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Cybersecurity 1:
Medical Device Cybersecurity Expectations

Wednesday, April 17, 2:00-3:30
Meridian Ballroom 2/3, Graduate Minneapolis

Organizers: Bill Aerts, Archimedes Center for Medical Device Security
Ken Hoyme, Boston Scientific Corporation

"Industry Expectations for Security of Medical Devices"
Ken Hoyme, Boston Scientific Corporation

"Regulatory Expectations for Security of Medical Devices"
Suzanne Schwartz, US Food & Drug Administration

"Medical Device Security by Design"
Lucas Rice, Deloitte


Session Abstract:

Cybersecurity expectations are raising for medical devices after several high-profile demonstrations and incidents. The FDA has published their guidance for security by design, and hospitals are demanding that security is maintained throughout the useful device life. This session will discuss these expectations and the response needed to create secure medical devices.


Session Organizer Bios:

Bill Aerts, Executive Director, Archimedes Center for Medical Device Security
Bill Aerts is currently Executive Director of the Archimedes Center for Medical Device Security at the University of Michigan. Prior to joining Archimedes, Bill was Global Director of Device Security at Medtronic.


Speaker Bios:

Ken Hoyme, BSciKen Hoyme, Director, Product and Engineering Systems Security, Boston Scientific Corporation
Ken Hoyme is Director, Product and Engineering Systems Security at Boston Scientific Corporation. Mr. Hoyme has over 30 years of experience in the design and development of safety-critical, real-time, fault-tolerant and secure systems in a variety of regulated domains. He is a recognized expert in the field of systems engineering. Mr. Hoyme was the co-chair of the AAMI Device Security working group, which developed guidance for the application of medical safety risk standard ISO 14971 to security risk management resulting in TIR57.

 

Suzanne Schwartz, Associate Director for Science & Strategic Partnerships, US Food & Drug Administration
Suzanne Schwartz, MD, MBA is the Associate Director for Science & Strategic Partnerships at FDA’s Center for Devices & Radiological Health (CDRH). Her portfolio includes medical device cybersecurity and efforts that span incident response, increasing awareness, outreach, partnering, policy, and coalition-building.

Lucas Rice, Senior Cybersecurity Consultant, Deloitte
Lucas Rice is a Senior Cybersecurity Consultant at Deloitte.


Presentation Abstracts:

"Industry Expectations for Security of Medical Devices"
Ken Hoyme will provide an overview of the current medical device security landscape, the current threats, and discuss the expectations for devices as required by regulators and healthcare providers.

"Regulatory Expectations for Security of Medical Devices"
Suzanne Schwartz will explain the role of the FDA in regulating medical device cybersecurity and explain the expectations they have for manufacturers and healthcare providers to ensure devices are safe.

"Medical Device Security by Design"
Lucas Rice will introduce the concept of “Security by Design,” which is a discipline for integrating security into the design and development of a medical device, and ensuring the device remains secure thoughout the lifetime of the device.


Related Sessions:

Cybersecurity 2: Medical Device Cybersecurity Responses
Plenary Keynote: Kevin Fu, University of Michigan

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