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
The Corner Series Podcast: Scaling Medical Aesthetics
The Corner Series Podcast: Patent Investment Strategies
The Corner Series Podcast: Integration Over Aggregation in Oral Surgery
Early-Stage Spotlight - Kyha's Approach to Women's Health — PE Pathways Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 260: Innovation and Policy in Animal Health with Ron Phillips of the Animal Health Institute
The Corner Series Podcast: Site-of-Care Optimization
As Americans kick off the new year with resolutions to get fit, sleep better, and take better care of themselves, the FDA has broadened access to the wearable wellness device market to a greater number of products. In a...more
On December 31, 2025, the federal Drug Enforcement Administration (DEA) extended current regulatory flexibilities related to tele-prescribing of controlled substances for another year. The DEA issued a fourth temporary...more
On January 20, 2025, the President signed Executive Order 14148, titled “Initial Rescission of Harmful Executive Orders and Actions.” A significant aspect of this Executive Order is the removal of previous protections against...more
The Trump Administration continues to pursue a policy of AI dominance, which began with its January 23, 2025 executive order to remove “barriers” to Artificial Intelligence (“AI”) innovation to promote “human flourishing,...more
A client calls and says, “We’re cooking up a bispecific antibody. We want to mix and match binding sequences like a molecular gastronomy tasting menu. Some will go into CAR-T dishes. And of course, we want patents...more
To the relief of food manufacturers rushing to find natural substitutes for synthetic food dyes, a federal court has temporarily halted the enforcement of West Virginia’s House Bill 2354 (HB 2354). HB 2354 banned several...more
The U.S. House of Representatives has passed a bill to extend the enhanced advanced premium tax credits (APTCs) for three years following a 230-196 vote, with 17 Republicans voting with Democrats to support its passage. The...more
Last week, the House passed a three-year clean extension of the enhanced advanced premium tax credits (APTCs), which expired December 31, 2025. While 17 Republicans supported the bill, it appears to be dead on arrival in the...more
Paula Stannard, the newish director of the HHS Office for Civil Rights (OCR), plans to continue two enforcement initiatives with which covered entities (CEs) and business associates (BAs) likely are familiar—but she’s...more
In a monumental decision almost five years in the making, the Alabama Medical Cannabis Commission on Thursday issued medical cannabis dispensary licenses to three applicants: GP6 Wellness LLC, RJK Holdings LLC and CCS of...more
As we step into 2026, the healthcare private equity landscape is defined by both powerful momentum and meaningful constraints. Record levels of dry powder and a growing pipeline of high‑quality assets suggest increased deal...more
Alternative prescription drug access models—including direct-to-employer (DTE) and direct-to-consumer (DTC)—are gaining traction as employers reassess traditional pharmacy benefit manager (PBM)-based pricing structures. As...more
New York City recently enacted a local law to address growing mental health concerns within the construction industry, reflecting increased attention on suicide prevention and substance abuse. The new law amends the New York...more
All readers of The Health Record understand the importance of complying with HIPAA’s Privacy, Security and Breach notification rules. But where do violations most often occur?...more
The U.S. Drug Enforcement Administration (DEA), jointly with the U.S. Department of Health and Human Services (HHS), issued a fourth temporary rule extending the full set of COVID‑19 telemedicine flexibilities for prescribing...more
Recent regulatory actions by the Centers for Medicare and Medicaid Services (CMS), the US Drug Enforcement Administration (DEA), and the US Department of Health and Human Services (HHS) highlight heightened federal scrutiny...more
On December 29, 2025, the US Food and Drug Administration (FDA) published its Report on the Use of PFAS in Cosmetic Products and Associated Risks (Report). The Report, as required under the Modernization of Cosmetics...more
In my November 2025 blog post, I discussed the uncertainty surrounding the DEA’s then-pending telemedicine rule and its implications for ketamine clinics. At that time, the future of pandemic-era telehealth prescribing...more
Utah has issued a policy, through the Utah Department of Commerce and its Office of Artificial Intelligence Policy, authorizing a pilot program that allows an artificial intelligence (AI) system to autonomously renew certain...more
Following up on its re-opening of the Opinion Letter program, the United States Department of Labor, Wage and Hour Division (“DOL”) issued six new opinion letters on January 5, 2026. These letters are helpful guidance for...more
The Department of Health and Human Services (HHS) previously finalized sweeping changes to 42 CFR Part 2 (Part 2), the federal rules protecting the confidentiality of substance use disorder (SUD) records....more
Takeaway: Wound care fraud is now one of the key enforcement priorities of the Department of Justice. An aging population, combined with Medicare’s pricing policies, nurtured an opportunity for Amniotic Allograft Fraud to...more
As part of the activities of the European Union (EU) Observatory for Nanomaterials (EUON), the European Chemicals Agency (ECHA) has commissioned a study on “Nanomaterials used as or integrated into flame retardants.”...more
Happy New Year, Founders! As we enter 2026, I encourage pharmaceutical innovators to approach intellectual property with energy and intention. The start of the year is the perfect time to step back and review your patent...more
Ultra-processed foods are a staple of diets throughout the nation. For many, these foods are more accessible, affordable and convenient due to their long shelf lives and ready-to-eat nature....more