It's that time of year again – CLE Compliance season! With the impact of COVID-19, we know many of our clients have found it challenging to meet their annual CLE requirements. Bradley is pleased to offer you a complimentary, online CLE addressing key topics with thought-leading speakers from inside and outside of Bradley. This CLE program includes 1 ethics hour and 2 general hours ...
On Nov. 20, 2020, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) issued two final rules, which implement changes to the Physician Self-Referral Law (Stark Law) and the Anti-Kickback Statute (AKS) regulations (respectively the CMS Final Rule and the OIG Final Rule, collectively the Final Rules) ...
With many medical practices and healthcare practitioners moving to telemedicine during the COVID-19 pandemic, questions abound on legal requirements, privacy, and the future of healthcare. Schwabe’s Healthcare team has taken a closer look at the legal issues surrounding the rise of telemedicine during the pandemic and the implications for our healthcare future in the four articles below ...
On November 12, 2020, the Washington Supreme Court extended corporate attorney-client privilege protection to appropriate ex parte communications between defendant hospitals and their non-employee agents. The court’s decision in Hermanson v. MultiCare Health Sys., Inc ...
Trademark owners with registrations in EU where the UK is designated should soon receive notification for treatment of registrations and applications following the Brexit transition period. The Brexit transitional period, during which EU laws and rights have continued in force in the UK, will end on December 31, 2020. Thereafter, EU Trade Mark and Design applications and registrations (and designations of the EU) will only cover the remaining 27 EU member states ...
By resolution adopted on October 7, 2020, the state of emergency has been extended until January 31, 2021 ...
The Ohio Board of Pharmacy (Board) recently issued updated guidance detailing certain conduct pharmacists and other regulated personnel (Licensees) must report to the Board ...
The legal status of CBD, a naturally occurring compound found in the cannabis plant, is murky. Certain Member States are more restrictive about it than others. The Court of Justice of the EU has very recently provided clarification in the context of a preliminary ruling (case C-663/18 of 19 November 2020). This case revolves around CBD’s ban in France, after it had been imported from the Czech Republic where it was lawfully produced ...
The Centers for Disease Control and Prevention has expanded the definition of close contact to now evaluate exposure cumulatively over a 24-hour period such that “15 cumulative minutes of exposure at a distance of 6 feet or less can be used as an operational definition for contact investigation,”[1] Because the newly expanded definition is not limited, it impacts many different industries (inclu
With the Universal Community Testing Programme for COVID-19 detection by the Hong Kong Government and temperature screening in the workplace, the collection and use of biometric data (such as DNA samples, fingerprints and facial images) have raised concerns among the public. In August 2020, the Privacy Commissioner (PC) has updated its guidance note on how data users should collect and use biometric data in compliance with the Personal Data (Privacy) Ordinance (Guidance Note) ...
On November 16, 2020, the Office of Inspector General of the Department of Health and Human Services (OIG) issued a Special Fraud Alert addressing the fraud and abuse risks of speaker programs that are commonplace in the pharmaceutical and medical device industries ...
On November 12, 2020, the Federal Trade Commission (FTC) sued to block the acquisition of two Memphis-area hospitals by Methodist Le Bonheur Healthcare. Eleven months earlier, on December 12, 2019, Methodist entered into an agreement with Dallas-based Tenet Healthcare Corporation to purchase Saint Francis-Memphis and St. Francis-Bartlett (along with their associated physician practices, urgent care centers, and other ancillary care providers) for $350 million ...
A minority of states have enacted statutes and taken other action to protect business owners from claims by persons who allegedly were infected by COVID-19 on their premises.1 The purpose of this article is to compare these statutes and discuss some of the differences between them. This article addresses statutes in effect as of October 27, 2020. The article does not address pending legislation ...
The Ohio Department of Health’s July 23, 2020 Order regarding facial covering mandates has been amended in light of the increasing number of COVID-19 cases in Ohio. The order became effective today, Nov. 16, 2020. See the order here. This new order includes the following additional mandates for retail stores (enterprises offering goods to the public) only. 1. Each business will be required to post at all public entrances to the store: A. A face covering requirement sign; B ...
On November 16, 2020, the Department of Health and Human Services Office of Inspector General (HHS OIG) issued Special Fraud Alert: Speaker Programs (Fraud Alert) to “highlight the fraud and abuse risks associated with the offer, payment, solicitation, or receipt of remuneration relating to speaker programs by pharmaceutical and medical device companies ...
In this report, you will find a summary of two important decrees published yesterday in the Official Gazette. Regulatory Decree of Law No. 27,350 of medical and scientific research on the medicinal use of the cannabis plant and its derivatives By means of Executive Branch’s Decree No ...
The HHS Office for the National Coordinator of Health Information Technology issued an interim final rule on October 29, 2020, extending the compliance date for the information blocking rule under the 21st Century Cures Act to April 5, 2021 ...
The Joint Resolution No ...
Introduction The rapid spread of COVID-19 pandemic has led to a significant increase in demand for medical devices (MDs) and personal protective equipment (PPE), masks for social use (textile articles) and other products destined to prevent the spread of the disease. As a result, it became clear that there was insufficient supply to meet existing needs during the state of emergency and the subsequent period ...
IP landscape While the world is in the grip of the deadly COVID-19 pandemic, the patenting of pharmaceutical and biological compositions and the launch of generic products is even more hotly debated than before, particularly in the world's developing and least-developed countries ...
If a branded medicine and its generic version are put on the EEA market by economically linked undertakings, is a parallel importer then allowed to rebrand and repackage the imported generic version as the branded reference medicine? This has been a hotly debated issue in recent years and recently led the Brussels Court of Appeal (CoA) to refer three questions to the European Court of Justice (ECJ) (Cases C-253/20 and C-254/20) ...
Belgium is, for the second time, in lockdown. The new Ministerial Decree of 1 November 2020 stipulates that, as from today until 13 December 2020, all workers are obliged to telework. However, an exception applies when either the employee’s role or the continuity of business operations, activities and services does not allow for teleworking ...
On October 20, 2020, San Francisco County was upgraded to the “minimal” tier within the California COVID-19 tracking system, meaning it has the fewest restrictions on reopening all businesses as promulgated by the State of California. In order to qualify for the “minimal” tier, a county must have an infection rate of less than one daily new positive COVID case per 100,000 residents and have a positive test rate of less than 2% for two consecutive weeks ...
On October 20, 2020, San Francisco County was upgraded to the “minimal” tier within the California COVID-19 tracking system, meaning it has the fewest restrictions on reopening all businesses as promulgated by the State of California. In order to qualify for the “minimal” tier, a county must have an infection rate of less than one daily new positive COVID case per 100,000 residents and have a positive test rate of less than 2% for two consecutive weeks ...
