Digital Health and FDA’s Efforts to Encourage Technology Innovation

April 16, 2019 | 1:45 p.m. – 2:30 p.m. CDT

From mobile medical applications and digital therapeutics to advanced analytics and AI, digital health products make up a rapidly expanding portion of the medical device economy. While these products hold tremendous potential, the question of their oversight has challenged regulators, including the U.S. Food and Drug Administration ( FDA ).

This session will discuss how the digital health sector is evolving and how it has been impacted by recent regulatory developments, including efforts by Congress and FDA to encourage digital health product innovation. The course will also discuss the practical and legal challenges that industry must navigate as new technologies are developed and integrated into an already changing healthcare system.

Speakers:

• Ian Pearson, JD, Attorney, Jones Day
• Emre Gulturk, Director of Quality and Information Security Officer, Akili Interactive
• Bryan Anderson, JD, Deputy General Counsel, Astellas
• Joe DeVivo, CEO, InTouch Health