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 20, 2025, the Alabama Board of Pharmacy (the “Board”) issued its long-awaited non-disciplinary penalty schedule via emergency rulemaking. The rule went into effect immediately and will expire on December 18, 2025....more
The New York State Department of Health (the Department) adopted amendments to its Certificate of Need (CON) regulations at Part 710 of Title 10 of the New York Codes, Rules and Regulations (NYCRR) to update, modernize and...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
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
On August 13, 2025, President Trump revoked the Biden Administration’s 2021 Executive Order (Promoting Competition in the American Economy). ...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
Background: The Payback Mechanism and Its Impact - Italy’s payback system for medical devices has been a source of significant upheaval in the sector, with both domestic and international companies closely monitoring...more
Welcome to our seventh issue of 2025 of Decoded - our technology law insights e-newsletter. What does the US GENIUS Act Mean for Stablecoins? “The White House categorically states it is a historic piece of legislation that...more
Key Takeaways - CMS proposes to significantly expand the use of virtual direct supervision for incident-to services, removing prior limitations based on Professional Component (PC)/Technical Component (TC) indicators and...more
On July 22, 2025, the US Food and Drug Administration (FDA) started accepting applications to participate in the Commissioner’s National Priority Voucher (CNPV) pilot. This one-year initiative – announced on June 17 – aims to...more
The One Big Beautiful Bill Act ("OBBB") expands exemptions for orphan drugs from mandatory Medicare price negotiations and modifies their eligibility timeline....more
On July 23, 2025, the president signed three AI-related Executive Orders (“E.O.s”) to accompany the recently released White House’s Artificial Intelligence (AI) Action Plan (“AI Action Plan”). These E.O.s seek to add clarity...more
CBO releases final scores for OBBBA. The Congressional Budget Office (CBO) estimates that the One Big Beautiful Bill Act (OBBBA) will increase the uninsurance rate by 10 million individuals over 10 years. House Energy and...more
Consistent with recent attention from Congress and rhetoric from the Trump administration, the Calendar Year 2026 Medicare Hospital Outpatient Prospective Payment System (OPPS) proposed rule (the Proposed Rule) includes...more
The One Big Beautiful Bill Act (P.L.119-21) (the “OBBB”) passed by slim margins in the U.S. Senate (51-50) and U.S. House (218-214) and was signed into law by President Trump on July 4, 2025....more
On 17 July 2025, a bipartisan bill aimed at uncovering the potential human health implications of exposures to microplastics in the food and water supply was introduced into Congress. Introduced by Rep. Janelle Bynum (D-OR),...more
On July 17, the U.S. House Committee on Agriculture hosted a closed-door roundtable briefing focused on the regulatory gray areas surrounding hemp-derived cannabinoid products. The session, convened in response to ongoing...more
Last month, New York State began a formal review of its Certificate of Need (CON) process for nursing homes, launching a timely conversation about how best to align regulatory oversight with evolving system needs. A new...more
With healthcare costs rising and biologics driving a large portion of drug spend, the next wave of biosimilar launches promises to reshape the U.S. pharmaceutical market in profound ways, including reduced prices for close...more
In June 2025, Colorado passed a new law that makes significant changes to the state’s Medicaid Recovery Audit Contractor (RAC) program. Colorado has one of the most aggressive RAC programs in the country that has been rife...more
On July 2, 2025, the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Justice (DOJ) announced that they are forming the DOJ-HHS False Claims Act Working Group to further combat healthcare fraud—an...more
Share on Twitter Share by Email Share Back to top The U.S. Food and Drug Administration (FDA) recently announced a new Commissioner’s National Priority Voucher (CNPV) program, via a press release accompanied by a list of...more
The biotechnology and life science sectors underpin breakthroughs in health care, agriculture, and environmental sustainability by leveraging living systems to create next-generation medicines, diagnostics, and bio-based...more
The Center for Medicare and Medicaid Innovation ("CMMI") announced sweeping changes to the Kidney Care Choices Model ("KCC Model"), a key set of value-based programs....more