Health Law and Policy Commons^™

Genetically-Engineered Begots, Have-Nots, And Tinkered Tots: (High Scoring Polygenic Kids As A Heredity-Camelot)-An Introduction To The Legalities And Bio-Ethics Of Advanced Ivf And Genetic Testing, Barbara Pfeffier-Billaeuer

Chicago-Kent Law Review

No abstract provided.

Does A Custodial Rights Understanding Of The Gdpr Justify Fraudulent Misrepresentation By Sperm Donors?, Dov Greenbaum

Chicago-Kent Law Review

No abstract provided.

Causation And Compensation For Intergenerational Harm, Dov Fox

Chicago-Kent Law Review

No abstract provided.

Learning From South Korea’S Covid-19 Response: Why Centralizing The United States Public Health System Is Essential For Future Pandemic Responses, Meghan Ricci

Seattle Journal of Technology, Environmental, & Innovation Law

The COVID-19 pandemic revealed stark differences in governmental preparedness across the globe. The United States, once thought of as a global leader in public health, had the theoretical skill and efficiency to handle the pandemic but failed to utilize those skills and resources during an actual health crisis. In the spring of 2020, everyone watched the U.S.’s reaction to the unfolding of the COVID-19 pandemic due to its historic placeholder as a global leader and innovator. However, the performance of the U.S. in response to the global pandemic disappointed both global commentators and U.S. citizens. This paper will compare the …

Liability For Use Of Artificial Intelligence In Medicine, W. Nicholson Price, Sara Gerke, I. Glenn Cohen

Law & Economics Working Papers

While artificial intelligence has substantial potential to improve medical practice, errors will certainly occur, sometimes resulting in injury. Who will be liable? Questions of liability for AI-related injury raise not only immediate concerns for potentially liable parties, but also broader systemic questions about how AI will be developed and adopted. The landscape of liability is complex, involving health-care providers and institutions and the developers of AI systems. In this chapter, we consider these three principal loci of liability: individual health-care providers, focused on physicians; institutions, focused on hospitals; and developers.

The Mental Health Crisis On Campus: Liability Implications Of Using Emerging Technology, Betsy J. Grey

American University Law Review

Institutions of higher education are facing a “mental health crisis.” Students are experiencing high rates of mental health issues, exacerbated by the pandemic. At the same time, the severity of psychological disorders is accelerating among students. These developments have put enormous pressure on traditional university support systems, and schools have turned to new technologies, like online mental health resources and monitoring systems using artificial intelligence, to expand their mental health services. This article explores the liability implications of using these emerging technologies to address these escalating needs. Universities offer mental health services in good faith to help their students succeed, …

Congressional Myopia In Biomedical Innovation Policy, W. Nicholson Price Ii

Reviews

Innovation policy is hard. Getting it right requires balancing incentives for developers, consumer access, rewards for later innovators, safety concerns, and other factors. This balance is vitally important and wickedly difficult—even when it’s the focus of concerted, careful, informed effort. How well should we expect it to go when innovation policy is made by accident? Enter The Accidental Innovation Policymakers, an illuminating new project by Professor Rachel Sachs. Sachs persuasively shows how Congress has repeatedly made substantial changes to innovation policy, seemingly without talking about, seriously considering, or even recognizing that it is doing so. There’s an asymmetry to this …

The Negative Impact Of Service Member And Veteran Post Traumatic Stress Disorder (Ptsd) Rating Or Specter Of Ptsd On Child Custody Arrangements, Erhan Bedestani

Catholic University Journal of Law and Technology

No abstract provided.

Reconnecting The Patient: Why Telehealth Policy Solutions Must Consider The Deepening Digital Divide, Laura C. Hoffman

Law Faculty Articles and Essays

This Article will attempt to untangle the complicated web of providing telehealth to those populations it is potentially capable of further alienating from access to healthcare including: 1) race/minority populations, 2) aging adults, 3) individuals with disabilities, 4) non-English speakers, 5) individuals living in rural areas, 6) socioeconomic class, and 7) children, in order to advance the argument that telehealth can be successful in providing healthcare access to these populations. Rather than suggesting that telehealth simply "cannot work" for these populations, instead consideration can and must meet these individuals through technology, access, and policy developments.

First, this Article will explain …

Fostering Production Of Pharmaceutical Products In Developing Countries, William Fisher, Ruth L. Okediji, Padmashree Gehl Sampath

Michigan Journal of International Law

The ways in which pharmaceutical products are currently developed, manufactured, and distributed fail to meet the needs of developing countries. The recent emergence of new infectious diseases, the associated surge of healthcare nationalism, and the prevalence of substandard and falsified drugs have strengthened substantially the net benefits of augmenting the capacity of developing countries to produce such products locally. Most previous efforts to do so have foundered. The chance of success in the future would be maximized by the adoption of five strategies : (a) clarifying the zones of discretion created by the relevant treaties to ensure that local firms …

A Proportionality-Based Framework For Government Regulation Of Digital Tracing Apps In Times Of Emergency, Sharon Bassan

Dickinson Law Review (2017-Present)

Times of emergency present an inherent conflict between the public interest and the preservation of individual rights. Such times require granting emergency powers to the government on behalf of the public interest and relaxing safeguards against government actions that infringe rights. The lack of theoretical framework to assess governmental decisions in times of emergency leads to a polarized and politicized discourse about potential policies, and often, to public distrust and lack of compliance.

Such a discourse was evident regarding Digital Tracing Apps (“DTAs”), which are apps installed on cellular phones to alert users that they were exposed to people who …

Artificial Intelligence In Canadian Healthcare: Will The Law Protect Us From Algorithmic Bias Resulting In Discrimination?, Bradley Henderson, Colleen M. Flood, Teresa Scassa

Canadian Journal of Law and Technology

In this article, we canvas why AI may perpetuate or exacerbate extant discrimination through a review of the training, development, and implementation of healthcare-related AI applications and set out policy options to militate against such discrimination. The article is divided into eight short parts including this introduction. Part II focuses on explaining AI, some of its basic functions and processes, and its relevance to healthcare. In Part III, we define and explain the difference and relationship between algorithmic bias and data bias, both of which can result in discrimination in healthcare settings, and provide some prominent examples of healthcare-related AI …

Exclusion Cycles: Reinforcing Disparities In Medicine, Ana Bracic, Shawneequa L. Callier, Nicholson Price

Articles

Minoritized populations face exclusion across contexts from politics to welfare to medicine. In medicine, exclusion manifests in substantial disparities in practice and in outcome. While these disparities arise from many sources, the interaction between institutions, dominant-group behaviors, and minoritized responses shape the overall pattern and are key to improving it. We apply the theory of exclusion cycles to medical practice, the collection of medical big data, and the development of artificial intelligence in medicine. These cycles are both self-reinforcing and other-reinforcing, leading to dismayingly persistent exclusion. The interactions between such cycles offer lessons and prescriptions for effective policy.

Fourth Amendment Issues And Covid-19 Tracking, Brooke A. Banks

Cardozo Arts & Entertainment Law Journal

The note argues that the special needs doctrine does not justify warrantless government access to cell site location information (CSLI) for COVID-19 tracking, as individual privacy interests outweigh public health benefits. It advocates for voluntary, privacy-protective measures, such as opt-in apps, to balance privacy and pandemic response.

Regulation Of Health-Related Artificial Intelligence In Medical Devices: The Canadian Story, Michael Da Silva, Colleen M. M. Flood, Matthew Herder

Articles, Book Chapters, & Popular Press

Artificial Intelligence (AI) may transform Canadian healthcare. The hope is that AI will enable more accurate and efficient care, thereby solving many access, quality, and safety problems. Yet, despite this tantalizing prospect, there are risks of unsafe AI harming patients, algorithmic bias, and threats to privacy. This work begins analysis of whether applicable Canadian laws are up to the task of ensuring Canadians can benefit from effective health-related AI while minimizing AI-related risks. It focuses on Health Canada’s regulation of medical devices, a ‘first line of defence’ that decides which devices are safe, effective, and thus permitted for trade in …

Reducing Barriers To Accessing Administrative Data On Sars-Cov-2 Vaccination For Research, Andrew Mcrae, Patrick Archambault, Patrick Fok, Hana Wiemer, Laurie Morrison, Matthew Herder

Articles, Book Chapters, & Popular Press

Public trust in scientific research, especially research regarding vaccines, has proven fragile during the COVID-19 pandemic. To counter abundant misinformation about SARS-CoV-2 vaccines, rigorous, ongoing evaluations of vaccine safety and effectiveness by independent Canadian researchers are important. However, researchers' efforts to conduct timely, national studies of vaccine effectiveness have been hindered by barriers to data sharing that have made it difficult to integrate patients' vaccination status into SARS-CoV-2 clinical and epidemiological studies. Here, McRae et al discuss how a risk-averse data-sharing culture has led to missed opportunities to conduct robust, timely, pan-Canadian SARS-CoV-2 clinical and vaccine effectiveness studies, and outline …

Paging Doctor Robot: Medical Artificial Intelligence, Tort Liability, And Why Personhood May Be The Answer, Benedict See

Brooklyn Law Review

Artificial intelligence (AI) is a part of everyday life. From our phones, to social media accounts, to online shopping, AI is present and enhances our daily experiences. One area where AI has a heavy (and an increasing) presence is the medical industry. Just as humans make mistakes, so does AI. However, when a human doctor makes a mistake, they can be sued for malpractice, but when AI makes a mistake, who is to be held responsible? Because tort law was designed with humans in mind, it may be hard to apply to medical AI, who’s “black box” algorithms make their …

A Trip Through Employment Law: Protecting Therapeutic Psilocybin Users In The Workplace, Benjamin Sheppard

Journal of Law and Health

In 2020, Oregon voters legalized therapeutic psilocybin in response to a plethora of scientific studies showing symptom reduction for depression, anxiety, substance use disorders, opioid addictions, migraines, other mental illnesses, HIV/AIDS, and cancer. The legal rethinking regarding therapeutic psilocybin continues in both state legislatures and city councils. Yet, despite state and local legalization or decriminalization of therapeutic psilocybin it remains illegal under the federal Controlled Substances Act. This tension between local and federal law places therapeutic psilocybin users and their employers in a difficult position. Because all types of psilocybin use remain illegal under federal law, a zero-tolerance drug use …

Contract Remedies Need Not Undercompensate Aspiring Parents When Cryopreserved Reproductive Material Is Lost Or Destroyed: Recovery Of Consequential Damages For Emotional Disturbance When Breach Of Contract Results In The Lost Opportunity To Become Pregnant With One's Own Biological Child, Joseph M. Hnylka

Journal of Law and Health

The Center for Disease Control and Prevention (CDC) has reported that the use of assisted reproductive technology (ART) has doubled over the past decade. In vitro fertilization (IVF) is the most prevalent form of ART. During IVF, a woman’s eggs are extracted, fertilized in a laboratory setting, and then implanted in the uterus. Many IVF procedures use eggs or sperm that were stored using a process called cryopreservation. A recent survey reported that cryopreservation consultations increased exponentially during the coronavirus pandemic, rising as much as 60 percent. It is estimated that more than one million embryos are stored in cryopreservation …

An Analysis Of The Patent Linkage System And Development Of The Biosimilar Industry In Taiwan, Jerry I-H Hsiao

Brooklyn Journal of International Law

In 2019, as an effort to join the Trans-Pacific Partnership (TPP) Agreement (now Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP)), Taiwan has implemented the patent linkage system which covers both small molecule generic drugs and large molecule biosimilar into the Pharmaceutical Affair Act. The system modeled after the U.S.’s patent linkage system designed for small molecule drugs under the Hatch Waxman Act (HWA). Based on the experience of the patent linkage system under the HWA, biosimilar industry representatives in Taiwan contended that the adoption of the patent linkage system will be detrimental to the development of local industry. By …

Copying Copyright: Adopting A Fair Use Defense In Patent Law In Times Of Public Health Crisis, Kellie C. Van Beck

Brooklyn Law Review

Epidemics have devastated humankind for centuries. Given the simultaneous rise of advanced disease prevention and treatment and the great potential for mass public uptake, it is unsurprising that the U.S. pharmaceutical industry has grown to $775 billion in annual sales revenue. It is clear that the commercialization of important public health measures is not without controversy. Of particular debate is that vaccine and other drug manufacturers monopolize their products and control them through patent laws. Yet there is a strong dichotomy between the importance of patents and the need for public access to innovations. This is not to say that …

The Ratio Method: Addressing Complex Tort Liability In The Fourth Industrial Revolution, Harrison C. Margolin, Grant H. Frazier

St. Mary's Law Journal

Emerging technologies of the Fourth Industrial Revolution show fundamental promise for improving productivity and quality of life, though their misuse may also cause significant social disruption. For example, while artificial intelligence will be used to accelerate society’s processes, it may also displace millions of workers and arm cybercriminals with increasingly powerful hacking capabilities. Similarly, human gene editing shows promise for curing numerous diseases, but also raises significant concerns about adverse health consequences related to the corruption of human and pathogenic genomes.

In most instances, only specialists understand the growing intricacies of these novel technologies. As the complexity and speed of …

Held V. State, Alec D. Skuntz

Public Land & Resources Law Review

On March 13, 2020, a group of 16 Montana children and teenagers filed a complaint in the First Judicial District, Lewis and Clark County against the State of Montana and several state agencies. These young Plaintiffs sought injunctive and declaratory relief against Defendants for their complicity in continuing to extract and release harmful amounts of greenhouse gases which contribute to climate change. Plaintiffs premised their argument on the Montana Constitution’s robust environmental rights and protections. The Defendants filed a motion to dismiss which the District Court granted in-part and denied in-part. Held provides a roadmap for future litigation by elucidating …

How Analogizing Socio-Legal Responses To Organ Transplantation Can Further The Legalization Of Reproductive Genetic Innovation, Myrisha S. Lewis

Faculty Publications

The Nobel Foundation emphasized the significance of genetic innovation to society, science, and medicine by awarding the 2020 Nobel Prize in Chemistry to “the CRISPR/Cas9 genetic scissors.” This Article focuses on “reproductive genetic innovation,” a term that includes cytoplasmic transfer, mitochondrial transfer, and germline or heritable gene editing techniques that are all categorized as “experimental” in the United States. These techniques all use in vitro fertilization, a legal and widely available practice. Yet reproductive genetic innovation has resulted in controversy and numerous barriers including a recurring federal budget rider, threats of federal enforcement action, and the unavailability of federal funding. …

Freedom Without Opportunity: Using Medicare Policy And Cms Mechanisms To Anticipate The Platform Economy’S Pitfalls And Ensure Healthcare Platform Workers Are Fairly Paid, Kim A. Aquino

Brooklyn Law Review

The rapidly aging population, along with the demand for innovative Medicare delivery models such as bundled payment programs have incentivized the use of technology in healthcare because of its potential to cut costs and improve quality of care. Like many industries embracing technological strides to automate and digitize services, the healthcare industry has welcomed new labor markets like the platform economy to facilitate connections between patients and workers with ease. Along with streamlining connections, the platform economy also promises workers flexibility and autonomy over their own schedule. The platform economy’s promise of freedom, however, is not enough to prevent the …

Shifting Antitrust Laws And Regulations In The Wake Of Hospital Mergers: Taking The Focus Off Of Elective Markets And Centering Health Care, Maya Inka Ureño-Dembar

Brooklyn Law Review

Access to health care requires access to a care center and access to comprehensive health care services. Rampant hospital mergers are uniquely poised to reduce both the number of hospitals, requiring patients to travel further, and the services provided within a newly merged hospital, namely reproductive health services. This phenomenon is clearly seen through the merging of secular and nonsecular hospitals, which often result in patients being forced to travel much further for reproductive health care. In the United States’ current model, health care is not a right, but is treated as a commodity. As such, it is governed by …

The Rise Of Ada Title Iii: How Congress And The Department Of Justice Can Solve Predatory Litigation, Sarah E. Zehentner

Brooklyn Law Review

The Americans with Disabilities Act (ADA) was enacted in 1990 to afford equal opportunities for individuals with disabilities. Title III of the ADA, specifically, was enacted to afford disabled individuals equal access to places of public accommodation. When the ADA was enacted, the internet was still in its infancy and Congress did not contemplate the need for governing accessibility to websites of public accommodations. Today, the internet has become embedded in virtually every aspect of our lives, yet there are still millions of disabled individuals who are unable to equally access the websites of American businesses. With the ADA being …

Covid-19 And Business Interruption Insurance: The Constitutionality Of Legislatively Mandated Coverage, William G. Arnold

South Carolina Law Review

No abstract provided.

Sharing Technology And Vaccine Doses To Address Global Vaccine Inequity And End The Covid-19 Pandemic, Matthew M. Kavanagh, Lawrence O. Gostin, Madhavi Sunder

Georgetown Law Faculty Publications and Other Works

Although COVID-19 cases are declining rapidly in the US, they have reached record highs in low- and middle-income countries (LMICs). The nucleus of the pandemic has shifted decidedly to the global south. The South-East Asia region and Latin America now represent 75% of global weekly deaths. On June 22, the Latin America region reported more than 1 million weekly new cases and 30 000 new deaths. Latin America has the highest deaths per capita, where deaths in countries such as Brazil, Argentina, Mexico, and Peru have reached 177 to 564 per hundred thousand. The Africa region has had increasing numbers …

The Future Of The Americans With Disabilities Act: Website Accessibility Litigation After Covid-19, Randy Pavlicko

Cleveland State Law Review

The Americans with Disabilities Act (ADA) was enacted in 1990 to eliminate discrimination against individuals with disabilities. Over time, as society has become more reliant on the internet, the issue of whether the ADA’s scope extends beyond physical places to online technology has emerged. A circuit split developed on this issue, and courts have discussed three interpretations of the ADA’s scope: (1) the ADA applies to physical places only; (2) the ADA applies to a website or mobile app that has a sufficient nexus to a physical place; or (3) the ADA broadly applies beyond physical places to online technology. …