Response to Open Peer Commentaries on “The Ethics of Smart Pills and Self-Acting Devices image

American Journal of Bioethics, Volume 18, October 2018
Craig M. Klugman, Laura B. Dunn, Jack Schwartz and I. Glenn Cohen (Faculty Director)

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We thank all of the insightful authors who wrote open peer commentaries to further the conversation about digital medicine that we raised in our article, “The Ethics of Smart Pills and Self-Acting Devices: Autonomy, Truth-Telling, and Trust at the Dawn of Digital Medicine.” As we hoped, many of these commentaries further probed the issues we laid out. We identified several themes across the commentaries that we wish to address: terminology, compliance/adherence, coercion, and new approaches to bioethics praxis.

Many of the commentaries joined an implicit debate about terminology: how to label these new approaches to medicine. We suggested that these technologies fit the definition of digital medicine as described by Shafer and Kigin, and are a subset of the broader category of digital health as described by the Food and Drug Administration (FDA). Other commentaries used terms like surveillance technology, self-acting medical devices (SAMD), eHealth, mHealth, electronic medicine, digital healthcare, digital health, and surveilled compliance. The term digital medicine is currently used by the manufacturer of MyCite and by Proteus Digital Health (the maker of the digital sensor). The popular press, meanwhile, is gravitating toward the terms “smart pill” and “digital pill” in reference to this specific melding of medicine and technology. Regardless of the specific term used—we argue that there is no “correct” term at this early stage of development—this product segment is one that is developing rapidly. For example, a digital form of Truvada (also using a Proteus sensor)—a preexposure prophylaxis (PrEP) against HIV infection—is being evaluated for its potential to improve adherence to this medication. Proteus is also pursuing digital medicine applications for numerous other disease categories, such as tuberculosis and cancer. The potential for digital pills, smart pills, or digital medicine to enhance individuals’ abilities to take their medications as prescribed—thereby providing the best chance of maintaining or improving their health—is clearly of interest to many stakeholders.

Thus, we looked for a term that was narrow enough to focus on our area of discussion—technological interventions that monitor and/or manipulate physiologic processes—but not so broad as to encompass many other applications of technology in health care—electronic records and telemedicine, for example.

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