Letter to the Editor on "From Concept to Clinic: Living Labs and Regulatory Sandboxes for Health System Digitalization and the Integration of Innovative Devices Into Clinical Workflows".

Digital health and AI-enabled technologies hold the promise of addressing gaps in healthcare, but balancing rapid market access with the need for safe, functional, and user-centered solutions remains a challenge [1], [2]. Regulatory requirements for device development and market approval demand detailed documentation and predetermined protocols, which can limit the adaptability developers require for iterative improvement and real-world testing with patients and healthcare professionals [1], [3], [4]-an approach that would be highly beneficial for digital and AI-enabled technologies. As a result, key factors like clinical workflow integration, interoperability, and usability with the real range of in-use devices are often overlooked or addressed in a cursory fashion [5].