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Regulatory Agenda Department of Health and Human Services (HHS) Today's Popular Updates

White & Case LLP

DOJ and HHS Relaunch False Claims Act Working Group, Sharpen Healthcare Enforcement Priorities

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On July 2, 2025, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) jointly announced the reestablishment of the DOJ-HHS False Claims Act (FCA) Working Group. While the two agencies...more

Ice Miller

FDA Final Rule for “Healthy” Nutrient Content Claims Effective Date Looms but Rule’s Future Is Uncertain

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After years of rulemaking with impassioned input from food producers, industry stakeholders, and consumer groups, on December 27, 2024, the Food and Drug Administration (FDA or Agency) published a final rule titled “Food...more

Gardner Law

FDA Layoffs, RFK Jr. at HHS, and What This Means for FDA-Regulated Companies

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In recent weeks, the FDA has faced significant cuts, including the layoffs of probationary employees. These employees, many of whom had been hired to fill roles left by retirees or to bolster the agency’s staffing during the...more

Bradley Arant Boult Cummings LLP

HHS Security Rule NPRM Proposes Makeover for Administrative Safeguard Compliance for Regulated Entities

In this week’s installment of our blog series on the U.S. Department of Health and Human Services’ (HHS) HIPAA Security Rule updates in its January 6 Notice of Proposed Rulemaking (NPRM), we are exploring the proposed updates...more

Skadden, Arps, Slate, Meagher & Flom LLP

Under RFK Jr., US Health Policy and FDA Operations May See Major Shifts

Robert F. Kennedy Jr. (RFK Jr.) has been confirmed by the Senate as secretary of the Department of Health and Human Services (HHS). In this capacity, RFK Jr. will oversee 13 agencies that are critical to U.S. health policy,...more

Holland & Knight LLP

Election Implications for Telehealth, Health Equity, AI and Life Sciences

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In 2025, Republicans will hold the majority in both chambers of Congress, and the incoming Trump Administration will preside over the executive branch. For healthcare issues at the intersection of access and equity, this...more

Health Care Compliance Association (HCCA)

Privacy Briefs: November 2024

Change Healthcare Inc. has amended its initial breach report to the HHS Office for Civil Rights (OCR) to state that 100 million individuals were impacted by its mammoth ransomware attack and breach. However, as of Oct. 24,...more

Carr Maloney P.C.

25 Lawmakers Oppose Cannabis Rescheduling

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On August 29, 2023, the Department of Health and Human Services sent a letter to the Drug Enforcement Administration (“DEA”) urging them to reclassify marijuana as a schedule III drug. The Department of Health and Human...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

McDermott Will & Schulte

Healthcare Regulatory Check-up Newsletter | April 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more

Bradley Arant Boult Cummings LLP

Veep Urges DEA to Reschedule Marijuana “As Quickly as Possible”

In case you missed it, Fat Joe visited the White House late last week to discuss federal marijuana policy. 2024, man. During a roundtable discussion with Mr. Joe (?), Kentucky Gov. Andy Beshear, and several individuals who...more

Bass, Berry & Sims PLC

HHS Releases Cybersecurity Performance Goals for Healthcare Organizations

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In response to the number of successful, large-scale ransomware attacks affecting healthcare organizations nearly tripling since 2018, the Department of Health and Human Services (HHS) has released guidance outlining its...more

Mintz - Health Care Viewpoints

Health Care Privacy and Security In 2024: Six Critical Topics to Watch

As we reflect on the flurry of activity in the health care data privacy and security space in 2023 and look ahead to what will continue to be a busy 2024, we are seeing the early stages of federal agency movement to align the...more

Mintz - ML Strategies

ML Strategies Outlook for 2024

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Congress — Big Agenda & Little Time - With the holidays behind us, Congress returned this week for the second half of the 118th Congress with a long list of items to address and, as the 2024 campaign season ramps up, limited...more

Holland & Knight LLP

New Artificial Intelligence Executive Order Contains Numerous Healthcare Implications

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President Joe Biden on Oct. 30, 2023, signed a sweeping executive order (EO) and invoked the Defense Production Act to establish the first set of standards for using artificial intelligence (AI) in healthcare and other...more

Goodwin

White House Unveils Landmark Executive Order on Safe, Secure, and Trustworthy Artificial Intelligence

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On October 30, 2023, President Biden issued an Executive Order (EO) on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence. The EO establishes sweeping directives and priorities for federal...more

Sheppard Mullin Richter & Hampton LLP

Private Equity and Digital Health in 2023: Policy Updates and Trends to Watch

As we approach the middle of the first quarter of 2023, private equity firms have continued to demonstrate their interest in investing in digital health. This does not come as a surprise, as most startups in the healthcare...more

Foley & Lardner LLP

Priorities of the 118th Congress and the Biden Administration

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As the final votes of the 2022 Midterm Elections are counted, Republicans have taken back control of the House of Representatives, while the Democrats will retain control of the Senate. Both chambers will be held by extremely...more

Foley Hoag LLP - Security, Privacy and the...

Cybersecurity 2020 — The Year in Preview: Changes in Health Data Privacy Legislation

Editors’ Note: This is the fourth in our fourth-annual end-of-year series examining important trends in data privacy and cybersecurity in the coming year. Our previous entry discussed the CCPA, energy, and Brexit. Up next:...more

Burr & Forman

Top Three Challenges Health Care Payers and Providers Will Face in 2020

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Health care providers operate in one of the most highly regulated industries in terms of compliance and governmental oversight. As a result, providers face a number of regulatory and compliance challenges each year....more

Robinson+Cole Health Law Diagnosis

HHS Proposes Changes to Permit Donation of Cybersecurity Technology

On October 17, 2019, the Department of Health and Human Services (HHS) published proposed rules to update the regulatory Anti-Kickback Statute (AKS) safe-harbors and exceptions to the Physician Self-Referral (PSR) Law, known...more

Akin Gump Strauss Hauer & Feld LLP

Artificial Intelligence Initiatives Announced by Administration and Federal Agencies

Artificial Intelligence Alert, February 19, 2019  February 19, 2019 Last week, the Trump administration and federal agencies announced several initiatives related to artificial intelligence (AI). In addition to these...more

Bradley Arant Boult Cummings LLP

A Sign of Things to Come? Trump’s Regulatory Freeze and Other Early Actions

Behind the pomp and circumstance of Friday’s inauguration, President Donald J. Trump and his administration set their sights on deploying a new guard of regulatory and economic policies focused on reducing burdensome...more

Bilzin Sumberg

Alphabet Soup and Data Security

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In the span of two days, mobile device users learned of two data breaches that could compromise their personal data. In one, Experian (a credit reporting agency) reported that it was hacked, potentially putting 15 million...more

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