Tag:Regulation
Skewed Success: Self-Regulation of Artificial Reproductive Technology in the US
In the United States, Assisted Reproductive Technology (ART) is predominantly self-regulated by a network of medical agencies that publish guidelines. ART refers generally to any fertility procedure where eggs or embryos are handled. ART clinics are not federally funded, and there is no specific national legislation that establishes a clear regulatory framework about the standard of operations, the quality-of-care patients should be provided with, the permissible uses of ART, or recourse for patients who have not benefited from their financial investments in ART. There are minimum standards set forth by the Food and Drug Administration (FDA) and the Clinical Laboratory Improvement Amendments of 1988 (CLIA), which require strict compliance before patients can consult and use clinics’ ART services including the use of pharmaceutical products. The Federal Trade Commission (FTC) also oversees truthful advertising and marketing practices within ART to ensure that clinics’ reports of success are consistent with their patient data. All states require that physicians obtain a license before providing care, and physicians are subject to investigation by state boards. Aside from this general regulation for safety and transparency, the only explicit regulation targeting the ART industry is the United States Fertility Clinic Success Rate and Certification Act, mandating all US fertility clinics to report their ART cycles performed to the Center for Disease Control (CDC). The data collected through this reporting act is governed by the NASS 2.0 (National Assisted Reproductive Technology Surveillance System), which is a collaborative surveillance system between the CDC, and private stakeholders. Self-reported data to NASS 2.0 is verified by comparing information from a patient’s medical record with data submitted for the report.
The SPAC Faces Its First Regulatory Obstacle
As Coronavirus (Covid-19) has slowed the global economy, business owners have been forced to adapt to volatile market conditions and use creativity to raise capital. Investors and financial industry professionals have turned their attention to Special Purpose Acquisition Companies (SPACs), which have already raised nearly $100 billion in 2021 compared to $83.4 billion during the previous year. A SPAC is a publicly-traded shell company formed by industry professionals such as institutional investors, private equity firms, and hedge funds. Then, SPAC sponsors will seek to complete a merger or acquisition with another private company, which enables the private company to become publicly traded and bypass the initial public offering (IPO) stage. SPACs usually are allowed two years from the IPO date to formalize an acquisition or return the funds to investors.
Monopoly Defined: Amazon Can Pass Go
With the recent antitrust lawsuit filed against Amazon and the new antitrust bills being debated in Congress, the online retail giant is at the forefront of everyone’s mind. The behemoth of a company has entered numerous markets including apparel, technology, and even grocery. The size and scope of the company begs the question, is Amazon a monopoly? As the law stands right now, Amazon is decidedly not.
The Clean Water Act Revisited: First Application of the County of Maui v. Hawaii’ Wildlife Fund Test Favors Strong Regulation of Water Pollution
Daniel Bourgault Senior Editor Loyola University of Chicago School of Law, JD 2022 On July 15, 2021, the Hawaii’ federal district court became the first court to publish an opinion utilizing the functional equivalent analysis (“FEA”) established by the Supreme Court of the United States last year in the County of Maui v. Hawaii’ Wildlife …
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Stronger Health Regulations in the Fracking Industry Benefit the Industry and Workers Alike
As a compliance deadline set by the Occupational Safety and Health Administration (“OSHA”) for the fracking industry approaches on June 23, 2021, both the industry and the workers employed by it are seeing benefits. Created by the Occupational Safety and Health Act, OSHA sets out regulations meant to protect employees from work conditions that threaten their health and monitors and enforces compliance with those standards.
Exploring COVID-19 Vaccine Authorization by the FDA
As of April 22, 2021, 218,947,643 million people have received the COVID-19 vaccine. Before or during the appointment, your provider directs you to a fact sheet for the Pfizer-BioNTech COVID-19 Vaccine or Moderna COVID-19 Vaccine. On the fact sheet, there were a couple of sentences that caught my eye “The Pfizer-BioNTech COVID-19 Vaccine is a vaccine and may prevent you from getting COVID-19. There is no U.S. Food and Drug Administration (“FDA”) approved vaccine to prevent COVID-19.” When I read this, I wanted more information about the difference is between being authorized or approved. Like many people, one can become hesitant when a product is not adequately tested; in fact, a Kaiser research project shows about 30% of people probably or definitely not get the vaccine.
COVID-19 Vaccine Passports and Privacy Concerns
As businesses begin to reopen and resume operations after the pandemic, there are discussions surrounding possible vaccine passports and the concerns protecting individuals’ personal health information. COVID-19 vaccines are becoming more available within the country and more Americans feel safe to resume their normal lives. Many states and businesses are contemplating the idea of making vaccine passports a requirement for travel and large events. The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) was created to protect personal health information. As other countries are beginning to require proof of vaccination, many are contemplating whether vaccine passports are permitted by HIPAA or if the requirement will actually violate the federal health privacy law.
The Aircraft Certification Process under the Federal Aviation Administration
Though the idea of a plane crash or any other incident with air travel is extremely unsettling, only about one accident per 2.5 million flights is fatal. Additionally, plane crashes also have about a ninety-five percent survivability rate. The regulations behind aviation are designed to implement the highest safety standards in all aircraft to prevent injury from occurring. The Federal Aviation Administration (“FAA”) is an agency of the U.S. Department of Transportation (“DOT”) that manages commercial and general aviation flights with a mission to provide safe air travel. The FAA is a crucial part of what makes air travel safe.
Together we go … to the White House?: The Cybersecurity Risks of Peloton
Peloton has a coined the term “together we go far” as their company slogan, and over the course of this year that is exactly what this company has done. Since the company launched in 2012, Peloton has gone far and wide delivering their fitness technology to millions of people across the globe. Peloton is an international company that designs at-home gym equipment and produces virtual workout classes for their customers to live-stream or watch on-demand through their Peloton products. Peloton provides an outlet for fitness and competition while building a positive and inclusive community for their members across the United States and the world. Of the millions of members in the Peloton community, one is our leading man in office President Joe Biden.
Crypto Confusion Leads to Legislative Action: Multiple Bills Introduced to Clarify Federal Regulation of Cryptocurrencies
Cryptocurrencies have often been associated with illegal activities due to the fact that they allow users to remain relatively anonymous. This anonymity is possible because, when transacting with Bitcoin and other cryptocurrencies, you can see where funds are being sent but not who sent or received them. However, there are signs that the use of crypto for unlawful purposes may be falling with illicit activity accounting for just 0.34% of all crypto transactions last year – down from roughly 2% a year earlier. Despite this improvement, cryptocurrency regulation appears to remain a top priority for federal lawmakers. One such example of this is the proposal of an anti-money laundering rule which would require people who hold their cryptocurrency in a private digital wallet to undergo identity checks if they make transactions of $3,000 or more. But Congress does not appear to be stopping there. As cryptocurrencies surged in value in recent days, lawmakers jumped to introduce two new bills aimed at advancing regulation of these precarious digital assets.