Popular, Comment Period, Department of Health and Human Services (HHS)

FDA’s Proposed Ranking Tool Gives Public Opinion a Seat at the Food Safety Table

Wiley Rein LLP on 8/12/2025

With food policy remaining a top priority for the Trump Administration, the U.S. Food and Drug Administration (FDA), acting under Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., has swiftly advanced a number...more

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

Foley Hoag LLP - Security, Privacy and the... on 12/30/2024

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

DOJ Proposes to Reschedule Marijuana (Cannabis) to Schedule III

McDermott Will & Schulte on 5/30/2024

On May 21, 2024, the US Department of Justice (DOJ) published the highly anticipated notice of proposed rulemaking (NPRM) to reschedule marijuana (cannabis) from a Schedule I controlled substance to Schedule III, taking the...more

FDA Issues Proposed Rule and Draft Guidance on Drug Importation

King & Spalding on 1/7/2020

In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more

HHS’s Regulatory Sprint to Coordinated Care – Part 3: CMS Proposes Expansive Set of Changes to Stark Regulations

Epstein Becker & Green on 10/31/2019

This Client Alert serves as the third in a three-part series in which we describe and analyze the rules proposed by the Department of Health and Human Services (“HHS”) Centers for Medicare & Medicaid Services (“CMS”) as part...more

HHS Proposes Changes to Permit Donation of Cybersecurity Technology

Robinson+Cole Health Law Diagnosis on 10/23/2019

On October 17, 2019, the Department of Health and Human Services (HHS) published proposed rules to update the regulatory Anti-Kickback Statute (AKS) safe-harbors and exceptions to the Physician Self-Referral (PSR) Law, known...more

CMS Proposes Changes to Physician Self-Referral Regulations to Promote Value-Based Health Care

Akin Gump Strauss Hauer & Feld LLP on 10/18/2019

• The Centers for Medicare and Medicaid Services (CMS) have issued a long-awaited proposal to reform the Physician Self-Referral Law’s (Stark Law’s) regulatory exceptions and to provide updated guidance for physicians and...more

HHS Announces Overhaul of Kickback and Stark Rules

Wilson Sonsini Goodrich & Rosati on 10/18/2019

On October 9, 2019, the U.S. Department of Health and Human Services' (HHS') Centers for Medicare and Medicaid Services (CMS) and Office of Inspector General (OIG) announced plans for sweeping changes to rules policing health...more

New Proposed Cybersecurity and EHR Donation Rules

Faegre Drinker Biddle & Reath LLP on 10/11/2019

On October 9, 2019, the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) simultaneously released a set of proposed rules (the “Proposed Rules”) that, among other...more

Healthcare Law Update: September 2018

Holland & Knight LLP on 9/7/2018

Regulation - CMS Contemplating Telemedicine Changes - The Centers for Medicare & Medicaid Services (CMS) recently published what it described as a "major proposed rule" that covers a number of topics that could have...more

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