US FDA's New Game Plan For Digital Health
Commissioner Scott Gottlieb outlined his plans to implement software provisions of the 21st Century Cures Act and go much further than that in clarifying regulatory policy and piloting novel strategies to streamline the path to market for digital health technologies.
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FDA is writing a report on key safety impacts from health software products that fall outside of its regulatory purview under the 21st Century Cures Act. To help the effort, the agency is asking industry, patient groups and other stakeholders to chime in by June 28.
Starting out 2018, Scott Gottlieb issued a new directive to US FDA staff outlining his priorities and vision. Among the directives is to promote digital health and diagnostics by creating efficient pathways for new products in the areas and focusing on technology to help consumers better track their health.
The past year saw US FDA and industry work hard and fast to prepare for what looks like an inevitable boom in the digital-health sector. According to interviews, the time is ripe for adoption of mobile health apps to help reduce health-care costs, but the brave new world also brings with it big challenges.