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The Oversimplification Of Deregulation: A Case Study On Clinical Decision Support Software, Deeva V. Shah
The Oversimplification Of Deregulation: A Case Study On Clinical Decision Support Software, Deeva V. Shah
Michigan Telecommunications & Technology Law Review
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 …
To Innovate Or Not To Innovate, That Is The Question: The Functions, Failures, And Foibles Of The Reward Function Theory Of Patent Law In Relation To Computer Software Platforms , Seth A. Cohen
Michigan Telecommunications & Technology Law Review
The patent system has traditionally been viewed as having two primary functions: the reward function and the prospect function. Although these theories do explain some behavior which results from the practical applications of the patent system, they also overlook some behavior of the patent system which indicates a failure of these functions. In order to properly prevent such failure, this paper proposes that the patent system adopt an orientation that will lead to increased innovative rivalry and competition. In Part I, using the computer operating system software market as an example, I propose a framework for reconceptualizing patent protection as …