Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
Modernizing and designing evaluation frameworks for connected sensor technologies in medicine
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DOI：
10.1038/s41746-020-0237-3
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发表时间：
2020-03-13
影响因子：
15.2
通讯作者：
Wood, William A.
中科院分区：
文献类型：
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作者：
Coravos, Andrea;Doerr, Megan;Wood, William A.
该手稿的重点是使用连接的传感器技术，包括可穿戴设备和其他生物传感器，用于广泛的卫生服务，如在临床试验中收集数字端点和在临床护理中远程监测患者。这些技术的采用带来了五大风险，目前超出了我们评估和保护这些产品的能力：(1)验证，(2)安全实践，(3)数据权利和治理，(4)实用性和可用性；(5)经济可行性。在这篇手稿中，我们对新兴的评估框架进行了景观分析，这些框架是为了更好地管理这些风险而开发的，广泛地应用于数字健康领域。然后，我们提出了一个专门用于连接传感器技术的框架。我们为如何将该评估框架付诸实践提供了实用指南，从药物和营养标签的概念中吸取教训，以制作连接的传感器技术标签。
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.