The Opportunity and Obstacles for Smartwatches and Wearable Sensors

Abstract

In September 2017, the U.S. Food and Drug Administration (FDA) made a striking announcement. Transforming its current regulatory practice for approving and certifying medical devices-the FDA announced a bold new plan, the Digital Health Software Precertification (Precert) Program, to offer an entirely new regulatory model to assess smartphone apps, wearables, sensors, and software. This transformation and medicalization of the consumer health market present both opportunities and obstacles, by opening up large markets for health monitoring and diagnosis using inexpensive mass-market, off-the-shelf devices. It also raises challenges, both related to privacy and effective uses of the devices to promote health. The Fitbit and Apple Watch are examples.