Suzanne Schwartz

Director, Office of Strategic Partnerships and Technology Innovation (OST), FDA’s Center for Devices & Radiological Health (CDRH)

Suzanne B. Schwartz, MD, MBA is the Director of the Office of Strategic Partnerships and Technology Innovation (OST) at FDA’s Center for Devices & Radiological Health (CDRH). Suzanne’s work in medical device cybersecurity includes raising awareness, educating, outreach, partnering and coalition-building within the Healthcare and Public Health Sector (HPH) as well as fostering collaborations across other government agencies and the private sector. Suzanne has been recognized for Excellence in Innovation at FDA’s Women’s History Month for her work in Medical Device Cybersecurity. Together with Health Canada, Suzanne has represented FDA in co-chairing the International Medical Device Regulators Forum (IMDRF) Work Group on Medical Device Cybersecurity leading to its first international guidance publication in March 2020. She chairs CDRH’s Cybersecurity Working Group, tasked with formulating FDA’s medical device cybersecurity policy and has additionally served as co-chair of the Government Coordinating Council (GCC) for the HPH Critical Infrastructure Sector, focusing on the sector’s healthcare cybersecurity initiatives. Suzanne earned an MD from Albert Einstein College of Medicine; an executive MBA from NYU Stern School of Business, completed Cohort X of the National Preparedness Leadership Initiative – Harvard School of Public Health & Harvard Kennedy School of Government executive education, and earned in September 2018 a certificate of mastery for completion of requirements at the Federal Executive Institute – Leadership for a Democratic Society.

►

Medical Device Cybersecurity: The Latest Challenges

Mitch Parker - Indiana University Health System, Suzanne Schwartz - FDA’s Center for Devices & Radiological Health (CDRH), Rob Suárez, HCISPP - Becton, Dickinson and Company • •

What’s the status of FDA’s latest guidance and other efforts to help strengthen the cybersecurity of medical devices – especially amid the surge in COVID-19 remote patient monitoring and shortages of certain critical medical equipment? How are medical device makers implementing better security controls and best...

Start this Session

►

Medical Device Cybersecurity: Addressing the Challenges

Jennings Aske - New York-Presbyterian, Chris Frenz - Interfaith Medical Center, Michael McNeil - Mckesson, Suzanne Schwartz - FDA’s Center for Devices & Radiological Health (CDRH) • •

Suzanne Schwartz, MD, Associate Director for Science and Strategic Partnerships, at the Food and Drug Administration's Center for Devices and Radiological Health, will provide an update on FDA's medical device cyber efforts. That includes the status of a draft update to the cybersecurity guidance for premarket...

Start this Session

►

Medical Devices: A Long Road Ahead to Security and Privacy

Sonia Arista - Fortinet, Kevin McDonald - Mayo Clinic, Dale Nordenberg, MD - Safety and Security Consortium, Anahi Santiago - Christiana Care Health System, Suzanne Schwartz - FDA’s Center for Devices & Radiological Health (CDRH) • •

Interconnected medical devices can pose tremendous risk to data security and patient safety. How can healthcare entities keep up with the ever growing list of vulnerabilities involving medical devices, and new emerging threats? A top FDA official provides an update on the state of medical device security, and FDA's...

Start this Session

►

Medical Devices: Treat Them Like Untrusted End-User Devices

Jennings Aske - New York-Presbyterian, Marianne Kolbasuk McGee - HealthcareInfoSecurity, Dave Nathans - Siemens Healthcare, Dale Nordenberg, MD - Safety and Security Consortium, Suzanne Schwartz - FDA’s Center for Devices & Radiological Health (CDRH), Steven W. Teppler - Mandelbaum Salsburg P.C. • •

Protecting end-user devices is an essential part of any information security strategy. But many healthcare organizations have literally thousands of connected medical devices - from infusion pumps to heart monitors - used in patient treatment that can be vulnerable, opening the door to a broader cyberattack....

Start this Session