Technology is changing how we practice medicine. Sensors and wearables are getting smaller and cheaper, and algorithms are becoming powerful enough to predict medical outcomes. Yet despite rapid advances, healthcare lags behind other industries in truly putting these technologies to use. A major barrier to entry is the cross-disciplinary approach required to create such tools, requiring knowledge from many people across many fields. We aim to drive the field forward by unpacking that barrier, providing a brief introduction to core concepts and terms that define digital medicine. Specifically, we contrast "clinical research" versus routine "clinical care," outlining the security, ethical, regulatory, and legal issues developers must consider as digital medicine products go to market. We classify types of digital measurements and how to use and validate these measures in different settings. To make this resource engaging and accessible, we have included illustrations and figures throughout that we hope readers will borrow from liberally. This primer is the first in a series that will accelerate the safe and effective advancement of the field of digital medicine.
Keywords: Clinical care; Clinical research; Cybersecurity; Data governance; Data rights; Decentralized clinical trials; Digital biomarkers; Digital health; Digital medicine; Digital technology tools; Ethics; FDA; Mobile technology; Privacy; Regulatory science; Research ethics; Sensors.
Copyright © 2019 by S. Karger AG, Basel.