Law Commons^™

The Mhealth Conundrum: Smartphones & Mobile Medical Apps – How Much Fda Medical Device Regulation Is Required?, Vincent J. Roth Esq

Vincent J Roth Esq

Smartphones and tablets have provided a plethora of new business opportunities for a number of industries including healthcare. Technology, however, appears to have outpaced the regulatory environment, which has spawned criticism over the current guidance of the Food and Drug Administration (“FDA”) with regard to software and what level of regulation is required for mobile medical applications. Commentators have remarked that the FDA’s guidance in this area is complex and unclear. This article explores the current FDA regulatory scheme for mobile medical applications and adapters for mobile devices designed to provide mobile healthcare, or “mHealth.” Attention is given to further …

The Mhealth Conundrum: Smartphones & Mobile Medical Apps – How Much Fda Medical Device Regulation Is Required?, Vincent J. Roth Esq

Vincent J Roth Esq

Smartphones and tablets have provided a plethora of new business opportunities for a number of industries including healthcare. Technology, however, appears to have outpaced the regulatory environment, which has spawned criticism over the current guidance of the Food and Drug Administration (“FDA”) with regard to software and what level of regulation is required for mobile medical applications. Commentators have remarked that the FDA’s guidance in this area is complex and unclear. This article explores the current FDA regulatory scheme for mobile medical applications and adapters for mobile devices designed to provide mobile healthcare, or “mHealth.” Attention is given to further …

Reports Of Its Death Are Greatly Exaggerated: Ebay, Bosch, And The Presumption Of Irreparable Harm In Hatch-Waxman Litgation, Kenneth C. Louis

Kenneth C. Louis

No abstract provided.

Synaptic Plasticity In Neurological Deficit As A Form Of Indemnification: The Utility Of Analogical Thinking, Madeleine Schachter, Madeleine Schachter

Madeleine Schachter

The need for creative problem-solving is as infinite as are the ways in which to engage in it. This article posits that one useful, albeit not flawless, mechanism in which to seek scientific advancements is through the use of analogical thinking. The technique has been invoked in virtually all disciplines, sometimes successfully and sometimes not. The utility of thinking by analogy lies, paradoxically, in its capacity to conceptualize a solution or a viable avenue of further inquiry as much as in its capacity to expose flaws in the analogical concept hypothesized. As such, it is an important means of stimulating …

The New Frontier Of Advanced Reproductive Technology: Reevaluating Modern Legal Parenthood, Yehezkel H. Margalit Dr., John D. Loike Dr., Orrie Levy Adv.

Hezi Margalit

Assisted reproductive technologies (ARTs) have challenged our deepest conceptions of what it means to be a parent by fragmenting traditional aspects of parenthood. The law has been slow to respond to this challenge, and numerous academic articles have proposed models for adapting parentage laws to ARTs. In the coming years, however, scientific advancements in reproductive technologies, such as somatic cell nuclear transfer and stem cell technologies, will challenge both parentage laws and proposed legal models for traditional ARTs in new and fascinating ways. For instance, these advanced technologies could allow two women to create a child without any male genetic …

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Ryan G. Vacca

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …