Tag:

COVID-19

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.

COVID-19 Vaccine Passports and Privacy Concerns

As businesses begin to reopen and resume operations after the pandemic, there are discussions surrounding possible vaccine passports and the concerns protecting individuals’ personal health information. COVID-19 vaccines are becoming more available within the country and more Americans feel safe to resume their normal lives. Many states and businesses are contemplating the idea of making vaccine passports a requirement for travel and large events. The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) was created to protect personal health information. As other countries are beginning to require proof of vaccination, many are contemplating whether vaccine passports are permitted by HIPAA or if the requirement will actually violate the federal health privacy law.

Illinois House Bill 3498: Telehealth Expansion and Payment Equality

The Coalition to Protect Telehealth and State Representative Deb Conroy of the Illinois 46th House District have introduced legislation that would permanently expand access to telehealth services for Illinoisans.  The legislation also details provisions that promote telehealth payment rate partity between telehealth services and in-person care.  In a direct response to the COVID-19 pandemic, telehealth providers have been granted temporary waivers to align their payment rates with those prescribed for traditional care in health care facilities.  These waivers have served as stabilizing financial mechanisms for many practitioners experiencing revenue loss due to the restrictions on elective procedures and non-emergency care.  The proposed legislation would give patients more freedom to utilize telehealth services by removing the patient responsibilities to demonstrate hardship or access issues.

New CDC Guidelines for K-12 Schools May Send More Students Back to Classrooms

Recently, the Centers for Disease Control and Prevention (“CDC”) released revised guidelines regarding physical distancing in K-12 schools. Originally, the CDC recommended that students should stay six feet away from each other in a classroom with mask but now recommends at least three feet between students in classrooms. These new guidelines will encourage more schools to return to the classroom around the nation.

Can Nursing Homes be Sued for COVID-19 Deaths?

Nursing homes have been devastatingly impacted by the COVID-19 pandemic. As of February 26, 2021, as many as 34% (172,000+) of all COVID-19 deaths in the United States have been nursing home residents and employees. While COVID-19’s lethality in older adults and likelihood of transmission in congregate facilities are to blame, plaintiffs’ attorneys specifically question sweeping legislation among various states regarding nursing home restrictions on refusing COVID-19 positive residents and immunity protections. A look at the Public Readiness and Emergency Preparedness (“PREP”) Act and recent federal cases sheds light on the future of plaintiff suits related to COVID-19 deaths in nursing homes.

Nursing Home Staff Turnover Rates Partially Explains Disproportionate Number of Deaths during COVID-19 Public Health Emergency

The COVID-19 pandemic has impacted residents and staff of nursing homes and long-term care facilities more than any other demographic, accounting for nearly 40 percent of the total mortality rate from the virus in the United States.  According to Centers for Medicare & Medicaid Services (“CMS”), at least 132,000 residents and employees have died from complications of the COVID-19 across 31,000 facilities, although some estimates place the death count closer to 200,000.  One factor aggravating the number of deaths in nursing homes is the extraordinarily high rate of staff turnover each year. 

Johnson & Johnson COVID-19 Vaccine Awaits Authorization from FDA

Recently, the U.S. Food & Drug Administration (“FDA”) announced a scheduled meeting of its Vaccines and Related Biological Products Advisory Committee (“VRBPAC”) to  discuss the request for emergency use authorization (“EUA”) for a COVID-19 vaccine from Janssen Biotech Inc. The FDA has just under three weeks to complete its report before the VRBPAC’s meeting to make its recommendation on the vaccine. The review process may be more challenging than the past two reviews for Pfizer and Moderna due to the composition differences and effectiveness.

President Biden’s COVID-19 Data-Driven Executive Order to Promote Health Equity

President Joe Biden has issued a number of Executive Orders, many of which address the ongoing COVID-19 public health emergency. On January 21, 2021, President Biden released another pillar of his Administration’s long-term plan to direct the United States out of the throes of the pandemic. The twelfth Executive Order titled, “Ensuring a Data-Driven Response to COVID-19 and Future High-Consequence Public Health Threats” orders the Department of Health and Human Services (“HHS”) Secretary Alex Azar to conduct a nationwide review of the interoperability of public health data systems in an effort to enhance the collection, sharing, analysis, and collaboration of de-identified patient data.

How Federal Data Privacy Regulation Could Help Curb the COVID-19 Pandemic

It cannot be denied that the COVID-19 pandemic has led to many novel legal and regulatory issues. One topic of major concern both domestically and abroad is how to manage the massive amounts of consumer data being collected in the attempt to quell the spread of the virus. This issue is especially complicated to address in the United States, where a convoluted patchwork of state and federal laws interact to create a relentlessly fragmented data regulation system. Now, as state and local governments, along with tech giants like Apple and Google, continue to roll out contact tracing applications, the need for comprehensive data privacy regulation is more pressing than ever.

Is Zoom Doomed?

There is no doubt that working from home has become a new normal for millions of employees worldwide, and for some, this may be the future of their employment. When the workforce made the shift to remote work and online meeting navigation, Zoom Video Communications, Inc. (“Zoom”) quickly became the frontrunning platform. Many companies flocked to Zoom because of its alleged higher levels of security and encryption capabilities. However, a recent lawsuit against Zoom, by nonprofit group Consumer Watchdog, reveals that Zoom may not actually be as safe for users as it once claimed to be. Other lawsuits allege privacy concerns including Zoom sending user data to Facebook. Most recently, the FTC filed a suit against Zoom on November 9th for allegations of unfair, deceptive, or abusive acts or practices (“UDAAP”) related to encryption, cloud storage, third-party safeguards, and failure to disclose information to users. Though various privacy concerns arise, the platform’s popularity continues to increase given its newfound necessity.