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On February 3, 2020, the U.S. Department of Health and Human Services (HHS) issued a bulletin (the Bulletin) to remind covered entities and business associates of how patient information may be shared under HIPAA in the event of an emergency, such as an outbreak of infectious disease. The Bulletin was issued in response to the…

On November 27, 2019, the U.S. Department of Health & Human Services Office for Civil Rights (OCR) announced a $2.175 million dollar settlement with a hospital system to resolve alleged violations of HIPAA’s Breach Notification Rule and Privacy Rule. The settlement is noteworthy as it represents OCR’s fourth HIPAA settlement in excess of $1 million…

In accordance with the Inflation Adjustment Act, the Department of Health and Human Services (HHS) has updated its regulations to reflect required annual inflation-related increases to civil monetary penalties, including those for certain violations of HIPAA’s “administrative simplification” provisions. The final regulations became effective on November 5, 2019, the date they were published in the…

Everyone knows how I feel about those home genetic testing kits—most people don’t understand that when they send their DNA to a private company that it is not protected by HIPAA or any other law, and the company can legally use and disclose it, including selling it to other companies. Understand what companies are doing…

On September 9, 2019, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced that it had settled its first ever HIPAA enforcement action arising from alleged violations of the individual right to access health information under HIPAA. OCR entered into a settlement with Bayfront Health St. Petersburg (Bayfront) in response…

On June 3, 2019, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a fraud alert to notify consumers about genetic testing fraud schemes (the Alert). According to the OIG, fraudulent actors are using the provision of free genetic testing kits to obtain Medicare information from unwitting consumers, and…

In a development that may – understandably – have been overlooked by many heading into Memorial Day weekend, on May 24, 2019, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a Fact Sheet on Direct Liability of Business Associates under the Health Insurance Portability and Accountability Act (HIPAA).…

The Office of Civil Rights (OCR), the enforcement arm of the Department of Health & Human Services (HHS), announced that a Tennessee diagnostic medical imaging services company has agreed to pay $3 million to settle potential HIPAA violations arising from a data breach that exposed over 300,000 patients’ protected health information. As part of the…

On April 26, 2019, the U.S. Department of Health and Human Services (HHS) issued a Notification of Enforcement Discretion (Notice) regarding imposition of Civil Money Penalties (CMPs) under HIPAA. In the Notice, HHS announces that it has revisited its prior interpretation of the standards for assessment of CMPs under the HITECH Act, and is exercising…

There was unfortunately some bleak news out of the Department of Health & Human Services, (HHS) Office of the Inspector General (OIG) recently. The OIG recently released the results of a performance audit of the HHS’ compliance with the Federal Information Security Modernization Act of 2014 (FISMA). The OIG Report states that FISMA requires that…