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The Apple Watch is in a different regulatory space than the devices listed in that source, since it's cleared as a class II medical device by the FDA. HIPAA law
by odyssey7 8y ago
The Apple Watch is in a different regulatory space than the devices listed in that source, since it's cleared as a class II medical device by the FDA. HIPAA laws will apply in some use situations, so their lawyers will have thought about it and made recommendations. (Lawyers aside, the feelings of both the medical community and Apple are generally that you shouldn't leak customer information. This seems like the kind of data that people would accidentally leave behind at the store without thinking about it, which doesn't feel right.)
https://hipaahealthlaw.foxrothschild.com/tags/class-ii-medical-device/ https://hipaahealthlaw.foxrothschild.com/tags/class-ii-medic...
- DoctorOetker 8y agoso we need to find someone with access to 2 identical watches, perhaps someone who bought some for the whole family? instead of strapping all to the same arm, just strap one on each wrist (assume the "left" heart's rate is approximately equal to "the heart on the right"). Are we claiming that every product needs 2 FDA applications: one for the end user and one for a special run of demo watches? I believe (but did not check) that demo watches would be either exempt or go unnoticed considering the amount of data it could gather...
- nradov 8y agoHeart rate data gathered from a store demo device without any personally identifiable information isn't subject to HIPAA rules. If it was reading inaccurately then most likely the band was loose or the sensor was dirty.