Health Law and Policy Commons^™

Controlling Health Care Spending: More Patient "Skin In The Game?", David Orentlicher

Scholarly Works

In this article, Professor Orentlicher explores the high cost of healthcare and the trend in health insurance to shift the cost of health care to patients in an attempt to influence their behavior and health decisions. He examines such strategies as reference pricing, scaled cost-sharing, and employee wellness programs.

G2i Knowledge Brief: A Knowledge Brief Of The Macarthur Foundation Research Network On Law And Neuroscience, David L. Faigman, Anthony Wagner, Richard J. Bonnie, Bj Casey, Andre Davis, Morris B. Hoffman, Owen D. Jones, Read Montague, Stephen J. Morse, Marcus E. Raichle, Jennifer A. Richeson, Elizabeth S. Scott, Laurence Steinberg, Kim Taylor-Thompson, Gideon Yaffe

Faculty Scholarship

Courts are daily confronted with admissibility issues – such as in cases involving neuroscientific testimony – that sometimes involve both the existence of a general phenomenon (i.e., “G”) and the question of whether a particular case represents a specific instance of that general phenomenon (i.e., “i”).

Unfortunately, courts have yet to carefully consider the implications of “G2i” for their admissibility decisions. In some areas, courts limit an expert’s testimony to the general phenomenon. They insist that whether the case at hand is an instance of that phenomenon is exclusively a jury question, and thus not an appropriate subject of expert …

Applying The Health Justice Framework To Diabetes As A Community-Managed Social Phenomenon, Lindsay Wiley

Scholarly Articles in Law Reviews & Journals

INTRODUCTION: In East Harlem, it is possible to take any simple nexus of people -the line at an A.T.M., a portion of a postal route, the members of a church choir -and trace an invisible web of diabetes that stretches through the group and out into the neighborhood, touching nearly every life with its menace.Ten years ago, the New York Times published "Bad Blood," a series of articles examining the impact of diabetes on the residents of New York City. In the years that followed, New York pioneered a series of groundbreaking legal interventions, including implementing measures to track diabetes …

Liability For Mobile Health And Wearable Technologies, Lindsay Wiley, Nicolas Terry

Scholarly Articles in Law Reviews & Journals

Most of the legal commentary regarding mobile health has focused on direct regulation leveraging existing laws and regulators such as HIPAA privacy through HHS-OCR or device regulation by the FDA. However, much of the mobile health revolution likely will play out in lightly regulated spaces bereft of most of the privacy, security, and safety rules associated with traditional health care. This article examines the potential for common law liability models to bridge these gaps (even on a temporary basis). Part II of this paper provides an introduction to the terminology used, and presents a brief typology of the apps appearing …

From Patient Rights To Health Justice, Lindsay Wiley

Scholarly Articles in Law Reviews & Journals

Models emphasizing professional autonomy, patient rights, market power, and health consumerism are no longer adequate to address the increasingly social, collective nature of health law institutions, instruments, and norms. What is needed is a new model that expressly recognizes the public-alongside the patient, the provider, and the payer-as an important stakeholder and active participant in decisions about medical treatment, health care coverage, and allocation of scarce resources. In a previous article, the author looked to the environmental justice, reproductive justice, and food justice movements for inspiration in developing a "health justice" approach to eliminating social disparities in health. This Article …

Minors, Parents, And Minor Parents, Maya Manian

Scholarly Articles in Law Reviews & Journals

As numerous scholars have noted, the law takes a strikingly incoherent approach to adolescent reproduction. States overwhelmingly allow a teenage girl to independently consent to pregnancy care and medical treatment for her child, and even to give up her child for adoption, all without notice to her parents, but require parental notice or consent for abortion. This Article argues that this oft-noted contradiction in the law on teenage reproductive decision-making is in fact not as contradictory as it first appears. A closer look at the law’s apparently conflicting approaches to teenage abortion and teenage childbirth exposes common ground that scholars …

The Affordable Care Act Is Not Tort Reform, Andrew F. Popper

Scholarly Articles in Law Reviews & Journals

On March 23, 2010, President Obama signed The Patient Protection and Affordable Care Act (PPACA). Prior to the enactment of the PPACA, Congress held several hearings focused on subrogation and relaxation of collateral source restrictions as well as caps on damages in an effort to promote tort reform. While the ACA included provisions on medical liability reform, the suggested tort reform was thwarted, and the ACA had no actual legal effect on limiting medical malpractice liability. This article argues that the reality is that the PPACA has done nothing to change the admissibility of collateral sources nor has it enhanced …

Said I, But You Have No Choice: Why A Lawyer Must Ethically Honor A Client's Decision About Mental Health Treatment Even If It Is Not What S/He Would Have Chosen, Michael L. Perlin, Naomi Weinstein

Articles & Chapters

This paper addresses a remarkably under-considered topic: the ethical standards for lawyers representing persons with mental disabilities. Although there is an extensive body of literature endorsing “zealous advocacy” as the standard for the criminal defense lawyer in “ordinary” cases, there is virtually no literature (or case law) on this question in this context.

Our thesis is simple. We reject the model of “paternalism/best interests” that is regularly substituted for a traditional legal advocacy position, and a substitution that is rarely questioned. We believe this presumption flies in the face of statutory law, constitutional law, and international human rights law, and …

Merchants And Thieves, Hungry For Power: Prosecutorial Misconduct And Passive Judicial Complicity In Death Penalty Trials Of Defendants With Mental Disabilities, Michael L. Perlin

Articles & Chapters

In spite of the Supreme Court’s decisions in Ford v. Wainwright (1986), Atkins v. Virginia (2002), and Hall v. Florida (2014), persons with severe psychosocial and intellectual disabilities continue to be given death sentences, in some cases leading to actual execution. Although the courts have been aware of this for decades -- dating back at least to the infamous Ricky Rector case in Arkansas -- these base miscarriages of justice continue and show no sign of abating. Scholars have written clearly and pointedly on this issue (certainly, more frequently since the Atkins decision in 2002), but little has changed.

I …

Buyers In The Baby Market: Toward A Transparent Consumerism, Jody L. Madeira, June Carbone

Articles by Maurer Faculty

This Article assesses the forces on the horizon remaking the fertility industry, including greater consolidation in the health care industry, the prospects for expanding (or contracting) insurance coverage, the likely sources of funding for future innovation in the industry, and the impact of globalization and fertility tourism. It concludes that concentration in the American market, in contrast with other medical services, may not necessarily raise prices, and price differentiation may proceed more from fertility tourism than from competition within a single geographic region. The largest challenge may be linking those who would fund innovation, whether innovation that produces new high …

Complying With The Hipaa Privacy Rule: Problems And Perspectives, 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 a final rule governing the use and disclosure of protected health information by covered entities and their business associates (Privacy Rule). This Article addresses the question of what it means for …

Of Mice And Men: On The Seclusion Of Immigration Detainees And Hospital Patients, Stacey A. Tovino

Faculty Articles

With a special focus on federal provisions strictly regulating Medicare-participating hospitals' use of seclusion, this Article uses developments in health law as a lens through which the uses and abuses of seclusion in immigration detention centers might be assessed and through which the standards governing detention centers might be improved. In particular, this Article argues that the unenforceable standards governing seclusion in immigration detention, including the most recent version of ICE's Performance-Based National Detention Standards, were incorrectly modeled on correctional standards developed for use in jails and prisons with respect to convicted criminals. This Article asserts that correctional standards are …

'Big Food' Is Making America Sick, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

“Big Food”—agribusiness, manufacturers, restaurants, and marketers—is making America sick. The industry produces and aggressively markets foods laden with sugar, salt, saturated fat, and calories. It obfuscates nutritional information to confuse consumers, targeting young people and minorities in particular. It purchases influence at every level of government and fights commonsense regulations by funding “shadow” advocacy groups and sympathetic scientists. Big Food is relentless in litigating against any law that is likely to be effective in curbing unhealthy eating.

Can Dna Be Speech?, Jorge R. Roig

Scholarly Works

DNA is generally regarded as the basic building block of life itself. In the most fundamental sense, DNA is nothing more than a chemical compound, albeit a very complex and peculiar one. DNA is an information-carrying molecule. The specific sequence of base pairs contained in a DNA molecule carries with it genetic information, and encodes for the creation of particular proteins. When taken as a whole, the DNA contained in a single human cell is a complete blueprint and instruction manual for the creation of that human being. In this article we discuss myriad current and developing ways in which …

Deference To Claims Of Substantial Religious Burden, Caroline Mala Corbin

Articles

No abstract provided.

Quasi-Public Spending, John R. Brooks

Georgetown Law Faculty Publications and Other Works

The United States has increasingly designed certain public spending programs not as traditional tax-financed programs, but rather as mixtures of private expenditures, subsidies, and limited taxes. Thus part of what could have gone to the government as a tax is instead used to purchase the good or service directly, with only incremental taxes and subsidies to manage distributional goals. This Article terms this “quasi-public spending,” and argues that it is descriptive of our evolving approaches to both health care and higher education. Based on this observation, the Article defines and analyzes quasipublic spending and compares it to both traditional public …

The International Right To Health: What Does It Mean In Legal Practice And How Can It Affect Priority Setting For Universal Health Coverage?, Rebecca Dittrich, Leonardo Cubillos, Lawrence O. Gostin, Ryan Li, Kalipso Chalkidou

Georgetown Law Faculty Publications and Other Works

The international right to health is enshrined in national and international law. In a growing number of cases, individuals denied access to high-cost medicines and technologies under universal coverage systems have turned to the courts to challenge the denial of access as against their right to health. In some instances, patients seek access to medicines, services, or technologies that they would have access to under universal coverage if not for government, health system, or service delivery shortfalls. In others, patients seek access to medicines, services, or technologies that have not been included or that have been explicitly denied for coverage …

The International Health Regulations: The Governing Framework For Global Health Security, Lawrence O. Gostin, Rebecca Katz

Georgetown Law Faculty Publications and Other Works

• The International Health Regulations (IHR) are the governing framework for global health security yet require textual and operational reforms to remain effective, particularly as parallel initiatives are developed.
• The World Health Organization (WHO) is the agency charged with oversight of the IHR, and its leadership and efficient functioning are prerequisites for the effective implementation of the IHR.
• We reviewed the historical origins of the IHR and their performance over the past 10 years and analyzed all of the ongoing reform panel efforts to provide a series of politically feasible recommendations for fundamental reform.
• This article offers proposals for fundamental reform—with …

Does Medical Malpractice Law Improve Health Care Quality?, Michael D. Frakes, Anupam B. Jena

Faculty Scholarship

Despite the fundamental role of deterrence in justifying a system of medical malpractice law, surprisingly little evidence has been put forth to date bearing on the relationship between medical liability forces on the one hand and medical errors and health care quality on the other. In this paper, we estimate this relationship using clinically validated measures of health care treatment quality constructed using data from the 1979 to 2005 National Hospital Discharge Surveys and the 1987 to 2008 Behavioral Risk Factor Surveillance System records. Drawing upon traditional, remedy-centric tort reforms — e.g., damage caps — we estimate that the current …

Contract Development In A Matching Market: The Case Of Kidney Exchange, Kimberly D. Krawiec, Wenhao Liu, Marc L. Melcher

Faculty Scholarship

We analyze a new transplant innovation — Advanced Donation, referred to by some as a kidney “gift certificate,” “layaway plan,” or “voucher — as a case study offering insights on both market and contract development. Advanced Donation provides an unusual window into the evolution of the exchange of a single good — a kidney for transplantation — from gift, to simple barter, to exchange with a temporal separation of obligations that relies solely on trust and reputational constraints for enforcement, to a complex matching market in which the parties rely, at least in part, on formal contract to define and …

What Is (And Isn't) Healthism?, Jessica L. Roberts, Elizabeth W. Leonard

Georgia Law Review

What does it mean to discriminateon the basis of health status? Health can, of course, speak to a number of things, such as the length of our lives, our ability to perform mentally and physically, our need for health care, and our risk of injury and incapacity. But the mere relevance of a particular attribute does not mean that considering it should be legally permissible. This Article explores when differentiating on the basis of health is acceptable- perhaps even desirable-and, by contrast, when it is normatively problematic. While we acknowledge that differentiations on the basis of health status can be …

The Collective Fiduciary, Lauren R. Roth

Scholarly Works

Can fiduciaries be made to serve public goals? The movement under the Patient Protection and Affordable Care Act (“ACA”) towards universal access to health insurance requires us to focus on the fiduciary relationships between large organizations providing access to healthcare and the populations they serve. These relationships have become a collective undertaking instead of a direct, personal relationship.

In this Article, I introduce the concept of the collective fiduciary in response to the shift towards uniform, national goals in the realm of health insurance and healthcare. Only through a collective approach can we hold fiduciaries accountable for the welfare of …

Poached Eggs: The Misclassification Of Egg Donors As Independent Contractors And How Egg Donors Can Contribute To The Argument For A New Category Of Worker-The Dependent Contractor, Carol L. Williamson

Georgia Law Review

As the growth in demand for egg donors is met with an
increasing number of women willing to supply their eggs,
changes need to be made to the way egg donors, and other
similarly situated workers, are classified in the
employment context. Most donor contracts are employer-
created forms that designate the donors as independent
contractors and thus spare the clinic the duty of providing
employment benefits. Unlike other on-demand service
providers, such as Uber-drivers, that have recently sought
re-classification as employees, women who donate eggs are
subject to physically invasive procedures and long-term
health risks that particularly obviate the …

The Guardian Ad Litem As The Child's Privilege Holder, Starla Doyal

University of Colorado Law Review

Children in therapy have a strong interest in maintaining the confidentiality of communications with their therapists. Without the assurance of confidential communications, children may not be as open with their therapists, which can make therapy less effective. Although children have privilege rights to their psychotherapist-patient communications just as adults do, their parents generally hold and exercise that privilege. Many courts have recognized that a parent should not hold a child's privilege when the parent and child have divergent interests. This raises the question of who should hold the privilege in the parent's place. In L.A.N. v. L.M.B., the Colorado Supreme …

Instrumental And Transformative Medical Technology, Nicole Huberfeld Professor Of Law

Vanderbilt Journal of Entertainment & Technology Law

This Article considers how medical technologies impact universality in health care. The universality principle, as embodied in the Patient Protection and Affordable Care Act (ACA), eliminated widespread discriminatory practices and provided financial assistance to those otherwise unable to become insured--a democratizing federal act that was intended to stabilize health care policy nationwide. This Article posits that medical technology, as with all of medicine, can be universalizing or exclusionary and that this status roughly correlates to its being "instrumental technology" or "transformative technology." Instrumental technology acts as a tool of medicine and often serves an existing aspect of health care; in …

Will The Internet Of Things Transform Healthcare?, Nicolas P. Terry, Professor Of Law,

Vanderbilt Journal of Entertainment & Technology Law

Emerging technologies like health apps on mobile computing platforms and wearable devices are believed to have the potential to improve individual and population health. Increasingly, however, attention should extend to a far larger cohort of connected devices known as the Internet of Things (IoT), an environment in which devices communicate with each other, health apps, and wearables. The resulting Internet of Health Things promises to do things conventional health providers either cannot do or do them faster and cheaper. First, services are "always on, "providing twenty-four/seven monitoring of the patient or pre-patient. Second, the multiple sensors contained in smartphones or …

Removing Barriers To Telehealth In Oklahoma: Increasing Access To Care And Improving Health Outcomes Across The State, Samuel P. Clancy

Oklahoma Law Review

No abstract provided.

A New Governance Recipe For Food Safety Regulation, Alexia Brunet Marks

Publications

Although food safety is a significant and increasing global health concern, international economic law does not adequately address today’s global food safety needs. While most countries rely on a collection of formalized legal rules to protect food safety, these rules too often fall short. As fiscal constraints impede raising the number of border inspections, formal international commitments (treaties) frequently limit governmental efforts to raise food safety standards. Private companies, meanwhile, can readily adopt higher standards to meet consumer demands and supply chain needs, thus demonstrating more nimbleness and flexibility in adopting the highest food safety standards available. Can countries learn …

Environmental Law, Big Data, And The Torrent Of Singularities, William Boyd

Publications

How will big data impact environmental law in the near future? This Essay imagines one possible future for environmental law in 2030 that focuses on the implications of big data for the protection of public health from risks associated with pollution and industrial chemicals. It assumes the perspective of an historian looking back from the end of the twenty-first century at the evolution of environmental law during the late twentieth and early twenty-first centuries. The premise of the Essay is that big data will drive a major shift in the underlying knowledge practices of environmental law (along with other areas …

Classification Standards For Health Information: Ethical And Practical Approaches, Craig Konnoth

Publications

Secondary health information research requires vast quantities of data in order to make clinical and health delivery breakthroughs. Restrictive policies that limit the use of such information threaten to stymie this research. While the Notice of Proposed Rulemaking (NPRM) for the new Common Rule permits patients to provide broad consent for the use of their information for research, that policy offers insufficient flexibility. This Article suggests a flexible consenting system that allows patients to consent to a range of privacy risks. The details of the system will be fleshed out in future work.