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2013

Health Law and Policy

Selected Works

Articles 1 - 30 of 222

Full-Text Articles in Law

The Empire Of Cancer: Gene Patents And Cancer Voices, Matthew Rimmer Dec 2013

The Empire Of Cancer: Gene Patents And Cancer Voices, Matthew Rimmer

Matthew Rimmer

In his book, The Emperor of All Maladies, Siddhartha Mukherjee writes a history of cancer — ‘It is a chronicle of an ancient disease — once a clandestine, “whispered-about” illness — that has metamorphosed into a lethal shape-shifting entity imbued with such penetrating metaphorical, medical, scientific, and political potency that cancer is often described as the defining plague of our generation’.Increasingly, an important theme in the history of cancer is the role of law, particularly in the field of intellectual property law. It is striking that a number of contemporary policy debates over intellectual property and public health have concerned …


Implementation Of Patients’ Rights Legislation In The Republic Of Macedonia: Gaps And Disparities, Gabriela Alcheva, Filip Gerovski, Leo Beletsky Dec 2013

Implementation Of Patients’ Rights Legislation In The Republic Of Macedonia: Gaps And Disparities, Gabriela Alcheva, Filip Gerovski, Leo Beletsky

Leo Beletsky

Background: Since its formation after the breakup of Yugoslavia, Macedonia has made major strides in formulating a framework for protecting patient rights through extensive legal reform. The impact of this reform had not been assessed before the work of this project. Methods/Objectives: Within the context of a larger project on improving human rights in patient care, this paper provides an overview of patients’ rights legislation in Macedonia and uses research, case reports, and other empirical information to highlight the gaps in the implementation of patient rights’ legislation on the ground. Results: The Law on the Protection of Patients’ Rights (2008) …


Overview Of The Gaps In The Health Care Legislation In Georgia: Short-, Medium-, And Long-Term Priorities, Nino Kiknadze, Leo Beletsky Dec 2013

Overview Of The Gaps In The Health Care Legislation In Georgia: Short-, Medium-, And Long-Term Priorities, Nino Kiknadze, Leo Beletsky

Leo Beletsky

Background: After gaining independence following the dissolution of the Soviet Union, Georgia has aspired to become the region’s leader in progressive legal reform. Particularly in the realm of health care regulation, Georgia has proceeded with extensive legislative reforms intended to modernize its health care system, and bring it in line with international standards. Objectives/Methods: As part of a larger project to improve human rights in patient care, we conducted a study designed to identify gaps in the current Georgian health care legislation. Using a cross-site research framework based on the European Charter of Patients’ Rights, an interdisciplinary working group oversaw …


Moderator, "New Regulatory Models Ensuring Safety And Accelerating Treatments", Mary Ann Chirba Dec 2013

Moderator, "New Regulatory Models Ensuring Safety And Accelerating Treatments", Mary Ann Chirba

Mary Ann Chirba

No abstract provided.


The World Trade Organization Dispute Over Genetically Modified Organisms: The Precautionary Principle Meets International Trade Law, David A. Wirth Dec 2013

The World Trade Organization Dispute Over Genetically Modified Organisms: The Precautionary Principle Meets International Trade Law, David A. Wirth

David A. Wirth

“Precaution” is increasingly accepted as a basis for governmental policy in the areas of public health and environment on both the domestic and international levels. A precautionary perspective counsels action to avert danger or threats in situations of scientific uncertainty or incomplete information. Precautionary approaches find expression in internationally harmonized formulations as non-binding exhortations, binding treaties, and meta-level principles. Precaution is a particular challenge to free trade agreements, whose purpose is to eliminate unjustified barriers to trade. In that context, precaution as a justification for a challenged governmental measure may appear to be nothing more than a pretext for protectionism. …


Why Primary Patents Covering Biologics Should Be Unforceable Against Generic Applicants Under The Biologics Price Competition And Innovation Act, Yaniv Heled Dec 2013

Why Primary Patents Covering Biologics Should Be Unforceable Against Generic Applicants Under The Biologics Price Competition And Innovation Act, Yaniv Heled

Yaniv Heled

No abstract provided.


Medical And Dental X-Rays--A Time For Re-Evaluation And State Action, James H. Seckinger Nov 2013

Medical And Dental X-Rays--A Time For Re-Evaluation And State Action, James H. Seckinger

James H. Seckinger

No abstract provided.


Abortion, The Law And Human Life, Thomas L. Shaffer Nov 2013

Abortion, The Law And Human Life, Thomas L. Shaffer

Thomas L. Shaffer

No abstract provided.


Loopholes In The Affordable Care Act: Regulatory Gaps And Border Crossing Techniques And How To Address Them, Timothy Stoltzfus Jost Nov 2013

Loopholes In The Affordable Care Act: Regulatory Gaps And Border Crossing Techniques And How To Address Them, Timothy Stoltzfus Jost

Timothy S. Jost

Not available.


The Real Constitutional Problem With The Affordable Care Act, Timothy Stoltzfus Jost Nov 2013

The Real Constitutional Problem With The Affordable Care Act, Timothy Stoltzfus Jost

Timothy S. Jost

Not available.


The Most Important Health Care Legislation Of The Millennium (So Far): The Medicare Modernization Act, Timothy Stoltzfus Jost Nov 2013

The Most Important Health Care Legislation Of The Millennium (So Far): The Medicare Modernization Act, Timothy Stoltzfus Jost

Timothy S. Jost

Whether or not one believes that the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) in fact improves or modernizes Medicare, the legislation obviously changes the program radically. The extent and nature of these changes make the MMA the most important piece of health care legislation to be adopted by Congress to date in this young millennium. The MMA also contains what are arguably the most important amendments to the Medicare program since its creation. This Essay first describes the identifying characteristics of the current Medicare program, then examines the significant changes that the MMA makes in the program, and …


Medicare And Medicaid False Claims: Prohibitions And Sanctions, Timothy Stoltzfus Jost Nov 2013

Medicare And Medicaid False Claims: Prohibitions And Sanctions, Timothy Stoltzfus Jost

Timothy S. Jost

Both state and federal agencies are cracking down on health care professionals who file false Medicare claims, but physicians who make good faith attempts to comply with the law are fairly secure from prosecution, since both criminal and civil penalties must be based on willful or knowing breaches of the law.


The Supreme Court And The Future Of Medicaid, Timothy Stoltzfus Jost Nov 2013

The Supreme Court And The Future Of Medicaid, Timothy Stoltzfus Jost

Timothy S. Jost

Not available.


Pharmaceutical Research And Manufacturers Of America V. Walsh: The Supreme Court Allows The States To Proceed With Expanding Access To Drugs, Timothy Stoltzfus Jost Nov 2013

Pharmaceutical Research And Manufacturers Of America V. Walsh: The Supreme Court Allows The States To Proceed With Expanding Access To Drugs, Timothy Stoltzfus Jost

Timothy S. Jost

On May 19, 2003, the Supreme Court in Pharmaceutical Research and Manufacturers of America v. Walsh affirmed a court of appeals decision allowing for the implementation of the Maine Act to Establish Fairer Pricing for Prescription Drugs.' The Maine program attempted to leverage the considerable market power of the Medicaid program to force drug companies to offer the state a discount on pharmaceuticals. The state in turn would pass the savings on to its uninsured residents. Manufacturers that refused to negotiate a discount with the state would face the prospect of their products being available to Maine Medicaid recipients only …


The Independent Medicare Advisory Board, Timothy Stoltzfus Jost Nov 2013

The Independent Medicare Advisory Board, Timothy Stoltzfus Jost

Timothy S. Jost

It is a common realization that neither unconstrained markets nor our current political institutions are capable of governing our health care system. The cost of health care is spinning dangerously out of control, yet market forces alone cannot manage these costs because of a host of relatively well-understood market failures. Moreover, our traditional political institutions - Congress and the executive administrative agencies - have also failed us in this respect. These institutions are too driven by special interest politics and too limited in their expertise and vision to control costs. Both Medicare payment formulas and coverage determinations often seem to …


The Uses Of The Social Transformation Of American Medicine: The Case Of Law, Timothy Stoltzfus Jost Nov 2013

The Uses Of The Social Transformation Of American Medicine: The Case Of Law, Timothy Stoltzfus Jost

Timothy S. Jost

Not available.


Professional Sovereignty In A Changing Health Care System: Reflections On Paul Starr's The Social Transformation Of American Medicine, Timothy Stoltzfus Jost, Keith Wailoo, Mark Schlesinger Nov 2013

Professional Sovereignty In A Changing Health Care System: Reflections On Paul Starr's The Social Transformation Of American Medicine, Timothy Stoltzfus Jost, Keith Wailoo, Mark Schlesinger

Timothy S. Jost

Not available.


The American Right-Wing Policy Agenda, Timothy Stoltzfus Jost Nov 2013

The American Right-Wing Policy Agenda, Timothy Stoltzfus Jost

Timothy S. Jost

Right-wing health policy is alive and well in the United States. Pro-business and libertarian health policy advocacy groups, generously funded by right-wing foundations (and, in some instances, by the health care industry), produce a continuous stream of press releases, policy-statements, books, articles, and symposia, as well as testimony before legislative and administrative bodies. Their positions are taken very seriously by the American media, who make certain that right-wing policy experts are represented in any discussion of current health policy issues.


Managed Care, Assisted Suicide, And Vulnerable Populations, M. Kaveny Nov 2013

Managed Care, Assisted Suicide, And Vulnerable Populations, M. Kaveny

M. Cathleen Kaveny

No abstract provided.


Prophecy And Casuistry: Abortion, Torture And Moral Discourse, M. Kaveny Nov 2013

Prophecy And Casuistry: Abortion, Torture And Moral Discourse, M. Kaveny

M. Cathleen Kaveny

No abstract provided.


Pregnant Pause: The Exclusion Of Pregnant Women From Clinical Research As Sex Discrimination, Richard M. Weinmeyer Nov 2013

Pregnant Pause: The Exclusion Of Pregnant Women From Clinical Research As Sex Discrimination, Richard M. Weinmeyer

Richard M Weinmeyer

Since the early 1990s, legislative and policy reforms have spurred the inclusion of women of childbearing potential in clinical research overseen by the National Institutes of Health and the U.S. Food and Drug Administration. Pregnant women have received no such help, however, despite the tremendous medical needs of this important demographic. This article argues that the exclusion of pregnant women from biomedical research in the United States constitutes sex discrimination as a matter of public policy given the interpretation of existing regulations governing human subjects protections. The current regulations that are in place guiding research on human subjects treat pregnant …


Foreword: Health In The Workplace, Barbara Fick Nov 2013

Foreword: Health In The Workplace, Barbara Fick

Barbara J. Fick

This article is a brief forward to the 1987 Notre Dame Law Review Symposium Issue.


Women's Reproductive Rights Advanced At Conference, Gabriel Eckstein Nov 2013

Women's Reproductive Rights Advanced At Conference, Gabriel Eckstein

Gabriel Eckstein

No abstract provided.


Troxel And The Limits Of Community, Margaret F. Brinig Oct 2013

Troxel And The Limits Of Community, Margaret F. Brinig

Margaret F Brinig

No abstract provided.


Federalism Doctrines And Abortion Cases: A Response To Professor Fallon, Anthony J. Bellia Oct 2013

Federalism Doctrines And Abortion Cases: A Response To Professor Fallon, Anthony J. Bellia

Anthony J. Bellia

This Essay is a response to Professor Richard Fallon's article, If Roe Were Overruled: Abortion and the Constitution in a Post-Roe World. In that article, Professor Fallon argues that if the Supreme Court were to overrule Roe v. Wade, courts might well remain in the abortion-umpiring business. This Essay proposes a refinement on that analysis. It argues that in a post-Roe world courts would not necessarily subject questions involving abortion to the same kind of constitutional analysis in which the Court has engaged in Roe and its progeny, that is, balancing a state's interest in protecting life against a pregnant …


Lead Poisoning In Children: A Proposed Legislative Solution To Municipal Liability For Furnishing Lead-Contaminated Water, Anthony J. Bellia Oct 2013

Lead Poisoning In Children: A Proposed Legislative Solution To Municipal Liability For Furnishing Lead-Contaminated Water, Anthony J. Bellia

Anthony J. Bellia

Lead poisoning has become one of the most widespread and serious environmental diseases facing children in the United States. In response to the problem of childhood lead exposure, the Environmental Protection Agency (EPA) has promulgated expansive regulations to reduce drinking water lead levels. However, the regulations are not without significant gaps and shortfalls. Many improvements that the EPA requires need not be in place for years, and some households at risk of unsafe lead exposure receive no regulatory protection at all. One question that arises amidst these regulatory gaps is whether a plaintiff can hold a public water system liable …


South Bend, Indiana: A Case Study Of The Possibilities And Realities Of Hospital Cooperation, Joseph P. Bauer Oct 2013

South Bend, Indiana: A Case Study Of The Possibilities And Realities Of Hospital Cooperation, Joseph P. Bauer

Joseph P. Bauer

South Bend, the county seat of St. Joseph County, Indiana, is a city with a population of slightly more than 100,000. Located about 100 miles from Chicago, it serves many of the educational, financial and health care needs of a five county metropolitan area of over 700,000 people. South Bend and its sister city, Mishawaka, are served by four general hospitals. The two largest each have about 40 percent of the available beds in the community. One of them, Memorial Hospital of South Bend, is a not-for-profit corporation which is unaffiliated with any other hospital; the other large hospital, St. …


Health Care Reform: Law And Practice, Mary Ann Chirba, Alice Noble, Michael Maddigan Oct 2013

Health Care Reform: Law And Practice, Mary Ann Chirba, Alice Noble, Michael Maddigan

Mary Ann Chirba

On March 23, 2010, President Obama signed comprehensive health reform, the Patient Protection and Affordable Care Act (PPACA) and commonly referred to as "Obamacare" or the Affordable Care Act (ACA), into law. With the passage of the ACA, Congress put an end to the century-long quest to secure coverage for all Americans facing steadily rising costs for increasingly sophisticated health care. In closing the book on that struggle, however, the law opened another. Health Care Reform: Law and Practice is designed to assist health care and legal professionals who need to understand what the law says, how it works, and …


The Affordable Care Act, Dean Hashimoto Oct 2013

The Affordable Care Act, Dean Hashimoto

Dean M. Hashimoto

No abstract provided.


Evolving Global Regulation Of Adult Stem Cell Therapies And Technologies, Mary Ann Chirba Oct 2013

Evolving Global Regulation Of Adult Stem Cell Therapies And Technologies, Mary Ann Chirba

Mary Ann Chirba

No abstract provided.