Tag:Regulation
COVID-19’s Detrimental Impact in Long-Term Care Facilities
According to the Centers for Disease Control (“CDC”), older adults and people with severe underlying medical conditions are at higher risk for developing more serious complications from the COVID-19 illness. For this reason, among others, long-term care facilities have been hit particularly hard by the virus. Although it was difficult to be prepared for this pandemic, there are concerns that many long-term care facilities did not have proper preventative measures in place in even before COVID-19 became an issue. Because of this, long-term care facilities have become hot spots for the viruses spread. As states and the federal government continue to monitor long-term care facilities’ compliance with local and federal laws, regulatory agencies are now also faced with added pressure to not only slow the spread of COVID-19 within the facilities, but also to control the legal environment in the anticipated aftermath of the outbreak.
Employer Compliance with CARES Act
On March 27, 2020, President Donald J. Trump signed into law the Coronavirus Aid, Relief, and Economic Security Act (H.R. 748), otherwise known as the “CARES” Act. Originally introduced in January as the Middle-Class Health Benefits Tax Repeal Act, the bill was then revised to address the needs of the United States amid the coronavirus pandemic. The bi-partisan CARES Act, with strong support from the White House, ultimately passed the House of Representatives with a 419-6 roll call and the Senate with 96-0 votes.
The Empire State’s New Data Privacy Law
Data privacy and more specifically, user privacy, has become the focus for many in the past year. Some may say that the European Union began this “trend” with the implementation of the General Data Protection Regulation (GDPR) with California soon following in their footsteps with the California Consumer Privacy Act (CCPA). However, seemingly more silently in New York, The Stop Hacks and Improve Electronic Data Security, or SHIELD Act has also been created in the interest of the protection of personal information. The SHIELD Act was enacted on July 25, 2019 as an amendment to the General Business Law and the State Technology Law to include breach notification requirements and stronger rules in place to enforce against businesses handling personal information. The SHIELD Act recently went into effect on March 21, 2020.
Action Against Individuals Regarding Fraudulent Genetic Testing
Michael Manganelli Associate Editor Loyola University Chicago School of Law, JD 2021 In October 2019, The Department of Justice (“DOJ”) announced a multi-agency and multi-state coordinated law enforcement action against 35 individuals involved in an alleged $2.1 billion genetic cancer testing scheme. The alleged scheme involved the payment of illegal kickbacks and bribes to medical professionals …
Read more
Promoting Interoperability Among the Electronic Health Record Systems
Last year, the Department of Health and Human Services (“HHS”) proposed new rules to improve the interoperability of electronic health information (“EHI”) to fulfill its statutory requirement under the 21st Century Cures Act. These proposed rules were issued by the Center for Medicare and Medicaid Services (“CMS”) and the Office of the National Coordinator for Health Information Technology (“ONC”) to address both technical and healthcare industry factors that create barriers to the interoperability of health information and limit a patient’s ability to access EHI. Epic, one of the largest programs for maintaining electronic health records (“EHR”), is attempting to halt the finalization of the interoperability rules before they take effect as they believe it posts privacy concerns. On March 9, 2020, HHS announced the joint final rules from CMS and ONC to spur innovation and to end information blocking.
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.