Health Law and Policy Commons^™

American Star Chamber: Online Misinformation, Government Intervention, And The Intellectual Matrix Of The First Amendment, Emily E. Burton

Catholic University Journal of Law and Technology

Just as monarchs and clerical authorities struggled to respond to seditious and heretical writings enabled by the invention of the printing press, twenty-first century governments are experiencing a similar information revolution as a result of the digital age and a rising tide of what the United States has labeled online misinformation. Like the printing press, the Internet has enabled the spread of information at an exponentially lower cost and an exponentially higher speed as it extends the ability to publish thoughts and opinions to an increasingly diverse array of individuals. Although this was largely celebrated during the first two decades …

The Consumer’S Choice To Boycott, Agnes Bresee

Seattle University Law Review

In the wake of employees losing their jobs upon voicing their political opinions concerning Israel, Harvard and Columbia law students’ job offers being rescinded upon expressing support for Palestine, and the names and social media profiles of individuals who support Palestine being collected and listed on Canary Mission, such backlash may leave many Americans wondering what form of resistance to settler-colonialist apartheid is acceptable in the twenty-first century. Recently, the movement to collectively boycott brands like Starbucks, which sued its Worker’s Union for a tweet expressing support for Palestine; Disney, which donated money to Israel; and McDonald’s, where a location …

A Different Approach To Agency Theory And Implications For Esg, Jonathan Bonham, Amoray Riggs-Cragun

Seattle University Law Review

In conventional agency theory, the agent is modeled as exerting unobservable “effort” that influences the distribution over outcomes the principal cares about. Recent papers instead allow the agent to choose the entire distribution, an assumption that better describes the extensive and flexible control that CEOs have over firm outcomes. Under this assumption, the optimal contract rewards the agent directly for outcomes the principal cares about, rather than for what those outcomes reveal about the agent’s effort. This article briefly summarizes this new agency model and discusses its implications for contracting on ESG activities.

Overseeing The Administrative State, Jill E. Fisch

Seattle University Law Review

In a series of recent cases, the Supreme Court has reduced the regulatory power of the Administrative State. Pending cases offer vehicles for the Court to go still further. Although the Court’s skepticism of administrative agencies may be rooted in Constitutional principles or political expediency, this Article explores another possible explanation—a shift in the nature of agencies and their regulatory role. As Pritchard and Thompson detail in their important book, A History of Securities Law in the Supreme Court, the Supreme Court was initially skeptical of agency power, jeopardizing Franklin Delano Roosevelt (FDR)’s ambitious New Deal plan. The Court’s acceptance …

The Sec, The Supreme Court, And The Administrative State, Paul G. Mahoney

Seattle University Law Review

Pritchard and Thompson have given those of us who study the SEC and the securities laws much food for thought. Their methodological focus is on the internal dynamics of the Court’s deliberations, on which they have done detailed and valuable work. The Court did not, however, operate in a vacuum. Intellectual trends in economics and law over the past century can also help us understand the SEC’s fortunes in the federal courts and make predictions about its future.

A Hard Pill To Swallow: The Abysmal Mental Health Standards Of Detained Immigrant Children In The United States, Rama Bankesly

Seattle University Law Review

After setting foot into the U.S., unaccompanied children must learn to navigate academic and legal systems while receiving little support and carrying the heavy burden of effects of trauma on their mental health. They need access to mental health care from qualified professionals, but as this Comment will explain, they systematically fail to receive care, as can be seen in cases like Doe v. Shenandoah Valley Juv. Ctr. Comm’n. In Shenandoah, an unaccompanied child arrived in the U.S. and was placed in a facility that failed to provide remotely adequate mental health care and in fact was subjected …

Psychedelics, Psychosocial Support, And Psychotherapy: Why It Matters For The Law, Ethics, And Business Of Medical Psychedelic Use, I. Glenn Cohen

Fordham Law Review

No abstract provided.

Students For Fair Admissions: Affirming Affirmative Action And Shapeshifting Towards Cognitive Diversity?, Steven A. Ramirez

Seattle University Law Review

The Roberts Court holds a well-earned reputation for overturning Supreme Court precedent regardless of the long-standing nature of the case. The Roberts Court knows how to overrule precedent. In Students for Fair Admissions v. Harvard (SFFA), the Court’s majority opinion never intimates that it overrules Grutter v. Bollinger, the Court’s leading opinion permitting race-based affirmative action in college admissions. Instead, the Roberts Court applied Grutter as authoritative to hold certain affirmative action programs entailing racial preferences violative of the Constitution. These programs did not provide an end point, nor did they require assessment, review, periodic expiration, or revision for greater …

Fda Modernization Act 2.0: The Beginning Of The End For Animal Testing In Drug Development, Julia Williams

Animal Law Review

Historical drug testing protocols utilized animal testing to determine whether drugs were safe and effective for use in humans. However, recognizing that testing drugs on other species is potentially dangerous for humans, troubled by failures, unnecessarily expensive, and time consuming, the FDA Modernization Act 2.0, passed in December 2022, removed animal testing as a requirement for new drug applications. While this was an important step forward, a notable failure of that Act is that it did not go far enough to end animal testing. Accordingly, this Article proposes an FDA Modernization Act 3.0.

The FDA Modernization Act 3.0 would ensure …

Can Informed Consent Solve Ai Bias?, W. Nicholson Price Ii

Reviews

Artificial intelligence (AI) is moving increasingly rapidly into health care (as indeed into everything else). But it has problems there (as indeed everywhere else!). What’s to be done, in particular, about the deeply embedded biases along racial and other lines that permeate the whole world of health and, as such, are likely to be encoded in AI?

Khiara Bridges gives an answer that seems mild but carries roots of revolution. In Race in the Machine: Racial Disparities in Health and Medical AI, she argues that informed consent is a key lever to pull in fighting these racial disparities. But not …

Reducing Food Scarcity: The Benefits Of Urban Farming, S.A. Claudell, Emilio Mejia

Journal of Nonprofit Innovation

Urban farming can enhance the lives of communities and help reduce food scarcity. This paper presents a conceptual prototype of an efficient urban farming community that can be scaled for a single apartment building or an entire community across all global geoeconomics regions, including densely populated cities and rural, developing towns and communities. When deployed in coordination with smart crop choices, local farm support, and efficient transportation then the result isn’t just sustainability, but also increasing fresh produce accessibility, optimizing nutritional value, eliminating the use of ‘forever chemicals’, reducing transportation costs, and fostering global environmental benefits.

Imagine Doris, who is …

Regulating The Revolution: A Legal Roadmap To Optimizing Ai In Healthcare, Fazal Khan

Minnesota Journal of Law, Science & Technology

No abstract provided.

The Current State Of Abortion Law In Virginia Leaves Victims Of Domestic And Sexual Violence Vulnerable To Abuse: Why Virginia Should Codify The Right To Abortion In The State Constitution†, Courtenay Schwartz

University of Richmond Law Review

All people must have access to safe and legal reproductive health care—especially victims of sexual and domestic violence who can and do become pregnant because of the violence they experience. This year, the United States Supreme Court overturned Roe v. Wade and Planned Parenthood of Southeastern Pennsylvania v. Casey in Dobbs v. Jackson Women’s Health Organization. In doing so, the Supreme Court held that the Constitution does not protect the right to an abortion. Though abortion access is currently protected in Virginia, this could change with each new General Assembly session. To guard against the danger that this poses to …

Transcript: The Future Of Ivf Post Dobbs, Rebecca Feinberg

Journal of Law and Health

The following is a transcription from The Healthcare and Privacy Law Consequences Following Dobbs presented at Cleveland State University College of Law by The Journal of Law & Health on February 17, 2023. This transcript has been lightly edited for clarity and to reflect updates in the relevant law since the time of transcription.

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

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 …

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 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

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 …

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 …

Femtechnodystopia, Leah R. Fowler, Michael Ulrich

Faculty Scholarship

Reproductive rights, as we have long understood them, are dead. But at the same time history seems to be moving backward, technology moves relentlessly forward. Femtech products, a category of consumer technology addressing an array of “female” health needs, seem poised to fill gaps created by states and stakeholders eager to limit birth control and abortion access and increase pregnancy surveillance and fetal rights. Period and fertility tracking applications could supplement or replace other contraception. Early digital alerts to missed periods can improve the chances of obtaining a legal abortion in states with ever-shrinking windows of availability or prompt behavioral …

America Is Tripping: Psychedelic Pharmaceutical Patent Reforms Fostering Access, Innovation, And Equity, Quentin Barbosa

Brooklyn Law Review

A resurgence in federally approved psychedelic research has spawned the Psychedelic Renaissance, and with each study it becomes increasingly clear that psychedelics have the potential to revolutionize mental health treatment. However, if Congress fails to reform the industry’s patent procedures, threats to innovation in the budding field of psychedelic medicine will manifest in their ugliest form. Psychedelics are a class of hallucinogenic drugs that primarily trigger substantially altered states of consciousness, including psychological, visual, and auditory changes. Medical research on psychedelics has produced staggering results that indicate psychedelics have the potential to be significantly more effective in treating mental illnesses …

Clicking Away Consent: Establishing Accountability And Liability Apportionment In Direct-To-Consumer Healthcare Artificial Intelligence, Stephanie L. Lee

Brooklyn Law Review

Artificial Intelligence (AI) and machine learning are making sweeping changes across all industries, and health care is no exception. AI promises to revolutionize patient treatment with the development of algorithm-driven tools to improve efficiency in clinical care. As alluring as machine-driven learning may be given its potentialities, however, the incorporation of AI into the healthcare field has also been received with trepidation. This fear is understandable given the lack of transparency to the public surrounding the exact mechanisms for creating algorithms and the reasoning followed by the software. Indeed, AI in the healthcare system is aptly known as “black-box medicine.” …

Pooling Patents For Pandemic Progress: Mrna Vaccines And The Broader Context Of Modernatx Inc V. Pfizer Inc., Francis Brefo

DePaul Journal of Art, Technology & Intellectual Property Law

No abstract provided.

Jurisgenerative Tissues: Sociotechnical Imaginaries And The Legal Secretions Of 3d Bioprinting, Roxanne Mykitiuk, Joshua Shaw

Articles & Book Chapters

Three-dimensional ‘bioprinting’ is under development, which may produce living human organs and tissues to be surgically implanted in patients. Like tissue engineering and regenerative medicine generally, the process of bioprinting potentially disrupts experience of the human body by redefining understandings of, and becoming actualised in new practices and regimes in relation to, the body. The authors consider how these novel sociotechnical imaginaries may emerge, having regard to law’s contribution to, as well as its possible transformation by, the process of 3D bioprinting. The authors draw on Gilbert Simondon and corporeal, material feminists to account for these disruptions as ‘ontogenetic,’ in …

Law Library Blog (March 2023): Legal Beagle's Blog Archive, Roger Williams University School Of Law

Law Library Newsletters/Blog

No abstract provided.

When Congress Passes The Buck: How Russia’S Invasion Of Ukraine Exposed Flaws In Granting The President Sanctioning Powers, Artem M. Joukov, Samantha M. Caspar

Seattle University Law Review

The United States (U.S.) Constitution provides few limitations on endowing the Executive Branch with powers to govern foreign trade, which was initially granted to the Legislature. In a world where global trade dominates, the power over foreign trade can be more important than the power over domestic matters. Leaving unrestrained trade authority to the Executive Branch may cause hazards for Americans and foreigners alike. Russia’s war in Ukraine demonstrates the flaws in permitting the Executive Branch to unilaterally sanction foreign states. This Article demonstrates how reactive Executive Branch policies infringed on the welfare and safety of American citizens and foreigners …

Pedaling Backwards: Examining The King County Board Of Health’S Choice To Repeal Its Bicycle Helmet Law, Schuyler M. Peters

Seattle University Law Review

In Part I, this Comment will explain the Helmet Law itself and the timeline that ultimately led to its repeal. Part II will focus on the positive impact of the Helmet Law, the dangers associated with the repeal, why the repeal should not have occurred in the manner it did, and what societal costs stem from the BOH’s decision. Part III will address the actions that must be taken to revoke this repeal and the reasons behind these alternative pathways, including an Equity Impact Review study specifically on the consequences of repeal, a collaborative outreach program to bring helmets to …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Beyond The Business Case: Moving From Transactional To Transformational Inclusion, Jamillah Bowman Williams

Seattle University Law Review

While workplace diversity is a hot topic, the extent to which the diversity management movement has effectively improved intergroup relations and reduced racial inequality remains unclear.1 Despite large investments in diversity and inclusion training and other company wide initiatives, historically excluded groups remain vastly underrepresented in leadership and the most lucrative careers, such as finance, law, and technology. This calls the efficacy of diversity, equity, and inclusion (DEI) efforts into question, particularly with respect to reducing racial inequality in the workplace.

This Article explains why it is time for organizational leaders to move beyond the transactional case for diversity and …