A practical, evidence-led guide to DiGA, G-BA methods assessment, §137e evidence generation, hospital NUB funding, §137h high-risk device assessment and the emerging problem of undocumented AI inside “usual care”. Editorial …

How London Region I, AI Airlock, real-world evidence and NICE evidence standards are beginning to connect AI regulation with credible NHS adoption. London Region I is a regulatory sandbox and …

The MHRA–NICE Aligned Pathway, Integrated Scientific Advice and ILAP in practice The strategic change is simple but profound: in the UK, regulatory authorisation and health technology assessment no longer have …

The Comparator Is Written Before the First Patient A single-arm trial does not remove the comparator. It relocates it into a natural-history study, registry, or external-control dataset, whose design may …

What the Poppins Clinical decision reveals about evidence, patient value, health-system capacity and the economics of early digital reimbursement. A precedent with wider significance France has granted early PECAN reimbursement …

What the Dutch Pluvicto judgment reveals about national pricing power, hospital-compounded comparators and the limits of European reimbursement precedent A European marketing authorisation can open a common regulatory route, but …