Cybersecurity and Digital Health
Stephen Lieb
Partner
Wissing Miller LLP (New York, NY)
Melissa Markey
Attorney
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