Regulating digital health technologies with transparency: the case for dynamic and multi-stakeholder evaluation
Regulating digital health technologies with transparency: the case for dynamic and multi-stakeholder evaluation
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DOI：
10.1186/s12916-019-1447-x
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发表时间：
2019-12-03
期刊：
影响因子：
9.3
通讯作者：
Torous, John
中科院分区：
文献类型：
--
作者：
Rodriguez-Villa, Elena;Torous, John
背景 当今智能手机的普及，加上数字功能日益提高的精确度和治疗潜力，为数字医学领域提供了前所未有的机遇。智能手机提供了新颖的可访问性、对身体和认知行为的独特见解以及旨在帮助健康的多样化资源。然而，许多数字资源的开发和共享速度超过了其有效性、安全性和安全性评估的速度，这给患者和临床医生带来了区分有用工具和有害工具的挑战。主要监管机构，例如美国 FDA 和英国 NHS，正在努力评估进入市场的移动医疗应用程序的涌入。然而，监管努力因需要提高透明度而受到挑战。他们需要有关这些数字健康工具的实际使用、效果、益处和危害的真实数据。鉴于快速的产品周期和频繁的更新，即使是最彻底的评估也只能与其所基于的数据一样准确。结论 在这篇辩论文章中，我们提出了一种通过动态自我认证清单来补充正在进行的工作的方法。我们概述了应用程序用户验证或质疑的简单自我认证如何提高透明度，让不同的利益相关者参与有意义的教育和学习，并激励安全可靠的医疗应用程序的设计。
Background The prevalence of smartphones today, paired with the increasing precision and therapeutic potential of digital capabilities, offers unprecedented opportunity in the field of digital medicine. Smartphones offer novel accessibility, unique insights into physical and cognitive behavior, and diverse resources designed to aid health. Many of these digital resources, however, are developed and shared at a faster rate than they can be assessed for efficacy, safety, and security-presenting patients and clinicians with the challenge of distinguishing helpful tools from harmful ones. Main text Leading regulators, such as the FDA in the USA and the NHS in the UK, are working to evaluate the influx of mobile health applications entering the market. Efforts to regulate, however, are challenged by the need for more transparency. They require real-world data on the actual use, effects, benefits, and harms of these digital health tools. Given rapid product cycles and frequent updates, even the most thorough evaluation is only as accurate as the data it is based on. Conclusions In this debate piece, we propose a complementary approach to ongoing efforts via a dynamic self-certification checklist. We outline how simple self-certification, validated or challenged by app users, would enhance transparency, engage diverse stakeholders in meaningful education and learning, and incentivize the design of safe and secure medical apps.