FDA to integrate analytics into regulatory decisions under new digital health incubator

FDA Commissioner Scott Gottlieb, MD, unveiled plans for a digital health incubator, dubbed INFORMED, during Academy Health’s Health Datapalooza conference in Washington, D.C., April 26.

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INFORMED, which stands for Information Exchange and Data Transformation, will investigate the best ways to integrate data science into regulatory decision-making, with an initial focus on digital health and advanced analytics related to cancer.

Here are three initial projects under the INFORMED umbrella.

1. A collaboration with Project Data Sphere, a nonprofit open-access cancer data repository, to develop algorithms that use medical imaging data to classify tumor dynamics.

2. A joint fellowship program with the National Cancer Institute at the National Institutes of Health to develop digital biomarkers as drug development tools.

3. A fellowship program with Cambridge, Mass.-based Harvard University focused on developing and implementing artificial intelligence and machine learning algorithms for regulatory science applications.

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