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.

Social Media And Our Misconceptions Of The Realities, Richard Sanvenero Jr.

Richard Sanvenero Jr.

This article will review the current laws of the expectations of privacy under the two-pronged Katz test, and more specifically other cases that the courts have tried to interpret the test as applicable to social media such as Facebook, Instagram, Twitter, and e-mail. Since there seems to be “no light at the end of the tunnel” with any uniform decision within the courts on the Fourth Amendment protections against search and seizure when there is a reasonable expectation of privacy with social media. This reasonable expectation standard is developed by the users themselves who will allow their rights to be …

Rescuing Access To Patented Essential Medicines: Pharmaceutical Companies As Tortfeasors Under The Prevented Rescue Tort Theory, Richard Cameron Gower

Richard Cameron Gower

Despite some difficulties, state tort law can be argued to create a unique exception to patent law. Specifically, the prevented rescue doctrine suggests that charities and others can circumvent patents on certain critical medications when such actions are necessary to save individuals from death or serious harm. Although this Article finds that the prevented rescue tort doctrines is preempted by federal patent law, all hope is not lost. A federal substantive due process claim may be brought that uses the common law to demonstrate a fundamental right that has long been protected by our Nation’s legal traditions. Moreover, this Article …

Fixing Frand: A Pseudo-Pool Approach To Standards-Based Patent Licensing, Jorge Contreras

Jorge L Contreras

Technical interoperability standards are critical elements of mobile telephones, laptop computers, digital files, and thousands of other products in the modern networked economy. Most such standards are developed in so-called voluntary standards-development organizations (SDOs) that require participants to license patents essential to the standard on terms that are “fair, reasonable and non-discriminatory” (FRAND). FRAND commitments are thought to avoid the problem of patent hold-up: the imposition of excessive royalty demands after a standard has been widely adopted in the market. While, at first blush, FRAND commitments seem to assure product vendors that patents will not obstruct the manufacture and sale …

Desktop Piracy Factories: Will Existing Law Be Enough?, Andrew J. Daddono

Andrew J Daddono

A brief essay on how the disruptive technology found in 3D printing will affect the future of our existing legal regimes for intellectual property, what foreseeable problems there are, and possible ways that we may address them.

Copyright Freeconomics, John M. Newman

John M. Newman

Innovation has wreaked creative destruction on traditional content platforms. During the decade following Napster’s rise and fall, industry organizations launched litigation campaigns to combat the dramatic downward pricing pressure created by the advent of zero-price, copyright-infringing content. These campaigns attracted a torrent of debate, still ongoing, among scholars and stakeholders—but this debate has missed the forest for the trees. Industry organizations have abandoned litigation efforts, and many copyright owners now compete directly with infringing products by offering licit content at a price of $0.

This sea change has ushered in an era of “copyright freeconomics.” Drawing on an emerging body …

The Game Of Clones, Hyun G. Lee

Hyun G Lee

This paper examines whether expressions closely related to game mechanics should enjoy copyright law protection. In particular, this paper examines two recent cases, Tetris Holdings v. Xio Interactive and Spry Fox v. LOLApps, that seem to support the expansion of copyright protection to this area, particularly in game level design.