Law Commons^™

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 …

Carte Blanche For Cruelty: The Non-Enforcement Of The Animal Welfare Act, Katharine M. Swanson

University of Michigan Journal of Law Reform

This Note explores both the judicial and administrative underenforcement of the Animal Welfare Act in protecting the welfare of laboratory animals used for purposes of experimentation. Specifically, the Note suggests that judicial underenforcement is borne as a result of the difficulties of lodging a private cause of action under the Act or gaining standing under the alternative statutory scheme of the Administrative Procedure Act. It further suggests administrative underenforcement in describing the promulgated regulations of the Act as inadequate and the lack of self-policing mechanisms. Finally, the Note suggests some ways that enforcement can be made more effective in these …

Fda Approved? A Critique Of The Artificial Insemination Industry In The United States, Karen M. Ginsberg

University of Michigan Journal of Law Reform

Artificial insemination by donor is becoming an increasingly popular means to achieving parenthood. While the majority of couples use artificial insemination to overcome fertility problems, many recipients use artificial insemination to avoid passing a genetic disease to their children. However, case studies reveal the inherent dangers of artificial insemination, namely the lack of proper screening methods to avoid passing genetic diseases to children born by artificial insemination. State-by-state regulation, federal guidelines, and private adjudication have all proven to be inadequate methods of regulating the artificial insemination industry. Ginsberg proposes federal regulation as the only means of achieving a safe artificial …

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 …

Police Use Of Cctv Surveillance: Constitutional Implications And Proposed Regulations, Gary C. Robb

University of Michigan Journal of Law Reform

This article evaluates the constitutionality of CCTV "searches." Part I discusses the present uses being made of closed circuit technology and evaluates the merits of the CCTV surveillance system. The critical policy trade-off is the system's effectiveness in combatting crime against the resulting loss of privacy to individual citizens.

Part II considers the constitutional implications of CCTV use in terms of three major doctrines: the Fourth Amendment prohibition against "unreasonable searches and seizures"; the constitutional right of privacy; and the First Amendment guarantees of free speech and association. This part briefly summarizes the state of the law concerning these constitutional …