Digital Pills and Promises: An Analysis of the Regulation of Digital Medication and Its Implications

In November 2017, the United States Food and Drug Administration (FDA) approved the world’s first ‘digital pill’, Abilify MyCite (aripiprazole, an anti-psychotic drug). The manufacture and marketing of digital medication has been accompanied by vigorous promoting of its benefits, most notably its positive effect on medication adherence. However, contrary to the spate of academic and media publications linking Abilify MyCite either directly or indirectly to the so-called “adherence crisis”, there is little published evidence to suggest that the technology improves adherence. In fact, the product is not meant to, nor is it approved for, improving patient adherence.

The official product information pamphlet, and product information on the pharmaceutical company’s official website clearly state that ‘[t]he ability of Abilify MyCite to improve patient compliance or modify aripiprazole dosage has not been established’. The vigorous marketing of Abilify MyCite as an adherence intervention raises a crucial question: How does a product with significant implications for patient privacy and autonomy come to be marketed around a use for which it was not regulated?

I attempt to address this question by examining which key stakeholders shape digital health product regulation, with a particular focus on recent inroads that big tech companies have made in digital health and the pharmaceutical industry. By critically analysing the regulation surrounding digital medication, I demonstrate the necessity of ethical considerations in the regulation process, thereby constructing a bridge between medical regulation and bioethics.