Tag:Regulation
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.
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.”