Conversation October 18, 2018
The heart rate monitor built into the new Apple Watch has sparked sharp debate over its risks and benefits, even though the feature was cleared by the Food and Drug Administration.
But out of the spotlight, the FDA has been doing away with regulatory action altogether on many diagnostic health apps targeting consumers, seeking to accelerate digital health adoption by defining many of these as “low risk” medical devices.
As the number of mobile health apps surged to a record 325,000 in 2017, app performance is going largely unpoliced, leading to what’s been dubbed a “Wild West” situation. Unfortunately for health consumers, the public can’t rely on the research community to play the role of sheriff.
When colleagues and I...
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