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 ...
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 ...
Law is an ever-evolving social construct and remains effective only insofar as it can be updated in a timely manner to keep up with real-life developments. The relevance of laws and their subject matter is always dictated by present-day realities and circumstances ...
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 ...
On August 26, 2020, Resolution No. 000093-2020-PRE/INDECOPI was published in the Official Gazette “El Peruano”, which adopts the Directive that establishes the procedure for payment of rewards under the scope of Article 28 of the Single Ordered Text of the Law for the Repression of Anticompetitive Conduct (the "Directive" and the "Competition Law", respectively) ...
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 ...
On August 25, 2020, Board Resolution No. 003-2020-EF/68.0 was published in the Official Gazette “El Peruano”, approving the “Guidelines for the State's response to the potential impacts of the COVID-19 pandemic on Public Private Partnership projects” (the “Guidelines”) ...
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 ...
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 ...
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 ...
In July, the German Federal Ministry for Economic Affairs and Energy (BMWi) compiled a draft law on data protection and the protection of privacy in the context of electronic communication and telemedia (the “Telecommunications and Telemedia Data Protection Act” [Telekommunikations-Telemedien-Datenschutz-Gesetz],“TTDSG”) – which has not yet been officially published ...
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 ...
With federal privacy legislation stalled and indefinitely delayed, states have moved forward to push an impressive number of privacy laws forward over the last several years. Some of these laws are still relatively obscure, but are being increasingly enforced by state regulators and through litigation ...
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 ...
The Baden-Württemberg Commissioner for Data Protection and Freedom of Information (LfDI) has imposed a fine of €1,240,000 on the AOK Baden-Württemberg health insurance provider. The reason? Data processing errors related to prize draws it ran: the health insurance provider had not obtained the valid consent for data processing of prize draw entrants in 500 cases. An internal whistleblower notified the LfDI about the breach ...
On 22 July 2020, data protection authorities from Australia, Canada, Gibraltar, Hong Kong, Switzerland and United Kingdom (together the Authorities), issued an open letter (Letter) on global privacy expectations of video teleconferencing companies (VTC companies)[1]. Why there is such a Letter? As a result of the COVID-19 pandemic, the Authorities have witnessed an increasing use of VTC tools, both in social and business contexts ...
