Blog Post

By: Elizabeth K. Harraka

Descovy is a new HIV prevention drug, created by Gilead pharmaceuticals, that the FDA recently approved for use by cisgender men and transgender women. This is the second drug of its kind available in the United States, the first being Truvada which is also sold by Gilead. These two drugs are categorized as PrEP, pre-exposure prophylaxis, which is an HIV prevention plan that requires a daily dosage of the drug to prevent contracting the disease before exposure. The ability to present options for patients to choose from is a success for continuing efforts to reduce HIV rates. However, the road to Descovy’s approval was not without criticism and controversy.

The FDA, an administrative agency, published a notice for the pending approval of the drug in the Federal Register. They scheduled a comment hearing on August 7, 2019. The notice and comment period are a requirement for informal rulemaking in administrative agencies. Gilead is a pharmaceutical company that must abide by the rules and policies set by the FDA. The notice and comment period are necessary so that the public may voice any concerns or issues regarding the proposed rule. There is no limit to the number of comments allowed; agencies are expected to listen and incorporate comments that would improve the rule to better serve the public’s health and safety. The hearing granted advocates and other various health organizations a venue to voice requests and raise concerns regarding Descovy and its impending FDA approval.

One main concern raised at the hearing was that Gilead wanted to infer the result by extrapolating data from other testing so that Descovy could be approved for use by cisgender women. Gilead proposed this idea because they never conducted their test trials to include women. People spoke out against this because there is no definite understanding of the drug effects in women long-term. The committee held a vote as to whether they should take the Descovy trial testing data and other PrEP data to extend the approval to use by women. The committee voted 10-8 against extending Descovy approval to women’s usage before conducting trial testing. Those who voted against its use were worried about setting a precedent that the FDA did not always have to conduct thorough and proper drug testing to get approval. Those who voted in favor considered that equity balance between men and women and the number of PrEP drugs available to each group.

Gilead failed to test Descovy for women. Instead, they ran trials on men and transgender men only. Gilead simply should have conducted testing on women as well. The company stated that the percentage of female patients is only 10%. This is a low percentage but that does not mean that these women should not have access to or be completely excluded from potential health treatments. Gilead also said that they tested only men so that the drug could be approved sooner.

The second issue raised at the hearing was that Gilead overstated the success and safety of Descovy over Truvada. Many people thought that Gilead exaggerated to ensure their profits and maintain customers once generic cheaper versions of the medication become available next year. Advocates and medical professionals questioned the degree to which Gilead touts the benefits of Descovy by pushing the new drug onto patients who currently take Truvada. They worry Gilead is over-hyping the safety of Descovy and the “minimal impact” on kidney and renal toxicity that the company says is much better than Truvada. Gilead seems to insinuate that Descovy is the safest prescription option. Many people think that the pharmaceutical company is doing this as a business practice so that patients continue paying for one of their products. Next year a rival pharmaceutical company will put out a generic version of Truvada on the market that will likely cost less than the current price. Truvada currently runs about $20,000 a year and Descovy will cost the same amount.

At the public meeting, one advocate group demanded a cost reduction of Descovy to $1 per pill (currently, each pill costs about $60). The exact price demand was dropped, but constant criticism remains regarding the costs of PrEP. Many people have questioned the motives behind Gilead’s actions and their ethical duty to provide medicine to individuals regardless of gender or income. While most insurance and healthcare providers cover the cost of PrEP, advocates worry that the company may create a stigma that the expensive drug is better and more effective than the cheaper drug.

The approval process for Descovy by the FDA highlights the informal rulemaking process. Agencies conduct rulemaking this way so that the public can be involved and so that the rules passed by agencies best serve the public by protecting our health and safety. Advocate groups and foundations, doctors and individual citizens were able to critique and voice potential solutions to issues regarding Descovy’s trial testing and costs. Without the public forum to hear multiple opinions, the FDA committee may have gone ahead and voted in favor of Gilead’s request to approve Descovy for women without ever conducting proper testing. Thankfully, the committee voted against this decision and understood that it would be too big of a risk to the public. The committee listened to the public’s request and the FDA issued a requirement that Gilead conduct a post-market study that will include women. Hopefully the company is receptive to the comments regarding the price of the pill and reduces the cost.

 

 

 

 

Sources:

Andrew F. Popper et al.,Administrative Law: A Contemporary Approach (3d ed. 2016).

Apoorva Mandavilli, F.D.A. Approves New H.I.V.-Prevention Drug, but Not for Cis-Gend Womener, N.Y. Times,(Oct. 8, 2019), https://www.nytimes.com/2019/10/04/health/fda-descovy-truvada-hiv.html.

Harron Walker, Congrats to Big Pharma on Finding a New Way to Profit Off of HIV Prevention, Vice(Oct. 4, 2019), https://www.vice.com/en_us/article/wjw4qn/descovy-prep-hiv-prevention.

Kyle Blankenship, Gilead called on to ‘significantly cut’ HIV med Descovy’s price in PrEP,FiercePharma(Oct. 7, 2019), https://www.fiercepharma.com/pharma/a-1-pill-gilead-called-to-significantly-cut-price-hiv-aids-med-descovy.

Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 84 Fed. Reg. 121, 29521 (June 24, 2019).

Post-Marketing Pediatric-Focused Product Safety Reviews; Establishment for a Public Docket; Request for Comments, 83 Fed. Reg. 181, 47177, 181, 47178 (Sept. 18, 2018).

FDA Panel Issues Split-Decision for Gilead’s HIV Prevention Drug, Drug Indus. Daily, Aug. 8, 2019.

Gilead’s Proposed PrEP Drug Sparks Data Extrapolation, Cost Concerns, Inside Health Reform, Aug. 14, 2019.

 

By: Jacqueline Chilbert

Tech giants and online industry leaders have come under great scrutiny in the past few years, every move seems to be followed by political unrest. But recent changes in legislation have forced the companies to become more creative in their practices while also being more transparent.

Technology giants, like Amazon, Google and Apple have rolled out several new Artificial Intelligence technologies in the past 5 years and are constantly announcing the newest edition of each of these products, but what are we sacrificing when we feed into this phenomenon?

While privacy has been a growing concern, there are more issues behind the scenes. Recently many states have begun investigations into potential anti-competitive behaviors of these tech companies. For example, Facebook has a newly launched dating site. This site has not been proven better or of greater quality, but the fear is that the data collection Facebook uses from profiles and ads, mixed with their intense reach of over a quarter of the population, they will prevent small start-ups from launching and may even diminish the use of current dating apps solely because the Facebook name is so well known and already has widespread use.

Google has also faced scrutiny in this call for revolution. There has been a call for action and investigation by 48 states who are fearful of Google’s influence and dominance. Texas Attorney General noted the company is threating the structure of the economy “as they dominate the buyer side, the seller side, the auction side, and even the video side with YouTube.” Google provides ‘free’ services to consumers, why would they not take advantage of them. The dilemma is these seemingly free services track usage and data to help set prices and influence the supply of goods. Almost 60% of digital advertising is controlled by Google and Facebook. This forces companies who want to advertise online to abide by any terms, conditions, and prices, the two major companies set.

Democratic candidate, Elizabeth Warren, has taken a forward stance on regulating the technology giants, when she “called for breaking up Amazon.com Inc., Facebook Inc. and Alphabet Inc,” and accused the companies of undermining democracy. It is likely that technology companies will come under even more scrutiny and will find themselves at the top of the reform “list” for many candidates in the wake of the coming elections.

Taking a look at these concerns beyond the United States, Europe has also taken great strides to combat the giant technology companies. Europe is known for their strict and expressed rights to privacy which guarantee much more protection to an individual than the implied privacy rights of the United States. The Court of Justice of the European Union, the equivalent of the U.S. Supreme Court, has just ruled that Facebook must take down slanderous and defamatory content from their site and remove all access to that information around the world.

However, Google still brought home a win for tech companies in another case where the court ruled that Europe’s rights cannot be extended beyond the European countries recognizing that individual rights in other countries may not be as expansive.

This court opinion emphasizes the need for regulation of the internet industry and with technology companies alike but also shows the difficulty of regulating companies who have a world-wide reach. When countries around the world have different standards for internet usage it is difficult to find neutral, all-inclusive regulations that will make a difference in practice.

The growing concerns for the dangers of anticompetitive behavior and privacy are not only coming from government perspectives but, Brad Smith, current Microsoft President has recently come out to warn of the dangers that lack of regulation on the tech industry can have on democracy. “If public leaders don’t… the Internet giants will cannibalize the very fabric of this country.”

There is a fine line to be found in these concerns. Does society want the best experience and use of technology, or does it want their right to privacy and fair competition protected? Tech companies have argued that the best way to keep the products to the highest standard and available to all is through the collection of user data. But by consumers use of these products they are consenting to an infringement of privacy. The companies also argue that their wide reach allows them to combat the concerns of misuse because there are clear communication channels between the services.

As the 2020 election approaches, the concerns voiced will only become more prominent. It is evident that anti-competitive behaviors and private data collection will remain at the forefront of political and legislative conversations. It will be interesting to see where many of these investigations go and whether the companies will be able to maneuver to stay steps ahead.

Cites:

Aarti Shahani, Microsoft President: Democracy Is At Stake. Regulate Big Tech, NPR Business (Sept, 13, 2019), https://www.npr.org/2019/09/13/760478177/microsoft-president-democracy-is-at-stake-regulate-big-tech

Andy Kroll, The Future of Election Meddling Is Americans Versus Americans, RollingStone Politics (Sept. 3, 2019), https://www.rollingstone.com/politics/politics-features/trump-election-interference-deepfake-instagram-whatsapp-879531/

Bill Chappell, ‘Right to be Forgotten’ Only Applies To Websites Inside EU, European Court Says, NPR Technology (Sept. 24, 2019), https://www.npr.org/2019/09/24/763857307/right-to-be-forgotten-only-applies-inside-eu-european-court-says

Chris Isidore, Hanna Ziady, A court ordered Facebook to take down a post. The decision could affect social media around the world. CNN Business (Oct. 3, 2019), https://www.cnn.com/2019/10/03/tech/facebook-eu-court/index.html

David Shepardson, Elizabeth Culliford, UPDATE 4-Facebook’s Zuckerberg says Warren as U.S. president would be bad for tech, CNBC Wires (Oct. 1, 2019), https://www.cnbc.com/2019/10/01/reuters-america-update-4-facebooks-zuckerberg-says-warren-as-u-s-president-would-be-bad-for-tech.html

Jennifer Liberto, Avie Schneider, Is Facebook Too Big? State Attorneys General Want To Know, NPR Technology (Sept. 6, 2019), https://www.npr.org/2019/09/06/758232704/is-facebook-too-big-state-attorneys-general-want-to-know

Julian Barnes, Adam Goldman, F.B.I. Warns of Russian Interference in 2020 Race and Boosts Counterintelligence Operations, The New York Times (Apr. 26, 2019),
https://www.nytimes.com/2019/04/26/us/politics/fbi-russian-election-interference.html

Katie Collins, EU can order Facebook to remove illegal content worldwide, court rules, MSN News, (Oct. 3, 2019), https://www.msn.com/en-us/news/technology/eu-can-order-facebook-to-remove-illegal-content-worldwide-court-rules/ar-AAIdFY9

By: Viviana C. Bro

The advent of the automobile turned city streets into havoc. Records from the early 1900s reveal countless hit-and-runs, the running over of children playing on the streets, and even the stoning of reckless motorists. The increasing number of vehicles, combined with a lack of regulation and enforcement, recklessness and intoxication has created a chaotic environment.[1]By the mid-1920s, however, the government had introduced a national, uniform approach to street and highway safety. This action brought order and security, and spurred the creation of a system of national and state roads that has been connecting people across the country ever since. This system has also been crucial to our nation’s economic development.[2]Echoing the early days of the automobile, public, private and governmental entities are actively engaged in developing a cogent aerial traffic management system for Unmanned Aerial Vehicles (“UAVs”), also known as “drones.”

Congress has vested on the Federal Aviation Administration (“FAA”) the exclusive authority to regulate airspace use, including the creation of plans and policy for the use of navigable airspace, assuring its efficient use and the safety of aircrafts. To that effect, the FAA “prescribe[s] air traffic regulations on the flight of aircrafts, including regulations on safety altitudes” intended to protect people and property on the ground. It also assists with navigation and identification of aircrafts, and helps prevent collision between aircrafts and land or water

vehicles, and aircrafts and other airborne objects.[3]Since UAVs are categorized as aircraft, their

operation falls under FAA control.

In the last couple of years, UAVs have increased dramatically in number as well as complexity. Regulation, on the other hand, has lagged behind. Currently, the operation of commercial drones, drones that are used for work or business, is controlled by 14 CFR part 107. Some of the most salient elements of this piece of legislation confine drone activity to daylight hours, impose an altitude restriction of below 400 feet, limit speeds to less than 100 mph, and require visual line of sight. Additionally, drone operators have to obtain a drone pilot certification. To request exceptions to these rules, operators have to apply for waivers, which are not guaranteed, and can take months for approval.Understandably, the public and business community have clamored for meaningful and comprehensive regulation that better aligns with ever-evolving drone technology, and is able to support the economic expansion of UAVs.

Recognizing this imperative, the government has deployed several initiatives. One of them, the Unmanned Aircraft System Traffic Management (“UTM”) is charged with investigating, developing and testing UAV operations within the shared navigable airspace.[4]

The UTM is led by NASA, which has partnered with the FAA, other federal agencies, as well as academic and commercial entities, to design a system that will manage drone traffic.[5]More specific goals include the creation of a concept of operation, determining data exchange requirements, and delineating a framework to enable operation of multiple UAVs at low altitudes, beyond visual line of sight, and without the support of air traffic services.[6]The UTM research findings will also inform future regulation. Once delineated, approved and implemented, the UTM system “will be separate from but complementary to the traditional FAA air management system.”[7]

Ancillary to the UTM is the UTM Pilot Program (“UPP”). This program is designed to provide proof that the UTM system, now in research and development stage, is operational and suitable for deployment.[8]Its mandate is to advance the safe integration of UAVs into the national airspace, and provide an informed understanding of the functional specifications for UTM deployment, and assessment of the investment requirements to bring the UTM system into reality. As of January of 2019, the Department of Transportation had identified three FAA UAS test sites to participate in the UPP: Nevada Institute for Autonomous Systems, Northern Plains UAS Test Site, and Virginia Tech, Mid Atlantic Aviation Partnership. The UPP final report is expected by the end of 2019.[9]

Another recent initiative is the Unmanned Aircraft Systems (UAS) Integration Pilot Program (IPP). Operating under the auspices of the Department of Transportation, this initiative has partnered the FAA with 10 local, state and tribal governments selected from a nation-wide pool of applicants. The selectees will join forces with private sector participants to explore the further integration of drone operations. The data to be gathered from this pilot project will be

used to inform a new regulatory framework for the safe integration of drones into the nation’s airspace.[10]

These initiatives matter because they represent steps toward some meaningful systems and regulation. The public and the business sector seek clarification and guidance as concerns surge due to increased drone activity. Without guidance, there is speculation, misinformation and economic stagnation as businesses are unwilling to develop and invest in technologies that may become unfeasible once legislation is enacted.

Other countries seem to share this sentiment. A research paper that analyzed current legal frameworks for drone operation across the world reveals various levels of drone regulation, with an emphasis on avoiding harm to other aerial vehicles, as well as people and property on the ground. The study also claims that the current state of regulation inhibits research and development as well as innovation because legislation straggle behind drone technology, which negatively impacts scientific projects.[11]

Unquestionably, implementing a UAV traffic management system is a monumental challenge. Such a system must overcome enormous logistical and practical considerations prior to becoming operational. Issues such as privacy concerns, safety of air space, remote-tracking of drones, and financing of operations are overwhelming, and tend to lead to execution paralysis. Under these circumstances, it is encouraging to see drone initiatives that engender collaboration among the government, the public and the private industry. These partnerships can only move us closer to a UAV traffic management system, and development of relevant regulations.

In the early part of the last century, the automobile surged like an unstoppable wave, and forced the government, and community at large to act in unison with admirable results. Once again, the nation grapples with a formidable technology that has the potential to reshape commerce and travel. As in the past, we must embrace the challenge and seize the opportunity to forge a lasting traffic management system and infrastructure capable of nourishing drone technology expansion, and unlocking its full economic potential.

 

 

 

 

[1]Bill Loomis, 1900-1930: The years of driving dangerously, The Detroit News (April 26, 2015), https://www.detroitnews.com/story/news/local/michigan-history/2015/04/26/auto-traffic-history-detroit/26312107/.

[2]Contributions and Crossroads Timeline, U.S. Department of Transportation Federal Highway Administration, https://www.fhwa.dot.gov/candc/timeline.cfm.

[3]  State and Local Regulation of Unmanned Aircraft Systems (UAS) Fact Sheet, Federal Aviation Administration Office of the Chief Counsel (Dec. 17, 2015), https://www.faa.gov/uas/resources/policy_library/media/UAS_Fact_Sheet_Final.pdf.

[4]Remarks Prepared for Delivery by U.S. Secretary of Transportation Elaine Chao, Transp. Research Board Annual Meeting, D.C., U.S. Dep’t of Transportation, (Jan. 14, 2019), https://www.transportation.gov/briefing-room/transportation-research-board-annual-meeting-washington-dc.

[5]FAQs: NASA’s Drone Traffic Management Research in Reno and Corpus Christi, NASA(May 21, 2019) https://www.nasa.gov/feature/ames/faqs-nasa-s-drone-traffic-management-research-in-reno-and-corpus-christi

[6]Unmanned Aircraft System Traffic Management(UTM), Federal Aviation Administration, https://www.faa.gov/uas/research_development/traffic_management/(last updated Feb. 1, 2019).

[7]Remarks Prepared for Delivery by U.S. Secretary of Transportation Elaine Chao, Transp. Research Board Annual Meeting, D.C., U.S. Dep’t of Transp., (Jan. 14, 2019), https://www.transportation.gov/briefing-room/transportation-research-board-annual-meeting-washington-dc.

[8]Frequently Asked Questions,Federal Aviation Admin., https://www.faa.gov/uas/research_development/traffic_management/utm_pilot_program/media/UTM_Pilot_Program_Information.pdf

[9]Id.

[10]U.S. Transportation Secretary Elaine L. Chao Announces Unmanned Aircraft Systems Integration Pilot Program Selectees(Press Release), Federal Aviation Admin., (May 9, 2018), https://www.faa.gov/news/press_releases/news_story.cfm?newsId=22755.

[11]Claudia Stoker et al., Review of the Current State of UAV Regulations, MDPI,(May 9, 2017), https://www.mdpi.com/2072-4292/9/5/459/htm.

By: Ashley Robinson

What is vaping? According to the Center on Addiction, “vaping is the act of inhaling and exhaling the aerosol, often referred to as vapor, which is produced by an e-cigarette or similar device.” Vaping is different from smoking in that e-cigarettes do not produce tobacco smoke; they produce an aerosol that consists of fine particles. E-cigarettes were introduced to the mass market in the United States in 2007 and variations of these e-cigarettes have been developed including vape pens and advanced personal vaporizers (MODS).
These various vaping devices generally work in the same way, with a battery that heats up the heating component which then turns the contents of the e-liquid into an aerosol that is inhaled into the lungs and then exhaled. The e-liquid originally contained propylene glycol or vegetable glycerin-based liquid with nicotine, flavoring and other chemicals, and metals. These devices do not contain tobacco.
The device that has been the current topic in many recent news stories is the JUUL. The JUUL is a vaping device that resembles a USB computer flash drive. This device has become increasingly popular with middle and high school students due in part to the variety of flavored e-liquid as well as the easy to hide design.
The original JUUL pods, the component that contains the e-liquid, contained nicotine. Recently, it has been discovered that people are creating THC -laced liquid to be used for vaping. There is a growing black-market for vaping products that is slowly being uncovered with drug busts, such as the one this month in Wisconsin. The police entered a house in a quiet suburban subdivision where they found slim boxes of flavored vaping cartridges. Next to these full cartridges, they found about 98,000 more empty cartridges with 57 mason jars nearby with THC-laced liquid to be used for vaping. These black-market JUUL accessories are popping up all around the country and serving customers their products online, in the streets, in pop-up stores, and even individual transactions that have been arranged through social media. All generations of buyers seem to overlook an important question, where did this accessory come from. They are not concerned with the source of their accessories, but they should be.
These contaminated THC-based vape cartridges are sold out of what are called “pen factories.” These factories buy empty vape cartridges and counterfeit packaging, and then fill them up with contaminated THC-based liquid and sell them. These cartridges may not necessarily be a health risk but for the practice of “cutting the product,” which is what occurs in other illegal drug operations to increase profit margins. The public health authorities have identified some cutting agents that may be the cause of the lung illnesses that have recently occurred. Vitamin E acetate, if not heated completely, can cause breathing problems and lung inflammation. Unfortunately, some people may not even realize that they are purchasing “contaminated” cartridges. These cartridges can come prepackaged in packaging that mimics legal vaping products. In states where THC is legal, these products end up on the market and can be sold under the guise of being legal and safe.
There have been close to 500 cases of lung illness and six deaths that have been linked to vaping so far. These numbers are staggering and due to this there is a large push to ban vapes, or at least ban flavored e-liquid. Many people believe that banning the flavored e-liquid would discourage minors from using these products. In early September, the Trump administration stated that it was going to ban the sale of most flavored e-cigarettes. The Food and Drug Administration (FDA) is working to outline a plan in the next few weeks to remove these flavored e-cigarettes and nicotine pods from the market. Some states have taken it upon themselves to ban the sale of flavored e-cigarettes. Although it seems like the number of teens using these products has actually increased recently, the FDA, the CDC, and the Trump administration are moving forward with bans and programs that are aimed at helping to decrease the number of people, especially teens, using e-cigarettes.

Citations:
1. Linda Richter, What is Vaping?, CENTER ON ADDICTION (Oct. 2018), https://www.centeronaddiction.org/e-cigarettes/recreational-vaping/what-vaping.
2. Julie Bosman and Matt Richtel, Vaping Bad: Were 2 Wisconsin Brothers the Walter Whites of THC Oils?, THE NEW YORK TIMES (Sept. 17, 2019), https://www.nytimes.com/2019/09/15/health/vaping-thc-wisconsin.html.
3. Matt Richtel and Denise Grady, Cases of Vaping-Related Lung Surge, Health Officials Say, THE NEW YORK TIMES (Sept. 11, 2019), https://www.nytimes.com/2019/09/06/health/third-death-vaping-related-disease.html?action=click&module=RelatedLinks&pgtype=Article.
4. Sheila Kaplan, Trump Administration Plans to Ban Flavored E-Cigarettes, THE NEW YORK TIMES (Sept. 11, 2019) https://www.nytimes.com/2019/09/11/health/trump-vaping.html?module=inline.

Landmark Data Privacy Legislation Serves as a Benchmark in a Rapidly Shifting Legal Landscape

By: Kevin Bampoe

Almost everyone has experienced the phenomenon of being bombarded with advertisements on social media for something they were thinking about only moments before. Search queries in search engines such as Google, Bing, or Yahoo are used to generate content and advertisements on unaffiliated sites and platforms including Facebook, Instagram, Amazon, YouTube and eBay almost instantaneously. This seemingly mysterious ability for advertisers to know exactly what a consumer wants, and when they want it, relies on the Wild Wild West-like data privacy regulation landscape in the U.S. and a lack of policy and legislation aimed at safeguarding consumers’ interests. Tech companies gather, store, and even sell human behaviors and preferences, a business model which has generated billions of dollars in ad revenue. California believes enough is enough and that consumers have a right to own and control their data as well as hold companies responsible for protecting their data and liable for failing to do so.

Last year the General Data Protection Regulation (GDPR) went into effect August 2018 and with it a large number of data privacy-related requirements and high fines for failure to comply. Currently in the United States there is a mess of laws enacted on both federal and state levels targeting a certain industry, activity, or type of data but no comprehensive privacy regulation policy. With the enactment of the GDPR came a shift in data privacy regulation and the first major piece of legislation in the United States, the California Consumer Privacy Act of 2018 (CCPA). The GDPR has been highly regarded since its approval and serves as a wake up call to the industry. Its impact has already reached far beyond the EU indicating a shift in priorities and willingness to legislate to protect individual rights.

In June 2018 California Governor Gavin Newson approved the CCPA which the American Bar Association considers “the absolute toughest data privacy law in the United States.” The basic mechanism of this legislation is a consumers’ ability to make requests to any business making more than $25 million in revenue, that buys or sells personal information of 50,000 consumers or more, or derives 50% or more of its revenue from the sale of consumer personal information and under the Act. This would apply to companies both within and outside the state of California. These requests embody four basic rights of the legislation: the right to know which entails requesting and the disclosure of how their data is being used, who it is being sold to, the right to opt-out of allowing businesses to sell their personal information, the right to receive equal service and pricing from businesses as to prevent companies from utilizing consumer data for targeted pricing, and the right to ask that their data be deleted.

An example highlighting the need for legislation such as this is how Facebook users do not control the data which Facebook collects and then sells. Even after deleting your Facebook account Facebook retains the data collected, continuing to utilize and sell it for their own interests. This legislation will finally give users the ability to compel Facebook to disclose how their information has been used and with whom it has been shared, opt-out of having their data sold, to delete all of their information which has been collected and to bring litigation should Facebook fail to comply.

With the CCPA going into effect on January 1, 2020 experts are waiting to see how this will affect consumer data collection practices by companies and whether consumers will actually utilize this legislation. Not everyone is patiently waiting as there are 17 other states that have recently introduced their own legislation aimed at protecting consumer data privacy and using the CCPA as a framework.

In June, the Maine Act to Protect the Privacy of Online Customer Information was approved, which when effective will prohibit broadband internet access service from using, disclosing, selling or permitting access to personal customer information without the customers express consent. The New York Privacy Act requires companies to disclose their methods of de-identifying personal information, to place safeguards around data sharing, and to allow consumers to obtain the names of all entities with whom their information has been shared. Nevada, Pennsylvania, Massachusetts, Hawaii, and Maryland have also introduced comprehensive legislation and Texas is updating their current policy as well. While not identical to each other they share common principles, supporting the belief that this jurisdictional-based trend will continue to expand, leading to calls for a comprehensive national or even global approach to privacy.

This new wave of legislation isn’t the only sign of change on the horizon.  On September 4, 2019 Google settled complaints against them by the Federal Trade Commission and the New York Attorney General for failing to obtain parental consent in collecting data on kids under 13. Google agreed to pay $170 million in fines and to limit ads on kids’ videos, making it one of the most significant enforcement actions against a big technology company in the U.S. This represents policy makers’ focus on privacy and antitrust of big internet platforms that have enjoyed few regulatory constraints up until now.

Google isn’t the only recent target of the FTC for Children’s Online Privacy Protection Act (COPPA) violations with other companies including Facebook are under scrutiny for failing to acquire parental consent when dealing with minors. A popular app, TikTok, was fined $5.7 million earlier this year for similar claims of failure to obtain parental consent  prior to collecting names, email addresses, and similar information from children under 13. This is not the first time complaints such as this have been settled with the FTC. Back in 2014 Google settled with the FTC for its failure to obtain parental consent for charges by children playing mobile games. Apple agreed to settle and changed its billing practice after similar complaints. Yelp also paid for allegations that they failed to test their age-registration feature on its app by collecting information from children as young as 9 without parental consent.

These changes are all waves resulting from the big splash the GDPR made when enacted last year in the EU. This, along with the political reaction to the fact that personal data has been used to persuade voters without their knowledge or consent, and the growing discontent with big data companies storing and selling significant amounts of personal data has led to a demand for consumer privacy protections and the ability to hold big data companies accountable. The GDPR gave California and other states a framework to draft their comprehensive legislation but all narrower in scope. The GDPR is based upon the principles of notice, consent, and establishing a legal basis for personal data collection. The overall EU approach to data privacy recognizes each individual has rights to their personal data and obligates those who collect, store and process this data to provide and protect said rights.

The GDPR gives one a right to access personal data held about them, a right to have inaccurate personal data rectified, a right to require one to erase personal data held, a right to restrict processing of personal data, a right to receive personal data and have it transferred to a third party, a right to object to the processing of one’s personal data, and a right to withdraw consent. The CCPA on the other hand does not require companies to transfer consumer’s personal data to another entity nor the right to obligate companies to correct inaccurate or incomplete information but it does give consumers a private right of action with statutory damages between $100-$750 per person, per incident when data has been breached.

After Google was fined $57 million for failing to properly disclose to users how data is collected across its services, including its search engine, Google Maps, and YouTube, to offer personalized advertisements the whole world took notice. Now with this recent  settlement for COPPA violations and the CCPA going into effect January 1, 2020 it is clear that the days of the Wild Wild West are rapidly coming to a close but what the future of data privacy regulation looks like is uncertain. This is only the beginning and while big data companies rush to ensure compliance they, and their lobbyists, won’t go down without a fight.

Citations

Kartikay Mehrotra, Laura Mahoney, Daniel Stoller, Google, Industry Try to Water Down First U.S. Data-Privacy Law, Bloomberg News(Sep. 4, 2019), https://www.bloomberglaw.com/document/XFM55GKC000000?bna_news_filter=tech-and-telecom-law&jcsearch=BNA%25200000016cfbb4dc83a5fffbfc213e0000#jcite

Tightening Government Privacy Laws Presents Challenges to Online Marketers, Yahoo News(Sep. 3, 2019), https://finance.yahoo.com/news/tightening-government-privacy-laws-presents-193000628.html

Shalina Chatlani, What California’s New Data Privacy Law Means For You, KPBS News(Sep. 5, 2019), https://www.kpbs.org/news/2019/sep/05/californias-new-data-privacy-law-what-it-means-you/

Dom Nicastro, Examining Where 8 US States Stand on Consumer Data Privacy Laws, CMSWire(Aug. 30, 2019), https://www.cmswire.com/customer-experience/examining-where-eight-us-states-stand-on-consumer-data-privacy-laws/

Wes Rapaport, Updates to Texas Digital Privacy Laws Take Effect, KXAN (Sep. 5, 2019), https://www.kxan.com/news/texas-politics/updates-to-texas-digital-privacy-laws-take-effect/

Ben Brody, Mark Bergen, Google to Pay $170 Million for YouTube Child Privacy Breaches, Bloomberg News(Sep. 04, 2019), https://www.bloomberglaw.com/document/X1S3OIA4000000?bna_news_filter=tech-and-telecom-law&jcsearch=BNA%25200000016cfc69dc83a5fffcf946130000#jcite

Robert Bowman, David Stauss, A Look At US Data Privacy Laws 1 Year After GDPR, Law360(Jun. 21, 2019), https://www.law360.com/articles/1170562/a-look-at-us-data-privacy-laws-1-year-after-gdpr

Adam Satariano, Google Is Fined $57 Million Under Europe’s Data Privacy Law, The NY Times(Jan. 21, 2019), https://www.nytimes.com/2019/01/21/technology/google-europe-gdpr-fine.html

Dr. Rao Papolu, In The Wake Of GDPR, It Can’t Be Business As Usual With Consumer Data Privacy, Forbes (Sep. 18, 2018), https://www.forbes.com/sites/forbestechcouncil/2018/09/18/in-the-wake-of-gdpr-it-cant-be-business-as-usual-with-consumer-data-privacy/#20a6d7fd61fb

By: Dejaih Johnson

With February being Black History Month, I find this is a great opportunity to look at a brief history of the U.S. patent system and some of the African American inventors, innovators, and scientists who have helped shape American innovation.

The history of patents in America is older than the U.S. Constitution. Prior to the Constitutional Convention, colonies would grant patents in solidarity. After 1787, the patent process was opened up to the people by what is now the Patent Copyright Clause of the Constitution. Though on its face race-neutral, the patent system did not apply for Black Americans born slaves since laws prohibited slaves from applying for or holding property. As a form of intellectual property, this included patents. In 1857, the U.S. commissioner for patents officially ruled that inventions by slaves could not be patented and were without protection.

Without a patent system, you cannot have innovation. Patents allow inventors to exercise a monopoly over their invention. Patents also allow inventors to make money from their patent by selling it or licensing it out for use by another party. Thus, the inability for slave inventors to be granted a patent for their inventions was detrimental during times where the American economy was experiencing rapid growth.

Although the laws prevented slaves from owning patents, that did not stop them from inventing. Often times, slave owners took credit for their slaves’ inventions through laws that said the “[slave master] is the owner of the fruits of the labor of the slave both manual and intellectual.” But Black inventors continued to provide major contributions. On March 3, 1821, Thomas Jennings became the first African-American inventor to be granted a patent for a process we now call “dry cleaning”. Definitively able to receive the fruits of his labor, Jennings spent the remainder of his years as a civil rights activist and much of his earnings promoting abolitionist causes. A short time after, Elijah McCoy, a free man from Canada, invented an automatic lubricator for oiling the steam engines of locomotives and ships. Over his lifetime, McCoy obtained 57 patents, and this legacy has extended through the 21^st Century. Former Air Force and NASA engineer, Lonnie Johnson, currently holds over 100 patents with over 20 more pending. Johnson is most famously known for his invention of the Super Soaker water gun and has generated more than $1 billion in U.S. sales. But success does not stop short of women. In 2006, Janey Emerson Bashen became the first Black woman to receive a patent for a software invention, and Dr. Hadiyah Green recently won a $1 million grant related to an invention that may help treat cancer.

African Americans have played a vital role in shaping innovation in this country. The effects of which can be felt every single day in the U.S. and around the world. True to the legacy of American innovation, today’s Black inventors continue to follow in the footsteps of those who came before them, in honor of their struggle and misused and underappreciated labor.

Citations:

American’s always had black inventors – even when the patent system explicitly excluded them, The Conversation, (Feb. 19, 2017), https://theconversation.com/americas-always-had-black-inventors-even-when-the-patent-system-explicitly-excluded-them-72619.

Biography, Lonnie Johnson, https://www.lonniejohnson.com/biography/ (last visited Feb. 8, 2019).

Diversity in Innovation: African-Americans’ Impact is Forever Reaching, InvetorsDigest, (Mar. 21, 2018), https://www.inventorsdigest.com/articles/diversity-innovation-african-americans-impact-forever-reaching/.

Dr. Hadiyah Green Wants to Use Lasers to Kill Cancer Cells, NBC News, (Mar. 17, 2017), https://www.nbcnews.com/news/nbcblk/dr-hadiyah-green-plans-defeat-cancer-lasers-n741206.

Elijah McCoy, Wikipedia, (Feb. 8, 2019), https://en.wikipedia.org/wiki/Elijah_McCoy.

11 African American Inventors Who Changed the World, Mental Floss, (Feb. 6, 2018), http://mentalfloss.com/article/86923/11-african-american-inventors-who-changed-world.

By: Joseph Mallek

The next generation of wireless, internet technology is now being rolled out around the world. The next generation, known as 5G, will bring greater speed, a more responsive, and greater connectivity. Not only will this be available on smartphones capable of connecting to the new network but the 5G network will also change the way we connect to the internet in our homes. Experts have described the 5G network as a revolutionary step for internet technology.

With the new generation of the internet set to roll out across the United States and the world, hardware manufacturers are all competing to provide countries with the new 5G infrastructure. One of these manufacturers is China’s largest telecommunication’s producer, Huawei. Huawei has long been suspected by U.S. intelligence officials to have an extremely close relationship with the Chinese Government. Use of Huawei phones for Government employees and Government contractors has been banned by the Trump administration, out of fear of spying and the use of backdoors in phones. The same fear exists if Huawei is allowed to sell its hardware to 5G providers.

The Trump administration is putting pressure on not only domestic internet providers to not use hardware from Huawei or anything Chinese manufacturer. Described as a new arms race, whoever controls this new technology will have a significant economic, intelligence, and military advantage this century. To protect the security of the United States and its allies, the administration is moving quickly to prevent the sale of Huawei hardware.

Citations:

David E. Sanger, Julian E. Barnes, Raymond Zhong & Marc Santora, In 5G Race With China, U.S. Pushes Allies to Fight Huawei, The New York Times (Jan. 26, 2019), https://www.nytimes.com/2019/01/26/us/politics/huawei-china-us-5g-technology.html.

Sascha Segan, What Is 5G?, PCMag (Jan. 28, 2019), https://www.pcmag.com/article/345387/what-is-5g.

Michael Ken, Report: Trump to Ban Huawei Tech in US Wireless Networks, PCMag (Feb. 8, 2019), https://www.pcmag.com/news/366440/report-trump-to-ban-huawei-tech-in-us-wireless-networks.

By: Jacqueline Collins

As the growing problem of child sex trafficking has gained more attention from law enforcement and researchers, scientists have begun using artificial intelligence in order to find children and young women who are victims of this illegal practice. United States researchers from Temple University, George Washington University and Adobe launched an application in 2016 that collected photographs of hotels that could be matched with photographs used in online advertisements created by sex traffickers. These photographs collected through the application are contained in a database, called Hotels-50K.

While the original application and database made up of the collected photographs is for law enforcement use and view only, such as the National Center for Missing and Exploited Children, an additional application became open to the public and allows people from all over the world to download it and upload photographs of hotel rooms that they see in online sex trafficking advertisements. So far, over 50,000 hotels are contained within the database that has been collected from the use of this application, called TraffickCam. Out of the 50,000 hotels that are included in the database, 13,900 of them have corresponding photographs that came from people submitting them through the application. The artificial intelligence system uses algorithms in order to match up photographs found on websites like Expedia, with photographs that have been submitted by people trying to help fight sex trafficking.

While this is a significant step towards saving victims of sex trafficking, law enforcement agencies have admitted that it is uncertain if the database has directly saved anyone from the practice. With more people learning about the existence of the application, however, more people may become involved, increasing the number of hotels depicted on the database. One thing that was made clear by researchers and law enforcement is that they do not intend to use the information on this database in order to identify victims in the images. In fact, when they receive an image including a victim, the first thing that they do is delete the victim from the photograph, in order to protect the victim and reduce the likelihood that her picture will be sent back and forth online. Overall, although the direct results are unclear as to whether this database has saved any victims, researchers and law enforcement insist that there is a good-hearted motive behind it, and the goal is to save people who have fallen victim to sex trafficking.

Citations:

Dan Robitzski, Scientists are using AI to Find Hotel Rooms Being used for Child Sex Trafficking, Futurism (Feb. 11, 2019), https://futurism.com/ai-identify-child-trafficking-hotel-rooms.

Donna Lu, AI has helped rescue children trafficked for sexual exploitation, NewScientist (Feb. 12, 2019), https://www.newscientist.com/article/2193727-ai-has-helped-rescue-children-trafficked-for-sexual-exploitation/.

Jason Fields, Scientists use AI to help children sold for sex in hotels, Reuters (Feb. 11, 2019), https://www.reuters.com/article/us-usa-trafficking-ai/scientists-use-ai-to-help-children-sold-for-sex-in-hotels-idUSKCN1Q018K.

Katyanna Quach, How AI can help halt human sex trafficking – by identifying victim’s hotel rooms from pics, The Register (Feb. 5, 2019), https://www.theregister.co.uk/2019/02/05/ai_human_trafficking/.