Medical device technology in the digital age

Falls Church, Virginia – What impact does connectivity have on medical devices and our healthcare system? What legal risks are posed by connected devices – regulatory, cybersecurity, product liability?

Join Scott Danzis, Jennifer Martin, and Mark Young – lawyers with Covington & Burling – on Aug. 10, 2016, as they delve into the FDA’s expectations related to cybersecurity in the Medical Technology in the Digital Age: Managing Cybersecurity and Other Legal Risks with Connected Medical Devices webinar.

After the webinar attendees will understand:

• What legal risks manufacturers face from hackers and how to mitigate that risk.
• How the vulnerability demonstrated in the Hospira Symbiq infusion system situation impacts the risk management initiative – and they bottom line.
• What FDA is really looking for by recommending that manufacturers 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 vs. the U.S. affect day-to-day operations.    

Register today and learn how to protect against the risks of cyberattacks.

Meet the 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.

Who will benefit

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

Webinar details

• Medical Technology in the Digital Age: Managing Cybersecurity and Other Legal Risks with Connected Medical Devices 
• Aug. 10, 2016 – 1:30pm - 3:00pm ET 

Tuition
$287 per site

Register
Online
Phone: 888.838.5578 or 703.538.7600

Source: FDANews