作者
Jennifer C Goldsack, Andrea Coravos, Jessie P Bakker, Brinnae Bent, Ariel V Dowling, Cheryl Fitzer-Attas, Alan Godfrey, Job G Godino, Ninad Gujar, Elena Izmailova, Christine Manta, Barry Peterson, Benjamin Vandendriessche, William A Wood, Ke Will Wang, Jessilyn Dunn
发表日期
2020/4/14
来源
npj digital Medicine
卷号
3
期号
1
页码范围
55
出版商
Nature Publishing Group UK
简介
Digital medicine is an interdisciplinary field, drawing together stakeholders with expertize in engineering, manufacturing, clinical science, data science, biostatistics, regulatory science, ethics, patient advocacy, and healthcare policy, to name a few. Although 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 focus on the evaluation of BioMeTs as fit-for-purpose for use in clinical trials. However, our intent is for this framework to be instructional to all users of digital measurement …
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