News & Analysis as of

Transparency Department of Health and Human Services (HHS) Regulatory Requirements

Akin Gump Strauss Hauer & Feld LLP

HHS, FDA Announce Multiple Initiatives on Food Safety, Quality and Compliance Fronts

In the past week, the U.S. Food and Drug Administration (FDA), in collaboration with the Department of Health and Human Services (HHS) announced three new initiatives related to food safety and food supply chain transparency....more

MoFo Life Sciences

HHS Secretary to FDA: Consider Elimination of GRAS Self-affirmation Pathway

MoFo Life Sciences on

On March 10, the U.S. Department of Health and Human Services (HHS) issued a press release emphasizing “radical transparency to make sure all Americans know what is in their food” and announcing that HHS Secretary Robert F....more

Ice Miller

RFK Jr. Calls to End the Self-Affirming GRAS “Loophole”

Ice Miller on

Through an Order that the Secretary of the U.S. Department of Health and Human Services (HHS) Robert F. Kennedy Jr. (RFK) called an act of “radical transparency,” the U.S. Food and Drug Administration (FDA) has been directed...more

Akin Gump Strauss Hauer & Feld LLP

Is Self-Affirming GRAS Off the Menu?

United States Department of Health and Human Services (HHS) Secretary Kennedy recently directed the U.S. Food and Drug Administration (FDA) to consider rulemaking to revise its longstanding regulations and guidance governing...more

McGuireWoods Consulting

Health Care Executive Orders And Legal Actions: Part Three

Public Health - Withdrawing from the World Health Organization (WHO)...more

Maynard Nexsen

HHS Abandons Public Comment Practices Under the Richardson Waiver

Maynard Nexsen on

On March 3, 2025, the Department of Health and Human Services (HHS), under Secretary Robert F. Kennedy Jr., officially announced the rescission of the Richardson Waiver, a policy in place since 1971 that required public...more

McGuireWoods Consulting

Department Of Health And Human Services Proposes Ending Public Comment For Grants And Contracts

On Feb. 28, 2025, the Federal Register listed a proposal to end mandatory public comment periods for the Department of Health and Human Services (HHS). This specifically relates to “agency management or personnel or to public...more

Vedder Price

Trump Administration Issues Executive Order Mandating Implementation and Enforcement of Health Care Pricing Transparency

Vedder Price on

On February 25, 2025, President Donald J. Trump signed an executive order titled “Making America Healthy Again by Empowering Patients with Clear, Accurate, and Actionable Healthcare Pricing Information” (the “2025 Order”)...more

Wiley Rein LLP

Trump Prioritizes Health Care Pricing Transparency in New Executive Order

Wiley Rein LLP on

On Tuesday, February 25, 2025, President Trump issued an Executive Order (EO), “Making America Healthy Again By Empowering Patients with Clear, Accurate, and Actionable Healthcare Pricing Information.” The EO aims to improve...more

Fenwick & West LLP

New Federal Requirements for AI and IT System Implementation in Healthcare

Fenwick & West LLP on

On October 30, 2023, the Biden administration issued Executive Order 14110 on the Safe, Secure and Trustworthy Development and Use of Artificial Intelligence (the “Executive Order”). As detailed in our previously published...more

McAfee & Taft

New health plan guidance regarding transparency regulations and last year’s budget act

McAfee & Taft on

Late last Friday afternoon, the Departments of Labor, Health and Human Services, and the Treasury issued some new frequently asked questions (FAQs) regarding implementation of the transparency in coverage (TIC) regulations...more

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