Medical Device Legal News with Sam Bernstein: Episode 10
Compliance Perspectives: Changes to the Physician Self-Referral and Anti-Kickback Rules
Investment Management Roundtable Discussion – Regulatory and Enforcement Update
FCPA Compliance and Ethics Report-Episode 131, The FCPA Professor Takes a Look Back at 2014
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
Kaiser Permanente is notifying 13.4 million current and former members that their personal information may have been compromised when it was transmitted to tech giants Google, Microsoft Bing and X (formerly Twitter) when...more
The HHS Office for Civil Rights (OCR) recently imposed a $50,000 civil monetary penalty on a dental practice that disclosed patient-identifying information in response to a negative online review. The case is a reminder that...more
Report on Patient Privacy 22, no. 5 (May, 2022) - Compared to other agencies, the HHS Office for Civil Rights (OCR) is a little fish in the big federal pond, but it has an outsize effect on HIPAA covered entities (CEs) and...more
On April 6, 2022, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released a Request for Information (RFI) seeking public comment on "recognized security practices" and on sharing civil...more
Report on Patient Privacy 21, no. 12 (December, 2021) - Amid the letters of congratulations to new HHS Office for Civil Rights (OCR) Director Lisa Pino is a plea from the American Hospital Association (AHA): “victims” of...more
The United States Court of Appeals for the Fifth Circuit (the “Court”) vacated a $4,348,000 civil monetary penalty (“CMP”) imposed by the U.S. Department of Health and Human Services’ Office for Civil Rights (“HHS-OCR”) in...more
Healthcare providers and other covered entities are not required by HIPAA regulations to have “bulletproof” protections for safeguarding patient information stored in electronic form, according to a January 14, 2021 decision...more
Report on Research Compliance 17, no. 1 (January 2020) - Ah, those pesky residents. If you’re a teaching hospital, you can’t live without them, right? But sometimes living with them is mighty costly, as the University of...more
The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services imposed a $2,154,000 civil money penalty (CMP) against Jackson Health System (JHS) for violations of the Health Insurance Portability and...more
On October 23, 2019, the Office for Civil Rights (OCR) at HHS announced the imposition of a $2,154,000 civil monetary penalty against a Florida hospital system (Hospital System) for alleged violations of the HIPAA Security...more
On October 23, 2019, the U.S. Department of Health and Human Services, Office for Civil Rights (“HHS”) announced a $2,154,000 civil money penalty for numerous violations of the Health Insurance Portability and Accountability...more
On April 30, 2019, the United States Department of Health and Human Services (HHS) published a notice of enforcement discretion that lowers most of the annual caps on civil money penalties (CMP). HHS may assess against...more
On April 26, 2019, the US Department of Health and Human Services (HHS), Office for Civil Rights (OCR) issued a Notification of Enforcement Discretion Regarding HIPAA Civil Money Penalties (the Notice) to inform the public...more
In two recent pronouncements, the United States Department of Health and Human Services (HHS) has taken a balanced approach to interpreting the Health Insurance Portability and Accountability Act (HIPAA) regulations that...more
The Department of Health and Human Services has announced that it is lowering the maximum amount it will assess for most types of HIPAA violations. Although the change is couched as an exercise of discretion, HHS states that...more
The U.S. Department of Health and Human Services (“HHS”) recently published a final rule on the 340B Drug Pricing Program (“340B Program”), moving the effective date for changes to the program up to January 1, 2019. Making...more
Two recent announcements by the Health Resources and Services Administration (HRSA) highlight the agency's plans for increased oversight in the next year of drug manufacturers under the 340B drug pricing program and...more
The U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) recently announced a no-fault settlement, including a $125,000 penalty and a two year corrective action plan for Allergy Associates of...more
Although the fate of the Affordable Care Act remains undecided, enforcement of the HIPAA privacy and security regulations by the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services is ongoing,...more
On January 5, 2017, the U.S. Department of Health and Human Services (“HHS”) and the Health Resources and Services Administration (“HRSA”) issued a final rule on the calculation of drug ceiling prices under the 340B Drug...more
For the second time in history, on January 13, 2016, an Administrative Law Judge (ALJ) upheld the imposition of civil money penalties charged against a covered entity by the Office of Civil Rights in the Department of Health...more
For only the second time in its history, the U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) has imposed a civil money penalty (CMP) on a covered entity for allegedly violating the HIPAA...more
On June 16, 2015, the U.S. Department of Health and Human Resources (HHS) and the Health Resources and Services Administration (HRSA) issued a notice of proposed rulemaking (Notice) related to the 340B Drug Pricing Program...more