Digital Medicine, the FDA, and the First Amendment

Abstract

Digital medicine will transform healthcare more fundamentally than the introduction of anesthesia or the discovery of the germ basis of infectious disease. Inexpensive computerized DNA sequencers will allow practitioners to individualize drugs and treatments. Digitalization will "democratize medicine," enabling individuals to create and use their own medical data, even diagnose or treat themselves. Already, tens of thousands of "medical apps" are available for smartphones that can do everything from take echocardiograms, blood pressure, pulse, lung function, oxygenation level, sugar level, breathing rate and body temperature to diagnose skin cancer and analyze urine. Medical apps, aimed at practitioners but available all, such as Isabel, diagnose diseases.

In fall 2013, the Federal Drug Administration (FDA) has asserted regulatory authority over mobile medical applications and other digital medical services, threatening, to chill, if not, destroy this innovation — and guaranteeing lengthy, high profile litigation in the near future. This article argues that the FDA stands on firm legal ground regulating medical devices that invasively measure bodily functions or take physical specimens. On the other hand, the FDA’s exercise of jurisdiction over applications that simply process information, such as Isabel, or use approved medical devices to provide medical information, like 23andMe, a genome analysis firm which the FDA recently shut down in a high profile action, raise legal concerns. Because these medical applications simply process information, they stand beyond the FDA’s regulatory reach under the Food, Drug and Cosmetics Act and the Administrative Procedure Act.

This paper adds to the large debate on the First Amendment, information and computer code. Building on recent Supreme Court decisions, this paper shows how code and applications which create healthcare information are protected speech. Given digital applications’ capacity to produce pools of data which researchers can mine for clinical and epidemiological insights and given government funding of medical services, healthcare data is both scientific and political speech, deserving of full First Amendment protection.

Keywords: health law, FDA, medical devices, First Amendment, medicine