Stay on top of developments in healthcare research compliance - Whether you missed the 2024 in-person Higher Education & Healthcare Research Compliance Conference in New Orleans, or are looking for additional insights...more
Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more
Attorney Peter Zeidenberg was surprised to learn that NIH had successfully clawed back $3.6 million—plus a nearly 100% penalty—from Cleveland Clinic. The Department of Justice (DOJ) claimed the award funds were ill-gotten...more
In 2022, the United States Department of Justice (“DOJ”) announced its decision to shut down the “China Initiative”—the controversial program used to investigate and prosecute academics, health care workers, and...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more
This is the fifth in our 2024 Year in Preview series examining important trends in white collar law and investigations in the coming year. We will be posting further installments in the series throughout the next several...more
Stay on top of the latest in research compliance - Do you want to learn: - Current best practices for building and maintaining a research compliance work plan? - How to better shift your program’s research focus in...more
Report on Research Compliance 19, no. 5 (May, 2022) - In an address at George Mason University in February, U.S. Assistant Attorney General Matthew Olsen said the government had “heard concerns from the civil rights...more
Report on Research Compliance 18, no. 10 (October, 2021) - An audit by the HHS Office of Inspector General (OIG) of the National Human Genome Research Institute’s (NHGRI) pre-award risk assessment process concluded that...more
Report on Research Compliance 18, no. 9 (September, 2021) - A former Harvard Medical School and Massachusetts General Hospital (MGH) researcher who was the principal investigator on a 2014 NIH award of $939,495.27 and...more
Report on Research Compliance 18, no. 9 (September, 2021) - To his supporters and colleagues, Song Guo Zheng, MD, PhD, was the most productive worker they’ve seen in 50 years, publishing nearly 300 papers, a man who lived...more
When Anming Hu, an engineering professor at the University of Tennessee, Knoxville (“UTK”) was indicted in February 2020 on charges related to his alleged failure to disclose ties to a state-run Chinese university, the case...more
Report on Research Compliance 18, no. 7 (July 2021) - In a review of more than 500 NIH awards, the HHS Office of Inspector General (OIG) found that about one-fifth were funded “out of rank order,” and for more than a...more
Report on Research Compliance 18, no. 6 (June 2021) - Clemson University is pushing back against recommendations by auditors for the National Science Foundation Office of Inspector General (OIG) that it repay $276,440,...more
China employs its Thousand Talents Program (“TTP”) to recruit overseas academic and scientific talent to work in China by promising research funding from the Chinese government and, occasionally, compensation. TTP has drawn...more
Report on Research Compliance 17, no. 12 (December 2020) - Finalizing a document issued last year, on Nov. 9 the Food and Drug Administration issued “Enhancing the Diversity of Clinical Trial Populations—Eligibility...more
Department of Education Report Warns that Academic Institutions Are Failing to Meet Compliance Obligations in Fight Against Foreign Influence Last month the Department of Education (“DOE” or “Department”) released an...more
Report on Research Compliance 17, no. 11 (November 2020) - In light of the ongoing COVID-19 pandemic, the HHS Office for Human Research Protections has issued an exception to the single institutional review board...more
Report on Research Compliance 17, no. 10 (September 24, 2020) What the federal government—and a whistleblower—allege were False Claims Act (FCA) violations actually resulted from an “accounting discrepancy,” according to the...more
Engineering Firm Settles $37 Million False Claims Act Allegations - As part of a settlement agreement with the Department of Justice, QuantaDyn Corporation has agreed to pay $37,757,713.91 in restitution to resolve...more
COVID-19- Bipartisan Group of Attorneys General Seeks to Expand Production of Antiviral Drug- A bipartisan group of 34 AGs, led by California AG Xavier Becerra and Louisiana AG Jeff Landry, sent a letter urging the U.S....more
This week: FCC requests comment on social media order as White House withdraws O’Rielly nomination; U.S. Justice Department asks court to block California net neutrality law; FTC Commissioners testify before Senate Commerce...more
Report on Research Compliance 17, no. 6 (June 2020) - A former assistant veterinary medicine professor at the University of Maryland will retract or correct seven papers published from 2013 to 2016 that contained reused or...more
The recent news of arrests of university professors for failing to disclose their participation in Chinese talent programs has hit the academic world like a thunderclap. But those surprised by these arrests have failed to...more