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
SEC Loses in ALJ Case, DOL’s Latest Fiduciary Rule Put on Hold, and SEC Reconsiders AI and Custody Rule Proposals - Welcome to our July Regulatory Roundup, where we provide a quick look at the latest regulatory developments....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
On November 7, 2023, the Division of Enforcement ("Division") of the United States Commodity Futures Trading Commission ("CFTC") released its annual report of the results of its enforcement efforts, announcing that it had...more
The Federal Acquisition Regulation (FAR) Council has proposed two new cybersecurity rules that would impose significant obligations and risks for federal government contractors. The proposed rules impose substantial cyber...more
On October 30, 2023, the US Securities and Exchange Commission ("SEC") announced that it filed charges against SolarWinds Corp. ("SolarWinds" or the "Company") and its Chief Information Security Officer ("CISO") in connection...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
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
Cyber whistleblowing is the newest and hottest area of exposure for organizations. All government contractors and grant recipients must develop an understanding of the use of the False Claims Act (FCA) to address...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
Gary Gensler was sworn in as chair of the Securities and Exchange Commission on April 17, 2021. Chairman Gensler has promised to strengthen transparency and accountability in the financial markets. Under Chairman Gensler, we...more
The U.S. Securities and Exchange Commission (SEC) has launched a stunning salvo across the bows of public companies with its announcement of civil monetary penalties and a cease-and-desist order against First American...more
On April 14, 2021, the New York Department of Financial Services (“NYDFS”) announced a settlement with National Securities Corporation (“National Securities”), a licensed insurer, in connection with claims under the NYDFS...more
The New York Department of Financial Services (NYDFS) has settled alleged violations of the Department’s strict cybersecurity regulations with National Securities Corp. (NSC) for $3 million, over four separate cybersecurity...more
Ransomware has emerged as one of the most virulent cybersecurity risks, affecting public and private sector alike. In recent years, ransomware attacks have become more focused, sophisticated, costly, and numerous. Threat...more
Earlier this month, the U.S. Supreme Court agreed to hear a pair of cases that provide it with the opportunity to severely restrict the Federal Trade Commission’s (“FTC’s”) authority to obtain equitable money relief in...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
On October 17, 2019, the Department of Health & Human Services (HHS) published two proposed rules (one by the Office of Inspector General (OIG) and one by the Centers for Medicare & Medicaid Services (CMS)) that, if...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
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
UNITED STATES - Regulatory—Policy, Best Practices, and Standards - NIST Releases Internal Report Regarding IoT Cybersecurity - In September, the National Institute of Standards and Technology ("NIST") released a draft...more
On November 2, 2018, the SEC Enforcement Division (“Division”) released its Annual Report summarizing the past year’s enforcement activity. In the 2018 fiscal year, the first full fiscal year that Stephanie Avakian and Steven...more
On November 2, 2018, the U.S. Securities and Exchange Commission (the SEC or Commission) Division of Enforcement (the Division) released its annual report discussing enforcement-related actions and key initiatives (the...more
• The California Legislature passed SB 1121 to revise certain sections of the CCPA – the nation’s strictest privacy protection statute which provides Californians with a right to learn what personal information certain...more
This issue of Skadden’s semiannual Cross-Border Investigations Update takes a close look at recent cases, regulatory activity and other key developments, including the use of legal holds in cross-border investigations,...more