News & Analysis as of

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

Venable LLP

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

Venable LLP on

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

Holland & Hart LLP

Avoiding HIPAA Penalties: A Checklist for Covered Entities

Holland & Hart LLP on

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

Davis Wright Tremaine LLP

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

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

Foley & Lardner LLP

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

Foley & Lardner LLP on

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

Holland & Knight LLP

Annual Adjustment Leads to Uncertainty in HIPAA Penalty Maximums

Holland & Knight LLP on

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

Akerman LLP - Health Law Rx

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

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

King & Spalding

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

King & Spalding on

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

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