Science and Technology Law Commons^™

Optimizing Cybersecurity Risk In Medical Cyber-Physical Devices, Christopher S. Yoo, Bethany Lee

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Medical devices are increasingly connected, both to cyber networks and to sensors collecting data from physical stimuli. These cyber-physical systems pose a new host of deadly security risks that traditional notions of cybersecurity struggle to take into account. Previously, we could predict how algorithms would function as they drew on defined inputs. But cyber-physical systems draw on unbounded inputs from the real world. Moreover, with wide networks of cyber-physical medical devices, a single cybersecurity breach could pose lethal dangers to masses of patients.

The U.S. Food and Drug Administration (FDA) is tasked with regulating medical devices to ensure safety and …

Dobbs In A Technologized World: Implications For Us Data Privacy, Jheel Gosain, Jason D. Keune, Michael S. Sinha

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In June of 2022, the U.S. Supreme Court issued its opinion in Dobbs v. Jackson Women’s Health Organization, overturning 50 years of precedent by eliminating the federal constitutional right to abortion care established by the Court’s 1973 decision in Roe v. Wade. The Dobbs decision leaves the decision about abortion services in the hands of the states, which created an immediately variegated checkerboard of access to women’s healthcare across the country. This in turn laid bare a profusion of privacy issues that emanate from our technologized world. We review these privacy issues, including healthcare data, financial data, website tracking and …

Regulating New Tech: Problems, Pathways, And People, Cary Coglianese

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New technologies bring with them many promises, but also a series of new problems. Even though these problems are new, they are not unlike the types of problems that regulators have long addressed in other contexts. The lessons from regulation in the past can thus guide regulatory efforts today. Regulators must focus on understanding the problems they seek to address and the causal pathways that lead to these problems. Then they must undertake efforts to shape the behavior of those in industry so that private sector managers focus on their technologies’ problems and take actions to interrupt the causal pathways. …

Privacy In The Age Of Contact Tracing: An Analysis Of Contact Tracing Apps In Different Statutory And Disease Frameworks, Christopher S. Yoo, Apratim Vidyarthi

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The Covid-19 pandemic is a historic pandemic that has affected the lives of virtually everyone on the globe. One approach to slowing the spread of the disease is to use contact tracing, facilitated by our internet-connected smartphones. Different nations and states have partnered to develop a variety of contact tracing apps that use different technologies and architectures.

This paper investigates how five contact tracing apps—Germany’s Corona-Warn-App, Israel’s HaMagen, North Dakota’s Care19 Diary and Alert apps, and India’s Aarogya Setu—fare in privacy-oriented statutory frameworks to understand the design choices and public health implications shaped by these statutes. The three statutes—the Health …

The Vaccine Race In The 21st Century, Ana Santos Rutschman

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In a world in which infectious diseases are spreading increasingly faster, the development of new human vaccines remains a priority in biopharmaceutical innovation. Legal scholars have addressed different aspects of vaccine regulation and administration, but less attention has been paid to the role of laws governing innovation during the stages of research and development (R&D) of vaccines.

This Article explores the race to develop new vaccines from its beginnings through the early 21st century, with a particular focus on the progressively pervasive role of intellectual property in governing vaccine innovation. It describes the insufficiencies of current innovation regimes in promoting …

Response To "Pervasive Sequence Patents Cover The Entire Human Genome", Shine Tu, Christopher M. Holman, Adam Mossoff, Ted M. Sichelman, Michael Risch, Jorge L. Contreras, Yaniv Heled, Gregory Dolin, Lee Petherbridge

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In a widely reported article by Jeffrey Rosenfeld and Christopher Mason published in Genome Medicine, significant misstatements were made, because the authors did not sufficiently review the claims – which define the legal scope of a patent – in the patents they analyzed. Specifically, the authors do not provide an adequate basis for their assertion that 41% of the genes in the human genome have been claimed.

Layers Of Law: The Case Of E-Cigarettes, Eric A. Feldman

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This paper, written for a symposium on "Layers of Law and Social Order," connects the current debate over the regulation of electronic cigarettes with socio-legal scholarship on law, norms, and social control. Although almost every aspect of modern life that is subject to regulation can be seen through the framework ‘layers of law,’ e-cigarettes are distinguished by the rapid emergence of an unusually dense legal and regulatory web. In part, the dense fabric of e-cigarette law and regulation, both within and beyond the US, results from the lack of robust scientific and epidemiological data on the behavioral and health consequences …

Exclusivity Without Patents: The New Frontier Of Fda Regulation For Genetic Materials, Gregory Dolin

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Over the last twenty years, the legal and scientific academic communities have been embroiled in a debate about the patent eligibility of genetic materials. The stakes for both sides could not be higher. On one hand are the potential multi-billion dollar profits on the fruits of research (from newly discovered genes), and on the other is scientists' ability to continue and expand research into the human genome to improve patients' access to affordable diagnostic and therapeutic modalities. This debate is currently pending before the Supreme Court, which is considering a petition for certiorari in Ass'n for Molecular Pathology v. U.S. …

Health Insurance, Employment, And The Human Genome: Genetic Discrimination And Biobanks In The United States, Eric A. Feldman, Chelsea Darnell

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Does genetic information warrant special legal protection, and if so how should it be protected? This essay examines the most recent (and indeed only) significant effort by the US government to prohibit genetic discrimination, the Genetic Information Nondiscrimination Act (GINA). We argue that the legislation is unlikely to have the positive impact sought by advocates of genetic privacy and proponents of biobanks. In part, GINA disappoints because it does too little. Hailed by its promoters as “the first civil rights act of the 21^st century,” GINA’s reach is in fact quite modest and its grasp even more so. But …

Incentivizing The Utilization Of Pharmacogenomics In Drug Development, Valerie Gutmann Koch

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Pharmacogenomics, the study and development of compounds according to how an individual’s genes affects the body’s response to drugs, holds enormous promise for increasing the safety and efficiency of drug development while decreasing adverse reactions and the trial-and-error nature of drug prescription. However, pharmacogenomics may not be the panacea for all development and prescription problems. This article explores some of the obstacles to pharmacogenomic advancement including industry reluctance to pursue research because of potentially prohibitive costs associated with developing products and legal liability concerns. The implications pharmacogenomics has for drug research and development as well as various areas of law …

Pgtandme: Social Networking-Based Genetic Testing And The Evolving Research Model, Valerie Gutmann Koch

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The opportunity to use extensive genetic data, personal information, and family medical history for research purposes may be naturally appealing to the personal genetic testing (PGT) industry, which is already coupling its direct-to-consumer (DTC) products with social networking technologies, as well as to potential industry or institutional partners. This article evaluates the transformation in research that the hybrid of PGT and social networking will bring about, and – highlighting the challenges associated with a new paradigm of “patient-driven” genomic research – focuses on the consequences of shifting the structure, locus, timing, and scope of research through genetic crowd-sourcing. This article …

The Social Context Of Oncofertility, Dorothy E. Roberts

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A field known as oncofertility provides female cancer patients with a variety of ways to preserve their fertility so that they may bear genetically related children after successful cancer treatment. Some women delay cancer therapy so doctors can collect their eggs, which are then cryopreserved in an unfertilized state or used to create embryos through in vitro fertilization for freezing. An experimental procedure for preserving the fertility of prepubertal girls, known as ovarian tissue cryopreservation, involves surgically removing their ovarian tissue and growing the immature eggs to a mature state so they can be frozen and stored until the girls …

Collateral Consequences, Genetic Surveillance, And The New Biopolitics Of Race, Dorothy E. Roberts

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This Article is part of a Howard Law Journal Symposium on “Collateral Consequences: Who Really Pays the Price for Criminal Justice?,” as well as my larger book project, Fatal Invention: How Science, Politics, and Big Business Re-create Race in the Twenty-First Century (The New Press, 2011). It considers state and federal government expansion of genetic surveillance as a collateral consequence of a criminal record in the context of a new biopolitics of race in America. Part I reviews the expansion of DNA data banking by states and the federal government, extending the collateral impact of a criminal record—in the form …

Preface To Fatal Invention: How Science, Politics, And Big Business Re-Create Race In The Twenty-First Century, Dorothy E. Roberts

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Fatal Invention documents the emergence of a new biopolitics in the United States that relies on re-inventing race in biological terms using cutting-edge genomic science and biotechnologies. Some scientists are defining race as a biological category written in our genes, while the biotechnology and pharmaceutical industries convert the new racial science into race-based products, such as race-specific medicines, ancestry tests, and DNA forensics, that incorporate false assumptions of racial difference at the genetic level. The genetic understanding of race calls for technological responses to racial disparities while masking the continuing impact of racism in a supposedly post-racial society. Instead, I …

What’S Wrong With Race-Based Medicine?, Dorothy E. Roberts

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This article is based on the 2010 Dienard Memorial Lecture on Law and Medicine at University of Minnesota and part of a larger book project, Fatal Invention: How Science, Politics, and Big Business Re-create Race in the Twenty-first Century (The New Press, 2011). In June 2005, the Food and Drug Administration approved the first pharmaceutical indicated for a specific race. Its racial label elicited three types of criticism – scientific, commercial, and political. I discuss the first two controversies en route to what I consider the main problem with race-based medicine – its political implications. By claiming that race, a …

A Defense Of Embryonic Stem Cell Research, Gregory Dolin

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On November 21, 2007, sensational scientific developments were reported by major newspapers, both in the United States and abroad. The media reported a new breakthrough in the area of stem cell research. According to two articles published in Science and Cell (both highly respected scientific journals), two teams of scientists were able to “reprogram” adult stem cells into embryonic stem cells, without actually having to experiment on embryos. The discovery was immediately hailed by the White House and other opponents of embryonic stem cell research. The New York Times gushed that the “stem cell wars” may be at an end. …

Conflicts Of Interest In Clinical Trial Recruitment & Enrollment: A Call For Increased Oversight, Valerie Gutmann Koch

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This White Paper makes several policy recommendations to eliminate or manage the conflicts of interest that arise pursuant to the compensation arrangements between investigators and their institutions with drug and medical device manufacturers as they affect the recruitment and enrollment of human research subjects in clinical trials. The paper seeks to accomplish overall financial neutrality as between treatment and research, so that physicians' decisions regarding inclusion of patients in clinical trials is unaffected by their own financial interests.

Race, Gender, And Genetic Technologies: A New Reproductive Dystopia?, Dorothy E. Roberts

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No abstract provided.

Torts And Innovation, Gideon Parchomovsky, Alex Stein

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This Essay exposes and analyzes a hitherto overlooked cost of the current design of tort law: its adverse effect on innovation. Tort liability for negligence, defective products, and medical malpractice is determined by reference to custom. We demonstrate that courts’ reliance on custom and conventional technologies as the benchmark of liability chills innovation and distorts its path. Specifically, the recourse to custom taxes innovators and subsidizes replicators of conventional technologies. We explore the causes and consequences of this phenomenon and propose two possible ways to modify tort law in order to make it more welcoming to innovation.

Compliance With Advance Directives: Wrongful Living And Tort Law Incentives, Holly Fernandez Lynch, Michele Mathes, Nadia N. Sawicki

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Modern ethical and legal norms generally require that deference be accorded to patients' decisions regarding treatment, including decisions to refuse life-sustaining care, even when patients no longer have the capacity to communicate those decisions to their physicians. Advance directives were developed as a means by which a patient's autonomy regarding medical care might survive such incapacity. Unfortunately, preserving patient autonomy at the end of life has been no simple task. First, it has been difficult to persuade patients to prepare for incapacity by making their wishes known. Second, even when they have done so, there is a distinct possibility that …

Tales From The Crypt: Scientific, Ethical, And Legal Considerations For Biohistorical Analysis Of Deceased Historical Figures, Lori B. Andrews, Jordan K. Paradise

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Biohistorical analysis involves using historic specimens of human remains or human material extracted or derived from historical artifacts to gather evidence about specimens that are identifiable or at least attributed to a historic figure at the time of the research. Biohistorical studies are being undertaken for myriad reasons, such as identification and authentication of remains, investigation into alleged criminal behavior, investigation into medical or psychological conditions, and even for purposes of commercialization. This article analyzes federal statutes, case law, and codes and guidelines from twenty-six professional organizations and societies informative to the field of biohistory. We surveyed the field, identified …

Nord Issues Gene Patenting Statement, Valerie Gutmann Koch

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No abstract provided.

Biology, Justice, And Women's Fate, Dorothy E. Roberts

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No abstract provided.