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Federal Funding National Institute of Health (NIH)

Dorsey & Whitney LLP

Some Serious Strings Attached: Sponsored Research Funding, Adequate Accounting Systems, and False Claims Act Exposure

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The federal government awards billions of dollars each year in sponsored research funding to institutions of higher education, academic research institutions, non-profit organizations, and companies—making federal grants an...more

Holland & Knight LLP

Senate Releases Bipartisan AI Roadmap

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A group of four bipartisan senators known as the Bipartisan Senate Artificial Intelligence (AI) Working Group (Working Group) on May 15, 2024, released "Driving U.S. Innovation in Artificial Intelligence: A Roadmap for...more

Holland & Knight LLP

Holland & Knight Health Dose: March 5, 2024

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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

Morrison & Foerster LLP - Government...

Biden Administration Proposes Novel Use Of Price As Justification For Agency Exercise Of March-In Rights For Government-Funded...

Presented as part of its effort to lower what it views as excessive prices for prescription drugs, the Biden administration on December 7, 2023, announced the release of a proposed framework to expand the use of government...more

Holland & Knight LLP

Holland & Knight Health Dose: November 7, 2023

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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

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 20, Number 1. With Greater Than Half Its Positions Vacant, OHRP Employing More Technology,...

The HHS Office for Human Research Protections (OHRP) is currently operating with a 62% vacancy rate among staff, as it has not filled open positions, agency officials say. OHRP has a staff of 20, but there are an additional...more

Holland & Knight LLP

What's In and Out for Healthcare in the Year-End Funding Package

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Lawmakers unveiled their long-awaited $1.7 trillion government funding package on Dec. 20, 2022. As of publishing, it seems likely that a vote on final passage in the U.S. Senate will occur at some point on Dec. 22, with a...more

Holland & Knight LLP

Holland & Knight Health Dose: September 13, 2022

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Holland & Knight Health Dose 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

Alston & Bird

Alston & Bird Health Care Week in Review - January 2022 #4

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 19, Number 1. In This Month's E-News: January 2022

Report on Research Compliance 19, no. 1 (January, 2022) - Although a continuing resolution is now in place that funds the federal government through Feb. 18, committees are still working on bills that could contain...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 9. In This Month’s E-News: September 2021

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

Health Care Compliance Association (HCCA)

First Jail Term for Undisclosed Foreign Support Appealed; NIH’s Lauer Laments ‘Tragic’ OSU Case

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

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 8. In This Month’s E-News: August 2021

Report on Research Compliance 18, no. 8 (August, 2021) - “As a steward of the nation’s biomedical research enterprise, NIH is dedicated to ensuring that when data and biospecimens are shared, that it is done ethically and...more

McCarter & English Blog: Government Contracts...

NIST On Track To Clarify Bayh-Dole To Ensure High Prices Cannot Be Used As Grounds For Exercising March-in Rights – Or Is It?

On January 4, 2021, the National Institute of Standards and Technology (NIST) published proposed rules for comment changing regulations promulgated under the Bayh-Dole Act (35 U.S.C. §§ 200-204), which allow businesses and...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 11. In This Month's E-News: November 2020

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

Haug Partners LLP

When the “States” Come Marching-In: The Bayh-Dole Act’s Effect on IP Rights of COVID-Related Patents and Knowledge Ecology...

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On August 4, 2020, a bipartisan coalition of over 30 attorneys general led by California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry sent a letter request to United States Health and Human...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Patent Prosecution Tool Kit: Federally Funded Inventions and Compliance with the Bayh-Dole Act

Organizations that receive federal funds or that license technology from third parties that receive Federal funds need to be aware of Federal funding obligations under the Bayh-Dole Act. Any invention conceived or reduced to...more

Baker Donelson

New Health Care Provider Opportunities in Fourth COVID-19 Bill and HHS Plans to Distribute Additional Funds

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On April 23, 2020, the House of Representatives passed the Paycheck Protection Program and Health Care Enhancement Act, which previously passed the Senate on April 21, 2020, and is expected to be signed into law by the...more

Bass, Berry & Sims PLC

OHRP Releases Guidance for Institutions Conducting Human Subjects Research During COVID-19

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The Office for Human Research Protections (OHRP) released guidance earlier this week in response to the COVID-19 pandemic, encouraging researchers to prioritize public health and safety. The guidance clarifies how the...more

Holland & Knight LLP

COVID-19 Funding and Recovery Opportunities for Healthcare Providers

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Congress has provided an unprecedented infusion of funding and other financial relief through a variety of new and existing programs to address the coronavirus (COVID-19) outbreak. This blog post outlines how the federal...more

Baker Donelson

Third Coronavirus Stimulus Package Includes Considerable Funding for Health Care Providers and Other Health Care Provisions

Baker Donelson on

Both the U.S. Senate and House of Representatives have now passed the Coronavirus Aid, Relief, and Economic Security (CARES) Act, and the President is expected to sign the bill into law shortly. The CARES Act appropriates...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 3. In This Month's E-News: March 2020

Report on Research Compliance 17, no. 3 (February 20, 2020) - Despite its earlier agreement to repay just $5,442 in costs questioned by the National Science Foundation (NSF) Office of Inspector General, the University of...more

Holland & Knight LLP

Legitimate Academic Pursuits or Illegal Espionage?

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A prominent professor at Harvard University, Charles Lieber, chair of the Harvard Chemistry Department, was arrested on Jan. 28, 2020, and charged with the federal crime of making a false statement to the government arising...more

Health Care Compliance Association (HCCA)

After $5.5M FCA Settlement, Institutions Face Bigger Risks for Mishandling Foreign Support

Report on Research Compliance 17, no. 2 (January 23, 2020) - Acting with “deliberate ignorance” and “reckless disregard” are not words that any institution wants to hear associated with its name. But these are at the heart...more

Health Care Compliance Association (HCCA)

Report on Research Compliance 17, no. 1. In This Month's E-News: January 2020

Report on Research Compliance 17, no. 1 (January 2020) - ? A man from Richland, Washington, is facing life in prison after being convicted of 47 counts of fraud for staging clinical trials that purportedly enrolled dozens of...more

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