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Biden Administration Regulatory Agenda Healthcare

McDermott+

Healthcare Preview for the Week of: May 27, 2025

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Short Congressional Recess, Short Preview - While Congress is in recess this week, we are still on reconciliation watch as consideration of the One Big Beautiful Bill Act moves to the Senate. We are on the lookout for a...more

McDermott+

Healthcare Preview for the Week of: January 21, 2025

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First Official Week of Trump 2.0 - President Trump officially began his second term yesterday. He briefly discussed healthcare in his first inaugural speech, committing to tackle chronic disease and keep children safe,...more

Alston & Bird

Look Ahead to the Week of December 16: One Week to Go

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Both the House and Senate are scheduled to depart Washington, DC on Friday but have a long list of tasks to finish before adjourning the 118th Congress. Last week, the House passed the annual defense authorization package,...more

McDermott+

McDermott+ Check-Up: November 15, 2024

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Congress Returns for Lame Duck Session. The House and Senate returned this week, kicking off the post-election lame duck session. The focus this week was not on legislating, but on organizing for the upcoming 119th Congress,...more

McDermott+

Medicare FFS Regs: Thrills and Chills Under the Trump and Biden Administrations

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Happy Halloween! In the health policy world, there are two things on everyone’s mind this spooky season: the upcoming election and the major calendar year (CY) 2025 Medicare fee-for-service (FFS) final regs that should be...more

McDermott+

It’s the Final Countdown: Comparing the Last Regulatory Actions of the Biden and Trump Administrations

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The election is approaching fast, and no matter who wins, there will be a change in administration come January 20, 2025. Thus, the Biden Administration is in the midst of making its final mark on priority healthcare...more

McDermott+

Regs Coming Through the End of the Year: Expect the Expected and the Unexpected

McDermott+ on

There could be an all-you-can-eat buffet of regs (and eggs) from now until the end of the year! As you may recall, a July 2024 Regs & Eggs blog post highlighted the spring 2024 “unified agenda” that listed all the regs...more

McDermott+

Biden Administration Issues Final Reg on Mental Health Parity Requirements

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Biden Administration Issues Final Reg on Mental Health Parity Requirements McDermott+ is pleased to bring you Regs & Eggs, a weekly Regulatory Affairs blog by Jeffrey Davis. Click here to subscribe to future blog posts....more

McDermott+

Regs, Regs and More Regs: The Biden Administration Releases Spring 2024 Unified Agenda

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We are in the midst of a storm of regulations that are being released by the Centers for Medicare & Medicaid Services (CMS) and the US Department of Health and Human Services (HHS), including the Calendar Year (CY) 2025...more

Akin Gump Strauss Hauer & Feld LLP

The Regulatory Race Is On: The Biden Administration Sprints to Issue Key Health Policies

The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more

Akin Gump Strauss Hauer & Feld LLP

Akin Intelligence - March 2024

Welcome to the March edition of Akin Intelligence. This month, the EU AI Act was approved by the European Parliament, moving one step closer to becoming the first major AI law. In the U.S., the DOJ brought criminal charges...more

McDermott+

Healthcare Preview for the Week of: March 18, 2024

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At midnight on Friday, funding runs out for the remaining six FY 2024 annual spending bills: State – Foreign Operations, Defense, Homeland Security, Labor – Health and Human Services, Legislative Branch, and Financial...more

Sheppard Mullin Richter & Hampton LLP

Recent Healthcare-Related Artificial Intelligence Developments

AI is here to stay. The development and use of artificial intelligence (“AI”) is rapidly growing in the healthcare landscape with no signs of slowing down. From a governmental perspective, many federal agencies are embracing...more

Troutman Pepper Locke

FTC Promotes Next Front in Administration's Efforts to Lower Pharmaceutical Prices: Bayh-Dole Act's "March-In" Rights

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The U.S. Federal Trade Commission (FTC) took the next step in its long-standing effort to encourage lower prices and increase competition in the pharmaceutical industry. As part of the Biden administration’s whole government...more

McDermott Will & Schulte

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

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

Fenwick & West LLP

Navigating Healthcare Antitrust in the Biden Era

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It’s no secret that Democrats are traditionally trustbusters, but the Biden Administration is taking things to a whole new level, bringing novel—and arguably weak—cases that nonetheless slow or block tie-ups among healthcare...more

Seyfarth Shaw LLP

Pill Politics: Unveiling Biden’s Bold Blueprint for Affordable Drugs

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On December 7, 2023, the Biden administration announced a blueprint for a framework that may be a tough pill to swallow for the pharmaceutical industry. This framework suggests that drug prices should be a crucial factor in...more

Sheppard Mullin Richter & Hampton LLP

AI’s Executive Order and Its Key Healthcare Implications 

Last week’s historic executive order (EO) on the development and use of artificial intelligence (AI) is teeming with urgency, both in caution and optimism, to keep pace with the technological advancements. The EO addresses...more

ArentFox Schiff

POTUS Issues Expansive Executive Order on AI, Calling for All Hands On Deck

ArentFox Schiff on

On October 30, 2023, President Biden issued an expansive Executive Order (EO) on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (AI), aiming to establish standards for AI technology to...more

Skadden, Arps, Slate, Meagher & Flom LLP

AI Insights: Biden Administration Passes Sweeping Executive Order on Artificial Intelligence

On October 30, the U.S. government released its long-awaited, sweeping executive order (the AI EO or Order) on artificial intelligence (AI). The Order directs various U.S. government departments and agencies to evaluate AI...more

McDermott Will & Schulte

Landmark Executive Order on AI: What Does It Mean for Healthcare?

On October 30, 2023, the White House released a long-awaited Executive Order (EO) on the “Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence.” The EO acknowledges the transformative potential of AI...more

Akin Gump Strauss Hauer & Feld LLP

What a Difference a Year Makes: IRA’s Drug Pricing Provisions Turn One

This week marks the one-year anniversary since the enactment of the Inflation Reduction Act (IRA), which included sweeping reforms empowering the Secretary of Health and Human Services (HHS) to set prices for certain...more

Foley & Lardner LLP

AI in Health Care: Regulatory Landscape & Risk Mitigation

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Health care, like most industries, is grappling with the proliferation of artificial intelligence (AI) and the novel risks and benefits it presents. Balancing these risks and benefits can be especially challenging for...more

Epstein Becker & Green

HHS Proposes Amendments to HIPAA that Protect Reproductive Health Care Information in Wake of Dobbs

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Introduction - Following the Supreme Court decision in Dobbs v. Jackson Women’s Health Organization overturning Roe v. Wade, the federal government, pursuant to President Biden’s Executive Order (the EO) took several steps...more

Polsinelli

HIPAA Notice of Proposed Rulemaking on Reproductive Health Care Privacy

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On April 12, 2023, the Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) issued a Notice of Proposed Rulemaking (“Notice” or “NPRM”) to solicit comments on proposed modifications to the HIPAA...more

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