External validation at five or more sites in two countries before clearance
No cancer AI would be approved until it has been tested on patients from at least five different hospitals in at least two countries, none of which contributed training data.
Many cleared AI devices were validated on data from one or two sites, often overlapping with development sites. The proposal sets a minimum external validation requirement (at least five independent sites, at least two countries or health systems, no training-site overlap, pre-registered analysis, subgroup reporting) for regulatory clearance of cancer AI, with the sequestered benchmarks as one accepted route.
- AI that is built but not validated or deployed · Thousands of cancer AI models are published; a handful are in clinical use, and fewer have shown they help patients.
- Regulatory divergence between regions · Regulatory divergence means a drug approved in one country can take years to reach another, or never arrive.
Pages like this
not linked directly; found by shared links- IdeaRed-team programmes that attack cancer AI before patients do
Shares Sequestered, prospectively collected benchmark datasets that no one can train on, AI that is built but not validated or deployed.
- IdeaA neutral public evaluator for cancer AI, on the model of NIST
Shares Sequestered, prospectively collected benchmark datasets that no one can train on, AI that is built but not validated or deployed.
- IdeaA regulatory sandbox for continuously learning cancer AI
Shares AI that is built but not validated or deployed, Regulatory divergence between regions.
- IdeaA shared AI review assistant that maps one dossier to every regulator's questions
Shares AI that is built but not validated or deployed, Regulatory divergence between regions.
- IdeaContinuous prospective validation for every oncology AI tool after deployment
Shares AI that is built but not validated or deployed, Regulatory divergence between regions.
- IdeaPre-agreed update rules so an MCED test is not obsolete when its trial reads out
Shares AI that is built but not validated or deployed, Regulatory divergence between regions.
- InstitutionMedicines and Healthcare products Regulatory Agency
Shares AI that is built but not validated or deployed, Regulatory divergence between regions.
- CollectionFDA Oncology Approvals (OCE) & Novel Drug Approvals
Shares AI that is built but not validated or deployed, Regulatory divergence between regions.