Penalties, Civil Monetary Penalty, Department of Health and Human Services (HHS)

OIG Reminds Us that Flat Fee Business Arrangements Aren’t Immune from AKS Scrutiny

Venable LLP on 7/15/2025

On July 1, 2025, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued Advisory Opinion No. 25-08, concluding that a medical device manufacturer’s proposed payment to access a...more

Avoiding HIPAA Penalties: A Checklist for Covered Entities

Holland & Hart LLP on 5/30/2024

The HIPAA Privacy, Security, and Breach Notification Rules apply to healthcare providers who engage in certain electronic transactions, healthcare clearinghouses, and health plans, including employee group health plans with...more

Old Rule, New Tricks: HHS Finalizes Most Substantial Changes to Substance Use Disorder Confidentiality Rule in Decades

Davis Wright Tremaine LLP on 2/21/2024

The long-anticipated final rule addressing substance use disorder (SUD) records at 42 C.F.R. Part 2, commonly referred to as Part 2, is here. The final rule is a joint undertaking by the U.S. Department of Health and Human...more

Appeals Court Vacates HIPAA Penalty Imposed Against M.D. Anderson

Foley & Lardner LLP on 1/29/2021

On January 14, 2021, the U.S. Court of Appeals for the Fifth Circuit vacated the civil monetary penalty (CMP) imposed by the Department of Health and Human Services (HHS) against the University of Texas M.D. Anderson Cancer...more

Annual Adjustment Leads to Uncertainty in HIPAA Penalty Maximums

Holland & Knight LLP on 11/14/2019

On November 5, 2019, the Department of Health and Human Services (the Department) issued its annual inflation adjustment to civil monetary penalties that fall under the Department’s purview (2019 Inflation Rule), including...more

Lack of Timely Action and Knowledge of Risk Results in $3.2 Million Civil Monetary Penalty for HIPAA Violations

Akerman LLP - Health Law Rx on 2/8/2017

Children’s Medical Center of Dallas (Children’s) was hit with a $3.2 million civil penalty from the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) for failing to take steps to properly protect...more

HHS Issues Final Rule that Expands the Requirements for Disclosure of Clinical Trial Data to ClinicalTrials.gov

King & Spalding on 10/27/2016

On September 21, 2016, the Department of Health and Human Services (HHS) published a final rule that greatly expands the information that sponsors of “applicable drug clinical trials” and “applicable device clinical trials”...more

Penalties › Civil Monetary Penalty › Department of Health and Human Services (HHS)