10.04.19
15 min. read

Building digital therapeutics studies for the FDA vs. payers

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It's a good one, too.
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Acacia Parks, Ph.D., the Chief Scientist at digital therapeutics company Happify Health, recently gave a presentation in Boston that focused on strategies and approaches to clinical studies for digital therapeutics companies.

Parks broke down how, in Happify's experience, the expectations and demands of the FDA and differ from what payers and employers would like to see in outcomes studies.

Given how popular this talk was at the event and the feedback from a number of attendees who told me it was the highlight of the event for them, I've written up her talk in full with a transcript of the session. Read on below for Parks' talk in her own words:

 

This slide (below) shows results from a clinical trial that my team and I published that has been appealing to the payers we have worked with. It's a randomized control study for a group of people using Happify. We have people using a

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