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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 intelligence in the clinical setting and the use of digital health tools in the premarket drug safety review process.

FDA created the INFORMED program with the Innovation, Design, Entrepreneurship and Action laboratory at the Department of Health and Human Services in a move to encourage collaborative scientific research and big data analytics efforts initially related to oncology.

The agency partnered with Project Data Sphere to develop algorithms to classify tumor dynamics with the use of medical imaging data and teamed up with the National Cancer Institute to create a fellowship program that aims to produce digital biomarkers.

Harvard University and FDA also collaborate on a fellowship program that explores machine learning and AI tools for potential use in the agency’s regulatory process.

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