By: G. Edward Powell III The CRISPR/Cas9 genome engineering platform is the first method of gene editing that could potentially be used to treat genetic disorders in human embryos. No past therapies, genetic or otherwise, have been intended or used to treat disorders in existent embryos. Past procedures performed on embryos have exclusively involved creation and implantation (e.g., in-vitro fertilization) or screening and selection of already-healthy embryos (e.g., preimplantation genetic diagnosis). A CRISPR/Cas9 treatment would evade medical malpractice law due to the early stage of the intervention and the fact that it is not a treatment for the mother. In most jurisdictions, medical professionals owe no duty to pre-viable fetuses or embryos as such, but will be held liable for negligent treatment of the mother if the treatment causes injury to a born-alive child. This issue brief discusses the science of CRISPR/Cas9, the background legal status of human embryos, and the case for considering genetically engineered embryos as patients for purposes of medical malpractice law. Download Full Article (PDF) Cite: 15 Duke L. & Tech. Rev. 344
Tag: Science and Technology
The Dawn of Fully Automated Contract Drafting: Machine Learning Breathes New Life Into a Decades-Old Promise
By: Kathryn D. Betts and Kyle R. Jaep Technological advances within contract drafting software have seemingly plateaued. Despite the decades-long hopes and promises of many commentators, critics doubt this technology will ever fully automate the drafting process. But, while there has been a lack of innovation in contract drafting software, technological advances have continued to improve contract review and analysis programs. “Machine learning,” the leading innovative force in these areas, has proven incredibly efficient, performing in mere minutes tasks that would otherwise take a team of lawyers tens of hours. Some contract drafting programs have already experimented with machine learning capabilities, and this technology may pave the way for the full automation of contract drafting. Although intellectual property, data access, and ethical obstacles may delay complete integration of machine learning into contract drafting, full automation is likely still viable. Download Full Article (PDF) Cite: 15 Duke L. & Tech. Rev. 216
Mitochondrial Replacement Therapy and the Regulation of Reproductive Genetic Technologies in the United States
By: Bob Zhao The ability to alter the genes of future generations no longer belongs in the realm of science fiction. The genetic modification capabilities of modern science are advancing rapidly. Mitochondrial replacement therapy (MRT) represents the first crossing of the germline barrier in humans, and as of February 2015, it is the first procedure of its kind to be legalized in the Western world. How Congress decides to regulate MRT will influence future regulation of all genetic manipulation technologies. This brief argues that the current patchwork regulatory framework established in the United States is insufficient to deal with the complex issues MRT presents. As such, the creation of a new regulatory agency specifically focused on the oversight of reproductive and genetic biotechnologies may be necessary to balance the goals of ensuring the safety of research participants, promoting public debate, and stimulating continued scientific progress. Download Full Article (PDF) Cite: 15 Duke L. & Tech. Rev. 121
Flying Under the Radar: Low-Altitude Local Drone Use and the Reentry of Property Rights
By: Kenneth Maher The characteristics and capabilities of civilian drones have proliferated in recent years, giving rise to a burgeoning industry. The popular media and academic literature have predominantly focused on privacy concerns, devoting considerably less attention to the regulatory challenges created by the new technology. Congress instructed the FAA to integrate drones into the National Airspace System in 2012, but rulemaking delays and a moratorium on commercial uses hampered the industry and withheld benefits from the public. Final regulations are now in place, but the new rules revive legal uncertainty over the constitutional limits of federal authority and the ambiguous vertical bounds of private property rights. Low-altitude local drone use is one of the most promising aspects of the technology, and lies at the outer edge of federal authority. Much of the current debate gets key questions exactly backwards. Under current Supreme Court precedent, the proper legal question is not whether federal airspace authority can extend lower to govern virtually all drone use, but whether drone use pushes private property rights in airspace higher, limiting federal authority. Therefore, this Issue Brief joins the scholarly criticism of FAA efforts to date and calls for a greater focus on clear property
The Red Dawn of Geoengineering: First Step Toward an Effective Governance for Stratospheric Injections
By: Edward J. Larson A landmark report by the National Academy of Sciences (NAS) issued in 2015 is the latest in a series of scientific studies to assess the feasibility of geoengineering with stratospheric aerosols to offset anthropogenic global warming and to conclude that they offer a possibly viable supplement or back-up alternative to reducing carbon dioxide emissions. The known past effect of major explosive volcanic eruptions temporarily moderating average worldwide temperatures provides evidence in support of this once taboo form of climate intervention. In the most extensive study to date, an elite NAS committee now suggests that such processes for adjusting global temperature, while still uncertain, merit further research and field testing. Every study stresses the need for transparent international governance of stratospheric injections, especially given that the benefits of such interventions are certain to be unevenly distributed and the risks are not fully known. After examining the roadblocks to such governance, this paper explores the statutory and common law frameworks that could provide some stop-gap approaches until the needed regulatory regime emerges. Download Full Article (PDF) Cite: 14 Duke L. & Tech. Rev. 157