FDA Finalizes Enforcement Policy Against Vaping

Amid the epidemic levels of youth use of e-cigarettes, the U.S. Food and Drug Administration, released a policy on January 2, 2020, requiring enforcement against certain unauthorized flavored e-cigarette products that appeal to kids. According to the policy, the FDA intends to prioritize enforcement against fruit and mint flavored, cartridge-based electronic nicotine delivery system (“ENDS”). The FDA looks to regulate all ENDS products that manufactures have failed to make safe for use, as well as any ENDS product marketed for use by minors. The 2019 National Youth Tobacco Survey (“NYTS”), a survey conducted annually by the FDA in conjunction with the Centers for Disease Control and Prevention, shows approximately 1.6 million youths were using ENDS products frequently, with nearly one million using e-cigarettes daily. The FDA’s enforcement policy is not a “ban” on flavored cartridges. If a company can demonstrate to the FDA that a specific product meets the applicable standard set forth by Congress, including considerations on how the marketing of the product may affect youth initiation and use, then the FDA could authorize that product for sale.

Emerging Risks Associated with AI and Machine Learning

Today the healthcare industry is being transformed using the latest technology to meet the challenges it is facing in the 21st century. Technology helps healthcare organizations meet growing demands and deliver better patient care by operating more efficiently. As the world population continues to grow and age, artificial intelligence (AI) and machine learning will offer new and better ways to identify the disease and improve patient care.

Ending Use of Seclusion Rooms in Illinois Schools

An article published on November 19, 2019 by ProPublica Illinois and the Chicago Tribune has alerted Illinois lawmakers, parents, and school personnel of the widespread use of seclusion rooms for isolated timeouts. The use of these rooms, which has now been halted by the Illinois State Board of Education (“ISBE”) and Governor J.B. Pritzker, has been legal in Illinois for over twenty years. The students who are most frequently placed in these rooms have an emotional, behavioral, or intellectual disability, and special education advocates are calling for an end to this practice. These rooms were introduced as a legally-sanctioned separation method to prevent students from harming themselves or others, but the investigative article found that students are often unlawfully placed in these rooms for minor behavioral infractions. The report also found that parents and school administrators did not have knowledge of the full scope of isolated time-out use for their students.

Illinois Amends the Cannabis Act. How Does This Affect Employers?

On June 25, 2019 Illinois Governor JB Pritzker signed the Illinois Cannabis Regulation and Tax Act, “The Cannabis Act” which legalized recreational cannabis beginning January 1, 2020 for adults aged 21 years and older. Illinois residents are permitted to possess 30 grams of cannabis flower, 5 grams of cannabis concentrate, and 500 milligrams of THC contained in a cannabis-infused product. The possession limits are to be considered cumulative. The legalization of adult-use marijuana for recreational purposes in Illinois does not modify the state’s medical cannabis pilot program.

Facing Facial Recognition Technology

In March 2019, Senator Brian Schatz and Senator Roy Blunt introduced a bill to Congress designed to provide oversight for facial recognition technology, known as the Commercial Facial Recognition Privacy Act. If passed, this law could change the way Americans deal with privacy.

How has the SEC’s Approach to Emerging Fintech Technologies Developed?

This October, the Securities and Exchange Commission filed an emergency action and obtained a temporary restraining order in the United States District Court for the Southern District of New York against two offshore entities, Telegram Group Inc. and its wholly-owned subsidiary, TON Issuer Inc. The SEC’s complaint asserted that the two offshore entities were conducting an unregistered offering of securities in the form of digital tokens in the United States and overseas, raising $1.7 billion to finance the businesses, including the development of its own blockchain the “Telegram Open Network” or “TON Blockchain.”

CMS Modernizing the Physician Self-Referral and Anti-Kickback Regulations

On October 9, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to modernize and clarify the regulations that interpret the Medicare physician self-referral law (often called the “Stark Law”), which has not been significantly updated since it was enacted in 1989. As CMS tries to reconstruct the healthcare field, it is imperative for compliance programs to prepare for the changes in regulations to come. The following discussion provides a brief overview of the proposed changes but is not an exhaustive list of all rulemakings related to the physician self-referral law.

Stark and Anti-Kickback Statute Get Modern Updates to Account for Value-Based Arrangements

On October 17, 2019, the U.S. Department of Health and Human Services (HHS) published two proposed rules in the Federal Register that could potentially transform key federal laws restricting health care arrangements. These rules address perceived or actual barriers to care coordination and value-based care under Stark Law, the Anti-Kickback Statute, and the Civil Monetary Penalty (“CMP”) law. The proposals are intended to “modernize and clarify” the regulations that implement and interpret these laws in order to drive innovation and more towards a more affordable health care delivery and payment system, while also maintaining barriers to prevent fraud and abuse. The proposed rules “will improve outcomes by moving away from the old modes of inpatient hospitalizations.”

Should Gift Cards Include Braille in Order to Comply with Title III of the ADA?

Over the past year, restaurants and retailers have had to improve access to their physical locations, websites, and mobile applications to ensure that they are accessible to all individuals and comply with the Americans with Disabilities Act (ADA). Now, restaurants and retailers may have another issue that they need to grapple with in order to comply with the ADA – including braille on gift cards.  

New Department of Labor Overtime Rules

In September, the Department of Labor announced a final revised “Overtime Rule” set to take effect on January 1, 2020, that raises the “standard-salary level” from $455 to $684 weekly to an annual total of $35,568. This will entitle anyone making less than this standard salary to receive fifty percent more in hourly wages for any hours worked in excess of forty in one week because they are no longer “exempted” from the overtime pay requirement in the Fair Labor Standards Act. The Rule is expected to allow 1.3 million previously-exempt workers access to overtime pay. Workers who make more than this threshold can still receive overtime pay if their roles do not include substantial decision making such as administrative, professional, or executive jobs.