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一种在学术医疗中心的临床和转化研究中启用数字健康技术的方法。

A Method for Enabling Digital Health Technologies in Clinical and Translational Research at an Academic Medical Center.

作者信息

Chen Cindy, Bradford Laura R, Epstein Melissa A, Gossey J Travis, Mansour Mohammad N, O'Connor Christy M, Tschinkel Brian J, Campion Thomas R

机构信息

Information Technologies and Services Department, Weill Cornell Medicine, New York, NY.

Office of General Counsel, Weill Cornell Medicine, New York, NY.

出版信息

AMIA Jt Summits Transl Sci Proc. 2025 Jun 10;2025:134-140. eCollection 2025.

Abstract

Federal- and state-level governance as well as local institutional oversight are changing rapidly to address the accelerated growth in the usage of digital health technologies (DHT) -such as apps, wearables, and websites-to enable clinical and translational research. While studies have described frameworks for assessing and/or implementing individual DHTs, to our knowledge there are none describing how to implement and support multiple DHTs at an academic medical center (AMC). A multi-disciplinary team including information technology, institutional review board, legal, and privacy professionals identified 33 items to evaluate as part of onboarding studies using DHTs. In a one-year period at one AMC, we applied the novel instrument to review 98 requests for research (93) and non-research (5) use of DHTs. The 33-item instrument may be valuable to researchers and practitioners in other settings seeking to scale institutional support for DHTs.

摘要

联邦和州层面的治理以及地方机构监督正在迅速变化,以应对数字健康技术(DHT)(如应用程序、可穿戴设备和网站)使用的加速增长,从而推动临床和转化研究。虽然已有研究描述了评估和/或实施单个DHT的框架,但据我们所知,尚无研究描述如何在学术医疗中心(AMC)实施和支持多种DHT。一个由信息技术、机构审查委员会、法律和隐私专业人员组成的多学科团队确定了33项内容,作为使用DHT进行入职研究的一部分进行评估。在一家AMC的一年时间里,我们使用这一新颖的工具审查了98项DHT研究(93项)和非研究(5项)用途的申请。对于其他寻求扩大机构对DHT支持的机构中的研究人员和从业者而言,这份包含33项内容的工具可能具有重要价值。

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