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Healthcare Proposed Rules Department of Health and Human Services (HHS)

McDermott+

Healthcare Preview for the Week of: July 28, 2025

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Senate Steers Toward Summer Break - With the House already on August recess, the Senate will consider several of President Trump’s nominees, including Gustav Chiarello III to be an assistant secretary of the US Department of...more

Holland & Knight LLP

Holland & Knight Health Dose: July 22, 2025

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With the One Big Beautiful Bill Act (OBBB) passed by U.S. Congress and signed into law, Congress now has less than three weeks that it will be in session before government funding expires on Sept. 30, 2025. Appropriators will...more

McDermott+

McDermott+ Check-Up – July 18, 2025

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THIS WEEK’S DOSE - - OBBBA implementation begins. While the administration focuses on implementing the new law, some lawmakers are already discussing adjustments to health provisions in the One Big Beautiful Bill Act...more

McDermott+

McDermott+ Check-Up: June 6, 2025

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THIS WEEK’S DOSE - - Senate Begins Work on Reconciliation. Democrats prepared to file points of order to exclude certain provisions under the Byrd rule, while Republicans discussed key health provisions. - White House Sends...more

Alston & Bird

Health Care Week in Review | Trump Administration Releases FY 2026 Budget Proposal; CMS Launches Oversight Initiative on Medicaid...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Health Care Week in Review | White House Issues Executive Orders on Biosecurity and Domestic Drug Production; House Committee...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | March 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights key regulatory and enforcement activity for March 2025. This month features: - Noteworthy enforcement actions demonstrating that the Anti-Kickback Statute...more

Schwabe, Williamson & Wyatt PC

Regulatory Changes Address Surge of Food-As-Health Initiatives and Shift “Healthy” ‎Standard; Plus New Labeling Requirements

Food and beverage products that promote health and well-being have proliferated. Demand has surged for foods and drinks that are loaded with nutrients and offer health benefits. Their growth is partly driven by an increased...more

McDermott+

McDermott+ Check-Up: March 14, 2025

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THIS WEEK’S DOSE - - Congress Debates Government Funding. A continuing resolution (CR) to fund the government through September passed the House and may pass the Senate today. - Senate HELP Committee Advances NIH, FDA...more

Frost Brown Todd

Proposed HIPAA Security Rule Requires AI Governance

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In terms of healthcare data breaches, 2024 was the worst year ever, with the records of at least 53% of the U.S. population involved and two of the biggest healthcare data breaches of 2024 ranking in the top 10 of all time. ...more

McDermott+

Regs & Eggs with a Side of DOGE

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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

Vorys, Sater, Seymour and Pease LLP

Proposed Update to the HIPAA Security Rule

In early January, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published a Notice of Proposed Rulemaking. The Proposed Rule would modify the Security Standards for the Protection of...more

McDermott+

Healthcare Preview for the Week of: January 13, 2025

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During the Biden Administration’s final week, congressional Republicans are moving full steam ahead with Senate confirmation hearings for Trump-nominated officials and with ongoing budget reconciliation discussions....more

McDermott Will & Schulte

HHS OCR Proposes Significant Modifications to HIPAA Security Rule

§ 160.101 Statutory basis and purpose. The requirements of this subchapter implement sections 1171–1180 of the Social Security Act (the Act), sections 262 and 264 of Public Law 104–191, section 105 of Public Law 110–233,...more

Troutman Pepper Locke

HIPAA Security Rule Revamp Is on the Horizon

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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

Foley & Lardner LLP

HHS Proposes Changes to Strengthen HIPAA Security Rule

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Material updates to the HIPAA Security Rule could be on the way — affecting all HIPAA-regulated entities — for the first time in two decades. The Department of Health and Human Services (HHS) issued a Notice of Proposed...more

Quarles & Brady LLP

Uncertainty on Health Care Rules Amid Administration Change

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In recent months, several changes to healthcare rules regulations focusing on reproductive health care have been introduced. These include (1) privacy protections for reproductive health data under HIPAA, (2) expanding access...more

McDermott+

McDermott+ Check-Up: November 8, 2024

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Republicans Win Control of White House and Senate, Seem Poised to Maintain Control of House. Former President Donald Trump will return to the White House, and Republicans also gained control of the Senate. Some toss-up House...more

Foley & Lardner LLP

New DEA Rule Expected to Extend Controlled Substance Telemedicine Prescribing Flexibilities Through 2025

Foley & Lardner LLP on

After considerable pressure from both Congress and the White House, the Drug Enforcement Administration (DEA) submitted a proposed rule regarding flexibilities on telemedicine prescribing of controlled substances on October...more

Seyfarth Shaw LLP

Final Rules Related to the Mental Health Parity and Addiction Equity Act May Drive You Wild

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Seyfarth Synopsis: On September 9, 2024, the Departments of the Treasury, Labor, and Health and Human Services (the “Departments”) released highly anticipated Final Rules under the Mental Health Parity and Addiction Equity...more

Proskauer - Health Care Law Brief

Shortly After its Online Tracking Technologies Bulletin is Declared Unlawful, HHS-OCR Stands Down, Withdraws Appeal

On August 29, 2024, the Office for Civil Rights of the United States Department of Health and Human Services (“HHS-OCR”) withdrew its appeal of an order by the United States District Court for the Northern District of Texas’...more

Seyfarth Shaw LLP

Agencies Release Final Mental Health Parity Rule

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On Monday, September 9, 2024, the Departments of Health and Human Services, Labor and Treasury (the “Departments”) issued their final rule regarding the nonquantitative treatment limitation (NQTL) comparative analysis...more

McDermott Will & Schulte

ASTP Proposes Certification Criteria for Patient, Payer and Provider APIs

On August 5, 2024, the US Department of Health and Human Services (HHS) Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP) published the Health Data,...more

Troutman Pepper Locke

2024 Mid-Year Review: State AGs Shaping Regulatory Landscapes

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In 2024, the landscape of state attorneys general (AGs) is poised for significant change, with numerous elections and regulatory actions reshaping priorities and enforcement strategies. This dynamic environment reflects the...more

Ballard Spahr LLP

Final Section 1557 Rules: Highlights for Health Plan Sponsors

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The U.S. Department of Health and Human Services (HHS) has issued final regulations on the nondiscrimination rules set forth in Section 1557 of the Affordable Care Act. The new rules apply to certain group health plans, as...more

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