Remote digital monitoring of medication intake: methodological, medical, ethical and legal reflections

In 2017, regulatory approval was given in the US for a 'digital pill', a pill for which actual ingestion could be remotely monitored. The pill, Abilify Mycite is marketed by Otsuka but the monitoring system derives from Proteus Digital Health. In this paper, we focus on this digital pill and another equivalent system from AiCure which relies on facial recognition. Both systems not only remind the patient to take a pill but also verify the actual intake. In this process, patient-related data beyond the fact that the pill has been taken are also collected and sent to a remote computer system of the system-providing company and possibly to third parties.Although marketed as 'innovative', the introduction of such systems raises questions as to the limitation of patient autonomy, secondary uses of patient data, impact on the physician's liability, and artificial inflation of drug prices. Whereas incorrect medication taking can be problematic, it can be questioned whether remote intake-monitoring systems are, from an ethical, legal and social perspective, the ideal way to address this. In this paper, we will reflect on this question from the position of the different potential stakeholders involved.