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 is a defining element of patient care quality, operational integrity, and public trust. Oversight from agencies such as the Office for Civil Rights (OCR), the Centers for Medicare...more
Significant data breaches have affected major players in the healthcare industry in the last year, with the methods of attack being as diverse as the affected entities themselves. Originally published in Law360 - June 4,...more
Welcome to our eighth issue of 2025 of Decoded - our technology law insights e-newsletter. Cybersecurity Ranks Among Top Three Risks to Manufacturing Sector - “Most companies are planning major AI investments to address...more
A $9.8 million False Claims Act (FCA) settlement between Illumina Inc. and the U.S. Department of Justice (DOJ) is unique among cybersecurity enforcement actions because it didn’t result from a data breach, but, according to...more
Illumina, Inc., a publicly-traded biotechnology company, agreed to a $9.8 million settlement with the U.S. Department of Justice (DOJ) in response to alleged violations of the False Claims Act (FCA). DOJ alleged that Illumina...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
At the very top of Fisher-Titus Medical Center’s website is a link to the Change Healthcare HIPAA notice informing visitors of the last day to register for credit monitoring related to the world’s largest breach, which...more
On July 31, 2025, the U.S. Department of Justice announced that Illumina Inc. agreed to pay $9.8 million to resolve False Claims Act (“FCA”) allegations concerning cybersecurity deficiencies in its genomic sequencing systems...more
With the first half of 2025 in the rearview mirror, the government’s continued focus on False Claims Act (FCA) enforcement shows no signs of slowing. In fact, the Department of Justice recently announced the results of a...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
The healthcare mergers and acquisitions (M&A) landscape is evolving rapidly, driven by factors such as value-based care, private equity, digital health, and labor shortages. In this article, we explore the key legal and...more
On July 11, 2025, the U.S. Department of Health and Human Services (“HHS”), Office of Inspector General (“OIG”) posted a report that announced the findings of a cybersecurity audit it conducted of a large Northeastern...more
On July 14, 2025, the Centers for Medicare and Medicaid Services (CMS) released the 2026 calendar year (CY 2026) Medicare Physician Fee Schedule (Proposed Rule). Among the many changes proposed, the Proposed Rule includes...more
Welcome to your monthly rundown of all things cyber, privacy, and technology, where we highlight all the happenings you may have missed. State Action: Texas Limits Punitive Damage Liability For Data Security Breach...more
In the 18 months since the Change Healthcare breach occurred, class action suits—filed by both patients and providers—continue to multiply, with no resolution yet in sight. In fact, in late June, the Minnesota judge presiding...more
In this episode, Monica Chmielewski, vice chair of Foley’s Health Care Practice Group and Shannon Sumner, Chief Compliance Officer and Nashville’s Office Managing Principal of PYA explore how supply chain compliance is...more
The New York State Department of Health has issued an urgent cybersecurity advisory (the Advisory) warning of increased threat levels and a higher likelihood of cybersecurity attacks from Iranian state-backed actors following...more
The U.S. House of Representatives returns from a district work period. The U.S. Senate is expected to consider the $9.4 billion rescissions package that passed the House last month. If not passed by July 18, 2025, the...more
THIS WEEK’S DOSE - - President Trumps signs OBBBA into law. After months of debate, Congress passed and President Trump signed H.R. 1, the One Big Beautiful Bill Act (OBBBA), into law on July 4, 2025. - Senate HELP...more
The Learned Concierge - Welcome to your monthly legal insights on the trends impacting the Retail, Hospitality, and Food & Beverage Industries. Cybersecurity & Privacy - The Monthly Rundown of All Things Cyber, Privacy,...more
On June 10th, Sheppard Mullin partner Carolyn Metnick and associate Esperance Becton, in collaboration with Marsh McLennan, presented the CLE webinar, “Navigating Healthcare Risks in a Rapidly Evolving Patient and Provider...more
Welcome to our seventh issue of 2025 of The Health Record -- our healthcare law insights e-newsletter. In this edition, we look at the so called “One, Big, Beautiful Bill Act” and its impacts on Medicaid and healthcare, the...more
As the pace of advancements in artificial intelligence (AI) innovations continues to accelerate, companies from various technology and industry sectors are turning to ArentFox Schiff’s Patent group for guidance in protecting...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