The Future of Telemedicine: Controlled Substance Proposed Rule
On January 31, 2020, the Secretary of the Department of Health and Human Services issued a public health emergency as a result of COVID-19. The emergency declaration requires public health professionals, first responders, and public officials to work together to minimize death while preventing illnesses. The declarations provided the government with the flexibility to waive or modify standard requirements as it relates to both public and private insurance, service providers, and authorizations including telehealth. Telehealth provided access to healthcare to those who face barriers as well as flexibility in being able to manage care while reducing the spread of COVID-19 along with other infectious diseases. There remained uncertainty regarding the freedom to prescribe controlled substances via telemedicine with the Biden administration set to end the public health emergency on May 11, 2023. However, on February 24, 2023, the Drug Enforcement Administration (DEA) released a proposed rule that aims to permanently extend controlled substance prescribing flexibilities.
California’s COVID-19 Workplace Requirements Continue to Evolve
Emily Zhang Associate Editor Loyola University Chicago School of Law, J.D. 2024 On October 13, the California Department of Public Health’s (CDPH) issued a change to the California Division of Occupational Safety and Health (Cal/OSHA) Covid-19 emergency standard and issued a revised proposal for the non-emergency standard. The order updates the definition of “close contact” …
FDA’s Response to Baby Formula Shortage
This year the Food and Drug Administration (FDA) has come under fire for its slow response to the nationwide baby formula shortage. In September 2022, FDA Commissioner Robert M. Califf authorized the release of an internal report. The report details how the baby formula shortage occurred, the FDA’s response to the shortage, and the challenges it faced in resolving the shortage. The report also revealed the changes in FDA regulatory procedure to ensure another shortage does not occur.
Employees Continue to Fight Compliance with Vaccine Mandates
An earlier blog post explored the challenges of employees returning to work, including questions about the legality of COVID-19 vaccine mandates. In response to the uptick in cases towards the end of the summer and into the fall, many large employers implemented vaccine mandates. As vaccine mandates have increased, so have the lawsuits contesting them. As of October 14, 2021, there have been at least thirty-nine federal cases contesting vaccine requirements imposed by either employers or governments and approximately fifty-seven total decisions, including federal and state cases. In most cases, courts are denying requests for temporary injunctions against the mandates or dismissing the cases.
The “Cyber Pandemic” – COVID-19’s Influence on Cybersecurity Practices
There is no doubt that the COVID-19 pandemic has affected almost every aspect of life for people around the globe. While the internet has allowed people to stay connected and continue working from home, it has also presented an opportunity for cybercriminals to take advantage of susceptible remote working setups. Cybercrime has significantly increased since the start of the pandemic, prompting corporations to mitigate the risk of a data breach against an onslaught of new vulnerabilities to their internal systems.
The Explosion of Remote Patient Monitoring in the Wake of COVID-19
The COVID-19 pandemic has fundamentally changed many aspects of healthcare delivery. Most notably, the pandemic increased the demand for digital health services. Telemedicine saw ten years’ worth of expansion in one year, but it was not the only digital health service that exploded as a result of the pandemic. Telehealth has evolved from merely meeting with a provider via a video conference to include more sophisticated technologies. Remote Patient Monitoring (“RPM”) allows for providers to collect patient data without the patient having to go to a healthcare facility for monitoring. RPM can improve the quality of healthcare delivery by more closely monitoring a patient while also reducing patient volumes within a healthcare setting. In addition, because RPM allows patients to get more care at home, it can largely reduce costs to the patient and the payor while increasing access. Despite the many benefits associated with RPM, there are considerable risks and compliance issues.
Coronavirus, Compliance, and the Brokerage Industry
COVID-19 has ushered in a new era for the brokerage industry as financial advisors and professionals across the world have been exiled from regional offices in favor of remote work. Numerous financial advisors may continue working remotely whether due to a novel sense of autonomy, elimination of a commute, or perceived increase in productivity. However, the remote-work era has introduced a plethora of compliance-related issues throughout the brokerage industry. Brokers working remotely possess additional independence to determine when to work and how to communicate with clients, which heightens compliance risks because firms are not able to monitor employees as stringently as they were before COVID-19. Federal regulators, including the Financial Industry Regulatory Authority (FINRA), are responding to newfound compliance risks by issuing updated guidance and investigating potential violations throughout the brokerage industry.
Professional Sports Leagues and Vaccine Mandates
Following President Biden’s announcement mandating vaccinations for companies with over one hundred employees, major professional sports leagues may be required to ensure compliance with the mandate. This mandate has the potential to have sweeping implications throughout professional sports, from the athletes, to staff and even spectators. The NFL, NBA, and MLB all have high vaccination rates among their players and the staff that works closely with them, since many teams have already mandated that players and those working in “close proximity” to them be vaccinated. However, their back-office staff are less protected, as those employees have yet to be subjected to strict protocols of the rest of the leagues. Despite these high vaccination rates among athletes and certain staff members, the leagues have been reluctant to institute absolute mandates. But that doesn’t mean that athletes don’t still have a responsibility not only to get vaccinated but also encourage others to do so as well.
Navigating the Return to the Workplace and the ADA
Despite the recent surge in COVID-19 cases, many Americans are still returning to the office. Kastle Systems, a large security services provider, reported that an average of 32.1 percent of employees across ten big cities were returning to work as of August 11, 2021. On August 23, 2021, the Food and Drug Administration (“FDA”) granted full approval to Pfizer/BioNTech’s COVID-19 vaccine. Polls have shown that the FDA approval will lead to an increase in vaccinations. While many people are not going back to the office, most Americans do have plans to return to work. As a result, employers are working to create return-to-work plans, while employees are left wondering about the extent of their rights. The Americans with Disabilities Act (“ADA”) covers employers with 15 or more employees, including government employers, agencies, and labor organizations. The ADA imposes restrictions on the amount and type of medical information that an employer may obtain from an employee or applicant in order to prevent discrimination on the basis of a disability. The ADA has been dissected to better understand the regulations that govern the return to the workplace.
Exploring COVID-19 Vaccine Authorization by the FDA
As of April 22, 2021, 218,947,643 million people have received the COVID-19 vaccine. Before or during the appointment, your provider directs you to a fact sheet for the Pfizer-BioNTech COVID-19 Vaccine or Moderna COVID-19 Vaccine. On the fact sheet, there were a couple of sentences that caught my eye “The Pfizer-BioNTech COVID-19 Vaccine is a vaccine and may prevent you from getting COVID-19. There is no U.S. Food and Drug Administration (“FDA”) approved vaccine to prevent COVID-19.” When I read this, I wanted more information about the difference is between being authorized or approved. Like many people, one can become hesitant when a product is not adequately tested; in fact, a Kaiser research project shows about 30% of people probably or definitely not get the vaccine.