Tag:Regulation
OIG Work Plan on Nursing Facility Staffing Levels
In August, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) made an additional focus in its Work Plan for the oversight of nursing facility staffing levels. These changes were made in the light of backlash from a July 2018 news article which reported that nearly 1,400 nursing homes had fewer qualified staff on duty than they were required or failed altogether to provide reliable staffing information to the Centers for Medicare and Medicaid Services (“CMS”).
Illinois Law Makers Seeking to Curb E-Cigarette Use Among Teens and Children
In the wake of rising e-cigarette use among teens and children, Illinois lawmakers seek a legal solution to protect Illinois youths from smoking-related illnesses and pre-mature death. Illinois’s Congress introduced Tobacco 21, a bill designed to raise the legal age to purchase tobacco products like e-cigarettes to 21 years of age. Despite a lack of support from Governor Bruce Rauner, Illinois politicians continue to fight to save the bill, and with good reason. The United States Food and Drug Administration (FDA) recently announced its Youth Tobacco Prevention Plan, which addresses the rising e-cigarette use among adolescents. The FDA’s plan is two-fold: (1) crack down on the sale and marketing of e-cigarettes and (2) educate teens and children about the dangers of using e-cigarettes. Tobacco 21 provides support for the FDA’s Plan.
Protections for Accused Students or Problems for Victims?
The Trump administration has proposed new rules for schools dealing with sexual assault and harassment allegations that narrow the definition of sexual harassment and offering greater protections for the accused. Under the new rules, the Education Department is altering the procedures colleges that receive federal funding use to adjudicate complaints of assault and harassment. The new proposed rules come during the #MeToo movement, which will likely prove to be very controversial to both those who support the changes and those who oppose the changes. The federal guidelines stem from Title IX, which bars sex discrimination at schools that receive federal funding.
International Concerns Regarding Southeast Asian Aviation
Aviation accidents, though rare, occur all over the world. However, the relatively high frequency of airplane disappearances and fatal incidents in Southeast Asia has been a primary cause of concern within the industry. Most recently, on October 29, 2018, a Boeing 737 Max 8 operated by Indonesian airline Lion Air crashed into the Java Sea off the coast of Jakarta. Just thirteen minutes into a scheduled hour-long flight, all 189 passengers and crewmembers aboard the aircraft lost their lives. Almost immediately,speculation arose regarding the cause of the accident as well as questions regarding the common occurrence of Indonesian aviation disasters.
Amazon Go versus the GDPR
New data privacy regulations entail questioning both current and future technologies. Recently, Amazon has introduced a store concept that eliminates everyone’s least favorite things about shopping, long lines and small talk. Amazon Go is the grocery store of the future and these stores allow consumers to walk in, pick up the items that they need, and then walk right back out. That’s it. No long lines, no cashiers, no shopping carts. However, as great as this concept seems, there are still concerns from a data privacy standpoint as Amazon needs to collect personal data from its consumers in order to be able to lawfully execute these checkout-less stores.
Impact of Provisions of Revised Rules of FDA-Regulated Clinical Investigations
The FDA regulationson human subject protection and Institutional Review Boards(IRBs) provide guidance to protect the rights, safety, and welfare of subjects who participate in FDA-regulated clinical investigations. The regulations conform with the requirements set forth by the Department of Health and Human Services (HHS) Federal Policy of Human Research Subjects(45 CFR 46, part A). In order to reduce confusion and burdens associated with complying with both the FDA regulations and the HHS policies regarding human subject protections, the FDA is revising the current “common rule”.
Compliance Spotlight: Joseph Adamczyk, OCC
Joseph Adamczyk, ’01 is the Senior Vice President and Chief Compliance Officer at OCC (Options Clearing Corporation). OCC is the world’s largest equity derivatives clearing organization, and works to promote stability and financial integrity in the marketplace. Mr. Adamczyk holds a J.D. from Loyola University Chicago School of Law, an MBA from the University of Chicago, and a B.S. in Business Administration from DePaul University.
SEC, DOL Advance New Fiduciary Rule After Adverse 5th Circuit Ruling
Both the Securities Exchange Commission (SEC) and Department of Labor (DOL) are pushing ahead with fiduciary standards for investment advisers despite the 5th Circuit striking down the DOL’s previous fiduciary rule earlier this year.
Managing Your Health in 2018: Mobile Medical Applications and FDA Regulations
Immediately upon introduction, mobile medical applications became favored by physicians and patients alike because the applications are user friendly and allow the patient to understand their care and participate in more meaningful discussions with their provider about their health. Due to the rapid development of technology and, as a result, a surge of mobile medical applications flooding the market, the Food and Drug Administration has issued three guidances on how they plan to regulate mobile medical applications. In order for mobile medical application manufacturers to remain compliant with the FDA guidances, they must meet the seven categories of requirements that are laid out in Appendix E of FDA’s 2015 guidance and also comply with any further guidance that is released.
How the Biggest Nitrogen Polluter of U.S. Waterways Achieves EPA Compliance
According to an Environmental Integrity Project report, an Illinois pork-processing plant discharged more nitrogen from animal waste into waterways than any other slaughterhouse in the United States. Yet, the facility has complied with the Clean Water Act since December 2015. Animal-processing operations are not only some of the top polluters, but the federal water pollution standards surrounding these operations are lacking.