Health Law and Policy Commons^™

A Closer Look: Deep South Has The Highest Hiv-Related Death Rates In The United States, Susan S. Reif, Donna Safley, Carolyn Mcallaster

Faculty Scholarship

No abstract provided.

Sickeningly Sweet: Analysis And Solutions For Adverse Dietary Consequences Of European Agricultural Law, Emilie K. Aguirre

Faculty Scholarship

Sixty-nine percent of adults in the United States, sixty-four percent in the United Kingdom, and over one-third worldwide are overweight or obese. These staggering figures continue to grow, with accompanying emotional, physical, and economic consequences, both for individuals and society as a whole. The role law plays in facilitating this global trend is significant, and yet puzzlingly, little recognized or understood. The current food system is profoundly structurally flawed: it establishes unhealthy dietary behaviors as the default option for consumers. This Article is the first to examine how agricultural law has facilitated these unhealthier diets for the past fifty years, …

The Importance Of The Right To Food For Achieving Global Health, Emilie K. Aguirre

Faculty Scholarship

The Framework Convention on Global Health (FCGH) represents a significant opportunity to realize the right to health globally. However, in order to succeed the FCGH must be carefully considered: it must take a new evidence-based approach that departs meaningfully from past shortcomings in realizing the right to health. Central to this approach is recognizing, formally incorporating, and operationalizing the right to adequate food. This right should be correctly interpreted as a right to a standard of nutritional quality and not as a right to a minimum number of calories. Because nutrition is critical to the achievement and maintenance of good …

Pharmaceutical Patents And The Human Right To Health: The Contested Evolution Of The Transnational Legal Order On Access To Medicines, Laurence R. Helfer

Faculty Scholarship

Disputes over the regulation of access to medicines are occurring in multiple transnational, national, and local venues. Competing groups of states and non-state actors shift horizontally and vertically among these forums in an effort to develop competing legal rules over the propriety of granting intellectual property (IP) protection to newly developed life-saving drugs. This chapter applies the framework of Transnational Legal Orders (Terence C. Halliday & Gregory Shaffer, eds. 2015) to explain the origins of these controversies and their consequences. The chapter argues that the current state of affairs arose from a clash between two previously discrete TLOs—one relating to …

Could Data Broker Information Threaten Physician Prescribing And Professional Behavior?, Marco D. Huesch, Michael K. Ong, Barak D. Richman

Faculty Scholarship

Privacy is threatened by the extent of data collected and sold by consumer data brokers. Physicians, as individual consumers, leave a ‘data trail’ in the offline (e.g. through traditional shopping) and online worlds (e.g. through online purchases and use of social media). Such data could easily and legally be used without a physician’s knowledge or consent to influence prescribing practices or other physician professional behavior. We sought to determine the extent to which such consumer data was available on a sample of more than 3,000 physicians, healthcare faculty and healthcare system staff at one university’s health units. Using just work …

Will Uncooperative Federalism Survive Nfib?, Abigail Moncrieff, Jonathan Dinerstein

Faculty Scholarship

In October Term 2012, the Supreme Court decided two cases that are fundamentally at odds: NFIB v. Sebelius and Douglas v. Independent Living Center of Southern California. In NFIB, the Court held that the federal government, at least under some circumstances, may not use the threat of reduced funding in cooperative federalism programs to require states to comply with federal statutory requirements. In Douglas, however, the Court indicated that private litigants should sue federal agencies under the Administrative Procedure Act if those agencies refuse to enforce federal statutory requirements against the states. The problem is that the withdrawal of funding …

The Universality Of Medicaid At Fifty, Nicole Huberfeld

Faculty Scholarship

This essay, written for the Yale Law School symposium on The Law of Medicare and Medicaid at 50, explores how the law of Medicaid after the ACA creates a meaningful principle of universalism by shifting from fragmentation and exclusivity to universality and inclusivity. The universality principle provides a new trajectory for all of American health care, one that is not based on individual qualities that are unrelated to medical care but rather grounded in non-judgmental principles of unification and equalization (if not outright solidarity). This essay examines the ACA's legislative reformation, which led to universality, and its quantifiable effects. The …

The Hidden Costs Of Health Care Cost-Cutting: Toward A Postneoliberal Health-Reform Agenda, Frank A. Pasquale

Faculty Scholarship

No abstract provided.

Heterogeneity In Irb Policies With Regard To Disclosures About Payment For Participation In Recruitment Materials, Megan S. Wright, Christopher Robertson

Faculty Scholarship

Scholars have documented variation in the way local Institutional Review Boards differently adjudicate identical research proposals. It is unclear whether such heterogeneity is due to variation in positive policies, or variation in human processes of interpretation and enforcement. A particularly interesting question relates to whether investigators are allowed to provide truthful information about research opportunities to potential participants, which some IRBs seem to forbid. We investigated local IRB policies on disclosing the amount of compensation in recruitment materials by conducting a census of the top 100 institutions by receipt of NIH funding in 2012. We downloaded the relevant policies and …

Our 'Patchwork' Health Care System: Melodic Variations, Counterpoint, And The Future Role Of Physicians, William M. Sage

Faculty Scholarship

This Foreword to a forthcoming symposium on the "patchwork" health care system to be published in the Houston Journal of Health Law & Policy considers whether current reactions to fragmentation in health care represent minor variations on a longstanding theme in US health policy or offer a more substantial counterpoint to that theme. The theme is this: that perfect physicians should be allowed to control health care even if safeguards are needed in practice because real physicians are not perfect. The Foreword previews four scholarly articles featured in the published symposium. It concludes that, while all the articles present original …

A Randomized Experiment Of The Split Benefit Health Insurance Reform To Reduce High-Cost, Low-Value Consumption, Christopher Robertson, David V. Yokum, Nimish Sheth, Keith A. Joiner

Faculty Scholarship

Traditional cost sharing for health care is stymied by limited patient wealth. The “split benefit” is a new way to reduce consumption of high-cost, low-value treatments for which the risk/benefit ratio is uncertain. When a physician prescribes a costly unproven procedure, the insurer could pay a portion of the benefit directly to the patient, creating a decision opportunity for the patient. The insurer saves the remainder, unless the patient consumes. In this paper, a vignette-based randomized controlled experiment with 1,800 respondents sought to test the potential efficacy of the split benefit. The intervention reduced the odds of consumption by about …

Themes, Doctrine, And Pedagogy In The 2013-2014 National Health Law Moot Court Competition Problem, Anita Bernstein

Faculty Scholarship

No abstract provided.

Themes, Doctrine, And Pedagogy In The 2013-2014 National Health Law Moot Court Competition Problem, Anita Bernstein

Faculty Scholarship

No abstract provided.

Paternalism, Public Health, And Behavioral Economics: A Problematic Combination, Wendy K. Mariner

Faculty Scholarship

Some critiques of public health regulations assume that measures directed at industry should be considered paternalistic whenever they limit any consumer choices. Given the presumption against paternalistic measures, this conception of paternalism puts government proposals to regulate industry to the same stringent proof as clearly paternalist proposals to directly regulate individuals for their own benefit. The result is to discourage regulating industry in ways that protect the public from harm and instead to encourage regulating individuals for their own good -- quite the opposite of what one would expect from a rejection of paternalism. Arguments favoring "soft paternalism" to justify …

Private Certifiers And Deputies In American Health Care, Frank Pasquale

Faculty Scholarship

No abstract provided.

None Of The Laws But One, Neil S. Siegel

Faculty Scholarship

This Symposium contribution explores differences in how congressional Republicans responded to Medicare and how they responded to the Patient Protection and Affordable Care Act (ACA). Given the narrowness of the constitutional challenges to the ACA that congressional Republicans promoted and the many federal taxes, expenditures, and regulations that they support, this Article rejects the suggestion that today's Republicans in Congress generally possess a narrow view of the constitutional scope of federal power. The Article instead argues that congressional Republicans then and now-and the two parties in Congress today-fracture less over the constitutional expanse of congressional authority and more over the …

Crowdsourcing Public Health Experiments: A Response To Jonathan Darrow's Crowdsourcing Clinical Trials, Ameet Sarpatwari, Christopher Robertson, David Yokum, Keith Joiner

Faculty Scholarship

We are pleased to have this opportunity to respond to Jonathan Darrow's article, Crowdsourcing Clinical Trials (CCT).' We seek to highlight its important contributions and to commence debate over some of its arguments. In particular, we qualify the ethical arguments that characterize early clinical use of drugs as if they were research, and suggest instead that, in either domain, the ethical (and legal) analysis should remain focused on whether all material information is provided so patients may make informed decisions. We also highlight the limits of what can be gleaned from the observational data collection efforts envisioned by CCT.

Ultimately, …

Putting Insurance Reform In The Aca's Rear-View Mirror, William M. Sage

Faculty Scholarship

This Commentary acknowledges and applauds efforts to understand the mechanisms of insurance reform contained in the ACA and to evaluate their success or failure. But the Commentary’s principal purpose is to examine the pros and cons of connecting insurance reform to health care and health—the pen and the french fry—and to convey the importance to the country of moving beyond insurance reform as quickly as possible. The Commentary begins by describing the potential synergies among the three health policy domains and offering reasons why the ACA sought to make simultaneous changes. It then identifies the vulnerabilities that are revealed in …

Analytical Framework For Examining The Value Of Antibacterial Products, Kevin Outterson, Aylin Sertkaya, John T. Eyraud, Anna Birkenback, Calvin Franz, Nyssa Ackerley, Valerie Overton

Faculty Scholarship

Antibacterial resistance is a growing global problem. According to the most recent statistics from the Centers for Disease Control and Prevention (CDC), at least 2 million people acquire serious infections with bacteria that are resistant to one or more of antibacterial drugs designed to treat those infections in the United States alone. Of these, approximately 23,000 die as a result of drug-resistant infections. Even though estimates vary widely, the economic cost of antibacterial resistance in the United States could be as high as $20 billion and $35 billion a year in excess direct healthcare costs and lost productivity costs, respectively …

The Affordable Care Act, Remedy, And Litigation Reform, Brendan S. Maher

Faculty Scholarship

The Patient Protection and Affordable Care Act of 2010 (“ACA”) rewrote the law of private health insurance. How the ACA rewrote the law of civil remedies, however, is — to date — a question largely unexamined by scholars. Courts everywhere, including the United States Supreme Court, will soon confront this important issue.

This Article offers a foundational treatment of the ACA on remedy. It predicts a series of flashpoints over which litigation reform battles will be fought. It identifies several themes that will animate those conflicts and trigger others. It explains how judicial construction of the statute’s functional predecessor, the …

The Drug Quality And Security Act - Mind The Gaps, Kevin Outterson

Faculty Scholarship

After the compounding pharmacy disaster at New England Compounding Center, Congress had an opportunity to assure that all compounded medicines were safe and effective. The Drug Quality and Safety Act, despite its name, fell short of that mark.

Setting The Stage: Enhancing Understanding Of Bioethical Challenges With Theatre, Karen H. Rothenberg

Faculty Scholarship

Theatre provides a dynamic platform to reflect upon the ethical, legal, and social implications of medical innovations and the powerful impact on personal and professional relationships. This article explores the last four to five decades of theatre, which coincide with the evolution of the formal discipline of bioethics and the field of medical humanities, to aid in the understanding of the bioethical challenges we face today and to place them in an historical and societal context. Four plays are discussed that reflect the ethical and legal context of their eras and reveal significant ethical challenges for us to consider.

Private Certifiers And Deputies In American Health Care, Frank A. Pasquale

Faculty Scholarship

So-called “public programs” in U.S. health care pervasively contract with private entities. The contracting does not merely involve the purchase of drugs, devices, information technology, insurance, and medical care. Rather, government agencies are increasingly outsourcing decisions about the nature and standards for such goods and services to private entities. This Article will examine two models of outsourcing such decisions. In private licensure, firms offer a stamp of approval to certify that a given technology or service is up to statutory or regulatory standards. Via deputization, firms can pursue a regulatory or law enforcement role to correct (and even punish) providers …

Redescribing Health Privacy: The Importance Of Health Policy, Frank A. Pasquale

Faculty Scholarship

Current conversations about health information policy often tend to be based on three broad assumptions. First, many perceive a tension between regulation and innovation. We often hear that privacy regulations are keeping researchers, companies, and providers from aggregating the data they need to promote innovation. Second, aggregation of fragmented data is seen as a threat to its proper regulation, creating the risk of breaches and other misuse. Third, a prime directive for technicians and policymakers is to give patients ever more granular methods of control over data. This article questions and complicates those assumptions, which I deem (respectively) the Privacy …

Perspectives On Outpatient Commitment, Richard C. Boldt

Faculty Scholarship

No abstract provided.

Protecting Health Privacy In An Era Of Big Data Processing And Cloud Computing, Frank A. Pasquale, Tara Adams Ragone

Faculty Scholarship

This Article examines how new technologies generate privacy challenges for both healthcare providers and patients, and how American health privacy laws may be interpreted or amended to address these challenges. Given the current implementation of Meaningful Use rules for health information technology and the Omnibus HIPAA Rule in health care generally, the stage is now set for a distinctive law of “health information” to emerge. HIPAA has come of age of late, with more aggressive enforcement efforts targeting wayward healthcare providers and entities. Nevertheless, more needs to be done to assure that health privacy and all the values it is …

Probiotics: Achieving A Better Regulatory Fit, Diane E. Hoffmann, Claire M. Fraser, Francis Palumbo, Jacques Ravel, Virginia Rowthorn, Jack Schwartz

Faculty Scholarship

In 2007, the National Institutes of Health (NIH) launched the Human Microbiome Project (HMP), a $150 million initiative to characterize the microbial communities found at several different sites on the human body and to analyze the role of these microbes in human health and disease. Many lines of research have demonstrated the significant role of the microbiota in human physiology. The microbiota is involved, for example, in the healthy development of the immune system, prevention of infection from pathogenic or opportunistic microbes, and maintenance of intestinal barrier function. The HMP findings are helping us understand the role and variation of …

Protecting Health Privacy In An Era Of Big Data Processing And Cloud Computing, Frank Pasquale, Tara Adams Ragone

Faculty Scholarship

No abstract provided.

Fertility Preservation For Medical Reasons And Reproductive Justice, Seema Mohapatra

Faculty Scholarship

No abstract provided.

Using Egg Freezing To Extend The Biological Clock: Fertility Insurance Or False Hope?, Seema Mohapatra

Faculty Scholarship

No abstract provided.