Tag:Regulation
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.
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.
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.”
The Covert Consequences of Organic Food Labeling
According to the United States Department of Agriculture (USDA) the organic food market is experiencing double-digit growth in recent years. Despite the list of reasons that bump up the cost of organic foods, consumers are increasingly willing to pay a premium. Unfortunately for consumers, the weak, unclear, and sometimes non-existent labeling regulations imposed on organic products means that they may not be getting what they think they are paying for.
HIPAA And The Growth Of Technology
Earlier in 2019, a lawsuit was filed against University of Chicago Medicine, University of Chicago Medical Center, and Google. The suit claims that patient information was shared with google as part of a study aimed to advance the use of Artificial Intelligence, however, patient authorization was not obtained and the data used was not properly de-identified. In 2017, University of Chicago (UChicago) Medicine started sending patient data to Google as part of a project to look to see if historical health record data could be used to predict future medical events.
Recent Movements in Biometric Data Privacy
In 2008, the Illinois legislature introduced and passed the Biometric Information Privacy Act (BIPA), which became the first law of its kind in the US. BIPA was passed to protect individuals against the unlawful collection and storing of biometric information. While many states have enacted similar laws, BIPA remains the most stringent among its contemporaries.
Are Tech Companies Doing Enough to Combat Social Media’s Harmful Effects?
Today, we have entire generations of people who do not know life without the internet. Social medial plays a central role in the lives of these individuals. Originally created to serve a purely social function, social media platforms have changed. Many consumers even use sites like Twitter, Snapchat, and Instagram as their primary source of news. In addition, social media is an integral marketing tool for many businesses. No matter its function, no one can deny the presence of social media in our everyday lives. The impact of social media is so profound that it is worth considering its negative effects. In particular, social media companies must be cognizant to their platform’s impact on adolescents. Many Americans, mainly parents, feel social media companies are not doing enough. But are they required to do more? Should the government become involved, similar to their involvement in the Facebook privacy controversy?