Law Commons^™

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. …

How Google Perceives Customer Privacy, Cyber, E-Commerce, Political And Regulatory Compliance Risks, Lawrence J. Trautman

William & Mary Business Law Review

By now, almost every business has an Internet presence. What are the major risks perceived by those engaged in the universe of Internet businesses? What potential risks, if they become reality, may cause substantial increases in operating costs or threaten the very survival of the enterprise?

This Article discusses the relevant annual report disclosures from Alphabet, Inc. (parent of Google), along with other Google documents, as a potentially powerful teaching device. Most of the descriptive language to follow is excerpted directly from Alphabet’s (Google) regulatory filings. My additions about these entities include weaving their disclosure materials into a logical presentation …

Digital Gold: Cybersecurity Regulations And Establishing The Free Trade Of Big Data, Victoria Conrad

William & Mary Business Law Review

Data is everywhere. With more than ten billion Internetenabled devices worldwide, each day individuals create a flood of information that is transferred onto the Internet as big data. Businesses that have the resources to capture and utilize data can better understand their consumers, allowing for reinforcement of customer relationship management, improvements to the management of operational risk, and enhancement of overall firm performance. However, big data’s advantages come with high costs. The cost of organization and storage coupled with the fact that no legal principle allows for any sort of property rights in big data creates a “digital divide” between …

Custom-Edited Dna: Legal Limits On The Patentability Of Crispr-Cas9'S Therapeutic Applications, Noah C. Chauvin

William & Mary Law Review

No abstract provided.

Adapting Bartnicki V. Vopper To A Changing Tech Landscape: Rebalancing Free Speech And Privacy In The Smartphone Age, Andrew E. Levitt

William & Mary Bill of Rights Journal

No abstract provided.

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

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 …

Another Day At The Breach: Cyber Intrusion: A Conference Of Experts, William & Mary Law School

Law School Conferences: Ephemera

Held on March 16-17, 2018 at William & Mary Law School and Raymond A. Mason School of Business.

The Biologics Price Competition And Innovation Act: Is A Generic Market For Biologics Attainable?, Kasey E. Koballa

William & Mary Business Law Review

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) provides an abbreviated approval pathway for biological therapeutic products shown to be biosimilar to an FDA-approved biological reference product. The BPCIA purported to reduce the price of biologics while promoting innovation. In two recent cases, the Federal Circuit interpreted a key provision of the BPCIA requiring an applicant to provide the reference product sponsor with notice 180 days before marketing the product. The Federal Circuit’s interpretation extends the exclusivity period already provided for the reference product sponsor, deterring innovation and price reduction. Thus, the Supreme Court granted certiorari in one …