The AI Validation Gap: Decision Support Tools Are Outrunning Their Own Evidence
AI clinical trial decision support is a $1.35B market growing at 12.5% annually—but FDA's draft ML guidance and real-world...
eClinical Technology
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...
AI Drug Discovery Has $8.9 Billion in Hype and Zero FDA Approvals: When Does the Bill Come Due?
AI drug discovery raised $8.9B in 2024, yet no AI-discovered drug holds FDA approval. The gap between algorithmic promise...
Ambient AI Is Not Losing Your Trial Data. It’s Quietly Deciding What Counts.
Ambient AI scribes reduce physician burnout—but a Lancet case reveals they systematically drop psychosocial context that drives protocol adherence...
The Consent Form Doesn’t Cover the Data: A Gap Regulators Can No Longer Ignore
Nature Medicine flags data rights as consent's missing pillar—and three converging signals show the FDA's frameworks haven't caught up...
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...
What Icon’s $300M Microsoft Bet Means for the Sites Running Their Trials
Icon's enterprise-wide Microsoft Copilot deployment and $300M AI investment will reshape how CRAs monitor, query, and escalate — here's...
The Specialized Clinical AI Trap: General-Purpose Chatbots Are Winning the Benchmark War
A Nature Medicine study shows general-purpose LLMs outperform specialized clinical AI tools on real physician questions—exposing a validation crisis...
The eCOA Vendor Stack You Built Is Already Obsolete
Signant Health's acquisition of Ametris on May 14 consolidates eCOA and wearable data streams—and exposes the real cost of...