“Whispers from the Wrist”: Wearable Health Monitoring Devices and Privacy Regulations in the U.S.: The Loopholes, the Challenges, and the Opportunities

Abstract

The growth of wearable technology has enabled the collection of even more personalized information on individuals. New health-related devices marketed to consumers collect health information that might not fall under the traditional category of Protected Health Information, and thus, HIPAA protections do not fully apply. Meaning, commercial wearable health devices do not fall under FDA oversight, and data not paired with a doctor–patient relationship do not fall under HIPAA privacy protection; thus, much of the gathered health-related metrics are left without regulation and open to be sold to data brokers. As such, these data can be leveraged by health insurance, law enforcement, and employers, to name a few. This manuscript explores the loopholes in current regulations and suggests a framework that categorizes wearable data and addresses challenges in data transfer. Furthermore, taking a user perspective, the suggested framework offers solutions that aim to guide users and policymakers in navigating privacy issues in wearable technology.