Digital Medicine: A Primer on Measurement

Abstract

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.

Modernizing and designing evaluation frameworks for connected sensor technologies in medicine

“…There are many ways to operationalize an improved evaluation framework for connected sensor technologies, and the optimal result will likely have a mix of actions ranging from regulatory, standards bodies, and communication tools like accessible labeling. The underlying principles we outlined for connected sensor technologies can be adapted for related digital medicine technologies 50 like ePROs or interventional products like digital therapeutics (DTx) 14 , although neither are the immediate focus of this work. Our hope is that the community will build on the five dimensions described here developing more robust thresholds so more technologies are worthy of the trust society places in them.…”

“…With respect to regulation, the FDA has oversight for digital specimen-collecting technologies, like wearables, when they are classified as a medical device. However, due to the narrow definition of device and the revisions with the 21st Century Cures Act, many connected sensor technologies fall outside of the FDA's purview 14 . These narrow frames leave oversight of connected sensor technology functionality and health claims primarily to the Federal Trade Commission, which policies unfair and deceptive trade practices, including enforcing rules against false or misleading advertising 15 .…”

Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs)

“…2 Elektra Labs, Boston, MA, USA. 3 Harvard-MIT Center for Regulatory Science, Boston, MA, USA. 4 Philips, Monroeville, PA, USA.…”

Translation of Digital Health Technologies to Advance Precision Medicine: Informing Regulatory Science

“…Collection, Interoperability, Interconnectivity, Portability: Clinical and Non-Clinical Approaches that capture, store, and analyze RWD and RWE operate across a range of systems [1]. Integrating the array of different data sources will require pre-agreed criteria to effectively operate, communicate, and interface.…”

“…Recent advances in digital technologies (e.g., sensors, software, and algorithms), and the increasingly ubiquitous presence of these technologies in everyday life, have introduced a new frontier in research, healthcare, and regulatory science [1,2]. These novel approaches are seen in patient engagement in research, the development of new forms of scientific evidence to support regulatory determinations, and in the potential realization of earlier "big data" aspirations in areas such as post-approval monitoring of medical products [3][4][5][6].…”