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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 …
Rent-Seeking And Inter Partes Review: An Analysis Of Invalidity Assertion Entities In Patent Law, W. Michael Schuster
Rent-Seeking And Inter Partes Review: An Analysis Of Invalidity Assertion Entities In Patent Law, W. Michael Schuster
Michigan Telecommunications & Technology Law Review
This Essay is the first analysis of a recent entrant on the patent landscape: the Invalidity Assertion Entity (IAE). IAEs engage in rent-seeking by demanding payment from patent holders in exchange for not attempting to invalidate their patents through administrative action before the U.S. Patent and Trademark Office. The response to IAEs has been uniformly negative. Reflexive proposals have been raised in Congress (unsurprisingly) to terminate the IAE business model. In contrast to the common response to IAEs, this Essay discusses how profit-driven IAEs may generate socially beneficial externalities and why legislating to end the IAE business model is imprudent.