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.
The Supreme Court has granted certiorari to consider whether the Securities and Exchange Commission (“SEC”) has the authority to obtain disgorgement in district court actions. Disgorgement is the repayment of “ill-gotten gains” imposed as a court sanction to recover funds that were received through illegal or unethical business transactions. These recovered or disgorged funds are paid back with interest to those who the practice affected. Each year, the SEC obtains billions of dollars in disgorgement, so an adverse ruling by the Supreme Court could eliminate one of the SEC’s most important remedies for securities violations. In 2018, for example, the agency returned $794 million to harmed investors.
The Health Insurance Portability and Accountability Act (HIPAA) and the Patient Protection and Affordable Care Act (ACA) jointly create national standards for electronic transactions, code sets, and unique identifiers. The ACA introduced Administrative Simplification provisions in 2010 and now the Centers for Medicaid and Medicare Services (CMS) has launched a Compliance Review Program to ensure that HIPAA covered entities are abiding by the Administrative Simplification rules.
Ever since the Facebook and Cambridge Analytica scandal, concerns surrounding data privacy and protection have been growing. Both government agencies and individual users have particularly been concerned on how their data is being collected and used on social media websites such as Facebook. Germany has taken action in response to such concerns and recently took a step against Facebook’s collection of data in a decision that outlawed Facebook’s entire advertisement regime.
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”).
On July 6, the Information Commissioner’s Office (ICO) issued their first Enforcement Notice to AggregateIQ (AIQ) under the General Data Protection Regulation (GDPR) and the United Kingdom’s Data Protection Act (DPA). The GDPR is a law regulating data protection and privacy as well as the export of personal data outside of the European Union (EU). It became enforceable on May 25, 2018. The DPA supplements the GDPR and regulates the processing of personal data. The ICO is a regulatory office in the UK which enforces regulations under the DPA and GDPR. AIQ is a Canadian digital advertising, web and software development company that was charged with violations regarding the use of data analytics in political campaigning. This article will address the AIQ enforcement notice and how companies ensure compliance with the GDPR to prevent receipt of an enforcement notice.
On September 11, 2018, the Securities and Exchange Commission (SEC) announced two enforcement actions relating to failures to register by market intermediaries in connection with digital asset activities. Despite earlier suggestions that the Commodity Futures Trading Commission (CFTC) might be the primary self-regulatory organization (SRO) regulating this market, the main takeaway from these cases is that market intermediaries dealing in digital assets may also have registration and customer protection liabilities, and the failure to observe them can result in serious penalties.
In a world where our reliance on technology and the cloud is increasing exponentially, data security’s growth has stagnated. The European Union (EU) passed the General Data Protection Regulation (GDPR) in hopes of ensuring that consumer data is protected and not harbored by businesses. The effects of the GDPR, however, have passed the borders of the European Union. In a world where our actions extend internationally with just the click of a button, the GDPR’s impact circles the globe as well. The GDPR has pushed for a shift in data privacy and regulation for companies within and outside of the EU as it holds to protect European citizens, no matter where they are in the world. This international reach has not only created forces to drive U.S. companies to comply, but states within the U.S. are now creating GDPR-inspired laws to protect their own citizens. The GDPR has started a trend that will soon become the norm and finally push compliance to keep up with the exponential growth of technology.
Modern business thinking has come to accept that reputation is as important as financials. As investors look for companies that demonstrate this understanding, compliance professionals are in a unique position to make their companies more appealing.
In early January of this year, the House Committee on Armed Services granted an extension to a bill that would increase border security. An unlikely opponent of this bill is the environmental lobby, since the bill would allow the Department of Homeland Security (DHS) to waive the requirements of some of the most important environmental protection statutes. These statutes have been the basis for almost all the citizen enforcement in the environmental arena; they work to maintain protections for 73 different areas along the border, along with numerous endangered species.