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Full-Text Articles in Law
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 …
Consumer-Directed Health Care And The Chronically Ill, John V. Jacobi
Consumer-Directed Health Care And The Chronically Ill, John V. Jacobi
University of Michigan Journal of Law Reform
Insurance plans with consumer-controlled spending accounts are advocated as tools for reducing health costs and empowering consumers. This Article describes their recent development and argues that they are likely to fail. Instead of focusing on the small number of consumers with chronic illnesses who account for the bulk of health spending they focus on the majority of relatively well consumers. This Article proposes market-based and regulatory changes focused on high-cost patients. To best serve cost and quality goals, health finance responsibility should be divided between consumers and their employers for predictable and routine costs, and government for chronic and catastrophic …
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 …
Exit And Voice In American Health Care, Marc A. Rodwin
Exit And Voice In American Health Care, Marc A. Rodwin
University of Michigan Journal of Law Reform
Until the 1960s, the main way for patients to affect health care institutions was by choosing their doctors or hospitals or leaving those with which they were dissatisfied. They had few avenues to exert their voice to bring about change through complaints, politics, or other means. The balance between exit and voice shifted in the 1960s, as the women's health and disability rights movements brought about change by increased use of political voice and, to a lesser degree, by exit. With the growth of managed care since the 1980s, enrolled individuals have had fewer opportunities for exit and greater potential …
Competing On Quality Of Care: The Need To Develop A Competition Policy For Health Care Markets, William M. Sage, Peter J. Hammer
Competing On Quality Of Care: The Need To Develop A Competition Policy For Health Care Markets, William M. Sage, Peter J. Hammer
University of Michigan Journal of Law Reform
As American health care moves from a professionally dominated to a market-dominated model, concerns have been voiced that competition, once unleashed, will focus on price to the detriment of quality. Although quality has been extensively analyzed in health services research, the role of quality in competition policy has not been elucidated. While economists may theorize about non-price competition, courts in antitrust cases often follow simpler models of competition based on price and output, either ignoring quality as a competitive dimension or assuming that it will occur in tandem with price competition. This unsystematic approach is inadequate for the formulation of …