Jack Schwartz

The Ethics of Smart Pills and Self-Acting Devices: Autonomy, Truth-Telling, and Trust at the Dawn of Digital Medicine

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.

A response to commentators on "Universal and uniform protections of human subjects in research".

We thank the commentators for their thoughtful and very useful comments. We agree with many of them. Our intention in writing the article, however, was not to address all issues of concern about the system of human subjects’ protections in research but rather to emphasize an important shortfall in the scope of the current system and suggest a remedy for this problem. More specifically, we would like to respond and comment on the following: