News & Analysis as of

Rulemaking Process NPRM Department of Health and Human Services (HHS)

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

Quarles & Brady LLP

Fresh From the Oven: OCR-HHS Issues a Notice of Proposed Rulemaking for the HIPAA Security Rule

Quarles & Brady LLP on

‘Tis the season for holiday baking and the elves at the U.S. Department of Health and Human Services (HHS), through its Office for Civil Rights (OCR), have been diligently crafting their own holiday treat. On December 27,...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

McDermott Will & Emery

DOJ Proposes to Reschedule Marijuana (Cannabis) to Schedule III

McDermott Will & Emery on

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

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

Mintz - Health Care Viewpoints

Administration Finally Releases Proposed Drug Importation Policies for Stakeholder and Public Comments

At the end of July 2019, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump Administration’s two-part...more

Polsinelli

Analyzing the Proposed 2019 Stark Reforms

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The United Stated Department of Health and Human Services (“HHS”) published a notice of proposed rulemaking (NPRM) containing proposed changes to the Physician Self-Referral Law (“Stark Law,” or “Stark”) on October 17, 2019....more

Polsinelli

Assessing the Stark and Anti-Kickback Proposals for Value-Based Arrangements

Polsinelli on

Through two separate notices of proposed rule-making (NPRMs), the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG), seek to remove...more

Robinson+Cole Health Law Diagnosis

Spurred by Opioid Crisis, Government Proposes Additional Changes to Substance Use Disorder Confidentiality Regulations to...

On August 26, 2019, the Department of Health and Human Services Substance Abuse and Mental Health Services Administration (SAMHSA) published a notice of proposed rulemaking (NPRM) to “better align” its substance use disorder...more

PilieroMazza PLLC

Weekly Update Newsletter - April 2015

PilieroMazza PLLC on

GOVERNMENT CONTRACTS - GSA and HHS Issue a Notice Regarding Conducting a National Dialogue To Reduce Reporting Compliance Costs for Federal Contractors and Grantees - The General Services Administration (GSA)...more

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