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
While the total number of filings declined in comparison to recent years, CFIUS's latest Annual Report to Congress highlights an uptick in penalties and an increased use of enforcement tools relating to national...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 United States manages more than three dozen separate economic and trade sanctions programs. Those programs target specified foreign governments along with thousands of named individuals, groups and entities in accordance...more
On January 4, 2024, Connecticut Banking Commissioner Jorge L. Perez issued a temporary order to cease and desist against LoanSnap, Inc., ordering LoanSnap to cease and desist certain activities and notifying LoanSnap that its...more
In connection with the November 2023 Health Care Compliance Association’s (HCCA) Healthcare Enforcement Compliance Conference, and with acknowledgment by the Chief Counsel to the Inspector General, Rob DeConti, of the long...more
Der Europäische Gerichtshof (EuGH) wird bald darüber entscheiden, ob europäische Datenschutzbehörden künftig leichter Bußgelder nach Art. 83 DSGVO gegen Unternehmen verhängen können. Diese Entscheidung kann großen Einfluss...more
Regulatory Developments - FinCEN Proposes Form of Report to Collect Beneficial Ownership Information and Application to Obtain FinCEN Identifiers - On January 17, FinCEN proposed a form of report to collect beneficial...more
The Consumer Privacy Rights Act (CPRA), which amended the California Consumer Privacy Act (CCPA), becomes fully effective on January 1, 2023. Businesses should review the new law and recent enforcement actions before the law...more
The amended California Consumer Privacy Act (CCPA), sometimes referred to as the California Privacy Rights Act (CPRA) or Proposition 24, takes effect on January 1, 2023 – and introduces new consumer rights, while...more
Headlines: ..OCC Publishes Security Standards for Video Teleconferencing With Agency Staff ..CFPB Imposes Civil Penalty and Customer Refunds for Authorized-Positive Overdraft Fees ..Treasury Department Recommends...more
The following is a summary of the 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 are...more
Report on Research Compliance 18, no. 6 (June 2021) - Nearly four years after noticing spending “irregularities” by a principal investigator (PI), the University of Nevada Las Vegas (UNLV) entered into a settlement...more
Keypoint: New York’s Division of Financial Services (DFS) now requires Property and Casualty Insurers writing cyber insurance to comply with the Division’s Cyber Insurance Risk Framework to manage their risk. In her...more
CMS and OIG released highly anticipated final changes to the rules implementing the Stark Law, the safe harbors issued under the Anti-Kickback Statute (AKS) and the beneficiary inducements provision in the civil monetary...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
We recently reported on the New York State Department of Financial Services' (DFS) first enforcement action under its 2017 cybersecurity regulation ("Part 500"), which prescribes how financial services companies licensed to...more
Report on Supply Chain Compliance 3, no. 2 (January 23, 2020) - The U.S. Treasury Department’s Office of Foreign Assets Control (OFAC), the primary U.S. government agency that administers U.S. economic sanctions, was busy...more
The US' ongoing trade wars—with various trading partners and particularly with China—are everywhere in the news. Putting politics and policy aside, the "trade wars" reflect a basic disagreement over the rules that should...more
Prioritizing compliance with federal and state law may be the last item on your never ending to-do list. Most days, you have bigger fish to fry - you want to increase sales and decrease overhead. However, a small investment...more
Firms will need to ensure their systems and controls to prevent financial crime and money laundering are working effectively: this is just part of the message contained in the FCA’s Business Plan for 2019/20. The Business...more
On the heels of the Justice Department’s announcement of its new compliance guidance, on May 2, 2019, the Treasury Department’s Office of Foreign Asset Control (“OFAC”) issued its promised guidance for sanctions compliance...more
I am hardly saying that SEC Regulation S-P is the sexiest of regulations. I mean, has any customer is history actually read one of those exciting statement stuffers that discloses in some dense font a BD’s privacy policy?...more
On June 18, 2018, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) announced that an HHS Administrative Law Judge (“ALJ”) granted summary judgment to OCR in an enforcement action...more
New Rules, Proposed Rules, Guidance and Alerts – SEC STAFF GUIDANCE AND ALERTS - SEC Staff Issues Guidance on Cryptocurrency-related Holdings - On January 18, 2018, the staff of the SEC’s Division of Investment...more
For the first time in twenty-five years, Occupational Safety and Health Administration (OSHA) fines have increased significantly. In particular, last fall Congress enacted legislation that required all federal agencies to...more