Assessing the Thin Regulation of Consumer-Facing Health Technologies

Abstract

This article addresses the data protection and product safety regulatory models currently applied to consumer-facing health technologies. It explains how the design and structures of existing data protection and safety regulation in the U.S. have resulted in exceptionally thin protection for the users of consumer-facing devices and products that rely on or that facilitate consumer collection or aggregation of health and wellness data. It also examines some appealing legislative alternatives to the current thin model used in the U.S. and suggests a framework for prioritizing ameliorative regulation. To better understand existing regulatory models, their deficiencies, and how they should be reformed, the article employs an analytical model describing these regulatory systems across two axes. The vertical axis describes the quantity or depth of regulation, such as, for example, the strictness of the rules imposed by the regulatory model. The horizontal axis describes the reach of the regulation, the behaviors, products, or industries to which the regulation applies.

Keywords: Privacy, Big Data, Mobile Health, Apps, Devices, FDA

JEL Classification: K32