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Public Comment Request For Information Department of Health and Human Services (HHS)

Holland & Knight LLP

HHS, FDA Issue Request for Information to Support Administration's Deregulatory Agenda

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The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) issued a Request for Information (RFI) on May 13, 2025, titled "Ensuring Lawful Regulation and Unleashing Innovation to...more

Quarles & Brady LLP

Justice Department’s New Task Force on Health Care Monopolies and Collusion

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DOJ recently formed the Antitrust Division’s (the “Division”) Task Force on Health Care Monopolies and Collusion (“HCMC”), signaling anticompetitive activity in health care markets as an enforcement priority....more

Seyfarth Shaw LLP

FTC and DOJ Seek Public Help Identifying “Serial Acquisition Strategy” Targets

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The Federal Trade Commission (“FTC”) and the Antitrust Division of the Department of Justice (“DOJ”) announced on Thursday, May 23, that they are expanding their search for businesses using “roll up” strategies to consolidate...more

Seyfarth Shaw LLP

All Gas No Brakes – The FTC, DOJ, and HHS Unveil Online Reporting Portal as Latest Effort to Combat Unfair and Anticompetitive...

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On April 18, 2024, the Federal Trade Commission (“FTC”), Justice Department (“DOJ”), and the U.S. Department of Health and Human Services (“HHS”) launched an online reporting portal, HealthyCompetition.gov, for the public to...more

King & Spalding

FTC and DOJ Increase Scrutiny of Private Equity’s Role in Healthcare

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On March 5, 2024, the Federal Trade Commission (FTC) hosted a virtual workshop titled “Private Capital, Public Impact: an FTC Workshop on Private Equity in Healthcare” (the Workshop). The agenda, together with a recording of...more

McDermott Will & Emery

Top Takeaways | FTC Hosts Workshop, Solicits Public Comments on Private Equity in Healthcare

McDermott Will & Emery on

On March 5, 2024, the Federal Trade Commission (FTC) hosted “Private Capital, Public Impact: An FTC Workshop on Private Equity in Health Care” to examine the role of private equity investment in healthcare markets. The same...more

Holland & Knight LLP

Holland & Knight Health Dose: March 5, 2024

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more

Foley Hoag LLP

CMS Releases Request for Information on Medicare Advantage Data

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On January 30, 2024, CMS published in the Federal Register an RFI to seek input from the public regarding increased public releases of MA data to improve transparency in the program. CMS stated responses to this RFI may be...more

McDermott Will & Emery

Biden Administration Proposes New Framework for Exercising March-In Rights on Government-Funded Inventions; Drug Pricing May Be...

McDermott Will & Emery on

Under the University and Small Business Patent Procedures Act of 1980 (35 U.S.C. §§ 200-212), commonly referred to as the Bayh-Dole Act, the federal government can exercise “march-in” authority in certain circumstances to...more

Nelson Mullins Riley & Scarborough LLP

The Drive for Equitable Healthcare Access: Departments Seek Public Input on Over-the-Counter Preventive Services

On September 29, the Centers for Medicare & Medicaid Services (CMS) reported that the federal Departments of Health and Human Services, Labor, and the Treasury departments are seeking public input on the possibility of...more

ArentFox Schiff

OCR Seeks Public Comments on HIPAA/HITECH Security and Enforcement Provisions

ArentFox Schiff on

The HHS Office for Civil Rights is requesting comments about HIPAA covered entities’ and business associates’ implementation of “recognized security practices” and payments to “harmed individuals” from funds the agency...more

Hogan Lovells

HHS seeks comment by June 6 on recognized security practices as mitigating factor in HIPAA enforcement

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The US Department of Health Human Services (HHS) is seeking public comments about the appropriate role of “recognized security practices” in enforcement of the HIPAA Security Rule. Congress, through an amendment to the HITECH...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

Health Care Compliance Association (HCCA)

Report on Research Compliance 17, no. 1. In This Month's E-News: January 2020

Report on Research Compliance 17, no. 1 (January 2020) - ? A man from Richland, Washington, is facing life in prison after being convicted of 47 counts of fraud for staging clinical trials that purportedly enrolled dozens of...more

Epstein Becker & Green

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

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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

Bass, Berry & Sims PLC

Key Takeaways from CMS' New Proposed Rule on Stark Law Advisory Opinions

While the industry awaits more sweeping value-based related changes to the Stark Law regulations, on July 29, 2019, the Centers for Medicare & Medicaid Services (CMS) took a small step toward updating its Stark Law advisory...more

Steptoe & Johnson PLLC

Some HIPAA Happenings

Proposed Modifications to HIPAA Regulations under Consideration - On December 14, 2018, HHS issued its Request for Information on Modifying HIPAA Rules to Improve Coordinated Care as part of its Regulatory Sprint to...more

Akin Gump Strauss Hauer & Feld LLP

Deadline Approaching to Submit Comments on Potential Updates to HIPAA in Response to Agency Request for Information

There are less than two weeks left to submit comments regarding potential updates to the privacy, security and breach notification regulations adopted under the Health Insurance Portability and Accountability Act of 1996 and...more

Bass, Berry & Sims PLC

Modifying the HIPAA Rules: The Next Leg in HHS’s Sprint to Coordinated Care

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On December 14, 2018, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) issued a Request for Information (RFI) seeking comments on potential modifications to the HIPAA Rules focused on...more

White and Williams LLP

OCR Seeks Feedback for Modifying HIPAA Rules to Promote Efficiency and Reduce Burdens Placed Upon Covered Entities

White and Williams LLP on

Last week, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR), issued a Request for Information (RFI) seeking public input on modification of the Privacy and Security Rules under the Health...more

Foley & Lardner LLP

Happy New Year! Potential Changes to HIPAA Requirements on the Horizon

Foley & Lardner LLP on

On December 12, 2018, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR), requested public comments on potential changes to the Health Insurance Portability and Accountability Act’s...more

Snell & Wilmer

HHS Seeks Public Comment on the HIPAA Privacy Rule

Snell & Wilmer on

Earlier today the U.S. Department of Health and Human Services Office of Civil Rights (HHS OCR) issued a Request for Information (RFI) seeking public input on the HIPAA Privacy Rule. Specifically, HHS OCR is interested in how...more

Baker Donelson

OIG Releases RFI Focused on Removing Barriers to Value-Based Care

Baker Donelson on

The Department of Health and Human Services, Office of Inspector General (OIG) recently released a request for information (RFI) seeking public input on "how to address any regulatory provisions that may act as barriers to...more

Bass, Berry & Sims PLC

Sprinting to Coordinated Care: Healthcare Industry Urges Stark Law Relief as OIG Solicits Feedback on Changes to the Anti-Kickback...

August 24, 2018 marked a busy day for the U.S. Department of Health & Human Services' (HHS) self-designated "Regulatory Sprint to Coordinated Care," an initiative aimed at dismantling the regulatory barriers to providers...more

Dorsey & Whitney LLP

Calls for Modernizing the Stark Law Continue; CMS Seeks Public Input on Stark Law Reforms

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Many regulatory and legislative calls for modernizing the federal physician self-referral law (or “Stark Law”) in light of the move to value-based payment under Medicare have been made in recent months. Most recently, a...more

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