Health Law and Policy Commons^™

Reforming Healthcare Reform, Jacqueline Fox

Faculty Publications

No abstract provided.

Electronic Health Records And Medical Big Data: Law And Policy, Sharona Hoffman

Faculty Publications

This book helps readers gain an in-depth understanding of electronic health record (EHR) systems, medical big data, and the regulations that govern them. It is useful both as a primer for students and as a resource for knowledgeable professionals. The book analyzes the shortcomings and benefits of EHR systems, explores the law's response to the technology’s adoption, highlights gaps in the current legal framework, and develops detailed recommendations for regulatory, policy, and technological improvements. Electronic Health Records and Medical Big Data addresses not only privacy and security concerns, but also other important challenges, such as those related to data quality …

The Scope Of Preemption Under The 2009 Family Smoking Prevention And Tobacco Control Act, Sam F. Halabi

Faculty Publications

The 2009 Family Smoking Prevention and Tobacco Control Act endeavored to alter the regulatory regime for tobacco products in the United States by allocating authority to regulate tobacco products to the U.S. Food and Drug Administration (FDA). While the law aims at greater transparency in the constituent components of cigarettes and non-combustible tobacco products, it also includes a provision which will bring FDA’s consumer protection and tobacco control mandates into tension: Section 911’s process for the approval of modified risk tobacco products. That provision allows tobacco manufacturers to submit applications to label products as “reduc[ing] the harm or the risk …

Collective Corporate Knowledge, The Federal False Claims Act, And The Future Of Federal Health Programs, Sam F. Halabi

Faculty Publications

While recent U.S. Supreme Court decisions have drawn focus to whether what corporations “say” is protected by the First Amendment or what they “believe” is protected by the federal Religious Freedom Restoration Act, the more relevant inquiry for a wide range of statutory and regulatory regimes is what corporations “know.” At the core of that question is what guides information relevant for legal compliance (including product safety, employee welfare, and material risks considered by investors) from its source to any given point in the firm, including decision-makers. This Article analyzes the federal False Claims Act as an underexploited resource in …

Of Kings To Come: The Future Of Health Care Reform Still Remains In Federal Court, Jonathan H. Adler

Faculty Publications

While King [v. Burwell] may be the last lawsuit potentially threatening a core feature of the ACA [Affordable Care Act] (at least for the time being) - and there will be few constitutional challenges of the sort seen in NFIB v. Sebelius - it was anything-but-the-end of ACA litigation. To the contrary, ACA lawsuits are certain to continue for years on end as the statute, the way it was enacted, and the way it is being implemented, create a perfect storm for continued litigation.

Continuing legal conflict creates uncertainty under the ACA. While health care reform remains in place, the …

Baptists, Bootleggers & Electronic Cigarettes, Jonathan H. Adler, Roger E. Meiners, Andrew P. Morriss, Bruce Yandle

Faculty Publications

Electronic cigarettes pose a competitive threat to the makers of cigarettes and other tobacco products, as well as to nicotine replacement therapies such as nicotine gum and patches. A common response to such a threat is support for government regulation to suppress competition. Predictably, cigarette manufacturers and other threatened producers, as well as the governments that earn revenue from tobacco taxes, are supporting greater regulation of electronic cigarettes that would replicate the cartel-supporting rules of the Master Settlement Agreement. These efforts are aided by anti-smoking organizations that would like to prevent the growth of demand for electronic cigarettes. This episode …

Dangerous Diagnoses, Risky Assumptions, And The Failed Experiment Of "Sexually Violent Predator" Commitment, Deirdre M. Smith

Faculty Publications

In its 1997 opinion, Kansas v. Hendricks, the U.S. Supreme Court upheld a law that reflected a new model of civil commitment. The targets of this new commitment law were dubbed “Sexually Violent Predators” (SVPs), and the Court upheld indefinite detention of these individuals on the assumption that there is a psychiatrically distinct class of individuals who, unlike typical recidivists, have a mental condition that impairs their ability to refrain from violent sexual behavior. And, more specifically, the Court assumed that the justice system could reliably identify the true “predators,” those for whom this unusual and extraordinary deprivation of liberty …

Modernizing The Emergency Medical Treatment & Labor Act To Harmonize With The Affordable Care Act To Improve Equality, Quality And Cost Of Emergency Care, Katharine A. Van Tassel

Faculty Publications

The Emergency Medical Treatment and Active Labor Act (EMTALA) is a federal statute passed almost 30 years ago which was designed to ensure equal access to emergency treatment and to halt the practice of “patient dumping.” Patient dumping is a situation where some patients—typically uninsured, disabled, and minority individuals—receive inferior emergency medical care or are denied emergency medical treatment altogether. The goal of EMTALA is to ensure that everyone coming to the emergency room will receive equal care.

Unfortunately, despite EMTALA, the practice of patient dumping has continued to this day. The most recent case in the news is the …

Legal Preparedness And Ebola Vaccines, Sam F. Halabi, John T. Monahan

Faculty Publications

On Dec 9, 2014, US Secretary of Health and Human Services Sylvia Burwell issued a declaration under the US Public Readiness and Emergency Preparedness Act to provide immunity from legal claims in the USA related to manufacturing, testing, development, distribution, and administration of three candidate Ebola vaccines except in instances of willful misconduct. Although progress in combating Ebola in west Africa has shifted public attention away from vaccine development and deployment, we should not forget that the management of legal liabilities related to vaccines has been an important subject of discussion between national governments, international organizations, vaccine manufacturers, and other …

Sharing The Burden Of Ebola Vaccine Related Adverse Events, Sam F. Halabi, John Monahan

Faculty Publications

Based upon past experience with other vaccines, the proposed administration of Ebola vaccines (once testing has been completed) will inevitably result in at least some adverse events that will give rise to legal liabilities of only crudely estimable magnitude at this time. Manufacturers, beneficiary governments (e.g., Guinea, Liberia, Sierra Leone), supporting governments (e.g. U.S., U.K.), individuals suffering adverse events, and populations benefiting from widespread vaccination against the Ebola virus all have a shared interest in recognizing, understanding, and managing potential liability as effectively as possible within the framework of a global public health response. There are multiple options available to …

Multipolarity, Intellectual Property And The Internationalization Of Public Health Law, Sam F. Halabi

Faculty Publications

This Article critically examines the proliferation of international legal agreements addressing global health threats like the outbreak of infectious diseases, tobacco use and lack of access to affordable medicines. The conventional wisdom behind this trend is that a global normative shift has occurred which has caused states to regard health as “special” and less subject to the normal rules of international law making because health threats endanger all of humanity. This Article challenges that thesis, arguing that at the same time the number and scope of international health law treaties has grown, developed states have subordinated health law to intellectual …

Liberty Without Capacity: Why States Should Ban Adolescent Driving, Vivian E. Hamilton

Faculty Publications

No abstract provided.

Mental Illness And Danger To Self, Cynthia V. Ward

Faculty Publications

No abstract provided.

Selling Hospice, Sam F. Halabi

Faculty Publications

Americans are increasingly turning to hospice services to provide them with medical care, pain management, and emotional support at the end of life. The increase in the rates of hospice utilization is explained by a number of factors including a “hospice movement” dating to the 1970s which emphasized hospice as a tool to promote dignity for the terminally ill; coverage of hospice services by Medicare beginning in 1983; and, the market for hospice services provision, sustained almost entirely by governmental reimbursement. On the one hand, the growing acceptance of hospice may be seen as a sign of trends giving substance …

Prison Health Care After The Affordable Care Act: Envisioning An End To The Policy Of Neglect, Evelyn Malavé

Faculty Publications

Inadequate prison health care has created a health crisis for reentering prisoners and their communities—a crisis that is exacerbated by barriers to employment and other collateral consequences of release. This Note will first examine how current Eighth Amendment doctrine has failed to sufficiently regulate prison health care so as to have any significant effect on the crisis. Next, it will argue that the Affordable Care Act (ACA) alters the Eighth Amendment analysis by triggering a change in the “evolving standards of decency” that guide the doctrine. Specifically, this Note will argue that, after the passage of the ACA, releasing sick, …

The Conflict Of Visions In Nfib V. Sebelius, Jonathan H. Adler

Faculty Publications

In 2010, few anticipated the fate of healthcare reform would rest with the Supreme Court. Yet National Federation of Independent Business v. Sebelius [hereinafter NFIB] emerged as a watershed case that could remake the constitutional landscape. NFIB presented a conflict between two constitutional visions of federal power and the role of the courts in policing such limits--an unconstrained vision, under which limits on federal power are enforced primarily through the political process, and a constrained vision, under which constitutional limits on federal power are enforced by the courts. The contrasting views of the constitutionality of the individual mandate and …

Taxation Without Representation: The Illegal Irs Rule To Expand Tax Credits Under The Ppaca, Jonathan H. Adler, Michael F. Cannon

Faculty Publications

The Patient Protection and Affordable Care Act (PPACA) provides tax credits and subsidies for the purchase of qualifying health insurance plans on state-run insurance exchanges. Contrary to expectations, many states are refusing or otherwise failing to create such exchanges. An Internal Revenue Service (IRS) rule purports to extend these tax credits and subsidies to the purchase of health insurance in federal exchanges created in states without exchanges of their own. This rule lacks statutory authority. The text, structure, and history of the Act show that tax credits and subsidies are not available in federally run exchanges. The IRS rule is …

Taxation Without Representation: The Illegal Irs Rule To Expand Tax Credits Under The Ppaca, Jonathan H. Adler, Michael F. Cannon

Faculty Publications

The Patient Protection and Affordable Care Act (PPACA) provides tax credits and subsidies for the purchase of qualifying health insurance plans on state-run insurance exchanges. Contrary to expectations, many states are refusing or otherwise failing to create such exchanges. An Internal Revenue Service (IRS) rule purports to extend these tax credits and subsidies to the purchase of health insurance in federal exchanges created in states without exchanges of their own. This rule lacks statutory authority. The text, structure, and history of the Act show that tax credits and subsidies are not available in federally run exchanges. The IRS rule is …

Special Topic Introduction: Minerva At The Departure Gate, Robert N. Strassfeld

Faculty Publications

No abstract provided.

The Use And Misuse Of Biomedical Data: Is Bigger Really Better?”, Sharona Hoffman, Andy Podgurski

Faculty Publications

Very large biomedical research databases, containing electronic health records (HER) and genomic data from millions of patients, have been heralded recently for their potential to accelerate scientific discovery and produce dramatic improvements in medical treatments. Research enabled by these databases may also lead to profound changes in law, regulation, social policy, and even litigation strategies. Yet, is “big data” necessarily better data?

This paper makes an original contribution to the legal literature by focusing on what can go wrong in the process of biomedical database research and what precautions are necessary to avoid critical mistakes. We address three main reasons …

Reducing The Discount Rate, Ben L. Trachtenberg

Faculty Publications

This article presents two arguments against the “discounting” of future human lives as part of cost benefit analysis, or CBA. Our first argument is that because CBA has thus far ignored evidence of rising health care expenditures, it underestimates the “willingness to pay” for health and safety that future citizens will likely exhibit, thereby undervaluing their lives. Our second argument is that until recently CBA has ignored the trend of improved material conditions in developed countries, and most agencies continue to ignore it entirely. As time advances, residents of rich countries tend to live better and spend more, meaning that …

Party Polarization And Judicial Review: Lessons From The Affordable Care Act, Neal Devins

Faculty Publications

Congress paid nearly no attention to the Constitution when enacting the Affordable Care Act (ACA) in 2010. Legislative hearings and committee reports ignored the Constitution altogether; legislative debates largely did the same. This Essay both highlights Congress’s indifference to the Constitution when enacting the ACA and examines the reasons behind this legislative failure. In particular, this Essay advances three explanations. First, Congress is generally uninterested in “public goods” like constitutional interpretation. Second, the polarization of Democrats and Republicans in Congress further depresses Congress’s interest in thinking about the Constitution; instead, the majority party seeks to limit opportunities for the minority …

Why Congress Did Not Think About The Constitution When Enacting The Affordable Care Act, Neal Devins

Faculty Publications

No abstract provided.

Professional Power And The Standard Of Care In Medicine, Maxwell J. Mehlman

Faculty Publications

Since before the founding of the Republic, American medicine has been fighting a war to control the standard of care that physicians are expected to provide to their patients. It has waged battles on two fronts: against internal disagreements within the profession over what constitutes proper care, and against attempts to delineate the standard of care by forces outside the profession, such as private health insurers, the government, and the judicial system.

The Drugs Stop Here: A Public Health Framework To Address The Drug Shortage Crisis, Sharona Hoffman

Faculty Publications

Drug shortages are emerging as a major public health threat. Grave concern has been expressed by the medical community and government officials, and the crisis has been highlighted in recent media stories. Nevertheless, little has been written to date in the legal literature about the drug shortage crisis, and this timely article begins to fill this gap. It provides a thorough analysis of the origins and implications of the drug shortage problem and formulates a multi-layered approach to addressing it. The article argues that drug shortages result from a combination of market failures and regulatory constraints. It proposes a blend …

How The Supreme Court Doomed The Aca To Failure, Thom Lambert

Faculty Publications

Now that the dust has settled somewhat, we may assess the likely consequences of the decision in National Federation of Independent Business v. Sebelius. This article briefly summarizes the reasoning underlying the decision's individual mandate ruling. It then considers what lies ahead for health insurance and medical care in the United States if the ACA, as modified by NFIB, is not repealed. Be warned: the picture isn't pretty.

All For One And One For All: Informed Consent And Public Health, Jessica Wilen Berg

Faculty Publications

The concept of informed consent is well established in the field of bioethics, but its application is unclear in the area of public health. The increasing prevalence of public health interventions creates a need to analyze the scope of government power as it relates to individual choice. This Article explores three different types of public health measures in which individual choice has been limited: (1) environmental interventions; (2) classic public health interventions to prevent contagious disease; and (3) public health information reporting or use. The reasons for limiting informed consent vary depending on the context, and the implications for the …

Balancing Privacy, Autonomy, And Scientific Needs In Electronic Health Records Research, Sharona Hoffman, Andy Podgurski

Faculty Publications

The ongoing transition from paper medical files to electronic health records will provide unprecedented amounts of data for biomedical research, with the potential to catalyze significant advances in medical knowledge. But this potential can be fully realized only if the data available to researchers is representative of the patient population as a whole. Thus, allowing individual patients to exclude their health information, in keeping with traditional notions of informed consent, may compromise the research enterprise and the medical benefits it produces.

This Article analyzes the tension between realizing societal benefits from medical research and granting individual preferences for privacy. It …

Drug-Drug Interaction Alerts: Emphasizing The Evidence, Sharona Hoffman, Andy Podgurski

Faculty Publications

Many analysts and users of contemporary clinical decision support ("CDS") systems have expressed grave concerns about the technology’s efficacy and functionality. Alerts generated by CDS systems are often inaccurate, and an excess of alerts leads some physicians to experience "alert fatigue" and to turn off CDS altogether. This article formulates recommendations to improve drug-drug interaction (DDI) alerts.

The paper comments upon a proposal by Susan Ridgely and Michael Greenberg, who call for the development of a consensus-based "clinically significant drug-drug interaction list" that could generate limited liability protection for users. We argue that instead of creating a list of always-contraindicated …

Introduction - Symposium Issue On Health Data Security Systems, Sharona Hoffman

Faculty Publications

Introduction to the Health Data Security System symposium 2012 Huston, TX.