Health Law and Policy Commons^™

Genome Editing And The Jurisprudence Of Scientific Empiricism, Paul Enriquez

Vanderbilt Journal of Entertainment & Technology Law

Humankind has reached, in tow by the hand of a scientific breakthrough called CRISPR, the Rubicon of precise genetic manipulation first envisioned over fifty years ago. Despite CRISPR's renown in science and its power to transform the world, it remains virtually unaddressed in legal scholarship. In the absence of on-point law, the scientific community has attempted to reach some consensus to preempt antagonistic regulation and prescribe subjective standards of use under the guise of a priori scientific empiricism. Significant and complex legal issues concerning this technology are emerging, and the void in legal scholarship is no longer tolerable.

This Article …

The Rise Of Ethical License, Christi Guerrini, Margaret Curnette, Jacob S. Sherkow, Christopher Scott

Other Publications

The Broad Institute's recent licensing of its gene editing patent portfolio demonstrates how licenses can be used to restrict controversial applications of emerging technologies while society deliberates their implications.

Patent Law's Reproducibility Paradox, Jacob S. Sherkow

Articles & Chapters

Clinical research faces a reproducibility crisis. Many recent clinical and preclinical studies appear to be irreproducible; their results cannot be verified by outside researchers. This is problematic for not only scientific reasons but legal ones: patents grounded in irreproducible research appear to fail their constitutional bargain of property rights in exchange for working disclosures of inventions. The culprit is likely patent law’s doctrine of enablement. Although the doctrine requires patents to enable others to make and use their claimed inventions, current difficulties in applying the doctrine mitigate or even actively dissuade reproducible data in patents. This Article assesses the difficulties …

Creating A Data Resource: What Will It Take To Build A Medical Information Commons?, Patricia A. Deverka, Mary A. Majumder, Angela G. Villanueva, Margaret Anderson, Annette C. Bakker, Jessica Bardill, Eric Boerwinkle, Tania Bubela, Barbara J. Evans, Nanibaa’ A. Garrison, Richard A. Gibbs, Robert Gentleman, David Glazer, Melissa M. Goldstein, Hank Greely, Crane Harris, Bartha M. Knoppers, Barbara A. Koenig, Isaac S. Kohane, Salvatore La Rosa, John Mattison, Christopher J. O’Donnell, Arti K. Rai, Heidi L. Rehm, Laura L. Rodriguez, Robert Shelton, Tania Simoncelli, Sharon F. Terry, Michael S. Watson, John Wilbanks, Robert Cook-Deegan, Amy L. Mcguire

Faculty Scholarship

National and international public–private partnerships, consortia, and government initiatives are underway to collect and share genomic, personal, and healthcare data on a massive scale. Ideally, these efforts will contribute to the creation of a medical information commons (MIC), a comprehensive data resource that is widely available for both research and clinical uses. Stakeholder participation is essential in clarifying goals, deepening understanding of areas of complexity, and addressing long-standing policy concerns such as privacy and security and data ownership. This article describes eight core principles proposed by a diverse group of expert stakeholders to guide the formation of a successful, sustainable …

Patenting Frankenstein's Monster: Exploring The Patentability Of Artificial Organ Systems And Methodologies, Jordana Goodman

Faculty Scholarship

The conception of Frankenstein’s monster bridges the ever-narrowing divide between man and machine. Long before Congress codified Section 33(a) of the America Invents Act (“AIA”), Mary Shelley’s vague description of the monster’s creation has left people wondering: what defines a human organism? Through an analysis of patent law and scientific progress in the development of artificial organ systems, this paper explores the boundaries of patentable subject matter in the United States and attempts to clarify Congress’s determination that “no patent may issue on a claim directed to or encompassing a human organism.” Though patent law should incentivize development of artificial …

Quintavalle: The Quandary In Bioethics, Lisa Cherkassky

Journal of Law and Health

The case of R. (Quintavalle) v. Human Fertilisation Embryology Authority (and Secretary of State for Health) presents a handful of legal problems. The biggest legal query to arise from the case is the inevitable harvest of babies, toddlers and very young children for their bone marrow. This article unpacks the judicial story behind Quintavalle to reveal how the strict provisions of the Human Fertilisation and Embryology Act 1990 - namely ‘suitable condition’ under schedule 2 paragraph 1(1)(a) and ‘treatment services’ and ‘assisting’ under section 2(1) - were widely misinterpreted to introduce the social selection of embryos into law. The legal …

R-Egg-Ulation: A Call For Greater Regulation Of The Big Business Of Human Egg Harvesting, Danielle A. Vera

Michigan Journal of Gender & Law

When it comes to young healthy women “donating” their eggs, America has a regulation problem. This Note explains the science behind the harvesting of human eggs, focusing on potential egg donors, and describes the specific factors that make egg donation a unique type of transaction. It describes the current regulatory status of the assisted reproductive technology industry in the United States and highlights the ways in which this scheme fails to protect egg “donors.” This Note concludes with a call for comprehensive regulation of the assisted reproductive technology industry.

Ebola, Experimental Medicine, Economics, And Ethics: An Evaluation Of International Disease Outbreak Law, Sara L. Dominey

Georgia Journal of International & Comparative Law

No abstract provided.

Marine Law Symposium: Legal And Policy Approaches To Reduce Marine Debris In New England 11/04/2016, Roger Wiliams University School Of Law

School of Law Conferences, Lectures & Events

No abstract provided.

The Lautenberg Act: Chemical Safety Overhaul Of The Toxic Substances Control Act, Alyssa S. Rosen

Elisabeth Haub School of Law Faculty Publications

On June 22, 2016, President Obama signed the Frank Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), a landmark bipartisan compromise legislation designed to overhaul the Toxic Substances Control Act (TSCA). The Lautenberg Act makes it easier for the U.S. Environmental Protection Agency (EPA) to regulate toxic substances while providing the chemical industry with regulatory clarity and certainty. Law Librarians, practicing lawyers, and academics have taken note of this groundbreaking law that most likely will set the template for the next generation of environmental reform by tackling issues such as preemption of state law, protection of vulnerable populations, …

Wearable Fitness Devices: Personal Health Data Privacy In Washington State, Steven Spann

Seattle University Law Review

Private entities are increasingly targeting individuals in the United States and around the world to gather personal data for such purposes as product development, market identification, and insurance risk assessment. While credit card records and online browsing histories have long been the medium through which this data is gathered, in more recent years, wearable fitness devices have added a new dimension to data production and collection. These devices are capable of gathering a significant amount of data regarding a person’s physical and physiological characteristics, thereby exposing these data producers to personal privacy infringement. Washington State lawmakers and citizens must be …

Neuroimaging Evidence: A Solution To The Problem Of Proving Pain And Suffering?, Brady Somers

Seattle University Law Review

Envision a plaintiff who was injured on the job at a construction site due to his employer’s negligence. The plaintiff has chronic back pain, but it is not verifiable on an X-ray, nor is a physical injury readily discernible by any other technology. Presently, fact finders are given the broad discretion to decide whether they find this plaintiff credible, and accordingly, whether they believe he is truly in pain and deserves damages for pain and suffering. However, neuroimaging—specifically functional magnetic resonance imaging (fMRI)—could allow those fact finders to visualize whether this plaintiff was hurting by depicting the unique signatures that …

The Treatment For Malpractice – Physician, Enhance Thyself: The Impact Of Neuroenhancements For Medical Malpractice, Harvey L. Fiser

Pace Law Review

This article will introduce some of the issues and offer some possible guidelines which may eventually guide cases of medical malpractice and medical care in the face of neurointerventions. First, I will briefly address the standard of care in medical malpractice cases in general. Second, I will discuss some of the existing and potential physical and neurological enhancements available for physicians. Finally, I will explore how these neurointerventions could alter the standards for medical malpractice for both the enhanced doctors and the entire medical profession.

Inquiry Into The Implementation Of Bush’S Executive Order 13211 And The Impact On Environmental And Public Health Regulation, Elizabeth Ann Glass Geltman, Gunwant Gill, Miriam Jovanovic

Publications and Research

Executive Order 13211, promulgated in 2001, requires the federal government to consider the impact of federal action on energy independence as part of the George W. Bush’s National Energy Policy. This law review examines whether EO 13211 was used to curtail environmental protection and natural resource conservation. The article begins with a review of the procedure required of federal agencies under EO 13211 and its associated documents. The paper then examines case law and published federal rulemaking proceedings and examines how federal agencies apply tests to evaluate the potential energy effect. The study concludes that EO 13211 strikes a reasonable …

Politically Correct Eugenics, Seema Mohapatra

Faculty Scholarship

No abstract provided.

Health Information And Data Security Safeguards, 32 J. Marshall J. Info. Tech. & Privacy L. 133 (2016), Jane Kim, David Zakson

UIC John Marshall Journal of Information Technology & Privacy Law

The healthcare industry possesses information coveted by cyber criminals. Unfortunately, healthcare providers are also among the most vulnerable and unprepared to deal with cyber attacks. The Introduction sets the background of this paper with cyber security statistics of the healthcare sector. Part A of this paper will discuss how new Russian law impacts global data security. Part B takes a broad look at data security safeguards. Part C focuses on U.S. attempts at safeguarding data through NIST and its Presidential Policy Directive. In Part D, the paper explores in greater detail causes that precipitate security breaches and specific security defenses …

Privacy And Accountability In Black-Box Medicine, Roger Allan Ford, W. Nicholson Price Ii

Michigan Telecommunications & Technology Law Review

Black-box medicine—the use of big data and sophisticated machine-learning techniques for health-care applications—could be the future of personalized medicine. Black-box medicine promises to make it easier to diagnose rare diseases and conditions, identify the most promising treatments, and allocate scarce resources among different patients. But to succeed, it must overcome two separate, but related, problems: patient privacy and algorithmic accountability. Privacy is a problem because researchers need access to huge amounts of patient health information to generate useful medical predictions. And accountability is a problem because black-box algorithms must be verified by outsiders to ensure they are accurate and unbiased, …

The Patenting Of Gene Based Diagnostic Assays In A Post Mayo And Myriad World, 16 J. Marshall Rev. Intell. Prop. L. 1 (2016), Michael Sanzo

UIC Review of Intellectual Property Law

Recent advances in biotechnology have given researchers the ability to comprehensively examine the genetic basis of disease in unprecedented ways and will undoubtedly result in many new and valuable gene based diagnostic assays in the near future. These advances came during a period of roughly thirty years during which the patent eligibility of such assays was essentially unquestioned. Then, beginning in 2010, the Supreme Court embarked on a series of decisions that will, in almost all cases, preclude the patenting of diagnostic assays that rely on genetic mutations or gene expression patterns. This article suggests that reason that the issue …

Can Dna Be Speech?, Jorge R. Roig

Scholarly Works

DNA is generally regarded as the basic building block of life itself. In the most fundamental sense, DNA is nothing more than a chemical compound, albeit a very complex and peculiar one. DNA is an information-carrying molecule. The specific sequence of base pairs contained in a DNA molecule carries with it genetic information, and encodes for the creation of particular proteins. When taken as a whole, the DNA contained in a single human cell is a complete blueprint and instruction manual for the creation of that human being. In this article we discuss myriad current and developing ways in which …

G2i Knowledge Brief: A Knowledge Brief Of The Macarthur Foundation Research Network On Law And Neuroscience, David L. Faigman, Anthony Wagner, Richard J. Bonnie, Bj Casey, Andre Davis, Morris B. Hoffman, Owen D. Jones, Read Montague, Stephen J. Morse, Marcus E. Raichle, Jennifer A. Richeson, Elizabeth S. Scott, Laurence Steinberg, Kim Taylor-Thompson, Gideon Yaffe

Faculty Scholarship

Courts are daily confronted with admissibility issues – such as in cases involving neuroscientific testimony – that sometimes involve both the existence of a general phenomenon (i.e., “G”) and the question of whether a particular case represents a specific instance of that general phenomenon (i.e., “i”).

Unfortunately, courts have yet to carefully consider the implications of “G2i” for their admissibility decisions. In some areas, courts limit an expert’s testimony to the general phenomenon. They insist that whether the case at hand is an instance of that phenomenon is exclusively a jury question, and thus not an appropriate subject of expert …

Technology, Gender And Fashion, Jeanne L. Schroeder

Cardozo Arts & Entertainment Law Journal

No abstract provided.

Liability For Mobile Health And Wearable Technologies, Lindsay Wiley, Nicolas Terry

Scholarly Articles in Law Reviews & Journals

Most of the legal commentary regarding mobile health has focused on direct regulation leveraging existing laws and regulators such as HIPAA privacy through HHS-OCR or device regulation by the FDA. However, much of the mobile health revolution likely will play out in lightly regulated spaces bereft of most of the privacy, security, and safety rules associated with traditional health care. This article examines the potential for common law liability models to bridge these gaps (even on a temporary basis). Part II of this paper provides an introduction to the terminology used, and presents a brief typology of the apps appearing …

The Phase-Out And Sunset Of Travel Restrictions In The International Health Regulations, Sarah R. Goldfarb

Brooklyn Journal of International Law

Whether and to what extent travel restriction should be implemented during international infectious disease epidemics became a controversial issue, most recently, during the 2014 Ebola outbreak. The primary authority on the manner in which to respond to such epidemics is the International Health Regulations (IHR). The IHR is a treaty, established by the World Health Organization (WHO), which governs and coordinates international responses to international infectious disease epidemics. Despite the WHO's strong advisement to the contrary, many countries who were signatories to the IHR implemented travel bans and other types of travel restrictions to prevent the transmission of the disease …

Environmental Law, Big Data, And The Torrent Of Singularities, William Boyd

Publications

How will big data impact environmental law in the near future? This Essay imagines one possible future for environmental law in 2030 that focuses on the implications of big data for the protection of public health from risks associated with pollution and industrial chemicals. It assumes the perspective of an historian looking back from the end of the twenty-first century at the evolution of environmental law during the late twentieth and early twenty-first centuries. The premise of the Essay is that big data will drive a major shift in the underlying knowledge practices of environmental law (along with other areas …

Regulating Drug Promotion To Promote The Public Health: A Response To Bennett, Et Al., Patricia J. Zettler

Faculty Publications By Year

No abstract provided.

Diagnostics Need Not Apply, Rebecca S. Eisenberg

Articles

Diagnostic testing helps caregivers and patients understand a patient's condition, predict future outcomes, select appropriate treatments, and determine whether treatment is working. Improvements in diagnostic testing are essential to bringing about the long-heralded promise of personalized medicine. Yet it seems increasingly clear that most important advances in this type of medical technology lie outside the boundaries of patent-eligible subject matter. The clarity of this conclusion has been obscured by ambiguity in the recent decisions of the Supreme Court concerning patent eligibility. Since its 2010 decision in Bilski v. Kappos, the Court has followed a discipline of limiting judicial exclusions from …

The Buying And Selling Of Human Organs From The Living: Why Not?, Timothy M. Hartman

Akron Law Review

This article will examine the propriety of establishing a system for the sale of human organs, especially the kidney. Initially, the debilitating malady of end stage renal disease will be discussed as will the marginal "cure" of the disease via hemodialysis. Next, the superior alternative to dialysis, i.e., kidney transplantation will be discussed in two ways. First, the current procedure of using living, related donors will be examined as well as harvesting kidneys from cadaver "donors". Second, the practice of transplantation will be explored for its ramifications to society and the participants in the following areas: medicine, psychology, and the …

Compassionate Use Of Experimental Therapies: Who Should Decide?, Patricia J. Zettler

Faculty Publications By Year

In addition to being an example of unsubstantiated hype about regenerative medicine, the controversy around the Italy-based Stamina Foundation's unproven stem cell therapy represents another chapter in a continuing debate about how to balance patients' requests for early access to experimental medicines with requirements for demonstrating safety and effectiveness. Compassionate use of the Stamina therapy arguably should not have been permitted under Italy's laws, but public pressure was intense and judges ultimately granted access. One lesson from these events is that expert regulatory agencies may be the institutions most competent to make compassionate use decisions and that policies should include …

3-D Bioprinting: Not Allowed Or Nota Allowed?, Robert Jacobson

Chicago-Kent Law Review

In 1984, Congress passed the National Organ Transplantation Act (NOTA) to improve the supply of vital human organs. A key provision of NOTA was the prohibition of acquiring, receiving, or otherwise transferring human organs. In effect, this provision bans the purchase of human organs. However, due to recent breakthroughs in 3-D bioprinting technology, scientists are on the verge of being able to create lab-grown organs suitable for transplantation. This Note will examine the applicability of NOTA to 3-D bioprinting technology and recommend amendments to NOTA that would clarify the legality of 3-D bioprinting.

Dna Storage Banks: The Importance Of Preserving Dna Evidence To Allow For Transparency And The Preservation Of Justice, Cristina Martin

Chicago-Kent Law Review

What is the duty to preserve information in today’s society? In order for humanity to evolve, change and flourish in the future, society needs to preserve its information from the past. In the criminal justice field, preservation of evidence has special significance. DNA evidence in particular has become a helpful aid for innocent defendants who have been improperly imprisoned. Over the past twenty years, the number of exonerations of imprisoned criminal defendants has increased dramatically. With the advancement of technology, old, previously untestable or improperly tested DNA evidence will need to be retested. However, most states do not have proper …