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.

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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