Boston, MA
Oct. 15-16, 2018

Suzanne Schwartz

Associate Director For Science And Strategic Partnerships
Food And Drug Administration (FDA)

Suzanne B. Schwartz, MD, MBA, is the Associate Director for Science and Strategic Partnerships in the Center for Devices and Radiological Health (CDRH) at the FDA. In this role, Suzanne is directly involved in preparedness and incident response for matters concerning cybersecurity of medical devices and their networked systems. Her programmatic efforts in this area have evolved beyond response to include increasing awareness, outreach, partnering, and coalition-building within the entire medical device ecosystem. Within the Center, Suzanne leads the Medical Device Cybersecurity Strategic Initiative, chairing the CDRH Cybersecurity Working Group where policy and guidance development occurs. She also serves as co-chair of the Government Coordinating Council (GCC) for the Healthcare and Public Health (HPH) Sector. Her efforts in this role are mainly focused on strategic engagement of Sector stakeholders to strengthen cybersecurity for the HPH critical infrastructure.

October 16, 2018
10:40am - 11:30am
America Ballroom

Gone are the days when loss of PHI was the industry’s biggest worry: We now face a looming patient-safety crisis.Vulnerable medical devices are being recalled and equally vulnerable devices continue to be produced.

In this session, two clinicians-security researchers simulate a medical device breach, demonstrating the peril and possibilities healthcare now confronts in a world of connected, technology-dependent medicine.

Following the simulation, the speakers, joined by the FDA's Suzanne Schwartz, will share medical-device security best practices and participate in an audience Q&A.

Key takeaways:

  • Healthcare cybersecurity threats are now patient safety threats - with real world implications on morbidity and mortality.
  • Collaborations between clinicians and information security professionals can produce secure solutions that lead to delivery of higher quality care.
  • Healthcare delivery organizations and information security firms need to move beyond a data protection, regulatory compliance mindset and tackle this challenge from a clinical outcomes perspective.

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