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'Cures' Bill Circumvents FDA On Medical Software Regs

Lobbyists for the medical software industry, and particularly clinical decision support tools are "delighted" that lawmakers are getting around the agency by explicitly stating the types of software it is not allowed to regulate in the 21st Century Cures Act, set to pass Congress by the end of the year.

More than three years of efforts in Congress to legislate regulatory oversight in the digital health space may be close to reaching fruition with a provision included in the 21st Century Cures Act that would circumvent US FDA's plans to regulate certain software that could be treated as medical devices.

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