"Ensuring the Safety and Effectiveness of Medical Devices Across the Product Lifecycle"
Monday, October 18, 2021
Dr. Jeffrey E. Shuren, MD, JD, Director of the FDA's Center for Devices and Radiological Health
"Consumer Facing Health AI: Ensuring the Safety and Effectiveness of Personal Health Devices and Technologies"
Wednesday, October 20, 2021
Dr. Jesse M. Ehrenfeld, MD, MPH, AMA Board of Trustees, Medical College of Wisconsin
The continued growth and availability of digital health AI tools poses challenges for both regulators and consumers. While regulators pursue balance in the need to ensure safety, reliability, and availability of medical devices and software, consumer
confidence has grown for both regulated and unregulated products. How should regulators and standards organizations address the expectations that consumers have that the health information they seek and AI tools they use are accurate and reliable
when a growing number of consumer facing digital tools are unregulated by the FDA or other regulatory bodies? In this session, Dr. Ehrenfeld, a dual board-certified anesthesiologist and informaticist who serves on the AMA Board of Trustees, will
review case examples and provide a physician's perspective on this looming challenge.
“The explosion of consumer-facing AI-enabled digital health tools raises a host of critical regulatory and oversight questions that simply must be addressed to maintain consumer and patient confidence”
For a look at the full list of sessions and breakouts, please see the Conference Program Schedule.
All those with personal or professional interests in medical device technologies and their safety, performance, or governance should attend. The information provided by this conference is especially critical for clinicians, industry professionals and regulators involved in the research, development, manufacture, and oversight of medical devices and companion healthcare technologies.
Our platform will provide attendees opportunities to meet and network with their colleagues from industry and government.