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Tag Archives: Scott Gottlieb

Scott Gottlieb: FDA Eyes Regulatory Framework for AI-Based Medical Devices

Scott Gottlieb, commissioner of the Food and Drug Administration, announced the release of a discussion paper as the agency considers developing new regulatory framework to advance the development of artificial intelligence-based medical devices. “We are exploring a framework that would allow for modifications to algorithms to be made from real-world learning and adaptation, while still ensuring safety and effectiveness of the software as a medical device is maintained,” Gottlieb said in a statement published Tuesday

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FDA Unveils Health Data Science Projects Under Incubator Program

Scott Gottlieb, commissioner of the Food and Drug Administration, has introduced information technology initiatives under the agency’s data science incubator program during  the Health Datapalooza conference in Washington, D.C., MedCityNews reported Thursday. Gottlieb highlighted the FDA’s Information Exchange and Data Transformation program that seeks to standardize methods to examine potential applications of artificial …

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