Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
AGG Talks: Cross-Border Business Podcast - Episode 28: How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
Daily Compliance News: May 1, 2025, The 100 Days of Corruption Edition
Beyond the Bylaws: The Medical Staff Show | The Role of Bylaws in Medical Staff Governance, Part II
Compliance Tip of the Day – AI and Behavioral Analytics
100 Days In: What Employers Need to Know - Employment Law This Week® - #WorkforceWednesday®
Upping Your Game: Episode 1 – Meeting Hui Chen’s Challenge
Compliance Tip of the Day: AI and Compliance Education
The Next FCRA Frontier: Identity Theft and CFPB Updates — FCRA Focus Podcast
Daily Compliance News: April 29, 2025, The GenZ/RTO Edition
FCPA Compliance Report: From Compliance to Commercial Value: Removing Friction with AI
Compliance Tip Of the Day: Using AI to Transform Whistleblower Response
Episode 366 -- DOJ Issues Data Security Program Requirements
10 For 10: Top Compliance Stories For the Week Ending April 26, 2025
Compliance Tip of the Day: The Future of Continuous Monitoring
FCPA Compliance Report: Ellen Hunt on Compliance ROI and on a Due Diligence and the US Sentencing Guidelines
Compliance Tip of the Day: Leveraging AI for Real-Time Third-Party Risk Management
Navigating the Future of Payment Stablecoins: Legislative Updates and Market Implications — Payments Pros – The Payments Law Podcast
Navigating the Future of Payment Stablecoins: Legislative Updates and Market Implications — The Crypto Exchange Podcast
On April 4, 2025, the Centers for Medicare & Medicaid Services (“CMS”) released the contract year (“CY”) 2026 final rule for the Medicare Advantage (“MA”) program, Medicare Prescription Drug Benefit Program (“Part D”),...more
This past week, the Trump administration put its first major stamp on the Medicare Advantage (MA) program. The Centers for Medicare & Medicaid Services (CMS) released two final regulatory documents related to MA: - The...more
Last Monday, the U.S. District Court for the Eastern District of Texas (the “District Court”) issued a highly anticipated – and unsurprising – opinion invalidating the U.S. Food & Drug Administration’s (“FDA’s” or the...more
Game On! 2026 Medicare Fee-for-Service Rulemaking Is About to Tip Off - It’s March, which means one thing for sports fans: the madness of the NCAA men’s and women’s basketball tournaments. However, to folks in the...more
On January 14, 2025, the US Departments of Labor, Health and Human Services (HHS), and the Treasury (collectively, the Departments), along with the Office of Personnel Management (OPM), jointly issued Part 69 of a series of...more
On March 10, 2025, Health Secretary Robert F. Kennedy Jr. initiated a significant shift in the regulation of ultra-processed foods by directing the Food and Drug Administration (FDA) to revise the GRAS (Generally Recognized...more
On January 6, 2025, the US Food and Drug Administration (FDA) published final guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...more
On January 7, 2025, the US Food and Drug Administration (FDA) issued two parallel guidance documents for the Section 503A and Section 503B bulk drug lists, announcing the end of FDA’s 2017 interim policies. Under the new...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
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
As many are aware, compliance with price transparency requirements continues to lag. Under the final rule, effective January 1, 2021, hospitals are required to provide clear, accessible pricing information online about the...more
On November 2, 2021, CMS put on display its final rule that, among other things, updates the home health and home infusion therapy services payment rates for calendar year (CY) 2022; makes significant changes to the provider...more
On 19 March 2021, the U.S. Department of Health and Human Services (the Department or HHS) postponed for one year the effective date of the Final Rule entitled “Securing Updated and Necessary Statutory Evaluations Timely...more
On November 27, 2019, the Centers for Medicare and Medicaid Services (CMS) published its final rule outlining new price transparency requirements as part of the 2020 update to the Outpatient Prospective Payment System....more
The Centers for Medicare and Medicaid Services (CMS) published the Price Transparency Requirements for Hospitals to Make Standard Charges Public Final Rule (the Final Rule, effective January 1, 2021), in the Federal Register...more
On November 15, CMS issued the Price Transparency Requirements for Hospitals to Make Standards Charges Public Final Rule (“Final Rule”), as directed by President Donald Trump’s Executive Order on Improving Price and Quality...more
On November 15, the Centers for Medicare and Medicaid Services (CMS) issued a final rule requiring public disclosure of hospital charges. Along with the Departments of Health and Human Services, Labor and the Treasury, CMS...more
The Centers for Medicare and Medicaid Services (CMS) is moving forward with its Patients over Paperwork initiative, which was created in accordance with President Trump’s Executive Order directing federal agencies to reduce...more
The U.S. Departments of the Treasury, Labor, and Health and Human Services have jointly issued final rules modifying the definition of short-term, limited-duration insurance (STLDI). STLDI provides health coverage that is...more