Tag Archives: coronavirus

FDA Takes Steps to Enhance Availability of Safe and Effective Face Masks

Over the past week, the U.S. Food & Drug Administration (FDA) has taken a number of steps to enable manufacturers and distributors of face masks to more efficiently make their products available to the marketplace. FDA has accomplished this by establishing criteria that would allow manufacturers to bypass normally required (and often time-consuming) regulatory review.

To read the full text of this Duane Morris Alert, please visit the firm website.

CARES Act Provider Relief Fund $30 Billion Distribution Announced by HHS

Immediate funds are now available for providers to receive a cash influx at a critical time. The challenge will not be receiving the funds, but rather keeping the funds after a future audit of compliance with the terms and conditions.

On April 10, 2020, the United States Department of Health and Human Services (HHS) announced the immediate distribution of an initial $30 billion in relief funding to providers in support of the nationwide COVID-19 response. The distribution is part of the $100 billion provider relief fund included in the Coronavirus Aid, Relief and Economic Security (CARES) Act recently passed by Congress. Importantly, HHS has noted that these are payments, not loans, to healthcare providers, and will not need to be repaid unless the provider does not comply with the terms and conditions.

To read the full text of this Duane Morris Alert, please visit the firm website.

Expansion of Immunity Protections for Covered Countermeasures and Healthcare Volunteers Under CARES Act

As discussed in our March 18 Alert, the Secretary of Health and Human Services has issued a declaration authorizing drugs, devices and biologics used to treat or mitigate COVID-19 as covered countermeasures under the Public Readiness and Emergency Preparedness (PREP) Act. Following Secretary Azar’s declaration of a public health emergency, covered persons may obtain immunity under federal law for all claims arising from manufacturing, distributing or administering covered countermeasures, subject to the conditions laid out at 42 U.S.C. § 247d-6d, the declaration and other applicable regulations.

Subsequent to our previous Alert, President Trump signed into law the Coronavirus Aid, Relief and Economic Security Act (CARES Act), which expanded the covered countermeasure protections offered by the PREP Act.

To read the full text of this Duane Morris Alert, please visit the firm website.

OCR Loosens HIPAA Enforcement Amidst Coronavirus Pandemic

Let’s face it, there has not been much positive news lately surrounding the Coronavirus (“COVID-19”).  However, the Office For Civil Rights (“OCR”), the agency within the Department of Health and Human Services (“HHS”) that enforces the Health Insurance Portability and Accountability Act (“HIPAA”) Privacy and Security Rules, announced several recent measures to allow health care providers avoid certain HIPAA penalties and sanctions amidst the COVID-19 pandemic.

There are several measures OCR/HHS has taken to lessen the regulatory burden of HIPAA for health care providers amidst COVID-19.  Here is the latest breakdown of important pronouncements and guidance set forth by OCR/HHS to help providers deal with COVID-19 and HIPAA compliance:

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