Digital health technologies (smartphones, smartwatches, and other body-worn sensors) can act as novel tools to aid in the diagnosis and remote objective monitoring of an individual's disease symptoms, both in clinical care and in research. Nonetheless, such digital health technologies have yet to widely demonstrate value in clinical research due to insufficient data interpretability and lack of regulatory acceptance. Metadata, i.e., data that accompany and describe the primary data, can be utilized to better understand the context of the sensor data and can assist in data management, data sharing, and subsequent data analysis. The need for data and metadata standards for digital health technologies has been raised in academic and industry research communities and has also been noted by regulatory authorities. Therefore, to address this unmet need, we here propose a metadata set that reflects regulatory guidelines and that can serve as a conceptual map to (1) inform researchers on the metadata they should collect in digital health studies, aiming to increase the interpretability and exchangeability of their data, and (2) direct standard development organizations on how to extend their existing standards to incorporate digital health technologies. The proposed metadata set is informed by existing standards pertaining to clinical trials and medical devices, in addition to existing schemas that have supported digital health technology studies. We illustrate this specifically in the context of Parkinson's disease, as a model for a wide range of other chronic conditions for which remote monitoring would be useful in both care and science. We invite the scientific and clinical research communities to apply the proposed metadata set to ongoing and planned research. Where the proposed metadata fall short, we ask users to contribute to its ongoing revision so that an adequate degree of consensus can be maintained in a rapidly evolving technology landscape.

中文翻译：

---

促进数字健康技术在临床研究中应用的元数据概念


数字健康技术（智能手机、智能手表和其他穿戴式传感器）可以作为新颖的工具，在临床护理和研究中帮助诊断和远程客观监测个人的疾病症状。尽管如此，由于数据可解释性不足且缺乏监管认可，此类数字健康技术尚未在临床研究中广泛展示价值。元数据，即伴随并描述原始数据的数据，可用于更好地理解传感器数据的上下文，并可协助数据管理、数据共享和后续数据分析。学术界和行业研究界已经提出了数字医疗技术数据和元数据标准的需求，监管机构也注意到了这一点。因此，为了解决这一未满足的需求，我们在这里提出了一个元数据集，它反映了监管指南，并可以作为概念图：（1）告知研究人员他们应该在数字健康研究中收集的元数据，旨在提高可解释性和可交换性(2) 指导标准开发组织如何扩展其现有标准以纳入数字健康技术。除了支持数字健康技术研究的现有模式之外，拟议的元数据集还参考了与临床试验和医疗设备相关的现有标准。我们在帕金森氏病的背景下具体说明了这一点，作为广泛的其他慢性病的模型，远程监测对于护理和科学都有用。我们邀请科学和临床研究界将提议的元数据集应用于正在进行和计划的研究。 如果提议的元数据不符合要求，我们要求用户为其持续修订做出贡献，以便在快速发展的技术环境中保持足够程度的共识。