AMA July 16, 2019
The Food and Drug Administration (FDA) has basic rules for regulating wearable devices and other digital health tools, but those rules may change as rapid innovation continues and the agency creates new pathways to ensure the safety and efficacy of new consumer-facing products. AMA experts outlined this and other need-to-know facts for physicians counseling patients who are increasingly looking to the wearable as a health tool.
Attorney Shannon Curtis, AMA assistant director for federal affairs, said during a recent education session that there are three important things for physicians to keep in mind when counseling patients about wearables or mobile health (mHealth) apps.
Be aware of an app or device’s regulatory status before recommending it to patients. “You want to...
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