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Rulemaking Process Proposed Rules Department of Health and Human Services (HHS)

Hogan Lovells

HHS and FDA Announce Plans to Phase Out Certified Colors

Hogan Lovells on

On April 22, 2025, the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) announced a series of measures to phase out all certified colors from the nation’s food supply by the end...more

Baker Donelson

What Food and Beverage Manufacturers Should Be Considering With HHS Secretary Kennedy at the Reins

Baker Donelson on

Human Health and Services (HHS) Secretary Robert F. Kennedy Jr. has instructed the Food and Drug Administration (FDA) to revisit and consider rulemaking regarding its Generally Recognized as Safe (GRAS) notification and...more

Beveridge & Diamond PC

GRAS Self-Affirmation for Food Ingredients – To Be or Not to Be?

Beveridge & Diamond PC on

Key Takeaways - What Happened: HHS Secretary Kennedy directed FDA to consider removing the current self-affirmation pathway for determining that a food ingredient is Generally Recognized as Safe (GRAS)....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

McDermott+

Regs & Eggs with a Side of DOGE

McDermott+ on

In the health policy world, nothing gets folks like me more “excited” than expecting and then seeing a new healthcare regulation pop up in the Federal Register. While the content of the reg is usually what public stakeholders...more

McCarter & English, LLP

DEA Telemedicine Update

The Drug Enforcement Administration (DEA), in concert with other federal agencies, has taken various steps in the past few months to strengthen a practitioner’s ability to prescribe controlled substances via telemedicine, a...more

Mintz - Health Care Viewpoints

FDA Continues Push to Improve Food Labeling Practices in the United States

In September 2022, former President Biden convened the White House Conference on Hunger, Nutrition, and Health, during which the White House introduced its National Strategy on Nutrition and Health (National Strategy). The...more

Troutman Pepper Locke

FDA Withdraws Proposed Bans on Menthol Cigarettes and Flavored Cigars

Troutman Pepper Locke on

In late January, the U.S. Food and Drug Administration (FDA) withdrew its proposed rules to prohibit menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars. Although either proposal could be...more

Troutman Pepper Locke

HIPAA Security Rule Revamp Is on the Horizon

Troutman Pepper Locke on

On January 6, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published significant proposed amendments (proposed rule) to the Security Rule under the Health Insurance Portability and...more

Sheppard Mullin Richter & Hampton LLP

HHS’ Last-Minute Holiday Gift: Proposed Changes to the HIPAA Security Rule

The U.S. Department of Health and Human Services (“HHS”) issued a Notice of Proposed Rulemaking (the “Proposed Rule”) on December 27, 2024, to significantly amend HIPAA’s Security Rule, which sets forth the security standards...more

Foley Hoag LLP - Security, Privacy and the...

HHS Office for Civil Rights Proposes Measures to Strengthen Cybersecurity in Health Care Under HIPAA

The Department of Health and Human Services (HHS) has proposed significant modifications to the HIPAA Security Rule and the HITECH Act in an attempt to strengthen cybersecurity protections for electronic protected health...more

Fisher Phillips

White House Takes Aim at Inefficient Business Practices Through “Time Is Money” Initiative: 5 Things Employers Should Do

Fisher Phillips on

The Biden Administration wants to crack down on corporate practices that it believes waste consumers’ time and money through excessive paperwork, long wait times, and other aggravations – and you’ll want to take note so you...more

ArentFox Schiff

No More Surprise Medical Bills: Biden Administration Issues New Surprise Billing Rulemaking Proposing Batching and Procedural...

ArentFox Schiff on

*This is the 12th article in a series analyzing the No Surprises Act and its implementation. To view the entire series, click here. A link to the proposed rule is here.  As background, Congress passed the Act to prevent...more

McDermott+

Departments Propose Broader Batching and IDR Process Changes for Surprise Billing Claims

McDermott+ on

On October 27, 2023, the US Departments of Health and Humans Services, Labor and the Treasury (the Departments), along with the Office of Personnel Management, issued a proposed rule titled Independent Dispute Resolution...more

Foley & Lardner LLP

ORI Proposes New Rulemaking for Research Misconduct Regulations

Foley & Lardner LLP on

On October 5, 2023, the Office of Research Integrity (ORI) of the Department of Health and Human Services (HHS) issued a notice of proposed rulemaking to update the Public Health Service (PHS) Policies on Research Misconduct...more

McDermott Will & Emery

HHS, DOL and Treasury Issue a Proposed Rule Increasing Federal IDR Fees

McDermott Will & Emery on

On September 20, 2023, the US Departments of Health and Human Services (HHS), Labor (DOL) and the Treasury (collectively, the departments) issued a proposed rule related to the No Surprises Act’s (NSA’s) federal independent...more

Health Care Compliance Association (HCCA)

FDA Consolidates, Revises Informed Consent Guidance; 2018 Common Rule Not Addressed

Nearly nine years to the day the Food and Drug Administration (FDA) issued a draft “information sheet” on informed consent, the agency published a 66-page final guidance document on the topic—marking the first time since 1998...more

ArentFox Schiff

Mental Health Parity Act: Biden Administration Issues Long-Awaited Rulemaking Cracking Down on Treatment Limitations

ArentFox Schiff on

On July 25, 2023, the US Departments of Labor (DOL), Treasury (DOT), and Health and Human Services (HHS) (the Departments) released a much-anticipated interim final rule to ensure that group health plans comply with the...more

Sheppard Mullin Richter & Hampton LLP

Proposed Rule Leverages Section 1557 for Healthcare Equity

On July 25, 2022, the U.S. Department of Health and Human Services (“HHS”) issued a proposed new rule that significantly expands the scope of protection available to vulnerable populations under Section 1557 of the Affordable...more

Sheppard Mullin Richter & Hampton LLP

The Biden Administration’s and HHS’s Plan to Advance Health Care Equity

President Biden issued Executive Order 13985, Advancing Racial Equity and Support for Underserved Communities Through the Federal Government (Executive Order) on inauguration day in 2021, signalizing the Administration’s...more

Bricker Graydon LLP

First rules implementing surprise medical billing law issued

Bricker Graydon LLP on

On July 1, 2021, the U.S. Departments of Labor, Treasury, and Health and Human Services (HHS) issued the first rules implementing the No Surprises Act, which prohibits health care providers from billing patients more than...more

Holland & Knight LLP

Health and Human Services Proposes Federal Rules That Could Sunset Many Health Regulations

Holland & Knight LLP on

On Nov. 4, 2020, the U.S. Department of Health and Human Services (HHS) published a notice of proposed rulemaking and proposed regulatory changes that would, effectively, cause many federal healthcare regulations to disappear...more

King & Spalding

Proposed Rule Would Require Retroactive Review of HHS Regulations

King & Spalding on

On November 4, 2020, HHS issued a notice of proposed rulemaking that would require HHS to review its regulations every ten years to determine whether or not the regulations are subject to agency review under the Regulatory...more

Akin Gump Strauss Hauer & Feld LLP

HHS Proposes to Rein In Its Use of Regulatory “Dark Matter”

- HHS is overhauling its process for developing interpretive guidance documents under a new Proposed Rule. - HHS proposes to no longer use “guidance documents” to establish broadly applicable legal obligations on the...more

Bricker Graydon LLP

Changes coming to the Stark Law and Anti-Kickback Statute regulations

Bricker Graydon LLP on

On October 9, 2019, the Centers for Medicare and Medicaid Services (CMS) and the Department of Health and Human Services Office of Inspector General (OIG) issued long-awaited proposed changes “to modernize and clarify the...more

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