Category:Uncategorized
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.
New Title IX Rules for Schools
On May 19, 2020, the Department of Education published a final Title IX regulation that changes the rights and responsibilities for schools, complainants, and respondents. In summary, these regulations respond to the need to provide a prompt and just response to individuals who have suffered sexual harassment and provide due process for an alleged perpetrator. These changes create a standard grievance process, define conduct that constitutes sexual harassment, outline conditions that activate a school’s obligation to respond, impose a minimum standard of school response, and establish procedural due process protections.
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.
Illinois Unemployment Benefits for Academic Personnel
During the expedited legislative session on May 20-24, the Illinois General Assembly passed HB 2455 which was signed into law as Public Act 101-633 on June 5, 2020. While well-intentioned, this Act could create a huge liability for school districts depending on how the Illinois Department of Employment Security (“IDES”) interprets the law. School districts are already facing an uncertain financial future and this law is adds more uncertainty and possibly more financial insecurity.
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.