# A regulatory sandbox for continuously learning cancer AI

Source: https://onco.cc/ideas/idea-data-regulatory-sandbox-adaptive-ai/  
OnCo record `idea-data-regulatory-sandbox-adaptive-ai` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Let AI tools that improve as they learn be used under close supervision in a few hospitals, with pre-agreed rules for what changes are allowed and how they are checked.

## Summary

Regulation assumes a frozen model; models that update on new data are effectively unapprovable, so deployed models age. The FDA's predetermined change control plan is a step. The proposal is a formal sandbox: a small number of sites, a pre-specified envelope of allowed updates, mandatory shadow evaluation of each update on sequestered data before activation, full audit logs, and a regulator seat at the table, generating the evidence needed to write general rules for adaptive AI.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Adaptive models in the sandbox will maintain or improve performance over two years while frozen comparators degrade, without safety events attributable to updates, providing the evidence for a general adaptive-AI pathway.
- Rationale: Sandboxes in fintech produced workable regulation for novel products faster than rulemaking; the same approach suits AI where the risks are poorly understood in advance.
- Proposed test: Run a two-year sandbox with three adaptive models at five sites; compare performance trajectories with frozen versions; publish the regulatory learnings.
- Maturity: early-clinical
- Actor: regulator

## Sources

- FDA Predetermined Change Control Plans (page moved; nearest live section): https://www.fda.gov/regulatory-information/search-fda-guidance-documents/

## Connected records

- fronts: [AI & Computation](https://onco.cc/fronts/ai-computation/)
- bottlenecks: [AI that is built but not validated or deployed](https://onco.cc/bottlenecks/b-ai-validation/), [Regulatory divergence between regions](https://onco.cc/bottlenecks/b-regulatory-fragmentation/)

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