FDA's Oversight of Digital Health Products and Medical Software
Holland & Knight, Harvard University, Harvard Business School Club of Dallas
Holland & Knight's Digital Healthcare Group will co-host a webinar with Harvard University and the Harvard Business School Club of Dallas on the U.S. Food and Drug Administration's (FDA) regulation of digital health products and medical software. The FDA regulates many digital health products such as wearables, medical apps and software that use different technologies, including artificial intelligence (AI) and machine learning (ML), to help patients manage their diseases and to help physicians diagnose and treat them. Depending on its use, a product may be subject to minimal or no FDA regulation while others may require FDA clearance prior to marketing.
During this webinar, Partner Robert Hill will moderate a panel discussion with Healthcare Policy attorneys Michael Werner and Sara Klock explaining how the FDA regulates digital health products and offering tips on how you can adjust your business strategy accordingly. This highly informative discussion will benefit healthcare providers, suppliers and developers across the healthcare and life science industry sectors.