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
President Donald Trump signed H.R. 1, known as the One Big Beautiful Bill Act (OBBB), into law on July 4, 2025. (For a detailed analysis of the bill, see Holland & Knight's previous alert, "Trump Signs the One Big Beautiful...more
Recent federal enforcement actions have brought home the lesson that there’s really no acceptable reason for denying a patient timely access to medical records. Last year, for example, the HHS Office for Civil Rights (OCR)...more
We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we present a timely discussion about increasing litigation and...more
Whistleblower Watch is a critical resource for in-house counsel and compliance professionals. Each quarter, Cozen O’Connor summarizes the most notable False Claims Act (FCA) enforcement actions, settlements, and legal trends,...more
Scammers are always looking for new ways to dupe victims. If you battle your weight, you think about it a lot and are always looking for easier ways to lose some pounds. There is no easy way, but we are always looking for an...more
On June 31, 2024, the Department of Health and Human Services (“HHS”) published a final rule establishing penalties for healthcare providers who violate the information blocking rules implemented under the 21st Century Cures...more
During this session, the panelists discussed how stakeholders in the clinical research market can leverage new technologies to better identify subjects, optimize trial conduct and reduce costs. For example, common use cases...more
Over the course of the past few months, the Office of Civil Rights (OCR) and the Office of the National Coordinator for Health Information Technology (ONC), both of which are divisions of the U.S. Department of Health and...more
The healthcare industry remains a popular target for ransomware attacks. If you haven’t been impacted by a ransomware attack, it’s likely only a matter of time before someone you do business with or buy services from is...more
Kaiser Permanente is notifying 13.4 million current and former members that their personal information may have been compromised when it was transmitted to tech giants Google, Microsoft Bing and X (formerly Twitter) when...more
The U.S. Food & Drug Administration (FDA) released a new proposed draft guidance in February that would change the FDA’s outlook on the engagement of a data monitoring committee (DMC) in clinical trials. Originally...more
The Cybersecurity and Infrastructure Agency (CISA) is seeking comment on a proposed rule to implement reporting requirements for critical infrastructure entities, including health care entities, on cyberattacks and ransomware...more
We’ve talked before about the FTC’s focus on consumer health privacy. In cases against BetterHelp and GoodRx, a blog post announcing rules it intends to enforce in the space, and a report summarizing its recent privacy and...more
Additional States Implement Notice Requirements for Healthcare Transactions - In a prior blog post, we noted the trend of states enacting legislation implementing reporting requirements for certain healthcare transactions....more
The Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) final rule, issued by the US Department of Health and Human Services (HHS) Office of...more
On Monday, March 11, 2024, the Office of the National Coordinator for Health Information Technology’s (ONC) Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information...more
On March 27, 2024, the Cybersecurity & Infrastructure Security Agency (“CISA”) released proposed regulations requiring expansive new cybersecurity incident and ransomware payment reporting across sixteen “critical...more
The World Trade Organization (WTO) Committee of Participants on the Expansion of Trade in Information Technology Products (ITA Committee) meets on April 11. The committee holds regular meetings twice a year to review...more
The U.S. Department of Homeland Security’s (DHS) Cybersecurity and Infrastructure Security Agency (CISA) is publishing a proposed rule (Proposal or NPRM) that will require broad segments of industry to meet onerous and quick...more
The healthcare industry is a major target for cyberattacks because of all of the personal information collected from patients. Recognizing that the healthcare industry is such a ripe hunting ground for cybercriminals, the...more
Updates to the Health Insurance Portability and Accountability Act Security Rule (“HIPAA Security Rule”) are planned for Spring 2024. New guidance from The Department of Health and Human Services (“HHS”) via a recently...more
House Passes Legislation to Prohibit Use of QALYs in All Federal Health Programs. The House passed H.R. 485, the Protecting Health Care for All Patients Act of 2023, a bill designed to prohibit the use of QALYs and similar...more
The American Hospital Association (AHA) has warned that information technology (IT) help desks are being targeted in a social engineering scheme that uses the stolen identity of revenue cycle employees or employees in other...more
On October 30, 2023, the Biden administration issued Executive Order 14110 on the Safe, Secure and Trustworthy Development and Use of Artificial Intelligence (the “Executive Order”). As detailed in our previously published...more