As we continue to be bombarded daily with the relentless 24/7 news cycle regarding Coronavirus Disease 2019 (COVID-19), the reality is that healthcare employees are currently the most likely to be exposed to the disease in the United States. Accordingly, healthcare employers must start, or continue, to think about the various situations that may arise in the workplace and the multitude of laws that may apply ...
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 ...
Introduction The recent spread of the coronavirus around the world is justifying significant concern among senior living operators and raising questions about how to prepare for and respond to the possibility that the disease will affect residents, staff, and visitors. This concern is exacerbated by the fact that seniors tend to be more vulnerable to such communicable diseases and live in close quarters with others at the community, sharing meals and participating in group activities ...
EUIPO On 16 March 2020, the Executive Director of the European Union Intellectual Property Office (EUIPO) has issued Decision No EX-20-3 extending all time limits expiring between 9 March 2020 and 30 April 2020, that affect all parties before the Office, to 1 May 2020. In principle, the new deadlines will not be communicated to the parties on a case-by-case basis ...
INFARMED has published a set of exceptional measures – which will remain in force during the period of risk to public health – to be adopted by sponsors, clinical trial sites, and research teams, to guarantee the safety, protection and rights of clinical trial subjects.It has also defined INFARMED’s evaluation of trials intended to treat or prevent the new Coronavirus disease (SARS-CoV-2) as a priority ...
The rapid spread of the new Coronavirus (SARS-CoV-2) and the Covid-19 pandemic have led to a very significant increase in demand for medical devices (MDs) and personal protective equipment (PPE), and there was insufficient supply to meet existing needs during the state of emergency and the period that will immediately follow it ...
INFARMED and the DGS have published a set of guidelines for manufacturers and wholesale distributors of medicinal products for human use. The aim of these guidelines is to ensure supply to the domestic market and, at the same time, to prevent the spread of Covid-19 and protect the employees of these operators ...
Following the differences that came to light with AstraZeneca at the end of last week, the European Commission approved Implementing Regulation (EU) 2021/111 of 29 January 2021, which came into force on Saturday, 30 January. The Regulation prohibits the unauthorised exportation of vaccines against SARS-CoV-2 outside the European Union ...
Brief notes on Commission Regulation 2021/111 of 29 January 2021 Following the differences that came to light with AstraZeneca at the end of last week, the European Commission approved Implementing Regulation (EU) 2021/111 of 29 January 2021, which came into force on Saturday, 30 January. The Regulation prohibits the unauthorised exportation of vaccines against SARS-CoV-2 outside the European Union ...
The recent accounting frauds and corporate scandals have many in-house counsel, as well as directors and officers, re-examining their responsibilities, obligations, and potential liabilities. New legislation, SEC regulations, stock exchange listing standards and public, media and shareholder scrutiny are imposing new or expanded processes for corporate accountability, financial reporting and business practices ...
By: Carol K. Lucas At a time when many are questioning the continued utility and viability of the corporate practice of medicine ban, California may be doubling down. On May 3, 2021, the California Senate Health Committee approved SB-642, the stated purpose of which is to protect medical decision-making from lay control. The bill is currently pending in the California Senate. Assembly Bill AB-705 is a substantially identical bill in the California Assembly ...
Appeared in Lone Star Express, a puclication of the Lone Star Chapter of the Healthcare Financial Management Association, September 2002. The recent reports of corporate fraud, improper accounting practices, and mismanagement have resulted in new legislation and stock exchange standards for publicly-traded corporations. In order to restore confidence in the nation’s financial markets, President George W ...
On December 29, 2022, the Modernization of Cosmetics Regulation Act (“MoCRA”) was signed into law.[1] MoCRA is the first federal cosmetics law since 1938 and will impose a number of new requirements on cosmetic products and the facilities where they are manufactured. Specifically, MoCRA requires the Food and Drug Administration (FDA) to implement enhanced oversight and regulation of cosmetic manufacturing facilities and products by December 29, 2023 ...
The use of telehealth skyrocketed during the COVID-19 public health emergency, as many regulatory barriers restricting its use were temporarily removed at the federal and state level and by private payors. Providers and patients adapted to the changes and are now relying on these flexibilities to deliver and receive high quality virtual care. This rapid expansion of the use of telehealth has ignited the need for permanent telehealth reform ...
The de novo medical device process is a little-used but potentially valuable means of securing approval for your medical device. The pathway was established in 1997 subject to the Federal Food Drug & Cosmetic Act, Section 513 (f) (2). It was designed to employ a risk-based strategy for novel devices that have not yet been classified. Basically, it establishes a new device type including classification, regulation, appropriate controls and product code ...
Upon reconsideration in Gerard v. Orange Coast Memorial Medical Center, Case No. G048039 (March 21, 2017) (Gerard II), the Fourth Appellate District decided that IWC Wage Order 5 is valid and that healthcare employees may waive one of their two required meal periods on shifts longer than 8 hours ...
On 7 August 2019 the Federal Administrative Court annulled a Federal Office of Public Health (FOPH) order that had limited the price increase of a medicinal product on the list of specialities to two years. The product manufacturer had requested a price increase under Article 67(2) of the Healthcare Insurance Ordinance (SR 832.102), having incurred higher costs following the loss of two suppliers ...
On June 5, I wrote about the suspension of the California End of Life Option Act (“EOLOA”) in the wake of Ahn v. Hestrin and several related court proceedings in May. On Friday, June 15, the Fourth District Court of Appeal determined that the EOLOA will in fact remain enforceable pending further proceedings. Thus, eligible Californians who have requested end-of-life drugs in accordance with the EOLOA may continue with the process described in that law ...
The U.S. Department of Health and Human Service’s Office of Civil Rights (“OCR”) has announced that several notifications of enforcement discretion issued during the COVID-19 public health emergency (“PHE”) will expire concurrently with the expiration of the PHE on May 11, 2023 at 11:59 PM ...
The Centers for Disease Control (CDC) reports swimming is the fourth most popular recreational activity in the United States and the most popular recreational activity for children (ages 7 to 17). Statistics further show 36 percent of children and 15 percent of adults go swimming at least six times a year in the United States ...
The impact of the pandemic can be seen across all sectors of society but those who are disabled have been particularly affected, not least because employees with an underlying disability are likely to have been identified as clinically extremely vulnerable and told to shield for considerable parts of the last year. Being away from the workplace and separated from colleagues has left many feeling insecure ...
In this article we look at the impact the COVID-19 pandemic has had on the social and health care sector in the build up to the upcoming Public Inquiry, due to commence in Spring 2022. Upsetting scenes arising from the COVID-19 pandemic included photographs of bereaved families with only six people in attendance at family funerals ...
This 28th edition of Unprecedented, our weekly update on COVID-19-related litigation, includes a number of updates on the mounting number of business interruption coverage disputes -- including a claim against a broker whose alleged failure to obtain infectious disease coverage left the insured without coverage for COVID-19-induced losses ...
