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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
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
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
The Securities and Exchange Commission (“SEC”) released an annual summary, on November 15, 2022, of actions brought by the Division of Enforcement (“Division”) over fiscal year 2022 (“Enforcement Summary”), providing an...more
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
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