Health Law and Policy Commons^™

Femtechnodystopia, Leah R. Fowler, Michael Ulrich

Faculty Scholarship

Reproductive rights, as we have long understood them, are dead. But at the same time history seems to be moving backward, technology moves relentlessly forward. Femtech products, a category of consumer technology addressing an array of “female” health needs, seem poised to fill gaps created by states and stakeholders eager to limit birth control and abortion access and increase pregnancy surveillance and fetal rights. Period and fertility tracking applications could supplement or replace other contraception. Early digital alerts to missed periods can improve the chances of obtaining a legal abortion in states with ever-shrinking windows of availability or prompt behavioral …

A Unified Theory Of Data, William Magnuson

Faculty Scholarship

How does the proliferation of data in our modern economy affect our legal system? Scholars that have addressed the question have nearly universally agreed that the dramatic increases in the amount of data available to companies, as well as the new uses to which that data is being put, raise fundamental problems for our regulatory structures. But just what those problems might be remains an area of deep disagreement. Some argue that the problem with data is that current uses lead to discriminatory results that harm minority groups. Some argue that the problem with data is that it impinges on …

A Code Of Ethics For Gene Drive Research, George J. Annas, Chase L. Beisel, Kendell Clement, Andrea Crisanti, Stacy Francis, Marco Galardini, Roberto Galizi, Julian Grunewald, Greta Immobile, Ahmad S. Khalil, Ruth Muller, Vikram Pattanayak, Karl Petri, Ligi Paul, Luca Pinello, Alekos Simoni, Chrysanthi Taxiarchi, J. Keith Joung

Faculty Scholarship

Gene drives hold promise for use in controlling insect vectors of diseases, agricultural pests, and for conservation of ecosystems against invasive species. At the same time, this technology comes with potential risks that include unknown downstream effects on entire ecosystems as well as the accidental or nefarious spread of organisms that carry the gene drive machinery. A code of ethics can be a useful tool for all parties involved in the development and regulation of gene drives and can be used to help ensure that a balanced analysis of risks, benefits, and values is taken into consideration in the interest …

Why We (Probably) Must Deliberately Infect, Adam J. Kolber

Faculty Scholarship

No abstract provided.

The Problems With Decision-Making, Joanna K. Sax

Faculty Scholarship

Our society faces major challenges in numerous areas, including climate change and healthcare. Addressing these problems with technological advances are of great importance. Increasingly, however, consumers are resisting or rejecting such technological interventions based on inappropriate assignment of risk. In other words, the consumer assessment of risk is not in line with evidence-based assessment of risk. This article focuses on two controversial areas, vaccines and genetically engineered food, as examples in which consumers assign a high risk despite an evidence-based assessment of low risk. This article describes how empirically tested decision-making theories explain why consumers inappropriately assign risk. While these …

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 …

Politically Correct Eugenics, Seema Mohapatra

Faculty Scholarship

No abstract provided.

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 …

Protecting Health Privacy In An Era Of Big Data Processing And Cloud Computing, Frank Pasquale, Tara Adams Ragone

Faculty Scholarship

No abstract provided.

Using Egg Freezing To Extend The Biological Clock: Fertility Insurance Or False Hope?, Seema Mohapatra

Faculty Scholarship

No abstract provided.

Imaging The Mind, Minding The Image: An Historical Introduction To Brain Imaging And The Law, Laura Stephens, Shahram Khoshbin

Faculty Scholarship

Since ancient times, people have yearned to attribute human behaviors to a physical source within the head. Recently, neuroimaging technologies have given us the technical ability to look at the living brain, its structures, and some of its functions without the need for invasive procedures. However, the science has a long way to go before these technologies can allow us fully to appreciate the anatomical and physiologic underpinnings of human thoughts, states of mind, motives, will, or behaviors.

In this Article, we use an historical overview to introduce the various new technologies for imaging the brain. Today, the goal of …

Some Principles Require Principals: Why Banning “Conflicts Of Interest” Won’T Solve Incentive Problems In Biomedical Research, William M. Sage

Faculty Scholarship

This Article seeks to bring greater discipline to the analysis of conflicts of interest in biomedical research, and by doing so to reveal trends and tensions in the research enterprise that require a more deliberate and longer term response. By comparing tensions in biomedical research to those affecting indisputably "relational" professionals such as lawyers, this Article concludes that "conflict of interest" is the wrong language to describe most of these situations, and leads to the wrong solutions. Conflict of interest analysis in law derives from an image of professional obligation running directly from expert agent to dependent principal. Because a …

Two Concepts Of Immortality: Reframing Public Debate On Stem-Cell Research, Frank Pasquale

Faculty Scholarship

No abstract provided.

Before It's Too Late- Addressing Fear Of Genetic Information, Karen H. Rothenberg, Sharon F. Terry

Faculty Scholarship

No abstract provided.

Genetic Testing For Susceptability To Disease From Exposure To Toxic Chemicals: Implications For Public And Worker Health Policies, Michael S. Baram

Faculty Scholarship

The Environmental Genome Program intends to identify "susceptibility genes" that would indicate if a person is more vulnerable to cancer or other disease as a result of exposure to certain chemicals in the workplace, the environment, foods, or other products. Research findings and the capability to test persons for such genes are likely to impugn and challenge health policies and regulatory programs that do not take genetic susceptibility into account when conferring health benefits and restricting chemical exposures. This article focuses on the Occupational Safety and Health Administration (OSHA) and discusses four options available to this agency for protecting genetically …

Symposium: Regulatory And Liability Considerations, Michael S. Baram, Ellen Flannery, Patricia Davis, Gary Marchant

Faculty Scholarship

You can tell from remarks by prior speakers that regulatory approvals and liability prevention are of critical importance to progress in biomaterials. Gene therapy trials and the tragic outcomes of some of those trials have raised the specter of government suspension of clinical studies, termination of funding, and potential liability for personal injury under malpractice or products liability doctrines. Regulatory requirements and the terms of research grants and contracts have to be very carefully addressed by organizations testing, developing, making, selling and using biomaterials, biotechnology, and medical devices. However, many regulatory requirements are incomplete, ambiguous and confusing because the agencies …

Symposium: Advances In Biomaterials And Devices, And Their Financing, Michael S. Baram, Ronald A. Cass, Steven Bauer, Joyce Wong, Martin Yarmush, Joshua Tolkoff, Rufus King

Faculty Scholarship

My name is Professor Michael Baram and I direct the Center for Law and Technology here at the law school. Today's meeting is the third annual Technology Law Symposium to be held here, sponsored by the high technology law firm of Testa, Hurwitz & Thibeault, LLP and the Center for Law and Technology.

Our meeting today is focused on an exciting area of research and product development. This area involves the use of conventional as well as new genetically engineered biomaterials in new medical device configurations for implantation and with the purpose of restoring bodily functions, regenerating tissue, bone, cartilage, …

Can Patents Deter Innovation? The Anticommons In Biomedical Research, Michael Heller, Rebecca S. Eisenberg

Faculty Scholarship

The "tragedy of the commons" metaphor helps explain why people overuse shared resources. However, the recent proliferation of intellectual property rights in biomedical research suggests a different tragedy, an "anticommons" in which people underuse scarce resources because too many owners can block each other. Privatization of biomedical research must be more carefully deployed to sustain both upstream research and downstream product development. Otherwise, more intellectual property rights may lead paradoxically to fewer useful products for improving human health.

The Laws Of Genetics, Michael S. Baram

Faculty Scholarship

It used to be that high technology meant nuclear physics and missile systems, and presented the threat of physical destruction. Today, "high tech" means biotechnology and electronic communication systems, and the focus has shifted to concerns about more subtle problems like loss of privacy, inability to control personal information, and the discriminations and other adversities that often follow.

The Biotechnology Revolution And Its Regulatory Evolution, Diane E. Hoffmann

Faculty Scholarship

No abstract provided.