Supplementary Material for: Translation of Digital Health Technologies to Advance Precision Medicine: Informing Regulatory Science

The proliferation of digital technologies and the application of sophisticated data analysis techniques are increasingly viewed as having the potential to transform translational research and precision medicine. While digital technologies are rapidly applied in innovative ways to develop new diagnostics and therapies, the ultimate approval and adoption of these emerging methods presents several scientific and regulatory challenges. To better understand and address these regulatory science gaps, a working group of the Clinical and Translational Science Awards Program convened the Regulatory Science to Advance Precision Medicine Forum focused on digital health, particularly examining gaps in the use, validation, and interpretation of data from sensors that collect and tools that analyze digital biomarkers. The key findings and recommendations provided here emerged from the Forum and include the need to enhance areas related to data standards, data quality and validity, knowledge management, and building trust between all stakeholders.

数字技术的蓬勃发展与复杂数据分析技术的应用，日益被认为具备变革转化研究与精准医学的潜力。尽管数字技术正以创新方式快速应用于新型诊断与治疗手段的开发，但这类新兴方法的最终审批与落地仍面临诸多科学与监管层面的挑战。为更好地理解并解决这些监管科学领域的空白，临床与转化科学奖计划（Clinical and Translational Science Awards Program）下属工作组发起了“推进精准医学监管科学论坛（Regulatory Science to Advance Precision Medicine Forum）”，聚焦数字健康领域，重点审视了采集数据的传感器与分析数字生物标志物（digital biomarkers）的工具所生成的数据，在使用、验证及解读方面存在的不足。本文所述的核心研究发现与建议均源自该论坛，内容涵盖需加强数据标准、数据质量与有效性、知识管理等相关领域，以及建立所有利益相关方之间的信任机制。