Episode 265: Redesigning Clinical Trials Through Technology with Patrick McCarthy of Validcare
From Diligence to Post-Closing: What’s Shifting in 2026 Health Care Transactions
Private Equity Investment in Health Care
Healthcare Trend Report: A Review of the Pharmacy and Drug Supply Chain Sectors
Point-of-Sale Finance Series: Health Care Financing Compliance, Regulatory, and Privacy Pitfalls — Payments Pros – The Payments Law Podcast
Point-of-Sale Finance Series: Health Care Financing Compliance, Regulatory, and Privacy Pitfalls — The Consumer Finance Podcast
AGG Talks: Government Insight for Life Sciences Leaders | Patient Assistance Programs and the False Claims Act: Enforcement Trends and Compliance Risks for Life Sciences Companies
Health-e Law Episode 19: From AI to OBBBA: Healthcare Law Insights from the 2025 WHLC Leadership Summit with Amy Dilcher and Chi Huynh, WHLC Co-Chairs
Video Overview: Healthcare Trend Report - A Review of the Pharmacy and Drug Supply Chain Sectors
Concierge Practices: Understanding the Model and Its Unique Challenges
Beyond the Bylaws: The Medical Staff Show - How to Build Compliant and Effective Peer Review Processes into Your Bylaws, Part 2
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 264: 2026 Healthcare Industry Trends & Challenges with Lauren DeMoss and Matthew Roberts
Investors Prepare to Navigate FDA Crosswinds Ahead of the J.P. Morgan Healthcare Conference
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 263: Building NC's Innovation Ecosystem with Andrea Conner of First Flight Venture Center
Hospice Insights Podcast - Hospital to Hospice: Managing Referrals and Relationships
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 262: Breaking the “Undruggable” Barrier with Marcel Frenkel of Ten63 Therapeutics
12 Days of Regulatory Insights: Day 7 – Tobacco and Nicotine Regulatory Roundup — Regulatory Oversight Podcast
Navigating FDA's 2025 AI Guidance: Risk-Based Framework, Public Comments, and Generative Models - The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 261: Transforming Lives with Advanced BioMaterials with Dr. Juliana Blum of BioAesthetics
The Down-Low on Data for Value-Based Enterprises and Their Participating Providers – Diagnosing Health Care Video Podcast
Every day, we see the increasing role of technology in our healthcare world. It wasn’t all that long ago that we began the transition to electronic medical records, and portable devices mostly meant BlackBerries....more
Addressing an issue of first impression, the First Circuit has clarified the burden to satisfy the knowledge element required in False Claims Act (FCA) cases in the context of laboratory testing and Medicare fraud....more
On January 16, the U.S. Department of Justice (DOJ) released its annual report on civil fraud recoveries (settlements and judgments) for FY2025, along with a press release highlighting DOJ’s civil enforcement efforts....more
On January 6, 2026, the U.S. Food and Drug Administration (“FDA”) published revised final guidance documents on Clinical Decision Support Software (“Revised CDS Guidance”) and its General Wellness Policy for Low Risk Devices...more
On January 2, 2026, the US Food and Drug Administration (FDA) began accepting statements of interest for its Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot, a program designed to accelerate access to digital...more
The U.S. Department of Justice (“DOJ”) announced last week that settlements and judgments under the False Claims Act (“FCA”) exceeded $6.8 billion in fiscal year 2025—a record-breaking figure and the highest in a single year...more
On this episode of Work This Way, Tina chats with fellow hosts and Maynard Nexsen attorneys Jennie Cluverius and Fay Edwards, along with a very special guest, Bing the pomsky, a service dog in training. Together, they break...more
Regulatory guidance from the Illinois Department of Financial and Professional Regulation (“IDFPR”) clarifies that med spas may be owned and operated by Advanced Practice Registered Nurses (“APRNs”), including those that...more
In Plastic & Reconstructive Surgery Group v. Aetna, Inc., the U.S. District Court for the District of Connecticut addressed a motion filed by petitioner Plastic & Reconstructive Surgery Group to allow discovery of the reasons...more
Lead Capital Partners (LCP) has announced an investment in PedsOne. PedsOne, founded in 2011 and based in Nashville, Tennessee, is a provider of outsourced revenue cycle management and consulting services to independent...more
To ring in the new year, New Jersey became the latest state to enact legislation banning intentionally-added PFAS in certain consumer products. In the final days of his term, Governor Murphy signed into law the Protecting...more
On January 16, 2026, the Department of Justice (DOJ) issued its annual year-end report on civil False Claims Act (FCA) accomplishments and highlights from Fiscal Year (FY) 2025. This follows DOJ’s announcement only a week...more
Recently, the U.S. Food and Drug Administration (FDA) issued a guidance document entitled Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. The guidance outlines the FDA’s current thinking...more
In February 2024, HHS finalized significant revisions to 42 CFR Part 2, the federal regulation governing the confidentiality of SUD treatment records. Part 2 has historically imposed stricter privacy protections than HIPAA,...more
Fiscal Year (“FY”) 2025 yielded a historic high of over $6.8 billion in False Claims Act (“FCA”) settlements and judgments, underscoring the Department of Justice’s (“DOJ”) aggressive enforcement. DOJ’s annual report,...more
The US Department of Labor’s Employee Benefits Security Administration (EBSA) has announced updated enforcement priorities for fiscal year 2026. These changes signal where EBSA will focus its investigative and enforcement...more
Welcome to Alston & Bird’s introduction to biological products regulation. In this five-part intro-level series, we provide answers to a number of questions drug developers may have about the regulation and regulatory pathway...more
The U.S. Department of Health and Human Services (HHS), working with the Drug Enforcement Administration (DEA), has issued a fourth temporary extension of telemedicine flexibilities, first introduced in response to the...more
The US Department of Justice (DOJ) has announced that recoveries from False Claims Act (FCA) settlements and judgments in fiscal year 2025 exceeded $6.8 billion, the highest annual amount in FCA history and more than double...more
The National Defense Authorization Act for Fiscal Year 2026, signed into law on 18 December 2025, includes the BIOSECURE Act (the Act), which establishes a new framework governing the use of certain biotechnology equipment...more
Against the backdrop of the San Francisco JPMorgan Healthcare Conference, Axinn, Cornerstone, and Concurrences hosted a reception and dinner on January 14, 2026, to discuss the Trump administration’s antitrust enforcement...more
In an advisory opinion published at the end of 2025, the U.S. Department of Health and Human Services Office of Inspector General (OIG) addressed—to a degree—several longstanding questions under the Discount Safe Harbor to...more
The European Commission’s (Commission) 2025 communication “A Strategic Framework for a Competitive and Sustainable EU Bioeconomy” (the Framework) positions bioeconomy as a core pillar of EU competitiveness and industrial...more
Spoiler alert. We are about to reveal the secret to learning what the U.S. Department of Labor’s Employee Benefits Security Administration (“EBSA”) will be focused on the next time it investigates your employee benefit...more
DOJ Reports Record FY 2025 False Claims Act Recoveries Exceeding $6.8 Billion - The US Department of Justice (DOJ) announced a record $6.8 billion in False Claims Act (FCA) settlements and judgments for fiscal year 2025,...more
