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)
The Centers for Medicare & Medicaid Services (CMS) released the calendar year 2026 Physician Fee Schedule (PFS) proposed rule, which was published in the Federal Register on July 16, 2025. The comment period ends on September...more
The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. ...more
China's State Administration for Market Regulation (SAMR) has released the draft Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (Draft Guidelines) for public comment. The Draft Guidelines,...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
Private equity acquisitions in healthcare will likely face increased scrutiny from multiple federal departments, as well as from state antitrust enforcement officials....more
The Department of Commerce and the National Institute of Standards and Technology are requesting comments on a “draft guidance framework designed to help federal agencies evaluate when it may be appropriate to exercise...more
The U.S. Food and Drug Administration ("FDA") has issued a revised draft guidance that seeks to address questions and provide recommendations regarding the sharing of scientific information with health care providers ("HCPs")...more
The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency's general enforcement discretion approach to such devices....more
The U.S. Food and Drug Administration (FDA) issued a long-awaited revised draft guidance on October 23, 2023, which focuses on communications to healthcare providers (HCPs) regarding scientific information on unapproved uses...more
Of particular interest to clinical laboratories and medical device manufacturers, the U.S. Food and Drug Administration (FDA or the Agency) released a controversial proposed rule on September 29 that would dramatically alter...more
The U.S. Food and Drug Administration (FDA) recently published a draft of its updated Good Clinical Practice (GCP) guidance for modernizing clinical trials. The draft guidance will be open for public comment for 60 days from...more
The U.S. Food and Drug Administration (FDA) announced the establishment of a docket requesting public comments on the identification, assessment, and control of N-nitrosamine drug substance-related impurities (NDSRIs) in drug...more
The U.S. Food and Drug Administration (“FDA”) has announced its first-ever draft guidance specifically addressing the use of artificial intelligence/machine learning (“AI/ML”) in medical devices (“Draft Guidance”).This...more
On June 10, 2022, the Mississippi Board of Pharmacy filed their much-anticipated proposed rule on pharmacy shared services, starting the clock on the 25-day public comment period. The Board simultaneously filed its...more
On February 4, 2022, the FDA released its long-awaited proposed national standards for the licensure of third party logistics providers (3PLs) and wholesale drug distributors. The draft rules were years over-due and the delay...more
On May 5, 2022, the FDA’s Center for Devices and Radiological Health (CDRH) issued draft guidance regarding the FDA’s Voluntary Improvement Program (“VIP”). The draft guidance, Fostering Medical Device Improvement: FDA...more
In the words of the rock band REO Speedwagon, from the 1978 song “Roll with the Changes,” “It had to happen, felt the tables turnin’.” Earlier this month, the Food and Drug Administration’s Device Good Manufacturing Practice...more
At its upcoming February 1, 2022 meeting, the Texas Board of Pharmacy will review and discuss a potential rule change that may have serious implications for resident Texas pharmacies providing central fill or prescription...more
On January 4, China’s National People’s Congress (NPC) released draft amendments to the Chinese Patent Law, proposing expanded and enhanced protections that may provide real benefits to companies that develop new drugs. ...more
Introduction The EMA has published a draft Guideline on clinical investigation of recombinant and human plasma-derived factor IX products....more