Blakes Continuity Podcast: Entering the COVID-19 Marketplace: Proceed with Care
Former Healthcare Executives Convicted for Health Insurance Policy Fraud Scheme - Steven Dorfman, the former chief executive officer and owner of the Florida-based healthcare company Simple Health, and John Sand, a former...more
The U.S. Justice Department’s COVID-related health care fraud crackdown continues to intensify. On a single day in September 2021, the Justice Department announced criminal charges against 138 defendants in 31 federal...more
CYBERSECURITY & DATA PRIVACY - Virginia Governor Signs Nation’s Second State Consumer Privacy Bill - The Washington Post reported that Governor Ralph Northam signed data privacy legislation into law, making Virginia the...more
President Joe Biden has signed an Executive Order (EO) on America's Supply Chains, mandating a 100-day review of the global supply chains used by key industries in an effort to avoid the shortages in medical equipment,...more
On December 31, 2020, the Federal Emergency Management Agency (“FEMA”) published a temporary final rule again extending and modifying export restrictions on scarce and critical health and medical supplies. The new rule...more
The Office of the United States Trade Representative (“USTR”) announced that it is extending certain product-specific exclusions related to the treatment of COVID-19 from the Section 301 tariffs on imports from China until...more
Eight months into the coronavirus (“COVID-19”) pandemic and employers in both healthcare and non-healthcare settings are grappling with requirements for employees’ use of personal protective equipment (“PPE”) and respiratory...more
In response to the COVID-19 outbreak, and the need to quickly develop medical products and services to fight the virus, the United States Patent and Trademark Office (“USPTO”) is allowing the trademark examination process for...more
- Legislation to bolster the U.S. supply chain for medical equipment becomes an issue of bipartisan focus in Congress. - Differing proposals included in the House and Senate “Phase 4” COVID-relief proposals as well...more
The Government Accountability Office (GAO) recently issued a report to Congress titled COVID-19: Opportunities to Improve Federal Response and Recovery Efforts. Of note, the GAO reports that government-wide contract...more
Report on Supply Chain Compliance 3, no. 13 (June 25, 2020): Chinese auto manufacturer BYD Auto Co. Ltd. received approval from the United States National Institute for Occupational Safety and Health (NIOSH) to sell U.S....more
COVID-19 is transforming the way businesses create products and go-to-market, especially when launching health products during a pandemic, on an expedited timeline. How are they managing the regulatory requirements and public...more
Healthcare providers who received or receive payments from the CARES Act Provider Relief Fund (“PRF”) may only use the payment for permissible purposes, must document and report the proper use, and return any excess funds to...more
Private nonprofit (“PNP”) organizations that own and/or operate medical facilities, such as hospitals and long term care facilities, are eligible for FEMA Public Assistance (PA) Program disaster relief funds. Under the...more
Citing poor quality, the U.S. Food and Drug Administration (FDA) has barred the importation of certain KN95 filtering facepiece respirators manufactured in China. On May 7, 2020, FDA revised and reissued the...more
The COVID-19 pandemic has had profound economic and political effects over the past several months. Increasingly, those effects have led a number of US policymakers, US allies, and others to question certain US sanctions...more
Changes will extend the scope of filing requirements in the healthcare sector and clarify factors for review of foreign investment in German companies. Key Points: ..Acquisitions of at least 10% of German companies that...more
In the midst of the Coronavirus (COVID-19) pandemic, states are closely monitoring companies’ pricing of personal protective equipment, food and other essential supplies. This On the Subject offers an overview of state price...more
An issue of concern for some manufacturers during the COVID-19 outbreak is the issue of potential liability in a product liability lawsuit if they switch their manufacturing process to produce items they don’t normally...more
In response to shortages of Personal Protective Equipment (PPE) critical to limiting the spread of and mitigating the impact of COVID-19, the United States has recently issued a series of rules, memoranda, and other guidance...more
The surge in COVID-19 cases in the past several weeks has had many hospitals scrambling to put in place allocation guidelines for ventilators or other potentially scarce treatment resources. Many forward-thinking state...more
As concern about availability of personal protective equipment (“PPE”) continues to grow amid the COVID-19 pandemic, the federal government continues to take action aimed at increasing the availability of PPE with important...more
In response to widespread shortages of protective masks, face shields and other medical devices and device components (e.g., ventilators and ventilator parts) in light of COVID-19, some colleges and universities with the...more
In recent weeks, the Chinese government has faced criticism from governments around the world about the quality of medical equipment manufactured in China. In response, the Chinese government has adopted measures to...more
On Mach 27, 2020, President Trump signed the CARES Act, providing in part for $100 billion in relief funds to eligible health care providers and suppliers affected by COVID-19. The funding is intended to support...more