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National Institute of Health (NIH)

Holland & Knight LLP

HHS Releases Strategy Positioning Artificial Intelligence as the Core of Health Innovation

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The U.S. Department of Health and Human Services (HHS or Department) on Dec. 4, 2025, released its 21-page artificial intelligence (AI) strategy as a continuation of its nearly year-long AI effort and follow-up to several...more

Holland & Knight LLP

Holland & Knight Health Dose: December 9, 2025

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With only two weeks left of U.S. Congress in session, a final push for a consensus on healthcare is underway. Both Democrats and Republicans are hoping to secure political wins for their parties and constituencies while the...more

Thompson Coburn LLP

Higher Education Litigation Summary: December 3, 2025

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Thompson Coburn’s Higher Education Litigation Summary is your resource for legal updates on key rulings and ongoing cases shaping the higher education sector. This installment covers updates related to Gainful Employment, the...more

Alston & Bird

Health Care Week in Review | CMS releases CY 2027 Medicare Advantage and Part D Proposed Rule; Trump Administration Announces...

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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 | Senate Finance Committee Holds Hearing on the Rising Cost of Health Care; CMS Released Additional...

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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

Akerman LLP

From Biologics to Bandages, Skin Substitutes Are No Longer the Biologics You Think They Are...

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CMS has a skin substitute problem.   Skin substitutes are wound coverings that are used for burns, trauma, or chronic conditions like wounds associated with diabetes, leg ulcers, etc. According to the National Institutes...more

Alston & Bird

Health Care Week in Review | CMS Announces New Drug Payment Model; Negotiations to End Government Shutdown Continue

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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

Morrison & Foerster LLP

NIH Follows in FDA’s Footsteps and Adopts “Bulk Sensitive Data” Policy That Goes Beyond DOJ Rule Requirements

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The National Institutes of Health (“NIH”) has become the latest federal agency to impose obligations that go beyond those required by the watershed U.S. Department of Justice (“DOJ”) data security program (“DSP”) with its new...more

Thompson Coburn LLP

IP Corner – October 2025 Edition

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Welcome to TC’s IP Corner® Halloween edition. We are excited to share this quarterly newsletter with our clients, colleagues, and friends as we examine hot topics, interesting cases, and weird yet entertaining happenings in...more

Foley & Lardner LLP

From Rare Genes to Precision Health: $80M in New NIH Funding to Study Longer, Healthier Lives

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The Long Life Family Study (LLFS) is a multi-decade, multicenter research program designed to uncover the genetic and biological factors that contribute to exceptional human longevity and healthy aging. First launched in the...more

Alston & Bird

Health Care Week in Review | OMB Initiates Significant Layoffs as Shutdown Continues; CMS Issues Updated Guidance to Temporarily...

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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 | Federal Government Shutdown Continues; CMS Issues Guidance to MACs on Medicare Claims Processing and...

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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

Tucker Arensberg, P.C.

What the Government Shutdown Means for Physicians

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As of October 1st, the federal government is officially shut down after Congress failed to pass funding legislation. While the biggest direct impact will certainly be on furloughed federal workers and government agencies, if...more

Ropes & Gray LLP

National Institutes of Health Announces New Restrictions on the Sharing of Human Biospecimens with China and other “Countries of...

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On September 24, 2025, the National Institutes of Health (“NIH”) published a policy entitled “Enhancing Security Measures for Human Biospecimens” (the “Policy”). The Policy is based on Executive Order 14117, “Preventing...more

Alston & Bird

Health Care Week in Review | Senate Blocks House-Passed Continuing Resolution; CMS Launches Rural Health Transformation Program

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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

Blank Rome LLP

Where Grant Litigation Stands After the Supreme Court’s Jurisdictional Ruling in NIH

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The Supreme Court issued a fractured, 4-1-4 ruling on its emergency docket in National Institutes of Health v. American Public Health Association, No. 25A103, 606 U.S. ____ (2025) (per curiam) (“NIH”) on August 21, 2025....more

Bergeson & Campbell, P.C.

HHS Announces Release of MAHA Strategy

On September 9, 2025, the U.S. Department of Health and Human Services (HHS) announced the release of the Make Our Children Healthy Again Strategy (MAHA Strategy) issued by the Make America Healthy Again (MAHA) Commission....more

Holland & Knight LLP

MAHA Commission Report Details Federal Response to Childhood Chronic Disease

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The Make America Healthy Again (MAHA) Commission was established by President Donald Trump's Feb. 13, 2025, executive order (EO) 14212 titled "Establishing the President's Make America Healthy Again Commission." As Holland &...more

Beveridge & Diamond PC

MAHA Commission Strategy Report Outlines Sweeping Federal Actions on Chemicals in Food and the Environment

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Key Takeaways - What Happened: The Make America Healthy Again (MAHA) Commission has released its final Make Our Children Healthy Again Strategy report. The Strategy outlines extensive executive branch actions intended to...more

Goodwin

Would Exercising March-in Rights Lower Biologic Prices?

Goodwin on

The Bayh-Dole Act provides that the federal government retains certain rights in inventions it funds. Many have sought to use those rights as a way to lower the cost of prescription drugs for consumers and for the federal...more

Blank Rome LLP

Supreme Court Weighs in for a Second Time on Jurisdiction over Grant Termination Cases

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The Supreme Court recently ruled for the second time that federal district courts likely lack jurisdiction under the Administrative Procedure Act (“APA”) to hear challenges to terminations of federal grants. The first such...more

Holland & Knight LLP

Holland & Knight Health Dose: September 3, 2025

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U.S. Congress returns from the August 2025 recess for a short session. Both chambers will be forced to address a looming to-do list, namely potentially extending government funding beyond Sept. 30, 2025....more

Beveridge & Diamond PC

Leaked Draft of MAHA Commission Strategy Report Outlines Sweeping Federal Actions on Chemicals in Food and the Environment

Key Takeaways - What Happened: A leaked draft of the Make Our Children Healthy Again Strategy (the Make America Healthy Again (MAHA) Commission’s action plan) is circulating. The draft outlines extensive executive branch...more

Miles & Stockbridge P.C.

The Supreme Court Grant Termination Hokey Pokey: Put Your First Foot in the Court of Federal Claims and Your Second Foot (Maybe)...

The U.S. Supreme Court agreed last week to permit the National Institutes of Health (NIH) to terminate hundreds of grants related to diversity, equity and inclusion (DEI) initiatives worth approximately $800 million. The...more

Vinson & Elkins LLP

A New Two-Step Dance: Supreme Court Decision Complicates Relief for Government Grant and Contract Terminations

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Organizations challenging an agency’s termination of a grant or government contract based on an allegedly illegal government policy need to master a two-step dance, according to a recent U.S. Supreme Court decision. Under the...more

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