical Considerations: Discuss the ethical implications of cybersecurity in healthcare, ensuring that patient safety and data integrity remain at the forefront of technological advancements.
Bio:
I coordinate across the Center for Devices and Radiological Health (CDRH) at FDA on medical device cybersecurity policy development, vulnerability and incident response, and policy implementation across the total product lifecycle (TPLC).
I have led and oversee the implementation of Section 524B, Ensuring Cybersecurity of Devices, of the Food, Drug, and Cosmetic (FD&C) Act and the FDA guidance, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. This includes making available training for over 1000 review staff and managers, developing submission support resources (eSTAR Template and help text), developing support resources for review staff, and answering policy questions.
Also, as the Program Director for the Cybersecurity Focal Point Program in the Office of Product Evaluation and Quality (OPEQ), I work to build reviewer subject matter expertise in medical device cybersecurity as well as build and maintain consistency across the review offices and the TPLC.