Tag:

Regulation

FDA Issues Warnings Regarding E-Cigarettes

On Wednesday, September 11, 2019, the Trump Administration issued a statement regarding the recent outbreak of illnesses and deaths related to the use of electronic cigarettes (“e-cigarettes”). Soon after, the Food and Drug Administration (“FDA”) quickly followed suit. The Trump Administration’s statement comes after reports of 380 cases of lung illness associated with the use of e-cigarettes in 36 states, in addition to 7 deaths. Both political parties have pressed for flavor bans, age restrictions, and other restrictions on the sale of vaping products. They have urged the FDA to move quickly and decisively to investigate and regulate e-cigarettes. E-cigarettes have been touted by manufacturers as a way to wean people from traditional cigarettes but have recently led to an “epidemic” of youth vaping of nicotine. E-cigarettes are popular among teens due to their availability, advertisements, e-liquid flavors, and the belief that they are safer than cigarettes. The long-term risks of vaping are currently unknown, but a growing numbers of studies show that e-cigarette vapor has severe health risks, including damaging lung tissue and blood vessels.

Methane Emission Regulation Newest Proposed Target for EPA Rollbacks

On August 29, 2019, the Environmental Protection Agency (“the EPA”) announced a proposed reconsideration amendment to an Obama Administration rule regulating the natural gas industry’s methane emissions. This proposal is in response to President Trump’s order for federal agencies to review their actions, purportedly to remove potential resource burdens. The EPA asserts that the changes will remove regulatory duplication and save the industry millions of dollars, but the savings may come at the expense of increasing the planet’s vulnerability.

When the American Dream Causes an American Nightmare

At first, the story of John Kapoor’s rise to the top of the pharmaceutical industry sounds like the American dream played out in real life. The first to attend college in his family, Kapoor graduated from Bombay University in India with a degree in pharmacy. He came to the United States after securing a fellowship at the University of Buffalo, and earned his Ph.D. in 1972. His scientific and business savvy was evident from the start – in a matter of a decade, Kapoor took over a struggling pharmaceuticals business, turned it around, and netted a personal gain of $100mm. From there Kapoor became a serial entrepreneur, with INSYS Therapeutics marking the pinnacle of his success. The company made him a billionaire, but later made him the target of a criminal racketeering investigation and the face of one of America’s darkest problems.

Regulating Artificial Intelligence – Is It Possible?

Artificial intelligence is all around us. Whether it exists in your iPhone as “Siri” or in complex machines that are detecting diabetic retinopathy, it is constantly growing and becoming a regular part of the modern day. As with any new technology, regulation surrounding artificial intelligence is becoming increasingly problematic. The question facing us now is how do we encourage further development without accidentally hindering its growth? Recently, the Food and Drug Administration has attempted to take steps toward further regulation of artificial intelligence by introducing a review process for medical artificial intelligence. This is just one instance of how regulation may affect the evolution of artificial intelligence.

Exploring COPPA through the FTC’s Complaint against TikTok

The Children’s Online Privacy Protection Act (“COPPA”) prohibits unfair or deceptive collection, use, and disclosure of the personal information of children on the internet. COPPA covers both website operators and app developers, and prevents collection of personal information without verified, written consent of parents. On February 27, 2019, the Federal Trade Commission (“FTC”) filed a complaint in U.S. District Court against TikTok, previously known as Music.ly. The complaint alleged that Music.ly knowingly violated COPPA when it collected data from children without written consent of parents. Music.ly settled for $5,700,000.00, the largest civil penalty obtained by the FTC for violations of COPPA.

FCPA Establishes Corporate Regulation of Text Messaging Apps

On March 12, 2019, the Department of Justice (“DOJ”) announced revisions of the Corporate Enforcement Policy in the Foreign Corrupt Practices Act. The changes now require company oversight of ephemeral messaging apps used by any employee, stock holder, or agent who discusses business records via the messaging platform. Publicly traded companies must now establish internal compliance policies to review use of ephemeral messaging services, provide ongoing oversight of the messaging services, and may want to completely prohibit the use of such messaging apps for business purposes.

How Will Recreational Marijuana Impact Illinois? 

During Governor-elect J.B. Pritzker’s election campaign, he heavily advocated for Illinois to be more accommodating to recreational marijuana usage. In Illinois, medical marijuana has already been legalized, and new bills are being introduced to make it more accessible. If recreational marijuana is legalized, Illinois will join ten states, and the District of Colombia, in its authorization.

Regulating the Un-Explainable: The Difficulties in Regulating Artificial Intelligence

From Siri to Alexa, to deep learning algorithms, artificial intelligence (AI) has now become commonplace in most peoples’ lives.  In a business context, AI has become an indispensable tool for businesses to utilize in accomplishing their goals. Due to the complexity of the algorithms required to make quick and complex decisions, a “black box problem” has emerged for those who utilize these increasingly more elaborate forms of AI. The “black box” simply refers to the level of opacity that shrouds the AI decision-making process. While no current regulation explicitly bans or restricts the use of AI in decision making processes, many tech experts argue that the black box of AI needs to be opened in order to deconstruct not only the technically intricate decision-making capabilities of AI, but the possible compliance-related problems this type of technology may cause.

“Grounding”: Federal Regulation in the Context of Aircraft Suspensions

On March 10, 2019, Ethiopian Airlines Flight 302 en route to Nairobi, Kenya crashed shortly after take-off leaving no survivors. It became the carrier’s most deadly crash and its first fatal crash since January 2010. Most notably, however, it was the second fatal crash involving Boeing’s new 737 MAX jet in less than five months after the Lion Air Flight 610 accident in October 2018. The day following the tragedy, Ethiopian Airlines grounded all of its Boeing 737 MAX 8 fleet until further notice. Many other airlines suspended operations of the aircraft as well and countless countries banned the 737 MAX from airspace.

Data Privacy Rules Step Up to the Next Level

The Federal Trade Commission (“FTC”) recently proposed two amendments to the Privacy Rule and Safeguards Rule under the Gramm-Leach-Bliley Act (“GLBA”). The Safeguards Rule requires financial institutions to develop, implement, and maintain a comprehensive information security system. This rule went into effect in 2003. The Privacy Rule requires financial institutions to inform customers about its information-sharing practices and allows customers to opt out of having their information shared with certain third parties. This rule went into effect in 2000. The recent amendments to these two rules are intended to further protect consumers’ data from third parties. However, the changes could also adversely affect businesses.