June 19, 2023
4 minutes watch
Source/disclosure information
panel. Adoption of innovations in regulation. Presented at: Digital Therapeutics Alliance Summit. June 7-9, 2023.
Disclosure:
Davar has reported employment with Arnold & Porter.
Important points:
- Digital therapeutics face regulatory unpredictability from the FDA.
- Increased availability of digital treatments requires change.
Washington — In this video from the Digital Therapeutics Alliance Summit, Mahnu DabarJDLet’s discuss the regulatory challenges facing emerging technologies, including artificial intelligence.
“Looking back at the development and digital therapeutics space over the last five years, it has been really encouraging to see the number of products that have made it through the FDA approval and clearance process,” said Davar, partner at Arnold & &. .Porter Law Firm Based in Washington, DC
“But I think there are challenges that we have been thinking about in the next five years.”
According to Davar, there is a need for FDA regulatory predictability and medical reimbursement.
When it comes to AI, the FDA is likely to designate AI-enabled technology as high-risk unless there is clinical data to show otherwise, Daver said.
“Without further legislative change, I don’t think it will be possible to take the lessons of the last five years and actually mathematically increase the availability of these technologies in the US market,” said Daver.
Healio is the Official Media Partner of the Digital Therapeutics Alliance Summit.
