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Can You Diagnose Me Now? A Proposal To Modify The Fda’S Regulation Of Smartphone Mobile Health Applications With A Pre-Market Notification And Application Database Program, Stephen Mcinerney
Can You Diagnose Me Now? A Proposal To Modify The Fda’S Regulation Of Smartphone Mobile Health Applications With A Pre-Market Notification And Application Database Program, Stephen Mcinerney
University of Michigan Journal of Law Reform
Advances in mobile technology continually create new possibilities for the future of medical care. Yet these changes have also created concerns about patient safety. Under the Food, Drug, and Cosmetic Act, the Food and Drug Administration (FDA) has the authority to regulate a broad spectrum of products beyond traditional medical devices like stethoscopes or pacemakers. The regulatory question is not if the FDA has the statutory authority to regulate health-related software, but rather how it will exercise its regulatory authority. In September 2013, the FDA published Final Guidance on Mobile Medical Applications; in it, the Agency limited its oversight to …
Nepa In The Hot Seat: A Proposal For An Office Of Environmental Analysis, Aliza M. Cohen
Nepa In The Hot Seat: A Proposal For An Office Of Environmental Analysis, Aliza M. Cohen
University of Michigan Journal of Law Reform
Judicial deference under the National Environmental Policy Act (NEPA) can be problematic. It is a well-established rule of administrative law that courts will grant a high degree of deference to agency decisions. They do this out of respect for agency expertise and policy judgment. This deference is applied to NEPA lawsuits without acknowledging the special pressures that agencies face while assessing the environmental impacts of their own projects. Though there is a strong argument that these pressures undermine the reasons for deferential review, neither the statute nor the courts have provided plaintiffs with adequate means to remedy this problem. Agency …
Federal Regulation Of Agricultural Biotechnologies, Thomas O. Mcgarity
Federal Regulation Of Agricultural Biotechnologies, Thomas O. Mcgarity
University of Michigan Journal of Law Reform
Part I of this Article describes some of the risks and benefits of newly emerging agricultural biotechnologies. After discussing, in Part II, the role of federal agencies in regulating agricultural biotechnologies, Part III of the Article proposes elements for an adequate regulatory regime. Part IV then measures the existing legal authorities, as implemented by the USDA and the EPA, against the ideal elements. Part V examines the willingness of these agencies to regulate. Finally, Part VI suggests changes that can be made in the current regulatory regime to bring about more effective regulation and to enhance public trust in regulatory …