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Unplanned Obsolescence: Interpreting The Automatic Telephone Dialing System After The Smartphone Epoch, Walter Allison
Unplanned Obsolescence: Interpreting The Automatic Telephone Dialing System After The Smartphone Epoch, Walter Allison
Michigan Law Review
Technology regulations succeed or fail based upon their ability to regulate an idea. Constant innovation forces legislators to draft statutes aimed at prohibiting the idea of a device, rather than a specific device itself, because new devices with new capacities emerge every day. The Telephone Consumer Protection Act (TCPA) is a federal statute that imposes liability based on the idea of an automatic telephone dialing system (ATDS). But the statute’s definition of the device is ambiguous. The FCC struggles to coherently apply the definition to new technologies, and courts interpret the definition inconsistently. Federal circuit courts have split over these …
Regulating Black-Box Medicine, W. Nicholson Price Ii
Regulating Black-Box Medicine, W. Nicholson Price Ii
Michigan Law Review
Data drive modern medicine. And our tools to analyze those data are growing ever more powerful. As health data are collected in greater and greater amounts, sophisticated algorithms based on those data can drive medical innovation, improve the process of care, and increase efficiency. Those algorithms, however, vary widely in quality. Some are accurate and powerful, while others may be riddled with errors or based on faulty science. When an opaque algorithm recommends an insulin dose to a diabetic patient, how do we know that dose is correct? Patients, providers, and insurers face substantial difficulties in identifying high-quality algorithms; they …
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 …
Stock Market Futurism, Merritt Fox, Gabriel Rauterberg
Stock Market Futurism, Merritt Fox, Gabriel Rauterberg
Articles
The U.S. stock market is undergoing extraordinary upheaval. The approval of the application of the Investors Exchange (IEX) to become the nation's newest stock exchange, including its famous "speed bump," was one of the SEC's most controversial decisions in decades. Other exchanges have proposed a raft of new innovations in its wake. This evolving equity market is a critical piece of national infrastructure, but the regulatory scheme for its institutions is increasingly frayed. In particular, current regulation draws sharp distinctions among different kinds of markets for trading stocks, treating stock exchanges as self-regulatory organizations immune from private civil litigation, while …
Economic Solutions To Nuclear Energy's Financial Challenges, Zachary Robock
Economic Solutions To Nuclear Energy's Financial Challenges, Zachary Robock
Michigan Journal of Environmental & Administrative Law
This Note presents a legal, economic, and regulatory roadmap to drive long-term innovation in sustainable energy generation. Next-generation nuclear power, which fundamentally mitigates many safety and nuclear waste issues, is the focus of this Note; however, the economic concepts can be applied to encourage solar, wind, advanced battery, and other sustainable technologies with high upfront costs and low long-term variable costs. Advanced nuclear energy generation is economically competitive on a long-term levelized cost basis, but suffers from a timing issue—a large amount of capital is needed upfront, with repayment over several decades, during which time significant capital costs can accrue …
Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry, Ariel Katz
Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry, Ariel Katz
Michigan Telecommunications & Technology Law Review
Before a new drug can be marketed, the Food and Drug Administration must be satisfied that it is safe and effective. According to conventional wisdom, the cost and delay involved in this process diminish the incentives to invest in the development of new drugs. Accordingly, several reforms aimed at restoring such incentives have been implemented or advocated. This Article challenges the central argument that drug regulation and drug innovation are necessarily at odds with one another. Although intuitively appealing, the argument that drug regulation negatively affects the incentives to innovate does not fully capture the role that regulation plays in …
The Role Of The Fda In Innovation Policy, Rebecca S. Eisenberg
The Role Of The Fda In Innovation Policy, Rebecca S. Eisenberg
Michigan Telecommunications & Technology Law Review
This Article reexamines the role of FDA regulation in motivating investment in biopharmaceutical innovation. I begin by challenging the standard story that it is the patent system that makes drug development profitable, and drug regulation that makes it costly, by showing how patents add to costs and how drug regulation works in tandem with patents to protect profits. I then compare FDA-administered exclusive rights to patents as a means of fortifying drug development incentives, suggesting ways that FDA-administered rights might be preferable both from the perspective of policy makers and from the perspective of firms. In the remainder of the …
Pathological Patenting: The Pto As Cause Or Cure, Rochelle Dreyfuss
Pathological Patenting: The Pto As Cause Or Cure, Rochelle Dreyfuss
Michigan Law Review
The Patent Act was last revised in 1952. The hydrogen bomb was exploded that year, vividly demonstrating the power of the nucleus; in the ensuing postwar period, the Next Big Thing was clearly the molecule. Novel compounds were synthesized in the hopes of finding new medicines; solid-state devices exploited the special characteristics of germanium and other semiconductors; as investments in polymer chemistry soared, advice to the college graduate soon boiled down to "one word ... just one word[:] ... Plastics." Over the next half-century, things changed dramatically. "Better living through chemistry" has begun to sound dated (if not sinister). Genomics …