By Miriam Swedlow

Let’s face it; the FDA has a tough job. It must navigate the thin line between balancing public safety and facilitating business innovation. It is perpetually in the zone of “damned if they do and damned if they don’t.” This scenario is currently playing out in the relatively new concept of mHealth, a term used to describe medical services delivered over a mobile device (“m” is for mobile).

The past decade has seen an explosion in health and medical-related apps available to medical professionals and consumers. Apps provide access to medical textbooks or allow users to track health data such as calories and blood pressure. Apps can also directly connect to medical devices such as blood pressure cuffs or cardiac leads, or allow doctors to remotely monitor a patient in real time. Given the broad range of applications, the FDA has struggled to determine when an app becomes a medical device subject to regulation under the Federal Food, Drug, and Cosmetic Act (FD&C Act). On February 9, 2015 the FDA published its updated Guidance for Industry and Food and Drug Administration Staff on Mobile Medical Applications. Despite providing manufacturers some clarity, the Guidance falls short of creating a clear indication of what will or will not fall within FDA oversight. Continue reading →

The Washington Journal of Law, Technology & Arts (LTA Journal) has published its Winter 2015 Issue. The LTA Journal publishes concise legal analysis aimed at practicing attorneys on a quarterly basis.

Patrick Holvey, a 2015 J.D. candidate at NYU School of Law and registered Patent Agent, wrote the first article, “The Anti-Clone Wars: Towards a Reinvigoration of the Doctrine of Patent Misuse and the Per Se Illegality of Anti-Cloning Provisions.” The article argues that anti-cloning provisions improperly broaden the patent grant, constrain competition in unpatented subject matter, harm competition, and should be considered by the courts to constitute per se patent misuse or, in the alternative, patent misuse under a rule of reason analysis.

Submissions Editor Christopher Ferrell wrote the second article, “Standing Room Only: MadStad Engineering and the Potential to Challenge the Constitutionality of the America Invents Act’s ‘First-Inventor-to-File’ Patenting System.” The article explores the ramifications of the MadStad Engineering v. USPTO ruling and examines the constitutionality of the first-inventor-to-file patent system.

In the issue’s third article, “The Code-Based Interpretation of Authorization: An Incomplete Picture,” Managing Articles Editor Nicholas Ulrich examines the two leading interpretive theories on the issue of authorization under the Stored Communications Act: the code-based theory and the trespass theory. The article argues that the appropriate approach to authorization looks to both theories.

Associate Editor-in-Chief of Operations Jeffrey Echert contributed the fourth article, “Radio Revolution: The Local Community Radio Act’s Expansion of Possibilities for Low-Power FM Stations.” The article explores the struggle to establish low-power FM radio stations (LPFMs) and argues that the Local Community Radio Act is a step in the right direction for LPFMs, but not without obstacles.

See the full issue here.

Visit the Washington Journal of Law, Technology & Arts Website: http://www.law.washington.edu/wjlta/

By Denise Kim

On April 1, 2015, President Obama signed a new executive order designed to block the property of certain persons engaging in significant malicious cyber-enabled activities. Over the past several years, the number of malicious cyber-attacks has continued to increase and experts predict that major cyber-attacks will continue to increase over the next decade.

In support of the new executive order, President Obama declared a national emergency to deal with this threat after finding that the “increasing prevalence and severity of malicious cyber-enabled activities originating from, or directed by persons located, in whole or in substantial part, outside the United States constitute an unusual and extraordinary threat to the national security, foreign policy, and economy of the United States.” Continue reading →

By Juliya Ziskina

The Department of Justice has charged two of the law enforcement agents involved in the complex multi-agency investigation into the Silk Road for stealing hundreds of thousands of dollars (at the very least) in bitcoins.

When charges were announced against Ross Ulbricht in October 2013 and the website was shut down, the authorities called Silk Road “the most sophisticated and extensive criminal marketplace on the internet.” Several thousand drug dealers and other vendors used the site from January 2011 through its closing to sell hundreds of kilograms of illegal drugs and other illicit goods to more than 100,000 buyers, according to charges filed in Manhattan. The site generated over $213 million in revenue during that period, and Mr. Ulbricht, operating under the pseudonym “Dread Pirate Roberts,” took millions of dollars in commissions, federal prosecutors in Manhattan charged. (We previously covered takeaways from the trial here.) Continue reading →