HIMSS News

FDA Announces a New Digital Health Innovation Plan

In a June 15 blog post, Scott Gottlieb, M.D., Commissioner of the U.S. Food and Drug Administration (FDA), unveiled that the FDA will be creating a broad innovation initiative that will include a plan to focus on the agency’s regulatory role in digital health technology. The new initiative is part of a broader FDA effort to advance policies that promote and develop safe and effective medical technologies.

The Digital Health Innovation Plan will include new guidance and clarity from the FDA on products with high-risk technologies that may or may not fall within FDA regulation.  It will also provide guidance on low-risk technologies that are not regulated by the FDA. The goal is to allow FDA to provide more resources for high-risk products and foster innovation by providing clarity on what types of technologies are subject to regulation. Additionally, a new post-marketing approach to how the FDA regulates technology will be developed.