Health Law and Policy Commons^™

Administering Health Innovation, Rachel E. Sachs

Cardozo Law Review

Scholars and policymakers have recently begun to focus on the role federal agencies charged with health-related missions can play in the development of innovative health technologies and promotion of access to those technologies. Appreciating the expertise of agencies like the National Institutes of Health, Food and Drug Administration, and Centers for Medicare and Medicaid Services has expanded the range of tools contemplated by scholars who had previously focused largely on the United States Patent and Trademark Office.

Yet much of this attention has so far focused on the capacities of single agencies, acting alone. This Article expands the existing scholarly …

Approaches To Carrier Testing And Results Disclosure In Translational Genomics Research, Ellen Wright Clayton, Kathryn M. Porter, Et Al.

Vanderbilt Law School Faculty Publications

Background: Clinical genome and exome sequencing (CGES) is primarily used to address specific clinical concerns by detecting risk of future disease, clarifying diagnosis, or directing treatment. Additionally, CGES makes possible the disclosure of autosomal recessive and X-linked carrier results as additional secondary findings, and research about the impact of carrier results disclosure in this context is needed.

Methods: Representatives from 11 projects in the clinical sequencing exploratory research (CSER) consortium collected data from their projects using a structured survey. The survey focused on project characteristics, which variants were offered and/or disclosed to participants as carrier results, methods for carrier results …

Drug Approval In A Learning Health System, W. Nicholson Price

Articles

The current system of FDA approval seems to make few happy. Some argue FDA approves drugs too slowly; others too quickly. Many agree that FDA—and the health system generally—should gather information after drugs are approved to learn how well they work and how safe they are. This is hard to do. FDA has its own surveillance systems, but those systems face substantial limitations in practical use. Drug companies can also conduct their own studies, but have little incentive to do so, and often fail to fulfil study commitments made to FDA. Proposals to improve this dynamic often suggest gathering more …

For Whom The Bell (Equitably) Tolls: Erisa Compliance And Denial Of Benefits Notices Circuit Split, Sarah Smith

Akron Law Review

The circuit courts are split as to how a plan administrator of an ERISA-governed employee benefit plan must notify a claimant of a time limitation placed on a claimant’s ability to seek judicial review of an adverse benefit decision. Some courts indicate that inclusion of this time limitation in the Summary Plan Description is sufficient to notify a claimant. Other courts have held that the time period must specifically be included in adverse determination notices, which are documents notifying claimants of the denial of their claim and the right to judicial review. Much of the debate among courts concerns the …

From Guns That Do Not Shoot To Foreign Staplers: Has The Supreme Court’S Materiality Standard Under Escobar Provided Clarity For The Health Care Industry About Fraud Under The False Claims Act?, Deborah R. Farringer

Brooklyn Law Review

In June of 2016, the U.S. Supreme Court issued an opinion in the case of Universal Health Services, Inc. v. United States ex rel. Escobar, in order to resolve a circuit split regarding the viability of the “implied false certification” theory of liability under the False Claims Act (FCA). This article examines what has happened in the twelve months since the Escobar opinion by observing the reaction and subsequent arguments arising out of the Department of Justice and exploring the analyses of district courts and courts of appeals in trying to apply a new and more demanding materiality standard as …

Health Data And Privacy In The Digital Era, Lawrence O. Gostin, Sam F. Halabi, Kumanan Wilson

Georgetown Law Faculty Publications and Other Works

In 2010, the social networking site Facebook launched a platform allowing private companies to request users’ permission to access personal data. Few users were aware of the platform, which was integrated into Facebook’s terms of service. In 2014, Cambridge Analytica, a UK-based political consulting firm, developed a data-harvesting app. That app prompted Facebook users to provide psychological profiles, including responses such as “I get upset easily” and “I have frequent mood-swings” as part of a “research project.”

The Facebook platform allowed users to share their friends’ data as well, enabling Cambridge Analytica to access tens of millions of personal profiles, …

Dying To Be Fresh And Clean? Toxicants In Personal Care Products, The Impact On Cancer Risk, And Epigenetic Damage, Katherine Drabiak

Pace Environmental Law Review

The FDA does not conduct pre-market review of chemicals contained in cosmetics—which encompasses not only makeup but also numerous personal care products including shampoo, lotion, perfume, aftershave, and shaving cream. Every day, consumers use cosmetic products that contain a variety of synthetic ingredients, none of which the FDA has approved for safety but each of which are being ingested, absorbed, and inhaled into our bodies and accumulating in our tissue. Many of these products contain endocrine disrupting chemicals (“EDCs”), which emerging research links to an increased risk of cancer as well as immune and neurological dysfunction. This Article examines how …

New Ebola Outbreak In Africa Is A Major Test For The Who, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

On May 8, the Democratic Republic of Congo (DRC) notified the World Health Organization (WHO) of a confirmed outbreak of Ebola in Bikoro, on the shores of Lake Tumba in Équateur Province. Ebola in the DRC is not unexpected. The first-ever identified Ebola outbreak occurred in the DRC—then Zaire—in 1976. This is the ninth of DRC’s outbreaks, which until now have been confined mainly to rural areas. With high fatality rates, earlier outbreaks quickly burned out due to the natural firewall of remoteness.

Bikoro and a nearby village, Ikoko-Impenge, are rural, but on May 16, the WHO confirmed spread to …

Law & Health Care Newsletter, Summer 2018

Law & Health Care Newsletter

No abstract provided.

Where's Dad? The Importance Of Integrating Fatherhood And Parenting Programming Into Substance Use Treatment For Men, Carla Smith Stover, Melissa Carlson, Sarika Patel, Raquel Manalich

Mental Health Law & Policy Faculty Publications

Large numbers of men enter substance use disorder treatment each year, yet very little attention is paid to the fatherhood and parenting status of these men. Substance use treatment programmes for men rarely incorporate a parenting component into their treatment planning, despite the increased success of women's treatment programmes that focus on gender and motherhood. This paper provides: (1) a review of the literature on the fathering of substance‐using men, what has been learned from substance use disorder treatment for mothers, and the implications for children and families; (2) pilot quantitative and qualitative outcomes resulting from the implementation of a …

The Global Person: Pig-Human Embryos, Personhood, And Precision Medicine, Yvonne Cripps

Indiana Journal of Global Legal Studies

Chimeras, in the form of pig-human embryos engineered by CRISPR-Cas9 and other biotechnologies, have been created as potential sources of organs for transplantation. Against that background, and in an era of "precision medicine," this Article examines the concept of the global genetically modified person and asks whether humanness and personhood are being eroded, or finding new boundaries in intellectual property and constitutional law.

Healthcare Law, Kathryn S. Dunnam

Mercer Law Review

This Article serves as a review of significant healthcare developments in the United States Court of Appeals for the Eleventh Circuit over the last two years and builds upon Mercer Law Review's last Healthcare Article in Volume 65. Specifically, this Article will cover cases dealing with physician speech, the False Claims Act, and the Medicare Secondary Payer Act.

Rural Health, Universality, And Legislative Targeting, Nicole Huberfeld

Faculty Scholarship

Health disparities are persistent and worsening for rural communities, which have smaller patient populations with higher rates of uninsurance and greater incidence of the diseases and deaths of despair. Hospital closures and provider shortages are more common than in urban areas, also contributing to worsening population health and crises in maternal and infant health. This paper posits that these disparities are tied to the unique rural features of space and population. Efforts to address persistent problems in health care through universal legislation, such as the ACA, have given rural communities important tools to address some long-standing health problems by improving …

End Of Life And Autonomy: The Case For Relational Nudges In End-Of-Life Decision-Making Law And Policy, Megan S. Wright

Maryland Law Review

Autonomy is a central principle in many areas of health law. In the case of end-of-life decision-making law and policy, however, the principle of autonomy requires revision. On the whole, law conceptualizes autonomy at the end of life as an individual making private, personal decisions based solely on their interests and values, and independent of others. But ordinary people understand autonomous decisionmaking at the end of life differently, in a way that acknowledges the importance of their interpersonal relationships. Social science research has documented that strengthening relationships with others, sharing responsibility in the decision-making process with healthcare providers, and taking …

Investment Spending And Gdp, Kevin Zaldivar

Celebration of Learning

This study's mission is to give a modern day analysis to investment spending and to provide insight to the degree of impact certain investments have on our GDP. This should interest local,state,and federal policy makers as well as anyone who practices their civic duty.

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 …

Strike Down Obamacare, Says Justice Department, Saikrishna B. Prakash, Neal Devins

Popular Media

No abstract provided.

Needles, Haystacks, And Next-Generation Genetic Sequencing, Teneille R. Brown

Utah Law Faculty Scholarship

Genetic testing is becoming more frequent and the results more complex. Not infrequently, genetic testing conducted for one purpose reveals information about other features of the genome that may be of clinical significance. These unintended findings have been referred to as “incidental” or “secondary” findings. In 2013, the American College of Medical Genetics (“ACMG”) recommended that clinical laboratories inform people if their genetic analyses indicate that they have certain secondary mutations. These mutations were selected because they probably cause a serious disease, which is treatable, and may go undetected. The ACMG’s recommendations galvanized critical responses by the genetics and ethics …

Missing: Where Are The Migrants In Pandemic Influenza Preparedness Plans?, Kolitha Wickramage, Lawrence O. Gostin, Eric A. Friedman, Phusit Prakongsai, Rapeepong Suphanchaimat, Charles Hui, Patrick Duigan, Eliana Barragan, David R. Harper

Georgetown Law Faculty Publications and Other Works

Influenza pandemics are perennial global health security threats, with novel and seasonal influenza affecting a large proportion of the world’s population, causing enormous economic and social destruction. Novel viruses such as influenza A(H7N9) continue to emerge, posing zoonotic and potential pandemic threats. Many countries have developed pandemic influenza preparedness plans (PIPPs) aimed at guiding actions and investments to respond to such outbreak events.

Migrant and mobile population groups—such as migrant workers, cross-border frontier workers, refugees, asylum seekers, and other non-citizen categories residing within national boundaries—may be disproportionately affected in the event of health emergencies, with irregular/undocumented migrants experiencing even greater …

Environmental Health Regulation In The Trump Era: How President Trump’S Two-For-One Regulatory Plan Impacts Environmental Regulation, Elizabeth Ann Glass Geltman

University of Michigan Journal of Law Reform

This Article explores the Trump regulatory reform agenda and its potential impact on environmental determinants of health. The Article begins with a discussion of the Department of Commerce’s (DOC or Commerce) initial fact-finding investigation to evaluate the impact of federal regulations on domestic manufacturing. The Article next presents an overview of the Trump administration’s regulatory reform formula as announced in E.O. 13771 and the interim guidance explaining E.O. 13771 and E.O. 13777 (the executive order announcing the Trump administration’s plans to enforce the regulatory reform plan announced in E.O. 13771). The Article then examines the federal agency initiatives undertaken in …

Passing The Baton: The Effect Of The International Olympic Committee's Weak Anti-Doping Laws In Dealing With The 2016 Russian Olympic Team, Saroja Cuffey

Brooklyn Journal of International Law

Following the investigation of a Russian state-sponsored doping ploy prior to the Olympic Games in Rio 2016; the International Olympic Committee (IOC) decided against a blanket ban of the Russian Olympic team. Instead; it allowed athletes’ individual international federations to decide whether Russian athletes could compete. In following the various anti-doping laws in place; the IOC sought to protect and give justice to clean athletes around the world. This Note argues that they did not achieve this result; due to the anti-doping laws in place and the actors applying these laws. It suggests that there should be a universal anti-doping …

Cold Genocide: Falun Gong In China, Maria Cheung, Torsten Trey, David Matas, Richard An

Genocide Studies and Prevention: An International Journal

The article explores patterns of a cold genocide in the eradication campaign against Falun Gong. Falun Gong is a spiritual practice that has been targeted for eradication by the Chinese regime since 1999. In comparison to the documented cases of genocide, the genocide of Falun Gong stands out as anomalous because it is virtually ignored. The article seeks to elucidate the multi-faceted nature of this concealed genocide from an interdisciplinary perspective encompassing social work, medicine and law, In particular, the article demonstrates that the eradication campaign against Falun Gong is distinguishable as a cold genocide as it is: (1) multi-dimensional …

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

Minnesota Journal of Law, Science & Technology

No abstract provided.

What Is Federalism In Health Care For?, Nicole Huberfeld

Faculty Scholarship

The Affordable Care Act offers a window on modern American federalism—and modern American nationalism—in action. The ACA’s federalism is defined not by separation between state and federal, but rather by a national structure that invites state-led implementation. As it turns out, that structure was only a starting point for a remarkably dynamic and adaptive implementation process that has generated new state-federal arrangements. States move back and forth between different structural models vis-à-vis the federal government; internal state politics produce different state choices; states copy, compete, and cooperate with each other; and negotiation with federal counterparts is a near-constant. These characteristics …

Making "Meaningful Access" Meaningful: Equitable Healthcare For Divisive Times, Leslie Francis

Center for Law and Biomedical Sciences (LABS)

Another anniversary of President Bush’s signing of the Americans with Disabilities Act (ADA) is coming up in late July, yet the nation remains far from offering even a semblance of equitable societal opportunity to most individuals with disabilities.

For them, full social participation is dismissed as merely an idealistic dream. With its focus on restoration of full functioning for patients, the health care delivery system might be supposed an exception, but a closer look shows the opposite is true.

Physicians’ offices, clinics, and hospitals too often have not been made accessible. Too frequently, these facilities have diagnostic or treatment equipment …

Illness, Injury And Medical Deportations At The Frontier: The Canadian Legal Regime For Health Care Protections For Agricultural Migrant Workers, Constance Macintosh

Articles, Book Chapters, & Popular Press

This paper explores how health interests and rights play out in the temporary agricultural worker regime. In particular, it illustrates how a system that–as discussed below–is formally positioned as granting such workers the same rights as nationals, may not in practice provide equivalent or meaningful protections. The assessment is not just about the social exclusion challenges that often undermine the ability or possibility of migrant workers to activate their legal rights (which is the usual critique of why post-national citizenship writing is overly optimistic), but about how the legal and regulatory system itself misses the mark.

Two & A Half Parents: Three-Parent Ivf And Medical Malpractice In The United States, Jay M. Fulk

Concordia Law Review

Fertility medicine is seeing a rapid advancement with the emergence of a new procedure called three-parent in vitro fertilization (IVF). This novel procedure provides an opportunity for women who have defective mitochondria to bear their own healthy genetic children. As women encounter fertility issues, they will often turn to regular IVF by receiving an egg from a donor—ultimately resulting in a child with no genetic relation to the mother. Women with defective mitochondria will likely pass down a mitochondrial disease to their children, therefore, bearing a child without the assistance from a donor does not present a viable option. Mitochondrial …

Trans Women In Incarceration: Housing, Healthcare, And Humanity, Stanislaw Bielous

Themis: Research Journal of Justice Studies and Forensic Science

This paper seeks to analyze the experience of male-to-female transgender inmates housed in men’s prisons and to propose housing and healthcare policies with humanity and safety for all in mind. To do this, the paper examines gender dysphoria and its treatments, transgender prisoners’ increased risk of victimization, current housing placement policies, and lastly, transgender prison healthcare practices. Ultimately, this paper proposes the use of fair and adequately trained panel-based placement teams, the provision of comprehensive mental and physical health care and the establishment of impartial grievance procedures.

Banning Abortion In Cases Of Down Syndrome: Important Lessons For Advances In Genetic Diagnosis, Rebecca Reingold, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

In December 2017, Ohio passed into law legislation that prohibited physicians from performing abortions if the pregnant woman’s decision was influenced by her belief that the fetus has Down syndrome. Physicians who perform abortions in these cases would face fourth-degree felony charges and revocation of their medical license. No other state bans abortion specifically for Down syndrome, but several ban abortions in cases of genetic diseases. Lower courts have struck down most such laws, holding they violate the constitutional rights of women. In February 2018, a federal district court judge blocked enforcement of Ohio’s law pending a final determination.

This …

Should Legal Precedent Based On Old, Flawed, Scientific Analysis Regarding When Life Begins, Continue To Apply To Parental Disputes Over The Fate Of Frozen Embryos, When There Are Now Scientifically Known And Observed Facts Proving Life Begins At Fertilization?, Rita Lowery Gitchell

DePaul Journal of Health Care Law

No abstract provided.