Health Law and Policy Commons^™

What I Talk About When I Talk About Health Law, Elizabeth Weeks

Scholarly Works

Invited contribution celebrating the 25th Anniversary of the Beazley Institute for Health Law & Policy.

Scientific Understandings Of Postpartum Illness: Improving Health Law And Policy?, Stacey A. Tovino

Faculty Articles

In its broadest sense, this Article examines the relationship between science and the law in the context of postpartum illness. From classical antiquity to the present day, physicians and scientists have investigated the causes, correlates, and consequences of the depressions and psychoses that develop in some women following their transition to motherhood. The scientific investigation of postpartum illness has been characterized by an open-ended search for knowledge with the recognition that scientific findings published one day are subject to revision the next. Legislators and judges also have sought to understand postpartum illness as necessary to make laws that affect and …

Pandemic Preparedness: A Return To The Rule Of Law, Wendy K. Mariner, George J. Annas, Wendy E. Parmet

Faculty Scholarship

Current discussions of pandemic influenza and emergency preparedness would do well to heed the lessons of US Airways flight 1549, which landed in the Hudson River in January 2009. This article examines what past emergencies teach us about how to prevent or control epidemics and argues that it is time for a return to the rule of law in pandemic preparedness. The most important resource in emergency preparedness is a healthy, resilient population, which depends importantly on sustainable systems of medical care and public health. Preparedness thus requires more money than law. After September 11, 2001, however, federal emergency preparedness …

Privacy And Health Information Technology, Deven Mcgraw

O'Neill Institute Papers

The increased use of health information technology (health IT) is a common element of nearly every health reform proposal because it has the potential to decrease costs, improve health outcomes, coordinate care, and improve public health. However, it raises concerns about security and privacy of medical information.

This paper examines some of the “gaps” in privacy protections that arise out of the current federal health privacy standard, the Health Insurance Portability and Accountability (HIPAA) Privacy Rule, the main federal law which governs the use and disclosure of health information.

Additionally, it puts forth a range of possible solutions, accompanied by …

Executive Authority To Reform Health: Options And Limitations, Madhu Chugh

O'Neill Institute Papers

Presidential power has provoked increasingly vigorous debate since the turn of this century. In recent years, scholars and lawyers have been grappling with how Congress's dictates may limit the President's Commander-in-Chief power to detain enemy combatants at Guantanamo Bay, to fight wars abroad, and to conduct intelligence activities at home. But policymakers have not yet explored the many possibilities for invoking the President's "Take Care" power to change health care policy.

This paper explores the scope and limits of President Barack Obama's ability to invoke his executive authority to reform health care. Specifically, it identifies ways the Obama Administration can …

The Purchase Of Insurance Across State Lines In The Individual Insurance Market, Stephanie W. Kanwit

O'Neill Institute Papers

Proposals to allow the purchase of insurance across state lines (PASL) have gained some support in recent years. Health insurers have traditionally been allowed to sell a policy only within the state that approved and regulates that particular policy. PASL would allow insurers to sell a policy approved in one state to people residing in any state.

Any federal legislation to enact PASL in an individual insurance market would have to address two main legal considerations: 1) the McCarran-Ferguson Act, which allows the states to retain their regulatory authority over insurance, and 2) a constitutional prohibition against the commandeering of …

E-Health Hazards: Provider Liability And Electronic Health Record Systems, Sharona Hoffman, Andy Podgurski

Faculty Publications

In the foreseeable future, electronic health record (EHR) systems are likely to become a fixture in medical settings. The potential benefits of computerization could be substantial, but EHR systems also give rise to new liability risks for health care providers that have received little attention in the legal literature. This Article features a first of its kind, comprehensive analysis of the liability risks associated with use of this complex and important technology. In addition, it develops recommendations to address these liability concerns. Appropriate measures include federal regulations designed to ensure the quality and safety of EHR systems along with agency …

Candor After Kadlec: Why, Despite The Fifth Circuit's Decision, Hospitals Should Anticipate An Expanded Obligation To Disclose Risky Physician Behavior, Sallie Thieme Sanford [email protected]

Articles

An anesthesiologist admitted to having been drug-impaired during a tubal ligation that left the patient with massive, incapacitating brain damage. In granting the anesthesiologist privileges, one of the items Kadlec Medical Center had relied upon was a short credentialing letter from Lakeview Regional Medical Center. That letter stated simply that the doctor had held anesthesia privileges there for several years; it did not disclose concerns about on-duty drug use, or that he could not exercise his privileges after having been terminated from his practice group for "put[ting] our patients at significant risk" by "report[ing] to work in an impaired physical, …

The Emergent Logic Of Health Law, Maxwell Gregg Bloche

Georgetown Law Faculty Publications and Other Works

The American health care system is on a glide path toward ruin. Health spending has become the fiscal equivalent of global warming, and the number of uninsured Americans is approaching fifty million. Can law help to divert our country from this path? There are reasons for deep skepticism. Law governs the provision and financing of medical care in fragmented and incoherent fashion. Commentators from diverse perspectives bemoan this chaos, casting it as an obstacle to change. I contend in this Article that pessimism about health law’s prospects is unjustified, but that a new understanding of health law’s disarray is urgently …

Answering The Millennium Call For The Right To Maternal Health: The Need To Eliminate User Fees, Margaux J. Hall, Aziza Ahmed, Stephanie E. Swanson

Faculty Scholarship

Complications during childbirth and pregnancy are a main source of death and disability among women of reproductive age. Approximately 536,000 women die from pregnancy-related complications each year. Developing countries suffer most profoundly, accounting for 99% of deaths. The world's nations, by endorsing U.N. Millennium Development Goals, recognized that most deaths are preventable; they have pledged to reduce maternal mortality by 75% by 2015. This Article assesses the barriers presented by user fees - formal charges for health services still charged by many countries - to the attainment of MDGs. It shows that user fees hamper healthcare access, particularly in emergency …

Teaching Sicko, Elizabeth Weeks

Scholarly Works

This article provides insights in how to make up cancelled law classes to ensure compliance with American Bar Association accreditation instructional hours requirements. How to cover the missed course content. How to find mutually agreeable make-up class times and locations with a group of busy, upper-level law students. Faced with the prospect of having to make up two hours each of my Health Care Financing and Regulation course and my Public Health Law seminar, I turned to the teacher's little helper: the DVD player

Ten Fingers, Ten Toes: Newborn Screening For Untreatable Disorders, Ellen Wright Clayton

Vanderbilt Law School Faculty Publications

This movie makes two important points despite its admitted unreality. The first, which the screen writer probably did not fully appreciate at the time, is that genetic testing cannot now and probably will never be able to predict with complete certainty the occurrence and course of complex diseases. It is not true that "Genes-R-Us." Rather, we are the products of complex interactions of our genes, the genomes of other organisms (many of which we live in relation with), and the environment, broadly understood to include the air we breathe, the water we drink, the food we eat, the drugs we …

Can Clinical Genetics Laboratories Be Sued For Medical Malpractice?, Ellen Wright Clayton, Alexandra L. Foulkes, Jessica L. Roberts, Et Al.

Vanderbilt Law School Faculty Publications

From a legal perspective, is a clinical laboratory a healthcare provider? Physicians are clearly healthcare providers who owe their patients the associated fiduciary duties. It is less clear, however, which-if any-legal duties genetic testing labs owe to the individuals who seek their services.

The question of whether clinical genetics laboratories are healthcare providers for legal purposes may be thornier than it could initially appear. Clinical genetics laboratories perform multiple tasks. Most significantly, they sequence genetic samples and then interpret the results. As "next generation sequencing" has become more accessible,' labs can generate and interpret more sequence data for a growing …

Toward An Architecture Of Health Law, Wendy K. Mariner

Faculty Scholarship

This article examines 3 questions: What is an academic field of law? Is health law such a field? If it is, how can or should it be described? The first question may have no answer; scholars and practicing lawyers have fashioned their owns spheres of expertise. Describing health law faces particular challenges, including the breadth of applicable doctrines and the decline of unique medically-oriented adaptations of general principles. The article offers a blueprint based on the health and human rights framework as a functional description of the eclectic and translegal field of health law. This approach can identify the principles …

Three Ways Of Looking At A Health Law And Literature Class, Jennifer S. Bard, Thomas Wm. Mayo, Stacey A. Tovino

Faculty Journal Articles and Book Chapters

The authors of this Article participated in a panel at the American Society of Law, Ethics & Medicine Conference in 2008 that discussed the use of literary materials in law school to teach medical ethics (and related matters) in a law school setting. Each author comes at the topic from a different perspective based on his or her own experience and background. This Article and the panel on which it was based reflect views on how literature can play a valuable role in helping law students, as well as medical students, understand important legal and ethical issues and concepts in …

Empirical Health Law Scholarship: The State Of The Field, Michelle M. Mello, Kathryn Zeiler

Georgetown Law Faculty Publications and Other Works

The last three decades have seen the blossoming of the fields of health law and empirical legal studies and their intersection--empirical scholarship in health law and policy. Researchers in legal academia and other settings have conducted hundreds of studies using data to estimate the effects of health law on accident rates, health outcomes, health care utilization, and costs, as well as other outcome variables. Yet the emerging field of empirical health law faces significant challenges--practical, methodological, and political.

The purpose of this Article is to survey the current state of the field by describing commonly used methods, analyzing enabling and …

You Get What You Pay For?: Rethinking U.S. Organ Procurement Policy In Light Of Foreign Models, J. Andrew Hughes

Vanderbilt Journal of Transnational Law

The U.S. organ transplant system is in crisis due to the paucity of transplantable organs. Such a shortage exists because otherwise viable organs are too often buried along with the bodies in which they reside. Organs are wasted because the existing U.S. organ transplant system sets up barriers to organ donation--chiefly the legal presumption of unwillingness to donate ("voluntary donation') and the National Organ Transplant Act's ban on the transfer of organs for valuable consideration. This Note surveys the qualified successes of Austria, Belgium, Brazil, and France with their various "presumed consent" models of organ procurement. It also considers other …

Three Ways Of Looking At A Health Law And Literature Class, Jennifer Bard, Thomas W. Mayo, Stacey A. Tovino

Scholarly Works

The authors of this Article participated in a panel at the American Society of Law, Ethics & Medicine Conference in 2008 that discussed the use of literary materials in law school to teach medical ethics (and related matters) in a law school setting. Each author comes at the topic from a different perspective based on his or her own experience and background. This Article and the panel on which it was based reflect views on how literature can play a valuable role in helping law students, as well as medical students, understand important legal and ethical issues and concepts in …

Bizarre Love Triangle: The Spending Clause, Section 1983, And Medicaid Entitlements, Nicole Huberfeld

Law Faculty Scholarly Articles

The first two terms of the Roberts Court signal a willingness to revisit precedent, even decisions that have been considered long-settled, and the United States Supreme Court may be ready to reinterpret another area of jurisprudence: the private enforcement of conditions on federal spending against states through actions under 42 U.S.C. § 1983. The most recent pre-Roberts Court precedent is Gonzaga University v. Doe, a 2002 decision that made it more difficult for individuals harmed by violations of federal laws to enforce rights through § 1983 actions. Federal courts have inconsistently and confusingly applied the Gonzaga framework, but the …

The Changing Face Of Family Law: Global Consequences Of Embedding Physicians And Biotechnology In The Parent-Child Relationship, George J. Annas

Faculty Scholarship

Sexual reproduction, also known as making babies the old-fashioned way, has always brought with it significant challenges for family law, especially regarding protecting the best interests of children, and the identification of parents with the right and responsibility to rear them. But these challenges often seem mundane in the face of what has evolved since physicians have been injected into baby making and thus into novel parent-child relationships. The addition of physicians and their "new" medical technologies, sometimes called Assisted Reproductive Technology (ART), have forced the law to reconsider the very definition of motherhood and have radically altered society's view …

Health Equity, Hpv And The Cervical Cancer Vaccine, Joanna Erdman

Articles, Book Chapters, & Popular Press

This article explores the relationship between technological innovation and health inequity. It examines in particular the relationship between the vaccine against human papillomavirus (HPV) infection, the cause of cervical cancer, and inequity in cervical cancer incidence and mortality. In Canada, screening programs have drastically reduced the incidence of cervical cancer, but their benefits have been unequally distributed. Prevention efforts have disproportionately failed women of disadvantaged social groups. Technological innovation alone will not remedy this inequity. The HPV vaccine merely expands the available means for reducing or increasing health inequity depending on its implementation. For this reason, the article looks beyond …

The Legacy Of The Nuremberg Doctors' Trial To American Bioethics And Human Rights, George J. Annas

Faculty Scholarship

In this lecture I argue that modern bioethics was born at the Nuremberg Doctors' Trial, a health law trial that produced one of the first major human rights documents: the Nuremberg Code. Accepting this conclusion has significant consequences for contemporary American bioethics generally, and specifically in the context of our continuing global war on terror in which the United States uses physicians to help in interrogations, torture, and force-feeding hunger strikers.

The primary force shaping the agenda, development, and current state of American bioethics has not been either medicine or philosophy, but law, best described as health law. Like bioethics, …

A Prescription For Racial Equality In Medicine, Barbara A. Noah

Faculty Scholarship

A significant body of evidence suggests that minority race adversely affects the quantity and quality of health care provided to minority patients. Although no one has documented systemic overt racism among health care providers, persistent inequities in the delivery of health care services pose serious problems for patients of color. Ultimately, the medical establishment must confront the reality that African Americans and other racial minorities often do not receive equal treatment in the health care system.

The continued implementation of affirmative action programs as part of the medical school admissions process plays a key role in improving health care delivery …

Relational Duties, Regulatory Duties, And The Widening Gap Between Individual Health Law And Collective Health Policy, William M. Sage

Faculty Scholarship

In response to a prominent editorial by Dr. Jeffrey M. Drazen, Professor Sage explains how a relational approach has impeded health law's ability to effectively govern the American health care system, arguing that health law has traditionally focused on the physician-patient encounter rather than on achieving collective objectives (which he calls regulatory duties). Professor Sage traces health law's relational emphasis to private and public law, professional ethics and bioethics, budgetary and general politics, and health care consumerism. He concludes that four areas of health policy-conflicts of interest in biomedical research, managed care and pay-for-performance, health care transparency and education, and …

Health Care Reform In America: Beyond Ideology, George J. Annas

Faculty Scholarship

The inspiration for the following keynote address was drawn from an article authored by Professor Annas in 1995 which appeared in the New England Journal of Medicine.² In that article, Professor Annas sought to explain the Clinton healthcare plan's failure by analyzing the power and importance of the healthcare reform metaphors used in promoting the plan. In his remarks here, Professor Annas extends his analysis of healthcare related metaphors to those common in current healthcare reform parlance, theorizing that current efforts at healthcare reform have been unsuccessful, in part, because the metaphors used fail to frame the issues involved …

A Gift Worth Dying For?: Debating The Volitional Nature Of Suicide In The Law Of Personal Property, Adam J. Macleod

Faculty Articles

Suicide poses difficult and foundational problems for the law. Those who most highly value personal autonomy, those who believe in the inviolability of human life, and those who remain uncommitted on end-of-life issues, all must settle challenging questions about suicide before advancing upon the more complex terrain of physician-assisted suicide, euthanasia, and infanticide. And the way in which a society fashions legal responses to suicidal choices reveals much about the society's cultural commitments and legal assumptions.

The bodies of insurance law, tort, and health care law are also among those areas of the law in which lawmakers reserve special exceptions …

Risk Governance And Deliberative Democracy In Health Care, Nan D. Hunter

Georgetown Law Faculty Publications and Other Works

I argue in this article that the concept of risk-centered governance is the best theoretical paradigm for understanding health law and the health care system. Over the past 20 years, an insurance-inflected discourse has migrated from the purely financial side of the health system into the heart of traditional medicine - the doctor-patient relationship. Rather than focus on doctrinal strands, I argue that scholars should analyze the law of health care as a set of governance practices organized around managing and allocating financial, as well as clinical, risk.

Over the same period, the body of law that structures most private …

Medical Judgment In Court And In Congress - Abortion, Refusing Treatment, And Drug Regulation, George J. Annas

Faculty Scholarship

Over the past four decades, the courts and Congress have consistently granted almost unqualified deference to physicians (and medical ethics), at least for treatment decisions made in the context of a consensual physician-patient relationship. The primary exception to this harmonious deference is the 2007 abortion decision of Gonzales v. Carhart, 127 S. Ct. 1610 (2007), and it is reasonable to review our continuing and seemingly intractable legal debate over abortion and the physician's role in it to determine if it could erode judicial and congressional deference to medical judgment in other areas of medical practice and medical ethics.

Introduction, Karen H. Rothenberg, Diane E. Hoffmann

Journal of Health Care Law and Policy

No abstract provided.

Pharma On The Hot Seat, Nicole Huberfeld

Law Faculty Scholarly Articles

The pharmaceutical industry has been receiving greater scrutiny lately due in large part to the many public and private legal enforcement actions taken against pharmaceutical manufacturers. These enforcement actions, along with legal developments such as the OIG Compliance Guidance for Pharmaceutical Manufacturers, the Sarbanes-Oxley Act’s statutory guidelines for public corporations, the HIPAA privacy regulations, and the Medicare Modernization Act, have the potential to encourage the pharmaceutical industry to self-regulate beyond the bounds currently required by the law. After a brief overview of enforcement actions and compliance programs directed toward the pharmaceutical industry, this Article reviews a similar situation the hospital …