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Full-Text Articles in Law
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 Systematic Risk Of Private Funds After The Dodd-Frank Act, Wulf A. Kaal
The Systematic Risk Of Private Funds After The Dodd-Frank Act, Wulf A. Kaal
Michigan Business & Entrepreneurial Law Review
The Financial Stability Oversight Council (FSOC) was created under the Dodd-Frank Act with the primary mandate of guarding against systemic risk and correcting perceived regulatory weaknesses that may have contributed to the financial crisis of 2008-2009. The Securities and Exchange Commission (SEC) collects data pertaining to private fund advisers in order to facilitate FSOC’s assessment of non-bank financial institutions’ potential systemic risks. Evidence that the SEC’s data collection encounters accuracy and consistency problems might hamper FSOC’s ability to evaluate the systemic risk of private fund advisers. The author shows that while the SEC’s data plays a crucial role in all …
The $1.75 Trillion Lie, Lisa Heinzerling, Frank Ackerman
The $1.75 Trillion Lie, Lisa Heinzerling, Frank Ackerman
Michigan Journal of Environmental & Administrative Law
A 2010 study commissioned by the Office of Advocacy of the U.S. Small Business Administration claims that federal regulations impose annual economic costs of $1.75 trillion. This estimate has been widely circulated, in everything from op-ed pages to Congressional testimony. But the estimate is not credible. For costs of economic regulations, the estimate reflects a calculation that rests on a misunderstanding of the definition of the relevant data, flunks an elementary question on the normal distribution, pads the analysis with several years of near-identical data, and fails to recognize the difference between correlation and causation. For costs of environmental regulation, …
Improving Post-Approval Risk Surveillance For Drugs: Active Post-Market Risk Identification, Matthew Gordon
Improving Post-Approval Risk Surveillance For Drugs: Active Post-Market Risk Identification, Matthew Gordon
Michigan Telecommunications & Technology Law Review
Pre-approval clinical trials cannot possibly ensure that a drug will not have disastrous side effects once it arrives on the market. Post-approval drug safety data gathering was put in place to address this problem, but as implemented, it has not proven to be as effective as hoped. Congress recently overhauled the legislation regarding post-approval drug risk identification, and in doing so made a deliberate decision to put much of the burden of post-approval drug surveillance on the FDA through data mining. Further, the legislation gave the FDA the power to require post-approval clinical trials from drug makers only in limited …
Federal Agency Treatment Of Uncertainty In Environmental Impact Statements Under The Ceq's Amended Nepa Regulation § 1502.22: Worst Case Analysis Or Risk Threshold, Charles F. Weiss
Michigan Law Review
This Note traces the judicial and administrative treatment of uncertainty under NEPA and supports the CEQ's replacement of worst case analysis with a qualitative probability threshold. Part I discusses the development of reasonableness standards in NEPA common law to define agency obligations prior to promulgation of the worst case analysis regulation. Part II reviews the worst case analysis regulation and its judicial construction. Finally, Part III outlines the amended regulation, which replaces worst case analysis with a probability threshold employing the rule of reason to limit EIS discussion to environmental effects shown through credible scientific evidence to be reasonably foreseeable. …