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Why Health Apps are Like the Wild West, with Apple just Riding into Town

by Michael L. Millenson

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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.

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