Research writing, methodology, and analysis — applying clinical causality assessment to the bidirectional interaction between humans and AI systems.
The FDA's proposed AI pilot program for early-phase clinical trials asks the right questions but misses the evaluation framework that already exists in pharmacovigilance — and the interaction layer that nobody is measuring.
AI tools are being deployed in clinical settings like off-label drugs — without the safety and risk mitigation protocols that would be required for any other clinical intervention.