04/02/2020

CMS Continues to Make Sweeping Regulatory Changes to Facilitate COVID-19 Response

Alert

Federal and state agencies continue to deliver tools and information to help healthcare providers respond to the COVID-19 pandemic since the President declared the COVID-19 outbreak

03/24/2020

FDA Revised Guidance on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic

Alert

On March 19, 2020, the FDA revised its guidance on postmarket adverse event reporting for medical products and dietary supplements during a pandemic to apply the guidance to the ongoing COVID-19...

03/24/2020

HHS Extends PREP Act Immunity to COVID-19 Countermeasures

Alert

The U.S. Department of Health and Human Services issued a declaration (the “Declaration”) under the Public Readiness and Emergency Preparedness Act (the “PREP Act”) to protect “Covered Persons” ...

03/24/2020

FDA Issues "Immediately in Effect" Guidance to Accelerate Availability of COVID-19 Diagnostic Tests

Alert

On March 16, 2020, the FDA issued immediately-in-effect guidance to accelerate the development of certain labora...

03/24/2020

FDA Demonstrates Regulatory Flexibility and Relaxes Policies on Hand Sanitizer Amid COVID-19

Alert

The rapid spread of Coronavirus Disease 2019 (COVID-19) has sparked public fear and panic-induced stockpiling of alcohol-based sanitizing gels, leaving retailers and consumers without access to ...

03/24/2020

FDA Issues Guidance for Conducting Clinical Trials During COVID-19

Alert

On March 18, 2020, the FDA issued Guidance for Industry, investigators, and institutional review bo...

03/24/2020

Life Sciences and FDA COVID-19 Update: A Special Edition of HB Health Law Vitals.

Alert

Health Law Vitals - special edition focused on Life Sciences, FDA and COVID-19. Browse a number of featured stories and quick reports on breaking news in this area.

03/23/2020

Health Law Vitals - COVID-19 Edition - March 2020

Alert

HIPAA Guidance During COVID-19. Amidst continuing COVID-19 concerns, regulators issued certain waivers of HIPAA requirements and penalties as well as additional guidance ap...

03/23/2020

Regulators Expand Opportunities for Telehealth Services Under COVID-19 Shadow

Alert

As the COVID-19 pandemic surges and the social distancing imperative continues, regulators have responded with various guidelines and policies that impact and expand the opportunities for telehe...

03/23/2020

Section 1135 Waivers Provide Some Regulatory Flexibility for Healthcare Providers During COVID-19

Alert

Under Section 1135 of the Social Security Act, the Secretary of the U.S. Department of Health & Human Services (“Secretary”) is authorized to waive or modify certain federal regulatory requirements wh...

View 10 More17 More