# Stale AI approvals

Medical AI keeps changing; its safety checks haven't kept up

Problem 0027 · Health · Theme: Measurement · What it would take: A funded startup · Scope: National · Editorial grade: High · Framed 26 September 2026 · Framed from public reporting

Before a hospital or clinic can use an AI tool, the tool is tested and approved. That happens once. Afterwards, the rules mostly wait for someone to report that something went wrong. But an AI tool does not stay the way it was tested. It gets updated. It behaves differently with real patients than it did in the test. And it can work well in one place and less well in another. So a single test, done once before the tool went into use, cannot tell you whether it is still safe where you are treated today. What is missing is a way to keep testing it while it is in use, to update it carefully, and to help hospitals and clinics see for themselves how it is doing.

## Who lives with it

Healthcare provider governance teams · Healthcare professionals using AI · Patients receiving AI-supported care

## Why now

The Medicines and Healthcare products Regulatory Agency’s report, published on 10 September 2026, warns that reliance on one-off pre-market assessment is insufficient and calls for more continuous monitoring after deployment.

## Why it matters

Existing assessment approaches suit relatively static products, while continuing safety depends on both the product and its clinical setting. A small team could begin with measuring changes in performance for a single clinical use across deployments, working with a provider to connect those measurements to review and escalation responsibilities.

## From public reporting

- [National Commission into the Regulation of AI in Healthcare: Recommendations for a future regulatory framework](https://www.gov.uk/government/publications/national-commission-into-the-regulation-of-ai-in-healthcare-recommendations-for-a-future-regulatory-framework/national-commission-into-the-regulation-of-ai-in-healthcare-recommendations-for-a-future-regulatory-framework), Medicines and Healthcare products Regulatory Agency, 10 September 2026
- [Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/artificial-intelligence-enabled-device-software-functions-lifecycle-management-and-marketing), FDA, draft guidance (January 2025), 1 January 2025

## Cite it

“Medical AI keeps changing; its safety checks haven't kept up.” Ainna Problem Radar, problem 0027, 26 September 2026. https://ainna.ai/problems/medical-ai-safety-checks-havent-kept-up

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