News & Analysis as of

Regulatory Requirements National Institute of Health (NIH) Healthcare

Alston & Bird

Health Care Week in Review | Trump Administration Releases FY 2026 Budget Proposal; CMS Launches Oversight Initiative on Medicaid...

Alston & Bird on

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

McDermott Will & Emery

NIH’s Mandatory 15% Indirect Rate – Next Steps Following Preliminary Injunction

On March 5, 2025, a US district court in Massachusetts issued a preliminary injunction blocking the National Institutes of Health (NIH) from implementing a February 7, 2025, “Supplemental Guidance” notice that would establish...more

Alston & Bird

Health Care Week in Review: OMB Issues and Rescinds Memo Freezing Federal Funds; Senate Finance and HELP Committees Hold HHS...

Alston & Bird on

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

Health Care Compliance Association (HCCA)

Tackling Review of ‘Uninformative’ Studies, SACHRP Joins Quest to Boost Research Caliber

In 2023, after two years of study, an NIH task force proposed a series of recommendations to improve stewardship of research it funds, including that the agency adopt “stopping rules” that would allow poorly designed or low...more

Health Care Compliance Association (HCCA)

Cleveland Clinic Pays $7.6M Related to PI Whose Charges Were Dropped; ‘He Was Treated Horribly’

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

Health Care Compliance Association (HCCA)

In This Month’s E-News: February 2024

The Food and Drug Administration (FDA) is seeking strategies from Jeffrey W. Taub, M.D., to prevent future violations of human subject regulations the agency said were documented during site visits in September and October...more

Littler

Upcoming Changes to NIH Harassment and Hostile Work Environment Reporting Requirements

Littler on

The National Institutes of Health (NIH) requires recipient institutions—i.e., any entity receiving funding from the NIH—to have policies that foster a harassment-free environment. Recipient institutions are required to...more

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