Journal of Regulatory Compliance
The Federal Bureau of Investigation (“FBI”), the Department of Health and Human Services (“HHS”), and the Department of Homeland Security Cybersecurity and Infrastructure Security Agency (“CISA”) recently announced that hackers have been and will continue to target the United States hospitals and health-care providers. These attacks are cyber in nature and often lead to ransomware attacks, data left, and inevitable disruption of health care services when patient information is locked until the ransom can be paid.
The Centers for Medicare & Medicaid Services (“CMS”) Innovation Center (“CMMI”) recently announced a new model for health care providers in rural areas to receive payment from the federal government. The Community Health Access and Rural Transformation (“CHART”) initiative aims to improve rural health care while promoting the Trump Administration’s push to shift health care providers into a more expansive value-based payment model.
The criminal case against the NFL New England Patriots’ franchise owner, Robert Kraft, has taken an astounding turn of events as the Florida Court of Appeals handed down its ruling on Kraft’s privacy objections against law enforcement’s surveillance video evidence showing the billionaire soliciting prostitution at a local spa. Kraft filed a motion to suppress the evidence arguing that Florida law enforcement’s non-consensual and surreptitious recording of non-audio video surveillance of the premises of a private business, that is open to the public, runs afoul of Kraft’s, and others’, Fourth Amendment right to be free from unreasonable government searches. The ruling of the Appeals Court not only affirmed a similar lower court ruling by the Palm Beach County trial court, favoring Kraft, but it served up an interesting compliance lesson on the privacy protections required of law enforcement during their surreptitious video surveillance operations.
The Drug Enforcement Administration (DEA) recently published an interim rule on hemp and hemp derivatives to reflect the statutory amendments to the Controlled Substances Act (CSA) made by the Agriculture Improvement Act (2018 Farm Bill). This new rule modifies the DEA’s existing regulations in an attempt to conform with the 2018 Farm Bill’s purposeof legalizing and regulating the hemp industry.
As Covid-19 restrictions begin to ease, sports leagues are tasked with implementing safety measures in an urgent and effective manner. Despite the rush for normalcy amid trying times, mitigating further spread and risks associated with the ongoing pandemic are at the forefront of these efforts. The National Collegiate Athletic Association (NCAA) is among the first organizations attempting to resume operations while facing significant health and safety considerations.
During February 2020, COVID-19 hit the United States and disrupted many lives all throughout the country. Many states shut down most businesses, stores, and restaurants except for all essential services. By March, schools were forced to create unconventional forms of teaching methods for the remainder of the school year such as e-learning and sending students lesson packets for the week. As the school year approaches, many school districts are still determining their instruction mode for the upcoming school year. The Centers for Disease Control and Prevention (CDC) provided guidelines to reopening schools and advised school districts to work closely with local and state health officials to determine the best practices for reopening.
With changes to the regulations of the National Collegiate Athletic Association (NCAA) student-athlete model looming overhead, the role of athlete representation is significant in the conversation relating to name, image, and likeness (NIL) of the student athlete. The NCAA has a long-standing “no-agent” rule that forbids student-athletes from being represented by an agent or organization in the marketing of his or her athletic ability until after the completion of their last intercollegiate contest. The NCAA determines a student-athlete’s eligibility based partly on their amateurism status, a term which is not expressly defined by the NCAA, although guided by several factors. Among those factors that would remove an athlete’s eligibility from NCAA competition, is a binding agreement to be represented by an agent at any time before or during a student-athletes collegiate career, however, there are a few exceptions to this factor.The underlying purpose of the “no-agent” rule is to protect student athletes from exploitation in the open market. To further regulate potential issues, the NCAA adopted the Uniform Athlete Agents Act, which effectively criminalizes contact between agents and athletes before the athletes completion of their last intercollegiate contest.
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.
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.
The Common Rule, the Federal policy protecting human subjects of biomedical and behavioral research, was published in 1991. The process to update the policy has taken place over the last several years, leading to the final rule revisions which were effective as of July 19, 2018. After January 20, 2019, institutions are now permitted to implement the entirety of the revised Common Rule. Any institution receiving funds, supervision, or review from any of the twenty Federal Departments and Agencies that have codified the Common Rule must implement this revised rule in their compliance programs.