Connected Medical Devices – Navigating the Regulatory Waters of Health Tech

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Medical devices currently dominate the internet of things. Connected devices – wearable fitness trackers, heart rate monitors, pacemakers, and glucometers – are being joined by even smarter devices for data analytics, to track outcomes and to improve patient care. The pace of innovation is dramatic. But, as you know, with innovation comes evolving regulation.

Using a case study of a notional new device, an interdisciplinary team of Venable lawyers from our healthcare, cybersecurity, HIPAA, FDA, IP, and government investigations teams will address various challenges the medical device manufacturer or medical device software developer faces – securing the clearance for the product (and its related apps), addressing cybersecurity in product design, privacy compliance, anti-kickback concerns, and the post-market considerations of recall, reporting, and potential enforcement by the FDA and FTC.

This program is designed for companies and entrepreneurs developing, manufacturing, selling, and marketing medical devices and related apps. We look forward to ‘connecting’ with you.

Moderator:
W. Andrew (Drew) H. Gantt, III – Co-chair of Venable's Healthcare Practice Group

Panelists:
Thora A. Johnson – Co-chair of Venable's Healthcare Practice Group
Todd A. Halpern – FDA Compliance
Michelle C. Jackson – FDA Compliance
Michael S. Blume – FDA and DOJ Enforcement
Alper T. Ertas – Intellectual Property
Jami Mills Vibbert – Privacy and Data Security