Abstract 

Consumer wearables have experienced rapid acceleration in the past few years, transitioning from basic fitness trackers to complex amalgamations of sensors and platforms which provide insights into a vast array of physiological data conventionally considered as clinical information. Irrespective of the transformation in technology, many leading industry products are not placed onto the market as medical devices, but instead are positioned as ‘wellness’ or ‘lifestyle’ technologies.

This article considers the regulatory, commercial and ethical considerations created by this form of market positioning, taking into account intended use, borderline guidance, advertising, the pros and cons of such a stance, and the potential ramifications for manufacturers, clinicians and policymakers. It explains that, while negating the requirements of formal medical device regulation may enable manufacturers to accelerate innovation and mass adoption in a wider market, it does so at the expense of providing substantive evidence of efficacy, potential mismanagement of end user expectations and the subsequent level of safety inherently involved.