Digital Commons Network^™

The Priority Review Voucher Program At The Fda: From Neglected Tropical Diseases To The 21st Century Cures Act, Ana Santos Rutschman

Annals of Health Law and Life Sciences

No abstract provided.

Zika And The Regulatory Regime For Licensing Vaccines For Use During Pregnancy, Sam Halabi

Annals of Health Law and Life Sciences

No abstract provided.

Telemedicine In Illinois: Untangling The Complex Legal Threads, 50 J. Marshall L. Rev. 885 (2017), Laura Wibberley

UIC Law Review

This Comment begins in Section II with an overview of the current telemedicine practices in healthcare, as well as the current law within Illinois regarding telemedicine use. Section III of this Comment discusses the flaws under the current Illinois law that act to impede licensed medical professionals from providing telemedicine services in patient care. Section III specifically focuses on the area of medical negligence to include the establishment of the physician-patient relationship, the applicable standard of care, and the scope of the requisite informed consent. This Section also examines and compares various legislation enacted in other states that provide a …

Underutilized Community Health Needs Assessments: Four Environmental Actions For Hospitals That Improve Community Health, Warren G. Lavey

Health Matrix: The Journal of Law-Medicine

Tax-exempt hospitals' community health needs assessments ("CHNAs") provide an underutilized resource for healthcare organizations and communities. These studies and action commitments, which the Affordable Care Act ("ACA") requires, are linked to financial incentives for hospitals to manage population health.

Non-Communicable Disease And Diabetes Screening In Community Settings In Low- And Middle-Income Countries: A Case Study In Senegal, West Africa, Rhonda Belue

Saint Louis University Journal of Health Law & Policy

Sub-Saharan Africa is faced with a significant and increasing burden of non-communicable diseases such as type 2 diabetes mellitus (diabetes). In Senegal, the prevalence of diabetes has been documented to be as high as 8.1% in urban-dwelling Senegalese and is fast approaching the United States prevalence of approximately nine percent; however, insufficient resources are available for prevention efforts and disease management. As a result, many cases remain undiagnosed, leading to an increased likelihood of diabetes complications and mortality. Many of these cases remain undiagnosed or are diagnosed only after complications have developed, such as the need for amputation, kidney failure, …

The Process Of Reclaiming Tribal Sovereignty Through Healthcare Autonomy, Karolina A. Serhan

Honors Theses

This honors thesis explores the complex interplay between health status, healthcare, and tribal sovereignty among native communities in the United States. These relationships are explored through analyzing the paradoxical and condescending nature of the Federal Trust Responsibility in relation to government-organized healthcare programs for natives. In establishing this relationship, the thesis goes on to illustrate how native communities have effectively fought to regain sovereignty through reclaiming autonomy of their healthcare systems through the use of the 1975 Indian Self-Determination and Education Assistance Act. The impact of tribal-led healthcare systems is further explored through an in-depth case study conducted regarding the …

A Global Vaccine Injury Compensation System, Sam F. Halabi, Saad B. Ommer

Faculty Publications

Vaccines are extremely safe and harm is rare. Worldwide, more than 30000 vaccine doses are delivered per second through routine immunization programs, which, in turn, prevent an estimated 2 million to 3 million deaths annually. Yet the specter of vaccine injury plays a central role in vaccine access and will continue to do so as vaccine technologies evolve.

Zika, Pregnancy, And The Law, Sam F. Halabi

Faculty Publications

This Essay situates a crucial component of the public health response to Zika - the effort to develop a safe and effective vaccine - within the broader literature. It does so in an effort to highlight the need to revisit the relationship between law and pregnancy - not only in the areas legal scholars have prioritized so far, but also in the context of routine and emergency maternal health, which has heretofore been largely assumed to be governed by straightforward norms and practices based on medical evidence and physician ethics. In fact, whereas the current literature tends to assume or …

Remedying Stigma-Driven Health Disparities In Sexual Minorities, Valarie K. Blake

Law Faculty Scholarship

No abstract provided.

Federalism And Health Care In Canada: A Troubled Romance?, Colleen M. M. Flood, William Lahey Prof., Bryan P. Thomas

Articles, Book Chapters, & Popular Press

Canadian federalism fragments health system governance. Although the Constitution has been interpreted as providing shared jurisdiction over health generally, with respect to health care, the courts have interpreted it as giving direct jurisdiction to the provinces. The federal role in health care is therefore indirect, but nevertheless potentially powerful. For example, the federal government has used its spending powers to establish the Canada Health Act (CHA), which commits funding to provinces on condition they provide first-dollar public coverage of hospital and physician services. However, in recent times, as federal contributions have declined, the CHA has been weakly enforced. …

Implementing Medicaid Health Homes To Provide Medication Assisted Treatment To Opioid Dependent Medicaid Beneficiaries, Page M. Smith

Kentucky Law Journal

No abstract provided.

Teaching The Hipaa Privacy Rule, Stacey A. Tovino

Scholarly Works

Twenty years ago, President Clinton signed the Health Insurance Portability and Accountability Act of 1996 (HIPAA) into law. Over the past two decades, the federal Department of Health and Human Services (HHS) has published several sets of rules implementing the Administrative Simplification provisions within HIPAA as well as the Health Information Technology for Economic and Clinical (HITECH) Act within the American Recovery and Reinvestment Act (ARRA). These rules include, but certainly are not limited to, a final rule published on January 25, 2013, governing the use and disclosure of protected health information by covered entities and their business associates (the …

Weapons Of Mass Hysteria, Faulty Biothreat Predictions, And Their Impact On National (In)Security: A Case-Study Of Smallpox, Barbara Pfeffer Billauer

Health Matrix: The Journal of Law-Medicine

Biothreat projections for pandemic and bioterrorist planning are generated by a straight-forward computational system, rather than scientific evidence.

Teaching The Hipaa Privacy Rule: Illustrative Comparisons, Stacey A. Tovino

Faculty Articles

Twenty years ago, President Clinton signed the Health Insurance Portability and Accountability Act of 1996 (HIPAA) into law. Over the past two decades, the federal Department of Health and Human Services (HHS) has published several sets of rules implementing the Administrative Simplification provisions within HIPAA as well as the Health Information Technology for Economic and Clinical (HITECH) Act within the American Recovery and Reinvestment Act (ARRA). These rules include, but certainly are not limited to, a final rule published on January 25, 2013, governing the use and disclosure of protected health information by covered entities and their business associates (the …

Global Health Security In An Era Of Explosive Pandemic Potential, Lawrence O. Gostin, Ana Ayala

Georgetown Law Faculty Publications and Other Works

Pandemics pose a significant risk to security, economic stability, and development. Annualized expected losses from pandemics are estimated at $60 billion per year. Despite the certainty and magnitude of the threat, the global community has significantly underestimated and underinvested in avoidance of pandemic threats.

We cannot wait or continue with the status quo, in which we pay attention to infectious disease threats only when they are at their peak and then are complacent and remain vulnerable until the next major outbreak. To reinforce and sustain international focus, funding, and action, it is crucial that pandemics rise to the level of …

Advancing The Right To Health: The Vital Role Of Law, Lawrence O. Gostin, Oscar A. Cabrera, David Patterson, Roger Magnusson, Helena Nygren-Krug

Georgetown Law Faculty Publications and Other Works

Effective laws and an enabling legal environment are essential to a healthy society. Most public health challenges – from infectious and non-communicable diseases to injuries, from mental illness to universal health coverage – have a legal component. At global, national and local levels, law is a powerful tool for advancing the right to health. This tool is, however, often underutilized.

This report aims to raise awareness about the role that public health laws can play in advancing the right to health and in creating the conditions for all people to live healthy lives. The report provides guidance about issues and …

Why Some Religious Accommodations For Mandatory Vaccinations Violate The Establishment Clause, Hillel Y. Levin

Scholarly Works

All states require parents to inoculate their children against deadly diseases prior to enrolling them in public schools, but the vast majority of states also allow parents to opt out on religious grounds. This religious accommodation imposes potentially grave costs on the children of non-vaccinating parents and on those who cannot be immunized. The Establishment Clause prohibits religious accommodations that impose such costs on third parties in some cases, but not in all. This presents a difficult line-drawing problem. The Supreme Court has offered little guidance, and scholars are divided.

This Article addresses the problem of religious accommodations that impose …

The Priority Review Voucher Program At The Fda: From Neglected Tropical Diseases To The 21st Century Cures Act, Ana Santos Rutschman

All Faculty Scholarship

The priority review voucher program at the Food and Drug Administration (FDA) was established in 2007 to incentivize research and development (R&D) in traditionally underfunded diseases.1 While shrouded in controversy and criticism, the program has recently been bolstered by the passage of the 21st Century Cures Act,2 which prevented the vouchers from sunsetting in late 2016 and furthered the overall scope of the program.3 As it reaches the end of its first decade, this Article discusses the impact of the program, with a focus on recent developments. The Article builds on literature suggesting that the voucher program has been ineffective …

Talking One For The Herd: Eliminating Non-Medical Exemptions To Compulsory Vaccination Laws To Protect Immunocompromised Children, Kylie Barnhart

West Virginia Law Review

No abstract provided.

Law And Health Care Newsletter, Vol. 24, No. 1, Fall 2016

Law & Health Care Newsletter

No abstract provided.

Imagining Global Health With Justice, Lawrence O. Gostin

Dalhousie Law Journal

This article offers a way to achieve global health with justice as a global health imperative. It is possible to have global health without justice, meaning that improvements in health outcomes could be achieved, but without a fair distribution of the benefits of good health. It is also possible to have justice without global health, where health outcomes are evenly distributed across the population but overall health is not improved. With this understanding, this article challenges current ways of understanding global health, and argues that absolute reductions in morbidity and premature mortality are not robust indicators of success in the …

Zika Virus And Global Health Security, Lawrence O. Gostin, James G. Hodge Jr.

Georgetown Law Faculty Publications and Other Works

Americans are largely apathetic about the risks of Zika virus and Congress cannot agree on preparedness funding. Strategies to counter the spread of Zika by the World Health Organisation (WHO) grossly underestimate the disease’s impact. WHO and member countries lack sufficient resources to respond. Consequences of fiscal apathy can be measured in lives lost and long-term disabilities. Zika prevention is a matter of global health security.

The epidemiologic brunt of Zika in South America falls largely on vulnerable women at heightened risk of exposure through mosquitoes and sexual transmission. Resulting transmission to fetuses and infants will have generational impacts in …

Ebola, Experimental Medicine, Economics, And Ethics: An Evaluation Of International Disease Outbreak Law, Sara L. Dominey

Georgia Journal of International & Comparative Law

No abstract provided.

The Right For Autonomy, The Duty Of Disclosure And Public Health Considerations – The 2013 Polio Crisis In Israel As A Case Study, Dr. Nili Karako Eyal

Pace Law Review

Despite sharing the same theoretical framework of discussion with other papers, this paper addresses an ethical and legal issue that has received little attention in academic and public discourse: the duty of disclosure in the context of vaccinations. In particular, the paper addresses the question whether public health considerations provide a justification for restricting the duty of disclosure in the case of vaccination.

Delimitating the research question to the issue of disclosure has several implications. First, the decision to vaccinate the population with bOPV as describe above and the decision to adopt a voluntary vaccination policy are not the focus …

Managing Our Microbial Mark: What We Can Learn About Pay For Performance From Ebola's Arrival At Our Shores, Ann Marie Marciarille

Faculty Works

The narrative of Ebola’s arrival in the United States has been overwhelmed by our fear of a West African-style epidemic. The real story of Ebola’s arrival is about our healthcare system’s failure to identify, treat, and contain healthcare associated infections. Having long been willfully ignorant of the path of fatal infectious diseases through our healthcare facilities, this paper considers why our reimbursement and quality reporting systems made it easy for this to be so. West Africa’s challenges in controlling Ebola resonate with our own struggles to standardize, centralize, and enforce infection control procedures in American healthcare facilities.

Masking Your Rights: Facemask Requirements Under Mandatory Influenza-Vaccination Policies Violate Privacy Rights Of Health Care Workers, Janet S. Kim

San Diego Law Review

Hospitals should abandon the facemask requirements in their mandatory influenza-vaccination programs because the facemasks can infringe on the privacy rights of health care workers, and hospitals can still achieve their vaccination goals through less restrictive practices. Part II introduces the recent rise of mandatory influenza-vaccination policies for health care workers, how hospitals exempt certain employees, and the consequences for those exempted. Part III discusses the legal implications of requiring exempted employees to wear facemasks and other identifying material under federal and state privacy law. Part IV recommends that health care employers abandon facemask requirements in their mandatory-vaccination programs in order …

Newsletter, Summer/Fall 2016

Newsletter

No abstract provided.

Will The Ebola Epidemic Serve To Make Reform Of The Broken Health Research And Development Framework Go Viral?, Jeremy Mcdonald

Indiana Journal of Global Legal Studies

The recent Ebola outbreak in West Africa has captured the public imagination as few other epidemics have, as its rapid spread and lethal effect demonstrated the devastating toll that infectious diseases can exact from a world unprepared to confront them. In light of the epidemic's tragic consequences, numerous experts have called for reform of the system of global health governance whose shortfalls allowed the epidemic to assume the horrifying dimensions it did. Among the many inadequacies that the outbreak uncovered is the insufficient amount of research into and development of treatments and vaccines for infectious diseases of poverty, among them …

Intersections Of Violence Against Women And Health: Implications For Health Law And Policy In Nigeria, Cheluchi Onyemelukwe

William & Mary Journal of Race, Gender, and Social Justice

No abstract provided.

Toward A Common Secure Future: Four Global Commissions In The Wake Of Ebola, Lawrence O. Gostin, Oyewale Tomori, Suwit Wibulpolprasert, Ashish K. Jha, Julio Frenk, Suerie Moon, Joy Phumaphi, Peter Piot, Barbara Stocking, Victor J. Dzau, Gabriel M. Leung

Georgetown Law Faculty Publications and Other Works

The world is becoming increasingly vulnerable to pandemics resulting from globalization, urbanization, intense human/animal interchange, and climate change. A series of global health crises have emerged since 2000, ranging from Severe Acute Respiratory Syndrome (SARS) and its phylogenetic cousin Middle East Respiratory Syndrome (MERS), to pandemic Influenza A (H1N1), Ebola, and the ongoing Zika virus epidemic. The Ebola epidemic gave rise to four global commissions proposing a bold new agenda for global health preparedness and response for future infectious disease threats.

Four global commissions reviewing the recent Ebola virus disease epidemic response consistently recommended strengthening national health systems, consolidating and …