Tag Archives: EpsteinBeckerGreen

Every HIPAA Waiver Has Its Thorn

On March 17, 2020, the Office for Civil Rights’ (“OCR”) announced that—for the duration of the COVID-19 emergency—it would exercise enforcement discretion and waive any potential penalties for HIPAA violations relating to health care providers’ use of “everyday communications technologies” in the provision of services via telehealth (the “HIPAA Waiver”). This move has resulted in a drastic increase in the number of telehealth encounters. The HIPAA Waiver has enabled many providers to immediately leverage these technologies to render services via telehealth for the first time, without the need to expend significant resources to quickly ramp up a HIPAA-compliant telehealth platform. A summary of the HIPAA Waiver can be found in a recent blog post. While the HIPAA Waiver applies only temporarily, it is likely that the increased reliance on telehealth evidenced over the past three months is here to stay.

Read full article

NJ Governor Again Increases Permissible Size of Gatherings and Clarifies the Meaning of “Outdoor Area” for Purposes of Outdoor Dining

On June 22, 2020, New Jersey Governor Phil Murphy issued Executive Order 156  (“EO 156”), which, effective immediately, increases the permissible number of attendees at indoor and outdoor gatherings from the limits he established in Executive Order 152  (“EO 152”) (which we wrote about here).

Read full article

Current Good Manufacturing Practices in the Time of COVID-19: FDA Announces New Expectations on Risk Assessment and Risk Management

FDA recently published its “Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing Guidance for Industry” (“Guidance”) which provides suggestions on managing the potential risk of products being contaminated by SARS-CoV-2, the virus behind COVID-19 infections for drug and biological product manufacturers, 503B outsourcing facilities, and 503A compounding pharmacies.

The Guidance builds on the current Good Manufacturing Practices (cGMPs) regulations for drugs and biological products, which require personnel with an illness that could adversely affect drug safety or quality be excluded from direct contact with drugs and drug components used in manufacturing.[1]  As the Guidance states, preliminary research indicating that SARS-CoV-2 “is stable for several hours to days in aerosols and on surfaces,” and that it has an incubation period of 2 to 14 days, which are both factors that increase the risk of spread and introduction into products.  The actual health risk is hard to calculate – FDA itself notes that there have not been documented transmissions through pharmaceuticals to date.  The regulatory risk, however, is an easier formula – FDA has a clear expectation that drug and biological product manufacturers evaluate the potential for COVID-19 contamination of their products under existing controls, or risk being out of compliance with cGMPs.

Read full article

FDA PDMA Guidance in Response to COVID-19 Pandemic

The FDA has issued the Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency.  The Prescription Drug Marketing Act of 1987 (PDMA) describes manufacturers’ drug sample storage, handling, and recordkeeping obligations as well as the written request and receipt requirements for prescribers.

Read full article

Texas Local Governments Impose New Face Covering and Health and Safety Plan Requirements Upon Employers, As COVID-19 Cases Surge

For the last two weeks, Texas is continuing to break records for daily coronavirus cases and hospitalizations.  According to the Texas Department of State Health Services, on June 23, 2020 Texas had the highest daily number of COVID-19 cases (5,489) since the pandemic began, and for twelve consecutive days had record-high hospitalizations.  Also on Wednesday, June 23rd, Houston Mayor Sylvester Turner said 97% of the intensive care unit beds in Houston are filled. Governor Abbott acknowledged this week that there is a massive outbreak of COVID-19 across the state of Texas, and announced that his office is examining greater localized restrictions.  Since June 3, Texas has been in Phase III of reopening, whereby all businesses in Texas are permitted to operate at up to 50% capacity, with very limited exceptions, and since June 12, 2020, restaurants have been permitted to expand their occupancy levels to 75%.

Read full article

Addressing Data Privacy and Security Provisions in COVID-19 Related Service Provider Agreements and Beyond

Employers’ engagement and use of various types of vendors has expanded recently, to include vendors who assist with office re-entry screening and contact tracing as employees return to work during the COVID-19 pandemic.  The service agreements that are negotiated and executed for this purpose should sufficiently address data privacy and security considerations related to employee personally identifiable information (PII). This is necessary for any service provider or vendor agreement.   In the absence of a federal law governing data security and breach notification of employee PII, employers must comply with increasing state and local legal requirements to ensure the protection of employee PII which employers obtain in the normal course of employment.  Many states have breach reporting laws that apply to data held by employers, such as employee social security numbers.  Other states, such as New York, have laws encompassing PII breach reporting and mandating certain data protections.  For example, the New York Stop Hacks and Improve Electronic Data Security Act (“Shield Act”) requires employers to implement a cybersecurity program providing protective measures for New York resident-employees’ PII.

Read full article

New Jersey Governor Allows Certain In-Person Higher Education to Resume on July 1

On June 18, 2020, New Jersey Governor Phil Murphy issued Executive Order 155 (“EO 155”), which as of July 1, 2020, allows degree-granting public and private institutions of higher education (“IHE”) to resume instruction that cannot be readily taught other than in-person.  Specifically, EO 155 allows resumption of in-person labs, technical, clinical, or hands-on instruction, with enhanced health and safety protocols.

IHEs that are authorized and intend to resume in-person instruction pursuant to EO 155 must submit a restart plan to the Secretary of Higher Education (the “Secretary”), in accordance with the Restart Standards for All New Jersey Institutions of Higher Education, no later than 14 days prior to the expected date of implementation of the plan. Certain IHEs that had previously received a waiver to hold in-person instruction pursuant to Executive Orders No.104 and 107 (2020) must do so by July 2, 2020 (i.e., within two weeks of E.O. 115’s date of issuance).

Read full article

UK Update: What Employers Need to Know About the Coronavirus Job Retention Scheme

As we previously reported, the COVID-19 pandemic has affected many employers and employees throughout Europe. Since mid-March 2020, the Government of the United Kingdom has implemented several measures and guidance to address the economic impact of the COVID-19 pandemic. Similar to other European jurisdictions, one such measure is the Coronavirus Job Retention Scheme (“CJRS”), designed to help employers retain their workforce. Currently, the CJRS provides partial subsidized wages to approximately 7.5 million UK employees across 935,000 employers. Recently, the UK has provided updates to the CJRS, including an extension of partial wage replacement grants and a shift toward allowing part-time work.

In late March 2020, Chancellor of the Exchequer Rishi Sunak announced the implementation of the CJRS. Under the CJRS, all UK employers with Pay As You Earn (“PAYE”) payroll schemes that were opened and in use on or before February 28, 2020 may apply for wage replacement grants to distribute to their furloughed employees. The CJRS recently has been extended to October 31, 2020.

Read full article

Special Immigration Alert: President Trump Expands Immigration Restrictions, DHS Extends Flexibility for Verifying Forms I-9, and More

Presidential Proclamation Temporarily Suspends New H-1B, H2B, J-1, and L-1 Visa and Travel from Abroad

On June 22, 2020, President Trump issued a proclamation (“Proclamation”) suspending and limiting the entry of individuals into the United States in the following employment-based nonimmigrant visa categories:

  1. H-1B or H-2B visas, and their H-4 family derivatives;
  2. J-1 visas, and their J-2 family derivatives; and
  3. L-1 visas, and their L-2 family derivatives.
Read full article

Virginia Prohibits Non-Compete Agreements with “Low-Wage” Workers

Virginia may be for lovers, but it no longer loves non-compete agreements.  Starting on July 1, 2020, employers may not “enter into, enforce, or threaten to enforce” a non-compete agreement with any “low-wage employee.”  As previously reported, this law is just one of the many new employment laws enacted during the 2020 legislative session.

Read full article