Health Law and Policy Commons^™

Accountability, Secrecy, And Innovation In Ai-Enabled Clinical Decision Software, Arti K. Rai, Isha Sharma, Christina Silcox

Faculty Scholarship

This article employs analytical and empirical tools to dissect the complex relationship between secrecy, accountability, and innovation incentives in clinical decision software enabled by machine learning (ML-CD). Although secrecy can provide incentives for innovation, it can also diminish the ability of third parties to adjudicate risk and benefit responsibly. Our first aim is descriptive. We address how the interrelated regimes of intellectual property law, Food and Drug Administration (FDA) regulation, and tort liability are currently shaping information flow and innovation incentives. We find that developers regard secrecy over training data and details of the trained model as central to competitive …

The Enhanced Danger Of Physicians’ Off-Label Prescribing, Doriane Lambelet Coleman, Philip M. Rosoff

Faculty Scholarship

The COVID-19 pandemic represents a major challenge to both technologically advanced and resource-poor countries. There are currently no effective treatments for severe disease other than supportive care and advanced life support measures, including the use of mechanical ventilators. With the urgency and necessity bred from desperation, there have been many calls to utilize unproven therapies, such as hydroxychloroquine, for which little evidence of efficacy exists. We have previously argued that such off-label use, while legal, is problematic (and even dangerous) and have suggested several regulatory remedies that could protect patients and advance their interests while preserving the reasonable authority of …

Kidney Donation And The Consent Of The Poor, Philip J. Cook, Kimberly D. Krawiec

Faculty Scholarship

In "Consentability," Nancy Kim tackles an important and current topic—in an age of increasing options about how to live, die, and procreate, what limits, if any, should the law place on those choices? "Consentability" is a valuable resource for scholars and policymakers alike, summarizing the arguments for and against government intrusion on the choices of consenting adults with encyclopedic thoroughness. After weighing the arguments, Kim proposes that “bodily integrity exchanges” be permitted, subject to limitations. Although we agree with the general conclusion that bodily integrity exchanges should be permitted, we disagree with the specific limitations that treat the decisions of …

Medical Civil Rights As A Site Of Activism: A Reply To Critics, Craig Konnoth

Publications

See Craig Konnoth, Medicalization and the New Civil Rights, 72 Stan. L. Rev. 1165 (2020).

See also Rabia Belt & Doron Dorfman, Response, Reweighing Medical Civil Rights, 72 Stan. L. Rev. Online 176 (2020), https://www.stanfordlawreview.org/online/reweighing-medical-civil-rights/; Allison K. Hoffman, Response, How Medicalization of Civil Rights Could Disappoint, 72 Stan. L. Rev. Online 165 (2020), https://www.stanfordlawreview.org/online/how-medicalization-of-civil-rights-could-disappoint/.

Unsafe At Any Campus: Don't Let Colleges Become The Next Cruise Ships, Nursing Homes, And Food Processing Plants, Peter H. Huang, Debra S. Austin

Publications

The decision to educate our students via in-person or online learning environments while COVID-19 is unrestrained is a false choice, when the clear path to achieve our chief objective safely, the education of our students, can be done online. Our decision-making should be guided by the overriding principle that people matter more than money. We recognize that lost tuition revenue if students delay or defer education is an institutional concern, but we posit that many students and parents would prefer a safer online alternative to riskier in-person options, especially as we get closer to fall, and American death tolls rise. …

Key Expert Stakeholder Perceptions Of The Law Of Genomics: Identified Problems And Potential Solutions, Lauren E. Clatch

Law Faculty Publications

The law on human genomics in the United States is currently in transition and under debate. The rapid evolution of the science, burgeoning clinical research, and growing clinical application pose serious challenges for federal and state law. Newer genomic assays, such as gene panels, whole exome and whole genome sequencing that can assess many or all of a patient’s genetic variants are different from former genetic assays that consist of assessing for variants in specific genes that indicate risk for medical conditions and for single-gene Mendelian disorders. Overall, single-gene genetic testing has primarily been used for risk prediction, disease diagnosis, …

Cruzan And The “Right To Die”, Thomas Wm. Mayo

SMU Law Review

No abstract provided.

Video Advance Directives: Growth And Benefits Of Audiovisual Recording, Thaddeus Mason Pope

SMU Law Review

No abstract provided.

Hiv Law And Policy In The United States: A Tipping Point, Scott Skinner-Thompson

Publications

The fight to effectively treat and stop the spread of the human immunodeficiency virus (HIV) has made meaningful progress both in the United States and globally. But within the United States that progress has been uneven across various demographic groups and geographic areas, and has plateaued. While scientific advances have led to the development of medicine capable of both treating and preventing HIV, law and policy dictate who will have ready access to these medicines and other prevention techniques, and who will not. Law and policy also play a crucial role in determining whether HIV will be stigmatized, discouraging people …

Regulatory De-Arbitrage In Twenty-First Century Cures Act's Health Information Regulation, Craig Konnoth

Publications

Health data regulation can be thought of at two levels. First, the micro- level of regulation has to do with Electronic Health Records (EHRs). Second, the macro-level concerns the networks on which EHRs are transmitted. The micro- and macro-levels of regulation interact. For example, EHRs need to be configured so that they can be transmitted on mandated networks. As a result, the lines do sometimes blur.

That said, the 21st Century Cures Act (Cures) clearly takes a dual approach to regulation. Cures was passed in December 2016 on a bipartisan basis. Its mandate was to address health data regulation at …

A Recent Renaissance In Privacy Law, Margot Kaminski

Publications

Considering the recent increased attention to privacy law issues amid the typically slow pace of legal change.

Reproductive Health Care Exceptionalism And The Pandemic, Helen Norton

Publications

No abstract provided.

Designing Policy Solutions To Build A Healthier Rural America, Elizabeth Weeks, Sameer Vohra, Carolyn Pointer, Amanda Fogleman, Thomas Albers, Anish Patel

Scholarly Works

Disparities exist in the livelihood and opportunities for people living in America’s rural communities. These differences result in a much sicker rural America compared to its urban counterpart. Rural counties have higher rates of smoking, obesity, child poverty, and teen pregnancies than urban counties.1 More uninsured adults live in rural areas, causing rural hospitals to close and/or cut vital services such as obstetrics care.2 Rural hospitals also provide fewer mental health services.3 The result is Americans living in rural areas are more likely to die from the five leading causes of death than those living in urban areas: heart disease, …

Private Schools' Role And Rights In Setting Vaccination Policy: A Constitutional And Statutory Puzzle, Hillel Y. Levin

Scholarly Works

Measles and other vaccine-preventable childhood diseases are making a comeback, as a growing number of parents are electing not to vaccinate their children. May private schools refuse admission to these students? This deceptively simple question raises complex issues of First Amendment law and statutory interpretation, and it also has implications for other current hot-button issues in constitutional law, including whether private schools may discriminate against LGBTQ students. This Article is the first to address the issue of private schools’ rights to exclude unvaccinated children. It finds that the answer is “it depends.” It also offers a model law that states …

Stopping The Resurgence Of Vaccine-Preventable Childhood Diseases: Policy, Politics, And Law, Hillel Y. Levin, Stacie Patrice Kershner, Timothy D. Lytton, Daniel Salmon, Saad B. Omer

Scholarly Works

Mandatory vaccination programs in the United States are generally successful, but their continued success is under threat. The ever-increasing number of parents who opt their children out of vaccination recommendations has caused severe outbreaks of vaccine-preventable diseases. Public health advocates have pushed for changes to state laws, but their efforts have generally been unsuccessful. We suggest that their lack of success is due to public health advocates’ failures to contend with the features of the political system that impede change and to propose reforms that are ethically defensible, efficacious, and politically feasible. Based on our earlier public health studies, ethical …

Designing Policy Solutions To Build A Healthier Rural America, Sameer Vohra, Carolyn Ponter, Amanda Fogleman, Thomas Albers, Anish Patel, Elizabeth Weeks

Scholarly Works

Disparities exist in the livelihood and opportunities for people living in America’s rural communities. These differences result in a much sicker rural America compared to its urban counterpart. Rural counties have higher rates of smoking, obesity, child poverty, and teen pregnancies than urban counties. More uninsured adults live in rural areas, causing rural hospitals to close and/or cut vital services such as obstetrics care. Rural hospitals also provide fewer mental health services. The result is Americans living in rural areas are more likely to die from the five leading causes of death than those living in urban areas: heart disease, …

A Commitment To The Whole Athlete: Embracing The Role Of Cannabinoids In Collegiate Athletics, Kelli Rodriguez Currie

Seattle University Law Review

Cannabinoids can be a highly effective way for athletes to combat various kinds of pain associated with intense training. Derivatives of cannabis, such as marijuana, have been used for centuries as a form of pain relief. Part I of this Article discusses how cannabinoids are used in sports medicine. Part II discusses the different approaches to marijuana and cannabidiol use across sports leagues. Part III highlights the inconsistencies between the NCAA’s approach to testing for substance abuse and its investment in student-athletes’ well-being. Part IV discusses how the NCAA must focus on student-athlete health. Finally, Part V concludes that the …

Say “No” To Discrimination, “Yes” To Accommodation: Why States Should Prohibit Discrimination Of Workers Who Use Cannabis For Medical Purposes, Anne Marie Lofaso, Lakyn D. Cecil

Seattle University Law Review

This Article addresses the question of how the law should treat medical cannabis in the employment context. Using Colorado as a primary example, we argue that states such as Colorado should amend their constitutions and legislate to provide employment protections for employees who are registered medical cannabis cardholders or registered caregivers.

Part I briefly traces the legal regulation of cannabis from an unregulated medicine known as cannabis to a highly regulated illicit substance known as marijuana under the Controlled Substances Act. Our travail through this history reveals, unsurprisingly, an increasing demonization of cannabis throughout the twentieth century. That socio-legal demonization …

In Memory Of Professor James E. Bond, Janet Ainsworth

Seattle University Law Review

Janet Ainsworth, Professor of Law at Seattle University School of Law: In Memory of Professor James E. Bond.

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Pedagogy And Policy: A Tribute To Karen Rothenberg’S Contributions To Health Law, Michael Ulrich

Faculty Scholarship

Professor Karen Rothenberg has had a significant influence on my life, impacting my education, my career, and the way I think. Professor Rothenberg has been a pillar in the health law community, but perhaps her most lasting impact for myself was creating the health law program at the University of Maryland, Francis King Carey School of Law. This nationally recognized program grew from her passion, expertise, and recognition of the importance of health, and is the reason I chose to attend the University of Maryland. The curriculum, faculty, and experience made it one of the best decisions of my life …

Antibiotic Development — Economic, Regulatory And Societal Challenges, Christine Årdal, Manica Balasegaram, Ramanan Laxminarayan, David Mcadams, Kevin Outterson, John H. Rex, Nithima Sumpradit

Faculty Scholarship

Antibiotic resistance is undoubtedly one of the greatest challenges to global health, and the emergence of resistance has outpaced the development of new antibiotics. However, investments by the pharmaceutical industry and biotechnology companies for research into and development of new antibiotics are diminishing. The public health implications of a drying antibiotic pipeline are recognized by policymakers, regulators and many companies. In this Viewpoint article, seven experts discuss the challenges that are contributing to the decline in antibiotic drug discovery and development, and the national and international initiatives aimed at incentivizing research and the development of new antibiotics to improve the …

Evaluating For-Profit Public Benefit Corporations As An Additional Structure For Antibiotic Development And Commercialization, Kevin Outterson, John H. Rex

Faculty Scholarship

While antibiotics are a key infrastructure underpinning modern medicine, evolution will continue to undermine their effectiveness, requiring continuous investment to sustain antibiotic effectiveness. The antibiotic R&D ecosystem is in peril, moving towards collapse. Key stakeholders have identified pull incentives such as Market Entry Rewards or subscription models as the key long-term solution. If substantial Market Entry Rewards or other pull incentives become possible, there is every reason to expect that for-profit companies will return to the antibiotic field. However, the political and financial will to develop such Market Entry Rewards or other similar incentives may be difficult to muster in …

“Unusual Care”: Groupthink And Willful Blindness In The Support Study, George J. Annas, Catherine L. Annas

Faculty Scholarship

The SUPPORT study of extremely premature newborns seems likely to go down as one of the most controversial studies of the 21st century (SUPPORT Study Group 2010). We previously suggested that the researchers in SUPPORT were "legally blind" in failing to understand that the "standard" that defines the content of informed consent is set by law, including the federal regulations, not by what physicians "usually" do or don't do (Annas and Annas 2013). Macklin and Natanson, also early critics of the SUPPORT study's failure to disclose the increased risk of death posed by the study, (Macklin et al. 2013) attack …

First Man And Second Woman: Reflections On The Anniversaries Of Apollo 11 And Cruzan, George J. Annas

Faculty Scholarship

THE United States Supreme Court's decision in Cruzan v. Director, Missouri Department of Health marks its thirtieth anniversary in 2020.' This follows closely after the fiftieth anniversary of the Apollo 11 moon landing.² Anniversaries provide an opportunity for reflection and to gain perspective. We can, I suggest, gain deeper insights regarding human life and death by considering these two anniversaries together. Apollo 11 may seem far from Nancy Cruzan-but the discovery of disturbing details about the death of Neil Armstrong, the first man on the moon, is a productive introduction to the topic of death in a modern American …

Is Tort Law The Tool For Fixing Reproductive Wrongs?, Christopher Robertson

Faculty Scholarship

In his 2019 book, Birth Rights and Wrongs: How Medicine and Technology are Remaking Reproduction and the Law, Dov Fox offers a compelling argument for new torts allowing recovery for wrongful reproduction. These torts would include three sorts of cases, those where wrongdoing (whether negligent, reckless, or intentional) caused undesired reproduction; stymied desired reproduction; or confounded reproduction, causing birth of a child different than that intended by the parents. The likely defendants in these torts are gynecologists, urologists, sperm banks, and IVF clinics.

Federalism, Erisa, And State Single-Payer Health Care, Erin C. Fuse Brown, Elizabeth Mccuskey

Faculty Scholarship

While federal health reform sputters, states have begun to pursue their own transformative strategies for achieving universal coverage, the most ambitious of which are state-based single-payer plans. Since the passage of the Affordable Care Act in 2010, legislators in twenty-one states have proposed sixty-six unique bills to establish single-payer health care systems. This paper systematically surveys those state legislative efforts and exposes the federalism trap that threatens to derail them: ERISA's preemption of state regulation relating to employer-sponsored health insurance. ERISA's expansive preemption provision creates a narrow, risky path for state regulation to capture the employer health care expenditures crucial …