The Mobile Health Revolution?

Abstract

Rarely does a class of technologies excite physicians, patients, financeers, gadgeteers, and policymakers alike. But mobile health — the use of mobile devices like smartphones and tablets for health or medical purposes — has captured our collective imagination. Observers predict that mobile health, also referred to as “mHealth” or “medical apps,” can save millions of lives, billions in spending, and democratize access to health care. Proponents argue that mobile health technologies will transform the ways in which we deliver, consume, measure, and pay for care; disrupting our sclerotic health care system.

This Article evaluates mobile health and its many ambitions. Given the significant hype surrounding mobile health, I try to provide a relatively sober, dispassionate review of the many claims here. I begin by surveying the universe of mobile health technologies, offering a typology of products based on their functions, many of which have regulatory significance.

The Article then considers the federal government’s posture towards mobile health. To date, Congress and over half a dozen federal agencies have addressed mobile health. Contrary to the prevailing wisdom, federal regulators are sympathetic, not hostile, to these technologies. However, I demonstrate how one agency, the U.S. Food and Drug Administration (FDA), is repeating the same mistakes that it made when it first confronted medical device software 25 years ago, relying on nonbinding guidance documents that are largely weak and unenforceable. I argue that, somewhat counter-intuitively, mobile health will only reach its immense potential if regulators like the FDA provide meaningful oversight. Otherwise, users will be flooded with mobile technologies that are ineffective, or worse, unsafe.

Keywords: mobile health, mHealth, medical apps, mobile apps, FDA, FCC, FTC, device regulation, medical devices, medical software, device software