FDA sleeps on AI/ML guidance. Google buys Fitbit for $2.1B

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Digital health research from Brian Dolan.

Welcome to E&O.

Last week's newsletter had a glass-is-half-full 56 percent open rate. Here's what's happening this week:

Have you read that Google is acquiring Fitbit for $2.1 billion? More on that below. This has been the newsiest week of 2019, so I'll try to keep these brief as this issue is now over-stuffed.
Stat reports that later today President Trump is expected to nominate MD Anderson's chief medical executive Stephen Hahn as the next FDA commissioner.
A trio of Democrat Senators sent another letter to the FDA loaded with questions and concerns about the way Pre-Cert will work. Read the latest letter here. Their letter from October 2018 here. And the FDA's June 2019 response to the first letter here.
The Unbearable Lightness of De-identified Data: The concept of "de-identified patient data" eroded

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It's a good one, too.

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FDA sleeps on AI/ML guidance. Google buys Fitbit for $2.1B

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