June 30, 2020
Last week, Illinois moved in to “Phase 4” of the state’s five-stage Restore Illinois Plan (the “Plan”). As part of this transition, the Illinois Department of Commerce and Economic Opportunity issued updated, industry-specific Phase 4 Guidelines (the “Guidelines”).
From an employer compliance standpoint, the transition from Phase 3 to 4 is not a radical change. Rather, the transition primarily involves loosened restrictions for already open businesses, and the reopening of additional industries (such as indoor recreation facilities like bowling alleys and skating rinks). Social distancing and other guidelines introduced in Phase 3 remain in effect. For an in-depth review of these guidelines, please see our advisory on Illinois and Chicago’s Phase 3 Reopening Guidance.
June 30, 2020
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.
June 30, 2020
Featured in #WorkforceWednesday: Attorney Denise Dadika examines the unique challenges health care employers face as they ramp business back up and reopen for both patients and employees.
June 30, 2020
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).
June 29, 2020
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. 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.
June 26, 2020
Featured in #WorkforceWednesday: As businesses across the United States open up, workers may increasingly turn to unions to help support their safety. Employers should take steps to properly prepare for this resurgence in union activity. Attorney RyAnn Hooper explains more.
June 26, 2020
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.
June 25, 2020
The ILN’s Labor & Employment Group has put together a summary document, addressing the question, “In the UK the government has stepped in with unprecedented aid such as paying 80% of employees’ salaries who are at home and not working up to £2500 per month. There are also a raft of other financial measures. What measures have been enacted in your jurisdictions, and what are the impacts?” Click the guide below to see responses from 11 jurisdictions.
June 25, 2020
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%.
June 24, 2020
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.