Beyond the Algorithm: How Lifecycle Regulation Is Building Entry Barriers and Concentrating the Healthcare AI Market

The U.S. Food and Drug Administration is building a new regulatory framework for artificial intelligence and machine learning in medical software. This article argues that the FDA’s evolving approach extends beyond a compliance issue for technology developers; it is a market-shaping force that will change how healthcare providers buy, deploy, and govern AI-enabled tools. Drawing on recent FDA guidance, academic research, and industry analysis, this study examines four downstream effects: shift