5.01.20
6 min. Read

Roche VR autism DTx. Pear pre-FDA launch. Welldoc reunion.

Issue 050.

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Digital health research from Brian Dolan.

Welcome to E&O.

Last week's newsletter had a 58 percent open rate. Here's what's happening this week:

  • I received some great responses to last week's The Hinge Health Report, so I'll have some more on the digital MSK market in next week's newsletter.
  • Speaking of MSK, the latest COVID--19-related regulatory rollback from CMS allows physical therapists and others to bill Medicare for services rendered via telehealth. More here.
  • Meanwhile, HHS's Secretary's Advisory Committee on Human Research Protections (SACHRP) suggested more regulations are needed for requirements around using digital health technologies in medical research. Dig in here.
  • Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) offered up a paper on what a Cures 2.0 Act might cover. Notably, their working paper mentions "digital

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Prescription Digital Therapeutics

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New wearable BP 510(k) sheds light on Whoop-FDA. Trials: BetterHelp, Click, DynamiCare, Axena, Kaiser
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Scoop: Whoop’s first FDA clearance (and what will likely be its second)
4.10.25
7 min. Read
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