Assessing the Thin Regulation of Consumer-Facing Health Technologies

Abstract

This article addresses the data protection and prod- uct safety regulatory models currently applied to con- sumer-facing health technologies. These are technolo- gies that increasingly support citizen science or other research not currently regulated by the NIH/Com- mon Rule/IRB triad. They also may facilitate corpo- rate “research,” the generation or aggregation of health or wellness data that data-driven companies seek to leverage to drive advertising or broader data-broker businesses. Regulatory questions arise because these technologies impact a broad array of ethical, legal, and social issues, in particular challenging our notions of safety, quality, efficacy, and data protection. The article 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 exam- ines some appealing legislative alternatives to the cur- rent thin model used in the U.S. and suggests a frame- work for prioritizing ameliorative regulation.