Law Commons^™

Can Dna Be Speech?, Jorge R. Roig

Jorge R Roig

The Treatment For Malpractice – Physician, Enhance Thyself: The Impact Of Neuroenhancements For Medical Malpractice, Harvey L. Fiser

Harvey L. Fiser

No abstract provided.

The "Uberization" Of Healthcare: The Forthcoming Legal Storm Over Mobile Health Technology's Impact On The Medical Profession, Fazal Khan

Fazal Khan

The nascent field of mobile health technology is still very small but is predicted to grow exponentially as major technology companies such as Apple, Google, Samsung, and even Facebook have announced mobile health initiatives alongside influential healthcare provider networks. Given the highly regulated nature of healthcare, significant legal barriers stand in the way of mobile health’s potential ascension. I contend that the most difficult legal challenges facing this industry will be restrictive professional licensing and scope of practice laws. The primary reason is that mobile health threatens to disrupt historical power dynamics within the healthcare profession that have legally enshrined …

Dumping Daubert, Popping Popper And Falsifying Falsifiability: A Re-Assessment Of First Principles, Barbara P. Billauer Esq

barbara p billauer esq

Abstract: The Daubert mantra demands that judges, acting as gatekeepers, prevent para, pseudo or bad science from infiltrating the courtroom. To do so, the Judges must first determine what is ‘science’ and what is ‘good science.’ It is submitted that Daubert is deeply polluted with the notions of Karl Popper who sets ‘falsifiability’ and ‘falsification’ as the demarcation line for that determination. This philosophy has intractably infected case law, leading to bad decisions immortalized as stare decisis, and an unworkable system of decision-making, which negatively impacts litigant expectations. Among other problems is the intolerance of Popper’s system for multiple causation, …

Consciousness And Futility: A Proposal For A Legal Redefinition Of Death, Christopher Smith

Christopher R Smith

Recent controversies in Texas (with the Marlise Muñoz case) and in California (with the Jahi McMath case) have highlighted a lamentable flaw in the current legal conception of human death, and the difficulty of defining when death finally occurs. The unworkable notion of “brain-death” remains the law in every state in the union, yet the philosophical and scientific foundations of this notion remain open to attack. This article posits that death is a fundamentally social construct, and that it is society at large (through its laws, public opinions, religious attitudes, etc.) that actually defines death. This essay then argues that …

Foreseeability Decoded, Meiring De Villiers

Meiring de Villiers

The Article reviews the conceptual and doctrinal roles of the foreseeability doctrine in negligence law, and analyzes its application in cases where a new technology or unexplored scientific principle contributed to a plaintiff’s harm. It adopts the common law definition of foreseeability as a systematic relationship between a defendant’s wrongdoing and the plaintiff’s harm, and demonstrates translation of the concept into the language of science so that the common law meaning of the foreseeability doctrine is preserved. An analysis of the foreseeability of HIV/AIDS as a blood-borne risk illustrates application of the concept to contemporary issues in medical science.

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 …

"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.

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 …

Ancillary Joint Ventures And The Unanswered Questions After Revenue Ruling 2004-51

Gabriel O Aitsebaomo

Ever since the Internal Revenue Service (the "Service") issued Revenue Ruling 98-15… in which it emphasized "control" as a critical factor in determining whether a tax-exempt hospital that enters into a whole-hospital joint venture with a for-profit entity would continue to maintain its tax-exemption, practitioners and scholars alike have sought guidance from the Service regarding whether such "control" would also be required of an exempt organization that enters into an "ancillary joint venture" with a for-profit entity. In response, the Service issued Revenue Ruling 2004-51 on May 6, 2004.

… In Revenue Ruling 2004-51, the Service enunciated that a tax-exempt …

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

Working Paper Series

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 …

Compliance With Advance Directives: Wrongful Living And Tort Law Incentives, Holly Lynch, Michele Mathes, Nadia Sawicki

Nadia N. Sawicki

Modern ethical and legal norms generally require that deference be accorded to patients' decisions regarding treatment, including decisions to refuse life-sustaining care, even when patients no longer have the capacity to communicate those decisions to their physicians. Advance directives were developed as a means by which a patient's autonomy regarding medical care might survive such incapacity. Unfortunately, preserving patient autonomy at the end of life has been no simple task. First, it has been difficult to persuade patients to prepare for incapacity by making their wishes known. Second, even when they have done so, there is a distinct possibility that …

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.

A Defense Of Stem Cell Research, Gregory Dolin

Gregory Dolin

Isolation of human embryonic stem cells in 1998 simultaneously caused great excitement and concern in the scientific community and the population at large. The great promises that the discovery held were viewed with suspicion by many, because the isolation of these stem cells involved destruction of an embryo, and thus, according to some, destruction of innocent human life. Full ten years later, the debate still rages. The present Article proposes a solution to this debate.The solution concedes that the embryo is a human being entitled to full moral protection. Having made that concession, however, the Article proceeds to argue that …

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

Journal Articles

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.

A Complete Property Right Amendment, John H. Ryskamp

ExpressO

The trend of the eminent domain reform and "Kelo plus" initiatives is toward a comprehensive Constitutional property right incorporating the elements of level of review, nature of government action, and extent of compensation. This article contains a draft amendment which reflects these concerns.

Brain Imaging And Privacy: How Recent Advances In Neuroimaging Implicate Privacy Concerns , David P. Finn

ExpressO

This paper deals with recent advances in neuroimaging technologies which could begin to implicate privacy concerns in the near future.

In Sickness, Health, And Cyberspace: Protecting The Security Of Electronic Private Health Information, Sharona Hoffman, Andy Podgurski

ExpressO

The electronic processing of health information provides considerable benefits to patients and health care providers at the same time that it creates serious risks to the confidentiality, integrity, and availability of the data. The Internet provides a conduit for rapid and uncontrolled dispersion and trafficking of illicitly-obtained private health information, with far-reaching consequences to the unsuspecting victims. In order to address such threats to electronic private health information, the U.S. Department of Health and Human Services enacted the HIPAA Security Rule, which thus far has received little attention in the legal literature. This article presents a critique of the Security …

Why It Is Time To Eliminate Genomic Patents, Together With Natural Extracts Doctrine That Have Supported Such Patents, Allen K. Yu

ExpressO

The constitutional purpose of intellectual property is to “promote the progress of science and useful arts.” Given the utilitarian basis of patents, it is critical that policies and laws must be continually adjusted to reflect the needs of new technologies. When the law tries to shield itself from rather than confront the realities of underlying technologies, patents end up actually subverting rather than promote technological progress. This paper explores why the natural extracts doctrine belongs to the class of doctrines that subvert progress. The doctrine, established over a century ago to enable the patenting of purified compounds for use as …

Bond Repudiation, Tax Codes, The Appropriations Process And Restitution Post-Eminent Domain Reform, John H. Ryskamp

ExpressO

This brief comment suggests where the anti-eminent domain movement might be heading next.

Stealing What's Free: Exploring Compensation To Body Parts Sources For Their Contribution To Profitable Biomedical Research, Jo-Anne Yau

ExpressO

It is undisputed in the biotechnology industry that human body parts play a vital role in research. The body parts donors, referred to as "Sources" in this article, are subjected to physical and financial exploitation. Forbidding the explosion of profits from trickling down to the Source presents an irrational inequity. Despite established law, it is evident from case analysis, prevailing social practices, and constitutional interpretation that Source compensation is a plausible solution.

This article proposes a model of compensation for Sources, whereby Sources are compensated based on a proportionate share of the research profits set aside for the Source as …

Global Pharmaceutical Patent Law In Developing Countries- Amending Trips To Promote Access For All, Angela J. Anderson

ExpressO

This comment will analyze the need to amend and revise the current global pharmaceutical patent system under TRIPS to take into account the needs of developing countries and overall public health. This comment will emphasize that the current international trade rules, which although administered by the WTO, are dictated by developed country governments and powerful pharmaceutical companies, and therefore, without reform will further diminish the access of poor people in developing countries to vital medicines. Part II of this comment will provide a general overview of the international trade law governing patents on pharmaceuticals focusing specifically on the development of …

The Custody Battle Over Cryogenically Preserved Embryos After Divorce: Advocating For Infertile Women’S Rights, Cori S. Annapolen

ExpressO

This paper focuses on the struggles that infertile women face to achieve motherhood because their rights are underrepresented in the American court system. It specifically centers on how the process of in vitro fertilization (IVF) helps infertile women conceive children, but then details the problems that increasing technology now causes for these women after they freeze embryos and then divorce. Because the courts of only four states have determined who gets custody of these embryos after a divorce, and because the divorce rate and the number of couples utilizing IVF are increasing, future states will likely be forced to answer …

Breaking The Bank: Revisiting Central Bank Of Denver After Enron And Sarbanes-Oxley, Celia Taylor

ExpressO

No abstract provided.

Cross-Examining The Brain: A Legal Analysis Of Neural Imaging For Credibility Impeachment, Charles N. W. Keckler

ExpressO

The last decade has seen remarkable process in understanding ongoing psychological processes at the neurobiological level, progress that has been driven technologically by the spread of functional neuroimaging devices, especially magnetic resonance imaging, that have become the research tools of a theoretically sophisticated cognitive neuroscience. As this research turns to specification of the mental processes involved in interpersonal deception, the potential evidentiary use of material produced by devices for detecting deception, long stymied by the conceptual and legal limitations of the polygraph, must be re-examined. Although studies in this area are preliminary, and I conclude they have not yet satisfied …

Ancillary Joint Ventures And The Unanswered Questions After Revenue Ruling 2004-51, Gabriel O. Aitsebaomo

ExpressO

Ever since the Internal Revenue Service (the "Service") issued Revenue Ruling 98-15… in which it emphasized "control" as a critical factor in determining whether a tax-exempt hospital that enters into a whole-hospital joint venture with a for-profit entity would continue to maintain its tax-exemption, practitioners and scholars alike have sought guidance from the Service regarding whether such "control" would also be required of an exempt organization that enters into an "ancillary joint venture" with a for-profit entity. In response, the Service issued Revenue Ruling 2004-51 on May 6, 2004.

… In Revenue Ruling 2004-51, the Service enunciated that a tax-exempt …