Amid the epidemic levels of youth use of e-cigarettes and the popularity of certain products among children, the U.S. Food and Drug Administration (FDA) today issued a policy prioritizing enforcement against certain unauthorized flavored e-cigarette products that appeal to kids, including fruit and mint flavors. Under this policy, companies that do not cease manufacture, distribution ...
West Georgia Ambulance, Inc. (West Georgia), has agreed to pay $65,000 to the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) and to adopt a corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Security Rule. West Georgia is an ambulance ...
Today, the Centers for Medicare & Medicaid Services issued the Exchange Program Integrity Final Rule, which implements policies aimed at protecting taxpayer dollars by ensuring that Exchange enrollees are accurately determined eligible for premium subsidies. HHS Secretary Alex Azar issued the following statement: “Being good stewards of taxpayer dollars and faithfully implementing the law are ...
The U.S. Department of Education and the Office for Civil Rights at the U.S. Department of Health and Human Services released updated joint guidance today addressing the application of the Family Educational Rights and Privacy Act (FERPA) and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to records maintained on students. ...
On Thursday, December 17, 2019, the Food and Drug Administration approved a vaccine made by Merck for the Zaire strain of the Ebola virus, which caused more than 11,000 deaths during the 2014 West Africa outbreak and has caused more than 2,000 deaths in the current outbreak in the eastern Democratic Republic of the Congo. ...
The U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR), has entered into a Voluntary Resolution Agreement (VRA) with the Pennsylvania Department of Human Services (PaDHS). The VRA resolves a compliance review and two complaint investigations, respectively, involving access to certain PaDHS health and welfare programs by individuals with limited English ...
Today, the U.S. Department of Health and Human Services (HHS) issued the first Project BioShield contract to fund the advanced development needed to support the expanded use of an existing antibiotic to treat exposure to inhalational anthrax. Under the contract, the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the ...
Today, President Trump, along with the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration, issued a notice of proposed rulemaking (NPRM) that, if finalized, would allow for the importation of certain prescription drugs from Canada. In addition, the Administration is announcing the availability of a new draft guidance for ...
The U.S. Department of Health and Human Services (HHS) today took major steps to increase the availability of organs for the 113,000 Americans on waitlists for lifesaving organ transplants – 20 of whom die each day. As directed by President Trump in his July 10 Executive Order on Advancing American Kidney Health, the Centers for ...
Today, the United States Senate voted, 72-18, to confirm Dr. Stephen Hahn as Commissioner of Food and Drugs. Health and Human Services Secretary Alex Azar issued the following statement: “I congratulate Dr. Hahn and thank the Senate for prioritizing his nomination. President Trump has chosen a superbly qualified leader for FDA, and Dr. Hahn garnered ...
