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)
Our Health Care Group discusses what businesses need to know about a new law in Maryland that creates new requirements for health plans’ use of artificial intelligence in making coverage and treatment decisions....more
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
With the rebound of private equity (“PE”) activity in healthcare across the United States, the Corporate Practice of Medicine and Dentistry (“CPOM” or “CPOD”) has likewise experienced renewed focus by state legislatures and...more
On August 25, 2025, the Department of Health and Human Services Office of Inspector General (OIG) issued a new report (Report) highlighting trends in remote patient monitoring (RPM) Medicare billing, recommending stronger...more
The United States Pipeline and Hazardous Materials Safety Administration (“PHMSA”) addressed in an August 7th Interpretive Letter the application of the federal Hazardous Materials Regulations (“HMR”) to the transportation of...more
Key Takeaways - The California legislature is advancing two bills that focus on the role of private equity groups, hedge funds and management services organizations in the state’s health care industry....more
In 2025, Life Sciences and Health Care (LS&HC) companies face rapidly evolving regulatory paradigms that create transactional risks and require daily monitoring. After more than 70 national elections in 2024, the dust hasn’t...more
The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more
Below is a tracker of healthcare-related executive orders (EOs) issued by the Trump administration, including overviews of each EO and the date each EO was signed. We will regularly update this tracker as additional EOs are...more
A new law in Florida, CS/CS/SB 1768, allows physicians to market and administer stem cell therapies that have not been approved by the U.S. Food and Drug Administration (FDA) for orthopedic conditions, wound care and pain...more
California’s Assembly Bill 489 (“AB 489”) signals more than just a tweak to existing healthcare law—it’s a glimpse into how the next generation of regulation may shape the future of AI development and deployment in...more
On August 6, 2025, the New York State Department of Health (DOH) finalized amendments to its Certificate of Need (CON) regulations in 10 N.Y.C.R.R. Part 710, raising the financial thresholds for full review, expanding...more
On July 24, 2025, the OIG released reports evaluating the prevalence of patient harm in hospitals and the extent to which hospitals detect and report such events. These evaluations follow up on OIG’s 2022 report and provide...more
On August 6, 2025, the U.S. Food and Drug Administration (FDA) became the latest governmental agency to confirm that fluoropolymers are both safe and necessary. After an independent safety review of fluoropolymers in medical...more
Among the many sweeping changes to the Medicaid program included in the One Big Beautiful Bill Act (“OBBBA”), Congress established new statutory caps on state-directed payments (“SDPs”) in Medicaid managed care. SDPs have...more
The Calendar Year 2026 Medicare Physician Fee Schedule (PFS) proposed rule (see Orrick’s analysis of the proposed rule here) contains important signals for the future of remote patient monitoring (RPM) and remote therapeutic...more
As government scrutiny of the healthcare industry intensifies, enforcement agencies are casting wider nets to recover funds based on narrowly interpreted violations. This puts not only healthcare providers but also those...more
On July 17, the offices of Senators Durbin (D. IL.), Warren (D. MA.), Sanders (I. VT.), and Welch (D. VT.) (collectively, “Senators”) released a report summarizing the results of a nine month investigation into...more
On July 14, the Consumer Financial Protection Bureau (CFPB or Bureau) filed a status report announcing its decision not to reissue its Medical Debt Collection Advisory Opinion, which had been issued in 2024 to “remind debt...more
Recently, it was reported that the U.S. Food and Drug Administration (FDA) is launching two cross-agency artificial intelligence (AI) councils. One AI council will be tasked with addressing how the agency uses AI internally...more
The Centers for Medicare & Medicaid Services (CMS) has launched the WISeR Model (Wasteful and Inappropriate Service Reduction) to modernize and streamline Medicare’s prior authorization process. ...more
On June 23, 2025, California’s Office of Health Care Affordability (OHCA) issued a determination that a transaction submitted by Covenant Care California, LLC and its subsidiaries under the Material Change Transaction Notice...more
The intersection of AI and healthcare is outpacing the development of laws and regulations governing the technology. Even in the early days of AI transformation, this is creating uncertainty for healthcare organizations....more
As we noted in our previous blog post, HealthBench, an open-source benchmark developed by OpenAI, measures model performance across realistic health care conversations, providing a comprehensive assessment of both...more
Summary The Ohio State Dental Board (the “Board”) recently updated its position statement, “Role of the Dentist in the Treatment of Sleep-disordered Breathing.” ...more