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	Podcast:		The Rock Health Podcast
	Episode:		The Current State of Digital Health Regulation
	Category:		Health
	Duration:		00:44:37
	Publish Date:		2019-05-20 15:00:30
	Description:		In 2017, the FDA launched its Digital Health Innovation Action Plan, detailing its plans to review and update regulation of software. Among the digital health programs is the Pre-Certification Program, also known as Pre-Cert, wherein FDA is working with innovators to develop a new approach to regulatory oversight for software-based medical technologies. Nearly two years into the pilot program, we wanted to get a status update and hear what’s in store this year and beyond. Rock Health Managing Director and CEO Bill Evans caught up with Bakul Patel, the FDA’s Director for Digital Health, and Jared Seehafer, cofounder and CEO of Rock Health portfolio company Enzyme, to discuss the FDA’s new look, the proposed framework for regulating AI and machine learning, and how startups should navigate—and participate in—the evolving regulatory process.
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