From Referee to Coach: Toward Smart Global Health Regulation

Developed from the 2025 Sir Alasdair Breckenridge Lecture, this Perspective draws on selective literature and illustrative examples from the United Kingdom, Singapore, and international frameworks. Adaptive, responsive, and agile approaches to regulation are well established in governance scholarship, yet their application to the combined challenges of health products, digital health-enabled services, and cross-border care remains fragmented. We argue that smart health regulation is best understood not as an entirely new paradigm, but as an integrative framework that synthesises adaptive, collaborative, and learning-oriented approaches for contemporary healthcare systems. The authors propose five practical design principles, four implementation mechanisms and an illustrative Smart Health Regulation Scorecard intended as non-validated heuristic for reflection rather than as a validated instrument or ranking system. The framework is informed by prior regulatory scholarship, comparative practice, the underlying lecture and the authors’ professional experience, and is offered to support discussion on how safety, innovation, accountability, and trust can be balanced across different regulatory settings.