Our FDA and digital health teams recently published a LawFlash on how a Biden administration will affect the US Food and Drug Administration’s (FDA’s) oversight and regulation of medical devices and digital health.
Health Law Scan
Legal Insights and Perspectives for the Healthcare Industry
Please join us for a webinar on Thursday, January 14 at 3:00 pm ET to discuss the refreshed Paycheck Protection Program (PPP) and the new PPP Second Draw program.
Our employee benefits team recently published a LawFlash discussing the Consolidated Appropriations Act, 2021, which contains provisions impacting employer sponsored group health plans, including to protect group health plan participants from surprise medical bills, ensure health plan price transparency, and offer relief related to health and dependent care flexible spending accounts.
Our finance, corporate and business transactions, litigation, and tax teams recently published a LawFlash discussing the new coronavirus (COVID-19) relief stimulus package that is part of the Consolidated Appropriations Act, 2021 (CAA), highlighting key provisions and guidance for small businesses seeking to participate in the revived Paycheck Protection Program (PPP).
Our FDA team published a LawFlash on the Food and Drug Administration’s (FDA’s) recent Emergency Use Authorizations (EUAs) for the first over-the-counter (OTC) COVID-19 test to be performed at home and the first OTC home sample collection kit for COVID-19 testing, as well as additional prescription at-home tests and sample collection kits.
On December 8, 2020, Judge Gerald Pappert in the US District Court for the Eastern District of Pennsylvania denied a request from the Federal Trade Commission (FTC) and Pennsylvania attorney general (AG) to preliminarily enjoin a proposed merger between Thomas Jefferson University (TJU) and Albert Einstein Healthcare Network (Einstein). The case was widely watched as the FTC sought to show that the combination of these two urban hospital systems would harm consumers.
Our tax team published a LawFlash on the recently released Internal Revenue Service Revenue Ruling 2020-27 and Revenue Procedure 2020-51, which provide guidance on the deductibility of certain expenses paid or incurred in a taxpayer’s business using loan proceeds from a “covered loan” provided under the CARES Act’s Paycheck Protection Program (PPP).
Our immigration team recently posted a LawFlash to discuss a recent decision by the US District Court for the Northern District of California that set aside two Interim Final Rules (IFRs) that sought to restrict severely eligibility for the H-1B Specialty Occupation nonimmigrant category.
The coronavirus (COVID-19) pandemic has made the development and use of drug and device products to diagnose, treat, or prevent COVID-19 essential.
HHS recently announced the forthcoming termination of FDA’s Unapproved Drugs Initiative (UDI), in an apparent effort to combat prescription drug shortages and price spikes.