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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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”

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?”

Achieving Clear and Reliable Legal Norms in Space to Encourage Commercial Transactions

Picture1By Rob Philbrick

SpaceX just successfully completed tests on the main core of the Falcon Heavy this week in Texas. The Falcon Heavy is a reusable super heavy lift space launch vehicle. By the end of the summer, Elon Musk projects his team will conduct a complete test launch of the Falcon Heavy. Even considering the requisite Musk Timeline Factor Adjustment, most private companies are preparing for commercial spaceflight to occur within 30 months.

How have we arrived here, and what extant law governs the expanse today?

The current international law governing outer space emerged in the late 1950s, and remains largely unchanged. The Soviet Union had just launched the first artificial satellite, Sputnik, and ushered in the Space Age, leading two professors to publish Perspectives for a Law of Outer Space in the American Journal of International Law. A key takeaway from this article was that the establishment of legal standards in this field would be a slow and deliberative process. True to that view, the Outer Space Treaty came into effect a full ten years later in October 1967.

The Outer Space Treaty, formally known as the Treaty on Principles Governing the Activities of States in the Exploration and Use of Out Space, including the Moon and Other Celestial Bodies, is the core of international space law. As the formal title acknowledges, this treaty is focused on the actions and responsibilities of states – not private actors. Article VI does touch on this topic, however, in requiring that “non-governmental entities in outer space . . . require authorization and continuing supervision by the appropriate State Party to the Treaty.” But with unpredictable government space program budgets and industry knowledge condensed in the private sector, are states truly in the best position to authorize and supervise non-governmental entity activities in outer space? Looking forward, what should be our goal when crafting laws for this rapidly changing and increasingly privatized field?

According to Sergio Marchisio, Chairman of the European Centre for Space Law and Professor of International Law at University La Sapienza of Rome, the primary goal of space law is to “ensure a rational and responsible approach to the exploration and use of outer space for the benefit and in the interest of humankind.” “The function of space law,” he continues, “is to maintain order and coordinate behavior and relations among [public and private subjects] involved in space activities.”

Have these stated goals and functions of space law remained effective through the budding commercial space industry?

President Obama defines “commercial space activities” in the National Space Policy issued June 2010 as “space goods, services, or activities provided by private sector enterprises that bear a reasonable portion of the investment risk and responsibility for the activity, operate in accordance with typical market-based incentives for controlling cost and optimizing return on investment, and have the legal capacity to offer these goods or services to existing or potential nongovernmental customers.” This definition follows the commonly-held notion that goods or services provided primarily to other private sector enterprises or consumers (e.g., DirecTV satellite television and Sirius XM satellite radio) are markedly distinct from goods or services provided primarily to government customers when the government shoulders most of the risk because it requires the services (e.g., remote sensing satellite company DigitalGlobe, Boeing-Lockheed Martin United Launch Alliance).

Under these definitions and understandings, the global space economy has doubled to $330 billion in the last 10 years. Revenue related strictly to commercial space activities doubled to $250 billion in that same period. Commercial space products, services, infrastructure, and support from private enterprises comprise over 75% of the space economy. The United States government space budget makes up less than 15%, and in combination with all other government space budgets makes up less than 25%.

What have years of growth in this industry given us? Well, massive investment activity has benefitted our lives in quite a few ways. Researchers can more capably track climate change, telecommunications have advanced at astounding rates, we can observe and warn communities of incoming natural disasters, and navigation tools through GPS is a luxury that has quickly been adopted as a necessity by much of the world.

Today, private companies such as SpaceX and Blue Origin have innovative and flexible organizations that are ready to take risks. There is even an air of one-upmanship between their sparring billionaire owners, Musk and Bezos. Fortunately, this one-upmanship has the effect of bringing down the cost of access to space as a commercial market. According to The Economist, the first stage booster section of the Falcon 9 rocket accounts for about $42 million of the $60 million total cost. Even though Musk and Bezos occasionally bicker on twitter, the reality is that their work to reuse these significant rocket cost drains – even though done separately and in competition with one another – will in turn bring about entirely new blue ocean industries: space tourism and planetary colonization.

It remains unclear whether space law, as it has been drafted and consolidated so far, can aptly face the many challenges ahead in the space economy. UN treaties dealing with space activities were born in a time when today’s expansive commercial space industry could hardly be imaged, let alone property regulated. Several commentators suggest that “these treaties no longer seem to provide for an adequate framework to address the complex relations that have resulted from the rapid growth of commercial activities in outer space.” Ultimately, we have inherited a thoughtful and well-meaning institutional framework that simply cannot satisfactorily resolve today’s substantive concerns around commercial space transactions.

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Virtual Trespass: Not in My Backyard

Picture1By Yonah Reback

Who could have predicted that last summer’s biggest fad would be the reemergence of a Japanese video game whose cultural relevance peaked fifteen years ago? If you had known that Pokémon Go would immediately sweep the nation’s interest upon its release in July 2016, call me—I want your stock tips for this summer. For the rest of us mortals, the game was a surprise hit, quickly drawing the attention of not just kids and gamers, but anyone tuned in to pop culture.  Continue reading “Virtual Trespass: Not in My Backyard”

The Other Type of Robot Battery

Picture1By Daniel Healow

While the words “robot” and “battery” are commonly used in the same sentence, these phrases are usually referring to electricity, not assault. Unfortunately, use of the latter definition is increasing in frequency due to an uptick in malicious human actions taken against intelligent robots undergoing real-world testing. As the number of independently-operating robots have multiplied in humans’ daily lives, so have instances of violence against them. Continue reading “The Other Type of Robot Battery”

Reasonably Expecting to Change the World: The CRISPR-Cas9 Patent Battle

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By Michael Rebagliati

In addition to the cited sources, the author would like to thank a family member with far more scientific knowledge, Michael R. Rebagliati, Ph.D., for his essential scientific edits, commentary and analysis.

Right now, a new gene-editing technology called CRISPR-Cas9 is spreading throughout the scientific and business communities and into the public consciousness. The scientific implications are vast because CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) is not just one scientific invention with one purpose. Rather, it is a natural process that has been harnessed and redirected into a gene-editing technique that is (relatively) easy to use. Moreover, its high efficiency means that scientists can use it to edit the genetic code of any gene in many kinds of organisms. Think Industrial Revolution for genetic engineering. Continue reading “Reasonably Expecting to Change the World: The CRISPR-Cas9 Patent Battle”

Virtual reality Crime Scenes: Demonstrative of Facts or Destructive of Rights?

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By CaroLea Casas

In trial advocacy classes, law students are often taught to use evidence to tell a story. Adept trial advocates can weave together the threads of a story so that jurors have a vivid sense of the circumstances – vivid enough to make them feel almost as if they were there. This ability is especially important for prosecutors and defense attorneys in the criminal realm, as these lawyers face a higher burden of proof than their civil counterparts.

Technological advances may soon take some of that burden off of the advocate’s shoulders. A recently funded Staffordshire University project led by Dr. Caroline Sturdy Colls is using virtual reality technology to digitally recreate crime scenes. The project seeks to provide tools for prosecutors to show the crime scene in virtual reality to jurors via headsets. Additionally, Durham University PhD researcher Mehzeb Chowdhury has developed MABMAT, a relatively low-cost autonomous robotic imaging system capable of scanning entire crime scenes. Field-testing has been arranged with various law enforcement agencies. Both projects aim to improve on inconsistencies in evidence collection. Continue reading “Virtual reality Crime Scenes: Demonstrative of Facts or Destructive of Rights?”

How to Fight Fake News in a World Spewing Alternative Facts

Picture1By Mackenzie Olson

Before you re-share an online article, before you give weight to its assertions—before you even begin to read the first line—ask yourself one question: “Does this look like a credible source?”

At a young age, I learned that I must first ask this question before citing to any given resource in a research paper or project. Accordingly, I learned where to look for reputable sources, how to determine which of these sources were credible, and the ways in which to best use these sources to locate further acceptable resources.

I was surprised when I learned just how frequently Internet users are duped into reading, believing, and ultimately re-sharing fake news stories. In the months immediately prior to the 2016 U.S. presidential election, the top performing fake news stories generated more engagement than the top performing real stories published by major news outlets. These leading fake stories generated over 8.7 million shares, reactions, and comments on social media, while the leading stories published by major news outlets generated about 7.3 million similar reactions. Continue reading “How to Fight Fake News in a World Spewing Alternative Facts”