Episode 381 -- NAVEX's 2025 Annual Hotline Report
AI and the False Claims Act
Disparate Impact & Enforcement Rollbacks: What’s the Tea in L&E?
What’s in Your Operating Agreement? Legal Tips for Healthcare Providers
A New Brand of Uncertainty? — PE Pathways Podcast
The Rise of OTAs in Defense Contracting: Opportunities, Risks, and What Contractors Need to Know
Breaking the Cycle: Flooding, Infrastructure, and Climate Law in Practice
No Password Required: Former Lead Attorney at U.S. Cyber Command, Cyber Law Strategist, and Appreciator of ‘Mad Men’ Hats
Understanding BBB Ratings: Building Trust and Mitigating Risks — Regulatory Oversight Podcast
Beyond the Bylaws: The Medical Staff Show - Need to Know: How to Manage Medical Staff Confidentiality and Privilege Protections
False Claims Act Insights - The Mathematics of Nuclear FCA Verdicts
PODCAST: Williams Mullen's Benefits Companion - Cost, Care and Captives: A Mid-Size Employer’s Guide to Benefit Trends
Lawyers Beware: There Could Be Serious Ethics Issues With The New AI Browsers
Avoiding a Bored Board
We get Privacy for work – Episode 6: The Potential Privacy Risks Inherent to Mergers and Acquisitions
LathamTECH in Focus: Tech Deals: The Emerging Focus of FDI Regulators?
Podcast - Tips for Maintaining FTC Compliance When Using AI
Great Women in Compliance: The Compliance Influencer with Bettina Palazzo
Innovation in Compliance: The Power of Accountability and Team Culture with Gina Cotner
On May 14, 2025, the U.S. Department of Health and Human Services (HHS) issued its Request for Information (RFI) “Ensuring Lawful Regulation and Unleashing Innovation To Make American Healthy Again,” which HHS describes as...more
This Executive Order establishes a policy of the United States to ensure that federally funded research benefits American citizens without jeopardizing national security, strength or prosperity. The order seeks to strengthen...more
On April 1, 2025, the subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce held a hearing on cybersecurity vulnerabilities in legacy medical devices. The hearing was largely a...more
In November 2024, the U.S. Department of Health and Human Services’ Office of the Inspector General (“OIG”) published the long-awaited Industry Segment-Specific Compliance Program Guidance for Nursing Facilities (“Nursing...more
On January 6, 2025, the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) released a joint draft guidance document: Considerations for...more
In its first advisory opinion of the year, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) assessed a pharmaceutical manufacturer’s free product program and found that, although the...more
Many healthcare organizations understand the importance of having a Compliance Committee but some struggle to use their committee effectively. The key to ensuring the Compliance Committee is effective is building smart...more
In February 2025, the Office of Inspector General (OIG) for the US Department of Health and Human Services issued favorable advisory opinions Advisory Opinion 24-10 and Advisory Opinion 24-12, providing additional guidance on...more
In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community. The value of merger and...more
In this week’s installment of our blog series on the U.S. Department of Health and Human Services’ (HHS) HIPAA Security Rule updates in its January 6 Notice of Proposed Rulemaking (NPRM), we are exploring the proposed updates...more
On December 27, 2024, the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (NPRM) to modify the HIPAA Security Rule and strengthen cybersecurity protections for electronic protected...more
The U.S. Food and Drug Administration (FDA), and the Office of Human Research protections (OHRP) released draft guidance titled, “Considerations for Including Tissue Biopsies in Clinical Trials.” Although non-binding, the...more
A nursing facility that participates in the Medicaid or Medicare programs may not require a third party to guarantee payment for a resident’s admission or continued stay. However, facilities are allowed to require a resident...more
The Department of Health & Human Services (HHS) issued proposed changes to the HIPAA Security Rule (“Proposed Rule”) on January 6, 2025, and is accepting comments from the public until March 7, 2025. The Proposed Rule...more
On May 6, 2024, OCR published the final rule interpreting and implementing Section 1557 at 45 C.F.R. § 92 (the Final Rule). The Final Rule regulates the use of patient care decision support tools, including AI algorithms for...more
Bradley has launched a multipart blog series on the U.S. Department of Health and Human Services’ (HHS) proposed changes to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule, beginning last...more
Fiduciaries should be aware of recent developments involving AI, including emerging and recent state law changes, increased state and federal government interest in regulating AI, and the role of AI in ERISA litigation. While...more
The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-11 (the “Opinion”), to a pharmaceutical manufacturer (the...more
2024 was a record year for cyberattacks in the healthcare sector. According to the Breach Portal maintained by the U.S. Department of Health and Human Services (“HHS”) Office of Civil Rights (“OCR”), to date this year, there...more
On March 26, 2024, the HHS Office of Inspector General (OIG) released a cybersecurity toolkit for HHS leaders to help them plan and deploy information systems in response to disasters and public health emergencies. The...more
Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education on a wide variety of current and emerging topics...more
Last week, the White House issued an update on President Biden’s October 30, 2023 Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (the “AI EO” or “EO”). The update detailed...more
Due diligence properly performed in connection with the purchase and sale of a health care entity is simply different—vastly so—than due diligence performed in other contexts. Failure to recognize this reality can lead to...more
The Texas Medical Association and additional plaintiffs have brought four Administrative Procedure Act (APA) challenges to the rules and guidance implementing the No Surprises Act (NSA) (termed TMA I, II, III and IV). The...more
Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more