JMIR Publications

ABSTRACT

Artificial intelligence (AI) and machine learning medical tools have the potential to be transformative in care delivery, however this change will only be realised if accompanied by effective governance that ensures patient safety and public trust. Recent digital health initiatives have called for tighter governance of digital health. The correct balance must be found between ensuring product safety and performance whilst also enabling the innovation needed to deliver better approaches for patients and affordable efficient healthcare for society. This requires innovative, fit-for-purpose approaches to regulation. Digital health technologies, particularly AI-based tools, pose specific challenges to the development and implementation of functional regulation. The approaches of regulatory science and ‘better regulation’ have a critical role in developing and evaluating solutions to these problems and ensuring effective implementation. We describe the divergent approaches of the EU and the US in the implementation of new regulatory approaches in digital health and we consider the UK as a third example, which is in a unique position of developing a new post-Brexit regulatory framework.