News & Analysis as of

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

Venable LLP

Operation Stork Speed Update: FDA Issues RFI for Infant Formula Nutrition Review

Venable LLP on

On May 14, as part of Operation Stork Speed (the Operation), the U.S. Food and Drug Administration (FDA) issued a request for information (RFI) to begin its review of infant formula nutrition requirements. FDA’s last...more

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

WilmerHale

PTAB/USPTO Update - January 2024

WilmerHale on

On January 4, the USPTO announced the appointment of new leaders for the agency’s policy and communications teams. Sharon Israel will serve as the Chief Policy Officer and Director for International Affairs, and Jack...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

Goodwin

CFPB, U.S. Department of Health and Human Services, and U.S. Department of Treasury Initiate Public Inquiry into Financial...

Goodwin on

​​​​​​​On July 7, 2023, the Consumer Financial Protection Bureau (CFPB), U.S. Department of Health and Human Services (DOH), and U.S. Department of Treasury (DOT) initiated a public inquiry into certain financial products,...more

Orrick, Herrington & Sutcliffe LLP

CFPB launches medical-debt inquiry with HHS and Treasury

On July 7, the CFPB, Department of Health and Human Services, and the Treasury Department announced they are looking into high-cost specialty financial products such as medical credit cards and installment loans used by...more

Proskauer on Privacy

Department of Health and Human Services Issues Request for Information on Cybersecurity Standards

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The Department of Health and Human Services (“HHS”) has issued a formal request for information from the public about how regulated entities are implementing industry recognized security practices. The request for information...more

McDermott Will & Emery

HHS-OIG Invites Participation in Modernization Initiative: RFI Comment Deadline Approaching

McDermott Will & Emery on

On September 24, 2021, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a request for information (RFI) to advance its guidance modernization initiative. The RFI seeks industry...more

Bass, Berry & Sims PLC

OIG Publishes Wide-Ranging Request for Information

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One of the Department of Health and Human Services (HHS) Office of Inspector General’s (OIG’s) key compliance priorities is modernizing the agency’s program integrity and compliance information. OIG has explained that its...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - May 2021 #2

Latham & Watkins LLP on

PhRMA Suit Challenges Co-Pay/Accumulator Portion of December 2020 Medicaid Rule - On May 21, 2021, Pharmaceutical Research and Manufacturers of America (PhRMA) filed suit in the US District Court for the District of...more

Foley Hoag LLP

Department of Health and Human Services Issues Request for Information on COVID-19 Best Practices

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On November 23, 2020, the Department of Health and Human Services (HHS) published a Request for Information (RFI) seeking insights from health systems and providers on innovative approaches and best practices implemented in...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

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

Epstein Becker & Green

HHS’s Regulatory Sprint to Coordinated Care – Part 1: CMS and OIG Issue Long-Awaited Proposed Rules

Epstein Becker & Green on

On October 9, 2019, the Centers for Medicare & Medicaid Services (“CMS”) and the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) took the next step in their Regulatory Sprint to Coordinated...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

Epstein Becker & Green

HHS OIG Proposes Anti-Kickback Safe Harbor Amendments to Regulate and Restrict the Provision of Manufacturer Remuneration to Plan...

On January 31, 2019, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a proposed rule (“Proposed Rule”) that would restrict safe harbor protection under the federal Anti-Kickback...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

Katten Muchin Rosenman LLP

New Cybersecurity Guidance for the Health Care Industry (and Last Call for HIPAA Rule Comments)

We discuss below two important updates impacting health care industry clients...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

Hogan Lovells

HHS Seeking Input on HIPAA Changes

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The Department of Health and Human Services (HHS) announced a Request for Information (RFI) regarding how the HIPAA Privacy, Security, and Breach Notification Rules could be modified to reduce regulatory burdens and to...more

Harris Beach Murtha PLLC

OCR Issues Anticipated RFI on HIPAA Modifications

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The Request for Information on Modifying HIPAA Rules to Improve Coordinated Care is slated for publication in the federal register tomorrow. The Department of Health and Human Services’ Office for Civil Rights (OCR) issued an...more

Mintz - Health Care Viewpoints

HHS Continues the “Sprint to Coordinated Care”

On August 27, 2018, the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) issued a request for information (RFI) seeking comment on the anti-kickback statute (AKS) and the beneficiary...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

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