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 following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...more
The proliferation of health apps and connected devices that allow individuals to track their health conditions, treatment, medications, fitness, fertility, sleep, mental health, diet and other vital areas has led to increased...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
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
Novartis Pharmaceuticals Corporation (Novartis) recently entered into a civil settlement agreement with the Department of Justice (DOJ) to resolve allegations that the company paid health care practitioners (HCPs) who spoke...more
On April 21, 2020, the U.S. Department of Health and Human Services released a series of announcements signaling its intention to finalize and enforce certain aspects of the Office of the National Coordinator (ONC) Cures Act...more
On April 21, 2020, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a proposed rule that would amend its civil money penalty (CMP) regulations to address a 21st Century Cures Act...more
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...more
This Client Alert serves as the third in a three-part series in which we describe and analyze the rules proposed by the Department of Health and Human Services (“HHS”) Centers for Medicare & Medicaid Services (“CMS”) as part...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
• The Centers for Medicare and Medicaid Services (CMS) have issued a long-awaited proposal to reform the Physician Self-Referral Law’s (Stark Law’s) regulatory exceptions and to provide updated guidance for physicians and...more
On October 9, 2019, the U.S. Department of Health and Human Services' (HHS') Centers for Medicare and Medicaid Services (CMS) and Office of Inspector General (OIG) announced plans for sweeping changes to rules policing health...more
The recent criminal conviction of a Massachusetts physician provides a stark reminder that violating HIPAA can result in more than civil monetary penalties and the financial and reputational fall-out that results from a...more
On June 18, 2018, the U.S. Department of Health and Human Services (HHS) and its Office for Civil Rights (OCR) announced an Administrative Law Judge’s (ALJ) ruling that OCR properly imposed penalties against The University of...more
Patient care is not confined to a single office or exam room, or a single physician or other provider. Caring for patients these days now includes complex coordination among physicians, nurse, technicians, staff, management,...more