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.

中文翻译：

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透明地监管数字卫生技术：动态和多方利益相关者评估的案例。

背景技术当今智能手机的普及，以及数字能力的日益提高的精度和治疗潜力，为数字医学领域提供了前所未有的机会。智能手机可提供新颖的辅助功能，对身体和认知行为的独特见解以及旨在帮助健康的多种资源。但是，许多数字资源的开发和共享速度比评估其有效性，安全性和安全性的患者和临床医生所能评估的速度要快，这是将有用工具与有害工具区分开的挑战。主要文本领先的监管机构，例如美国的FDA和英国的NHS，正在评估进入市场的移动医疗应用的涌入。但是，需要更多的透明度挑战了监管工作。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。在快速的产品周期和频繁的更新的情况下，即使是最彻底的评估也仅取决于其所基于的数据的准确性。结论在本辩论中，我们通过动态的自我认证清单提出了一种补充方法，用于正在进行的工作。我们概述了简单的自我认证（由应用程序用户验证或挑战）如何提高透明度，使不同的利益相关者参与有意义的教育和学习，以及如何激励设计安全的医疗应用程序。我们建议通过动态的自我认证清单来补充正在进行的工作。我们概述了简单的自我认证（由应用程序用户验证或挑战）如何提高透明度，使不同的利益相关者参与有意义的教育和学习，以及如何激励设计安全的医疗应用程序。我们建议通过动态的自我认证清单来补充正在进行的工作。我们概述了简单的自我认证（由应用程序用户验证或挑战）如何提高透明度，使不同的利益相关者参与有意义的教育和学习，以及如何激励设计安全的医疗应用程序。