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Full-Text Articles in Health Law and Policy

Owning Geronimo But Not Elmer Mccurdy: The Unique Property Status Of Native American Remains, Alix Rogers Dec 2019

Owning Geronimo But Not Elmer Mccurdy: The Unique Property Status Of Native American Remains, Alix Rogers

Boston College Law Review

This Article unifies two areas of legal scholarship that have not historically intersected. In the fields of biotechnology and the law, it is generally understood that human remains and many body parts are not objects of legal property. This general rule has a startling exception, which heretofore has gone unnoticed in the literature and relevant case law. The bodily remains of Native Americans were, and I argue, continue to be, objects of legal property. With the passage of the Native American Graves Protection and Repatriation Act of 1990 (“NAGPRA”) Native American remains are classified as familial and tribal property. In ...


Concussions And Contracts: The National Football League's Limitations To Protecting Its Players From Chronic Traumatic Encephalopathy, Julia Wolpert Dec 2019

Concussions And Contracts: The National Football League's Limitations To Protecting Its Players From Chronic Traumatic Encephalopathy, Julia Wolpert

Journal of Law and Health

Chronic Traumatic Encephalopathy (CTE) is a neurodegenerative brain injury that has become prevalent among high-contact professional sports, especially American football. More and more retired players are exhibiting symptoms of CTE and being diagnosed with CTE post-mortem. While the neuroscience community constantly releases studies showing a causal connection between brain trauma and CTE, the National Football League (NFL) continues to deny that any brain injury can arise from playing football. The NFL must implement provisions in their contracts to fully inform and protect players from this lethal brain injury. This article examines the repercussions of CTE, how players’ contracts do and ...


A New Age Of Evolution: Protecting The Consumer’S Moral And Legal Right To Know Through The Clear And Transparent Labeling Of All Genetically Modified Foods, Halie M. Evans Dec 2019

A New Age Of Evolution: Protecting The Consumer’S Moral And Legal Right To Know Through The Clear And Transparent Labeling Of All Genetically Modified Foods, Halie M. Evans

Journal of Law and Health

The United States government, until recently, did not require the labeling of genetically modified organisms (GMOs). On July 29, 2016, President Barack Obama signed into law the National Bioengineered Food Disclosure Standard (NBFDS). This law directs the United States Department of Agriculture (USDA) to create regulations that require manufacturers to disclose certain bioengineered products on food labels. On December 20, 2018, the USDA released the final regulations for the NBFDS, which requires food manufactures, importers, and certain retailers to ensure bioengineered foods are appropriately disclosed. The final regulations include provisions that will leave the majority of GMO derived foods unlabeled ...


The Internet Of Bodies, Andrea M. Matwyshyn Oct 2019

The Internet Of Bodies, Andrea M. Matwyshyn

William & Mary Law Review

This Article introduces the ongoing progression of the Internet of Things (IoT) into the Internet of Bodies (IoB)—a network of human bodies whose integrity and functionality rely at least in part on the Internet and related technologies, such as artificial intelligence. IoB devices will evidence the same categories of legacy security flaws that have plagued IoT devices. However, unlike most IoT, IoB technologies will directly, physically harm human bodies—a set of harms courts, legislators, and regulators will deem worthy of legal redress. As such, IoB will herald the arrival of (some forms of) corporate software liability and a ...


Table Of Contents, Seattle University Law Review Sep 2019

Table Of Contents, Seattle University Law Review

Seattle University Law Review

No abstract provided.


Got Mylk?: The Disruptive Possibilities Of Plant Milk, Iselin Gambert May 2019

Got Mylk?: The Disruptive Possibilities Of Plant Milk, Iselin Gambert

Brooklyn Law Review

Milk is one of the most ubiquitous and heavily regulated substances on the planet—and perhaps one of the most contested. It is tied closely to notions of purity, health, and femininity, and is seen as so central to human civilization that our own galaxy—the Milky Way—is named after it. But despite its wholesome reputation, milk has long had a sinister side, being bound up with the exploitation of the (human and nonhuman) bodies it comes from and being a symbol of and tool for white dominance and superiority. The word itself, in verb form, means “to exploit ...


Narrowing In On The Problem: A Component-Level Analysis Of "Hybrid" Medical Devices, Jillian Friedmann Apr 2019

Narrowing In On The Problem: A Component-Level Analysis Of "Hybrid" Medical Devices, Jillian Friedmann

Boston College Law Review

The Medical Device Amendments of 1976 (“MDA”) classify medical devices into three categories, each of which represents a different level of risk, and requires a different level of federal oversight. Class III devices, which pose the most risk, are subject to the highest level of oversight. Those devices are protected from any claims based on state laws that differ from or add to the requirements imposed by the MDA. On March 1, 2018, the United States Court of Appeals for the Third Circuit, in Shuker v. Smith & Nephew, PLC, considered the application of preemption under the MDA to a “hybrid ...


Healthtech: How Blockchain Can Simplify Healthcare Compliance, Kathryn M. Bennett Mar 2019

Healthtech: How Blockchain Can Simplify Healthcare Compliance, Kathryn M. Bennett

Washington and Lee Journal of Civil Rights and Social Justice

This Note broadly explores solutions to modern-day accessibility and security problems latent in electronic health records. Specifically, this Note discusses HIPAA and HITECH, the current law in place, and how blockchain technology can be used to fix the accessibility and security problems of current electronic health records. This Note proposes that blockchain technology can help a healthcare industry struggling to adhere to the current rule of law in an era of Big Data. Further, Blockchain technology can help individual consumers, particularly those with significant health issues, obtain the best possible medical care while simultaneously keeping their private and sensitive information ...


Negligent Disruption Of Genetic Planning: Carving Out A New Tort Theory To Address Novel Questions Of Liability In An Era Of Reproductive Innovation, Tracey Tomlinson Mar 2019

Negligent Disruption Of Genetic Planning: Carving Out A New Tort Theory To Address Novel Questions Of Liability In An Era Of Reproductive Innovation, Tracey Tomlinson

Fordham Law Review Online

This Essay will address current concerns pertaining to ART-related negligence, and ultimately recommends the adoption of a new tort— negligent disruption of genetic planning (NDGP). This tort would enable plaintiffs to recover damages when an ART clinic’s negligent actions thwart reproductive planning, while simultaneously balancing the serious moral and ethical questions that arise in these situations. This argument proceeds in three Parts. Part I discusses the technological evolution of ART and gives examples of ART-related negligence cases that have occurred in the United States. Part II lays out the current U.S. tort remedies relied on by plaintiffs in ...


Table Of Contents, Seattle University Law Review Feb 2019

Table Of Contents, Seattle University Law Review

Seattle University Law Review

No abstract provided.


The "Art" Of Future Life: Rethinking Personal Injury Law For The Negligent Deprivation Of A Patient's Right To Procreation In The Age Of Assisted Reproductive Technologies, Erika N. Auger Feb 2019

The "Art" Of Future Life: Rethinking Personal Injury Law For The Negligent Deprivation Of A Patient's Right To Procreation In The Age Of Assisted Reproductive Technologies, Erika N. Auger

Chicago-Kent Law Review

No abstract provided.


Mitochondrial Replacement Therapy: How A Government For The People, Failed The People, Jeffery Mark Sauer Oct 2018

Mitochondrial Replacement Therapy: How A Government For The People, Failed The People, Jeffery Mark Sauer

University of Miami Law Review

Despite having the potential to significantly reduce the passage of many lethal diseases and devastating birth defects, mitochondrial replacement therapy—a controversial medical procedure in which mitochondrial RNA from a healthy female replaces the mitochondrial RNA from the intended mother in vitro—will have no place in the United States anytime soon. Under the guise of purported safety concerns and ethical dilemmas, the Republican Congress used its “power of the purse” to halt any and all research furthering mitochondrial replacement therapy, notwithstanding the fact that many leaders in the medical community have advocated for further research. Several developed countries have ...


The Overdose/Homicide Epidemic, Valena E. Beety Aug 2018

The Overdose/Homicide Epidemic, Valena E. Beety

Georgia State University Law Review

This Article explores the lack of regulation of coroners, concerns within the forensic science community on the reliability of coroner determinations, and ultimately, how elected laypeople serving as coroners may influence the rise in drug-induced homicide prosecutions in the midst of the opioid epidemic.

This Article proposes that the manner of death determination contributes to overdoses being differently prosecuted; that coroners in rural counties are more likely to determine the manner of death for an illicit substance overdose is homicide; and that coroners are provided with insufficient training on interacting with the criminal justice system, particularly on overdose deaths. Death ...


Crispr/Cas-9 Technologies: A Call For A New Form Of Tort, Kendall Lovell Jun 2018

Crispr/Cas-9 Technologies: A Call For A New Form Of Tort, Kendall Lovell

San Diego International Law Journal

Once relegated to the domains of science fiction, modern day scientists and researchers are poised on the precipice of making genome editing clinically available. Once introduced into a clinical setting the effects of an off-target mutation or germline edit will remain largely unknown until health issues arise later in life or in the following generation. The novelty of the injuries that will arise require a system that is able to balance the interests of physicians with single and multi-generational plaintiffs, while providing a realistic framework for courts to follow. This comment offers a brand-new context that accounts for these needs ...


Securing The Internet Of Healthcare, Scott J. Shackelford, Michael Mattioli, Steve Myers, Austin Brady Jun 2018

Securing The Internet Of Healthcare, Scott J. Shackelford, Michael Mattioli, Steve Myers, Austin Brady

Minnesota Journal of Law, Science & Technology

No abstract provided.


The Burgeoning “Biorights Movement”: Its Legal Basis, What’S At Stake, And How To Respond, Mark A. Hayden May 2018

The Burgeoning “Biorights Movement”: Its Legal Basis, What’S At Stake, And How To Respond, Mark A. Hayden

Boston College Law Review

The advent of genetic and genomic technologies has the power to transform the understanding, prevention, and treatment of disease on a scale unprecedented in modern medicine. The promise of the era of precision medicine risks being tempered by the emergence of what is increasingly being referred to as the “biorights movement.” Of particular concern is the growing trend of individuals refusing to contribute their biological material to research studies absent some form of monetary compensation. Recently announced, but yet to be implemented, regulations seek to mitigate some of the potentially harmful and progress-impeding positions advanced by the biorights movement. The ...


Suggestions For State Laws On Biosimilar Substitution, Gary M. Fox May 2018

Suggestions For State Laws On Biosimilar Substitution, Gary M. Fox

Michigan Telecommunications & Technology Law Review

Biologic drugs offer major advancements over small-molecule drugs when it comes to treating serious diseases. Biosimilars, which mimic innovative biologic drugs, have the potential to further revolutionize the practice of medicine. States now have decades of experience regulating the substitution of generic, small-molecule drugs for their brand-name equivalents. But the complexities of biologic drugs and biosimilars force states to confront novel scientific and legal issues. Many states have begun tackling those issues by passing laws that regulate when pharmacists may substitute biosimilars for their corresponding biologic drugs. Other states have yet to do so. This Note surveys five provisions common ...


The Computer Made Me Do It: Is There A Future For False Claims Act Liability Against Electronic Health Record Vendors?, Deborah R. Farringer May 2018

The Computer Made Me Do It: Is There A Future For False Claims Act Liability Against Electronic Health Record Vendors?, Deborah R. Farringer

Nevada Law Journal

No abstract provided.


Whose Sperm Is It Anyways In The Wild, Wild West Of The Fertility Industry?, Tatiana E. Posada May 2018

Whose Sperm Is It Anyways In The Wild, Wild West Of The Fertility Industry?, Tatiana E. Posada

Georgia State University Law Review

Imagine a couple that is unable to conceive a child naturally. Luckily, they had the money and resources available to them to conceive a child through assisted reproductive technology (ART), so they decided to start their family through the use of intrauterine insemination. They selected a sperm bank and began the arduous process of selecting a sperm donor who fit the desired traits and characteristics for their child. The sperm bank matched them with an anonymous donor, Donor 9623, and assured the couple that the donor was “a healthy male with an IQ of 160, a bachelor’s of science ...


Reforming Regenerative Medicine Regulation, Sarah Duranske May 2018

Reforming Regenerative Medicine Regulation, Sarah Duranske

Georgia State University Law Review

Regenerative medicine is defined as the branch of medicine that develops methods to regrow, repair, or replace damaged or diseased cells or tissues. It includes a variety of approaches, such as transplanting cells to promote healing, editing genes in cells to attack cancer, and even building organs from biological materials. Regulating regenerative medicine therapies is no easy task. Finding a balance between competing interests–enabling timely access for needy patients while simultaneously ensuring a positive benefit/risk profile and promoting the development of beneficial innovations–is hard enough at any given point in time. But add in constantly advancing scientific ...


The Biologics Price Competition And Innovation Act: Is A Generic Market For Biologics Attainable?, Kasey E. Koballa Feb 2018

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 ...


The Price Tag On Designer Babies: Market Share Liability, Boston College Law Review Staff Jan 2018

The Price Tag On Designer Babies: Market Share Liability, Boston College Law Review Staff

Boston College Law Review

The prospect of genetically modifying humans has loomed over the public for decades. Now, science fiction is becoming reality. New technology and expanding research are positioned to make genetic alteration a routine, pre-conception appointment. For several years, China has been experimenting with germline editing on non-viable human embryos. In April 2016, the UK also approved a group of scientists to begin similar research. In the United States, genetic engineering is a multibillion-dollar industry. Although ethical debates over human genetic modification have checked the industry, the potential for clinical trials has become a reality as companies race to dominate the technology ...


Privacy Of Information And Dna Testing Kits, Shanna Raye Mason Jan 2018

Privacy Of Information And Dna Testing Kits, Shanna Raye Mason

Catholic University Journal of Law and Technology

In modern times, consumers desire for more control over their own health and healthcare. With this growing interest of control, direct to consumer DNA testing kits have never been more popular. However, many consumers are unaware of the potential privacy concerns associated with such use. This comment examines the popularity and privacy risks that are likely unknown to the individual consumer. This comment also addresses the shortcomings of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as well as the Genetic Information Nondiscrimination Act of 2008 (GINA) in regard to protecting individual’s genetic information from misuse. This ...


Celebrating Wisconsin Entrepreneurs: Lessons Learned From Wisconsin Entrepreneurs And Businesses, And Future Prospects For A Healthcare Sector That Is Healthcare Reform, Daniel S. Sem, Si Gou, Taleb Aljabban Jan 2018

Celebrating Wisconsin Entrepreneurs: Lessons Learned From Wisconsin Entrepreneurs And Businesses, And Future Prospects For A Healthcare Sector That Is Healthcare Reform, Daniel S. Sem, Si Gou, Taleb Aljabban

Marquette Intellectual Property Law Review

Wisconsin has a rich history of entrepreneurial activity, which is often not appreciated beyond its well-recognized strength in the beer and cheese industries. However, Wisconsin’s entrepreneurial nature has been called into question. Recently, Wisconsin was ranked fiftieth in the United States for startup activity by the Kauffman Foundation. In contrast, Wisconsin ranks at the top of the country for startups that are local and established business with more longevity. The first half of this article will review some of the challenges and opportunities that have faced Wisconsin entrepreneurs, and will provide an overview of over 150 Wisconsin companies (Table ...


Noa V. Doa: Increasing Medical Diagnostic Patentability After Mayo, Karen Mckenzie Jan 2018

Noa V. Doa: Increasing Medical Diagnostic Patentability After Mayo, Karen Mckenzie

Marquette Intellectual Property Law Review

The medical diagnostics market is expected to reach 65 billion by 2018. In March 2012, in Mayo Collborative Services v. Prometheus Labs, Inc. , ("Mayo") the U.S. Supreme held that the Mayo Clinic (the "Clinic") had not infringed on Prometheus Labs’ (“Prometheus”) diagnostic patent because the Prometheus patent involved ineligible subject matter, and was therefore invalid. Section 101 of the Patent Act defines eligible subject matter an “any new and useful process, machine, manufacture, or composition of matter” as patentable subject matter. Courts have held that Section 101 contains an implicit exception, making laws of nature, natural phenomena, and abstract ...


Telemedicine Is The New Narcotics Candy Store: Teladoc Opens The Floodgates For The Unrestricted Sale Of Dangerous Drugs, Madeleine Rosuck Jan 2018

Telemedicine Is The New Narcotics Candy Store: Teladoc Opens The Floodgates For The Unrestricted Sale Of Dangerous Drugs, Madeleine Rosuck

Science and Technology Law Review

No abstract provided.


Germline Editing: Two Steps Forward, One Step Back?, Kristina Smith Jan 2018

Germline Editing: Two Steps Forward, One Step Back?, Kristina Smith

Science and Technology Law Review

No abstract provided.


Regulating Black-Box Medicine, W. Nicholson Price Ii Dec 2017

Regulating Black-Box Medicine, W. Nicholson Price Ii

Michigan Law Review

Data drive modern medicine. And our tools to analyze those data are growing ever more powerful. As health data are collected in greater and greater amounts, sophisticated algorithms based on those data can drive medical innovation, improve the process of care, and increase efficiency. Those algorithms, however, vary widely in quality. Some are accurate and powerful, while others may be riddled with errors or based on faulty science. When an opaque algorithm recommends an insulin dose to a diabetic patient, how do we know that dose is correct? Patients, providers, and insurers face substantial difficulties in identifying high-quality algorithms; they ...


Patent Arbitration: The Underutilized Process For Resolving International Patent Disputes In The Pharmaceutical And Biotechnology Industries, Alessandra Emini Aug 2017

Patent Arbitration: The Underutilized Process For Resolving International Patent Disputes In The Pharmaceutical And Biotechnology Industries, Alessandra Emini

Arbitration Law Review

No abstract provided.


Germ-Line Gene Editing And Congressional Reaction In Context: Learning From Almost 50 Years Of Congressional Reactions To Biomedical Breakthroughs, Russell A. Spivak, J.D., I. Glenn Cohen, J.D., Eli Y. Adashi, M.D., M.S. Jul 2017

Germ-Line Gene Editing And Congressional Reaction In Context: Learning From Almost 50 Years Of Congressional Reactions To Biomedical Breakthroughs, Russell A. Spivak, J.D., I. Glenn Cohen, J.D., Eli Y. Adashi, M.D., M.S.

Journal of Law and Health

On December 18, 2015, President Obama signed into law a policy rider forestalling the therapeutic modification of the human germ line. The rider, motivated by the science’s potential unethical ends, is only the most recent instance in which the legislature cut short the ongoing national conversation on the acceptability of a developing science. This essay offers historical perspective on what bills were proposed and passed surrounding four other then-developing scientific breakthroughs—Recombinant DNA, in vitro fertilization, Cloning, Stem Cells—to better analyze how Congress is, and should, regulate this exciting and promising science.