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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 …
Power To The People: Why We Need Full Federal Preemption Of Electrical Transmission Regulation, Max Hensley
Power To The People: Why We Need Full Federal Preemption Of Electrical Transmission Regulation, Max Hensley
University of Michigan Journal of Law Reform
State and federal governments have made significant investments in the development and installation of renewable energy technology. However, further increases in renewable power use have been stymied by the continued mismatch between the national interest in connecting consumers with utility-scale wind and solar installations and state and local control over the siting of electrical transmission lines. Because renewable power potential is often located far from consumers, transmission lines must cross multiple jurisdictions whose local interests have tended to prevent or significantly delay development. This Note analyzes that disconnect, reviews academic and legislative proposals to overcome it, and proposes a way …
Technology Convergence And Federalism: Who Should Decide The Future Of Telecommunications Regulation?, Daniel A. Lyons
Technology Convergence And Federalism: Who Should Decide The Future Of Telecommunications Regulation?, Daniel A. Lyons
University of Michigan Journal of Law Reform
This Article critically examines the division of regulatory jurisdiction over telecommunications issues between the federal government and the states. Currently, the line between federal and state jurisdiction varies depending on the service at issue. This compartmentalization might have made sense fifteen years ago, but the advent of technology convergence has largely rendered this model obsolete. Yesterday's telephone and cable companies now compete head-to-head to offer consumers the vaunted "triple play" of voice, video, and internet services. But these telecommunications companies are finding it increasingly difficult to fit new operations into arcane, rigid regulatory compartments. Moreover, services that consumers view as …
Increasing Consumer Power In The Grievance And Appeal Process For Medicare Hmo Enrollees, Kenneth J. Pippin
Increasing Consumer Power In The Grievance And Appeal Process For Medicare Hmo Enrollees, Kenneth J. Pippin
University of Michigan Journal of Law Reform
Federal law requires that Health Maintenance Organizations (HMOs) and Managed Care Organizations (MCOs) provide Medicare beneficiaries with specific grievance and appeal rights for challenging adverse decisions of these organizations. The Health Care Financing Administration (HCFA) is charged with enforcing these regulations. Currently, however, HCFA contracts with HMOs, allowing them to enroll Medicare beneficiaries despite the fact that many of the statutory and regulatory requirements are ignored by the Medicare HMOs. This is problematic because the elderly Medicare population may not be able to independently and adequately challenge the HMO's denial of care or reimbursement. Because HCFA has been reluctant and …