关于"从概念到临床:生活实验室和监管沙箱为医疗系统数字化和创新设备集成到临床工作流程"的书信
Rebecca Mathias1, Anett Schonfelder1, Cindy Welzel1
1Else Kröner Fresenius Center for Digital HealthTUD Dresden University of Technology Dresden 01307 Germany.
概括
数字健康和人工智能技术提供医疗保健解决方案,但在平衡市场速度,安全性和用户需求方面面临挑战. 当前的法规阻碍了代开发,影响了工作流集成和可用性.
科学领域:
- 数字健康数字健康
- 医疗保健中的人工智能
- 医疗器械规则 医疗器械规则
背景情况:
- 数字健康和人工智能技术有望改善医疗保健的获取和结果.
- 然而,医疗器械的传统监管途径对这些快速发展的技术构成挑战.
- 与严格的安全性,功能性和以用户为中心的设计平衡快速进入市场是一个关键障碍.
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