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Articles 1 - 2 of 2
Full-Text Articles in Law
Admit Or Deny: A Call For Reform Of The Sec's "Neither-Admit-Nor-Deny" Policy, Priyah Kaul
Admit Or Deny: A Call For Reform Of The Sec's "Neither-Admit-Nor-Deny" Policy, Priyah Kaul
University of Michigan Journal of Law Reform
For four decades, the SEC’s often-invoked policy of settling cases without requiring admissions of wrongdoing, referred to as the “neither-admit-nor-deny” policy, went unchallenged by the courts, the legislature, and the public. Then in 2011, a harshly critical opinion from Judge Jed Rakoff in SEC v. Citigroup incited demands for reform of this policy. In response to Judge Rakoff’s opinion, the SEC announced a modified approach to settlements. Under the modified approach, the Commission may require an admission of wrongdoing if a defendant’s misconduct was egregious or if the public markets would benefit from an admission. Many supporters of the neither-admit-nor-deny …
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 …