Digital pills for the remote monitoring of medication intake: a stakeholder analysis and assessment of marketing approval and patent granting policies.

This article explores whether 'digital pills' that track medication intake should be used to enhance adherence. We concentrate on psychiatric conditions since these pose unique challenges. We analyze two public policies that potentially encourage the development of systems for remote monitoring of intake, namely the granting of patents and marketing authorization, and identify key stakeholders and their main interests so as to discuss whether these policies provide disproportionate benefits to some. The stakeholders identified are patients, system providers, drug manufacturers, insurers or healthcare systems, physicians, data users, and society at large. We discuss relevant industry reports, regulatory data, patent documents, and academic literature, and argue that there is concern that the drivers for these tracking systems are revenue and the monitoring of 'compliance' rather than 'adherence'. While accepting that the use of these systems can be justified in some circumstances, in our view these systems pose risks to patient autonomy, Shared Decision-Making, and privacy. We also find that policies on granting patents and marketing authorization overly favor the commercial actors and put patients' interests at risk. Accordingly, we propose that additional safeguards are required.