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Articles 1 - 3 of 3
Full-Text Articles in Law
Halted Innovation: The Expansion Of Federal Jurisdiction Over Medicine And The Human Body, Myrisha S. Lewis
Halted Innovation: The Expansion Of Federal Jurisdiction Over Medicine And The Human Body, Myrisha S. Lewis
Faculty Publications
Modern medical innovations are blurring the line between medical practice and medical devices and drugs. Historically, many techniques have been developed in medicine, without any interference from the federal government, as medical practice is (and has historically been) an area of state jurisdiction. Over the past two decades, however, the U.S. Food and Drug Administration (FDA) has been exerting jurisdiction over the human body and the practice of medicine by targeting new medical techniques for oversight and subjecting the continued use of those treatments to onerous and legally questionable regulatory requirements that hinder the use of those treatments in practice. …
A Legal Perspective On The Trials And Tribulations Of Ai: How Artificial Intelligence, The Internet Of Things, Smart Contracts, And Other Technologies Will Affect The Law, Iria Giuffrida, Fredric Lederer, Nicolas Vermeys
A Legal Perspective On The Trials And Tribulations Of Ai: How Artificial Intelligence, The Internet Of Things, Smart Contracts, And Other Technologies Will Affect The Law, Iria Giuffrida, Fredric Lederer, Nicolas Vermeys
Faculty Publications
No abstract provided.
How Subterranean Regulation Hinders Innovation In Assisted Reproductive Technology, Myrisha S. Lewis
How Subterranean Regulation Hinders Innovation In Assisted Reproductive Technology, Myrisha S. Lewis
Faculty Publications
Most scholars believe assisted reproductive technology is subject only to minimal regulation, especially by the federal government. This belief, I contend, is wrong. In this Article, I examine agency documents, statements by officials, and letters that the U.S. Food and Drug Administration (FDA) has sent to physicians and researchers over the past fifteen years to reveal an overlooked regulatory program. The FDA has been targeting new forms of assisted reproductive technology that involve small genetic modifications (advanced assisted reproductive technologies or AARTs) through regulatory actions that receive little public, media, or scholarly attention. I term this method of regulation “subterranean …