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Articles 1 - 30 of 55
Full-Text Articles in Health Law and Policy
An Introduction To Personal Growth Bets: Using Contract Law To Lose Weight And Quit Smoking, Max Raskin, Jack Millman
An Introduction To Personal Growth Bets: Using Contract Law To Lose Weight And Quit Smoking, Max Raskin, Jack Millman
Notre Dame Journal on Emerging Technologies
Self-improvement is hard. Whether losing weight or quitting smoking, individuals have a difficult time honoring their commitments, especially if the only person they are disappointing is themselves. In this Article, we introduce a new legal mechanism for incentivizing personal growth. We describe this mechanism as a personal growth contract, which allows an individual to make an enforceable agreement with either a counterparty or himself with the aim of self-improvement. We propose the use of smart contracts to help execute unilateral personal growth contracts. Our conclusion is that personal growth contracts should be presumptively legal, provided they do not violate some …
The Code Of Life And Death, Braden R. Leach
The Code Of Life And Death, Braden R. Leach
Notre Dame Journal on Emerging Technologies
Biotechnology is advancing at an astonishing clip, but our safeguards are decades behind. Given new technologies and economies of scale, it is possible for nefarious actors to assemble deadly viruses from scratch using synthetic DNA ordered off the internet. The Select Agents statute helps to prevent malicious actors from acquiring dangerous pathogens, but the Department of Health and Human Services has interpreted it to not cover synthetic DNA. Recognizing the gap, HHS issued guidance recommending that gene synthesis companies verify their customers to ensure their legitimacy and screen genetic sequences for matches to pathogen sequences. Unsurprisingly, voluntary guidance has not …
The High Cost Of Pharmaceutical Acquisitions: Increasing Social Welfare Or Furthering Inequality?, Timothy J. Haltermann
The High Cost Of Pharmaceutical Acquisitions: Increasing Social Welfare Or Furthering Inequality?, Timothy J. Haltermann
Notre Dame Journal on Emerging Technologies
This note will argue that government and regulatory authorities should focus on easing access to downstream innovation by broadening research exemptions to patent infringement. Part I of this note will focus on the current state of patent protection and exclusivity afforded to pharmaceutical companies. Part II will discuss incentives created that lead rational actors to engage in M&A instead of through internal R&D. Part III will address the development of innovation as a standalone theory of harm in merger review, and the fallacies associated with labeling certain transactions as “killer acquisitions.” Finally, Part IV of the note will look at …
A Sleeping Giant: Mhelath Applications, The Gdpr, And The Need For Federal Privacy Regulation In The United States, Kali Peeples
A Sleeping Giant: Mhelath Applications, The Gdpr, And The Need For Federal Privacy Regulation In The United States, Kali Peeples
Notre Dame Journal on Emerging Technologies
An analysis of privacy regulation concerning mHealth apps is a multifaceted process that requires the examination of changes within not only the healthcare space but also the technological world, as well as the legislative history and intent of various nations.The main issue being addressed in this paper is whether the United States should create nationwide legislation that directly relates to mHealth data protection or continue with a self-regulatory method. Part I focuses on the development and rapid creation of mHealth apps within the past decade. Part II seeks to illustrate the distinct privacy concerns of mHealth apps by concentrating on …
The Price Of Competition: Analyzing Anticompetitive Tactics In Pharmaceutical Markets During The Hatch-Waxman Era, William Ulrich
The Price Of Competition: Analyzing Anticompetitive Tactics In Pharmaceutical Markets During The Hatch-Waxman Era, William Ulrich
Notre Dame Journal on Emerging Technologies
Pharmaceutical manufacturers can delay the generic entry for a blockbuster drug. In order to keep the generic system on track, it is critical to expose the various avenues of generic delay. Part I of this Note briefly describes the generic entry process as prescribed by the Hatch-Waxman Act. Part II details four well-known tactics used by brand-name manufacturers to block or delay the entry of generic competition, highlighting how the tactics are successful. Part III concludes by examining the nature of the various problems and arguing that the first step towards ending the different forms of anticompetitive behavior is through …
Remedying The Immortal: The Doctrine Of Accession And Patented Human Cell Lines, Julia E. Fissore-O'Leary
Remedying The Immortal: The Doctrine Of Accession And Patented Human Cell Lines, Julia E. Fissore-O'Leary
Notre Dame Law Review
Importantly, though this Note employs Henrietta Lacks as the illustrative, paradigmatic case for the theory of accession it proposes, accession can be, and should be, broadly construed to apply to all like-situated patients. Part I of this Note briefly explains the timeless human-body-as-property debate. Next, Part II addresses the concept of accession—its theoretical underpinnings, definitions, and amenability to this and other lawsuits. Part III applies accession to HeLa and develops a methodology for calculating damages in this unique setting. This Note does not pretend to present a perfectly wrought formula. Instead, it offers several possibilities for determining compensation. Finally, …
Vaccination Evasion: Legislating A Solution Through A Revised Vaccinate All Children Act Of 2019, Sophia C. Aguilar
Vaccination Evasion: Legislating A Solution Through A Revised Vaccinate All Children Act Of 2019, Sophia C. Aguilar
Journal of Legislation
No abstract provided.
Efficient Ethical Principles For Making Fatal Choices, W. Kip Viscusi
Efficient Ethical Principles For Making Fatal Choices, W. Kip Viscusi
Notre Dame Law Review
Resource allocations of all kinds inevitably encounter financial constraints, making it infeasible to make financially unbounded commitments. Such resource constraints arise in almost all health and safety risk contexts, which has led to a regulatory oversight process to ascertain whether the expected benefits of major regulations outweigh the costs. The economic approach to monetizing health and safety risks is well established and is based on the value of a statistical life (“VSL”). Government agencies use these values reflecting attitudes toward small changes in risk to monetize the largest benefit component of regulations—that dealing with mortality risks. This procedure consequently bases …
How Congress Can Help Raise Vaccine Rates, Dorit Rubinstein Reiss, Y. Tony Yang
How Congress Can Help Raise Vaccine Rates, Dorit Rubinstein Reiss, Y. Tony Yang
Notre Dame Law Review Reflection
2019 saw an unusually high number of measles cases, and other preventable disease outbreaks, at least in part linked to vaccines refusal. States are considering legislative responses. This Essay examines what role the federal government can fill in increasing vaccines rates. The Essay suggests that the federal government has an important role to fill in funding research, coordination, and local efforts. It also suggests that a federal school vaccine mandate is likely not the solution: first, such mandates can run into plausible constitutional challenges, and second, there are policy arguments against it. The policy contentions include the unfairness of imposing …
Covid-19 And Domestic Travel Restrictions, Katherine Florey
Covid-19 And Domestic Travel Restrictions, Katherine Florey
Notre Dame Law Review Reflection
The strict controls that many jurisdictions, including most U.S. states, established to contain the COVID-19 pandemic have proven difficult to sustain over time, and most places are moving to lift them. Internationally, many plans to ease lockdowns have retained some form of travel restrictions, including the “green zone” plans adopted by France and Spain, which limit travel between regions with widespread community transmission of COVID-19 and those without it. By contrast, most U.S. states lifting shelter-in-place orders have opted to remove limits on movement as well. This Essay argues that this situation is unwise: it tends to create travel patterns …
Preventing The Corruption Of Healthcare Algorithms, Philip M. Nichols
Preventing The Corruption Of Healthcare Algorithms, Philip M. Nichols
Notre Dame Journal on Emerging Technologies
The intersection of technology and healthcare will radically change the provision of healthcare services. The full extent of the changes cannot be known now, but the direction is clear: collection of voluminous data and tools powerful enough to analyze that data will facilitate the design of algorithms that will enable machines to make important decisions regarding diagnoses and treatments. In addition to the possible benefits, policymakers and scholars have focused on issues of privacy and potential bias. The potential for corruption of the design of healthcare algorithms has been ignored, but the potential for corruption is real and dangerous. This …
The Invisible Prison: Pathways And Prevention, Margaret Brinig, Marsha Garrison
The Invisible Prison: Pathways And Prevention, Margaret Brinig, Marsha Garrison
Journal Articles
In this paper, we propose a new strategy for curbing crime and delinquency and demonstrate the inadequacy of current reform efforts. Our analysis relies on our own, original research involving a large, multi-generational sample of unmarried fathers from a rust-belt region of the United States as well as the conclusions of earlier researchers.
Our own research data are unusual in that they are holistic and multigenerational: The Court-based record system we utilized for data collection provided detailed information on child maltreatment, juvenile status and delinquency charges, child support, parenting time, orders of protection, and residential mobility for focal children (the …
Going Rogue: Mobile Research Applications And The Right To Privacy, Stacey A. Tovino
Going Rogue: Mobile Research Applications And The Right To Privacy, Stacey A. Tovino
Notre Dame Law Review
This Article investigates whether nonsectoral state laws may serve as a viable source of privacy and security standards for mobile health research participants and other health data subjects until new federal laws are created or enforced. In particular, this Article (1) catalogues and analyzes the nonsectoral data privacy, security, and breach notification statutes of all fifty states and the District of Columbia; (2) applies these statutes to mobile-app-mediated health research conducted by independent scientists, citizen scientists, and patient researchers; and (3) proposes substantive amendments to state law that could help protect the privacy and security of all health data subjects, …
The Unconstitutionality Of The Protecting Access To Care Act Of 2017’S Cap On Noneconomic Damages In Medical Malpractice Cases, Kaeleigh P. Christie
The Unconstitutionality Of The Protecting Access To Care Act Of 2017’S Cap On Noneconomic Damages In Medical Malpractice Cases, Kaeleigh P. Christie
Journal of Legislation
No abstract provided.
There’S A Pill For That! State Law Approaches To Workplace Drug Testing Policy In The Age Of Prescription Opioids, Katie Meikle
There’S A Pill For That! State Law Approaches To Workplace Drug Testing Policy In The Age Of Prescription Opioids, Katie Meikle
Journal of Legislation
No abstract provided.
Illegitimate Overprescription: How Burrage V. United States Is Hindering Punishment Of Physicians And Bolstering The Opioid Epidemic, Alyssa M. Mcclure
Illegitimate Overprescription: How Burrage V. United States Is Hindering Punishment Of Physicians And Bolstering The Opioid Epidemic, Alyssa M. Mcclure
Notre Dame Law Review
Due to the concerns Burrage raises and its implications for the nation’s current opioid crisis, this Note proposes that Congress should broaden the circumstances in which the penalty enhancement of section 841(b) may be applied. Part I of this Note discusses the opioid crisis and the role physicians play in it. Part II explores the section of the Controlled Substances Act used to criminally charge physicians and the exception the Act provides for physicians prescribing opioids within the scope of relevant medical conduct and professional practice. Part III analyzes Burrage v. United States and examines the immediate legal consequences of …
Prolegomenon On Pornography, Gerard V. Bradley
Prolegomenon On Pornography, Gerard V. Bradley
Journal Articles
Debates about pornography have always included arguments about its “effects.” Now we can gauge the effects of specifically computerized pornography. These novel effects include scientific research showing that digitalized pornography affects the brain and nervous system in harmful ways that no centerfold ever could. Accessing pornography online makes interactive and directive engagement with it possible, so that the consumer is no longer limited to staring at a two-dimensional representation of a stranger in the nude. The action now is more adventurous. The consumer’s involvement is more intimate and directive. What he does lies somewhere between looking at a centerfold and …
Mental Health Crisis In Maryland: A Lack Of Hospital Beds For The Mentally Ill Presents Maryland Legislature With Concerns About The Legality And Practicality Of Detainment, Ryan D. Konstanzer
Mental Health Crisis In Maryland: A Lack Of Hospital Beds For The Mentally Ill Presents Maryland Legislature With Concerns About The Legality And Practicality Of Detainment, Ryan D. Konstanzer
Journal of Legislation
No abstract provided.
Do Desperate Times Really Call For Desperate Measures? The Ethical Dilemma Behind The Regulation And Use Of Experimental Drugs, Lauren Kuehn
Do Desperate Times Really Call For Desperate Measures? The Ethical Dilemma Behind The Regulation And Use Of Experimental Drugs, Lauren Kuehn
Notre Dame Journal of International & Comparative Law
This Note will argue that, unlike what many patients believe, the U.S. Food and Drug Administration (FDA) plays an invaluable and imperative role in seeking the efficacy and safety of new treatment options and drugs. The balance of interests between those who are terminally ill, who wish to see increased access to unapproved medicines; the general public, who has an interest in preserving the drug approval process; and the FDA, who has been mandated by law to safeguard the safety of the general public, creates a tension that will continue to go unresolved. Thus, the patients who continue to advocate …
U.S. Biological Quarantine: A Look At The Legal Framework, Katherine T. Rooney
U.S. Biological Quarantine: A Look At The Legal Framework, Katherine T. Rooney
Journal of Legislation
Biological terrorism is a growing problem. Search and seizure protections have an on-going balancing relationship with national security that is balanced by a least restrictive means test. The Kaci Hickox case exposed the difficulty of maintaining the civil rights protections of search and seizure while combating a potentially catastrophic danger.
King V. Burwell: The Supreme Court's Missed Opportunity To Cure What Ails Chevron, Vanessa L. Johnson, Marisa Finley, J. James Rohack
King V. Burwell: The Supreme Court's Missed Opportunity To Cure What Ails Chevron, Vanessa L. Johnson, Marisa Finley, J. James Rohack
Journal of Legislation
The article outlines the construct of the ACA’s premium assistance tax credits, explores the legal controversies surrounding these subsidies, uses the tax subsidies cases to demonstrate the flaws in the Chevron framework, and argues that the Supreme Court should have framed its King v. Burwell analysis in a way that would have cured, rather than ignored, the ails of Chevron.
The Priority Of Persons Revisited, John Finnis
The Priority Of Persons Revisited, John Finnis
Journal Articles
This essay, in the context of a conference on justice, reviews and reaffirms the main theses of “The Priority of Persons” (2000), and supplements them with the benefit of hindsight in six theses. The wrongness of Roe v. Wade goes wider than was indicated. The secularist scientistic or naturalist dimension of the reigning contemporary ideology is inconsistent with the spiritual reality manifested in every word or gesture of its proponents. The temporal continuity of the existence of human persons and their communities is highly significant for the common good, which is the point and measure of social justice, properly understood. …
Science, Public Bioethics, And The Problem Of Integration, O. Carter Snead
Science, Public Bioethics, And The Problem Of Integration, O. Carter Snead
Journal Articles
Public bioethics — the governance of science, medicine, and biotechnology in the name of ethical goods — is an emerging area of American law. The field uniquely combines scientific knowledge, moral reasoning, and prudential judgments about democratic decision making. It has captured the attention of officials in every branch of government, as well as the American public itself. Public questions (such as those relating to the law of abortion, the federal funding of embryonic stem cell research, and the regulation of end-of-life decision making) continue to roil the public square.
This Article examines the question of how scientific methods and …
Public Bioethics And The Bush Presidency, O. Carter Snead
Public Bioethics And The Bush Presidency, O. Carter Snead
Journal Articles
Public bioethics figured prominently during the tenure of President George W. Bush. This Article explores the Bush legacy in this domain. It begins by articulating and examining the grounding norms of President Bush’s approach to public bioethics. Next, it analyzes how these norms were applied to concrete areas of concern. Building on this analysis, the next section reflects on what the President’s actions illustrate about the capacity of the Executive Branch to shape public bioethics. The Article concludes with a brief discussion of the possible metrics by which the Bush Administration’s efforts might be judged, and then offers several assessments …
Federalism Doctrines And Abortion Cases: A Response To Professor Fallon, Anthony J. Bellia
Federalism Doctrines And Abortion Cases: A Response To Professor Fallon, Anthony J. Bellia
Journal Articles
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 …
Unenumerated Rights And The Limits Of Analogy: A Critque Of The Right To Medical Self-Defense, O. Carter Snead
Unenumerated Rights And The Limits Of Analogy: A Critque Of The Right To Medical Self-Defense, O. Carter Snead
Journal Articles
Volokh’s project stands or falls with the claim that the entitlement he proposes is of constitutional dimension. If there is no fundamental right to medical self-defense, the individual must, for better or worse, yield to the regulation of this domain in the name of the values agreed to by the political branches of government. Indeed, the government routinely restricts the instrumentalities of self-help (including self-defense) in the name of avoiding what it takes to be more significant harms. This same rationale accounts for current governmental limitations on access to unapproved drugs and the current ban on organ sales. The FDA …
Prophecy And Casuistry: Abortion, Torture And Moral Discourse, M. Cathleen Kaveny
Prophecy And Casuistry: Abortion, Torture And Moral Discourse, M. Cathleen Kaveny
Journal Articles
In turn of the 21st century United States there are serious moral disputes over issues such as abortion and torture among persons who see themselves as belonging to the same moral tradition. These disputes have not given rise to fruitful discussion about differences, but instead led to a breakdown of conversation and even of community. A part of these clashes and breakdowns are not the result of mutually inconsistent moral premises, but are driven by tensions between two styles of moral discourse, the prophetic and casuistical. The former invokes the absolute and fiery rhetorical style of biblical prophets while the …
The (Surprising) Truth About Schiavo: A Defeat For The Cause Of Autonomy, O. Carter Snead
The (Surprising) Truth About Schiavo: A Defeat For The Cause Of Autonomy, O. Carter Snead
Journal Articles
A survey of the commentary following the conclusion of the Theresa Marie Schiavo matter leaves one with the impression that the case was a victory for the cause of autonomy and the right of self-determination in the end-of-life context. In this essay, I seek to challenge this thesis and demonstrate that, contrary to popular understanding, it is the defenders of autonomy and self-determination who should be most troubled by what transpired in the Schiavo case. In support of this claim, I will first set forth (in cursory fashion) the underlying aim of the defenders of autonomy in this context. Then, …
Preparing The Groundwork For A Responsible Debate On Stem Cell Research And Human Cloning, O. Carter Snead
Preparing The Groundwork For A Responsible Debate On Stem Cell Research And Human Cloning, O. Carter Snead
Journal Articles
The debate over both cloning and stem cell research has been intense and polarizing. It played a significant role in the recently completed presidential campaign, mentioned by both candidates on the stump, at both parties' conventions, and was even taken up directly during one of the presidential debates. The topic has been discussed and debated almost continuously by the members of the legal, scientific, medical, and public policy commentariat. I believe that it is a heartening tribute to our national polity that such a complex moral, ethical, and scientific issue has become a central focus of our political discourse. But, …
Dynamic Complementarity: Terri's Law And Separation Of Powers Principles In The End-Of-Life Context, O. Carter Snead
Dynamic Complementarity: Terri's Law And Separation Of Powers Principles In The End-Of-Life Context, O. Carter Snead
Journal Articles
The bitter dispute over the proper treatment of Theresa Marie Schiavo - a severely brain-damaged woman, unable to communicate and with no living will or advance directive - has garnered enormous attention in the media, both national and international. What began as a heated disagreement between Ms. Schiavo's husband and parents mushroomed into a massive political conflict involving privacy advocates on one side, and right-to-life and disability activists on the other. The battle raged on the editorial pages of the world's newspapers, in the courts, and ultimately, in the legislative and executive branches of the Florida state government. After nearly …