Lessons Learned About Autonomous AI: Finding a Safe, Efficacious, and Ethical Path Through the Development Process

The autonomous AI evaluation rules discussed in this article both implicitly and explicitly played a role in ongoing discussions with the FDA and the medical and legal community, to establish the safety, efficacy, and equity of autonomous AI. It led to the first preregistered, prospective clinical trial—the standard in FDA drug trials—and de novo FDA authorization of an autonomous AI system, in a real-world clinical setting, with primary...