BACKGROUND Digital Pills (DP) are an innovative drug-device technology that permits to combine traditional medications with a monitoring system that automatically records data about medication adherence as well as patients' physiological data. Although DP are a promising innovation in the field of digital medicine, their use has also raised a number of ethical concerns. These ethical concerns, however, have been expressed principally from a theoretical perspective, whereas an ethical analysis with a more empirically oriented approach is lacking. There is also a lack of clarity about the empirical evidence available concerning the application of this innovative digital medicine. METHODS To map the studies where DP have been tested on patients and discuss the ethically relevant issues evident therein, we performed a scoping review of the empirical literature concerning DP. RESULTS Our search allowed us to identify 18 papers reporting on studies where DP were tested on patients. These included studies with different designs and involving patients with a variety of conditions. In the empirical literature, a number of issues with ethical relevance were evident. At the patient level, the ethical issues include users' interaction with DP, personal sphere, health-related risks and patients' benefits. At the provider level, ethically relevant issues touch upon the doctor-patient relationship and the question of data access. At the societal level, they concern the benefits to society, the quality of evidence and the dichotomy device-medicine. CONCLUSIONS We conclude that evidence concerning DP is not robust and that more research should be performed and study results made available to evaluate this digital medicine. Moreover, our analysis of the ethically relevant aspects within empirical literature underscores that there are concrete and specific open questions that should be tackled in the ethical discussion about this new technological solution.

中文翻译：

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数字药丸：实证文献的范围审查和伦理方面的分析。


背景技术数字药丸(DP)是一种创新的药物设备技术，其允许将传统药物与自动记录有关药物依从性的数据以及患者的生理数据的监测系统相结合。尽管 DP 是数字医学领域一项有前途的创新，但它们的使用也引起了一些伦理问题。然而，这些伦理问题主要是从理论角度表达的，而缺乏以经验为导向的伦理分析。关于这种创新数字医学应用的现有经验证据也缺乏明确性。方法 为了绘制对患者进行 DP 测试的研究并讨论其中明显的伦理相关问题，我们对有关 DP 的实证文献进行了范围界定审查。结果 通过搜索，我们找到了 18 篇论文，这些论文报告了对患者进行 DP 测试的研究。其中包括具有不同设计并涉及患有各种病症的患者的研究。在实证文献中，许多与伦理相关的问题是显而易见的。在患者层面，伦理问题包括用户与 DP 的互动、个人领域、健康相关风险和患者利益。在提供者层面，道德相关问题涉及医患关系和数据访问问题。在社会层面，他们关注社会效益、证据质量以及器械与医学的二分法。结论 我们的结论是，有关 DP 的证据并不充分，应该进行更多的研究并提供研究结果来评估这种数字医学。 此外，我们对实证文献中伦理相关方面的分析强调，在关于这种新技术解决方案的伦理讨论中应该解决一些具体和具体的开放性问题。