Tag:Journal of Regulatory Compliance
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.
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.
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.
Safeguarding Your Face: Regulating Facial Recognition Technologies
The use of facial recognition technology in the commercial context generates numerous consumer privacy concerns. As technology becomes increasingly present in many aspects of our life, regulations on states and federal level are struggling to catch up. Currently, only three states (Illinois, Washington, and Texas) implemented biometric privacy laws, and only Illinois grants individuals with a private right of action.
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.
FDA Issues Warnings Regarding E-Cigarettes
On Wednesday, September 11, 2019, the Trump Administration issued a statement regarding the recent outbreak of illnesses and deaths related to the use of electronic cigarettes (“e-cigarettes”). Soon after, the Food and Drug Administration (“FDA”) quickly followed suit. The Trump Administration’s statement comes after reports of 380 cases of lung illness associated with the use of e-cigarettes in 36 states, in addition to 7 deaths. Both political parties have pressed for flavor bans, age restrictions, and other restrictions on the sale of vaping products. They have urged the FDA to move quickly and decisively to investigate and regulate e-cigarettes. E-cigarettes have been touted by manufacturers as a way to wean people from traditional cigarettes but have recently led to an “epidemic” of youth vaping of nicotine. E-cigarettes are popular among teens due to their availability, advertisements, e-liquid flavors, and the belief that they are safer than cigarettes. The long-term risks of vaping are currently unknown, but a growing numbers of studies show that e-cigarette vapor has severe health risks, including damaging lung tissue and blood vessels.
The FDCA and Cosmetics Enforcement: Better Late than Never
In March 2019, the FDA issued a statement explaining that asbestos was found in certain cosmetic products sold at retail stores Claire’s and Justice. The Food, Drug, and Cosmetics Act (FDCA) has always granted the FDA similar authority to monitor cosmetic products for adulteration or misbranding as it does food. However, litigation in this area was notably silent. The FDA’s change in position on its authority is long overdue.