Cybersecurity and Digital Health

July 27, 2017 2:30pm

Stephen Lieb
Wissing Miller LLP (New York, NY)

Melissa Markey
Hall, Render, Killian, Heath & Lyman, PLLC (Troy, MI)

Gretchen Vandal
Associate Director, Device Regulatory Affairs
Biogen Inc. (Cambridge, MA)

  • Determining when software is classified as a medical device and navigating the review process
  • Reviewing FDA’s “Postmarket Management of Cybersecurity in Medical Devices” Guidance
  • Best practices for mitigating and controlling cybersecurity threats while maintaining patient safety and product performance
    • Controlling cybersecurity threats arising with intercommunication between devices
  • The world of mobile medical applications
  • Maintaining compliance with FTC’s data security requirements