In a speech at Datapalooza on Thursday (April 26), FDA commissioner Scott Gottlieb announced a slew of new agency initiatives aimed at spurring use of data analytics and digital health tools in regulatory decision making and drug development. The agency also unveiled a working model for its emerging digital health software precertification program, as well as a draft guidance clarifying FDA will take a hands-off regulatory approach toward certain functions of digital devices that don't directly affect the product's safety...