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Articles 1 - 30 of 349

Full-Text Articles in Health Law and Policy

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.


The Vaccine Race In The 21st Century, Ana Santos Rutschman Jan 2019

The Vaccine Race In The 21st Century, Ana Santos Rutschman

All Faculty Scholarship

In a world in which infectious diseases are spreading increasingly faster, the development of new human vaccines remains a priority in biopharmaceutical innovation. Legal scholars have addressed different aspects of vaccine regulation and administration, but less attention has been paid to the role of laws governing innovation during the stages of research and development (R&D) of vaccines.

This Article explores the race to develop new vaccines from its beginnings through the early 21st century, with a particular focus on the progressively pervasive role of intellectual property in governing vaccine innovation. It describes the insufficiencies of current innovation regimes in ...


The Rutabaga That Ate Pittsburgh: Federal Regulation Of Free Release Biotechnology, Michael P. Vandenbergh Dec 2018

The Rutabaga That Ate Pittsburgh: Federal Regulation Of Free Release Biotechnology, Michael P. Vandenbergh

Michael Vandenbergh

When the Environmental Protection Agency (EPA) first approved a field test of a bioengineered microbe,' one EPA official remarked: "We're not expecting this to be the rutabaga that eats Pittsburgh.' 2 But regulators cannot afford to be wrong. Bioengineered microbes may serve many useful purposes, but they may also cause harm to the environment and to human health.3 Although the risks of an accident stemming from the deliberate release of bioengineered microbes into the environment may be low, the resulting damage could be substantial. This note examines the possible consequences of two recent trends in biotechnology-the development of ...


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 ...


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.


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 ...


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 ...


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 Growing Consumer Exposure To Nanotechnology In Everyday Products: Regulating Innovative Technologies In Light Of Lessons From The Past, Katharine Van Tassel Mar 2018

The Growing Consumer Exposure To Nanotechnology In Everyday Products: Regulating Innovative Technologies In Light Of Lessons From The Past, Katharine Van Tassel

Katharine Van Tassel

This Article discusses the public health, regulatory, legal, and ethical issues raised by the developing appreciation of the negative physical effects and potential health risks associated with nanotech products, and is arranged as follows. After this Introduction, this Article describes the present scientific understanding of the health risks associated with the consumption of nanoparticles. Next, a summary of the existing FDA regulatory structure that governs food, dietary supplements, cosmetics, and sunscreens is provided along with an explanation of why these regulations fail to protect public health when applied to regulate the nanotech versions of these products. The Article goes on ...


Regulating In Uncertainty: Animating The Public Health Product Safety Net To Capture Consumer Products Regulated By The Fda That Use Innovative Technologies, Including Nanotechnologies, Genetic Modification, Cloning, And Lab Grown Meat, Katharine A. Van Tassel Mar 2018

Regulating In Uncertainty: Animating The Public Health Product Safety Net To Capture Consumer Products Regulated By The Fda That Use Innovative Technologies, Including Nanotechnologies, Genetic Modification, Cloning, And Lab Grown Meat, Katharine A. Van Tassel

Katharine Van Tassel

This Article will use nanotechnology as an example that highlights how regulation based on novelty rather than hazard achieves the proper balance between protecting public health while encouraging innovation through the animation of the public health product safety net. In Part II, this Article starts by explaining what nanotechnology is and the remarkable growth of its use in everyday consumer products. It then summarizes the steadily increasing number of studies that suggest that there are likely to be serious health risks associated with the use of nanotech consumer products. Next, it explains how the FDA [Food and Drug Administration] is ...


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 ...


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.


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 ...


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 ...


Risk And Resilience In Health Data Infrastructure, W. Nicholson Price Ii Dec 2017

Risk And Resilience In Health Data Infrastructure, W. Nicholson Price Ii

Articles

Today’s health system runs on data. However, for a system that generates and requires so much data, the health care system is surprisingly bad at maintaining, connecting, and using those data. In the easy cases of coordinated care and stationary patients, the system works—sometimes. But when care is fragmented, fragmented data often result. Fragmented data create risks both to individual patients and to the system. For patients, fragmentation creates risks in care based on incomplete or incorrect information, and may also lead to privacy risks from a patched together system. For the system, data fragmentation hinders efforts to ...


Artificial Intelligence In Health Care: Applications And Legal Implications, W. Nicholson Price Ii Nov 2017

Artificial Intelligence In Health Care: Applications And Legal Implications, W. Nicholson Price Ii

Articles

Artificial intelligence (AI) is rapidly moving to change the healthcare system. Driven by the juxtaposition of big data and powerful machine learning techniques—terms I will explain momentarily—innovators have begun to develop tools to improve the process of clinical care, to advance medical research, and to improve efficiency. These tools rely on algorithms, programs created from healthcare data that can make predictions or recommendations. However, the algorithms themselves are often too complex for their reasoning to be understood or even stated explicitly. Such algorithms may be best described as “black-box.” This article briefly describes the concept of AI in ...