On April 2, 2020, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced that, effective immediately, it will be halting enforcement of certain HIPAA provisions in order to enable state and federal public health authorities and emergency operations …›
As the number of COVID-19 cases in the U.S. grows, the potential shortage of ventilators has become an increasing concern. This week, the U.S. Food and Drug Administration (FDA) took two important steps to keep medical facilities equipped with life-saving ventilators. Read our Class Dismissed …›
The U.S. antitrust agencies – the Department of Justice Antitrust Division (DOJ) and the Federal Trade Commission (FTC) – have recognized a need for “unprecedented cooperation between federal, state, and local governments and among private businesses to protect Americans’ health and safety” during the …›
Last week, the U.S. Food and Drug Administration (FDA) took yet another step to encourage production of basic medical supplies in the battle against COVID-19. On Friday, March 20, FDA published two new guidance documents communicating its policy on the manufacture of certain alcohol-based …›
With brexited UK announcing that it will not join Europe’s long-awaited Unified Patent Court (UPC), the establishment of an efficient pan-European patent litigation system faces ever‑mounting challenges. Last Friday, the German Federal Constitutional Court declared that the German Act of Approval of the UPC …›
COVID-19 is, quite literally, putting the medical supply industry to the test. Manufacturers are being pushed to develop novel products like therapies and vaccines to combat the disease as quickly as possible. The Public Readiness and Emergency Preparedness (PREP) Act encourages drug and medical …›
The rapid spread of coronavirus has spawned prolific marketing claims that any number of products can treat or prevent coronavirus. It comes as no surprise then that the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) recently issued their first round of …›
On March 16, 2020, FDA issued its Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (the “Guidance”). The purpose of the Guidance is to expedite the availability of novel coronavirus (SARS-CoV-2) diagnostic tests in view of the current public health …›
In response to the recent outbreak of the novel coronavirus (2019-nCoV or COVID-19) and associated preparation and response, the Department of Health and Human Services Office for Civil Rights (OCR) recently released a bulletin (the “Bulletin”) outlining how entities subject to HIPAA may share …›
The Biomedical Advanced Research and Development Authority (BARDA), part of the U.S Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, has modified an existing broad agency announcement (BAA) through which it will award government funding to companies …›