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)
In today’s healthcare environment, compliance with federal regulations is more than a legal necessity—it’s a cornerstone of ethical and sustainable practice management. Two of the most critical laws that medical practices...more
European cybersecurity risk management and reporting obligations have received a substantial facelift. The Directive (EU) 2022/2555 on measures for a high common level of cybersecurity across the EU (“NIS 2”) became effective...more
On June 3, 2025, the Federal Trade Commission (FTC) announced its staff had sent warning letters to 37 contact lens prescribers that, according to the FTC, were the subject of consumer complaints concerning possible...more
Important changes are coming to 42 CFR Part 2 (Part 2), which deals with the confidentiality of patients’ substance use disorder (SUD) records. On April 16, 2024, the US Department of Health and Human Services (HHS) published...more
Medical practices across the United States are grappling with new compliance obligations under the Corporate Transparency Act (CTA). This article addresses the CTA’s applicability to medical practices, its current legal...more
On January 8, 2025, Massachusetts Governor Maura Healey signed into law House Bill 5159 (the “Bill”). The Bill grants the state new regulatory powers to oversee and review health care transactions involving private equity...more
Understanding reporting rules for the Affordable Care Act (ACA) is more than a best practice. It’s a legal imperative. If your reports aren’t timely and accurate, you face penalties....more
It’s not immediately obvious why someone would want to disclose a health care test result as part of a job application. But one such request spurred a Pennsylvania entity to provide a lot more than that: it sent her whole...more
The European Union (EU) is leading the global charge with AI regulations. U.S. companies are not beyond their regulatory reach, however, and should be preparing their AI risk mitigation efforts accordingly....more
As the backbone of patient care, healthcare organizations must meet Form I-9 requirements. However, it can sometimes get lost in the hiring process. There are a lot of things happening at the same time during hiring!...more
On June 27, 2023, the Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) released its final rule (“Final Rule”) implementing penalties for information blocking....more
The start of 2023 has brought with it significant changes to data privacy – new state laws concerning data privacy came into effect January 1 (the California Privacy Rights Act and the Virginia Consumer Data Protection Act),...more
In its continuing quest to push the message of aggressive FCPA enforcement, the SEC resolved FCPA charges against Orthofix, a medical device company, for $6 million in penalties and disgorgement. In a related action, the SEC...more
Employer Shared Responsibility Penalties - There are two types of employer shared responsibility payments, also known as pay or play penalties, under the Affordable Care Act (ACA). The first penalty under Internal...more
On the heels of last week’s announcement that the Affordable Care Act’s (ACA) reporting requirements and Play or Pay penalties will not go into effect until 2015, the IRS has released transition relief clarifying that the...more
The Affordable Care Act’s (ACA’s) employer shared responsibility provisions (commonly called “pay or play”) impact “large” employers and go into effect in 2014. Although effective in 2014, employers must plan NOW. Advance...more
For better or worse, the ACA or Health Care Reform is still with us. If you do not want to end up in the penalty box in 2014, you must know whether you are subject to the employer shared responsibility provisions of the ACA...more
Hospitals, health care providers, and managers of other businesses across the country may be surprised to learn that under a new federal court ruling, their organizations may now qualify as government contractors or...more
A recently issued government rule may unknowingly create significant liability and legal risk for many technology enterprises. The expanded definition of "business associates" and related interpretations by the Department of...more
Last week, the IRS issued a Notice of Proposed Rulemaking (“2013 Proposed Rule”) regarding the community health needs assessment (“CHNA”) requirement of 26 U.S.C. § 501(r)(3) (added to the Internal Revenue Code by the...more
In This Alert: - A. What Is The Employer Shared Responsibility Penalty? - What Is The “Failure To Offer Coverage Penalty”? - How Is The “Failure To Offer Coverage Penalty” Calculated? - What Is...more
Changes to the HIPAA Enforcement Rule - Background: On October 30, 2009, HHS issued an interim final rule revising the Enforcement Rule to incorporate provisions of the HITECH Act. The NPRM then proposed a number of...more
The Supreme Court’s decision in National Federation of Independent Business v. Sibelius upholding the Patient Protection and Affordable Care Act (PPACA) leaves in place the market reforms and tax provisions that have become...more
Today the U.S. Supreme Court issued its long-awaited decision on the Patient Protection and Affordable Care Act (ACA). In what is easily the most significant decision this term, and arguably one of the most important rulings...more