A Precedent for Regulating Clinical AI Models

Academic medical centers are training clinical AI models on their own electronic health records and deploying them only inside the single academic system where they were developed, mirroring the laboratory developed test (LDT) pathway that for decades sat outside US Food and Drug Administration review. The FDA vacated its final rule regulating LDTs as medical devices in September 2025, and the article argues clinical AI now faces the same regulatory crossroad between local clinical innovation and broader marketplace reach.

For decades, academic hospitals developed and ran their own diagnostic tests https://www.aha.org/topics/laboratory-developed-tests-ldts without any regulatory review. A test built and used inside a single laboratory laboratory developed test LDT was generally regarded as a clinical service rather than a medical device and, therefore, outside the purview https://www.aha.org/news/headline/2025-09-18-fda-vacates-final-rule-regulating-lab-developed-tests-medical-devices of the US Food and Drug Administration FDA . Clinical artificial intelligence AI is now developing along the same lines. Academic medical centers are training AI models using their own electronic health records and incorporating these tools into existing workflows, in which the AI is used only inside the single academic system where it was developed. The FDA accommodation that allowed LDTs to flourish accelerated some local clinical innovation but sometimes kept these advances from reaching the broader marketplace. Clinical AI faces a similar crossroad.