Health Law and Policy Commons^™

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 …

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.

After Tackett: Incomplete Contracts For Post-Employment Healthcare, Maria O'Brien

Faculty Scholarship

This paper examines the recent U.S. Supreme Court retiree health care decision in Tackett v. M & G Polymers and focuses, in particular, on the ostensibly odd silence with respect to a critical contract term — whether the parties in fact agreed that these benefits were vested. Although the union in Tackett insisted these welfare benefits were clearly intended to vest and the employer now asserts they can be modified at any time, the collective bargaining agreement and supporting documents are ambiguous on this question. This paper examines how and why this “silence” persisted for so many decades and concludes …

Introduction To Thinking About A Post-Aca World: Litigation, Cost Shifting And Enforcement Of Statutory Rights, Maria O'Brien

Faculty Scholarship

At its annual gathering in 2016, members of the Employee Benefits and Executive Compensation and Law, Medicine and Healthcare Sections of the Association of American Law Schools (AALS) jointly sponsored a discussion of the future of the Affordable Care Act (ACA) following the Supreme Court's decision in King v. Burwell.' What follows are the papers generated for the panel discussion. The panelists² were asked to evaluate the future of the ACA from a distinct perspective.

An Assessment Of The Human Subjects Protection Review Process For Exempt Research, Jonathan D. Loe, Alex Winkelman, Christopher Robertson

Faculty Scholarship

Medical and public health research includes surveys, interviews, and biospecimens - techniques that do not present substantial risks to subjects. Consequently, this research is exempt from regulation under the Federal Common Rule. Nevertheless, at many institutions, exempt research is frequently subject to the same regulatory process that is required for non-exempt research, requiring the consumption of time and resources for review by Institutional Review Board members or staff. The federal government has indicated an intention to reform and centralize this system, but has not yet specified the form that it will use instead. By examining the policies of the top …

Adjudicating Risk: Aids, Crime, And Culpability, Aziza Ahmed

Faculty Scholarship

The AIDS epidemic continues to pose significant public health challenges, especially given that the spread of the virus outpaces the AIDS response.¹ Importantly, HIV continues to disproportionately impact socially and economically marginalized communities. In countries with concentrated epidemics,² it is racial minorities, sex workers, men who have sex with men, and drug users who face the brunt of the epidemic.³ In the United States, the data is startling⁴ : 44% of new infections were among African-Americans, and among African-Americans contracting HIV, 57% were among gay and bisexual men.⁵ In 2016, the CDC found that one …

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 …