Digital Medicine, the FDA, and the First Amendment

Abstract

Digital medicine might transform healthcare more fundamentally than the introduction of anesthesia or germ basis theory of disease. Already, tens of thousands of "medical apps" are available for smartphones. These computer applications can measure blood pressure, pulse, lung function, oxygenation level, sugar level, breathing rate and body temperature — and can even diagnose skin cancer, analyze urine, take an echocardiogram.

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. 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, or use approved medical devices to provide medical information, like 23andMe, a genome analysis firm against which the FDA brought enforcement proceedings, raise legal concerns. In particular, because these medical applications simply process information, the First Amendment places them beyond the FDA’s regulatory reach.

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

Keywords: Privacy, Identification, Anonymity