Tag:Regulation
On this Day: Federal Register Update
Ryan Meade Editor-in-Chief Director of Regulatory Compliance Studies at Loyola University Chicago School of Law As we approach the end of another calendar year, let’s see how the Federal Register page count is going. We have occasionally checked in on the status of the horse race of pages compared to previous years. Here is …
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Donald Trump and What It Means for Regulatory Compliance
Mac Matarieh Associate Editor Loyola University Chicago School of Law, JD 2018 Inside of President-Elect Donald Trump’s 100 Day Action Plan is a requirement that for every new federal regulation, two existing regulations would be eliminated. Mr. Trump has consistently pushed the narrative of an outright repeal of the Affordable Care Act. Further, Mr. …
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The Opening of 2017 in Regulatory Compliance
Ryan Meade Editor-in-Chief Director of Regulatory Compliance Studies at Loyola University Chicago School of Law In continuing to examine the regulatory Wunderkammer of the Federal Register, the first volume of the year holds some interesting items in its opening pages. Page 1 of the 81st volume starts out somberly with Executive Order 13757, “Taking …
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Regulatory Freeze for Review of Pending Rules
Ryan Meade Editor-in-Chief Director of Regulatory Compliance Studies at Loyola University Chicago School of Law As has been the case for every new Administration since 1981, the President has issued a freeze of final regulations that have not gone into effect. The instruction usually comes through the Chief of Staff and is referred to …
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Finalized Rule: Tough Love for Medicaid MCOs?
Kaitlin Lavin Executive Editor Loyola University Chicago School of Law, JD 2017 Last May, the Centers for Medicare and Medicaid Services (CMS) issued a final rule for Medicaid managed care, which told states to stop making pass-through payments to healthcare providers. Pass-through payments have played a critical role in funding safety net hospitals which …
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Financial Fair Play’s Impact on European Football
In the past 12 years, Manchester City has seen a dramatic rise to the European Elite. In 2008, Sheikh Mansour, who has ties to the United Arab Emirates’ royal family, took over ownership of the club. Following the take-over, Manchester City has gone on to win 10 major trophies. On February 14, 2020, Manchester City was handed a two year ban on European competitions, as well as a $32.5 million fine. This is the largest fine ever by Union of European Football Associations (“UEFA”), the governing body of European Football. The UEFA found that Manchester City overstated its sponsorship revenue in its accounts. This, according to the Adjudicatory Chamber of the Club Financial Control Body, is a “serious breach” of Licensing and Financial Fair Play. If the ban is upheld, Manchester City would be fined approximately $232.5 million, a sum of the initial fine plus potential winnings in European Football competitions. According to Simon Chadwick, director at the Centre for the Eurasian Sport Industry, “UEFA must win this ban, if it doesn’t then its position on Financial Fair Play beings to unravel.” This is a pivotal moment in UEFA’s history as a governing body.
Regulatory Waivers Under a Public Health Emergency
On January 31, 2020, the Secretary of Health and Human Services (“HHS”) Alex Azar declared a public health emergency (“PHE”) over the outbreak of the new coronavirus. The PHE response requires coordination with a complex set of federal, state, tribal and local laws and effective compliance calls for a comprehensive understanding of the legal implications and ramifications—which impose challenges from adherence to certain federal laws.
Updates to the Caremark Standard
In re Caremark International Inc. Derivative Litigation was a landmark Delaware case that changed the way what is expected out of a board of directors, and how they are in turn able to run a corporation. In 2019, Delaware courts brought Caremark to meet modern day duty of care standards in the cases of In re Clovis Oncology, Inc. Derivative Litigation and Marchand v. Barnhill.
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.