A roadmap for safe, regulation-compliant Living Labs for AI and digital health development

Abstract

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.

Fig. 1.. Current testing and experimentation environments that involve multistakeholder collaboration.

Relevant to DHT development are Test Beds, Living Labs, and Regulatory Sandboxes. Here, we focus on Living Labs involving real patient and HCP interactions in a real-world clinical environment, enabling risk-controlled experimentation. This figure was created using Canva Pro.

Fig. 2.. Comparison of the conventional development of DHT and the Living Lab approach.

The upper panel depicts conventional evaluation strategies that use minimal experimentation within the regulatory framework, resulting in minimal flexibility in further or participatory development or in testing strategies. The lower panel depicts how a Living Lab can enable flexible and safe codevelopment and evaluation of technologies and can stretch traditional regulatory boundaries while maintaining patient safety by leveraging digital patient, HCP, and environmental monitoring. This figure is a representation of a Living Lab, which can be adapted to meet actual needs. It was created by-hand by the authors, with all conceptualization and design created through human effort, and AI tools were used only for minor visual enhancements to specific components. Figure credit: Concept authors, R.M. and S.G.; figure creation author, R.M. This figure was created using Canva Pro.

Fig. 3.. Flexibility of Living Lab environments and their relationship to Regulatory Sandboxes.

(A) Different degrees of flexibility offered by Living Lab environments. There are three dimensions: (i) flexibility in ongoing development of the DHT; (ii) flexibility in the ongoing development of research data measurement and evaluation methodologies; and (iii) flexibility in interaction of the DHT with other DHTs and health systems and workflows. (B) Different degrees of flexibility offered by Regulatory Sandbox environments. There are three dimensions: (i) close interaction with the regulator and sometimes (ii) further development of regulations and (iii) a degree of flexibility in the application of the regulations while in the experimentation spaces. (C) Toggling Living Lab flexibility phases. This figure was created using Canva Pro.

Fig. 4.. Development of DHTs using conventional strategies versus proposed Living Lab approaches.

The left panel shows conventional clinical investigation strategies, which have regulatory processes with limited flexibility and evaluate products in test settings, which are often artificial or narrow. This can result in false reassurance and products that ultimately underperform in real-world use. The right panel illustrates how Living Lab strategies that involve distinct steps with stakeholders, which are aligned to TRL, can help in the development of innovative, usable products. If well planned, these approaches can comply with regulatory requirements while also better serving the needs of patients and health care professionals, enabling a smoother transition from prototype to real-world practice. This figure was created using Canva Pro.