Podcast - Navigating the New Landscape of Private Equity in Healthcare
The fatal flaws in the 2023 CRA rule
New Executive Order Targets Disparate Impact Claims Nationwide - #WorkforceWednesday® - Employment Law This Week®
Welcoming a New Payment Pro: Jason Cover Joins the Payments Pros Podcast — Payments Pros – The Payments Law Podcast
Constangy Clips Ep. 10 - 3 Ways the GDPR Is Evolving with Today’s Tech Landscape
Medicaid Cuts: Potential Challenges and Legal Implications for Long-Term Care Facilities — Assisted Living and the Law Podcast
Rewriting the Rules: The Supreme Court's Landmark Decision on Clean Water Act Permits
Tariffs and Trade Series: What Boards of Directors Need to Know
Under the Hood: Exploring the CFPB's 2025 Focus — Moving the Metal: The Auto Finance Podcast
Evolving AI Legislation: Federal Policies, Task Forces, and Proposed Laws — The Good Bot Podcast
Episode 369 -- Stepping Into the Enforcement Spotlight -- Customs and Border Patrol and Import Enforcement
10 For 10: Top Compliance Stories For the Week Ending May 17, 2025
Tariffs and Trade Series: What Investors Need to Know
Compliance Tip of the Day: Using Supply Chain to Innovate in Compliance
State AGs Unite: New Privacy Task Force Signals Shift in Regulatory Power Dynamics — The Consumer Finance Podcast
Early Returns Podcast - Oliver Roberts: AI and the Law, and an Education
Compliance into the Weeds: Leaving on a (Qatari) Jet Plane
(Podcast) California Employment News: Back to the Basics of Employee Pay Days
Compliance Tip of the Day: Multiplying the Influence of Compliance
Innovation in Compliance: Navigating Regulatory Changes and Compliance in Trade and Data Privacy with Stephanie Font
The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) are requesting public comment on nutrient requirements for infant formulas intended for healthy, full-term infants. FDA’s...more
In the fall of 2024, several pharmaceutical companies reacted to HRSA's decision to prevent them from implementing a rebate model for their respective 340B Programs by filing lawsuits against HHS and HRSA claiming that the...more
The Department of Health and Human Services (“HHS”) recently proposed a policy that would require all new vaccines to undergo placebo-controlled clinical trials prior to FDA approval. The proposal, while controversial, is...more
On April 15, 2025, President Trump issued an Executive Order (the EO) titled, “Lowering Drug Prices By Once Again Putting Americans First,” directing HHS to take action on a list of specific proposals with the goal of lower...more
On April 22, 2025, the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) announced a series of measures to phase out all certified colors from the nation’s food supply by the end...more
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
The National Institutes of Health (NIH) announced on April 21, 2025, a significant change to the terms and conditions governing federal funding (the Notice) applicable to all NIH grants, cooperative agreements and other...more
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
Human Health and Services (HHS) Secretary Robert F. Kennedy Jr. has instructed the Food and Drug Administration (FDA) to revisit and consider rulemaking regarding its Generally Recognized as Safe (GRAS) notification and...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
On March 10, 2025, Robert F. Kennedy, Jr., Secretary of the U.S. Department of Health and Human Services (“HHS”), in a seismic shift, announced that the U.S. Food and Drug Administration (“FDA”) would “explore potential...more
On March 10, the U.S. Department of Health and Human Services (HHS) issued a press release emphasizing “radical transparency to make sure all Americans know what is in their food” and announcing that HHS Secretary Robert F....more
Earlier this month, the Centers for Medicare & Medicaid Services (CMS) released its 2025 Marketplace Integrity and Affordability Proposed Rule (Proposed Rule), proposing a number of enrollment and eligibility policies...more
This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape. Secretary Kennedy takes first steps to eliminate GRAS exception. Health and...more
Key Takeaways - What Happened: HHS Secretary Kennedy directed FDA to consider removing the current self-affirmation pathway for determining that a food ingredient is Generally Recognized as Safe (GRAS)....more
United States Department of Health and Human Services (HHS) Secretary Kennedy recently directed the U.S. Food and Drug Administration (FDA) to consider rulemaking to revise its longstanding regulations and guidance governing...more
On March 3, 2025, the Department of Health and Human Services (HHS), under Secretary Robert F. Kennedy Jr., officially announced the rescission of the Richardson Waiver, a policy in place since 1971 that required public...more
The U.S. Food and Drug Administration (FDA) began 2025 with a resolution to make food “healthy” again by announcing a trio of new final and proposed rules that are intended to make it easier for consumers to identify healthy...more
On Friday, February 14, 2025, the Drug Enforcement Administration (“DEA”) and the U.S. Department of Health and Human Services (“HHS”) announced that the effective dates for two recently published final rules involving...more
On December 27, 2024, the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (NPRM) to modify the HIPAA Security Rule and strengthen cybersecurity protections for electronic protected...more
On December 28, 2024, a long-awaited Centers for Medicare & Medicaid Services (CMS) final rule became effective, significantly updating laboratory personnel requirements under Subpart M of the Clinical Laboratory Improvement...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
Bradley has launched a multipart blog series on the U.S. Department of Health and Human Services’ (HHS) proposed changes to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule, beginning last...more
The U.S. Department of Health and Human Services (“HHS”) issued a Notice of Proposed Rulemaking (the “Proposed Rule”) on December 27, 2024, to significantly amend HIPAA’s Security Rule, which sets forth the security standards...more
The Department of Health and Human Services (HHS) has proposed significant modifications to the HIPAA Security Rule and the HITECH Act in an attempt to strengthen cybersecurity protections for electronic protected health...more