Abstract
BackgroundDigital Pills (DP) are an innovative drug-device technology that permits to combine traditional medications with a monitoring system that automatically records data about medication adherence as well as patients’ physiological data. Although DP are a promising innovation in the field of digital medicine, their use has also raised a number of ethical concerns. These ethical concerns, however, have been expressed principally from a theoretical perspective, whereas an ethical analysis with a more empirically oriented approach is lacking. There is also a lack of clarity about the empirical evidence available concerning the application of this innovative digital medicine.MethodsTo map the studies where DP have been tested on patients and discuss the ethically relevant issues evident therein, we performed a scoping review of the empirical literature concerning DP.ResultsOur search allowed us to identify 18 papers reporting on studies where DP were tested on patients. These included studies with different designs and involving patients with a variety of conditions. In the empirical literature, a number of issues with ethical relevance were evident. At the patient level, the ethical issues include users’ interaction with DP, personal sphere, health-related risks and patients’ benefits. At the provider level, ethically relevant issues touch upon the doctor-patient relationship and the question of data access. At the societal level, they concern the benefits to society, the quality of evidence and the dichotomy device-medicine.ConclusionsWe conclude that evidence concerning DP is not robust and that more research should be performed and study results made available to evaluate this digital medicine. Moreover, our analysis of the ethically relevant aspects within empirical literature underscores that there are concrete and specific open questions that should be tackled in the ethical discussion about this new technological solution.
Highlights
Digital Pills (DP) are an innovative drug-device technology that permits to combine traditional medications with a monitoring system that automatically records data about medication adherence as well as patients’ physiological data
DP are comprised of three complementary elements: an ingestible sensor, a wearable patch and a mobile application connected to an external web server
The wearable patch is a plaster applied to the abdomen of the patient that records data about the occurred ingestion transmitted by the digital marker, and other physiological data – such as heartbeat and daily steps
Summary
Digital Pills (DP) are an innovative drug-device technology that permits to combine traditional medications with a monitoring system that automatically records data about medication adherence as well as patients’ physiological data. DP are drug-device combinations that collect and transmit individual measurement data from patients both in the clinical and the research setting to monitor some health-related lifestyle habits and, in particular, medication-taking behaviour [8]. The wearable patch is a plaster applied to the abdomen of the patient that records data about the occurred ingestion transmitted by the digital marker, and other physiological data – such as heartbeat and daily steps. DP have been designed to integrate traditional drugs, in that the ingestible sensor can be co-encapsulated with normal medicines to allow a reliable monitoring of medication-taking behaviour and the collection of data concerning other health-related lifestyle habits [8, 9]
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