Key Notes FDA announces flexible approach to enforcement of Nutrition and Supplement Facts labeling requirements for small food manufacturers and manufacturers of packaging for single-ingredient sugars, in part due to the impacts of COVID-19. The FDA adopted final rules updating the Nutrition and Supplement Facts1 labeling requirements (the “Rules”) that are effective on Jan ...
Complementary Law No. 175/2020, enacted in September 23, 2020, determined that the Service Tax (ISS) must be shared between the municipalities where the service providers and the clients are located. Complementary Law No. 175/2020, enacted in September 23, 2020, determined that the Service Tax (ISS) must be shared between the municipalities where the service providers and the clients are located ...
Key Points Under Assembly Bill 685, Cal/OSHA can shut down a worksite if the worksite exposes employees to a COVID-19 related imminent hazard. AB 685 subjects employers to increased notification requirements that must be met within one business day of a potential exposure to COVID-19. Employers must notify local public health agencies of all workplace COVID-19 outbreaks amongst employees. Cal/OSHA can now issue serious citations more quickly. On Sept ...
On Sept. 14, 2020, Ohio Governor Mike DeWine signed into law a bill, which provides significant protections against tort claims arising from COVID-19 to all entities, including individuals, businesses, health care providers, property owners, government entities, churches, and schools. Amended Sub ...
San Francisco’s Department of Public Health (“SFDPH”) issued yet-another update to its Shelter-in-Place Order, C19-07, on September 14, 2020 (now up to version “i”). This order has been frequently modified to reflect changes in other state and local directives, as more is learned about the disease and as more businesses are allowed to re-open ...
On 12 September 2020, the UAE Ministry of Health and Prevention (MoHAP) reported 1007 new COVID-19 cases in the UAE. With the number of cases rising both within the UAE and in most other countries, the UAE government has reiterated the importance of adhering to preventive guidelines and has further placed safeguards, particularly in Abu Dhabi, to ensure that those traveling to the UAE are confined to prevent the transmission of the virus ...
Presidential Decree no. 229/20 of 8 September 2020 has been published and its aim is to reassess the measures imposed by Presidential Decree no. 142/20, considering the evolution of the epidemiological situation. The new decree renews most of the measures already in force, although it also eases some restrictions ...
Coronavirus Digest no. 4 Patents and other intellectual property rights 1. Patents Moderna reveals that it may not hold the patent rights for the vaccine against Covid-19, because it was not the first to file the patents. This came after the US National Institute of Health claimed co-ownership of the rights to this vaccine. Read more here ...
The International Trade Commission (ITC) sits in a nondescript office building about a block farther south of the National Mall than tourists usually care to venture. Patent owners come from around the country to this tree-lined street in Washington, D.C., to seek a powerful remedy to protect their patented products: an exclusion order. An exclusion order directs U.S. Customs and Border Protection to block infringing imports at the United States border ...
Key Points On Aug. 25, 2020, the Centers for Medicare and Medicaid Services (CMS) published an interim final rule with a comment period (IFC) establishing new Long-Term Care Facility COVID-19 Testing Requirements for Staff and Residents. CMS has added 42 CFR §483.80(h), which requires that the facility test all residents and staff for COVID-19. Noncompliance related to this new requirement will be cited at new tag F886 ...
Key Points HHS Provider Relief Fund payments are being extended to private pay assisted living facilities under Phase II. Relief will be equal to 2 percent of annual gross revenue from resident care. Interested providers must act swiftly: the deadline to submit basic information to HHS is Sept. 13 Provider relief funds need not be repaid if recipients comply with the program criteria. HHS Announcement: On Sept.1, the U.S ...
As many will know, Federal Law 18 of 1981 (the Commercial Agency Law; or CAL) regulates agency, distributorship and franchise relationships in the UAE, regardless of the nomenclature used to describe them ...
The Department of Justice is stepping up its scrutiny of health-care fraud, especially in testing laboratories, during the Covid-19 pandemic. Former federal prosecutor Jason Mehta, a partner with Bradley, says now is not the time to tout profits over patient care and offers insights on compliance. In the midst of a global pandemic, much attention and praise is rightfully being showered on health-care providers ...
Skilled nursing facilities have faced unprecedented challenges since the outbreak of the coronavirus pandemic. Individuals with many high-risk characteristics are the typical patients of these facilities. Add to this, necessarily close proximity of these patients, scarcity of personal protective equipment and shortage of testing common across the healthcare industry, and you have a perfect storm of increased risk with limited options for mitigation ...
On August 6, 2020, the U.S. Court of Appeals for the First Circuit affirmed the conviction of Massachusetts gynecologist Rita Luthra for criminal HIPAA violations and obstructing a health care investigation. Although such HIPAA prosecutions are uncommon, the case underscores the risks health care providers and others run when handling protected patient information and when speaking with government investigators ...
In an August 14, 2020 response to a letter written on behalf of the American Seniors Housing Association and Argentum, the General Counsel’s office of the Department of Health and Human Services has determined that senior living communities are a “covered person” under the Public Readiness and Emergency Preparedness (PREP) Act, which creates immunity from liability for the administration or use of “Covered Countermeasures” in response to COVID-19 ...
Did you know? The new Trade Marks (Amendment) Ordinance 2020 which came into effect on 19 June 2020 empowers the Registrar of Trade Marks to make the rules for implementing the long-awaited Protocol Relating to the Madrid Agreement Concerning the International Registration of Marks (the “Madrid Protocol”) in Hong Kong ...
Key Points New York federal district court vacates the DOL’s “health care provider” definition in the DOL’s Final Rule implementing the Families First Coronavirus Response Act. The court also vacates the DOL’s employer consent requirement for intermittent leave and the “unable to work” requirement for receipt of leave benefits. The national impact of the decision is currently unknown as the DOL contemplates next steps ...
Electronic cigarettes and vaping have been heralded by many as a safer alternative to smoking traditional cigarettes. An outbreak of illnesses last fall allegedly related to vaping, however, ignited public hysteria and will almost certainly lead to substantial mass tort litigation aimed at manufacturers of e-cigarette devices and vaping liquids ...
The Department of Labor’s Wage and Hour Division (WHD) recently released streamlined forms employers may use to coordinate leave under the Family and Medical Leave Act (FMLA) ...
As workplaces continue to reopen, the U.S. Department of Labor (DOL) and Centers for Disease Control and Prevention (CDC) issued additional guidance addressing various return to work issues and leave under the Family and Medical Leave Act (FMLA) and Families First Coronavirus Response Act (FFCRA). The new DOL guidance, summarized below, appears on the DOL’s FFCRA Questions and Answers page ...
California’s cannabis-related businesses will face a dual battle in complying with Proposition 65 requiring businesses to warn the public about cancer-causing chemicals present in products they purchase, writes Buchalter’s Anne Marie Ellis. Businesses are going to have to change their labeling and packaging to list marijuana smoke as a reproductive toxicant and cancer causing agent ...
The Food and Drug Administration (“FDA”) issued its Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry on June 30, 2020. This nonbinding guidance is intended to remain in effect for the duration of the COVID-19 public health emergency declared by the Secretary of Health and Human Services. The guidance advises vaccine development and licensure following the standard trial progression but on an accelerated timeline ...
