A novel diagnostics technology that reads gene expression patterns in the immune system to distinguish bacterial infections from viral infections and determines the severity within minutes will receive advanced development support from the U.S. Department of Health and Human Services (HHS). The technology is being designed for use in outpatient and inpatient healthcare settings. The ...
The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) has imposed a $1,600,000 civil money penalty against the Texas Health and Human Services Commission (TX HHSC), for violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules between 2013 and 2017. TX ...
Today, the United States, on behalf of the Department of Health and Human Services, filed a complaint in federal district court against Gilead Sciences, Inc. and Gilead Sciences Ireland UC (collectively, Gilead) seeking damages for Gilead’s infringement of HHS patents related to pre-exposure prophylaxis (or PrEP) for HIV prevention. Despite multiple attempts by HHS to license ...
The University of Rochester Medical Center (URMC) has agreed to pay $3 million to the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS), and take substantial corrective action to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules. URMC includes healthcare ...
This week, the Department of Health and Human Services, the American Society of Nephrology, and the National Kidney Foundation signed a memorandum of understanding to create an education, awareness, and prevention campaign regarding kidney disease, as called for in President Trump’s Executive Order on Advancing American Kidney Health. The campaign will aim to improve health ...
Today, as part of delivering on President Trump’s Executive Order on Protecting and Improving Medicare for Our Nation’s Seniors, the Centers for Medicare & Medicaid Services finalized policy changes under the Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System. HHS Secretary Alex Azar issued the following statement: “The payment changes CMS ...
Today, the Department of Health and Human Services is announcing that Dr. Ned Sharpless, who has been serving as Acting Commissioner of Food and Drugs, will be returning to his role as Director of the National Cancer Institute (NCI). The Federal Vacancies Reform Act requires that a person may not serve in an “Acting” capacity ...
Today, the Department of Health and Human Services (HHS) issued a Notice of Nonenforcement to inform the public that certain regulatory provisions in The Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards”HHS grants regulation”) will not be enforced because of serious concerns regarding the prior administration’s implementation of the Regulatory Flexibility Act, ...
On Thursday, the Centers for Medicare & Medicaid Services finalized changes to the Medicare payment rules for Durable Medical Equipment Prosthetics, Orthotics, and Supplies (DMEPOS) program, End-Stage Renal Disease (ESRD) Prospective Payment System (PPS), and the ESRD Quality Incentive Program (QIP), delivering on President Trump’s “Advancing American Kidney Health” initiative. HHS Secretary Alex Azar issued ...
Today, the Department of Health and Human Services’ Substance Abuse and Mental Health Services Administration (SAMHSA) announced the launch of FindTreatment.gov, a newly designed website that will help connect Americans looking for substance abuse treatment with approximately 13,000 locations across the United States. HHS Secretary Alex Azar and SAMHSA Assistant Secretary Elinore McCance-Katz issued the ...
