News & Analysis as of

Department of Health and Human Services (HHS) Universities

Health Care Compliance Association (HCCA)

In This Month’s E-News: March 2024

The Association of American Universities (AAU) and the Council on Governmental Relations (COGR) are among a handful of groups “urging the Biden administration to rescind a policy proposal that would threaten the American...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: January 2024

The Department of Commerce and the National Institute of Standards and Technology are requesting comments on a “draft guidance framework designed to help federal agencies evaluate when it may be appropriate to exercise...more

Health Care Compliance Association (HCCA)

Bucking History, ORI Deputy Denies Requests For Misconduct NPRM Comment Extension

Report on Research Compliance 20, no. 12  (December 2023) In a move that is unprecedented in recent memory, a federal agency has denied a request to extend the comment period on a substantive proposed rule, turning down a...more

Spilman Thomas & Battle, PLLC

DHHS and New Disability Protections Under Section 504

The Department of Health and Human Services (DHHS) plays a critical role in ensuring that all individuals have access to necessary healthcare and social services, regardless of their disabilities. One of the key regulations...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: June 2023

After reviewing recommendations from its Office of Inspector General (OIG), the National Science Foundation (NSF) required Yale University to repay $172,213 of the $251,973 auditors flagged in a 2020 report. According to a...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 20, Number 1. In This Month’s E-News: January 2023

Alice C. Chang, formerly an associate professor of basic medical sciences in the College of Veterinary Medicine at Purdue University, “falsified and/or fabricated data from the same mouse models or cell lines by reusing the...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 19, Number 9. In This Month's E-News: September 2022

Report on Research Compliance Volume 19, Number 9 (September, 2022) - According to the HHS Office of Research Integrity (ORI), Janina Jiang, M.D., Ph.D., a former assistant researcher in the University of California, Los...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 19, Number 7. In This Month's E-News: July 2022

Report on Research Compliance 19, no. 7 (July, 2022) - Given the already “heavy …burden” faced by small institutions and the National Science Foundation's (NSF) low award rate, the Council on Governmental Relations (COGR)...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 19, Number 5. In This Month's E-News: May 2022

Report on Research Compliance 19, no. 5 (May, 2022) - Nearly a decade after irregularities were first noticed in clinical trials that ultimately led to a misconduct finding and a guilty plea for embezzlement, the HHS...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 19, Number 4. In This Month's E-News: April 2022

Report on Research Compliance 19, no. 4 (April, 2022) - A six-year review of the institutional review board (IRB) at National Jewish Health (NJH) of Denver has been resolved, with the organization outsourcing the...more

Health Care Compliance Association (HCCA)

Two Washington Universities Ink Settlements For Exceeding Salaries, Falsified Application

Report on Research Compliance 18, no. 12 (December, 2021) - Washington State University’s (WSU) recent settlement with the HHS Office of Inspector General (OIG) for more than $800,000 followed a university-wide audit that...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 11. In This Month’s E-News: November 2021

Report on Research Compliance 18, no. 11 (November, 2021) - A professor in the University of Washington (UW) College of Engineering allegedly falsified award documents submitted to the National Science Foundation (NSF)...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)

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

Steptoe & Johnson PLLC

Can Colleges Mandate Vaccines? Yes, But Beware.

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As institutions of higher education (“IHEs”) approach their summer and fall terms, the question on every administrator’s mind is: Can our institution legally implement a mandatory COVID-19 vaccine policy for students and/or...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 7. In This Month’s E-News: July 2021

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

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 6. In This Month’s E-News: June 2021

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

Saul Ewing LLP

The 21st Century Cures Act and Higher Education: Does Your Institution Need to Comply?

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Background - On December 13, 2016, the 21st Century Cures Act (the “Cures Act”) was signed into law and made changes to the Public Health Service Act related to health information technology. The Office of the National...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 4. In This Month’s E-News: April 2021

Report on Research Compliance 18, no. 4 (April 2021) - A new report by the National Academies of Sciences, Engineering, and Medicine examining the impact of the COVID-19 pandemic found “intensified complications related...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 3. In This Month's E-News: March 2021

Report on Research Compliance 18, no. 3 (March 2021) - ◆ A former post-doctoral fellow at the McGovern Medical School, part of the University of Texas (UT) Health Science Center, admitted to committing research misconduct...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 1. In This Month's E-News: January 2021

Report on Research Compliance 18, no. 1 (January 2021) - The National Science Foundation (NSF) will be accepting comments on a revised version of its Proposal & Award Policies & Procedures Guide (PAPPG) expected to be...more

Saul Ewing LLP

Academic Medical Center Agrees to Pay $65,000 in the 12th OCR Settlement as Part of OCR’s HIPAA Right of Access Initiative

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On November 19, 2020, the Office for Civil Rights (“OCR”) at the U.S. Department of Health and Human Services (“HHS”) announced it had settled its 12th enforcement action in its HIPAA Right of Access Initiative (the...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

Saul Ewing LLP

New Guidance From the Department of Health and Human Services on Title IX in Academic Medical Centers

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On September 25, 2020, the Office for Civil Rights at the U.S. Department of Health and Human Services (“HHS”) published a document entitled, “Effective Practices for Preventing Sexual Harassment.” ...more

Bass, Berry & Sims PLC

Significant Change to ClinicalTrials.gov Reporting Requirements: Ten Years' Worth of Back Data Owed

The National Institutes of Health (NIH) has warned clinical trial sponsors – including not only drug and device companies, but also universities and hospitals with investigator-initiated trials – to submit significant...more

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