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)
Reproductive health privacy is once again in the legal spotlight with a recent federal district court decision that struck down nearly all of a recent rule under the Health Insurance Portability and Accountability Act (HIPAA)...more
The Supreme Court's decision in McLaughlin Chiropractic Associates v. McKesson Corporation seismically shifts how courts will evaluate FCC interpretations of the TCPA, creating new compliance challenges for healthcare...more
On June 30, 2025, CMS issued its annual Home Health Prospective Payment System Proposed Rule for Calendar Year (CY) 2026 (the Proposed Rule). The Proposed Rule continues the agency’s policy of using provisions of the...more
Congress is weighing a sweeping proposal that could significantly reshape how artificial intelligence (AI) is regulated across the United States. At the end of May, the United States House of Representatives passed, by a vote...more
On February 25, 2025, President Trump signed an Executive Order directing federal agencies to “rapidly implement and enforce” federal healthcare price transparency regulations....more
President Trump’s Executive Order 14224 reinforces and expands a 2019 Executive Order which aimed to improve healthcare price transparency. On February 25, 2025, President Trump signed a new 2025 Executive Order entitled...more
On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of...more
Many existing office-based surgical centers in Massachusetts will soon be required to obtain a new type of healthcare facility license. Massachusetts Gov. Maura Healey signed House Bill No. 5159 into law on Jan. 8, 2025,...more
The clock is ticking for medical device and pharmaceutical companies to fulfill their obligations under the Physician Payments Sunshine Act (the "Sunshine Act"). With the reporting deadline of March 31 looming and CMS...more
On December 30, 2024, both the Massachusetts House of Representatives and the Massachusetts Senate enacted House Bill 5159 (H.5159), and Governor Maura Healey signed it on January 8, 2025. The bill seeks to strengthen...more
In United States v. California Stem Cell Treatment Center, Inc.[1], the FDA brought a lawsuit against doctors who create and administer a stem cell mixture called stromal vascular fraction (SVF), alleging violations of the...more
On January 8, 2025, Massachusetts Governor Maura Healey signed House Bill 5159, An Act Enhancing the Market Review Process (the “Act”) into law, effective April 8, 2025. The Act is a compromise redraft of the separate health...more
In a significant ruling, the Second Circuit Court of Appeals recently expanded the scope of the Anti-Kickback Statute (AKS).The Court joined other circuit courts across the country in adopting, for the first time, the...more
The Massachusetts Senate proposed an amendment on Monday December 2, 2024, that would delay implementation and enforcement of the 2021 Patients First Act addressing health care cost transparency. Section 31 of the amendment...more
Although private equity (PE) sponsors have been active investors in the health care services industry for the last decade, PE-backed health care providers today constitute only 4% of the United States health market by...more
On July 17, 2024, Pennsylvania passed a new law concerning noncompete agreements within the healthcare industry, which is known as the Fair Contracting for Health Care Practitioners Act (the “Act”). The Act will take effect...more
On April 26, the Federal Trade Commission (FTC) approved its Final Rule revising the Health Breach Notification Rule (HBNR) (“Final Rule”) by a 3-2 vote. The HBNR requires vendors of personal health records (PHR) and related...more
If your organization has not updated its policies to comply with Utah’s Artificial Intelligence Policy Act (the “Act”), now is the time. As we noted in a prior blog post, this law took effect on May 1st. While it imposes...more
The Antitrust Division of the U.S. Department of Justice (“DOJ”) last week announced the formation of a new task force to guide its enforcement strategy and policy approach to health care, with an apparent focus on industry...more
On April 25, 2024, the attorneys general of 22 states issued a letter encouraging UnitedHealth Group and its subsidiary, Change Healthcare, to take additional steps to respond to a massively disruptive cyberattack. The broad,...more
On April 9, 2024, the United States Department of Justice (DOJ) released a report on the COVID-19 Fraud Enforcement Task Force (“Task Force”), by far DOJ’s most comprehensive review of the Task Force since its creation in...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for February 2024. We discuss various regulatory developments, including guidance on the use of AI in coverage decisions and texting...more
Like most industries, the health care sector is grappling with the uses of artificial intelligence (AI) and what AI means for the future. At the same time, many health care companies already have integrated algorithms and AI...more
The U.S. Department of Health and Human Services ("HHS") issued a concept paper describing its overarching strategy to address healthcare cybersecurity. The concept paper builds on the Biden-Harris Administration's National...more
While health care providers have been required to comply with the 21st Century Cures Act Information Blocking Rule (the Rule) since April 5, 2021, as of yet there is no enforcement mechanism in place with respect to the Rule...more