Bridging the Regulatory Divide: Ensuring Safety and Equity in Wearable Health Technologies
Akshay Kelshiker, Susan Cheng, Jivan Achar, Leo Anthony Celi, Divya Jain, Thinh Nguyen, Harsh Patel, Nina Prakash, Alice Wong, Barbara Evans
Published: 2025/8/27
Abstract
As wearable health technologies have grown more sophisticated, the distinction between "wellness" and "medical" devices has become increasingly blurred. While some features undergo formal U.S. Food and Drug Administration (FDA) review, many over-the-counter tools operate in a regulatory grey zone, leveraging health-related data and outputs without clinical validation. Further complicating the issue is the widespread repurposing of wellness devices for medical uses, which can introduce safety risks beyond the reach of current oversight. Drawing on legal analysis, case studies, and ethical considerations, we propose an approach emphasizing distributed risk, patient-centered outcomes, and iterative reform. Without a more pluralistic and evolving framework, the promise of wearable health technology risks being undermined by growing inequities, misuse, and eroded public trust.