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A comment on Bike crash left Spokane man unconscious, so his Apple Watch called 911. Parent comment

Re:Bike crash left Spokane man unconscious, so his Apple Wat... by kohanz on Tuesday September 24, 2019 @08:44PM (#21066403)
Whether you officially list it or not, if your device is diagnosing and reporting heart attacks to people, the FDA will be involved sooner or later.
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Re:Bike crash left Spokane man unconscious, so his Apple Wat... by Twisell on Tuesday September 24, 2019 @11:29PM (#21067335)
The FDA was involved in the Apple Watch.

That being said of course they will state that the watch can’t detect accurately hearth attack to avoid any liability.

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Re:Bike crash left Spokane man unconscious, so his Apple Wat... by andy_ppp on Wednesday September 25, 2019 @02:06AM (#21068111)
And because it can’t...
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Re:Bike crash left Spokane man unconscious, so his Apple Wat... by galangalalgol on Tuesday September 24, 2019 @09:16PM (#21066602)
If they only diagnosed but didn't report to the user but instead anonymized the data and used it for marketing would the fda care?
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