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Abstract
Digital medicine is a medical treatment that combines technology with drug delivery. The promises of this combination are continuous and remote monitoring, better disease management, self-tracking, self-management of diseases, and improved treatment adherence. These devices pose ethical challenges for patients, providers, and the social practice of medicine. For patients, having both informed consent and a user agreement raises questions of understanding for autonomy and informed consent, therapeutic misconception, external influences on decision making, confidentiality and privacy, and device dependability. For providers, digital medicine changes the relationship where trust can be verified, clinicians can be monitored, expectations must be managed, and new liability risks may be assumed. Other ethical questions include direct third-party monitoring of health treatment, affordability, and planning for adverse events in the case of device malfunction. This article seeks to lay out the ethical landscape for the implementation of such devices in patient care.
Funding
Cohen’s work was supported by the Collaborative Research Program for Biomedical Innovation Law, which is a scientifically independent collaborative research program supported by Novo Nordisk Foundation (grant NNF17SA0027784).
Disclosure Statement
All four authors served as consultants for Otsuka Pharmaceuticals, advising on the use of digital medicine. The company neither funded the preparation of this article nor played a role in its drafting or review. ▪
Notes
1. Deidentification is a moving target and better conceived of as a continuum, since only useless data are truly completely deidentified. Under the updated Common Rule for human subjects research, a new provision states that standards of deidentification will be updated every 4 years.