Secured Health: Cyber Guidelines on Medical Devices Explained

Overview of Secured Health: Cyber Guidelines on Medical Devices Explained

Healthcare is among the most targeted industries for cyber attacks, and connected medical devices are especially vulnerable. This seminar introduces the role of cybersecurity in healthcare, reviews the types of medical devices and their vulnerabilities, and explains the December 2022 FD&C Act cybersecurity amendment (Section 524B) and the FDA's 'Cybersecurity in Medical Devices' guidance. It closes with recommendations on how manufacturers should build in and monitor cybersecurity to avoid lengthening the premarket approval process.

What you’ll learn in Secured Health: Cyber Guidelines on Medical Devices Explained

• Explain why healthcare is a top target for cyber threat actors and how medical devices are uniquely vulnerable
• Summarize FD&C Act Section 524B and its cybersecurity provisions for device application submissions
• Apply the FDA 'Cybersecurity in Medical Devices' guidance to device design and approval
• Advise manufacturers on incorporating and monitoring cybersecurity measures

Curriculum

1. 1. Secured Health: Cyber Guidelines on Medical Devices Explained

   In this online seminar, our expert panelists begin by introducing the role of cybersecurity in the healthcare industry, including the uses of technology in medicine and the factors that make healthcare the most targeted industry by threat actors. Our speakers review the distinct types of medical devices and their specific cyber vulnerabilities. They discuss the recent addition of regulations and guidelines, including what they entail. Lastly, our experts give advice on how manufacturers should incorporate cybersecurity measures and the importance of monitoring of these medical devices. Topics covered in this webinar: Introduction to Cybersecurity and Medical Devices FD&C Amendment Section 524B FDA Guidance: “Cybersecurity in Medical Devices” Cybersecurity Recommendations for Manuf

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Your instructors

Daniel B. Garrie

Founder, Law & Forensics; Neutral at JAMS; Faculty at Harvard

Law & Forensics LLC · JAMS · Harvard · Rutgers Law School · Journal of Law & Cyber Warfare

Daniel B. Garrie is the founder and executive managing partner of Law & Forensics LLC, a boutique cybersecurity and forensic engineering firm he co-founded in 2008. He serves as a neutral, arbitrator, and forensic special master at JAMS, focusing on cybersecurity, cryptocurrency, and complex technology disputes, and holds faculty appointments at Harvard and Rutgers Law School. A patented software inventor and prolific author, he is editor-in-chief of the Journal of Law & Cyber Warfare and a widely cited authority on computer forensics, eDiscovery, and cyber litigation.

David Rifkind

Chief Legal Officer, Caidya

Caidya

David Rifkind is Chief Legal Officer at Caidya, a clinical research organisation, which he joined in March 2022. He has more than 30 years of legal experience in business and corporate transactions in highly regulated industries, covering corporate governance, compliance and data privacy, protection and security initiatives. At Caidya he built a data privacy team drawing on inside legal, the chief information security officers and IT personnel to meet global requirements including the GDPR and China's PIPL. He has held roles at General Electric and Avantor, and earlier worked in private practice and as a prosecutor in the Delaware Attorney General's office. He holds a B.A. in political science from The George Washington University and a J.D. from Columbia Law School. At Legal Cyber Academy, David Rifkind teaches on cyber guidelines for medical devices.

Tom Mustac

Senior Director & Head of Systems, Cloud & Biomed Security, Mount Sinai Health System

Mount Sinai Health System

Tom Mustac (Tomislav Mustac) is senior director and head of systems, cloud and biomedical security at Mount Sinai Health System, responsible for the cybersecurity of connected devices across the Icahn School of Medicine at Mount Sinai, eight hospital campuses and more than 400 ambulatory practices. His remit covers three domains — traditional IT infrastructure, cloud systems, and medical and IoT devices — including remediating the vulnerabilities that have long affected the medical device sector. He previously worked at GE Healthcare, on the device manufacturer side of healthcare technology, and his professional affiliations include InfraGard, H-ISAC, the Health Sector Coordinating Council and AEHIS. He holds a doctorate in information assurance from the University of Fairfax and an MBA from Iona. At Legal Cyber Academy he teaches on cyber guidelines for medical devices.