Modernizing and designing evaluation frameworks for connected sensor technologies in medicine.

This manuscript is focused on the use of connected sensor technologies, including wearables and other biosensors, for a wide range of health services, such as collecting digital endpoints in clinical trials and remotely monitoring patients in clinical care. The adoption of these technologies poses five risks that currently exceed our abilities to evaluate and secure these products: (1) validation, (2) security practices, (3) data rights and governance, (4) utility and usability; and (5) economic feasibility. In this manuscript we conduct a landscape analysis of emerging evaluation frameworks developed to better manage these risks, broadly in digital health. We then propose a framework specifically for connected sensor technologies. We provide a pragmatic guide for how to put this evaluation framework into practice, taking lessons from concepts in drug and nutrition labels to craft a connected sensor technology label.

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© The Author(s) 2020.

Déclaration de conflit d'intérêts

Competing interestsJ.G. is an employee of HealthMode. M.D. is a co-inventor of the Cleveland Clinic’s MyLegacy intellectual property portfolio, now licensed to Family Care Path, Inc.; as part of this license, she is entitled to a share in both royalties and returns on equity. W.W., B.W. are advisors and equity-holders, and A.C., C.M., and M.S. are employees of Elektra Labs, a healthcare-security company working in digital medicine. W.W. is also an advisor for Koneksa Health, a consultant for Best Doctors, and has received research funding within the last 12 months from Pfizer and Genentech. The other authors declare no competing interests.