Streamlining regulation to Unlock Digital Health Innovation in the NHS.

Digital health adoption in the National Health Service (NHS) remains fragmented despite significant technological advances and substantial government investment in innovation initiatives. Many promising digital solutions fail to progress beyond pilot phases, with implementation remaining inconsistent across trusts despite national strategies including the 2022 digital health and social care plan. This Viewpoint examines the principal obstacles to digital health commercialisation within the NHS, focusing on regulatory complexity, organisational fragmentation, limited financial capacity and cultural resistance to change. We review existing support mechanisms including the Digital Technology Assessment Criteria (DTAC), NHS Innovation Accelerator and Clinical Entrepreneur Programme, highlighting their strengths and persistent limitations. To accelerate adoption, we propose two key reforms: formalising DTAC as a mandatory national standard with subsidised compliance pathways for small and medium-sized enterprises, and establishing a national 'innovation passport' that harmonises DTAC, Medicines and Healthcare products Regulatory Agency and procurement requirements into a single, transferable assessment. These reforms, complemented by strengthened procurement coordination and cultural change initiatives, could create a more predictable pathway for digital innovation while maintaining rigorous patient safety standards and enabling equitable access to validated digital health tools across the NHS.