False Claims Act Insights - An FCA Perspective on Artificial Intelligence in the Healthcare Industry
The State of Healthcare Enforcement
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with Ming-Wei Chen and Fangheng Zhou of RephImmune
What’s in Your Operating Agreement? Legal Tips for Healthcare Providers
10 For 10: Top Compliance Stories For the Week Ending, July 26, 2025
Key Discovery Points: Don’t Get Caught with Your Hand in the Production Cookie Jar
Work this Way: An Employment Law Video Podcast | Episode 50: Creating a Competitive Advantage Through Employee Benefits with Connor Shaw of Gallagher
False Claims Act Insights - Will Recent Leadership Changes Lead to FCA Enforcement Policy Changes?
Podcast: Addressing Patient Complaints About Privacy Violations
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney Severance of Operation Upright
Podcast - Navigating the New Landscape of Private Equity in Healthcare
Taking the Pulse: A Health Care and Life Sciences Video Podcast | Episode 235: Revolutionizing Cancer Care with Eric Perrault of Kiyatec
Evolving AI Legislation: Federal Policies, Task Forces, and Proposed Laws — The Good Bot Podcast
CareYaya: A Revolutionary Approach to Elder Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences Industry with John Crowley, President & CEO of BIO
False Claims Act Insights - Trump DOJ Sharpens Its Focus on Healthcare Fraud
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Breaking Down the Shifting Vaccine Policy Landscape – Diagnosing Health Care Video Podcast
Criminal Health Care Fraud Enforcement: Projections for 2025 and Beyond – Diagnosing Health Care Video Podcast
Healthcare Industry Segment-Specific Compliance Program Guidances (ICPGs)
On August 22, 2025, FDA suspended the biologics license for Ixchiq, one of only two marketed chikungunya vaccines. The decision to suspend comes only a few weeks after FDA approved a Safety Labeling Change supplemental...more
In the early days of the second Trump Administration, several federal funding agencies announced caps to indirect cost (“IDC”) rates for federally funded research awards. In many cases, these caps would substantially reduce...more
Earlier this month, the United States District Court for the Eastern District of Texas approved a consent judgment vacating the Consumer Financial Protection Bureau’s (CFPB) Medical Debt Rule. The decision holds that the CFPB...more
In a surprising move, the U.S. Department of Health and Human Services (HHS) announced it is reconstituting the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP), removing...more
On March 31, 2025, a judge in the Eastern District of Texas struck down a 2024 Final Rule (the "Final Rule") by the Food and Drug Administration ("FDA") that exerted jurisdiction over the regulation of laboratory-developed...more
President Trump issued a Memorandum on April 6 directing the heads of all executive departments and agencies to identify on a fast-track basis (60 days) certain categories of “unlawful and potentially unlawful” regulations...more
No legislation has garnered more attention in the life sciences industry in recent past than the so-called Drug Price Negotiation Program of the Inflation Reduction Act (the "Program"). ...more
On March 20, 2025, a New York Supreme Court Justice in Albany County issued a decision and order declaring the New York State Department of Health (NY DOH)’s August 2024 implementation of an administrative rate reimbursement...more
On March 5, 2025, a US district court in Massachusetts issued a preliminary injunction blocking the National Institutes of Health (NIH) from implementing a February 7, 2025, “Supplemental Guidance” notice that would establish...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
Ronald Reagan famously asked voters, on the eve of the 1980 presidential election, to ask themselves whether they were better off than they were four years ago. It was a powerful question that asked Americans to take stock of...more
A group of four state associations and a hospice provider have filed a federal lawsuit in Texas challenging the Special Focus Program (“SFP”) Final Rule and the resulting list of hospices identified as poor performers. The...more
Welcome back to The Week in Weed, your Friday look at what’s happening in the world of legalized marijuana. This week, we give you an update on the DEA re-scheduling hearing. ...more
On November 25, 2024, the Illinois State Legislature introduced House Bill 5918 IL HB5918, the Artificial Intelligence Systems Use in Health Insurance Act (“AI Act”). It provides the Illinois Department of Insurance (the...more
On June 28, 2024, in Loper Bright Enterprises v. Raimondo, the US Supreme Court overruled the decades-old Chevron doctrine. This decision means that courts must now determine the meaning of federal statutes and effectively...more
ACA International, the association representing the accounts receivable industry, has filed suit against the CFPB, alleging that the bureau’s advisory opinion on medical debt was overtly political, issued in violation of the...more
On August 29, 2024, the Office for Civil Rights of the United States Department of Health and Human Services (“HHS-OCR”) withdrew its appeal of an order by the United States District Court for the Northern District of Texas’...more
Tensions between the Federal Trade Commission (FTC) and pharmacy benefit managers (PBMs) continue to mount, bringing PBM practices and calls for reform back into the spotlight. On September 17, 2024, one of the largest PBMs,...more
On June 28, 2024, the U.S. Supreme Court issued a decision that overrules the “Chevron doctrine.” This means that federal agencies are limited in their ability to rely on their own interpretation of the laws they...more
The Supreme Court of the United States issued its highly anticipated ruling in a pair of cases challenging the long-standing Chevron doctrine on June 28, 2024. Foreshadowed by decisions in recent years slighting Chevron, it...more
On August 20, 2024, the United States District Court for the Northern District of Texas (Dallas Division) struck down the Federal Trade Commission’s (FTC) non-compete rule, 16 CFR § 910.1-6, that was set to take effect...more
On August 15, 2024, CMS announced the results of the first round of the negotiated prices between CMS and participating drug manufacturers for the 10 selected drugs under the Inflation Reduction Act’s (IRA) Medicare Drug...more
Although the U.S. healthcare industry has weathered the storm over the past couple of years, we may be reaching calmer waters in the coming months. Dry powder held by U.S. private equity investors has reached an all-time...more
The July Monthly Minute considers the impact of the Supreme Court’s Loper decision in overturning the longstanding Chevron deference standard, along with a district court case awarding penalties for failing to produce plan...more
Welcome to our third issue of The Health Record - our healthcare law insights e-newsletter! We are winding down the summer with our talented group of law students and they have continued to research and write, shadow...more