In recognition of the infant formula crisis facing the United States supply chain, the Food and Drug Administration (“FDA”) issued guidance on May 16, 2022 providing for enforcement discretion with respect to certain requirements for infant formulas that may not
Triage Health Law
Ohio Expands Availability of Telehealth
Since the beginning of the COVID-19 pandemic, policymakers at both the federal and state level have worked to expand the availability of telehealth services. Since telehealth , in many cases, is viewed to provide a convenient, accessible and safe alternative…
Government Continues Aggressive Antitrust Enforcement in the Healthcare Space
On February 24, 2022, the U.S. Department of Justice (“DOJ”) filed suit to block UnitedHealth’s proposed acquisition of Change Healthcare. UnitedHealth owns the largest health insurer in the U.S., while Change Healthcare is a data company whose software is the…
Judge Strikes Down Part Of Administration’s Surprise Billing Rules In Win For Physicians
By Shams Hirji
The Biden Administration’s Interim Final Rule implementing provisions of the No Surprises Act suffered its first major legal setback yesterday. Judge Kernodle of the Eastern District of Texas issued a decision vacating portions of the Rule relating to the independent…
Highest French Administrative Court Freezes Ban on CBD Flowers and Leaves
The regulation of CBD/Hemp products has been a very hot topic in France these past months since the “Kanavape” ruling. In Kanavape, the CJEU asked France to review its very strict CBD regulations, more specifically its Regulation (arrêté) of 22…
Italian Ministers Announce Timetable for Investment in Digital Health
On January 8, 2022, Minister of Health Roberto Speranza and Minister for Technological Innovation and Digital Transition Vittorio Colao, in an article published in the Italian press, made a number of announcements about the timing of the Italian government’s intended…
AMA and AHA Challenge IDR Process under the No Surprises Act
By Max Czernin & Shams Hirji
The American Medical Association and the American Hospital Association filed suit under the Administrative Procedure Act in the District of Columbia District Court challenging portions of the interim final rule (the “Rule”) issued by the Department of Health and Human…
Judge Blocks Portions of Centers for Medicare and Medicaid Services (CMS) Vaccine Mandate (US)
A federal court decision has created a new wrinkle for healthcare employers that are preparing to comply with the new vaccine mandate from the Centers for Medicare and Medicare Services (CMS). On November 29, 2021, Judge Matthew Schelp of…
Healthcare Research: A Transatlantic and Trans-European Dialogue Seminar
On November 23rd, Squire Patton Boggs partner Elliot Golding will lead a panel of industry thought leaders in a discussion of transcontinental health research and data issues. Topics to be explored include:
- What are the challenges that companies need to
…
COVID-19 Vaccine Mandate Fundamentals for Healthcare Employers
Now that OSHA has issued its emergency temporary standard and CMS has issued its own emergency rule, the landscape has changed once again for healthcare employers in terms of addressing employees’ vaccination status. Fortunately, they now have much more…