Science and Technology Law Commons^™

How Analogizing Socio-Legal Responses To Organ Transplantation Can Further The Legalization Of Reproductive Genetic Innovation, Myrisha S. Lewis

Faculty Publications

The Nobel Foundation emphasized the significance of genetic innovation to society, science, and medicine by awarding the 2020 Nobel Prize in Chemistry to “the CRISPR/Cas9 genetic scissors.” This Article focuses on “reproductive genetic innovation,” a term that includes cytoplasmic transfer, mitochondrial transfer, and germline or heritable gene editing techniques that are all categorized as “experimental” in the United States. These techniques all use in vitro fertilization, a legal and widely available practice. Yet reproductive genetic innovation has resulted in controversy and numerous barriers including a recurring federal budget rider, threats of federal enforcement action, and the unavailability of federal funding. …

Is Germline Gene Editing Exceptional?, Myrisha S. Lewis

Faculty Publications

Advances in gene editing have recently received significant scientific and media attention. Gene editing, especially CRISPR-Cas9, has revived multiple longstanding ethical debates, including debates related to parental autonomy, health disparities, disability perspectives, and racial and economic inequalities. Germline, or heritable, gene editing generates several newer, neglected bioethical debates, including those about the shared human germline and whether there is a "line" that humans should not cross.

This Article addresses several interrelated ethical and legal questions related to germline gene editing. Those questions address why, if at all, germline gene editing needs to be regulated and, if germline gene editing needs …

Keeping Ai Under Observation: Anticipated Impacts On Physicians' Standard Of Care, Iria Giuffrida, Taylor Treece

Faculty Publications

As Artificial Intelligence (AI) tools become increasingly present across industries, concerns have started to emerge as to their impact on professional liability. Specifically, for the medical industry--in many ways an inherently "risky" business--hospitals and physicians have begun evaluating the impact of Al tools on their professional malpractice risk. This Essay seeks to address that question, zooming in on how AI may affect physicians' standard of care for medical malpractice claims.

American Democratic Deficit In Assisted Reproductive Technology Innovation, Myrisha S. Lewis

Faculty Publications

In many areas of innovation, the United States is a leader, but this characterization does not apply to the United States' position in assisted reproductive technology innovation and clinical use. This article uses a political science concept, the idea of the "democratic deficit" to examine the lack of American public discourse on innovations in ART. In doing so, the article focuses on America's missing public consultation in health care innovation. This missing discourse is significant, as political and ethical considerations may impact regulatory decisions. Thus, to the extent that these considerations are influencing the decisions of federal agency employees, namely …

Health Care Cost Containment And Medical Technology: A Critique Of Waste Theory, Maxwell J. Mehlman

Faculty Publications

The high cost of health care has led to proposals to reduce wasteful medical technology under Medicare and other payment systems. Professor Mehlman warns that achieving this objective, while laudable in theory, is problematic because of the difficulties of defining, detecting and eliminating technology waste. A particular danger is that, in an effort to reduce waste, patients will be denied not only technologies that are wasteful from the patient's own perspective but technologies that yield net patient benefit. This risk is exacerbated by the Medicare prospective payment system, which rewards hospitals financially in inverse proportion to the amount of care …