clinical AI validationLung Cancer AI: Chart Data Held Up. Scans and Slides Didn't.
I3LUNG's 2,396-patient Nature Medicine study found chart and blood data drove lung cancer immunotherapy predictions, while CT and pathology gains didn't survive held-out testing. Validate locally before funding new data pipelines.
September 15, 2026 · 10 min readclinical AI validationFDA Cleared 1,357 AI Devices. Three Were Tested on Patients.
A PLOS Digital Health analysis found that only 3 of 1,357 FDA-cleared AI/ML medical devices were ever evaluated on patient outcomes. Clearance certifies substantial equivalence to a predicate, not benefit — so health systems have to write the evidence, subgroup coverage and drift monitoring into procurement themselves.
August 19, 2026 · 11 min readhealthcare AIHospitals Test Vendor AI. Fewer Than Half Have a Sandbox.
More than nine in ten health systems have deployed third-party AI, and 23 of 25 say they test it before go-live. Only 11 have a platform to test on — so most hospitals are validating against the vendor's own accuracy numbers, measured on somebody else's patients.
August 7, 2026 · 11 min read