Stephen Gilbert
The last months of 2025 have brought major new policy initiatives and pilots for digital medicine and AI regulatory sandboxes from the EU, UK, and US regulators. The EU has seen a regulatory simplification package with the promotion of sandboxes for innovative technologies. The UK sees the start of an important second phase of the world-leading ‘AI Airlock’ regulatory sandbox program. TEMPO, a major voluntary alternative pathway regulatory innovation pilot for digital health in chronic disease has been announced by the US FDA. These frameworks bring flexible approaches to explore digital health technology innovation together with regulatory innovation. They will all substantially advance digital medicine, with the US TEMPO project being the most innovative, bringing sandboxing principles to the on-market phase.