Gilbert Stephen, Mathias Rebecca, Schönfelder Anett, Wekenborg Magdalena, Steinigen-Fuchs Julia, Dillenseger Anja, Ziemssen Tjalf
Else Kröner Fresenius Center for Digital Health, TUD Dresden University of Technology, Fetscherstr. 74, 01307 Dresden, Germany.
Member of the ethics committee at TUD Dresden University of Technology, Fetscherstr. 74, 01307 Dresden, Germany.
Sci Adv. 2025 May 16;11(20):eadv7719. doi: 10.1126/sciadv.adv7719. Epub 2025 May 14.
Safe and agile experimentation spaces are essential for developing AI-enabled medical devices and digital health innovations. "Living Labs" offer a collaborative environment for testing technologies in near-real-world settings, capturing user perspectives and outcomes, often missed in traditional testing. However, the flexibility of Living Labs often clashes with the European Union's rigid regulatory frameworks for medical devices that were not designed for digital technologies. We examine this intersection, showing how flexibility in evaluation and patient interaction can coexist with safety guardrails. Our approach integrates technology readiness, preemptive planning, and iterative modifications to bridge innovation and regulation, fostering adaptive health care technology development.
安全且灵活的实验空间对于开发人工智能驱动的医疗设备和数字健康创新至关重要。“生活实验室”为在接近现实世界的环境中测试技术提供了一个协作环境，能够捕捉到传统测试中常常缺失的用户观点和结果。然而，生活实验室的灵活性往往与欧盟针对医疗设备的严格监管框架发生冲突，这些框架并非为数字技术而设计。我们研究了这一交叉点，展示了评估和患者互动中的灵活性如何能与安全保障措施共存。我们的方法整合了技术成熟度、预先规划和迭代修改，以弥合创新与监管之间的差距，促进适应性医疗技术的发展。
