Penalties, Disclosure Requirements, Civil Monetary Penalty

OFSI Issues First-Ever Monetary Penalty for a Failure To Provide Information: Key Considerations for Companies

Skadden, Arps, Slate, Meagher & Flom LLP on 5/19/2025

The Offence and Penalty - On 8 May 2025, the UK’s Office of Financial Sanctions Implementation (OFSI) published its 11 April 2025 notice of its first-ever monetary penalty for an information offence relating to financial...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

Business Associate Agreements: Requirements and Suggestions

Holland & Hart LLP on 10/20/2023

The HIPAA Privacy and Security Rules generally require covered entities (including most healthcare providers) to execute written agreements (“business associate agreements” or “BAAs”) with their business associates before...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

DOJ Reaffirms Commitment to Prosecuting Individuals, Toughens Expectation for Corporate Response

Polsinelli on 10/1/2015

The U.S. Department of Justice (DOJ) recently issued a memorandum ("The Yates memo") on September 9, 2015 by Deputy Attorney General Sally Yates, reaffirming the Government's commitment to prosecuting individuals. Say...more