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2018

Health Law and Policy

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Full-Text Articles in Law

Housing, Healthism, And The Hud Smoke-Free Policy, Dave Fagundes, Jessica L. Roberts Dec 2018

Housing, Healthism, And The Hud Smoke-Free Policy, Dave Fagundes, Jessica L. Roberts

NULR Online

No abstract provided.


Requiring Human Papilloma Virus Vaccination For School Entry, Michelle J. Bayefsky, Lawrence O. Gostin Dec 2018

Requiring Human Papilloma Virus Vaccination For School Entry, Michelle J. Bayefsky, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Over 40,000 Americans are diagnosed as having HPV-associated cancer each year, including oropharyngeal cancer for men and cervical cancer for women. These diseases cause significant morbidity and mortality and are largely preventable if people are vaccinated against HPV before they are exposed to the virus. Unfortunately, despite strong evidence of safety and effectiveness of the HPV vaccine, vaccination rates have been disappointingly low – much lower than for the varicella, measles, mumps, rubella, and hepatitis B. The disparity in vaccination rates stem mainly from the fact that HPV vaccination is not universally required for school entry, while the other childhood …


Pharmacy-Based Travel Health Services In The United States, Keri Hurley-Kim, Jeffery Goad, Sheila Seed, Karl M. Hess Dec 2018

Pharmacy-Based Travel Health Services In The United States, Keri Hurley-Kim, Jeffery Goad, Sheila Seed, Karl M. Hess

Pharmacy Faculty Articles and Research

The aim of this paper is to review pharmacy laws and regulations, pharmacist training, clinic considerations, and patient care outcomes regarding pharmacy-based travel health services in the United States. Pharmacists and pharmacies in the United States are highly visible and accessible to the public, and have long been regarded as a source for immunization services. As international travel continues to increase and grow in popularity in this country, there is a pressing need for expanded access to preventative health services, including routine and travel vaccinations, as well as medications for prophylaxis or self-treatment of conditions that may be acquired overseas. …


70 Years Of Human Rights In Global Health: Drawing On A Contentious Past To Secure A Hopeful Future, Lawrence O. Gostin, Benjamin Mason Meier, Rebekah Thomas, Veronica Magar, Tedros A. Ghebreyesus Dec 2018

70 Years Of Human Rights In Global Health: Drawing On A Contentious Past To Secure A Hopeful Future, Lawrence O. Gostin, Benjamin Mason Meier, Rebekah Thomas, Veronica Magar, Tedros A. Ghebreyesus

Georgetown Law Faculty Publications and Other Works

The Universal Declaration of Human Rights, adopted on Dec 10, 1948, established a modern human rights foundation that has become a cornerstone of global health, central to public health policies, programmes, and practices. To commemorate the 70th anniversary of this seminal declaration, we trace the evolution of human rights in global health, linking the past, present, and future of health as a human right. This future remains uncertain. As contemporary challenges imperil continuing advancements, threatening both human rights protections and global health governance, the future will depend, as it has in the past, on sustained political engagement to realise human …


Evaluating The Legality Of Age-Based Criteria In Health Care: From Nondiscrimination And Discretion To Distributive Justice, Govind Persad Dec 2018

Evaluating The Legality Of Age-Based Criteria In Health Care: From Nondiscrimination And Discretion To Distributive Justice, Govind Persad

Sturm College of Law: Faculty Scholarship

Recent disputes over whether older people should pay more for health insurance, or receive lower priority for transplantable organs, highlight broader disagreements regarding the legality of using age-based criteria in health care. These debates will likely intensify given the changing age structure of the American population and the turmoil surrounding the financing of American health care. This Article provides a comprehensive examination of the legality and normative desirability of age-based criteria. In the Article, I defend a distributive justice approach to age-based criteria. Rather than viewing age as a personal characteristic akin to race or religion, the distributive justice approach …


Preserving Life By Ranking Rights, John William Draper Dec 2018

Preserving Life By Ranking Rights, John William Draper

Librarian Scholarship at Penn Law

Border walls, abortion, and the death penalty are the current battlegrounds of the right to life. We will visit each topic and more in this paper, as we consider ranking groups of constitutional rights.

The enumerated rights of the Due Process Clauses of the Fifth and Fourteenth Amendments—life, liberty, and property—merit special treatment. They have a deeper and richer history that involves ranking. Ranking life in lexical priority over liberty and property rights protects life first and maximizes safe liberty and property rights in the absence of a significant risk to life. This is not new law; aspects of it …


The Private Insurance Market: Not Very Big And Not Insuring Much, Either, Jacqueline R. Fox Dec 2018

The Private Insurance Market: Not Very Big And Not Insuring Much, Either, Jacqueline R. Fox

Faculty Publications

Creating a single national health insurance pool is not likely to destabilize the economy by supplanting the private health insurance industry. This industry insures a relatively small percentage of the population and holds very little of the risk such insurance implies. In effect, insurance companies function as middlemen, bundling risk packages to distribute to other, larger companies and so serve a limited purpose. Were insurers to handle claims for a national pool as they do for the Medicare program, any destabilization to the economy more broadly would be further minimized.


Legal Principles And Seminal Legal Cases In Oocyte Donation, Jody L. Madeira, Susan L. Crockin Dec 2018

Legal Principles And Seminal Legal Cases In Oocyte Donation, Jody L. Madeira, Susan L. Crockin

Articles by Maurer Faculty

Oocyte donation has played an increasingly important role in assisted reproductive technologies since the early 1980s. Over the past 30 years, unique legal standards have evolved to address issues in the oocyte donation procedure itself as well as the disputes over issues, such as parentage, that inevitably arise with new technologies, particularly for individuals seeking to build nontraditional families. This essay will explore oocyte donation's legal aspects as well as seminal law concerning the procedure, including statutory law (uniform and model provisions and enacted state laws) and selected judicial opinions concerning surrogacy and parentage, testing of oocyte donors, mix-ups of …


Using The Engagedmd Multimedia Platform To Improve Informed Consent For Ovulation Induction, Intrauterine Insemination, And In Vitro Fertilization, Jody L. Madeira, Jennifer Rehbein, Mindy S. Christianson, Miryoung Lee, J. Preston Parry, Guido Pennings, Steven R. Lindheim Md Dec 2018

Using The Engagedmd Multimedia Platform To Improve Informed Consent For Ovulation Induction, Intrauterine Insemination, And In Vitro Fertilization, Jody L. Madeira, Jennifer Rehbein, Mindy S. Christianson, Miryoung Lee, J. Preston Parry, Guido Pennings, Steven R. Lindheim Md

Articles by Maurer Faculty

Objective: To study patient and provider feedback on how a multimedia platform (EngagedMD) helps patients to understand the risks and consequences of in vitro fertilization (IVF), ovulation induction (OI), and intrauterine insemination (IUI) treatments and the impact of the informed consent process.

Design: Prospective survey study.

Setting: IVF units in the United States.

Patient(s): Six-thousand three-hundred and thirty-three patients who viewed the multimedia platform before IVF or OI-IUI treatment at 13 U.S. IVF centers and 128 providers.

Intervention(s): Quantitative survey with 17 questions.

Main Outcome Measure(s): Assessment of the impact of a multimedia platform on patient anxiety, comprehension, and satisfaction …


Ebola And War In The Democratic Republic Of Congo: Avoiding Failure And Thinking Ahead, Lawrence O. Gostin, Matthew M. Kavanagh, Elizabeth Cameron Nov 2018

Ebola And War In The Democratic Republic Of Congo: Avoiding Failure And Thinking Ahead, Lawrence O. Gostin, Matthew M. Kavanagh, Elizabeth Cameron

Georgetown Law Faculty Publications and Other Works

The Ebola epidemic in the Democratic Republic of Congo (DRC) is exceptionally dangerous, occurring within active armed conflict and geopolitical volatility, including a million displaced persons. With 421 cases, 240 deaths, and the numbers increasing, this Ebola outbreak is the second deadliest in history. Recent spread to Butembo, home to 1.2 million people, raised concerns. The DRC, World Health Organization (WHO), and partners are leading a vigorous international response, yet despite deploying an experimental vaccine, cases doubled in October 2018 and many cases had unknown origin.

Uncontrolled Ebola outbreaks can expand quickly, as occurred in West Africa in 2014. Averting …


Falling Between The Cracks: Understanding Why States Fail In Protecting Our Children From Crime, Michal Gilad Nov 2018

Falling Between The Cracks: Understanding Why States Fail In Protecting Our Children From Crime, Michal Gilad

All Faculty Scholarship

The article is the first to take an inclusive look at the monumental problem of crime exposure during childhood, which is estimated to be one of the most damaging and costly public health and public safety problem in our society today. It takes-on the challenging task of ‘naming’ the problem by coining the term Comprehensive Childhood Crime Impact or in short the Triple-C Impact. Informed by scientific findings, the term embodies the full effect of direct and indirect crime exposure on children due to their unique developmental characteristics, and the spillover effect the problem has on our society as …


Public Health Emergency Preparedness: Globalizing Risk, Localizing Threats, Lawrence O. Gostin Nov 2018

Public Health Emergency Preparedness: Globalizing Risk, Localizing Threats, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Infectious diseases are a constant reality, yet it takes a shock to jolt the public’s attention and spur political action. The past weeks saw such as a shock at busy US airports, with the emergency quarantine of 3 flights. At the same time, seemingly a world away, insecurity, weak health systems, and distrust are fueling a second major Ebola outbreak in the Democratic Republic of Congo (DRC) this year. Yet reacting to periodic shocks won’t safeguard our collective future. Emergency preparedness requires proactive planning and funding, with US leadership pivotal.


Child Obesity, School Food Environments And The Best Interests Of The Child, Benedetta Faedi Duramy Nov 2018

Child Obesity, School Food Environments And The Best Interests Of The Child, Benedetta Faedi Duramy

Publications

This article is about child obesity, school food, and the key role schools can play in creating environments that can enhance children’s eating patterns and lifestyle behaviours and, thus, can support the realization of children’s best interest in relation to food and health. In contrast to the traditional approach that frames the obesity problem as a personal issue or as a matter of parental responsibility, this article argues that the prevention of child obesity should be interpreted as a State obligation under both international and domestic laws. Analysis turns to the example of the Healthy, Hunger-Free Kids Act, adopted in …


Legalization Of Physician-Assisted Suicide For Increased Patient Autonomy, Morgan Mcenroe Oct 2018

Legalization Of Physician-Assisted Suicide For Increased Patient Autonomy, Morgan Mcenroe

Religion: Student Scholarship & Creative Works

This essay features an assessment of the various factors which play into the argument for legalization of physician-assisted suicide (PAS) in the United States for increased patient autonomy. Arguments for legalization of PAS as a means of end-of-life care remain separate from voluntary euthanasia. National legalization of PAS, for this fundamental principle of hospice care, is necessary to allow a choice to those in their final stages of life of how they wish to leave. If the values of PAS advocates are maximization of autonomy and minimization of suffering, then it follows that the chronically depressed, as well as patients …


Substantial Shifts In Supreme Court Health Law Jurisprudence, Lawrence O. Gostin, James G. Hodge Oct 2018

Substantial Shifts In Supreme Court Health Law Jurisprudence, Lawrence O. Gostin, James G. Hodge

Georgetown Law Faculty Publications and Other Works

President Trump’s nomination of jurist Brett Kavanaugh to the U.S. Supreme Court presents significant, potential changes on health law and policy issues. If confirmed by the U.S. Senate, Kavanaugh’s approaches as a federal appellate court judge and scholar could literally shift the Court’s balance on consequential health policies. Judge Kavanaugh has disavowed broad discretion for federal agency authorities, cast significant doubts on the constitutionality of the Affordable Care Act, and narrowly interpreted reproductive rights (most notably abortion services). He has supported gun rights pursuant to the Second Amendment beyond U.S. Supreme Court recent interpretations. His varying positions related to consumer …


Agricultural Investments Under International Investment Law, Jesse Coleman, Sarah Brewin, Thierry Berger Oct 2018

Agricultural Investments Under International Investment Law, Jesse Coleman, Sarah Brewin, Thierry Berger

Columbia Center on Sustainable Investment Staff Publications

International investment law, based primarily on international investment treaties, plays an important role in the governance of investment in agriculture, forestry, and fishing. The obligations established by these treaties, and enforced by means of investor–state arbitration, can present challenges for policy-makers and others seeking to ensure that investments are sustainable, including by affecting the ways in which the costs and benefits of investments are distributed among different actors.

CCSI partnered with the International Institute for Environment and Development (IIED) and the International Institute for Sustainable Development (IISD) to produce a briefing note on agricultural investments under international investment law. The …


Law & Health Care Newsletter, Fall 2018 Oct 2018

Law & Health Care Newsletter, Fall 2018

Law & Health Care Newsletter

No abstract provided.


Mid-Atlantic Ethics Committee Newsletter, Fall 2018 Oct 2018

Mid-Atlantic Ethics Committee Newsletter, Fall 2018

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.


A Systematic Literature Review Of Individuals' Perspectives On Privacy And Genetic Information In The United States, Ellen W. Clayton, Colin M. Halverson, Nila A. Sathe, Bradley A. Malin Oct 2018

A Systematic Literature Review Of Individuals' Perspectives On Privacy And Genetic Information In The United States, Ellen W. Clayton, Colin M. Halverson, Nila A. Sathe, Bradley A. Malin

Vanderbilt Law School Faculty Publications

Concerns about genetic privacy affect individuals' willingness to accept genetic testing in clinical care and to participate in genomics research. To learn what is already known about these views, we conducted a systematic review, which ultimately analyzed 53 studies involving the perspectives of 47,974 participants on real or hypothetical privacy issues related to human genetic data. Bibliographic databases included MEDLINE, Web of Knowledge, and Sociological Abstracts. Three investigators independently screened studies against predetermined criteria and assessed risk of bias. The picture of genetic privacy that emerges from this systematic literature review is complex and riddled with gaps. When asked specifically …


If You Would Not Criminalize Poverty, Do Not Medicalize It, William M. Sage, Jennifer E. Laurin Oct 2018

If You Would Not Criminalize Poverty, Do Not Medicalize It, William M. Sage, Jennifer E. Laurin

Faculty Scholarship

American society tends to medicalize or criminalize social problems. Criminal justice reformers have made arguments for a positive role in the relief of poverty that are similar to those aired in healthcare today. The consequences of criminalizing poverty caution against its continued medicalization.


Introduction And Geographic Availability Of New Antibiotics Approved Between 1999 And 2014, Cecilia Kållberg, Christine Årdal, Hege Salvesen Blix, Eili Klein, Elena Martinez, Morten Lindbæk, Kevin Outterson, John-Arne Røttingen, Ramanan Laxminarayan Oct 2018

Introduction And Geographic Availability Of New Antibiotics Approved Between 1999 And 2014, Cecilia Kållberg, Christine Årdal, Hege Salvesen Blix, Eili Klein, Elena Martinez, Morten Lindbæk, Kevin Outterson, John-Arne Røttingen, Ramanan Laxminarayan

Faculty Scholarship

Despite the urgent need for new, effective antibiotics, few antibiotics of value have entered the market during the past decades. Therefore, incentives have been developed to stimulate antibiotic R&D. For these incentives to be effective, geographic availability for recently approved antibiotics needs to be better understood. In this study, we analyze geographic availability and market introduction of antibiotics approved between 1999 and 2014.


Limiting State Flexibility In Drug Pricing, Nicholas Bagley, Rachel E. Sachs Sep 2018

Limiting State Flexibility In Drug Pricing, Nicholas Bagley, Rachel E. Sachs

Articles

Throughout the United States, escalating drug prices are putting immense pressure on state budgets. Several states are looking for ways to push back. Last year, Massachusetts asked the Trump administration for a waiver that would, among other things, allow its Medicaid program to decline to cover costly drugs for which there is limited or inadequate evidence of clinical efficacy. By credibly threatening to exclude such drugs from coverage, Massachusetts hoped to extract price concessions and constrain the fastest-growing part of its Medicaid budget.


Will Courts Allow States To Regulate Drug Prices?, Christopher Robertson Sep 2018

Will Courts Allow States To Regulate Drug Prices?, Christopher Robertson

Faculty Scholarship

Pharmaceuticals are consuming increasingly large portions of U.S. state budgets, and high prices are preventing patients from getting, and adhering to, essential medicines. In mid-May 2018, President Donald Trump announced a heavily hyped but relatively modest federal plan to bring down drug prices. Meanwhile, several states are moving forward with their own solutions, and Maryland’s approach is particularly ambitious. In 2017, responding to notorious cases such as the 5000% increase in the cost of Daraprim (pyrimethamine) and the 10-fold increase in the cost of EpiPens (epinephrine auto-injectors), Maryland enacted a statute that prohibits manufacturers from “price gouging” on any “essential …


Medical Malpractice Cuts Not The Answer, Ruqaiijah A. Yearby Sep 2018

Medical Malpractice Cuts Not The Answer, Ruqaiijah A. Yearby

All Faculty Scholarship

Tort reform--legislation that aims to reduce medical malpractice suits --will not cut medical costs and improve health care unless the government addresses the proliferation of unnecessary medical errors that victimize hundreds of thousands of patients every year.

Yearby's research considers how laws enacted to grant equal access to quality health care actually can pose barriers to the disenfranchised, and she is critical of health care reform efforts that do not address the far-reaching problem of medical errors. Finding ways to curb what she calls the "alarming rate of these medical errors," not only will reduce medical malpractice suits, but save …


Hospital Mergers And Public Accountability: Tennessee And Virginia Employ A Certificate Of Public Advantage, Erin C. Fuse Brown Sep 2018

Hospital Mergers And Public Accountability: Tennessee And Virginia Employ A Certificate Of Public Advantage, Erin C. Fuse Brown

Faculty Publications By Year

No abstract provided.


Negative Voice-Content As A Full Mediator Of A Relation Between Childhood Adversity And Distress Ensuing From Hearing Voices, Cherise Rosen, Simon Mccarthy-Jones, Nev Jones, Kayla A. Chase, Rajiv P. Sharma Sep 2018

Negative Voice-Content As A Full Mediator Of A Relation Between Childhood Adversity And Distress Ensuing From Hearing Voices, Cherise Rosen, Simon Mccarthy-Jones, Nev Jones, Kayla A. Chase, Rajiv P. Sharma

Mental Health Law & Policy Faculty Publications

A key predictor of whether or not an individual who hears voices (auditory verbal hallucinations; AVH) meets criteria for a psychiatric diagnosis is the level of negative content of the voices (e.g., threats, criticism, abuse). Yet the factors that contribute to negative voice-content are still not well understood. This study aimed to test the hypotheses that levels of childhood adversity would predict levels of negative voice-content, and that negative voice-content would partially mediate a relation between childhood adversity and voice-related distress. These hypotheses were tested in a clinical sample of 61 patients with formally diagnosed psychotic disorders (48 schizophrenia …


Patient Safety And The Ageing Physician: A Qualitative Study Of Key Stakeholder Attitudes And Experiences, Andrew A. White, William M. Sage, Paulina H. Osinska, Monica J. Salgaonkar, Thomas H. Gallagher Sep 2018

Patient Safety And The Ageing Physician: A Qualitative Study Of Key Stakeholder Attitudes And Experiences, Andrew A. White, William M. Sage, Paulina H. Osinska, Monica J. Salgaonkar, Thomas H. Gallagher

Faculty Scholarship

Background Unprecedented numbers of physicians are practicing past age 65. Unlike other safety-conscious industries, such as aviation, medicine lacks robust systems to ensure late-career physician (LCP) competence while promoting career longevity.

Objective To describe the attitudes of key stakeholders about the oversight of LCPs and principles that might shape policy development.

Design Thematic content analysis of interviews and focus groups.

Participants 40 representatives of stakeholder groups including state medical board leaders, institutional chief medical officers, senior physicians (>65 years old), patient advocates (patients or family members in advocacy roles), nurses and junior physicians. Participants represented a balanced sample from …


Developing An Opioid Use Disorder Treatment Cascade: A Review Of Quality Measures, Arthur Robin Williams, Edward V. Nunes, Adam Bisaga, Harold A. Pincus, Kimberly A. Johnson, Aimee N. Campbell, Remien Remien, Stephen Crystal, Peter D. Friedmann, Frances R. Levin, Mark Olfson Aug 2018

Developing An Opioid Use Disorder Treatment Cascade: A Review Of Quality Measures, Arthur Robin Williams, Edward V. Nunes, Adam Bisaga, Harold A. Pincus, Kimberly A. Johnson, Aimee N. Campbell, Remien Remien, Stephen Crystal, Peter D. Friedmann, Frances R. Levin, Mark Olfson

Mental Health Law & Policy Faculty Publications

Background: Despite increasing opioid overdose mortality, problems persist in the availability and quality of treatment for opioid use disorder (OUD). Three FDA-approved medications (methadone, buprenorphine, and naltrexone) have high quality evidence supporting their use, but most individuals with OUD do not receive them and many experience relapse following care episodes. Developing and organizing quality measures under a unified framework such as a Cascade of Care could improve system level practice and treatment outcomes. In this context, a review was performed of existing quality measures relevant to the treatment of OUD and the literature assessing the utility of these measures in …


Drug Approval In A Learning Health System, W. Nicholson Price Jul 2018

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 …


Health Data And Privacy In The Digital Era, Lawrence O. Gostin, Sam F. Halabi, Kumanan Wilson Jul 2018

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, …