Category Archives: Blog Post

Stranger than Fiction? The Legal Challenges of Augmented and Virtual Reality

By: Timothy Murphy

As it stands today, most people only associate augmented and virtual reality (AR/VR) technology with video game products like the Oculus Rift, the Playstation VR or the augmented reality game Pokemon Go. However, industry insiders are keen to utilize so-called “immersive technology” in all manner of new applications, such as the fields of medicine, education, and even the military. According to the “2020 Augmented and Virtual Reality Survey Report,” which surveyed 191 experts within the industry, we have only begun to scratch the surface of the functionality and applications of this technology. Most experts in the survey predict that AR/VR technology will become a mainstream product within the next two to five years.

There are still, however, several hurdles this burgeoning industry must overcome. As some technological limitations begin to shrink with the onset of 5G, experts are anticipating challenges in another setting: the legal field. The most readily apparent legal risks in the industry take the form of user privacy concerns, government regulation, and product liability.

As with most technology industries, user data protection is a foremost concern. One of the most promising aspects of augmented reality for large companies is the potential for advertising their brand in ways never before possible. Last year, Burger King utilized an augmented reality promotion where users could point their phone’s camera at a McDonald’s advertisement. The app would then overlay a “burning” effect and reveal a voucher for a free Whopper beneath the digitally razed McDonald’s advert. As marketing efforts like this become more widespread, so too does the public concern over potential data collecting. Imagine a future where AR apps not only entertain the user, but also collect information about their home, routines, and desires. 

Several laws have already been passed to protect user privacy that will have ramifications in the AR/VR field. One such law is the California Consumer Privacy Act. This law, which became effective on January 1, 2020, gives Californians the right to request all data that large companies have collected on them, and even to have that data deleted upon request. As potentially invasive technologies continue to grow in popularity and ingenuity, it is likely that more states will need to update their privacy protection laws to keep up. 

Another legal risk stems from the sensory deprivation that consumers experience while immersed in virtual reality. There have already been several instances of VR users dying as a result of injuries sustained while wearing a headset, such as a man in Moscow who passed away after falling onto a glass table while he was using VR. There have also been hundreds of accidents attributed to Pokemon Go, the most popular AR game to date. As the AR/VR industry continues to rise in ubiquity, it is likely that there will be an equally large uptick in AR/VR injuries, and subsequent lawsuits.

It is clear that virtual and augmented reality technology has not yet fully reached its true potential. Like the internet or the cell phone, this new technology could drastically change the way we communicate with one another. Like all new technology, it is hard to predict exactly how the dust will settle, but hopefully lawmakers can strike the correct balance between encouraging the growth of this new field while also protecting consumers.

Sources:

About the California Consumer Privacy Act, Californians For Consumer Privacy, https://www.caprivacy.org/about.

Callum Patton, Virtual Reality Gamer Slips and Dies From Blood Loss After Falling On Glass Table. Newsweek (December 23, 2017), https://www.newsweek.com/virtual-reality-gamer-slips-and-dies-blood-loss-after-falling-glass-table-757966.

Dan Robitzski, The U.S. Army Is Using Virtual Reality Combat to Train Soliders. Futurism (March 22, 2019), https://futurism.com/army-soldiers-vr-combat-training.

Sol Rogers, AR Advertising: A Gimmick Or A New Advertising Frontier?Forbes (June 28, 2019),

https://www.forbes.com/sites/solrogers/2019/06/28/ar-advertising-a-gimmick-or-a-new-advertising-frontier/#2088811d184d.

Zach Warren, Augmented and Virtual Reality Tech Is Here, but Legal Risks Still Evolving.Law.com (April 3, 2020), https://www.law.com/legaltechnews/2020/04/03/augmented-and-virtual-reality-tech-is-here-but-legal-risks-still-evolving/.

ZoëBernard,Maybe You Shouldn’t Catch ‘Em All — A New Study Links ‘Pokémon Go’ to Traffic Deaths, Injuries, and Vehicle damage. Business Insider (November 27, 2017), https://www.businessinsider.com/pokemon-go-linked-to-traffic-deaths-accidents-and-hundreds-of-thousands-of-dollars-in-vehicular-damage-2017-11.

2020 Augmented and Virtual Reality Survey Report, Perkins Coie LLP (March 2020), https://www.perkinscoie.com/en/ar-vr-survey-results/2020-augmented-and-virtual-reality-survey-results.html.

Telemedicine: Striking the Balance Between Distancing and Dishonesty

By: Matthew Feibert

In one inconspicuous aspect, access to health care is no different than ordinary household items—it can be procured by using the internet.  This is done via telemedicine.  Specifically, telemedicine is the “practice of medicine using technology to deliver care at a distance.”[1]  In the majority of settings, telemedicine uses real-time digital face-to-face video-chatting to allow a health care professional to speak with and examine a patient.[2]  Instead of traveling to your doctor’s office and making the effort to avoid contracting an illness while sitting in the waiting room, telemedicine offers the benefit and ease of visiting your doctor from the comfort of your own home.  While telemedicine has steadily gained traction over the recent years, its use has skyrocketed since the arrival of COVID-19 in the United States.[3]  Though the use of telemedicine appears to be facially innocent, telemedicine is particularly vulnerable as it has been used as a vehicle to perpetuate health care fraud.[4]

Individuals have exploited the use of telemedicine for the purpose of enriching themselves.  The U.S Department of Justice has investigated and prosecuted egregious instances of health care fraud relating to the improper use of telemedicine.[5]  Unfortunately, telemedicine fraud schemes have resulted in the loss of staggering amounts of taxpayer dollars.

In 2019, Lester Stockett, the owner of numerous telemedicine companies, pleaded guilty to federal charges and admitted his role in a massive telemedicine fraud scheme.[6]  Over the course of the conspiracy, Stockett submitted or induced the submission of over $424 million in fraudulent claims to Medicare, over $200 million of which was paid and ultimately lined the pockets of the Stockett and his co-conspirators.[7] 

The companies that were used to perpetrate this fraud scheme were not nearby in geographic proximity.  Instead, the companies named in the indictment were registered and controlled in Florida, Wyoming, Delaware, and the Dominican Republic.[8]  This smattering of proximity between these companies demonstrates how the technological component of telemedicine allows for fraud schemes to be more far reaching and complex than ordinarily possible.  This case is only one illustration of the magnitude that telemedicine offers for those who seek to defraud the United States.

Today, although the medical community’s attention is currently focused on addressing the COVID-19 pandemic, the practice of medicine in non-COVID-19 areas must continue.  Yes, you can still become sick of an illness other than COVID-19.  In an effort to continue treating patients while simultaneously containing the spread of COVID-19 in the United States, health care providers of wide-ranging specialties have resorted to transitioning their office visits from an in-person interaction to now, a virtual interaction.[9]

On March 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) relaxed their ordinary reimbursement requirements for services performed via telemedicine.[10]  Using the “1135 waiver authority and the Coronavirus Preparedness and Response Supplemental Appropriations Act,” CMS expanded the use of telemedicine.[11]  “Prior to this waiver[,] Medicare could only pay for telehealth on a limited basis: when the person receiving the service is in a designated rural area” and in order to receive medical attention, they would need to travel a great distance.[12]  Now, among other rollbacks under the 1135 Waiver, CMS will reimburse for telemedicine services that a beneficiary receives, regardless of the geographic distance between their residence and treatment site.[13]

Given this relaxation in policy, CMS should expect to see an increase in fraudulent billing submissions relating to the use of telemedicine.  After all, it is the harsh reality in that even during times of crisis, the frequency of fraud schemes tend to experience an uptick.[14]  We can be rightfully disheartened, yet not be surprised to learn of telemedicine fraud schemes that have occurred so far during the COVID-19 pandemic.


[1]                What’s the Difference Between Telemedicine and Telehealth?, Am. Academy of Family Physicians, https://www.aafp.org/media-center/kits/telemedicine-and-telehealth.html (last visited Apr. 9, 2020).

[2]                Yolanda Smith, Types of Telemedicine, News Medical, https://www.news-medical.net/health/types-of-telemedicine.aspx (last updated Aug. 23, 2018).

[3]                Jeff Lagasse, Telemedicine is Poised to Grow as its Popularity Increases Among Physicians and Patients, Healthcare Finance (July 16, 2019), https://www.healthcarefinancenews.com/news/telemedicine-poised-grow-its-popularity-increases-among-physicians-and-patients.

[4]                Jackie Drees, 5 Things to Know About Telehealth Fraud, Becker’s Hospital Review (May 2, 2019), https://www.beckershospitalreview.com/telehealth/5-things-to-know-about-telehealth-fraud.html.

[5]                See, e.g., Two Owners of Telemedicine Companies Charged for Roles in $56 Million Conspiracy to Defraud Medicare and Receive Illegal Kickbacks in Exchange for Orders of Orthotic Braces, U.S. Dep’t Justice (Feb. 5, 2020), https://www.justice.gov/opa/pr/two-owners-telemedicine-companies-charged-roles-56-million-conspiracy-defraud-medicare-and.

[6]                Owner and Chief Executive Officer of Telemedicine Company Pleads Guilty to $424 Million Conspiracy to Defraud Medicare and Receive Illegal Kickbacks in Exchange for Orders of Durable Medical Equipment, U.S. Dep’t Justice (Sept. 6, 2019), https://www.justice.gov/opa/pr/owner-and-chief-executive-officer-telemedicine-company-pleads-424-million-conspiracy.

[7]                Id.

[8]                Id.

[9]                Medicare Telemedicine Health Care Provider Fact Sheet, Ctrs. for Medicare & Medicaid Servs. (Mar. 17, 2020), https://www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-health-care-provider-fact-sheet.

[10]              See id.

[11]              Id.

[12]              Id.

[13]              Supra, note 9.

[14]              Greg Iacurci, Coronavirus Scams, Feeding off Investor Fears, Mimic Fraud From the 2008 Financial Crisis, CNBC (Mar. 21, 2020), https://www.cnbc.com/2020/03/20/coronavirus-scams-on-the-rise-mimic-fraud-in-2008-financial-crisis.html.

Emergency Use Authorizations by the FDA in the Wake of COVID-19

By: Kaitlyn Crobar

The basic idea of the Food and Drug Administration (the “FDA”) is to look at approval of food, drugs, medical devices, and other related things for safety and efficacy. Approved products should be safe for the consumer to use and not create their own risks. Drug manufacturers must determine the highest tolerable dose and the potential effects of the drug to ensure safe measures are employed by prescribers and consumers. Efficacy means that the medical product must produce a positive clinical benefit.

            Typically for FDA approval the medical product manufacturers must take several steps. Drug approval requires pre-clinical steps, conducting pre-clinical studies, and conducting clinical trials in various phases which takes on average twelve years to complete. Medical devices must also undergo several pre-market tests and trials which take an average of three to seven years to complete. However, in times of crisis, like during the current COVID-19 epidemic, the FDA allows for Emergency Use Authorizations of both drugs and medical devices under the Food, Drug, and Cosmetic Act.

            The Emergency Use Authorization process moves very fast. Authorization must first be granted from the supplier of a medical product for emergency use. Then an application can be submitted to the FDA for Emergency Use Authorization. Once the FDA gives authorization, the manufacturer can send the medical product to the physician who can then use the product with a patient. In the case of a drug, the patient must give informed consent before receiving the drug and the FDA must be notified of any adverse reactions. This process can occur all within the same day, making it much faster than the typical approval timeline for medical products.

            There are two types of Emergency Use Authorizations. The first allows for medical professionals to use unapproved medical products to diagnose, treat, or prevent a disease in emergency situations. The second allows medical professionals to use an FDA approved medical product in an unapproved way. Either way before mass distribution the products granted Emergency Use Authorizations must undergo a fast-tracked safety and efficacy testing.

            On March 28th, 2020 the drugs hydroxychloroquine sulfate and chloroquine phosphate were granted Emergency Use Authorizations for the treatment of COVID-19. These drugs are not new drugs, but old drugs that obtained FDA approval for other uses, placing them in the second category of Emergency Use Authorizations. Hydroxychloroquine sulfate has been approved to treat malaria, lupus, and rheumatoid arthritis. Some versions of chloroquine phosphate have been approved to treat malaria. Neither drug has been FDA approved to treat COVID-19.

            The Emergency Use Authorization allows labs to test the effect of the drugs on COVID-19. Lab testing, often completed in the form of in vitro studies, has shown that the drugs help prevent the growth of the virus. With successful initial lab testing, clinical trials for hydroxychloroquine sulfate and chloroquine phosphate have begun. The clinical trials will take time to complete, although the process will be sped up. Doctors and researchers hope to have results in one year as opposed to twelve years.

            Existing drugs that other nations have identified as potentially helpful in curing COVID-19 are favipiravir (a flu drug), remdesivir (a failed Ebola treatment), hydroxychloroquine with azithromycin (an antibiotic), convalescent plasma, and arthritis drugs. Tests are being performed on these drugs in countries like China, Japan, and France. We should not be surprised for the US to announce they have begun trials on these as well. However, the FDA has not yet provided any official Emergency Use Authorization for these drugs. As research continues, it is likely that Emergency Use Authorizations will be granted for new drugs created to combat COVID-19.

            In addition to Emergency Use Authorizations for drugs, the FDA has granted Emergency Use Authorizations for new test kits, personal protective equipment, and ventilators. With the tests for COVID-19 taking several days to return results, many patients waited in worry. Additionally, the need for test kits far overgrew the supply available. This presented the need for more tests and for rapid tests so that patients could have same day results. The FDA has given over thirty Emergency Use Authorizations for both in vitro diagnostic products and molecular-based laboratory developed tests.

            One new diagnostic test that was granted Emergency Use Authorization was created by the BD Company and BioGX Inc. Their test is run on a molecular diagnostic platform that is capable of analyzing hundreds of samples per day. This test is said to yield results in as little as three hours and is expected to increase the number of tests available nationwide by 50,000 per week. While their test has been given Emergency Use Authorization, it has not been approved by the FDA as a medical device to diagnose COVID-19. This means that the test can only be used to detect COVID-19 for as long as the FDA deems that there is an ongoing emergency.

            As we continue to combat COVID-19, we will likely see the number of Emergency Use Authorizations rise rapidly. This is all in part of the dedicated medical professionals who are working tirelessly day in and day out to find solutions in order to end this epidemic.

Sources:

  • Emergency Use Authorization, U.S. Food and Drug Administration, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#LDTs (last visited Apr. 9, 2020).
  • Frequently Asked Questions on the Emergency Use Authorization (EUA) for Chloroquine Phosphate and Hydroxychloroquine Sulfate for Certain Hospitalized COVID-19 Patients, U.S. Food and Drug Administration, https://www.fda.gov/media/136784/download (last visited Apr. 9, 2020).
  • Gail A. Van Norman, Drugs, Devices, and the FDA: Part 1: An Overview of Approval Process for Drugs, 1 JAAC: Basic to Translational Sci. 170, 170-179 (2016).
  • Gail A. Van Norman, Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices, 1 JAAC: Basic to Translational Sci. 277, 277-287 (2016).
  • Matthew Herper, When might experimental drugs to treat Covid-19 be ready? A forecast, STAT (Mar. 24, 2020) https://www.statnews.com/2020/03/24/when-might-experimental-drugs-to-treat-covid-19-be-ready-a-forecast/.
  • Troy Kirkpatrick, BD, BioGX Announce FDA Emergency Use Authorization for New COVID-19 Diagnostic for Use in the U.S., BD (Apr. 3, 2020) https://www.bd.com/en-us/company/news-and-media/press-releases/bd-biogx-announce-fda-emergency-use-authorization–for-new-covid-19-diagnostics-for-use-in-us.

Maternal Mortality: The Disturbing Reality of Childbirth Deaths Across Racial and Ethnic Lines

By: Ryan Thompson

“Let me be clear: everymother, regardless of race or background, deserves to have a healthy pregnancy and childbirth,” tennis star Serena Williams said in a Facebook post speaking to the racial disparities and bias present in maternal healthcare, following her Vogue cover story where she opened up about her own personal experience. “I personally want all women of all colors to have the best experience they can have.” For the numerous fatal obstetric outcomes resulting from childbirth, there exist clear disparities across racial groups. In 2019, the Centers for Disease Control and Prevention (‘CDC’) reported that Black, Native American, and Alaska Native women are approximately three times more likely to die from pregnancy-related causes than White women.

On December 21, 2018, the Preventing Maternal Deaths Act (H.R. 1318) was signed into law, allowing for the allocation of resources to collect and analyze data on every maternal death in the country. Through this bill, the Federal Government intends to use funds for the establishment and support of existing maternal mortality review committees (‘MMRCs’) in states and tribal nations across the United States. These committees collect data and recommend preventive measures to be taken during the prenatal and postpartum stages. Principal Deputy Director of the CDC, Dr. Ann Schuchat, said: “The bottom line is that too many women are dying [from] largely preventable deaths associated with their pregnancy…we have the means to identify and close gaps in the care they receive, we can and should do more.”

Maternal health amongst black women has garnered much attention in recent years as more data became available. Of the approximate 3.8 million births each year, there are an estimated 700 pregnancy-related deaths. The CDC has reported that while 13 white women die per every 100,000 live births, the figure increases to 42.8 for Black women, and 32.5 for Native American/Alaska Natives women.  These statistics have prompted the Federal government to take action to ensure that there are closer studies of the information available and a dramatic reduction in these figures for women, particularly those for women of color. Though the reasons for the differences remain unclear, the passing of H.R. 1318 was a good step in the right direction.

Current and former presidential candidates have also made it a priority to shed light on this issue, with Senator Kamala Harris even proposing new legislation in her fight against maternal mortality. A reduction in cognitive implicit biases by healthcare providers and a call for improvement facilities through the care provided in the disproportionately affected communities may lead to a better result in the years to come. It is saddening that in one of the leading countries of the world, there exists a reality where black women from all socioeconomic statuses and the death rate for black infants exponentially surpasses that of non-Hispanic white women. Healthcare for all women must be a priority, especially in one of the most precious and vulnerable times of their lives.

References:

Julia Curley, Serena Williams reflects on post-birth complications: ‘It made me stronger’, Today, (Jan. 15, 2018), https://www.today.com/parents/serena-williams-reflects-post-birth-complications-it-made-me-stronger-t121223.

Rob Haskell, Serena Williams on Motherhood, Marriage, and Making Her Comeback, Vogue, (Jan. 10, 2018), https://www.vogue.com/article/serena-williams-vogue-cover-interview-february-2018?mbid=zr_serenawilliams.

Roni Caryn Rabin,Huge Racial Disparities Found in Deaths Linked to Pregnancy, The New York Times, (May 7, 2019), https://www.nytimes.com/2019/05/07/health/pregnancy-deaths-.html.

Emily E. Petersen, MD ET AL,Vital Signs: Pregnancy-Related Deaths, United States, 2011-2015, and Strategies for Prevention, 13 States, 2013-2017, CDC, (May 10, 2019), https://www.cdc.gov/mmwr/volumes/68/wr/mm6818e1.htm.

SEC HALTS ZOOM TECHNOLOGIES TRADING DUE TO INVESTOR CONFUSION

By: Emily Aziz

Investors eager to benefit from the COVID-19 pandemic rushed to purchase shares of Zoom, a video-calling platform that has seen an increase in surge share prices due to COVID-19. Many traders, however, purchased the wrong stock. On March 25, 2020, the Securities and Exchange Commission (“SEC”) announced the temporary suspension, pursuant to Section 12(k) of the Securities Exchange Act of 1934 (the “Act”), of trading in the securities of Zoom Technologies Inc. due to this confusion. 

Under Section 12(k) of the Act, the Commission is authorized to suspend trading in any security for a period not exceeding 10 business days if, in its opinion, is necessary to protect the public interest and investors. 

Zoom Technologies, a Delaware Corporation that has its principal executive offices in China, primarily engages in technology and communication businesses. The company has not filed a public disclosure statement since 2015. Because of this, the SEC had concerns about the adequacy and accuracy of publicly available information concerning Zoom, including its financial data. Zoom Video Communications, on the other hand, has become incredibly popular amid the coronavirus pandemic as more people work or study from home, and as a result, have become reliant on videoconferencing for maintaining day-to-day communications. 

According to Business Insider, the shares of Zoom Video are up roughly 116 percent year-to date. Zoom Technologies stock was up more than 800 percent year-to-date before its trading halt.  This is not the first time this mix up between the two companies has occurred; In April 2019, Zoom Video went public and Zoom Technologies rallied nearly 100% on the initial public offering day despite, again, not having released any new financial information. 

The temporary suspension ends on April 8, 2020 at 11:59 PM. 

CITATIONS: 

Securities Exchange Act Section 12(k), 15 U.S.C. § 781(k) (1988)

Order of Suspension of Trading, Zoom Technologies, Inc., No. 500-1 (Securities Exchange Comm’n March 25, 2020) 

Jonathan Garber, A company called Zoom Technologies is surging because people think it’s Zoom Video Communications (ZOOM, ZM), Markets Insider (Apr. 18, 2019 10:57 AM) https://markets.businessinsider.com/news/stocks/publicly-listed-zoom-video-communications-traders-buying-zoom-technologies-2019-4-1028122561?utm_source=markets&utm_medium=ingest

Ben Winck, The SEC stopped trading on an over-the-counter stock because people were confusing it with Zoom Video, which has soared amid the coronavirus lockdown, Market Insider (Mar. 26, 2020 12:33 PM) https://markets.businessinsider.com/news/stocks/zoom-technologies-stock-halted-sec-confusion-with-zoom-video-coronavirus-2020-3-1029036453

 Jessica Bursztynsky, SEC pauses Zoom Technologies trading because people think it’s Zoom Video, CNBC (Mar. 26, 2020 11:57 AM) https://www.cnbc.com/2020/03/26/sec-pauses-zoom-technologies-as-traders-confuse-it-with-zoom-video.html

David Canellis, SEC halts $ZOOM after coronavirus traders confuse it for Zoom app, The Next Web (Mar. 27, 2020 2:12 PM) https://thenextweb.com/hardfork/2020/03/27/sec-halts-zoom-after-coronavirus-traders-confuse-it-for-zoom-app/

Photo: Courtesy of Forbes

Regulation of Price Gouging During COVID-19

By: Joseph Mallek

Across the country consumers are seeking cleaning and other products to protect themselves due to the COVID-19 outbreak. Supermarkets and online retailers are struggling to keep up with the rise in demand. Businesses and third-party sellers are now increasing their prices due to this rise in demand and decrease in supply. States attorney generals across the country are receiving and responding to complaints from price gouging consumers.[1]This practice is normally lawful but in the current health crisis, states are using price gouging statutes to protect consumers.[2]

Although many states have price gouging statutes, these statutes vary in terminology and penalties. Michigan Gov. Gretchen Whitmer prohibited the resale of a product at a price that is grossly in excess of the purchase price.[3]Price gouging is penalized in Michigan under the Michigan’s Consumer Protection Act.[4]Under the governors executive order, the sale of a product “at a price that is more than 20% higher” than the price charged for that product as of March 9 is prohibited.[5]

In New York, Attorney General Letitia James ordered merchants from price gouging sanitation products and set up a website for consumers to submit price gouging complaints.[6]Under New York law, it is prohibited to sell goods or services at an “unconscionably excessive price” during a declared state of emergency.[7]The New York statute reserves the right to the courts to determine whether a price is unconscionably excessive.[8]Some of the factors the courts consider include the exercise of unfair leverage or unconscionable means and that the “amount of the excess in price is unconscionably extreme.”[9]

In the past few weeks, consumers have reported that the prices on these items have significantly increased.[10]Attorney general’s offices around the country are warning sellers against price gouging necessary products.[11]In addition to consumers reporting abuses, retailers like Amazon must do their part to monitor third-party retailers. As well, it is important for all retailers to keep records and documentation to prove that increases in cost led to the price increase. 


[1]Michael Levenson, Price Gouging Complaints Surge Amid Coronavirus Pandemic, The New York Times, https://www.nytimes.com/2020/03/27/us/coronavirus-price-gouging-hand-sanitizer-masks-wipes.html (last visited Mar. 28, 2020).

[2]Price Gouging Laws by State,FindLaw, https://consumer.findlaw.com/consumer-transactions/price-gouging-laws-by-state.html (last visited Mar. 28, 2020).

[3]Ryan Jarvi, AG’s Office Receives New COVID-19 Scam Report, More Than 800 Price-gouging Complaints, Official Website of Michigan.gov (https://www.michigan.gov/coronavirus/0,9753,7-406-98158-522347–,00.html) (last visited Mar. 28, 2020).

[4]Supranote 2. 

[5]Supra note 3.

[6]AG James: Price Gouging Will Not Be Tolerated, NYS Attorney General(https://ag.ny.gov/press-release/2020/ag-james-price-gouging-will-not-be-tolerated) (last visited Mar. 28, 2020).

[7]Supranote 2.

[8]General Business Law § 396-r

[9]Id.

[10]Jessica Guynn, Coronavirus price gouging: eBay bans face masks, hand sanitizer and disinfecting wipes, USA Today(https://www.usatoday.com/story/tech/2020/03/06/coronavirus-price-gouging-ebay-bans-face-masks-hand-sanitizer-sales/4976292002/) (last visited Mar. 28, 2020).

[11]Jack Nicas, He Has 17,700 Bottles of Hand Sanitizer and Nowhere to Sell Them, The New York Times(https://www.nytimes.com/2020/03/14/technology/coronavirus-purell-wipes-amazon-sellers.html) (last visited Mar. 28, 2020).

Protection at the Cost of Privacy: Facial Recognition and the Fourth Amendment

By: George Daoud

On its surface, facial recognition software does not seem threatening.  After all, many people use it to unlock their latest iPhone.  In fact, in the hands of law enforcement and federal agencies, it can be used to track and apprehend criminal suspects or victims of crimes.  Companies like Clearview AI, for example, produce facial recognition software that they claim is created for just that purpose.  

The Clearview AI concept is relatively simple.  They provide law enforcement with a tool to upload someone’s picture onto their software, then, the algorithm does the rest.  Through online scraping, the algorithm searches Facebook, Twitter, Google, Instagram, LinkedIn, and endless other web sources, to identify a host of information about the selected person within seconds.  This information can include address, place of work, friends, recent travel, and arrest records.  Needless to say, the usefulness of this type of technology is apparent for certain law enforcement and surveillance purposes, but the question is where to draw the line in terms of privacy.

To further this privacy dilemma, Clearview AI’s entire client list was recently exposed in a massive data breach. This discovery shed light on the fact that Clearview had not only sold its technology to more than 2,200 law enforcement organizations, government agencies, and security companies around the world, but that some of these entities were not law enforcement at all. Well known companies like, Macy’s, Kohl’s, Walmart, and the NBA to name a few, were amongst the Clearview clients that were found to be regularly using the software.  Furthermore, it was discovered that Clearview’s founders gave potential investors and friends free access to the technology, escalating the public unease that already existed.

How Does It Work? 

Facial recognition software is a type of artificial intelligence (AI) that uses ‘machine learning’ and more specifically ‘deep learning’ methods to operate.  Deep learning in AI involves digital algorithms that function similarly to a human brain, and analyze information using artificial neural networks. These neural networks are composed of interconnected neurons, like a brain, that break down and analyze data. Moreover, each neural network is composed of layers, namely an input, hidden, and output layer.  The hidden layer is where an AI algorithm does the majority of its computing.  In order for facial recognition software to function at its maximum potential, it requires a multitude of hidden layers which require more data points to provide greater accuracy and more efficient results.  In these hidden layers, however, is where companies, like Clearview AI, focus their development, and where the public concern for privacy protections lies.

            Since the hidden layers of facial recognition algorithms require more data to be accurate, everyday individuals, and those wrongly suspected, could be subject to massive invasions of privacy through digital data mining.  This not only brings the possibility of Fourth Amendment unreasonable searches and seizures violations into the forefront, but also highlights the level of scrutiny that should be given to personal digital information in the eyes of the law.

Carpenter Concerns

In the 2018 Supreme Court case, Carpenter v. U.S., the Court decided that the warrantless acquisition of a person’s cell-cite information by law enforcement was an unconstitutional search in violation of the Fourth Amendment.  Furthermore, the Court made the distinction between when privacy should and should not be expected.  They deemed that digital cell-cite information given to a third party, like a phone company, and acquired by police, was only pseudo-voluntary.  Therefore, the owner of the information does not have a genuine choice in terms of allowing third-party access.  This pseudo-voluntariness, according to the Court, leads a reasonable person to have a higher expectation of privacy for their information.  If a reasonable person does not think that their digital information would be subject to regular scrutiny by a third-party, then their privacy expectation is inviolable by law enforcement.  That being said, where does that leave a company like Clearview AI?

More Questions Than Answers…

            The crux of the problem with current facial recognition software, is that, unlike in Carpenter, the information that is utilized by law enforcement will not likely hold the same privacy weight in a court of law.  This is mainly due to the fact that the information used, is publicly available and is voluntarily provided to third parties. When one creates an online profile and purposefully puts their digital footprint on the web, the expectation for privacy is assumed to be lessened.  As a result, the liability that companies and law enforcement agencies will face, when using facial recognition to track people, will be drastically reduced. This has the potential to not only increase its unfettered usage in both the private and public sector, but also to incentivize future developers to push the boundaries.  How much and what type of information can be mined and utilized by an algorithm’s hidden layers are open to interpretation.  The only concern companies have right now is getting the most accurate results.  The question is though, who watches the watchmen?    

There is no doubt that there are benefits to facial recognition software, especially in the context of law enforcement.  However, when private companies and individuals can peek into the lives of anyone through a picture, protection at the cost of privacy may not be as good as it sounds. 

Sources: 

Kashmir Hill, The Secretive Company That Might End Privacy as We Know It, The New York Times (Jan. 18, 2020), https://www.nytimes.com/2020/01/18/technology/clearview-privacy-facial-recognition.html.

Ben Gilbert, Clearview AI Scraped Billions of Photos from Social Media to Build a Facial Recognition App That Can ID Anyone — Here’s Everything You Need to Know About the Mysterious Company, Business Insider(Mar. 6, 2020),https://www.businessinsider.com/what-is-clearview-ai-controversial-facial-recognition-startup-2020-3#then-in-march-another-new-york-times-piece-on-the-company-revealed-another-stunning-detail-the-companys-founders-casually-gave-access-to-the-software-to-potential-investors-and-friends-who-immediately-abused-it-6.

Peter Margulies, Surveillance By Algorithm: The NSA, Computerized Intelligence Collection, and Human Rights, Fla. L. Rev. (July 2016), https://scholarship.law.ufl.edu/cgi/viewcontent.cgi?article=1321&context=flr.

Carpenter v. United States, 138 S. Ct. 2206 (2018).

UNIDIR, The Weaponization of Increasingly Autonomous Technologies: Artificial Intelligence a Primer for CCW Delegates, U.N. Docs.No. 8 (2018).  

PAY TO PLAY: THE SECRET BEHIND THE NINTENDO SWITCH’S HIGH PRICES IN 2020

By: Robert Baurley

By the start of 2020, the Nintendo Company sold approximately 46.79 million units of their “Nintendo Switch” gaming consoles, worldwide.[i]Arguably, one of the reasons behind the Switch’s success derives from Nintendo’s inclusion of previously published games, on their new mobile gaming device.[ii]This feature allowed Nintendo to not only expand their video-game library, but also encourage new users to purchase their systems through the option to play familiar games found on older game consoles of competitors. 

This marketing and business strategy, leaves many customers questioning Nintendo’s pricing policies regarding older— “remastered”—video games. For example, Bethesda Studios’ iconic role-playing video game, The Elder Scrolls V: Skyrim was originally released in 2011, since then, Bethesda Studios offered remastered versions of the game on other “next generation game consoles”, including the Playstation 4 and the Xbox One. Today, a remastered copy of Skyrim can be purchased on the Playstation 4 and Xbox One for $39.99 each.[iii]The exact same remastered game is now available on the Nintendo Switch for a price of $59.99.[iv]

The natural—and seemingly unjust—frustration associated with Nintendo’s remastered game titles is easily explained. When Nintendo created (and patented) their Nintendo Switch gaming console designs, they also created a proprietary gaming card. Their creation of this new proprietary gaming card platform has now artificially increased the price of Nintendo videogames.[v]These prices are accurately described as artificial, not only because of the mere fact that that game is the exact same version that can be played on Sony or Microsoft game consoles, but also because the problem was directly created by Nintendo themselves. 

Often coined “the Nintendo Tax,” this increased price for Nintendo games has left customers hoping for change in 2020. One area where Nintendo has decided to meet customers’ needs, is by allowing the integration of third-party memory cards to the Nintendo Switch’s operating system.[vi]However, Nintendo’s continued direct control over their intellectual property (when it comes to creating game cartridges or system improvements) and unwavering global sales, likely indicates that the Nintendo Tax will continue for as long as the company can collect “taxes” from Switch customers.

So, what does this mean for the future of the Nintendo Switch? Most likely, the Switch will continue to create a niche placement as a mobile gaming console that operates at a higher price point for consumers. Aside from cheaper console options (Nintendo Switch Lite),[vii]Nintendo’s games will continue to cost customers more to play, in the long run.

Hopefully, overtime Nintendo will loosen the reigns on their proprietary game cards and storage systems. But as of yet, that remains unlikely with an extremely profitable yearly sales model. 


[i]Erik Kain, The Nintendo Switch Has Now Sold More Units Than the Super NES, Forbes, (Jan. 2, 2020),https://www.forbes.com/sites/erikkain/2020/01/02/the-nintendo-switch-has-now-sold-more-units-than-the-super-nes/#2278557946cd.

[ii]Chad Sapieha, Nintendo Switch: The Good, the Bad and the Pricey, postmedia breaking news(Jan. 13, 2017), https://business.financialpost.com/technology/gaming/nintendo-switch-the-good-the-bad-and-the-pricey.

[iii]Sony Computer Entertainment, https://store.playstation.com/en-us/product/UP1003-CUSA05333_00-SKYRIMHDFULLGAME?emcid=se-pi-225351; Microsoft, https://www.microsoft.com/en-us/p/the-elder-scrolls-v-skyrim-special-edition/BQ1W1T1FC14W?activetab=pivot:overviewtab.

[iv]Nintendo Co. Ltd., https://www.nintendo.com/games/detail/the-elder-scrolls-v-skyrim-switch/

[v]Matthew Humphries, Cartridges Mean Switch Games Will Always Cost More, ziff Davis media Inc., (Mar. 13, 2017),https://www.pcmag.com/news/cartridges-mean-switch-games-will-always-cost-more.

[vi]Matthew Humphries, Nintendo Switch-Branded Micro SD Cards Launching, ziff Davis media Inc., (Jan. 30, 2017), https://www.pcmag.com/news/nintendo-switch-branded-micro-sd-cards-launching. 

[vii]Scott Stein, Be Happy with the Nintendo Switch You’ve Got, Because You’re Not Getting a New One This Year, CNET Networks Inc., (Mar. 1, 2020), https://www.cnet.com/news/be-happy-with-the-nintendo-switch-youve-got-because-youre-not-getting-a-new-one-this-year/.

Is Your Trademark Really Protecting You?

By: Monique Witter

We live in a generation where millennials are constantly finding innovative and creative ways to contribute to society through entrepreneurship. Some even go as far as applying for trademark protection through the U.S. Patent and Trademark Office (USPTO). However, the same protection they think will protect their business may be what actually ends it. 

The USPTO introduced a new rule requiring all trademark applications to include an email address for the applicant and the applicant lawyer. Like other contact information, the applicant’s information will be published on USPTO’s public database website. Trademark owners are opposed to this rule. The rule has led to digital versions of scam letters to plague brand owners. The USPTO reason for implementing this rule is to further digitize trademark proceedings to ensure that the agency can still email applicants if they are no longer represented by their attorney. However, trademark lawyers have reacted negatively to this rule. Lawyers have seen their clients get hit with a deluge of scam letters aimed at duping trademark owners into paying fake fees. The mailing address used for those letters are pulled from the same database in which the USPTO will now feature email address.

This rule has invoked a furious reactions from other U.S. trademark counsels. U.S. trademark counsel claims that the USPTO is not considering the privacy of its users, especially in light of new data protection and privacy laws in California (California Consumer Privacy Act) and the European Union (General Data Protection Regulation). According to attorney Stacy J. Grossman, “I appreciate the trademark office’s efforts to prevent fraud, and its need to have necessary information to contact trademark owners. However, I don’t understand why this information has to be published in a public database, and why the failure to include a proper email address could cause a trademark applicant to lose its filing date.”

            Attorney Peter J, Riebling reiterates these issues by noting that the issue is more problematic for well-known public figures. “We have heard from numerous counsels overseas who represent celebrity clients, who are genuinely concerned about the privacy aspects, and the extra burden of having to file a petition to the director of the USPTO for a special waiver of the rule. Yes, a petition may be filed to redact the applicant’s email address in the TSDR documents tab in an ‘extraordinary situation’. And yes, an applicant being a celebrity – and the related privacy and safety concerns – will likely qualify as an extraordinary situation to waive the rule as allowed under TMEP (Trademark Manual of Examining Procedure) §1708. But is not every applicant a ‘celebrity’ in some way or form, if even in their own mind?  What is the legal test the director will use for who is and not a celebrity? Where is the line?”

            In response to the criticism, the USPTO will allow for trademark applicants to create a “unique” email address for dealing with the agency. The new filing released by the USPTO stated “to avoid receiving unsolicited communications at a personal or business email address, applicants and registrants may wish to create an email address specifically for communication and correspondence related to their trademark filings at the USPTO.” The USPTO responded to stakeholders’ concerns regarding the potential for misuse of owner email addresses and for owners represented by attorneys. 

The USPTO responded “in order to address these concerns, and balance them against the need for contact information concerning registrations, the USPTO is reissuing the examination guide. The USPTO is continuing to explore additional improvements, including potentially masking email addresses, and will provide notice of any such system updates in the future.” 

Bill Donahue, After Backlash, USPTO Trying To Hide TM Email Addresses, Law 360, (February 11, 2020), https://advance.lexis.com/document/?pdmfid=1000516&crid=10e9a042-caaf-4c2f-9f2e71e5cf73873a&pddocfullpath=%2Fshared%2Fdocument%2Flegalnews%2Furn%3AcontentItem%3A5Y7J-SBN1-F30T-B05R-00000-00&pddocid=urn%3AcontentItem%3A5Y7J-SBN1-F30T-B05R-00000 00&pdcontentcomponentid=122080&pdteaserkey=sr5&pditab=allpods&ecomp=spnqk&earg=sr5&prid=adad6bc3-12f4-4c9d-b0ee-1130ec9833c1.

 Liz Brodzinski, IP Alert | USPTO Trademark Rule Changes: Electronic Filing, Email Addresses and More, (February 20, 2020) https://bannerwitcoff.com/ip-alert-uspto-trademark-rule-changes-electronic-filing-email-addresses-and-more/.

Tim Lince, USPTO urged to halt applicant email requirement following revolt by trademark attorneys, (February 10, 2020), https://www.worldtrademarkreview.com/governmentpolicy/uspto-urged-halt-applicant-email-requirement-following-revolt-trademark.

 

 

Suits & Scrubs: Regulating Robotically Assisted Surgeries

By: Dejaih Johnson

Medicine is rapidly approaching a time where robots will perform surgeries autonomously. From minimally invasive surgery to emergency response and medical robotics, robotically assisted surgeries now represent one of the fastest growing sectors in the medical devices industry. The introduction of these robotic medical devices has made medical operations much more efficient and effective. Surgeons have reported quicker recovery times, less pain, and less blood loss when using a robotic medical device. Though these devices have the capacity to greatly improve the practice of medicine, their usage is not without issue. Over the past twenty years, robotic surgeries have resulted in more than 144 deaths, 1391 injuries, and 8061 device malfunctions. 

Lack of regulation in this area raises many regulatory, ethical, and legal issues. In the European Union (EU), for example, they have yet to establish a clear regulatory framework. Under the Medical Devices Directive, the EU classifies these devices as “Class IIb medical devices”. This means that surgical robots are regulated in the same category as scissors and scalpels. Additionally, the EU does not recognize separate qualifications for surgeons. This approach has proven problematic since surgeons using medical robots require special skills different from that of regular surgeons, such as the ability to control the robot’s manipulators. EU manufacturers are required to seek a certificate for each medical device they wish to sell, but the process is not specific to robotically assisted surgeries. 

On the other hand, the United States has taken a bit of a different approach. Currently, the Food and Drug Administration (FDA) regulates robots as medical devices. The issue, however, lies in the fact that the FDA can regulate them only as medical devices since the FDA lacks the authority to regulate the practice of medicine. Presently, robotic devices in the United States are only used under the supervision of surgeons. For example, surgeons enter calculations and program decisions into their robotically assisted surgical devices. But the United States has failed to fully develop an appropriate regulatory scheme to address this unique issue.

Scholars from varying disciplines have weighed in on the question of how to regulate this practice. One approach, developed by Guang-Zhong Yang, takes into account the uniqueness of medical robotics: the varying levels of autonomy at which the device may operate. As the level of autonomy increases, more stringent regulations and additional requirements would apply. Yang proposes six levels of autonomy for medical robotics, with accompanying levels of regulation and procedure for each. The six levels would break down as follows:

Level 0 – No autonomy: Includes tele-operated robots or prosthetic devices that respond to and follow the user’s command; may also include a surgical robot with motion scaling. 

Level 1 – Robot assistance: Robot provides some mechanical guidance or assistance during a task while the human has continuous control of the system (e.g., surgical robots with virtual fixtures and lower-limb devices with balance control). 

Level 2 – Task autonomy: Robot is autonomous for specific tasks initiated by a human. Operator has discrete, rather than continuous, control of the system (e.g., suturing where the surgeon indicates where a running suture should be placed, and the robot performs the task autonomously while the surgeon monitors and intervenes as needed). 

Level 3 – Conditional autonomy: System generates task strategies but relies on the human to select from among different strategies or to approve an autonomously selected strategy. Robot can perform a task without close oversight (e.g., where active lower-limb prosthetic device can sense the wearer’s desire to move and adjusts automatically without any direct attention from the wearer). 

Level 4 – High autonomy: Robot can make medical decisions but under the supervision of a qualified doctor (e.g., robotic resident who performs the surgery under the supervision of an attending surgeon). 

Level 5 – Full autonomy: No human needed; robot can perform an entire surgery. 

In addition to taking into account the varying levels of autonomy, manufacturers of the device would have to seek licensing and certification from the hospital. The upside of this would be that the framework allows regulators to establish a forward-thinking approach to the robotic medical devices. 

As technology advances faster than regulation, regulators must determine an appropriate framework to address the myriad of issues. Even in the uncertainty, however, it still remains there must be a response to the influx of regulatory, ethical, and legal questions raised. 

References:

Damini Kunwar, Robotic Surgeries Need Regulatory Attention(Jan. 8, 2020), The Regulatory Review, https://www.theregreview.org/2020/01/08/kunwar-robotic-surgeries-need-regulatory-attention/.

Guang-Zhong Yang, et al., Medical robotics – Regulatory, ethical, and legal considerations for increasing levels of autonomy(Mar. 15, 2017), Science Robotics, http://robotics.tch.harvard.edu/publications/pdfs/yang2017medical.pdf.