Health Law and Policy Commons^™

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

SMU Law Review

No abstract provided.

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, …

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.

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 …

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.

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 New Age Of Evolution: Protecting The Consumer’S Moral And Legal Right To Know Through The Clear And Transparent Labeling Of All Genetically Modified Foods, Halie M. Evans

Journal of Law and Health

The United States government, until recently, did not require the labeling of genetically modified organisms (GMOs). On July 29, 2016, President Barack Obama signed into law the National Bioengineered Food Disclosure Standard (NBFDS). This law directs the United States Department of Agriculture (USDA) to create regulations that require manufacturers to disclose certain bioengineered products on food labels. On December 20, 2018, the USDA released the final regulations for the NBFDS, which requires food manufactures, importers, and certain retailers to ensure bioengineered foods are appropriately disclosed. The final regulations include provisions that will leave the majority of GMO derived foods unlabeled. …

Concussions And Contracts: The National Football League's Limitations To Protecting Its Players From Chronic Traumatic Encephalopathy, Julia Wolpert

Journal of Law and Health

Chronic Traumatic Encephalopathy (CTE) is a neurodegenerative brain injury that has become prevalent among high-contact professional sports, especially American football. More and more retired players are exhibiting symptoms of CTE and being diagnosed with CTE post-mortem. While the neuroscience community constantly releases studies showing a causal connection between brain trauma and CTE, the National Football League (NFL) continues to deny that any brain injury can arise from playing football. The NFL must implement provisions in their contracts to fully inform and protect players from this lethal brain injury. This article examines the repercussions of CTE, how players’ contracts do and …

Frontiers In Precision Medicine Iv: Artificial Intelligence, Assembling Large Cohorts, And The Population Data Revolution, Adam Bress, Rich Albrechtsen, Monika Baker, Jorge L. Contreras, Zachary Fica, Austin Gamblin, Chelsea Ratcliff, Bianca E. Rich, Matt A. Szaniawski, Alyssa Thorman, Chad Vansant-Webb, Willard Dere

Utah Law Faculty Scholarship

Large cohort studies and more recently electronic medical records (EMR) are being used to collect massive amounts of genetic information. Implementation of artificial intelligence has become increasingly necessary to interpret this data with the goal of augmenting patient care. While it is impossible to predict what the future holds, policy makers are challenged to create guiding principles and responsibly roll out these new technologies. On March 22, 2019, the University of Utah hosted its fourth annual Precision Medicine Symposium focusing on artificial intelligence, assembling large cohorts, and the population data revolution. The symposium brought together experts in medicine, science, law …

The Internet Of Bodies, Andrea M. Matwyshyn

William & Mary Law Review

This Article introduces the ongoing progression of the Internet of Things (IoT) into the Internet of Bodies (IoB)—a network of human bodies whose integrity and functionality rely at least in part on the Internet and related technologies, such as artificial intelligence. IoB devices will evidence the same categories of legacy security flaws that have plagued IoT devices. However, unlike most IoT, IoB technologies will directly, physically harm human bodies—a set of harms courts, legislators, and regulators will deem worthy of legal redress. As such, IoB will herald the arrival of (some forms of) corporate software liability and a new legal …

Potential Liability For Physicians Using Artificial Intelligence, W. Nicholson Price Ii, Sara Gerke, I Glenn Cohen

Articles

Artificial intelligence (AI) is quickly making inroads into medical practice, especially in forms that rely on machine learning, with a mix of hope and hype. Multiple AI-based products have now been approved or cleared by the US Food and Drug Administration (FDA), and health systems and hospitals are increasingly deploying AI-based systems. For example, medical AI can support clinical decisions, such as recommending drugs or dosages or interpreting radiological images.2 One key difference from most traditional clinical decision support software is that some medical AI may communicate results or recommendations to the care team without being able to communicate the …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

No abstract provided.

Medical Ai And Contextual Bias, W. Nicholson Price Ii

Articles

Artificial intelligence will transform medicine. One particularly attractive possibility is the democratization of medical expertise. If black-box medical algorithms can be trained to match the performance of high-level human experts — to identify malignancies as well as trained radiologists, to diagnose diabetic retinopathy as well as board-certified ophthalmologists, or to recommend tumor-specific courses of treatment as well as top-ranked oncologists — then those algorithms could be deployed in medical settings where human experts are not available, and patients could benefit. But there is a problem with this vision. Privacy law, malpractice, insurance reimbursement, and FDA approval standards all encourage developers …

From Fitbits To Pacemakers: Protecting Consumer Privacy And Security In The Healthtech Age, Justin Evans, Katelyn Ringrose

Et Cetera

As wearable and analytics technology continues to be aggressively adopted, there is a congruent rise in data collection from wearable healthtech devices. This unprecedented rise in data collection poses massive privacy and security issues. This note addresses the benefits of IoT healthcare wearables and implants, as well as identifies where the privacy and security of data accrued by such devices could be improved. In an effort to better encapsulate the issue surrounding wearable device data collection, the authors analyze the many benefits of wearable healthcare devices, as well as look into the false sense of trust consumers have in the …

Artificial Intelligence In The Medical System: Four Roles For Potential Transformation, Will Nicholson Price Ii

Articles

Artificial intelligence (AI) looks to transform the practice of medicine. As academics and policymakers alike turn to legal questions, a threshold issue involves what role AI will play in the larger medical system. This Article argues that AI can play at least four distinct roles in the medical system, each potentially transformative: pushing the frontiers of medical knowledge to increase the limits of medical performance, democratizing medical expertise by making specialist skills more available to non-specialists, automating drudgery within the medical system, and allocating scarce medical resources. Each role raises its own challenges, and an understanding of the four roles …

The Courtroom Turned Classroom: A Model Procedure For Educating The Gatekeepers Of Expert Evidence In Complex Toxic Tort Cases, Izabelle Tully

Cardozo Law Review

This Note maintains that in order for Rule 702 and the Daubert standard to have their intended effect, judges need more guidance and structure in how they approach scientific admissibility decisions. An analysis of how courts following Daubert currently address novel science, specifically in toxic tort cases where some members of the scientific community label causation evidence as junk science, supports this argument. This Note will focus on procedures courts have used to make gatekeeping decisions. From a study of these procedures, this Note will suggest a model framework that courts should employ to tackle novel science issues in mass …

Got Mylk?: The Disruptive Possibilities Of Plant Milk, Iselin Gambert

Brooklyn Law Review

Milk is one of the most ubiquitous and heavily regulated substances on the planet—and perhaps one of the most contested. It is tied closely to notions of purity, health, and femininity, and is seen as so central to human civilization that our own galaxy—the Milky Way—is named after it. But despite its wholesome reputation, milk has long had a sinister side, being bound up with the exploitation of the (human and nonhuman) bodies it comes from and being a symbol of and tool for white dominance and superiority. The word itself, in verb form, means “to exploit.” It is also …

American Democratic Deficit In Assisted Reproductive Technology Innovation, Myrisha S. Lewis

Faculty Publications

In many areas of innovation, the United States is a leader, but this characterization does not apply to the United States' position in assisted reproductive technology innovation and clinical use. This article uses a political science concept, the idea of the "democratic deficit" to examine the lack of American public discourse on innovations in ART. In doing so, the article focuses on America's missing public consultation in health care innovation. This missing discourse is significant, as political and ethical considerations may impact regulatory decisions. Thus, to the extent that these considerations are influencing the decisions of federal agency employees, namely …

Healthtech: How Blockchain Can Simplify Healthcare Compliance, Kathryn M. Bennett

Washington and Lee Journal of Civil Rights and Social Justice

This Note broadly explores solutions to modern-day accessibility and security problems latent in electronic health records. Specifically, this Note discusses HIPAA and HITECH, the current law in place, and how blockchain technology can be used to fix the accessibility and security problems of current electronic health records. This Note proposes that blockchain technology can help a healthcare industry struggling to adhere to the current rule of law in an era of Big Data. Further, Blockchain technology can help individual consumers, particularly those with significant health issues, obtain the best possible medical care while simultaneously keeping their private and sensitive information …

Negligent Disruption Of Genetic Planning: Carving Out A New Tort Theory To Address Novel Questions Of Liability In An Era Of Reproductive Innovation, Tracey Tomlinson

Fordham Law Review Online

This Essay will address current concerns pertaining to ART-related negligence, and ultimately recommends the adoption of a new tort— negligent disruption of genetic planning (NDGP). This tort would enable plaintiffs to recover damages when an ART clinic’s negligent actions thwart reproductive planning, while simultaneously balancing the serious moral and ethical questions that arise in these situations. This argument proceeds in three Parts. Part I discusses the technological evolution of ART and gives examples of ART-related negligence cases that have occurred in the United States. Part II lays out the current U.S. tort remedies relied on by plaintiffs in these situations, …

Artificial Intelligence In The Medical System: Four Roles For Potential Transformation, W. Nicholson Price Ii

Articles

Artificial intelligence (AI) looks to transform the practice of medicine. As academics and policymakers alike turn to legal questions, including how to ensure high-quality performance by medical AI, a threshold issue involves what role AI will play in the larger medical system. This Article argues that AI can play at least four distinct roles in the medical system, each potentially transformative: pushing the frontiers of medical knowledge to increase the limits of medical performance, democratizing medical expertise by making specialist skills more available to non-specialists, automating drudgery within the medical system, and allocating scarce medical resources. Each role raises its …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

No abstract provided.

The "Art" Of Future Life: Rethinking Personal Injury Law For The Negligent Deprivation Of A Patient's Right To Procreation In The Age Of Assisted Reproductive Technologies, Erika N. Auger

Chicago-Kent Law Review

No abstract provided.

A Mathematical Solution To The Sine Of Madness That Is Pharmaceutical Compulsory Licensing Under The Trips Agreement And The Doha Declaration, Ashley E. Sperbeck

Marquette Intellectual Property Law Review

A viable economic solution is necessary to address the shortcomings, textual ambiguities, and deficiencies engulfing international patent protection, leading to the inability of LDCs facing public health crises or national emergencies and lacking pharmaceutical manufacturing facilities to obtain generic pharmaceuticals. This Note poses a solution to this problem via another Amendment to the TRIPS Agreement and the Doha Declaration, which provides a mathematical framework to determine when and under what circumstances a compulsory license should be granted. Furthermore, this Note contemplates establishment of a WTO subcommittee to oversee this proposed solution and to ensure compliance with this Amendment. This concrete …

Tribal Sovereign Immunity As A Defense At The Patent Trial And Appeal Board? Or A Violation Of U.S. Antitrust Laws?, Samantha Roth

Marquette Intellectual Property Law Review

This Comment will address two primary issues. First, it will analyze the basis of sovereign immunity rights of tribes, with a focus on the relationship between intellectual property rights and sovereignty. Second, it will discuss whether this arrangement violates the antitrust laws of the United States. This Comment concludes that even if a claim of tribal sovereign immunity is legitimate, it is likely that such an arrangement still violates the relevant antitrust claims.

Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg

Marquette Intellectual Property Law Review

This article examines the intersection of patent law, FDA regulation, and Medicare coverage in a particularly promising field of biomedical innovation: genetic diagnostic testing. First, I will discuss current clinical uses of genetic testing and directions for further research, with a focus on cancer, the field in which genetic testing has had the greatest impact to date. Second, I will turn to patent law and address two recent Supreme Court decisions that called into question the patentability of many of the most important advances in genetic testing. Third, I will step outside patent law to take a broader view of …

Finding A Forest Through The Trees: Georgia-Pacific As Guidance For Arbitration Of International Compulsory Licensing Disputes, Karen Mckenzie

Marquette Intellectual Property Law Review

This paper will examine the challenges of international compulsory licensing by examining the issue historically and legally as well as offer possible solutions. Thus, this paper will explore the challenge of balancing corporate interests against the affordability and availability of pharmaceuticals by focusing on discrete situations in developing countries, the history of compulsory licensing, and how the World Health Organization (the “WHO”) and the WTO have attempted to tackle these challenges through compulsory licensing, and it will suggest a possible framework for use in arbitration, which balances equities through a Georgia-Pacific analysis.

Risks And Remedies For Artificial Intelligence In Healthcare, W. Nicholson Price Ii

Other Publications

Artificial intelligence (AI) is rapidly entering health care and serving major roles, from automating drudgery and routine tasks in medical practice to managing patients and medical resources. As developers create AI systems to take on these tasks, several risks and challenges emerge, including the risk of injuries to patients from AI system errors, the risk to patient privacy of data acquisition and AI inference, and more. Potential solutions are complex but involve investment in infrastructure for high-quality, representative data; collaborative oversight by both the Food and Drug Administration and other health-care actors; and changes to medical education that will prepare …

Unjust Timing Limitations In Genetic Malpractice Cases, Lauren E. Clatch

Law Faculty Publications

As genomic data are increasingly being collected and applied in clinical care, physicians, laboratories, and other health care providers are more frequently being sued for alleged medical malpractice or negligence. Because the genetic underpinnings of an existing or future health condition may not be immediately apparent, such cases sometimes raise unique timing issues involving the applicable statute of limitations, statute of repose, or statutory notification requirements. Although these timing limitations on when a lawsuit can be brought have important policy rationales and justifications, such as helping to protect providers from open-ended liability, their application to genetic liability cases may sometimes …

Health Care Ai: Law, Regulation, And Policy., W. Nicholson Price Ii

Book Chapters

As discussed in previous chapters, artificial intelligence (AI) has the potential to be involved in almost all aspects of the health care industry. The legal landscape for health care AI is complex; AI systems with different intended uses, audiences, and use environments face different requirements at state, federal, and international levels. A full accounting of these legal requirements, or of the policy questions involved, is far beyond the scope of this chapter. Additionally, the legal and regulatory framework for AI in health care continues to evolve, given the nascent stage of the industry.

In this chapter, we offer an overview …