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Review
. 2020 Mar 13:3:37.
doi: 10.1038/s41746-020-0237-3. eCollection 2020.

Modernizing and designing evaluation frameworks for connected sensor technologies in medicine

Affiliations
Review

Modernizing and designing evaluation frameworks for connected sensor technologies in medicine

Andrea Coravos et al. NPJ Digit Med. .

Erratum in

Abstract

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.

Keywords: Health policy; Technology.

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Conflict of interest statement

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.

Figures

Fig. 1
Fig. 1. Current Evaluation Frameworks for Connected Sensor Technologies.
This figure illustrates many of the known evaluation frameworks for connected technologies, categorized by source, type, audience, scope and dimension. References are provided.
Fig. 2
Fig. 2. Proposed Evaluation Framework for Fit-For-Purpose Connected Sensor Technologies.
The proposed framework describes the key dimensions to be considered when evaluating connected sensor technologies. Dimensions can be grouped into broader categories of data and results; functionality and ease of use; and value and costs.
Fig. 3
Fig. 3. Connected sensor facts.
This is an example of a nutrition label-type visualization that includes the key dimensions of the evaluative framework for connected sensor technologies, and metrics related to facts within each dimension. This approach permits a user to have a concise but comprehensive picture of a sensor’s appropriateness and fitness for use.
Fig. 4
Fig. 4. Connected sensor comparison table.
This is an example of how sensors might be compared in a side by side visualization that incorporates dimensions from the proposed evaluative framework. In this illustrative visualization, additional detail and metrics are provided for the utility and usability dimension, in order to facilitate a rapid evaluation for appropriateness within an intended population.

References

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