Abstract：
Digital health technology (DHT) is increasingly used to facilitate the conduct of clinical drug trials. The European regulatory environment would benefit from some adjustments to realize the full potential of DHTs. Considering current discussions such as the European Accelerating Clinical Trial Initiative (ACT EU), we propose four concrete adjustments to this regulatory landscape to introduce risk-based qualification approaches for DHTs. In our view, these changes would have the potential to facilitate the use of DHT in clinical research and thus provide access to innovative therapies in Europe.
摘要：
数字健康技术（DHT）越来越多地用于促进临床药物试验的进行。欧洲监管环境将受益于一些调整，以实现DHT的全部潜力。考虑到目前的讨论，如欧洲加速临床试验倡议(ACTEU)，我们建议对这一监管环境进行四项具体调整，为DHT引入基于风险的资格认证方法。在我们看来,这些变化将有可能促进DHT在临床研究中的使用,从而为欧洲提供创新疗法.
