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
This summer, the Ohio House of Representatives passed the Campus Accountability and Modernization to Protect University Students (CAMPUS) Act. This law, if enacted, would require institutions of higher education throughout...more
Answering the question of how much money a compliance and ethics program saves an organization when there’s been a violation is often a very difficult task, which presents a challenge in defending the investment in a program....more
Last week, California Governor Gavin Newsom announced an agreement had been reached on reforms to the Private Attorneys General Act (PAGA). The Governor, legislative leaders, business groups, and labor collaborated in...more
The SEC recently settled charges against five registered investment advisers for violations of the marketing rule (“Marketing Rule”) under the Investment Advisers Act of 1940 (“Advisers Act”)....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
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
The Centers for Medicare and Medicaid Services (CMS) has increasingly focused its efforts on investigating hospital emergency departments for potential violations of the Emergency Medical Treatment and Labor Act (EMTALA),...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
As the SEC closed its fiscal year, it filed three separate enforcement actions against companies for purported violations of Rule 21F-17 under the Securities and Exchange Act of 1934, which prohibits persons from impeding...more
We have often written about the SEC’s whistleblower program and, in particular, the success of the program with respect to detecting and preventing violations of the federal securities laws. The success of the program...more
Who may be interested: Investment Advisers. Quick Take: The SEC recently settled charges with nine investment advisers related to their use of hypothetical performance information on their websites without adopting or...more
Who may be interested: Registered Investment Advisers, Mutual Funds, Compliance Officers - Quick Take: The SEC settled charges against two affiliated registered investment advisers, alleging that the advisers failed to...more
On November 29, the OCC released a revised Policies and Procedures Manual relating to the assessment of civil money penalties (“CMP Matrix”), which will be effective as of January 1, 2023. The CMP Matrix is a reference guide...more
Federal enforcement of the 21st Century Cures Act’s (the Cures Act) prohibitions on improper blocking of electronic health information is ramping up. The Cures Act already targets technology developers and health information...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
It can be cathartic responding to a negative online review. It can also backfire, as can failing to cooperate with an OCR investigation as required under HIPAA. The Office for Civil Rights (OCR) recently announced four...more
Case Overview - This week’s U.S. Securities and Exchange Commission enforcement cease-and-desist order (Order) In re App Annie Inc., out of the SEC’s San Francisco Regional Office, underscores the importance of taking...more
On February 16, 2021, the SEC filed a litigated civil complaint in the Southern District of New York against Morningstar Credit Ratings LLC, a former Nationally Recognized Statistical Rating Organization (“NRSRO”) alleging...more
On February 22, 2021, Governor Phil Murphy signed the New Jersey Cannabis Regulatory, Enforcement Assistance, and Marketplace Modernization Act (“NJCREAMMA”), which legalizes the recreational use of cannabis for adults age 21...more
- A tone-at-the-top business culture with CEO leadership is a critical component of effective anti-corruption and anti-bribery policy implementation. - CEO leadership helps set an example for lower management and company...more
On August 20, 2019, the U.S. Securities and Exchange Commission (SEC) issued a cease-and-desist order against TherapeuticsMD, a pharmaceutical company, finding that it violated Regulation FD and Exchange Act Section 13(a),...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
I have been busy the last month getting ready for a big arbitration, and attending the first week of what looks like is going to be a four- or five-week slog when all is said and done. So, I am just catching up on some recent...more
In December 2018, the SEC announced two enforcement actions involving business development companies (BDCs) – one against Fifth Street Management, LLC, the former external registered investment adviser to two BDCs, and the...more
Last Thursday, the Bureau of Consumer Financial Protection (the “Bureau”) announced a settlement with State Farm Bank, FSB (“State Farm”) regarding alleged violations of the FCRA as well as the Consumer Financial Protection...more