COVID-19 Viewpoints

Watch this webinar in which Mintz’s Employment, Labor & Benefits and Health Law attorneys and noted immunologist Dr. Darryl Carter discussed key takeaways from the EEOC’s recently updated vaccination guidance and other COVID-19–related workplace questions.

As 2021 begins and intellectual property (IP) strategies are being developed for the new year, it is a good time to reflect on what IP issues were prominent in 2020.  According to many readers, hot topics included Chinese foreign filing licenses, patenting involving either artificial intelligence (AI) or COVID-19, inter partes review, and attorney fee awards.

Recently enacted H.R. 133, the Consolidated Appropriations Act, 2021 (“the Act”), is a massive, 5,593-page piece of legislation that includes appropriations for the U.S. government for the upcoming fiscal year and funding for coronavirus emergency response and relief, among many other things.

Please join Mintz’s Employment, Labor & Benefits and Health Law attorneys and noted immunologist Dr. Darryl Carter for a webinar to discuss key takeaways from the EEOC’s recently updated vaccination guidance and other COVID-19–related workplace question.

Happy New Year! While many of us are thrilled to see 2020 in the rear view, 2021 ushers in a huge challenge for Massachusetts employers – the beginning of benefits and Job protections under the Massachusetts Paid Family and Medical Leave law (MAPFML).

Politics will have an effect on FDA policies in 2021, including with respect to the ongoing COVID-19 response, manufacturing, compliance, digital health, laboratories, user fees, device servicing, and more.

Mounting anxiety over how to control the spread of infectious disease outbreaks encourages public and political discourse of bioethics.

As we’re all painfully aware, public health issues dominated 2020 and with the country’s attention focused on COVID-19 testing, status, transmission and care, HIPAA went mainstream. Health information became critical not only for health care providers, but for all manner of businesses, employers, property owners, and the national media. HIPAA – or more often than not “HIPPA” – was frequently touted in the news and on social media as the reason why COVID-related information could or could not be shared. As we head into 2021 with the pandemic raging on, the vaccination program underway, and a new administration taking over, here is a look at what we expect for “HIPPA” in 2021.

The new COVID-19 stimulus package is now law. As discussed herein, it provides some employers an incentive to extend COVID-19 related FFCRA leave benefits through Q1 2021.

In addition to the incredible work of agency scientists and reviewers to get the first COVID-19 vaccines authorized for emergency use in December (as we covered in Part 2 of our year-end post), the Food and Drug Administration (FDA) has continued to make substantial progress on its non-COVID priorities as well, which we cover in this part 3 of our year-end post.

Following up on our colleagues’ post earlier this month covering the Food and Drug Administration’s 2020 device law and policy activities, this post will explore prescription drug and biologic law and policy developments over the past year. We’ll also begin looking forward into 2021 and the agency’s transition to an incoming Biden Administration.

Late on December 21, 2020, the Senate debated and approved a COVID-19 relief package and omnibus spending bill for 2021 that included, deep in its 5,500-plus pages, tax extenders for a selection of renewables tax credits, including a one-year extension for the wind production tax credit ("ITC") and a two-year extension for the solar investment tax credit ("ITC"), as well as a five-year extension for offshore wind projects taking the ITC. The bill, which was earlier approved by the House, is expected to be signed by President Trump later this week.

On December 15, 2020, United States Citizenship and Immigration Services (USCIS) announced that it is still experiencing delays in issuing receipt notices for filed petitions and applications.

The EEOC has updated its guidance regarding mandatory vaccination in the workplace and has outlined the permissible scope of a mandatory vaccination program. While the guidance has neither the force nor application of a statute or regulation, it provides a compelling structure for a legally compliant mandatory workplace vaccination program.

What a year for the Food and Drug Administration! FDA, an agency with regulatory oversight of 20-25% of products on which consumers spend, including food and medicines, but which typically stays out of the limelight, was thrust into the public eye amidst the COVID-19 pandemic. This was the year many Americans became familiar with lesser-known and niche policies like those governing emergency use authorizations (EUAs) and with the role of FDA in regulating laboratory developed tests (LDTs). The agency also took some flak for seeming to bow to political pressure in authorizing hydroxychloroquine for emergency use as a potential COVID-19 treatment, then rescinding the authorization, as well as for its less-than-accurate pronouncements of positive data concerning convalescent plasma treatment. These were reminders that the agency Americans trust to protect the public does get things wrong sometimes and is susceptible in some ways to political pressure, and that effectively ensuring the public health requires a balance between safety and effectiveness and patient access to medical products. As we look ahead, we eagerly anticipate how FDA will protect and promote public health in a Biden administration. In this post we’ll explore the FDA’s device law and policy activities from 2020.

Mintz Member Jennifer B. Rubin authored an article published by Law360 that examined legal challenges employers face as they contemplate the impact of the coronavirus vaccine on the workforce, and how mandatory vaccination programs may create a workforce of immuno-haves, or those who have received the vaccination, and potentially expose employers to employment and consumer claims.

California employers are now subject to three new COVID-19 related reporting obligations when there is a COVID-19 positive employee or employees in their workplaces, including: reporting to their (1) workers’ compensation carrier, (2) employees and other workers, and (3) local public health authority. We address each obligation below.

The fiscal year 2021 (“FY2021”) budget process has been anything but typical. Shortly after Governor Baker’s budget proposal was released in January, the COVID-19 pandemic struck, reorienting the legislative calendar for the remainder of the 2019-2020 legislative session.

In the inaugural episode of Mintz’s Health Law Diagnosed, Dianne Bourque (Member, Mintz Health Law Practice) discusses why HIPAA is so engrained in our collective consciousness, how it was already equipped to handle public health emergencies, and the important changes made over the last several months to address the COVID-19 outbreak.