INSIDE COMPLIANCE – Page 61 – Loyola University Chicago School of Law

Welp, The New Title IX Regulations Are Here

August 13, 2020Uncategorized

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.

EducationRegulation

Title IX Reform

August 4, 2020Athletic Regulation

On May 6, 2020, Secretary Betsy Devos, through the Department of Education (the “Department”) issued the new Title IX regulations (the Final Rule) scheduled to take effect August 14, 2020. The U.S. Department of Education’s Office for Civil Rights (OCR) enforces Title IX of the Education Amendments of 1972. The statute states that “No person in the United States shall, on the basis of sex, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any education program or activity receiving Federal financial assistance”, yet it does not define sexual harassment. The Final Rule is heavily contested due to its demanding provisions and implementation period during the pandemic.

Education

New Title IX Rules for Schools

August 3, 2020Uncategorized

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.

complianceDepartment of EducationEducationElementary and Secondary Schoolssexual harassmentTitle IX

Establishing Expanded Use Programs

July 17, 2020Drugs & Devices

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.

FDAFDA regulationsJournal of Regulatory ComplianceRegulationRight to Try

Clinical Trials and Human Participants

July 16, 2020Uncategorized

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.

clinical testingclinical trialsCOVID-19DrugsHuman ParticipantsHuman TrialsJournal of Regulatory ComplianceVaccine

Illinois Unemployment Benefits for Academic Personnel

June 29, 2020Uncategorized

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.

#unemploymentAcademic PersonnelCOVIDEducationEmploymentHB2455IDESPA 101-633School

New Rules for Illinois Firearms Dealers

June 26, 2020The Art of Compliance, Uncategorized

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.

Journal of Regulatory ComplianceRegulation

COVID-19 Break in Regulation of Waivers for State Medicaid Agencies

June 26, 2020Uncategorized

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.

appendix KCMSCOVID-19Health InsuranceJournal of Regulatory ComplianceMedicaidpublic health emergencyRegulationSection 1115 Waiversection 1135Waivers

Telehealth in the Age of COVID-19

June 18, 2020HIPAA & Health Information, Uncategorized

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.

#CoronavirusCOVID-19HIPAAJournal of Regulatory CompliancePrivacy & SecurityRegulationtelehealthtelemedicine

The Regulation of Meat and Poultry Processing Facilities in COVID-19

June 4, 2020The Marketplace, Uncategorized

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.

CDCCOVID-19environmental regulationFood ProcessingJournal of Regulatory ComplianceOSHARegulation