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Articles 1 - 30 of 1024

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.


Due Process Supreme Court Appellate Division Second Department Jul 2019

Due Process Supreme Court Appellate Division Second Department

Touro Law Review

No abstract provided.


Due Process Supreme Court Appellate Division Jul 2019

Due Process Supreme Court Appellate Division

Touro Law Review

No abstract provided.


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 ...


Hard Choices And Deficient Choosers, Mark Kelman Mar 2019

Hard Choices And Deficient Choosers, Mark Kelman

Northwestern Journal of Law & Social Policy

No abstract provided.


The Ever-Changing Landscape Of Informed Consent And Whether The Obligation To Explain A Procedure To The Patient May Be Delegated, Samuel D. Hodge, Maria Zambrano Steinhaus Feb 2019

The Ever-Changing Landscape Of Informed Consent And Whether The Obligation To Explain A Procedure To The Patient May Be Delegated, Samuel D. Hodge, Maria Zambrano Steinhaus

Arkansas Law Review

Informed consent is an integral part of the shared decision making process and requires a patient be informed of the benefits, risks and alternatives to a medical procedure. This information, which requirement has been codified into the law and practice of every healthcare provider, helps a patient decide whether to proceed with the recommended treatment plan. Informed consent has its foundation in the ethical notion of patient autonomy and fundamental human rights. After all, it is the patient’s decision to determine what may be done to his or her body and to ascertain the risks and benefits before undertaking ...


Table Of Contents, Seattle University Law Review Feb 2019

Table Of Contents, Seattle University Law Review

Seattle University Law Review

No abstract provided.


The Illusion Of Autonomy In Women's Medical Decision-Making, Jamie R. Abrams Feb 2019

The Illusion Of Autonomy In Women's Medical Decision-Making, Jamie R. Abrams

Jamie R. Abrams

This Article considers why there is not more conflict between women and their doctors in obstetric decision-making. While patients in every other medical context have complete autonomy to refuse treatment against medical advice, elect high-risk courses of action, and prioritize their own interests above any other decision-making metric, childbirth is viewed anomalously because of the duty to the fetus that the state and the doctor owe at birth. Many feminist scholars have analyzed the complex resolution of these conflicts when they arise, particularly when the state threatens to intervene to override the birthing woman’s autonomy.

This Article instead considers ...


Billion Dollar Orphans: Tension Between The Legal Intent And Social Purpose Of The Orphan Drug Act, John Sheridan Jan 2019

Billion Dollar Orphans: Tension Between The Legal Intent And Social Purpose Of The Orphan Drug Act, John Sheridan

Texas A&M Law Review

This Comment examines the extent to which Congress empowered the FDA to address the increase in petitions and the general accessibility of orphan drug remedies. Specifically, this Comment seeks to understand why the FDA’s interpretation of the purpose of the ODA seems to conflict with the statutory intent as interpreted by federal courts. This Comment considers a statute’s ultimate goal or social purpose to be the purpose of the statute, whereas the express mechanisms by which Congress seeks to bring about these goals is best understood as the statute’s intent. To understand the FDA and judiciary’s ...


Robots Are Coming: A Discussion Of Choice-Of-Law Issues And Outcomes In Telesurgical Malpractice, Megan Cloud Jan 2019

Robots Are Coming: A Discussion Of Choice-Of-Law Issues And Outcomes In Telesurgical Malpractice, Megan Cloud

Texas A&M Law Review

New technology frequently emerges that challenges the legal status quo. Early adopters must then grapple with uncertainty over how the law will apply to novel legal quandaries. There is no better example of this than in medicine; however, the health care field is notoriously risk averse. Despite this, the practice of medicine stands to gain tremendously from these technological advancements. One such advancement is the relatively new ability to perform robotic surgery in which the surgeon is remote from the patient. Widespread use of this technology would improve rural access to surgical care, as well as improve access to more ...


Dr. Tele-Corporation: Bridging The Access-To-Care Gap, Nader Amer Jan 2019

Dr. Tele-Corporation: Bridging The Access-To-Care Gap, Nader Amer

Dickinson Law Review

The United States is currently confronting an access-to-healthcare crisis, which rural regions are experiencing at a disproportionate rate. Many commentators have touted telemedicine as a solution for the access-to-care issue. Telemedicine uses video and telecommunication technology to allow physicians to treat patients from distant locations and thus facilitates a more equal distribution of physicians throughout the United States.

Although the telemedicine industry is quickly growing, the corporate practice of medicine doctrine impedes the industry’s expansion and consequently obstructs a viable solution to the access-to-care crisis. Generally, the corporate practice of medicine doctrine prohibits corporations and limited liability companies from ...


Challenges In Navigating Disability Discrimination And Privacy Laws In Addressing Physician Health, Rick D. Barton Jan 2019

Challenges In Navigating Disability Discrimination And Privacy Laws In Addressing Physician Health, Rick D. Barton

CHLB Scholarship

No abstract provided.


The Opioid Crisis: The States' And Local Governments' Response To Bigpharma's Deception And Why The Supremacy Clause May Provide A Cloak For Opioid Manufacturers To Hide Behind, Tracie Childers Jan 2019

The Opioid Crisis: The States' And Local Governments' Response To Bigpharma's Deception And Why The Supremacy Clause May Provide A Cloak For Opioid Manufacturers To Hide Behind, Tracie Childers

Barry Law Review

No abstract provided.


Understanding The Sexual Assault Kit Backlog In Pennsylvania, Kallie Crawford, Lyndsie Ferrara Aug 2018

Understanding The Sexual Assault Kit Backlog In Pennsylvania, Kallie Crawford, Lyndsie Ferrara

Graduate Student Research Symposium

According to the FBI, to date, there are more than 400,000 untested sexual assault kits nationwide. While this is a huge issue that cannot be solved overnight, continual improvements and changes are needed to reduce and hopefully eliminate the backlog.

This research examines work going on nationwide and aims to better understand the backlog issues specifically in Pennsylvania. Furthermore, the research examines a program utilized by the law enforcement community that garnered necessary resources. First, a comprehensive review of improved practices in proactive jurisdictions of Ohio, Houston, Texas, and Detroit, Michigan was conducted to identify general policies and procedures ...


Avoiding Prolonged Dementia, Norman L. Cantor Aug 2018

Avoiding Prolonged Dementia, Norman L. Cantor

Norman Cantor

The scourge of Alzheimer's is daunting.  For me, the specter of being mired in progressively degenerative dementia is an intolerably degrading prospect. One avoidance tactic -- suicide while still competent – risks a premature demise while still enjoying a tolerable lifestyle.  The question arises whether an alternative tactic -- an advance directive declining all life-sustaining intervention once a certain point of debilitation is reached -- might be preferable as a device to avoid a prolonged, unwanted limbo.  My article in the forthcoming Hastings Center Report (HCR) presents the legal and moral foundation for my advance directive declining even simplistic interventions at a relatively ...


Health Care Referrals Out Of The Shadows: Recognizing The Looming Threat Of The Texas Patient Solicitation Act And Other Illegal Remuneration Statutes, Trenton Brown Aug 2018

Health Care Referrals Out Of The Shadows: Recognizing The Looming Threat Of The Texas Patient Solicitation Act And Other Illegal Remuneration Statutes, Trenton Brown

St. Mary's Law Journal

Abstract forthcoming


Informed Consent And The Role Of The Treating Physician, Eric Feldman, Holly Fernandez Lynch, Steven Joffe Jun 2018

Informed Consent And The Role Of The Treating Physician, Eric Feldman, Holly Fernandez Lynch, Steven Joffe

Faculty Scholarship at Penn Law

In the century since Justice Benjamin N. Cardozo famously declared that “[e]very human being of adult years and sound mind has a right to determine what shall be done with his own body,” informed consent has become a central feature of American medical practice. In an increasingly team-based and technology-driven system, however, who is — or ought to be — responsible for obtaining a patient’s consent? Must the treating physician personally provide all the necessary disclosures, or can the consent process, like other aspects of modern medicine, take advantage of specialization and division of labor? Analysis of Shinal v. Toms ...


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 ...


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 ...


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 ...


A Surging Drug Epidemic: Time For Congress To Enact A Mandate On Insurance Companies And Rehabilitation Facilities For Opioid And Opiate Addiction, Alanna Guy May 2018

A Surging Drug Epidemic: Time For Congress To Enact A Mandate On Insurance Companies And Rehabilitation Facilities For Opioid And Opiate Addiction, Alanna Guy

Journal of Law and Health

This Note begins with a discussion of both the national opioid problem as well as the specific epidemic in Ohio as an example of how it has grown within all of the states. Part II discusses the differences between prescription opioids and opiates, how they can be obtained, what effects they have on the human body, and why the government has an interest in this growing problem. Next, this Note explains how and why there was an increase in access and addiction to prescription opioid pain medication. Following this explanation, the steps the government has taken to try to rectify ...


Informing Consent: Medical Malpractice And The Criminalization Of Pregnancy, Laura Beth Cohen May 2018

Informing Consent: Medical Malpractice And The Criminalization Of Pregnancy, Laura Beth Cohen

Michigan Law Review

Since the early 1990s, jurisdictions around the country have been using civil child abuse laws to penalize women for using illicit drugs during their pregnancies. Using civil child abuse laws in this way infringes on pregnant women’s civil rights and deters them from seeking prenatal care. Child Protective Services agencies are key players in this system. Women often become entangled with the Child Protective Services system through their health care providers. Providers will drug test pregnant women without first alerting them to the potential negative consequences stemming from a positive drug test. Doing so is a breach of these ...


Marijuana Agriculture Law: Regulation At The Root Of An Industry, Ryan Stoa Mar 2018

Marijuana Agriculture Law: Regulation At The Root Of An Industry, Ryan Stoa

Ryan B. Stoa

Marijuana legalization is sweeping the nation. Recreational marijuana use is legal in eight states. Medical marijuana use is legal in thirteen states. Only three states maintain an absolute criminal prohibition on marijuana use. Many of these legalization initiatives propose to regulate marijuana in a manner similar to alcohol, and many titles are variations of the "Regulate Marijuana Like Alcohol Act." For political and public health reasons the analogy makes sense, but it also reveals a regulatory blind spot. States may be using alcohol as a model for regulating the distribution, retail, and consumption of marijuana, but marijuana is much more ...


Modernizing The Emergency Medical Treatment And Labor Act To Harmonize With The Affordable Care Act To Improve Equality, Quality And Cost Of Emergency Care, Katharine A. Van Tassel Mar 2018

Modernizing The Emergency Medical Treatment And Labor Act To Harmonize With The Affordable Care Act To Improve Equality, Quality And Cost Of Emergency Care, Katharine A. Van Tassel

Katharine Van Tassel

This Article will propose a very simple, two-step way to modernize EMTALA [Emergency Medical Treatment and Active Labor Act (1986)] to deal with this cascade of problems. This solution converts EMTALA into a powerful tool to enhance equal access to healthcare while at the same time changing EMTALA so that it works in tandem with, instead of against, the efforts of the Affordable Care Act, Medicare and Medicaid to improve healthcare quality, cost and equal access.

This solution also works across systems to resolve the conflict between the tort, licensure and hospital peer review systems that all discourage evidence-based treatment ...


Hospital Peer Review Standards And Due Process: Moving From Tort Doctrine Toward Contract Principles Based On Clinical Practice Guidelines, Katharine A. Van Tassel Mar 2018

Hospital Peer Review Standards And Due Process: Moving From Tort Doctrine Toward Contract Principles Based On Clinical Practice Guidelines, Katharine A. Van Tassel

Katharine Van Tassel

This Article proposes a solution to the problems associated with the current use of vague standards in peer review. This Article will examine the proposal that medical staffs switch from ad hoc judicial decision-making to rule-making. This switch will allow medical staffs to abandon the troublesome practice of applying vague 'standard of care' measures ex post facto. In its stead, express contractual terminology could be adopted, such as 'expectations of performance,' which incorporates specifically chosen and uniquely tailored clinical practice guidelines ('CPGs') directly into the medical staff by-laws. Describing the expectations of physician performance in express contractual terms enables physicians ...


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 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 ...


Removing Obstacles To A Peaceful Death, Kathy L. Cerminara, Barbara A. Noah Jan 2018

Removing Obstacles To A Peaceful Death, Kathy L. Cerminara, Barbara A. Noah

Faculty Scholarship

We all will die, but the American health care system often impedes a peaceful death. Instead of a quiet death at home surrounded by loved ones, many of us suffer through overutilization of sometimes-toxic therapeutic interventions long past the time when those interventions do more good than harm. This article proposes revisions to health professional training and payment policy to eliminate as much as possible physical and existential suffering while progressing through the terminal phase of illness. The solution lies in seamless progression from treatment with integrated palliative care to hospice before death, but provider attitudes and payor practices must ...


Baby M Turns 30: The Law And Policy Of Surrogate Motherhood, Eric A. Feldman Jan 2018

Baby M Turns 30: The Law And Policy Of Surrogate Motherhood, Eric A. Feldman

Faculty Scholarship at Penn Law

This article marks the 30th anniversary of the Supreme Court of New Jersey’s Baby M decision by offering a critical analysis of surrogacy policy in the United States. Despite fundamental changes in both science and society since the case was decided, state courts and legislatures remain bitterly divided on the legality of surrogacy. In arguing for a more uniform, permissive legal posture toward surrogacy, the article addresses five central debates in the surrogacy literature.

First, should the legal system accommodate those seeking conception through surrogacy, or should it prohibit such arrangements? Second, if surrogacy is permitted, what steps can ...


Patent Infringement In Personalized Medicine: Limitations Of The Existing Exemption Mechanisms, Jiyeon Kim Jan 2018

Patent Infringement In Personalized Medicine: Limitations Of The Existing Exemption Mechanisms, Jiyeon Kim

Washington University Law Review

Mr. X suffers from recurrent glioblastoma, a type of deadly brain cancer. One of his physicians reads a study reporting a novel immunotherapy, which uses the chimeric antigen receptor T cell (CAR-T) technology, leading to regression of glioblastoma in a small number of patients. Although the therapy has recently been approved by the U.S. Food and Drug Administration (FDA) and is now offered by two major pharmaceutical companies, it is only approved for certain hematological cancers. In addition, Mr. X’s cancer does not express the biomarker that is necessary for the CAR-T therapy used in the published glioblastoma ...