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Full-Text Articles in Health Law and Policy
21st Century Cures Act: The Problem With Preemption In Light Of Deregulation, Megan C. Andersen
21st Century Cures Act: The Problem With Preemption In Light Of Deregulation, Megan C. Andersen
University of Michigan Journal of Law Reform
The 21st Century Cures Act introduced innovative changes to the Food and Drug Administration’s regulatory processes. In an effort to address the slow, costly, and burdensome approval process for high-risk devices, the Cures Act modernized clinical trial data by allowing reviewers to determine whether devices merit expedited review and to consider post-market surveillance data in the premarket approval process. These changes will get life-saving devices to the people who need them faster than ever before. But the tradeoff is a greater risk of injury to the patient. The 2008 Supreme Court decision Riegel v. Medtronic, Inc., held that any …
Clearing The Way For An Effective Federal-State Partnership In Health Reform, Eleanor D. Kinney
Clearing The Way For An Effective Federal-State Partnership In Health Reform, Eleanor D. Kinney
University of Michigan Journal of Law Reform
At century's end, states have assumed a very different role in the design, implementation, and operation of health service programs than they did twenty-five years ago. In the current volatile political atmosphere particularly at the federal level, states have taken up the mantle of healthcare reform in the final years of the 1990s. Yet there remain problems and difficulties with the current federal-state relationship in health reform. The critical question is whether states can successfully accomplish genuine reform given its politically charged, complex and costly nature. This question takes on particular significance for the most important reform-expanding coverage to the …
Michigan's Nursing Home Reform Law, John D. Croll
Michigan's Nursing Home Reform Law, John D. Croll
University of Michigan Journal of Law Reform
This article examines Michigan's new nursing home reform law, which has been hailed as "landmark legislation" and as a model for the entire country. Part I examines the past failures of nursing home regulation and the need for reform. Part II analyzes the law's key provisions. Part III examines the weaknesses of certain enforcement measures. The article proposes the following improvements: (1) extension of the law's protection to residents of homes for the aged; (2) greater access to patients by approved organizations; (3) adoption of nurse-patient ratios; (4) improvement of inspection procedures; and (5) allowance for patients or their representatives …