Question: A science policy analyst is evaluating federal regulation of AI in clinical decision-making. Which regulatory framework emphasizes risk-based assessment and accountability for high-risk AI systems in healthcare?

Mon, 04 May 2026 11:20:05 +0000

**A Science Policy Analyst Evaluates Federal Regulation of AI in Clinical Decision-Making — What Framework Ensures Risk-Based Oversight?** As artificial intelligence becomes increasingly embedded in clinical decision-making, a critical question guides policymakers, researchers, and healthcare leaders: Which regulatory framework ensures high-risk AI systems in medicine undergo rigorous, risk-based evaluation and clear accountability? The growing urgency to balance innovation with patient safety has placed federal regulation of AI in clinical settings at the forefront of national tech policy discussions. Right now, experts and stakeholders are engaging deeply with how AI tools—used for diagnosis, treatment planning, and risk prediction—can be governed to protect patients while enabling progress. This attention reflects broader societal concerns about reliability, bias, and transparency in systems that directly impact human health. The framework that explicitly emphasizes risk-based assessment and accountability for high-risk AI in healthcare is the **U.S. regulatory approach aligned with the FDA’s AI/ML-Based Software as a Medical Device (SaMD) guidelines**. Though not a standalone law, this evolving structure combines risk classification, continuous monitoring, and clear responsibility models, ensuring that AI systems posing significant clinical risk undergo rigorous scrutiny before deployment—and beyond.