VIDEO: Digital therapeutics, AI face similar challenges on the US market

Key takeaways:

• Digital therapeutics face regulatory unpredictability from the FDA.
• Change is needed to increase the availability of digital therapeutics.

WASHINGTON — In this video from the Digital Therapeutics Alliance Summit, Mahnu Davar, JD, discusses regulatory challenges faced by emerging technologies including artificial intelligence.

“When I look back at the last 5 years of development and the digital therapeutic space, I’m really encouraged to see the number of products that have made it through the FDA approval process and clearance process,” said Davar, partner at Arnold & Porter law firm based in Washington, D.C.

“But I think there are challenges in the next 5 years that we’ve been thinking about.”

According to Davar, there is a need for regulatory predictability from the FDA and a need for reimbursement of health care.

When it comes to AI, Davar said the FDA will likely identify AI-enabled technologies as high risk unless there are clinical data to show otherwise.

“Without further statutory change, I think it’s going to be difficult to take the learnings from the last 5 years and really mathematically increase the availability of these technologies in the U.S. market,” Davar said.

Healio is an official media partner of the Digital Therapeutics Alliance Summit.