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
The Corner Series Podcast: Equipping PE Partners With Services for Success
The Corner Series Podcast: Rooting Out Bad Actors in Private Equity
The Corner Series Podcast: State Regulatory Interventions in Healthcare
The Corner Series Podcast: Proving Private Equity’s Value in Healthcare
The Corner Series Podcast: From Transactions to True Impact
The Corner Series Podcast: Tracking the Fast-Growing Payor Services Market
The Corner Series Podcast: Private Equity Partnerships and Market Trends
The Corner Series Podcast: Shedding Light on Healthcare Compliance
The Corner Series Podcast: Life Sciences Investors: Keep These Developments Top of Mind
Managing employee time away from work shouldn’t be complicated—but without a thoughtful framework, paid sick leave, family and medical leave, short-term disability, and accommodation obligations intersect in ways that make...more
On December 5, 2025, FDA announced its Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, a new voluntary pilot that seeks to accelerate innovation and expand access to digital health...more
Abbott recently announced that it agreed to acquire Exact Sciences for approximately $21 billion to enter the fast-growing cancer diagnostic segment. Under the terms of the agreement, Abbott will acquire all outstanding...more
In a move aimed at tying reimbursement to patient outcomes, the Centers for Medicare & Medicaid Services (CMS) Innovation Center announced the “Advancing Chronic Care with Effective Scalable Solutions” (ACCESS) model, a...more
While much of the industry’s attention on the calendar year (CY) 2026 Hospital Outpatient Prospective Payment System (OPPS) final rule has focused on immediate payment cuts, a more complex challenge lies in the finalized OPPS...more
The U.S. Court of Appeals for the First Circuit has weighed in on Omni Healthcare, Inc.’s (Omni) False Claims Act (FCA) allegations against MD Labs, issuing a decisive win for the defendant. On December 1, 2025, a unanimous...more
On December 9, 2025, the IRS issued Notice 2026-05, which provides guidance on the HSA provisions in the One Big Beautiful Bill Act (“OBBB”). The Notice provides much-anticipated guidance right before many of these provisions...more
President Trump’s new executive order on artificial intelligence (“AI”) seeks to impose broad and strict impediments to state-level regulation of AI. Signed on December 11, 2025, the order establishes a “minimally burdensome...more
Since 2000, pharmaceutical manufacturing has increasingly moved offshore. Today, approximately 53% of brand drug products and 69% of generics have at least one manufacturer outside the United States. Additionally, the United...more
The manner in which services are provided via telehealth has the potential to look very different for healthcare providers—particularly those providing services to Medicare patients—in 2026. As 2025 draws to a close, the...more
The 21st Century Cures Act (“Cures Act”) required states to adopt electronic visit verification (EVV) systems for Medicaid-covered personal care services (“PCS”) by January 1, 2020 and for home health care services (“HHCS”)...more
On June 17, 2025, FDA Commissioner Marty Makary launched a new priority review pilot program intended to accelerate FDA review for drug and biologic companies supporting U.S. national interests. Specifically, the...more
DOJ Once Again to Corporate Community: White Collar Criminal Enforcement Not Slowing Down - On December 9, at the Practising Law Institute White Collar Crime symposium in New York City, New York, Acting Chief Counselor of...more
Federal regulators are taking a coordinated step to accelerate the responsible integration of digital health technologies into routine care....more
Colorado House Bill 25-1002, effective January 1, 2026, amends Colorado Revised Statutes § 10-16-104(5.5) to require health benefit plans to use nationally recognized, not-for-profit clinical criteria when making coverage and...more
On November 25, 2025, the Centers for Medicare & Medicaid Services (CMS or the “Agency”) released the 2027 Medicare Advantage and Part D Proposed Rule (the “Proposed Rule”)....more
On 11 December 2025, the Council and the European Parliament reached agreement on the EU Pharma Law Package, also known as the General Pharmaceutical Legislation. No text has been published yet. The agreement will need to be...more
The landscape surrounding Colorado’s healthcare malpractice damage caps continues to shift. Earlier this year, the Colorado General Assembly enacted wholesale changes to the Health Care Availability Act (HCAA). These changes...more
In Williams v. Bally Management Group, LLC, the US District Court for the District of Rhode Island became the first court to grant a motion to dismiss in a class action challenging Bally Management Group’s (Bally) tobacco...more
Below is this week’s congressional update by BakerHostetler’s Federal Policy team. We’ll continue to post in weeks when both chambers of Congress are in session....more
FDA has published a proposed administrative order to include bemotrizinol (BEMT) as an active ingredient in over-the-counter (OTC) sunscreen products under the U.S. sunscreen monograph. The list has remained largely unchanged...more
The U.S. Department of Justice (DOJ) has escalated its criminal enforcement efforts with the formation of the new Health & Safety Unit (HSU) within its Criminal Division’s Fraud Section, effective December 2, 2025. ...more
The U.S. Food and Drug Administration (FDA) announced the Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot, or “TEMPO pilot,” on December 5, 2025, alongside a Federal Register notice seeking...more
U.S. Senators Sheldon Whitehouse (D-RI) and John Barrasso (R-WY) have introduced bipartisan legislation to expand access to high-quality, coordinated health care. The ACO Assignment Improvement Act aims to increase...more
Two and a half years after the initial proposal, agreement has been reached by the EU institutions on the so-called EU Pharma Package. The Package represents a comprehensive overhaul of the European Union’s pharmaceutical...more
