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Abstract

Until the December 2016 passage of the Cures Act, the FDA had regulatory power over clinical decision support (CDS) software; however, the Act removed a large group of CDS software from the FDA’s statutory authority. Congressional intent was to increase innovation by removing regulatory blockades—such as device testing and certification—from the FDA’s purview. This note argues that the enactment of this specific provision of the Act will instead stymie innovation and overlook the unfortunate safety consequences inherent in its deregulation. CDS software is a burgeoning field ripe for innovation; however, rapid innovation can often lead to a slew of mistakes—mistakes in software coding, mistakes in software implementation, and even mistakes in software design. This note considers the issues with deregulating CDS software, focusing on the health and safety concerns, as well as the lack of incentive for software creators to share algorithms. This note then proposes other, less-invasive regimes for CDS software regulation to address these problems.

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