Science and Technology Law 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 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 …

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 …

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 …

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, …

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.