Science and Technology Law Commons^™

The World Trade Organization Dispute Over Genetically Modified Organisms: The Precautionary Principle Meets International Trade Law, David A. Wirth

David A. Wirth

“Precaution” is increasingly accepted as a basis for governmental policy in the areas of public health and environment on both the domestic and international levels. A precautionary perspective counsels action to avert danger or threats in situations of scientific uncertainty or incomplete information. Precautionary approaches find expression in internationally harmonized formulations as non-binding exhortations, binding treaties, and meta-level principles. Precaution is a particular challenge to free trade agreements, whose purpose is to eliminate unjustified barriers to trade. In that context, precaution as a justification for a challenged governmental measure may appear to be nothing more than a pretext for protectionism. …

The Battle Over The Embryo: How West Virginia Should Legally Define The Embryo And Regulate Embryo Adoption, Alyssa Lechmanik

West Virginia Law Review

No abstract provided.

Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski

Michael J. Malinowski

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research and …

The Mhealth Conundrum: Smartphones & Mobile Medical Apps – How Much Fda Medical Device Regulation Is Required?, Vincent J. Roth Esq

Vincent J Roth Esq

Smartphones and tablets have provided a plethora of new business opportunities for a number of industries including healthcare. Technology, however, appears to have outpaced the regulatory environment, which has spawned criticism over the current guidance of the Food and Drug Administration (“FDA”) with regard to software and what level of regulation is required for mobile medical applications. Commentators have remarked that the FDA’s guidance in this area is complex and unclear. This article explores the current FDA regulatory scheme for mobile medical applications and adapters for mobile devices designed to provide mobile healthcare, or “mHealth.” Attention is given to further …

The Mhealth Conundrum: Smartphones & Mobile Medical Apps – How Much Fda Medical Device Regulation Is Required?, Vincent J. Roth Esq

Vincent J Roth Esq

Smartphones and tablets have provided a plethora of new business opportunities for a number of industries including healthcare. Technology, however, appears to have outpaced the regulatory environment, which has spawned criticism over the current guidance of the Food and Drug Administration (“FDA”) with regard to software and what level of regulation is required for mobile medical applications. Commentators have remarked that the FDA’s guidance in this area is complex and unclear. This article explores the current FDA regulatory scheme for mobile medical applications and adapters for mobile devices designed to provide mobile healthcare, or “mHealth.” Attention is given to further …

Reports Of Its Death Are Greatly Exaggerated: Ebay, Bosch, And The Presumption Of Irreparable Harm In Hatch-Waxman Litgation, Kenneth C. Louis

Kenneth C. Louis

No abstract provided.

Synaptic Plasticity In Neurological Deficit As A Form Of Indemnification: The Utility Of Analogical Thinking, Madeleine Schachter, Madeleine Schachter

Madeleine Schachter

The need for creative problem-solving is as infinite as are the ways in which to engage in it. This article posits that one useful, albeit not flawless, mechanism in which to seek scientific advancements is through the use of analogical thinking. The technique has been invoked in virtually all disciplines, sometimes successfully and sometimes not. The utility of thinking by analogy lies, paradoxically, in its capacity to conceptualize a solution or a viable avenue of further inquiry as much as in its capacity to expose flaws in the analogical concept hypothesized. As such, it is an important means of stimulating …

"Introduction" (Chapter 1) Of Stories About Science In Law: Literary And Historical Images Of Acquired Expertise (Ashgate 2011), David S. Caudill

David S Caudill

This is the introductory chapter of Stories About Science in Law: Literary and Historical Images of Acquired Expertise (Ashgate, 2011), explaining that the book presents examples of how literary accounts can provide a supplement to our understanding of science in law. Challenging the view that law and science are completely different, I focus on stories that explore the relationship between law and science, and identify cultural images of science that prevail in legal contexts. In contrast to other studies on the transfer and construction of expertise in legal settings, the book considers the intersection of three interdisciplinary projects-- law and …

Throwing Dirt On Doctor Frankenstein's Grave: Accesss To Experimental Treatments At The End Of Life, Michael J. Malinowski

Michael J. Malinowski

Abstract

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research …

Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski

Michael J. Malinowski

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research and …

A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski

Michael J. Malinowski

This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.

Exclusivity Without Patents: The New Frontier Of Fda Regulation For Genetic Materials, Gregory Dolin

All Faculty Scholarship

Over the last twenty years, the legal and scientific academic communities have been embroiled in a debate about the patent eligibility of genetic materials. The stakes for both sides could not be higher. On one hand are the potential multi-billion dollar profits on the fruits of research (from newly discovered genes), and on the other is scientists' ability to continue and expand research into the human genome to improve patients' access to affordable diagnostic and therapeutic modalities. This debate is currently pending before the Supreme Court, which is considering a petition for certiorari in Ass'n for Molecular Pathology v. U.S. …

Commensal Microbiotica - Biological Frontier And Legal Challenge, Kenneth L. Sanders Md

Kenneth L Sanders MD

Recent advances in bacteriology and medical science affirm that the commensal relationship between surface microbial flora and the human host is intricate and important. Legal theory has thus far lagged behind the impact of the medical discoveries.

Rescuing Access To Patented Essential Medicines: Pharmaceutical Companies As Tortfeasors Under The Prevented Rescue Tort Theory, Richard Cameron Gower

Richard Cameron Gower

Despite some difficulties, state tort law can be argued to create a unique exception to patent law. Specifically, the prevented rescue doctrine suggests that charities and others can circumvent patents on certain critical medications when such actions are necessary to save individuals from death or serious harm. Although this Article finds that the prevented rescue tort doctrines is preempted by federal patent law, all hope is not lost. A federal substantive due process claim may be brought that uses the common law to demonstrate a fundamental right that has long been protected by our Nation’s legal traditions. Moreover, this Article …

The New Frontier Of Advanced Reproductive Technology: Reevaluating Modern Legal Parenthood, Yehezkel H. Margalit Dr., John D. Loike Dr., Orrie Levy Adv.

Hezi Margalit

Assisted reproductive technologies (ARTs) have challenged our deepest conceptions of what it means to be a parent by fragmenting traditional aspects of parenthood. The law has been slow to respond to this challenge, and numerous academic articles have proposed models for adapting parentage laws to ARTs. In the coming years, however, scientific advancements in reproductive technologies, such as somatic cell nuclear transfer and stem cell technologies, will challenge both parentage laws and proposed legal models for traditional ARTs in new and fascinating ways. For instance, these advanced technologies could allow two women to create a child without any male genetic …

Christopher V. Smithkline Beecham Corporation: An Unsurprising Loss For Pharmaceutical Sales Representatives And An Erosion Of Power For Administrative Agencies, Anna Johnston

Proxy

No abstract provided.

Dependence On Cyberscribes - Issues In E-Security, Thomas R. Mclean, Alexander B. Mclean

Journal of Business & Technology Law

No abstract provided.

Compliance In The Ether: Cloud Computing, Data Security And Business Regulation, J. Nicholas Hoover

Journal of Business & Technology Law

No abstract provided.

Parent In Life, Stranger At Law: Addressing The Inequality And Inconsistency Of Parentage Rights Of Same-Sex Parents, 46 J. Marshall L. Rev. 867 (2013), Paul Coogan

UIC Law Review

No abstract provided.

The Mobile Health Revolution?, Nathan Cortez

Faculty Journal Articles and Book Chapters

Rarely does a class of technologies excite physicians, patients, financeers, gadgeteers, and policymakers alike. But mobile health — the use of mobile devices like smartphones and tablets for health or medical purposes — has captured our collective imagination. Observers predict that mobile health, also referred to as “mHealth” or “medical apps,” can save millions of lives, billions in spending, and democratize access to health care. Proponents argue that mobile health technologies will transform the ways in which we deliver, consume, measure, and pay for care; disrupting our sclerotic health care system.

This Article evaluates mobile health and its many ambitions. …

Applying Bioethics In The 21st Century: Principlism Or Situationism?, George P. Smith Ii

Scholarly Articles

After an examination of the four cardinal bioethical principles which define Principlism — autonomy, beneficence, non maleficence and justice — an explication of Joseph Fletcher’s theory of Situationism is undertaken.

The conclusion of this Article is that when an ethical dilemma arises and is “tested” as to its moral efficacy, rather than judge the acts in question in order to determine whether they are in conformance with one of the four bioethical principles, it is more humane and practical to determine the ethical propriety of questioned conduct by use of a situation ethic which in fact is more sensitive. This …

Health Insurance, Employment, And The Human Genome: Genetic Discrimination And Biobanks In The United States, Eric A. Feldman, Chelsea Darnell

All Faculty Scholarship

Does genetic information warrant special legal protection, and if so how should it be protected? This essay examines the most recent (and indeed only) significant effort by the US government to prohibit genetic discrimination, the Genetic Information Nondiscrimination Act (GINA). We argue that the legislation is unlikely to have the positive impact sought by advocates of genetic privacy and proponents of biobanks. In part, GINA disappoints because it does too little. Hailed by its promoters as “the first civil rights act of the 21^st century,” GINA’s reach is in fact quite modest and its grasp even more so. But …

The Future Of Gene Patents And The Implications For Medicine, Jacob S. Sherkow, Henry Greely

Other Publications

The Supreme Court decision in Myriad Genetics struck down the patenting of human genomic DNA. What will this mean for genetic testing and medicine, more broadly?

Does The Constitution Protect Abortions Based On Fetal Anomaly?: Examining The Potential For Disability-Selective Abortion Bans In The Age Of Prenatal Whole Genome Sequencing, Greer Donley

Articles

This Note examines whether the state or federal government has the power to enact a law that prevents women from obtaining abortions based on their fetus’s genetic abnormality. Such a ban has already been enacted in North Dakota and introduced in Indiana and Missouri. I argue below that this law presents a novel state intrusion on a woman’s right to obtain a pre-viability abortion. Moreover, these pieces of legislation contain an outdated understanding of prenatal genetic testing—the landscape of which is quickly evolving as a result of a new technology: prenatal whole genome sequencing. This Note argues that the incorporation …

Energy And Environment Policy Case For A Global Project, Thomas A. Faunce

Thomas A Faunce

A policy case is made for a global project on artificial photosynthesis including its scientific justification, potential governance structure and funding mechanisms.