Currently submitted to: JMIR Preprints
Date Submitted: Nov 29, 2019
Open Peer Review Period: Nov 29, 2019 - Jan 29, 2020
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Verification, Analytical Validation, and Clinical Validation (V3): The Foundation of Determining Fit-for-Purpose for Biometric Monitoring Technologies (BioMeTs)
ABSTRACT
Digital medicine is an interdisciplinary field, drawing together stakeholders with expertise in engineering, manufacturing, clinical science, data science, biostatistics, regulatory considerations, ethics, patient advocacy, and healthcare policy, to name a few. While this diversity is undoubtedly valuable, it can lead to confusion regarding terminology and best practices. There are many instances, as we detail in this paper, where a single term is used by different groups to mean different things, as well as cases where multiple terms are used to describe essentially the same concept. Our intent is to clarify core terminology and best practices for the evaluation of Biometric Monitoring Technologies (BioMeTs), without unnecessarily introducing new terms. We propose and describe a three-component framework intended to provide a foundational evaluation framework for BioMeTs. This framework includes 1) verification, 2) analytical validation, and 3) clinical validation. We aim for this common vocabulary to enable more effective communication and collaboration, generate a common and meaningful evidence base for BioMeTs, and improve the accessibility of the digital medicine field.
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