Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
Open accessAbstract
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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Coravos et al. developed an evaluation framework to test the accuracy and validity of connected sensor technologies, including wearables.
“At the beginning of 2020, Coravos et al. developed a timely evaluation framework to test the accuracy and validity of connected sensor technologies, which included wearables95.”
From Smart wearable devices in cardiovascular care: Where we are and how to move forward (2021) · cites this paper as [95]
The Coravos et al. framework covers hardware and software and outlines resources, evaluation criteria and target thresholds for five dimensions: V3; data security and privacy; data rights and governance; utility and usability; and economic feasibility.
“In this comprehensive framework covering both the hardware and software components of these technologies, the authors outline the potential resources, evaluation criteria and target thresholds for five dimensions: verification, analytical validation and clinical validation (V3); data security and privacy; data rights and governance; utility and usability; and economic feasibility95.”
From Smart wearable devices in cardiovascular care: Where we are and how to move forward (2021) · cites this paper as [95]
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References 17 · Cited by 82
Research works printed but not linked: 1
- [16]FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) Resource. Food and Drug Administration (US). https://www.ncbi.nlm.nih.gov/books/NBK326791 (2016). 27010052
- Authors
- Coravos, A., Doerr, M., Goldsack, J., Manta, C., Shervey, M., Woods, B., & Wood, W. A.
- Affiliations
- Harvard University (US)
- Sage Bionetworks (US)
- Atlantic Council (US)
- UNC Lineberger Comprehensive Cancer Center (US)
- Corresponding author
- Wood, William A.
- Venue
- npj Digital Medicine
- Published
- 2020-03-13
- Volume
- 3
- Issue
- 1
- Pages
- 37-37
- ISSN
- 2398-6352 (ISSN-L)
- PMC
- PMC7070075
- OpenAlex
- W3012339291
- Cited by
- 82
- References
- 17
- Citations by year
- 2026: 6 · 2025: 7 · 2024: 13 · 2023: 8 · 2022: 9 · 2021: 22 · 2020: 17
- FWCI
- 2.66
- Type
- journal article
- Language
- en
- Update notices
- correction (2020-04-02)
- Open access
- gold
- doi.org
- Locations
- npj Digital Medicine (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- Mozilla Foundation
- Harvard Kennedy School
- Topics
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Health Sciences › Medicine › Surgery › Healthcare Technology and Patient Monitoring
- Physical Sciences › Computer Science › Information Systems › Internet of Things and AI
- Keywords
- wearable devices, biosensors, evaluation framework, digital health, clinical trial endpoints, remote patient monitoring, technology validation, security practices, data governance, data rights, usability, economic feasibility
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