A roadmap for safe, regulation-compliant Living Labs for AI and digital health development.
review · Level V
Where this comes from
- Record sourced from PubMed, PMID 40367163.
- Also identified by DOI 10.1126/sciadv.adv7719 and PMC identifier 12077496.
- Licence recorded as CC BY.
- The licence permits redistribution, so the abstract is shown in full and the full text is available from the publisher.
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.
Medical subject headings
- Artificial Intelligence
- Digital Technology