EU Antitrust Policy: Favoring Innovation over the Googles’ of the World

Picture1By Amela Zukic

As many of us have heard, the European Commission recently slapped Google with a 2.7-billon dollar antitrust fine for allegedly favoring its own comparison-shopping service, an illegal practice in the EU. Google now has 90 days to cease this practice or it could face a fine of up to 5% of the average daily worldwide turnover of its parent company, Alphabet. While many in the U.S. may reject this decision, the EU’s ruling reflects its underlying goal of fostering innovation and should not be quickly dismissed. Continue reading “EU Antitrust Policy: Favoring Innovation over the Googles’ of the World”

Spotify Proposes $43 Million Settlement Class Action Lawsuit for Unlawful Distribution of Copyrighted Music

Picture1By: Adam Roberts

Popular music streaming service Spotify has agreed to pay $43.45 million to settle a class action lawsuit brought by a collection of songwriters and music copyright holders.  The class plaintiffs allege that Spotify unlawfully distributed their music to consumers without paying what are known as ‘mechanical royalties.’  Mechanical royalties are the payments made to a songwriter which gives one the legal right to reproduce a piece of music.  Under Section 115 of the Copyright Act, services like Spotify must pay mechanical royalties for all songs streamed on their web service.  Although the class action has reached a proposed resolution, there may still be legal issues in seeking court approval of the settlement.  Continue reading “Spotify Proposes $43 Million Settlement Class Action Lawsuit for Unlawful Distribution of Copyrighted Music”

Texting Too Far

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By Ari Robbins

On Friday, June 16th, a Massachusetts Juvenile Court Judge found twenty-year old Michelle Carter guilty of the involuntary manslaughter of Conrad Roy III. Carter was found guilty of recklessly causing Roy III’s death. However, when eighteen-year old Roy III took his own life in 2014, he was alone. Roy closed himself in his truck in a Walmart parking lot and allowed a generator to fill his truck cab with carbon monoxide until he died. When he killed himself, Roy hadn’t spoken to Carter in person for over a year. The two maintained a close relationship entirely through text and e-mail. Continue reading “Texting Too Far”

Regulatory Landscape Remains Unclear for Mobile Health App Developers

8585047526_37a5bed3ff_bBy Mariko Kageyama

The digital health field has been growing exponentially and is now expanding rapidly into emerging markets. As a result, mobile health apps, or “mHealth apps,” have exploded in popularity. If you search for “health” on online app stores such as Apple’s App Store or Google Play, you will have no problem finding countless apps with various health-related purposes. One survey reports that nearly 260,000 mHealth apps were available worldwide by 2016.

However, what mHealth app developers and consumers may not realize is that these new technologies are becoming the target of increasingly tight regulations by both federal and state laws in the United States.

At the federal level, mobile health apps may be scrutinized under the following federal agency laws:

  • Health Insurance Portability and Accountability Act (HIPAA) and HITECH Act – These acts regulate data privacy and security of health information. They are enforced by the U.S. Department of Health & Human Services’ Office for Civil Rights (OCR) and Office of the National Coordinator for Health Information Technology (ONC);
  • Food, Drug, and Cosmetic Act (FDCA) – This act allows the Food and Drug Administration (FDA) to regulate the safety and effectiveness of “medical devices;” and
  • Federal Trade Commission Act (FTC Act) – This act both creates the FTC and allows it to enforce and penalize deceptive or unfair business practices including false or misleading claims about apps’ performance.

Among these major agency players, the FDA has struggled the most with trying to adapt its existing regulatory framework to include and regulate mHealth apps.

For instance, the FDA can regulate “medical devices,” but what qualifies as a “medical device” under FDA law? According to its 2015 Guidanace, the FDA does not want to regulate every single smartphone app that tangentially relates to fitness or wellness. Instead, the FDA only wants to keep an eye on a small subset of apps called “mobile medical apps” that may pose moderate to high risks to a patient’s safety if the apps fail to work as intended. “Mobile medical apps” can either be those connected to existing medical devices already regulated by FDA, or those that “transform” mobile platforms into an FDA-regulated device.

The FDA explains that a mobile app “transforms” into a medical device when it uses attachments, display screens, or sensors, or when it uses a mobile platform’s built-in features such as light, vibrations, and camera to create functionalities similar to those of currently regulated devices. But the exact actions that constitute a “transformation” are not yet known and remain open to significant agency discretion.

Therefore, if you were to create a new mHealth app that “transforms” a mobile device, you may need to seek FDA approval for a specific medical device classification based on the level of safety risks it poses. The classes are ranked I, II, or III and any class of device can be subject to what is known as Premarket Notification 510(k).

In anticipation of ambiguities in this field, multiple federal agencies collaborated in 2016 to create the Mobile Health Apps Interactive Tool. What is unique about this user-friendly educational website is that it is clearly intended for IT developers, not healthcare professionals or general consumers.

State laws have also come into play. Earlier in 2017, the New York Attorney General settled with three mHealth app developers for state law violations over their misleading marketing and privacy practices. Those mHealth apps are: My Baby’s Beat–Prenatal Listener; Heart Rate Monitor & Pulse Tracker; and Cardiio-Heart Rate Monitor + 7 Minute Workout. As illustrated in the settlement documents, these apps do not look any more sophisticated than other similar apps, but the New York AG maintained that these cardiac rate monitors probably fall under FDA Class II medical devices. Such a classification means that these are higher risk devices than Class I and thus subject to greater regulatory controls. Although the investigation did not go further, these state cases show that mHealth app developers and manufacturers can be exposing themselves to large amounts of liability at the state level as well as the federal level.

Despite this heightened oversight, the current FDA Guidance is clearly nothing more than a temporary fix when much more is needed to address these issues in such a rapidly growing and changing field. Because Congress has a less-than-great track record of quickly enacting laws, the FDA and other relevant agencies should act swiftly to reevaluate these regulations in order to ensure consumer health and safety while simultaneously fostering innovation in this massively beneficial field.

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Developments in the Dispute About Nazi-Loot; Heirs No Longer in Limbauch-Limbo?

Berlín_KGM_güelfos_02By Sebastian R Stock

Germany will likely be forced to defend itself for the first time in a U.S. Court against claims relating to the theft of art by the Nazi party. The complicated issue of ownership and title to art looted by the Nazi regime is not new, but this case could have extensive implications to ongoing and future litigation in this area of law nonetheless. Continue reading “Developments in the Dispute About Nazi-Loot; Heirs No Longer in Limbauch-Limbo?”

Pink is the New (Vanta)black – The Story Behind the World’s First Open-Source Paint

Picture1By Seth Parent

A petty, back-and-forth social media feud between two artists has finally given the world more than just mindless entertainment and threatened lawsuits. In the latest recurrence of this feud, one of the artists has created the world’s first “open-source” paint product, demonstrating that open-source licensing schemes may have incredible value outside of the software industry.

So, what led to the creation of this entirely new way to buy, sell, and create paint? Continue reading “Pink is the New (Vanta)black – The Story Behind the World’s First Open-Source Paint”

Fyre Festival 2017: A Transformative Way to Fraudulently Trap Millennials on a Remote Private Island in the Caribbean

Picture1By Miles Bludorn

If you had to scam thousands of uber-rich millennials into trapping themselves on a remote island in the Caribbean, how would you even begin to accomplish such a feat? Allow me to offer you some free advice based on the recent debacle that was the Fyre Festival 2017.   Continue reading “Fyre Festival 2017: A Transformative Way to Fraudulently Trap Millennials on a Remote Private Island in the Caribbean”

The Key to the YouTube Advertisement Crisis: an Improved AI

maxresdefaultBy Derk Westermeyer

A little over 4 years ago, comedian Ethan Klein uploaded his first video on his YouTube Channel, h3h3productions. That video’s premise was about how people use toilet paper. While this type of comedy may not be for everyone, Ethan’s channel has largely been a success. Since that first video, Ethan has uploaded hundreds more videos to his channel, a large portion of which generate millions of views each. Continue reading “The Key to the YouTube Advertisement Crisis: an Improved AI”

Conjuring Copyright Protection and Adjudicating Apparitions: Should the Law Consider Ghost Stories Historical Facts?

Picture1By Daniel Hagen

If Warner Bros. fails to prove the existence of ghosts and demons in court, it may have to pay out nearly one billion dollars. Or, at least that’s how the entertainment media has positioned a lawsuit that is currently pending in Federal Court in the Eastern District of Virginia. Brittle v. Time Warner involves a copyright dispute over the popular 2013 film The Conjuring, as well as its sequels and spin-offs. The film series follows the adventures of two alleged paranormal investigators, Ed and Lorraine Warren, who investigate hauntings, demon possessions, witchcraft, and satanic rituals. During their adventures, they confront evil spirits and demons using a variety of methods, including séances and exorcisms. The outcome of the case may depend to some degree on whether the events portrayed in the film are properly characterized as “historical facts.” Continue reading “Conjuring Copyright Protection and Adjudicating Apparitions: Should the Law Consider Ghost Stories Historical Facts?”

Grammy Award-Winning Band The Eagles Sues Hotel California

Hotel CABy Daniel J Goodman

Approximately 1,300 miles from a corner in Winslow, Arizona is a hotel in Todos Santos, B.C.S., Mexico. Its name? Hotel California. One can only assume that it’s a lovely place with plenty of room for all to live it up and enjoy the beautiful Tequila Sunrise Mexico has to offer. But, according to Grammy award-winning band the Eagles, this New Kid in Town is a downright Desperado trademark infringer. On May 1, 2017, the Eagles filed a complaint in the Central District of California for trademark infringement under § 1125(a) of the Lanham Act and for trademark infringement and unfair competition under California common law. Continue reading “Grammy Award-Winning Band The Eagles Sues Hotel California”