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 August Monthly Minute highlights new IRS guidance addressing student loan matching programs, HHS’s increases to civil monetary penalties and Form 5330 paper filing updates....more
The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) recently announced that it ordered American Medical Response (AMR) to pay a civil monetary penalty of $115,200 for failing to comply with the...more
On August 1, 2024, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) announced a civil monetary penalty of $115,200 against American Medical Response (“AMR”) based on a complaint that...more
On August 1, 2024, the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) announced the imposition of a civil monetary penalty (“CMP”) of $115,200 collected against American Medical Response...more
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 Department of Health & Human Services’ Office of Inspector General (HHS OIG) and U.S. Department of Justice (DOJ) have published important guidance and recommendations for pharmaceutical companies to develop and implement...more
Indiana AG Todd Rokita sued home healthcare equipment and services provider Apria Healthcare, LLC for allegedly failing to investigate and inform consumers regarding data breaches beginning in 2019 in violation of state data...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
From 1998-2008, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published compliance program guidelines for various industries in the Federal Register....more
More than three years after the federal government issued rules to prohibit “information blocking,” penalties for violating those rules are taking effect. September 1 marks the first day on which certain entities may face...more
A final rule published on July 3, 2023, empowers the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) to impose civil monetary penalties (CMP) of up to $1 million for unlawful acts of...more
The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently posted the final rule establishing civil monetary penalties (CMPs) for information blocking (IB Enforcement Rule). The Rule...more
On June 27th, Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) posted its final rule (Final Rule), which amends the OIG’s civil monetary penalty (CMP) regulations to implement the...more
A mobile application developer of ovulation and period tracking software agrees to pay civil penalties and 20 years of independent monitoring for violating the Health Breach Notification Rule for sharing sensitive personal...more
On February 17, 2023, the US Department of Health and Human Services Office for Civil Rights (OCR) released two companion reports to Congress detailing its actions in 2021 to enforce the privacy, security, and breach...more
After three years, the federal public health emergency (PHE) will expire May 11, 2023. Most of the relaxed regulatory and payor standards will end on or within a few months after the deadline, including many relating to: ...more
For the first time since it became law on Aug. 25, 2009, the Federal Trade Commission (“FTC”) has taken enforcement action under 16 C.F.R. § 318, also known as the Health Breach Notification Rule, with a $1.5 million civil...more
The Office of Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) recently submitted two annual reports to Congress setting forth a summary of complaints and breaches reported to the OCR during...more
For the first time, the Federal Trade Commission has brought an enforcement action under its 2009 Health Breach Notification Rule (HBNR). The case was brought against a digital health company, GoodRx Holdings, Inc., for...more
On January 30, 2023, the Biden Administration announced its intent to end the COVID-19 public health emergency (PHE) on May 11, 2023. The PHE has been in place for over three years during which time many telehealth and...more
Report on Patient Privacy Volume 22, Number 11. (November 2022) Nearly five years passed from the time the University of Texas MD Anderson Cancer Center reported to the HHS Office for Civil Rights (OCR) that three...more
The U.S. Department of Health and Human Services Office for Civil Rights (OCR) continues its enforcement activities to emphasize compliance with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule’s...more
The Office of Civil Rights of the Department of Health and Human Services (“OCR”) announced the resolution of three more right of access cases, bringing the total to a whopping 41 since the start of its drive to increase...more
OCR’s HIPAA Right of Access Initiative shows no signs of slowing down. On July 15, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced the resolution of 11 more cases at a total of...more
On August 23, 2022, the Office for Civil Rights (OCR) issued a press release announcing that it had settled with New England Dermatology, P.C. (NED) for $300,640 “over the improper disposal of protected health information.” ...more