The COVID-19 pandemic has exposed the difficulties in reacting at European level to a major health crisis and the intention of the European Commission is to respond more effectively to future problems in the area of health. As a result, it is currently conducting an initial assessment of possible legislative changes in the area of medicinal products for human use ...
When President Biden announced in December 2020 that he intended to nominate California Attorney General Xavier Becerra to head the Department of Health and Human Services (HHS), the appointment raised eyebrows in certain policy circles. Becerra does not fit the typical administrative profile of past HHS heads. In fact, he has no actual experience in health care or public health policy. Rather, his background is primarily rooted in law enforcement ...
Did you know? The Chinese National Intellectual Property Administration (CNIPA) revised Patent Examination Guidelines came into force on 15 January 2021. The changes significantly relax the patentability requirements for inventions in the pharmaceutical, chemical and biotech field. Why does this matter to you? The revised guidelines focus on the examination criteria for novelty and inventive step in relation to the rapidly developing field of chemical and biotech inventions ...
On March 26, 2021, the Internal Revenue Service (“IRS”) published Announcement 2021-7, which notifies taxpayers that certain amounts paid for personal protective equipment (such as masks, hand sanitizer, and sanitizing wipes) for the primary purpose of preventing the spread of COVID-19 (“COVID-19 PPE”) may be an eligible expense that can be reimbursed from certain health care account based plans ...
Further to the decline of the Covid-19 spread in Israel after the successful vaccination rollout, Israel has announced changes in foreign entry policy into the country, which will allow, among others, the regular entry of foreign experts and businessmen. These reliefs come after several months in which the state borders were almost completely closed to foreigners ...
A new bill in the California Assembly has the potential to alter substantially the existing legal framework of products liability for online retailers. Assembly Bill No. 1182 (“AB 1182”), which was introduced on February 18, 2021, would impose strict products liability on online retailers who (1) communicate offers of sale and (2) facilitate payment between a third-party seller and a purchaser, even if the online retailer never takes physical possession of the product ...
On April 8, 2021, the Center for Medicare & Medicaid Services (“CMS”) announced a proposed rate increase of 1.3 percent for skilled nursing providers in fiscal year 2022. It is estimated this will result in approximately $444 million increase in payments to skilled nursing facilities (SNF) under Medicare Part A for the fiscal year. This increased payment rate does not incorporate the SNF Value-Based Program (VBP) reductions that CMS estimates to be $184 ...
Gennex Media LLC, a customizable product online marketplace, and its sole officer and shareholder Akil Kurji, have agreed to an FTC consent decree resolving allegations the company falsely claimed its Brandnex novelty products were “Made in USA,” “USA MADE,” and “Manufactured Right Here in America!” when, in many instances, they were wholly imported from China ...
On 24 March 2021, the EU Member States agreed to begin negotiations with the European Parliament concerning a legislative proposal on health technology assessment. Health technology includes medicinal products, medical devices or medical and surgical procedures, as well as measures for disease prevention, diagnosis or treatment used in healthcare ...
Research and development ("R&D") of medicinal products is fundamentally important in peoples’ daily lives. This is true both from an individual perspective – when considering the objective of identifying and treating pathologies (with a consequent increase in the quality of life of patients) – and from a collective perspective, when considering the role of R&D in controlling the spread of diseases and in eradicating them altogether ...
Food producers can breathe a sigh of relief, at least temporarily, thanks to efforts by the California Chamber of Commerce resulting in a preliminary injunction barring the State of California and all private plaintiffs from filing any new Proposition 65 lawsuits targeting acrylamide in food and beverage products. On March 31, 2021, Chief United States District Judge for the Eastern District of California, Kimberly J ...
It has been a long road for everyone’s favourite cheese. The protection of halloumi cheese should have never been complicated. The firm cheese which has the unique quality of retaining its shape even when fried or grilled, has its origins in the island of Cyprus where it has been produced for many centuries ...
Wellbeing, selfcare is key in order to give the world the best of you, not what’s left of you…. Shoosmiths’ Learning & development Manager, Yvonne Oakenfull gives us an insight into HeartMath – how different patterns of the heart activity have different effects on your thoughts and behaviours ...
ENSafrica recently released Africa Regulatory Insight: Coronavirus (COVID-19) Regulatory Measures. This comprehensive report outlines the COVID-19 regulatory measures for each country across Sub-Sahara Africa, providing the sector, measure, effective date/status and key points and impact for each region. The information provided herein is intended to provide a general overview, and is not an exhaustive list of all legislatice developments across Sub-Sahara ...
The government’s recently announced low-carbon industrial sector strategy, supported by over £1 billion in funding to cut emissions from industry and public buildings, if nothing else, shows great ambition but does it also deliver the wherewithal to achieve those objectives? It builds on the proposals in the Energy White Paper which themselves expanded upon the Ten Point Plan for a Green Industrial Revolution announced by Prime Minister in November last year ...
On March 22, 2021, through a televised address, the President of the Republic announced the strengthening and extension of the Social Protection Network, destined to mitigate the adverse effects caused by the restrictions due to the COVID-19. These measures are based on 5 pillars: • Greater protection to the families’ incomes. • Strengthening of the middle-class support. • Greater job protection ...
Beginning of Stage 2 of the National Vaccination Plan The Colombian Ministry of Health and Social Protection (Minsiterio de Salud y Protección Social) declared the initiation of stage 2 of the National Vaccination Plan against COVID-19 for the population between 60 and 79 years of age. This does not mean that vaccination for those over 80 years of age will be stopped; these people will continue to be vaccinated without any interruption ...
President Biden signed the American Rescue Plan Act of 2021 (the Act) on March 11, 2021. The Act provides COBRA premium subsidies, increases the tax-exclusion amount for employer-sponsored dependent care assistance programs and expands who may be eligible to receive premium tax credits for marketplace coverage. This alert explains how these provisions may impact your welfare benefit plans. Please contact your Dykema benefits attorney to explore the new provisions in greater depth ...
Now that we have persevered through one year of the COVID-19 pandemic, much has been written about pandemic fatigue and associated social isolation, mental stress, and anxiety. Employers may be seeing an increase in the incidence of mental illness claims in their workplaces ...
As a reminder to our life sciences clients including drug manufacturers, medical device manufacturers, and group purchasing organizations, all Open Payments data from the 2020 program year must be reported to CMS by no later than March 31, 2021. Organizations that participate in the Open Payments program are also reminded that they must submit a final attestation that their data is timely, complete and accurate in addition to reporting data from fiscal year 2020 ...
Courts nationwide have struggled for years with the question of when a subjective opinion is false under the False Claims Act. The Supreme Court’s decision to deny review of two cases involving health-care providers that had allegedly submitted false claims for payment based on subjective clinical judgment still leaves us without a uniform, national answer, says Nicholas A. Danella. The U.S ...
On March 9, 2021, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) announced a 45-day extension of the public-comment period for the Notice of Proposed Rulemaking (NPRM) to modify the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. OCR first released the NPRM to the public on the HHS website on Dec. 10, 2020, and it was published in the Federal Register on Jan. 21, 2021 ...
On March 10, 2021, the Centers for Medicare & Medicaid Services (CMS), in association with the Centers for Disease Control and Prevention (CDC), issued updated guidance for nursing homes to resume visitation options during the COVID-19 pandemic. Nursing homes have been devastatingly effected by COVID-19, with outbreaks causing high rates of infection and death ...
In connection with the adoption of a new law on the ethical treatment of clinical trials of medical devices, the Folketing has made a number of changes to the rules on the affiliation and financial support of pharmaceutical and medical companies to healthcare professionals. The amendments will enter into force on 26 May 2021 ...
