A new proposal argues regulators and healthcare systems should apply risk-based oversight for generative AI used in clinical settings, emphasizing accountability once tools enter practice. The American Medical Association urged the FDA to clarify who bears responsibility for safety, monitoring, and outcomes after deployment. The framing also intersects with broader regulatory questions about the evidence bar for algorithmic devices and digital therapeutics, with stakeholders seeking clearer guidance on how risk should determine the scope and intensity of validation. In parallel, discussions around regulatory readiness for AI-enabled medical care continue to intensify as autonomy and clinical decision support move toward real-world workflows. For biotech and medtech developers, the message is that product strategy increasingly depends on compliance plans—post-market monitoring, safety case documentation, and accountability frameworks—rather than only premarket performance.