Richmond Journal of Law and Technology

By: Sarah Wenrich,

EpiPen, a product produced by Mylan Pharmaceutical, has become a household word in the last decade thanks to its reliable, life-saving technology that can be used to easily and safely administer epinephrine to someone experiencing anaphylaxis.[1] However, as EpiPens have become more well known, their prices have also increased over 500% within the last ten years,[2] even though the only noticeable difference was the addition of a flip-top cap on the case. [3] While the EpiPen’s widespread distribution is crucial in case of emergency, this extraordinary increase in price has caused patients who are in need of the product to refrain from filling their prescriptions because they cannot afford the cost.[4] The FDA has said that they will speed up the approval process for competitors or generic versions of the EpiPen[5], but the technology behind the EpiPen makes that much easier said than done. [6]

Most recently, Teva Pharmaceuticals submitted a product to the FDA that would directly compete with the EpiPen, but it was rejected in March of 2016. [7] While the reasons behind the rejection have not been made public, it has been speculated that it had to do with the design of the cap. Teva’s model had a cap that had to be unscrewed before use, whereas Mylan’s EpiPen does not.[8] This is an aspect of the design that Mylan actively lobbied against while Teva was awaiting approval. [9] Mylan reasoned that having to screw off the cap in an emergency could be confusing[10], but their own product has not been foolproof. There have been instances of patients confusing the needle end in emergencies and stabbing their thumbs instead of their thighs. [11]

Other companies have created competing products, but insurance companies refused to cover them, forcing the pharmaceutical companies to discontinue their production. [12] Adrenaclick was one of the products originally pulled from the market for this reason, but it has since returned.[13] Even with Adrenaclick back in the market, Mylan continues to hold 90% of the market share on epinephrine auto-injectors.[14] Contributing to this near monopoly is the fact that unlike most medical prescriptions where the pharmacist can swap out a name brand drug for a generic, the FDA has made it illegal for pharmacies to substitute alternatives, such as Adrenaclick, for the EpiPen.[15]

Perhaps most concerning aspect of the outrageous price increase of the EpiPen is the fact that people have begun to create their own DIY versions of the life-saving product, as they cannot afford to fill their prescriptions. [16] A group of men have created a YouTube video on how to build your own “EpiPencil” with items that you can purchase at the store, with the exception of the liquid epinephrine, which requires a doctor’s prescription.[17] Its design is bulky, but the video shows that it will adequately administer the drug in an emergency for less than $35.[18] However, patients and doctors alike are aware of the dangers that this could present in an emergency[19]. The “Epipencil” faces the hurdle of being unable to accurately administer the correct dosage of the drug, in addition to presenting other concerns associated with creating your own medical device, such as issues with sterilization.[20]

This potentially dangerous alternative to which people have turned showcases just how imperative the drug is to people with allergies that cause anaphylaxis. The patent for EpiPen’s design expires in 2025,[21]but it is clear that something must be done to combat EpiPen’s price hike before then. Right now, people with allergies that result in anaphylaxis have three choices: they can shell out $608 annually for an EpiPen, create their own EpiPencil for under $35 and face a slew of health risks, or hope that they do not come into contact with whatever it is that causes their anaphylaxis. For people who have insurance that covers the cost of the EpiPen or are financially able to foot the bill, the choice is an easy one. For others, it is a difficult choice that they should not have to make.

 

[1] See About EpiPen Auto-Injector, EpiPen, http://www.epipen.com/en/about-en/about-epipen (last visited Oct. 1, 2016).

[2] See Beth Mole, EpiPen maker CEO to seething lawmakers: We’re doing the world a favor, Ars Technica (Sept. 22, 2016, 2:25 PM), http://arstechnica.com/science/2016/09/epipen-maker-ceo-to-seething-lawmakers-were-doing-the-world-a-favor/.

[3] See Meghana Keshavan, 5 reasons why no one has built a better EpiPen, STAT (Sept. 9, 2016), https://www.statnews.com/2016/09/09/epipen-lack-of-innovation/.

[4] See Rising cost of potentially life-saving EpiPen puts pinch on families, CBS News (Aug. 16, 2016, 7:02 AM), http://www.cbsnews.com/news/allergy-medication-epipen-epinephrine-rising-costs-impact-on-families/.

[5] See Mole, supra note 2.

[6] See Keshavan, supra note 3.

[7] See Jonathan Newman, The Lack of EpiPen Competitors is the FDA’s Fault, Mises Institute (Aug. 24, 2016), https://mises.org/blog/lack-epipen-competitors-fdas-fault.

[8] See Michael Gibney, Could EpiPen’s plastic cap be Mylan’s secret weapon?, FiercePharma (Sept. 1, 2016, 4:21 AM), http://www.fiercepharma.com/drug-delivery/could-a-plastic-cap-epipen-have-given-mylan-its-market-dominance.

[9] See id.

[10] See id.

[11] See Keshavan, supra note 3.

[12] See Newman, supra note 7.

[13] See id.

[14] See Mole, supra note 2.

[15] See Brett Trout, Government is to blame for the skyrocketing price of EpiPens, not patents, IPWatchdog (August 29, 2016), http://www.ipwatchdog.com/2016/08/29/government-blame-price-epipens-patents/id=72412/.

[16] See Larson, supra note 16.

[17] See id.

[18] See id.

[19] See id.

[20] See id.

[21] See Gibney, supra note 8.

Photo Source:

http://media2.s-nbcnews.com/i/MSNBC/Components/Video/201608/a_101_epipen_price_160823.jpg

By: Nick Mirra,

When Google released its Google Glass platform in April of 2012 , the market was shaken by such a new and exciting innovation.[1] The glasses were touted to be innovative and invaluable to its users through features including: weather forecasting, reminders, GPS, taking photos, and recording video, among many others.[2] Ultimately, Google Glass fizzled out due to its expensive pricing structure and low sales.[3] Because Google vacated the market segment, (with the exception of a few less-publicized offerings in development) the opportunity to develop glasses-based tech was once again wide open.[4]

With the introduction of Spectacles, Snap Inc. (formerly known as SnapChat) is attempting to capture what Google and its competitors were never able to do.[5] Snap Inc.’s new product has streamlined the functionality of their smart eyewear product into something simple: glasses with an easy-to-use camera that photographs what you see.[6] Snap Inc. began their company as Snapchat, a photo sharing app which displayed photos for up to 10 seconds before the pictures vanished forever.[7] The brand’s Spectacles will be the first time the software company has ventured into the realm of hardware.[8]

Spectacles are set to retail for $130 which will make them accessible to most consumers who have a legitimate interest in them.[9] While it is impossible to forecast exactly how many units will sell, it is almost certain that more units of Spectacles will be sold than of Google Glass because of the significantly lower retail price.[10] With the potential to sell to the masses, familiar concerns of privacy that were raised by Google Glass are resurfacing at a rapid pace.

Snap Inc. has taken at least one step to safeguard against the privacy concerns. In anticipation of the discomfort that a wearable camera may cause the public, the company decided to place a ring of led lights on the front frame of the glasses that illuminate when the glasses are recording.[11] Even though the light ring is present, what is stopping someone from disabling it or covering it with a piece of tape? While that is a measure which may put some at ease, many members of the public may remain uncomfortable knowing that people are walking around with cameras pointing at them.

In response to various technological advancements, the expectation of privacy has evolved more frequently in the past decades than in any other period in history.[12] Prior to the digital age, the right to privacy was a more straightforward – albeit still complex – concept.[13] Now that the market is becoming saturated with wearable technologies such as Snap Inc.’s Spectacles, questions of privacy are popping up more than ever.[14] What are the consequences of constantly pointing a camera at everyone you see?

Google Glass faced a similar issue by having a camera mounted on the platform.[15] Glass was met with immense social opposition, including the product being banned from certain restaurants, movie theaters and other public venues.[16] The root of the issue stems from social discomfort with having a camera pointing everywhere you are looking.[17] Courts may soon be confronted with the issue of someone wearing the glasses in a setting which has legitimate expectations of privacy. What are the implications of someone wearing a head mounted camera in a bathroom or locker room? Why would it be okay to wear glasses that have a camera, but not walk in brandishing a standard handheld digital camera and pointing it at people?

While the concept of wearable technology is gaining traction and popularity, it is evident that the legal system needs to adapt to respond to the new issues. Perhaps it will require a lawsuit to bring these specific issues to light, but if Spectacles are wildly popular, a lawsuit is likely in the near future. Snap Inc. is basing their entire product on the one aspect of Google Glass that made the public uncomfortable. It is a head mounted camera that can be discreetly actuated. If someone walked into a bathroom with these glasses on, would you be comfortable?

 

[1] See The History of Google Glass, Glass Almanac, http://glassalmanac.com/history-google-glass/ (last visited 9/26/2016).

[2] See Evan Dashevsky & Mark Hachman, 16 Cool Things you can do with Google Glass, PC Mag, http://www.pcmag.com/slideshow/story/308711/16-cool-things-you-can-do-with-google-glass (last visited Sep. 26, 2016).

[3] See Jim Edwards, Google Ends Sale of Google Glass, Business Insider, http://www.businessinsider.com/google-ends-sales-of-google-glass-2015-1 (last visited Sep. 26, 2016).

[4] See Paul Lamkin, The Best Smartglasses 2016, Wareable, http://www.wareable.com/headgear/the-best-smartglasses-google-glass-and-the-rest (last visited Sep. 26, 2016).

[5] See Josh Constine, The Hopes and Headaches of Snapchat’s Glasses, Tech Crunch https://techcrunch.com/2016/09/24/more-than-just-specs/ (last visited Sep. 25, 2016).

[6] See Id.

[7] See Margaret Rouse, Snapchat, Search Mobile Computing, http://searchmobilecomputing.techtarget.com/definition/Snapchat (last visited Sep. 27, 2016).

[8] See Supra note 5.

[9] See Id.

[10] See Supra note 3. (Stating it is speculated that Google only sold around 10,000 units of Google Glass).

[11] See Supra note 5.

[12] See e.g., Heather B. Repicky, Reasonable Expectations of Privacy in the Digital Age, Nutter, http://www.nutter.com/Reasonable-Expectations-of-Privacy-in-the-Digital-Age-07-09-2012/ (last visited Sep. 27, 2016) (Discussing the concerns at the “increasingly complex intersection of privacy and technology).

[13]The Evolution of the Concept of Privacy, EDRi, https://edri.org/evolution-concept-privacy/ (last visited 9/27/2016).

[14] See id.

[15] See Jake Swearingen, How the Camera Doomed Google Glass, The Atlantic, http://www.theatlantic.com/technology/archive/2015/01/how-the-camera-doomed-google-glass/384570/ (last visited Sep. 26, 2016).

[16] See Alyssa Newcomb, From ‘Glassholes” to Privacy Issue: The Troubled Run of the First Edition of Google Glass, ABC News, http://www.consumerwatchdog.org/story/glassholes-privacy-issues-troubled-run-first-edition-google-glass (last visited Sep. 26, 2016).

[17] See id.

Photo Source:

http://1u88jj3r4db2x4txp44yqfj1.wpengine.netdna-cdn.com/wp-content/uploads/2016/09/Snapchat-Spectacles-2-930×495.jpg

By: Andrew Toney,

The Internet grows every second. Companies collect data from clients and store it on vast online databases, online shoppers trade their credit card numbers for groceries, and grandparents upload embarrassing pictures of their grandchildren on their MySpace pages. Some browsers create accounts on various websites that they may never visit again, leaving sensitive data behind a password less creative than my first-grade niece’s art projects. The Internet is meant for fun right? Much of the information that we share online is relatively meaningless, but, when we do provide sensitive data, we expect the web designers to keep that information a secret, right? So what are we, the consumer, supposed to do when covert criminals smuggle our data into their own hard drives? This blog post explores the expanding cyber-security industry, the protection of our privacy, and the new challenges emerging from our reliance on the Web.

Yahoo Inc. recently reported that 500 million of its user accounts were stolen in 2014, in what may be the largest data breach in the history of the Internet.[1] News has also broken on the Democratic Party’s recent frustration with hackers, who they believe have intercepted Party correspondence for over a year.[2] The most recent instance of online sabotage has come from the largest target of all – the White House. Government officials reported that they were currently “looking into” a cyber breach after a scan of Michelle Obama’s passport was posted online.[3] It would appear that the frequency of cyber attacks has not changed; indeed, cyber attacks are as old as the Internet itself. Rather, the sophistication and devastation of recent attacks has the US government and major companies sounding a call for action.

Many solutions offered by the government thus far have created a game of give-and-take between server security and rights to privacy. A highly contentious bill, the Cyber Intelligence Sharing and Protection Act (CISPA), is currently being debated in Congress.[4] CISPA is aimed at curbing cyber attacks by creating a data-sharing system between private companies and the federal government.[5] CISPA would allow major companies to share sensitive data with the government in order to identify and exterminate potential cyber-threats. Companies who agree to share client data would be free from any legal ramifications stemming from the release of sensitive client data.[6] Opponents of the bill point to the broad language defining a “cyber threat,” contending that an event as small as a spam email could warrant the release of personal information from local to federal authorities.[7] The original form of this bill was shot down in 2012 amid obvious concerns regarding Internet privacy. However, CISPA is making headway in the legislature as cyber attacks continue to threaten sensitive data held by major companies.

Private companies specializing in cyber-security technologies have taken a different route that may reduce such an impact on Internet privacy. An Israeli-based firm, Illusive Networks, is currently developing a system designed to misdirect hackers while simultaneously tracking their movements.[8] The design creates a series of false “doors” that hackers may choose to exploit in an attempt to reach a data payload in a valuable company server. If a hacker chooses the wrong door, then the company can detect the mistake and begin tracking movements on a simulated computer system.[9] The system is ultimately designed to frustrate hackers away from big business databases, but it also allows trackers to understand new methods used by hackers in order to prepare for future attacks. Of course, there is also a possibility that experienced hackers can avoid simulated systems in their infancy, further exposing sensitive company data.

The cyber security industry is experiencing rapid growth and for good reason. Huge companies are being exposed to legal action from their clients due to a lack of data protection, while classified documents held by the federal government are being leaked to the average Joe. The climate of fear surrounding this issue will certainly lead to some change in the near future. Will we allow our legislators to solve this issue for us, or will power ultimately fall to the engineers and programmers in the private sphere?

 

[1] Dustin Volz, Yahoo Says at Least 500 Million Accounts Hacked in 2014, Huffington Post (Sept. 22, 2015, 2:52 PM), http://www.huffingtonpost.com/entry/yahoo-hack-500-million-accounts_us_57e4278ce4b0e28b2b52da7f?section=us_technology.

[2] Ruth Sherlock, Russia Hacked Democratic National Committee Computer Network and Obtained All of its Trump Research, Telegraph (June 14, 2016, 7:45 PM), http://www.telegraph.co.uk/news/2016/06/14/russia-hacked-democrat-national-committee-computer-network-and-o/.

[3] Michelle Obama’s Passport Scan Posted Online in Apparent Hack, Telegraph (Sept. 23, 2016, 12:16 AM), http://www.telegraph.co.uk/news/2016/09/22/michelle-obamas-passport-scan-posted-online-in-apparent-hack/.

[4] H.R. 234 – Cyber Intelligence Sharing and Protection Act, Congress.gov, https://www.congress.gov/bill/114th-congress/house-bill/234/text.

[5] Jordan Pearson, America’s NewCybersecurity Agency Can’t Function Without CISPA, Vice (Feb. 10, 2015, 4:49 PM), http://motherboard.vice.com/read/americas-new-cybersecurity-agency-cant-function-without-cispa.

[6] Id.

[7] Jason Koebler, The New CISPA is Identical to the Old One, but the Political Climate is Scarier, Vice (Jan. 9, 2015, 11:44 AM), http://motherboard.vice.com/read/the-new-cispa-is-identical-to-the-old-one-but-the-political-climate-is-scarier.

[8] Lance Higdon, Cybersecurity Professionals are Using Misdirection to Combat Hacking, Vice (May 2, 2016, 11:33 AM), http://motherboard.vice.com/blog/cybersecurity-professionals-are-using-misdirection-to-combat-hacking.

[9] Id.

Photo Source:

http://uwf.edu/media/cybersecurity/Cyber-Security-(2).jpg

By: Cambridge Lestienne,

Paid brand endorsements are on the rise, and the trend seems to be causing a quite a stir for celebrities and marketers alike. Some social media and celebrity personalities, such as the Kardashian sisters, now find themselves at the center of an ethical debate over the nature of this form of advertising.[1] The issue at hand is whether these types of endorsements made by celebrities and public figures are deceptive because the individuals posting them are being paid for their posts. While celebrity Instagram and Snapchat accounts may be a visual example of such potentially deceptive advertising, the practice is also taking place in another booming media market that is not visual at all: podcasting.

As media transitions to more mobile consumption, podcasts continue to surge in popularity. Reports from both Edison Research and Wondery found that about 20% of adults in the U.S. listen to at least one podcast a month, which is an increase of 17% from last year.[2] This boom is likely due in part to the success of podcasts such as Serial, which had 75 million episode downloads within the first six months of its debut.[3] As the popularity of podcasts increases, so does their money-generating potential. Podcast advertising is up 48% over last year and projected to grow another 25% a year through 2020.[4] ZenithOptimedia estimates that advertisers will spend approximately $35.1 million on podcasts in 2016, up roughly 2% from 2015.[5]

While podcasters may not be posting visual advertisements like celebrities do on Instagram and Snapchat, they are still advertising on behalf of their sponsors. These advertisements are most often conducted through “host-read” ads.[6] According to Mark DiCristina, marketing director at MailChimp, one of the largest podcast advertisers, “When the host is personally reading the ad and telling a story about the product in her own words, it lands with the audience in a different and more authentic way than a traditional ad spot.”[7] But what happens when listeners are unaware that the podcast hosts are being paid to tell these personal stories? Are podcasters not falling into the same rabbit hole as celebrities like the Kardashians? And where does the law draw the line between paid endorsements and deceptive advertisements?

The Federal Trade Commission (“FTC”) has been grappling with this issue for years in light of developments in the social media space.[8] In its Guides Concerning the Use of Endorsements and Testimonials in Advertising, the FTC stated, “Advertisers are advised that using unrepresentative testimonials may be misleading if they are not accompanied by information describing what consumers can generally expect from use of the product or service.”[9] The FTC also stated that endorsers should avoid describing experiences with a product they have never used.[10] Endorsers should further disclose any connection between themselves and the marketer of a product that could affect how consumers evaluate the endorsement.[11]

Though the FTC has issued guidelines for advertising through endorsements, they have stopped short of enacting regulations on the practice.[12] This has led podcasters, like those from Gimlet Media, to question how they advertise on behalf of their sponsors.[13] In an effort to make the distinction between content and advertisements clear to listeners, Gimlet Media uses special musical backgrounds and disclaimers to notify listeners of when an ad has begun.[14] Additionally, while the hosts of Gimlet Media podcasts talk about their personal experiences using products, they have opted to stop explicitly endorsing the products of their sponsors.[15]

It seems that for the time being, podcasters, like celebrities on Instagram and Snapchat, should proceed with caution when advertising on behalf of their sponsors. A director of the FTC’s Bureau of Consumer Protection said, in relation to a settlement with Warner Bros. regarding paid endorsements, “Consumers have the right to know if reviewers are providing their own opinions or paid sales pitches.”[16] As media advertising continues to grow, specifically in the context of podcasts, it likely will not be long before firm regulations are put into place to constrain these potentially deceptive practices.

 

[1] See Sapna Maheshwari, Endorsed on Instagram by a Kardashian, But Is It Love or Just an Ad?, N.Y. Times (Aug. 30, 2016), http://www.nytimes.com/2016/08/30/business/media/instagram-ads-marketing-kardashian.html.

[2] See Andrew Meola, Podcasts are Becoming More Popular Among Listeners and Advertisers, Bus. Insider (Jun. 6, 2016, 11:07 AM), http://www.businessinsider.com/podcasts-are-becoming-more-popular-among-listeners-and-advertisers-2016-6.

[3] See Id.

[4] See Ken Doctor, An Island No More: Inside the Business of the Podcasting Boom, NeimanLab (Sept. 12, 2016), http://www.niemanlab.org/2016/09/an-island-no-more-inside-the-business-of-the-podcasting-boom/.

[5] See Steven Perlberg, Podcasts Face Advertising Hurtles, Wall St. J. (Feb. 18, 2016), http://www.wsj.com/articles/podcasts-face-advertising-hurdles-1455745492

[6] Ken Doctor, And Now a Word From Our Sponsor: Host-read Ads and the Play Between Nice and Scale, NeimanLab (Sept. 13, 2016,), http://www.niemanlab.org/2016/09/and-now-a-word-from-our-sponsor-host-read-ads-and-the-play-between-niche-and-scale/.

[7] Dino Grandoni, Ads for Podcasts Test the Line Betweem Story and Sponsor, N.Y. Times (Jul. 26, 2015), http://www.nytimes.com/2015/07/27/business/media/ads-for-podcasts-test-the-line-between-story-and-sponsor.html.

[8] See Manatt, Phelps & Phillips, LLP, Advertising Law – September 2016 #3, JD Supra (Sept. 22, 2016), http://www.jdsupra.com/legalnews/advertising-law-september-2016-3-88862/

[9] Fed. Trade Comm’n, The FTC’s Endorsement Guides: Being Up-Front with Consumers, https://www.ftc.gov/news-events/media-resources/truth-advertising/advertisement-endorsements.

[10] See id.

[11] See id.

[12] See Grandoni, supra note 7.

[13] See id.

[14] See id.

[15] See id.

[16] See Fed. Trade Comm’n, Warner Bros. Settles FTC Charges It Failed to Adequately Disclose It Paid Online Influencers to Post Gameplay Videos (Jul. 11, 2016), http://www.mediapost.com/publications/article/280028/ftc-warner-bros-paid-influencers-to-promote-vid.html?edition=94532.

Photo Source:

http://lifechurchlancaster.org/wp-content/uploads/2012/07/download.jpeg.

By: Madison Jennings,

On July 6, 2016, North America experienced the beginning of a Pokémon craze the likes of which our nation had not seen since the nineties.

The release of Pokémon Go, an augmented reality video game designed to be played on a smart phone, had young and old alike dreaming of becoming Pokémon Masters. In true lawyerly fashion, however, the legal community immediately began to do all it could to ruin the fun. It adjusted its glasses, cleared its throat, and said, “Well, there are a lot of potential issues here, is this really such a good idea?”[1]

To which, of course, the world responded, “Please be quiet—I’m trying to catch a Charizard!”

Augmented Reality (or “AR”) is a gaming feature that inserts digital characters and checkpoints into the physical world, visible only via gaming device.[2] This is a not entirely new, if severely underused, gaming model. Pokémon Go creator Niantic has previously employed AR in its 2012 release titled ‘Ingress’.[3] In Ingress, players join factions and visit real-life monuments, cultural hubs, and other similar public areas which act as in-game ‘portals’ to win points, defeat their enemies, or whatever it is video game nerds do to feel a sense of accomplishment.[4] Pokémon Go follows much the same model.

You begin by downloading the game and creating an avatar, which you can design to look exactly (or nothing at all) like you. Once your character is ready, it will appear on a map and your phone will buzz as three familiar characters pop into view. Players can choose to tap on and attempt to capture either Charmander, Squirtle, or Bulbasaur. Once tapped, the Pokémon will appear on the screen as the app uses the phone’s camera to fill the background will real time images of your surroundings, giving the impression that Squirtle really is in your living room, your bathtub, or wherever else it is you were when you decided to give this Pokémon Go thing a try.

Once you’ve captured your first Pokémon, you’re encouraged to walk around to find more. In the bottom right of your screen, a small box offers silhouettes of nearby critters, enticing you to venture forth and find them.

Of course, to catch Pokémon, you need Pokéballs. To get Pokéballs, you need to find a Pokéstop. Pokéstops are real-world locations given digital properties by the game. Niantic uses the same ‘portals’ from its previous game (Ingress) as Pokéstops.[5] These locations were originally submitted by Ingress players, and can be anything from fountains and memorial benches to historical landmarks and restaurants.[6] You visit Pokéstops to get Pokéballs, you get Pokéballs to catch Pokémon, you catch Pokémon to, well, catch them all! The format is pleasantly simplistic, and imbued with just enough nostalgia for a remarkably popular childhood game for it to be instantly and infinitely more successful than any other mobile game in existence. Pokémon Go shattered the record for downloads in its first week from the Apple App Store.

That’s all very well and good, but where do the legal issues arise? What’s the problem, lawyers?

The problem is that newly developed technology dispersing into the population in such a rapid, uncontrolled way inevitably gives rise to previously unimagined legal issues. Not long after the game’s release, reports starting surfacing of players being lured into secluded areas by in-game treats (Lure Modules designed to attract digital Pokémon and real life trainers) and robbed, car accidents as a result of playing Pokémon Go while driving, and distracted players literally walking off of a cliff while hunting Pokémon.[7] Then, of course, there was the body camera footage of a player distractedly plowing into the rear of a parked police vehicle—he steps out of the car with the game still open on his phone screen, telling officers, “That’s what I get for playing this dumba— game.”[8]

Then, of course, the fascinating question: what are your rights, if there’s a Pokémon, a Pokéstop, or even a Pokémon Gym on your private property?

(Pokémon Gyms, like Pokéstops, are real world locations given digital significance by the game. At gyms, players can battle their Pokémon for a chance to earn some in-game currency.)

Often, gyms are located at churches, which proved to be a problem for a Massachusetts man living in a renovated church.[9]

When Boon Sheridan, of Holyoke, Massachusetts, moved into the former Victorian-style church with his wife, they did not anticipate that at some point dozens of individuals would begin showing up to loiter outside their front door, staring at their phone screens.[10]

Pokémon Go doesn’t typically place in-game locations onto private homes, and it’s fairly obvious that the inclusion of the Sheridan’s house was a mistake—a holdover from the home’s previous time spent as a church. Luckily, the couple play the game themselves, and don’t mind the visitors.[11] But if they did, would they have legal recourse to remove them?

Against the players—probably. Trespassing is likely to still be considered trespassing, whether the individual is there for a physical or digital purpose. But what about Niantic? Would the Sheridans have a cause of action against the company for giving his private property a digital attribute they hadn’t approved of, thus enticing strangers to trespass?

And what of the liabilities a homeowner could have for strangers wandering onto their property in pursuit of Pokémon? Generally speaking, property owners aren’t liable for injuries suffered by trespassers, but anyone who owns a pool is familiar with the doctrine of attractive nuisance.[12] The idea behind attractive nuisance is that some things are just too enticing, particularly to children, and as a result property owners are liable regardless of whether a person is a trespasser.[13] Is a Pokémon Gym an attractive nuisance? Does it depend upon whether a child is playing the game? What about a trespasser tracking down a Pokémon, which are generated in a somewhat random manner, and appear on private property regularly? Does it matter whether the property owner is aware of the digital features given to their real property by a third party?

Does the fact that their home is a Pokéstop increase or decrease the Sheridans’ property value? Are they obligated to disclose the status to potential buyers, in the event they decide to sell their house?

In the context of Pokémon, all of these questions seem a tad silly, but the fact is that at this moment, none of these questions have actual answers. When it comes to AR, the legal field is brand new, and any cases brought because of Pokémon Go will end up shaping the playing field and establishing the rules for future augmented reality endeavors. Keep a close eye on these issues as they develop; I promise it isn’t just lawyers trying to ruin everybody’s fun.

 

 

[1] See Ed Beeson, Pokémon No Go: How Lawyers Are Spoiling The Fun With The World’s Latest Craze, Law360, July 22, 2016, http://www.law360.com/articles/820143/pokemon-no-go-how-lawyers-are-spoiling-the-fun-with-the-world-s-latest-craze-.

[2] See Dave Thier, What Is Pokémon Go And Why Is Everyone Talking About It?, Forbes, July 11, 2016, http://www.forbes.com/sites/davidthier/2016/07/11/facebook-twitter-social-what-is-pokemon-go-and-why-is-everybody-talking-about-it/#6e0813b21c7b.

[3] See Alan Henry, How Ingress, Google’s Real-World Smartphone Game, Got Me Out of My Shell, Lifehacker, June 10, 2015, http://lifehacker.com/how-ingress-googles-real-world-smartphone-game-got-me-1710320867.

[4] See id.

[5] See Andrew Hayward, Why Pokémon Go Fans Should (Or Shouldn’t) Play Ingress, Greenbot, July 26, 2016, http://www.greenbot.com/article/3097573/android/why-pokemon-go-fans-should-or-shouldnt-play-ingress.html.

[6] See id.

[7] See Eric Lindfield, Pokémon Go’s Product Liability Woes, Law360, Aug. 3, 2016, http://www.law360.com/articles/824588/pokemon-go-s-product-liability-woes.

[8] PoliceActivity, Bodycam Shows Driver Playing Pokémon Go Crashes Into Police Car, YouTube (Jul. 19, 2016), https://www.youtube.com/watch?v=KvA9ZgC73vc.

[9] Madeline Billis, This Church-Turned-House Is Also An Unwilling Pokémon Gym, Boston Magazine, July 11, 2016, http://www.bostonmagazine.com/property/blog/2016/07/11/church-house-pokemon-go-gym/.

[10] See id.

[11] See id.

[12] See supra note 1.

[13] See id.

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By: Andrew Toney,

The personal genomics industry has experienced rapid growth since 2006, when influential genome information service companies opened web-based exchange points to their customers.[1] Big players in the personal genomics industry including 23andMe, deCODEme, and Navigenics offer customers a glimpse into their health and ancestry. A customer need only submit a saliva sample for testing and – voila! – they uncover DNA qualities that explain their quirks, their family’s origin, and their susceptibility to certain diseases. Companies target consumers’ intellectual curiosity by providing an answer to life’s greatest question – Who am I? However, the DNA collection process, along with the accuracy of the findings, raises many pertinent legal questions: Who owns the rights to this data? Can third parties view this information, or is consumer data kept safely with the company? Just how accurate are these findings?

Researchers on the subject have developed a working definition of “genetic privacy,” concluding that the term encompasses four aspects: 1) informational privacy that relates to access to personal information; 2) physical privacy, which relates to access to persons and personal spaces; 3) decisional privacy, which relates to access to governmental or other third party interference with personal choices; and 4) proprietary privacy that relates to ownership interest in the human body.[2]

Determining the rights of ownership over genetic information has been a hotly contested issue due to the potential utility of such information in other industries. Companies make individual findings by comparing a customer’s DNA sample with an ever-expanding online genotype/phenotype database. In 2008, the federal government passed the Genetic Information Nondiscrimination Act (“GINA”) in response to increasing concerns of third party access to these massive databases of genetic information. GINA is designed to protect Americans against discrimination based on their genetic information with regard to employment or the receipt of health insurance.[3] Under GINA, an individual’s genetic information is categorized as a confidential medical record and, as a result, prevents employers from disclosing such information to third parties.[4]

What does this mean for consumers? On the one hand, consumers may continue to choose personal genomics because of GINA’s protections against personal data distribution. Likewise, this may encourage an employee to disclose their genetic information to an employer in order to supplement existing medical records. However, rapid growth in this industry, coupled with major technological advancements, show that customers may be storing data on company servers that GINA is not designed to protect.[5] As company databases continue to grow with newly added customer data, they become a juicier target for cyber attacks. Likewise, companies in the industry typically include provisions within their terms of service authorizing them to share information with affiliated entities.[6] Such provisions make clear that the consumer does not have exclusive rights to their own genetic information, nor is there any assurance that the information will remain within a company’s database. If the company collecting consumer data also has rights of ownership over that data, then they are free to treat it as they would any other commodity, including selling or transferring the data to third parties without consumer consent.[7]

Another concern with the personal genomics industry is whether consumers are really getting any substantial data in return for their DNA samples. Specifically within the realm of health data, many genomics companies market their products toward consumers concerned with hereditary health issues. This presents an obvious concern regarding the accuracy of a company’s findings. In 2013, the Food and Drug Administration issued a cease and desist letter to 23andMe, ordering the company to discontinue marketing its product as a means for analyzing consumer health data.[8] The FDA reasoned that foreboding health data would induce customers to seek unnecessary medical procedures or treatments.[9] Likewise, some state health departments have taken stances against customer health data collection in the wake of industry growth.[10] Growing concern at the state and federal levels points back to the original problem behind personal genomics, the protection of individual data from unwanted data distribution.

What the preceding information tells us is that personal genomics is currently opening a new avenue for legal conflicts in the realm of individual privacy. Personal genomics, as an industry, is still a relatively new concept. The unique services offered by this industry have piqued the interest of American consumers and have raised valid personal privacy concerns along the way. Indeed, the industry will no doubt continue experiencing growing pains as a result of such concerns. As databases continue to expand, and companies begin to offer more accurate findings, we may see personal genomics play a larger role in other industries, such as healthcare or family planning. Will this quell the unrest surrounding the storage and trading of genetic data? Until then, take solace in the fact that you, your genes, and your personal genomics service provider are contributing to one of technology’s newest frontiers

 

[1] D. Gurwitz & Y. Bregman-Eschet, Personal Genomics Services: Whose Genomes?, Eur. J. Hum. Genetics (Mar. 4 2009), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2986500/.

[2] See Anita L. Allen, Genetic Privacy Emerging Concepts and Values, Genetic Secrets: Protecting Privacy And Confidentiality In The Genetic Era 31, 33-34 (Mark Rothstein ed., 1997).

[3] 42 U.S.C. § 2000ff (2016).

[4] See id.

[5] See Barbara Prainsack, What are the Stakes? Genetic Nondiscrimination Legislation and Personal Genomics, ResearchGate (Apr. 2, 2015), https://www.researchgate.net/publication/229439788_What_are_the_stakes_Genetic_non-discrimination_legislation_and_personal_genomics.

[6] See 23andme Privacy Highlights, (last visited Sept. 18, 2016) https://www.23andme.com/about/privacy/. (“We may share some or all of your information with other companies under common ownership or control of 23andMe, which may include our subsidiaries, our corporate parent, or any other subsidiaries . . .”). It is worth mentioning here that Google is a major investor in 23andMe, donating $3.9 million in 2007, when the company was still in its second year.

[7] See Gurwits, supra note 1.

[8] R. Green and N. Farahany, Regulation: The FDA is Overcautious on Consumer Genomics, Nature (Jan. 15, 2014), http://www.nature.com/news/regulation-the-fda-is-overcautious-on-consumer-genomics-1.14527.

[9] See id.

[10] Alexis Madrigal, 23andMe to California: We’re not Ceasing or Desisting, Wired (June 24, 2008), https://www.wired.com/2008/06/23andme-were-no.

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By: Nick Mirra,

Millennials have already infiltrated the workforce for several of the nation’s most time-honored professions. As 2017 draws near, more of the technological natives are earning their ranks among these established fields. For example, the average age of matriculating medical students for the 2015-16 year was 24, which means the average medical student is a millennial.[1] What are the implications of this generation beginning to take the reins of the medical profession? One prominent consequence is that doctors are becoming much more technologically savvy as medical techniques, procedures, and protocols evolve with the incoming influx of millennial medical students. As with any advancement in technology, there are new uncharted legal questions which arise almost as quickly as the technology itself springs to life.

Telemedicine has grown increasingly popular over the last several years.[2] Patients are able to get quality medical attention from the comfort of their homes or offices.[3] Waiting lines are minimized, patients do not have to arrange for transportation to the doctor’s office, and relative costs are decreased for both patient and provider.[4] Any communications that occur over the secure telemedicine program are protected by the Health Insurance Portability and Accountability Act of 1996 (HIPAA).[5] There are many benefits to this type of treatment, and they tend to outweigh the drawbacks in the eyes of a majority of doctors.[6]

In a conscious effort to be more connected with the younger generation, doctors are charting avenues to interact with their patients in new and innovative ways, beyond the scope of conventional telemedicine. One such advancement that falls outside the protections of the telemedicine forum is that some doctors are accepting pictures of their patients’ ailments over text message and email for medical assessment. As this practice has emerged, the potential for legal mishap closely followed. It didn’t take long before patients began sending their doctors pictures of their genitalia in order to diagnose a myriad of symptoms.[7] According to one doctor, a majority of these patients are obtaining their doctor’s consent prior to sending the pictures, but some do not.[8] Another potential benefit of this type of doctor-patient interaction is that patients often do not feel as embarrassed as if they were to disrobe in front of a doctor in person.

This emerging trend is crossing into a new plane of legality that has never been addressed before. What happens when the patient who is texting a picture of their genitals to their doctor is a minor?

Receipt of child pornography is in violation of 18 U.S.C. § 2252 which states in pertinent part that it is a crime for any person to knowingly receive child pornography by means of interstate commerce.[9] The statute continues by explaining that receipt by computer satisfies the interstate commerce requirement.[10] Further, “sexually explicit conduct” is defined in part as “lascivious exhibition of genitals… of any person.”[11] Through plain meaning statutory interpretation it is evidently clear that if a doctor consented to receive a picture of a child’s genitals for the purpose of diagnosis, then it could be considered per se child pornography.

A further confounding scenario would be when a doctor receives the images without having given consent to their receipt. Would the doctor have knowingly received the pictures? In regard to child pornography, the 11th Circuit Court of Appeals has held that “a person ‘knowingly receives’ something when he… takes in that thing through the mind or the senses.”[12] The court continued to state that a person does not have to save images to a hard drive in order to receive or be in possession of child pornography.[13]

Technology has advanced the medical profession far beyond what could have been imagined even half a century ago. As progress has been made, new liabilities have also been imposed. Most currently, the scope of telemedicine is still being established. What is the legality of minors sharing explicit images of themselves with their doctors via unsecured telemedicine such as texting or email? This emerging phenomenon continues to generate a host of questions regarding the legality of such exchanges. Until the issue is taken to court, or until the legislature responds, there will continue to be gaps in the law and doctors need to be extremely cautious.

 

[1] See Age of Applicants to U.S. Medical Schools at Anticipated Matriculation, Association of American Medical Colleges, tbl.A-6, https://www.aamc.org/download/321468/ data/factstablea6.pdf (last visited Sep. 20, 2016).

[2] See AIHM Survey of Healthcare Practitioners Shows That Telemedicine Technology Is Ahead of the Current State Medical Board Guidelines, Cio Today, http://www.cio-today.com/article/index.php? storyid=030000IWF6ZO (last visited Sep. 20, 2016).

[3] See Jessica Harper, Pros and Cons of Telemedicine for Today’s Workers, Us News, http://health.usnews.com/health-news/articles/2012/07/24/pros-and-cons-of-telemedicine-for-todays-workers (last visited Sep. 20, 2016).

[4] See id.

[5] See Amanda Holpuch, Sexting for your Health, The Guardian, https://www.theguardian.com/ society/2016/apr/07/patients-texting-doctors-genitalia-photos-ethics-law (last visited Sep. 20, 2016).

[6] See Supra note 2.

[7] See Supra note 5.

[8] See id.

[9] See 18 U.S.C. § 2252(a)(2)(A).

[10] See id.

[11] 18 U.S.C. § 2256(2)(v).

[12] United States v. Woods, 684 F.3d 1045, 1057-58 (11th Cir. 2012).

[13] See id.

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By: Ryan Martin,

As recently reported, the global telemedicine industry is expected to grow to $57.92 Billion by the year 2020.[1] While that is still a small share of the total health care industry, it represents a 17.85% compound growth rate, signaling that telemedicine services are here to stay.[2]

Telemedicine, also known as telehealth, aims to provide medical services via electronic communications.[3] Often, these services can help provide medical care in rural areas where the accessibility to physicians is limited.[4] In a typical visit, a patient will “chat” with a physician through a webcam service, then be advised on a treatment or recommended to seek further treatment.[5] While the concept of telemedicine has been around as long as the telephone, it has seen a dramatic take off with the rise of mobile and video technology.[6] The Federal Government is now showing an interest in growing access to these services by providing grants to community hospitals for use in rural areas.[7]

However, as the industry continues to grow there are several legal and regulatory aspects that will need to be addressed to ensure that healthcare providers can provide telemedicine services in a cost effective manner. Among them are restrictions to reimbursement through Medicaid and Medicare, privacy concerns regarding HIPPA, and the threat of malpractice suits resulting from the inability to conduct a full physical examination of the patient.[8] Perhaps the most daunting hurdle—specifically in the United States—is individual state licensing restrictions.[9]

States are responsible for regulating and monitoring healthcare professionals within their state and generally require full licensure to provide services to patients in that state.[10] For example, a physician practicing internal medicine in California would need to be fully licensed by the state of Florida in order to provide a telemedicine consultation to a patient who is located in Florida. While it is understandable that a state would want to protect its citizens from an unlicensed physician, telemedicine transcends geographic boundaries; putting heavy licensing restrictions frustrates its purpose of providing common, low risk services, where the often alternative option is no healthcare service at all.

A few states have amended their state laws to allow for easier access to telemedicine. Several states allow for physicians from boardering states to provide medical services.[11] Ten states have taken steps to establish special telehealth licenses that allow a physician to practice through telemedicine services but not physically in that state.[12] This helps expedite the physician’s license and shortens what is often a lengthy review of her application.[13] However, no state has allowed for direct reciprocity.[14]

The American Telemedicine Association publishes an annual report card for each state, grading their licensure policies from A to F, based on the reasonableness of its telemedicine practice standards, licensure requirements, and policy on Internet prescribing.[15] In its latest report, there were no “A’s” issued, indicating that there is still work to be done if states want to expand telemedicine services.[16]

There is currently one potential resolution to the licensing problem. Seventeen states have signed a Federation of State Medical Boards (FSMB) compact that requires an expedited licensing process for out-of-state practitioners.[17] However, the FSMB does not create federal licensure law and each individual state has to affirmatively adopt the compact.[18] Because of this, the FSMB compact likely falls short of being a sufficiently comprehensive plan.

The future appears to be positive for telemedicine services, but if nothing is done to change the current regulations, telemedicine providers may be stuck with navigating the often-complex state regulations that limit the availability to such services. Should the federal government truly desire to increase healthcare accessibility in rural areas through telemedicine, more will need to be done to alter state licensing regulations.

 

[1] See Telemedicine Market to Reach $ 57.92 Billion by 2020, Thanks to Evolving Reimbursement Policies; Reveals Market Data Forecast Analysis, PR Newswire, (Sept. 14, 2016), http://www.prnewswire.com/news-releases/telemedicine-market-to-reach–5792-billion-by-2020-thanks-to-evolving-reimbursement-policies-reveals-market-data-forecast-analysis-593396911.html.

[2] See id.

[3] See What is Telemedicine, American Telemedicine Association, http://www.americantelemed.org/about-telemedicine/what-is-telemedicine#.V9w6BDuTUb0 (last visited Sept. 16, 2016).

[4] See Jonah Comstock, How telemedicine, remote patient monitoring help extend care in Mississippi, MobiHealthNews, (Sept. 13, 2016), http://www.mobihealthnews.com/content/how-telemedicine-remote-patient-monitoring-help-extend-care-rural-mississippi.

[5] See What is Telemedicine, supra note 1.

[6] See id.

[7] See Joseph Goedert, Federal grants give rural telehealth programs a boost, HealthData Management, (Aug. 16, 2016), http://www.healthdatamanagement.com/news/federal-grants-give-rural-telehealth-programs-a-boost.

[8] See John Donohue, Telemedicine: What the future holds, Healthcare IT News, (Sept. 6, 2016, 11:06:00 AM), http://www.healthcareitnews.com/blog/telemedicine-what-future-holds; HIPPA Guidelines on Telemedicine, HIPPA Journal , http://www.hipaajournal.com/hipaa-guidelines-on-telemedicine (last visited Sept. 16, 2016); Neil Chesanow, Do Virtual Patient Visits Increase Your Risk of Being Sued?, Medscape, Oct. 22, 2014) http://www.medscape.com/viewarticle/833254.

[9] See Kristi VanderLaan Kung, Recent Relaxation of State-level Challenges to Expansion of Telemedicine but Barriers Remain, The National Law Review, (Aug. 18, 2016), http://www.natlawreview.com/article/recent-relaxation-state-level-challenges-to-expansion-telemedicine-barriers-remain.

[10] See id.

[11] See Latoya Thomas & Gary Capistrant, State Telemedicine Gaps Analysis, AM. TELEMEDICINE ASS’N 4 (Jan. 2016), http://www.americantelemed.org/docs/default-source/policy/50-state-telemedicine-gaps-analysis–physician-practice-standards-licensure.pdf.

[12] See id.

[13] See id.

[14] See id.

[15] See id.

[16] See Thomas, supra note 11.

[17] See Kung, supra note 9.

[18] See id.

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By: Will MacIlwaine,

Over the past few years, auto manufacturers have been experimenting with autopilot features that, in certain situations, essentially allow a vehicle to drive itself. One such vehicle is the Tesla Model S. A recent software update for the Model S allows it to “use its unique combination of cameras, radar, ultrasonic sensors and data to automatically steer down the highway, change lanes, and adjust speed in response to traffic.”[1] Further, this Tesla model has the ability to search for a parking space once the driver has arrived at his or her destination, and will even parallel park the vehicle on its own.[2]

The Tesla must obtain certain data before it can enter into autopilot mode.[3] Among other things, there must be clear lane lines, a consistent travel speed, and the car must be able to sense other vehicles around it.[4] Tesla points out on its website that, although the vehicle does most of the driving for the consumer, drivers must still keep their hands on the steering wheel.[5] Even so, there have been reports of Tesla drivers taking pictures of themselves with their hands off the steering wheel, drinking coffee, reading the paper, or even riding on the roof, while the car does the driving.[6]

Tesla claims that the autopilot feature can make it easier, safer, and more pleasant to deal with traffic.[7] Some drivers of both Tesla vehicles with autopilot features, and drivers of other similar vehicles, would beg to differ.

This past week, reports surfaced of an accident involving a Tesla vehicle that occurred in January of 2016.[8] The accident took place in China, when the Tesla, thought to be in autopilot mode, failed to brake and slammed into a road sweeper, killing the driver.[9]

Later, in May of this year, a man was killed when the autopilot feature failed to recognize the white side of a tractor-trailer against the bright sky, and the brakes were not applied.[10]

Legally, what’s at stake for Tesla in introducing this innovative feature? The National Highway Traffic Safety Administration (“NHTSA”) classifies car automation by levels ranging from one to four.[11] One is akin to a standard car, while four is parallel with a fully capable autopilot vehicle.[12] According to attorney Gabriel Weiner, Tesla’s autopilot feature is similar to a level two classification.[13] Drivers could be fooled by the term “autopilot” and falsely believe that they do not have to be fully alert when the feature is being used.[14] If this is the case, and Tesla fails to warn the customer to always remain alert, the company could be liable if the autopilot feature caused an accident. On the other hand, Tesla’s owner’s manuals state that the driver is still responsible for controlling the vehicle, and a message reminding the user to keep his or her hands on the wheel and to be prepared to take over at any time is displayed on the vehicle’s center screen when the feature is in use.[15]

If a user sees these messages and decides to ignore them, it would seem that Tesla could escape liability, as this could be seen as an implied assumption of risk by the user. Under that theory, if the vehicle user knows and understands the danger that the autopilot feature presents and still voluntarily chooses to use it, there would likely be no liability on the part of Tesla.

In a claim that Tesla acted negligently in selling a car with the autopilot feature, Tesla could also make contributory negligence argument. By failing to have hands on the steering wheel, or by not paying attention to the road, the driver could be contributorily negligent if an accident were to occur.

There are certainly other questions surrounding the autopilot feature. For one, who is legally responsible for a car crash if the car is driving itself?[16] Tesla? The owner of the car? What implications might autopilot malfunctions have on an owner’s drivers license? Will an owner get points on his license, or worse, lose it, if the autopilot feature causes a crash?

The technological breakthrough that the autopilot feature offers is obviously not perfect. It may take years to fully perfect this advancement in the automotive industry. That being said, the question remains: will consumers continue to utilize this compelling feature while potentially sacrificing safety for convenience?

 

[1] Model S Software Version 7.0, https://www.tesla.com/presskit/autopilot (last visited Sept. 17, 2016).

[2] See id.

[3] See Ryan Bradley, Tesla Autopilot, MIT Technology Review, https://www.technologyreview.com/s/600772/10-breakthrough-technologies-2016-tesla-autopilot/ (last visited Sept. 17, 2016).

[4] See id.

[5] See Model S Software Version, supra note 1.

[6] See Bradley, supra note 3.

[7] See Model S Software Version, supra note 1.

[8] See Neal E. Boudette, Autopilot Cited in Death of Chinese Tesla Driver, New York Times, Sept. 14, 2016, http://www.nytimes.com/2016/09/15/business/fatal-tesla-crash-in-china-involved-autopilot-government-tv-says.html.

[9] See id.

[10] See Bill Vlasic & Neal E. Boudette, Self-Driving Tesla Was Involved in Fatal Crash, U.S. Says, New York Times, June 30, 2016, http://www.nytimes.com/2016/07/01/business/self-driving-tesla-fatal-crash-investigation.html.

[11] See William Turton, Tesla’s Autopilot Driving Mode is a Legal Nightmare, Gizmodo (July 23, 2016), http://gizmodo.com/teslas-autopilot-driving-mode-is-a-legal-nightmare-1783280289.

[12] See id.

[13] See id.

[14] See id.

[15] See id.

[16] See id.

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