Tag:Regulation
Corporate Cybersecurity: Managing Data in the Era of Cyberattacks
Within the last decade, data has surpassed oil as the world’s most valuable commodity. Earlier this year the Securities and Exchange Commission (SEC) released its observations made during audits that detailed the methods used by corporations to secure their data. This included the kinds of cybersecurity practices employed by companies as well as advice on how to better deal with sensitive data and protect against potential cyberattacks. The SEC’s observations coincide with a recent announcement from the National Security Agency (NSA) that showcases an increased concern surrounding cybersecurity in the corporate world.
Income Share Agreements; a Solution to Increasing Educational Debt in America or Just Another Student Loan?
In times of economic recession, Americans historically have sought additional education to mitigate minimal employment prospects and retrain for an evolving job market. Coding bootcamps may be especially attractive in the era of COVID as they provide vocational training in a growing field and many programs are offered remotely by design. These programs may become even more enticing because of a new financing instrument called an income share agreement (“ISA”).
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.
Welp, The New Title IX Regulations Are Here
Earlier this May, Betsy DeVos, the US Secretary of Education, announced the new Title IX regulations that were to be implemented by the beginning of August. DeVos argued that the regulations did not provide due process to students accused of sexual assault. Victim advocacy groups contended that her amended rules discourage victims from reporting their sexual assaults or harassment. Victim advocacy groups also state that schools are unprepared to implement many of the changes to Title IX. Students, women’s rights organizations and educational groups have come together and have filed a law suit to stop the new relegations from taking effect. This is only one of many suits that have been filed to stop the regulations. When people think of sexual assault on college campuses, many people automatically think of Title IX. However, many states around the country have their own state laws that also regulate how colleges and universities are supposed to handle sexual assault and harassment cases. These state laws will also have to be amended to follow the new Title IX regulations.
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.
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.
The Regulation of Meat and Poultry Processing Facilities in COVID-19
The meat and poultry packing industry has recently fallen victim to the spread of COVID-19. Among fierce backlash over the federal government’s lack of action to protect meat packing facility workers, the CDC and OSHA released interim guidelines. These guidelines are to be followed by employers not only to keep workers safe, but to avoid a shortage of one of America’s most prized food sources: meat and poultry. The meat packing industry, as one of the most heavily-regulated industries in the United States, now faces increased regulation during a global pandemic.