Our House of Lords evidence on SMEs and the NHS

• Assurance is repeated. A product that has passed the NHS's digital assessment is still evaluated again by each integrated care board, trust or primary care network that considers it. For a small supplier each round is a real cost before any revenue.
• Access to clinical systems is the hidden barrier. Tools in primary care must connect to the systems that hold the patient record, and the terms for doing so are negotiated privately, supplier by supplier.
• Regulation needs more capacity. The MHRA's AI Airlock is the right instrument, but it takes a small number of projects at a time, and real-time conversational AI sits at the edge of existing categories.
• The infrastructure layer is overlooked. The layer underneath clinical applications is neither procured nor regulated as a category of its own.

1. 01

   One recognised pathway

   Addressed to: Department of Health and Social Care; NHS England

   A single, nationally recognised deployment pathway for small suppliers in the 2026 to 2027 procurement framework: one technology assessment and one clinical safety review, recognised across NHS organisations, with a published commitment on decision times.

2. 02

   Published access terms

   Addressed to: NHS England; Department of Health and Social Care

   Published, standardised terms, on a fair, reasonable and non-discriminatory basis, for small UK suppliers with an assured product to connect to the NHS-funded primary care systems: the NHS Spine, GP Connect, EMIS, SystmOne and Vision.

3. 03

   A permanent AI Airlock

   Addressed to: MHRA

   The AI Airlock regulatory sandbox placed on a permanent footing with a published quarterly intake, open to real-time conversational AI and to predetermined change control plans for AI that is updated over time.

4. 04

   Recognition of UK voice AI infrastructure

   Addressed to: Department for Science, Innovation and Technology; Department of Health and Social Care

   UK voice AI infrastructure recognised within the Sovereign AI Unit, and connected to the government's work with AI companies on national cyber defence.

We build to the standards we asked the Committee to keep. Prime Assist has a clinical safety case under DCB0129, signed off by our Clinical Safety Officer, and we are opening a route into the NHS.