Medical Technology in the Digital Age - Webinar CD/Transcript

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Medical Technology in the Digital Age: Managing Cybersecurity and Other Legal Risks with Connected Medical Devices

Device manufacturers: What legal and regulatory risks do you face with connected medical devices? What can you do to help mitigate the risks?

Join Scott Danzis, Jennifer Martin and Mark Young — all lawyers with Covington & Burling — on Aug. 10 as they delve into the FDA’s expectations related to cybersecurity.

After attending this webinar you’ll understand:

  • What legal risks you face from hackers and how to mitigate that risk.
  • How the vulnerability demonstrated in the Hospira Symbiq infusion system situation impacts your risk management initiative — and your bottom line.
  • What FDA is really looking for by recommending that you identify and address cybersecurity risks as part of its required design and control validation activities for medical devices.
  • How to comply with the provisions of the Cybersecurity Information Security Act of 2015 that affect all medical device manufacturers.
  • How to share cyber threat information without incurring additional risk.
  • How the similarities and differences of medical device interconnectivity regulation in Europe v. the U.S. affect your day-to-day operations.    

Register today and learn how to protect your company and patients from the risks of cyberattacks.

  • QA/QC personnel
  • Data management and statistics personnel
  • Engineering and design controls teams
  • Risk management specialists
  • Compliance officers

Meet Your Presenters

Scott Danzis, Partner, Covington & Burling, Food & Drug and Health Care
Scott Danzis’s practice focuses primarily on the regulation of medical devices, but also includes regulation of drugs, biologics, and tobacco products. He regularly works with companies in developing strategies for interacting with the FDA, including strategies for clinical development and premarket review.

Jennifer Martin, Counsel, Covington & Burling
Jennifer Martin has worked at the intersection of law and cybersecurity for the past 15 years. Her expertise in this area has been uniquely honed through her experience managing cyber risks and responding to threats from a variety of perspectives.

Mark Young, Special Counsel, Covington & Burling
Mark Young advises clients on data protection, cybersecurity and intellectual property matters. He has particular expertise in regulatory compliance, legislative advocacy and online IP enforcement.