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)
DOJ Addresses AI in Corporate Compliance Programs — The Good Bot Podcast
On July 9, 2025, the U.S. Department of Justice (“DOJ”) announced it sent more than 20 subpoenas to physicians and clinics involved in providing gender-affirming care to minors, and that the subpoenas related to...more
On July 24, 2025, the Federal Trade Commission (“FTC”) and the U.S. Department of Justice (“DOJ”) convened the second of three public listening sessions aimed at identifying barriers to drug price competition in the U.S....more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2025, including a new Centers for Medicare & Medicaid Services (CMS) innovation model; proposed rules with significant...more
On July 2, 2025, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) jointly announced the reestablishment of the DOJ-HHS False Claims Act (FCA) Working Group. While the two agencies...more
On July 2, 2025, the Departments of Justice and Health & Human Services announced a joint working group aimed at “strengthening their ongoing collaboration to advance priority enforcement areas” under the False Claims Act...more
On Wednesday, June 18, 2025, the Supreme Court of the United States issued a landmark 6-3 decision in United States v. Skrmetti, directly addressing the constitutionality of state laws banning gender-affirming care for...more
In January 2025, The ERISA Industry Committee (ERIC) filed a complaint against the US Departments of Labor, Health and Human Services, and the Treasury (the departments) seeking to invalidate the 2024 final regulations under...more
President Trump’s Executive Order No. 14267, “Reducing Anti-Competitive Regulatory Barriers” (“EO 14267”), requires agency heads to provide by June 18, 2025, a list of anticompetitive regulations to the Federal Trade...more
Private Equity focused on investment and operations within the Life Science industry faces significant compliance, operational and business risk due to the heavily regulated nature of the investment targets and portfolio...more
On April 4, Washington became the first state to adopt the Uniform Premerger Notification Act (Act) when Washington Governor Jay Inslee signed the bill into law. The new statute imposes state-level premerger filing...more
Illinois AG Kwame Raoul warns legal community against ‘being complicit’ with Trump - “Hours after joining 22 other states in filing a lawsuit aimed at President Donald Trump’s cuts to health services, Illinois Attorney...more
Over the past two months, the second Trump administration has shifted federal policies and priorities regarding abortion, in vitro fertilization (IVF), contraception, and other reproductive-health-related matters – and it is...more
At the 2025 American Bar Association (“ABA”) White Collar Crime Institute in Miami, industry veterans forecasted the new Trump Administration’s white collar objectives by examining trends during the first Trump presidency. In...more
Government Funding Deadline, Healthcare Program Expirations Approach. Following recent House and Senate passage of their competing budget resolutions, Congress’ attention has now turned to the March 14, 2025, government...more
Holland & Knight Health Dose 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
On December 11, 2024, a bill was introduced in the U.S. House of Representatives that, if enacted, would have substantial implications for pharmacy benefit managers (“PBMs”) and pharmacies across the country. Titled the...more
Following through on a campaign theme focused on transgender issues and access to gender-affirming health care, on Friday, January 28, President Trump signed an Executive Order, titled “Protecting Children from Chemical and...more
In the wake of the December 4, 2024 fatal shooting of UnitedHealthcare’s CEO Brian Thompson, questions were raised about insurance claim denial practices. Several news outlets noted that UnitedHealth Group’s profits have been...more
Key Points - - It remains to be seen what priorities Robert F. Kennedy Jr. and Marty Makary might set if confirmed as HHS secretary and FDA commissioner, respectively. - The Trump administration will likely focus on drug...more
On June 6, 2024, California Attorney General Rob Bonta announced that he led a multistate coalition of eleven (11) state attorneys general in in submitting a comment letter (the “Comment Letter”) in response to the Federal...more
The Department of Justice recently published a notice of proposed rulemaking applicable to healthcare entities covered under Title II of the Americans with Disabilities Act that relates to accessibility to medical diagnostic...more
In October 2023, the International Organization for Standardization (ISO) published ISO 7101, Healthcare organization management: Management systems for quality in healthcare organizations. ISO 7101 is the latest in a series...more
Appropriations Update. On March 3, Congress released bill text for the CAA, 2024, which includes funding for six of the 12 appropriations bills: Agriculture-FDA, Military Construction-VA, Energy-Water, Transportation-HUD,...more
The US Department of Health and Human Services (HHS) and the US Department of Justice (DOJ) recently published new proposed rules that update and create various requirements under Section 504 of the Rehabilitation Act of 1973...more
Ballard Spahr attorneys from the firm’s Life Sciences and Health Care Industry Teams were on the ground for the 42nd Annual J.P. Morgan Healthcare Conference (JPM24) from January 7-10. While still less crowded than...more