Tag:Journal of Regulatory Compliance
Flint Water Crisis: Where We Go From Here
There is poison in the water. The Flint water crisis has ravaged the city of Flint, Michigan, permanently altering how many in the community see the role of government.
On August 20th, Michigan Attorney General Dana Nessel announced a $600 million settlement between several state actors and victims of the Flint water crisis. Finally, six years after exposing residents to dangerous levels of lead in the water, the residents of Flint will receive their duly needed compensation. Unfortunately, it may be too little, too late for Flint, and there is little to prevent the crisis from repeating itself elsewhere without deliberate action.
High-Frequency Trading and its Need for Increased Regulation
With the rapid innovation of technology penetrating our lives comes the need for increased regulation on the industries that are being impacted, and the stock market is no different. In the late nineties, the Securities and Exchange Commission (SEC) approved the use of an electronic stock exchange system and by 1998, they authorized the use of High- Frequency Trading (HFT). HFT is a method of electronic stock trading where the trader uses high powered technology to complete automated trading at a large volume and speed. Because these trades are not made by people, but instead computers, they can be executed within millionths of a second. As the speed that HFTs have allowed for stocks to be traded at has decreased over time, their popularity has increased. By 2012, it was estimated that HFT accounted for almost 50 percent of all U.S. equity trades. Their popularity is contributed to HFT’s ability to allow traders to ensure they have the most up to date information on the market and ensure that they get the lowest price. This gives traders the power to buy and sell at high speeds, increasing liquidity in the market.
K-12 Schools Returning In-Person During COVID-19
During February 2020, COVID-19 hit the United States and disrupted many lives all throughout the country. Many states shut down most businesses, stores, and restaurants except for all essential services. By March, schools were forced to create unconventional forms of teaching methods for the remainder of the school year such as e-learning and sending students lesson packets for the week. As the school year approaches, many school districts are still determining their instruction mode for the upcoming school year. The Centers for Disease Control and Prevention (CDC) provided guidelines to reopening schools and advised school districts to work closely with local and state health officials to determine the best practices for reopening.
Voting in the 2020 Election
Most United States citizens have certain expectations when they go to their polling station; voters expect to stand in a line, to be handed a ballot by an official, or to vote on a touch screen system. Yet, amid COVID-19, for many Americans, going to a polling station presents too many opportunities for the transmission of the virus. As a result of the danger of voting in-person and the desire to vote by mail, it is projected that the United States Postal Services (hereinafter “USPS”) will deliver an unprecedented number of mail-in ballots.
Pre-Approval Access and Pathways to Investigational Drugs
The Federal Food, Drug, and Cosmetic (FDC) Act of 1938 requires pharmaceutical drugs to provide evidence of their safety before they are allowed on the market. As such, pharmaceutical companies submit applications to the Federal Drug Administration for approval. There are situations, however, in which patients seek to receive access to a particular pharmaceutical drug before the FDA approval process is complete. This blog will explore the various pathways to pre-approval access in addition to recent legislation and legal considerations for such pathways, in addition to the principles and common obstacles that pharmaceutical companies face within such pathways.
Establishing Expanded Use Programs
The ability to access experimental drug treatments has long been contentious in the United States. Prior to the 1938 Food, Drug & Cosmetic Act, pharmaceutical drugs were largely unregulated. This Act required, for the first time, that drugs sold to the public were safe. Increasing regulations regarding the marketing, testing, and distribution of pharmaceutical drugs were established throughout the next fifty years. In the 1980s, however, a puzzling illness became known to the public. This illness was called HIV/AIDS, a debilitating virus that caused the body’s own immune system to attack itself. This illness has killed over 32 million people in the United States and worldwide, and particularly impacted the population of gay men. Because homosexuality was still fairly taboo in the 1980s, many argue that the country dragged its foot in researching and approving treatment for HIV/AIDS. Due to significant advocacy, much progress has been made with this particular illness, and the country has slowly evolved from the slow and strict processes that once regulated potential pharmaceutical drug treatments.
Clinical Trials and Human Participants
This past spring the world locked down. Stores were closed, everyone was required to work from home, and masks became the latest fashion trend. This shift occurred because a virus, Covid-19, began making its way around the world. It has been about 4 months since our society locked down for the protection of its people and while it is slowly opening back up there are fears that without a vaccine or cure for Covid-19 it is going to keep spreading and we are going to have to remained locked down. Many pharmaceutical companies are working night and day to create a vaccine that can be widely distributed to help stop the spread of Covid-19. A drug that is for humans needs to be tested on humans to ensure it works before it can be approved and sold.
New Rules for Illinois Firearms Dealers
The Firearms Dealers License Certification Act (also known as the Combating Illegal Gun Trafficking Act) was signed into law on January 18, 2019 and requires all Federal Firearms License (FFL) dealers engaged in the business of transferring firearms to have their FFL certified by the Illinois State Police. Nevertheless, many areas of the regulations remain in dispute and strong opposition has led to the delay of dates for required compliance. The Act is also being challenged by the Illinois State Rifle Association and a number of gun dealers in Illinois who deem that the Act is an unconstitutional infringement on their right to keep and bear arms.
COVID-19 Break in Regulation of Waivers for State Medicaid Agencies
COVID-19 was an unexpected pandemic that hit the United States, causing Centers for Medicare and Medicaid Services (“CMS”) to rush to make accommodations for the states. States administer their Medicaid programs following a state plan and under the regulation of federal rules. With approval, states are allowed to amend their state plan and apply for waivers to improve the effectiveness of their Medicaid program. During COVID-19, the Trump Administration made available for states to apply for 1115 waivers, creating a new section labeling 1115(a), the 1135 waiver, and Appendix K to amend 1915(c) waivers for national emergencies. As of May 2020, CMS reported over 200 approved waivers across multiple states.
Telehealth in the Age of COVID-19
The Health Insurance Portability and Accountability Act – enacted in 1996 by the U.S. Congress and signed by then-President Bill Clinton – has long served to maintain the standards of electronic health records and patient privacy, among many other provisions. Violating HIPAA can result in both criminal prosecution as well as steep civil penalties. As the healthcare industry transitioned from the use of paper records to storing patient data on electronic health records over the last two decades, health organizations have learned to adapt to HIPAA compliance, with many increasing their compliance programs by hiring full-time compliance officers, designating an individual as the compliance manager, and/or appointing a compliance committee within the organization.