Benchmark Scores Don’t Save Patients: Why Clinical AI Needs RCT-Grade Evidence Before It Touches a Workflow
Med-Gemini scores 91% on MedQA. OpenAI's o1-preview hits 96%. Neither number tells you what happens when the algorithm meets...
FDA Regulation
Nature Medicine Just Published the AI Mental Health Audit Framework the FDA Hasn’t Written Yet
Nature Medicine's clinically validated AI chatbot audit framework arrives as FDA still lacks generative AI mental health approval standards—here's...
Your AI Scored 92% on the Medical Exam. That Number Is Lying to You.
Health AI acing benchmarks while failing real clinical tasks exposes a validation gap that trial sponsors and the FDA...
Definium’s Phase 3 LSD Win Is Real. The Fracture It Exposed Is Bigger.
Definium's LSD trial hit p<0.0001 and a $700M raise. But credible voices are asking whether FDA's drug model can...
Benchmark Scores Don’t Break. Clinical Reality Does. The Health AI Readiness Illusion.
Nature Medicine's frontier AI evaluation exposes a dangerous gap: models acing medical benchmarks collapse under adversarial pressure, and the...
The Oversight Gap Nobody Is Naming: State Sandboxes Are Filling a Void the FDA Has Left Open
Utah's clinical AI sandbox and the FDA's 1,451 AI device authorizations reveal a structural oversight gap—states are building what...
FDA Real-Time Clinical Trials: Why AI Systems That Update Themselves Are Breaking Clinical Trial Design
FDA's April 2026 real-time clinical trial push exposes a fatal flaw: when AI updates itself mid-study, your protocol is...