False Claims Act Insights - Will Recent Leadership Changes Lead to FCA Enforcement Policy Changes?
Breaking Down the Shifting Vaccine Policy Landscape – Diagnosing Health Care Video Podcast
Healthcare Industry Segment-Specific Compliance Program Guidances (ICPGs)
2025 Outlook: The Department of Health and Human Services Under the Second Trump Administration – Diagnosing Health Care
New HIPAA Final Rule: Key Changes to Reproductive Health Care Privacy - Thought Leaders in Health Law®
Navigating the Labyrinth of Private Equity Investments in Health Care – Diagnosing Health Care
HHS Office for Civil Rights Director Melanie Fontes Rainer on Progress and News at OCR
ERISA Blog | Changes to the HIPAA Privacy Rules A Primer for Self-Insured Group Health Plans
Hospice Insights Podcast - A Refresh: What’s New in the New OIG General Compliance Program Guidance
The Presumption of Innocence Podcast: Special Edition | Episode 36 - Rolling Change: The DEA Turns Over a New Leaf on Marijuana Scheduling
Understanding the HHS OIG’s General Compliance Program Guidance
OMG. . .The OIG is at it Again
The FTC's Health Privacy Enforcement Actions
Medical Device Legal News with Sam Bernstein: Episode 19
Episode 303 --- Deep Dive into the HHS-OIG Compliance Program Guidance
Counsel That Cares - The Private Payer's Perspective on Value-Based Care
Medical Device Legal News with Sam Bernstein: Episode 17
Podcast - Data Privacy and Tracking Technology Compliance
Podcast - A Conversation on Cannabis: Are Challenges or Changes Coming?
Episode 280 -- Healthcare Compliance and Fraud
The U.S. Food and Drug Administration (FDA) recently announced plans to update its post-market food chemical review program. In its announcement, FDA explained that its forthcoming plans will take a proactive approach to...more
The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) are requesting public comment on nutrient requirements for infant formulas intended for healthy, full-term infants. FDA’s...more
On May 12, 2025, the White House issued an Executive Order (EO) entitled “Delivering Most Favored Nation Prescription Drug Pricing to American Patients.” The EO directs the Secretary of Health and Human Services (HHS) to...more
On April 22, 2025, the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) announced a series of measures to phase out all certified colors from the nation’s food supply by the end...more
Human Health and Services (HHS) Secretary Robert F. Kennedy Jr. has instructed the Food and Drug Administration (FDA) to revisit and consider rulemaking regarding its Generally Recognized as Safe (GRAS) notification and...more
Key Takeaways - What Happened: HHS Secretary Kennedy directed FDA to consider removing the current self-affirmation pathway for determining that a food ingredient is Generally Recognized as Safe (GRAS)....more
United States Department of Health and Human Services (HHS) Secretary Kennedy recently directed the U.S. Food and Drug Administration (FDA) to consider rulemaking to revise its longstanding regulations and guidance governing...more
In the health policy world, nothing gets folks like me more “excited” than expecting and then seeing a new healthcare regulation pop up in the Federal Register. While the content of the reg is usually what public stakeholders...more
The Drug Enforcement Administration (DEA), in concert with other federal agencies, has taken various steps in the past few months to strengthen a practitioner’s ability to prescribe controlled substances via telemedicine, a...more
In September 2022, former President Biden convened the White House Conference on Hunger, Nutrition, and Health, during which the White House introduced its National Strategy on Nutrition and Health (National Strategy). The...more
In late January, the U.S. Food and Drug Administration (FDA) withdrew its proposed rules to prohibit menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars. Although either proposal could be...more
On January 6, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published significant proposed amendments (proposed rule) to the Security Rule under the Health Insurance Portability and...more
The U.S. Department of Health and Human Services (“HHS”) issued a Notice of Proposed Rulemaking (the “Proposed Rule”) on December 27, 2024, to significantly amend HIPAA’s Security Rule, which sets forth the security standards...more
The Department of Health and Human Services (HHS) has proposed significant modifications to the HIPAA Security Rule and the HITECH Act in an attempt to strengthen cybersecurity protections for electronic protected health...more
The Biden Administration wants to crack down on corporate practices that it believes waste consumers’ time and money through excessive paperwork, long wait times, and other aggravations – and you’ll want to take note so you...more
*This is the 12th article in a series analyzing the No Surprises Act and its implementation. To view the entire series, click here. A link to the proposed rule is here. As background, Congress passed the Act to prevent...more
On October 27, 2023, the US Departments of Health and Humans Services, Labor and the Treasury (the Departments), along with the Office of Personnel Management, issued a proposed rule titled Independent Dispute Resolution...more
On October 5, 2023, the Office of Research Integrity (ORI) of the Department of Health and Human Services (HHS) issued a notice of proposed rulemaking to update the Public Health Service (PHS) Policies on Research Misconduct...more
On September 20, 2023, the US Departments of Health and Human Services (HHS), Labor (DOL) and the Treasury (collectively, the departments) issued a proposed rule related to the No Surprises Act’s (NSA’s) federal independent...more
Nearly nine years to the day the Food and Drug Administration (FDA) issued a draft “information sheet” on informed consent, the agency published a 66-page final guidance document on the topic—marking the first time since 1998...more
On July 25, 2023, the US Departments of Labor (DOL), Treasury (DOT), and Health and Human Services (HHS) (the Departments) released a much-anticipated interim final rule to ensure that group health plans comply with the...more
On July 25, 2022, the U.S. Department of Health and Human Services (“HHS”) issued a proposed new rule that significantly expands the scope of protection available to vulnerable populations under Section 1557 of the Affordable...more
President Biden issued Executive Order 13985, Advancing Racial Equity and Support for Underserved Communities Through the Federal Government (Executive Order) on inauguration day in 2021, signalizing the Administration’s...more
On July 1, 2021, the U.S. Departments of Labor, Treasury, and Health and Human Services (HHS) issued the first rules implementing the No Surprises Act, which prohibits health care providers from billing patients more than...more
On Nov. 4, 2020, the U.S. Department of Health and Human Services (HHS) published a notice of proposed rulemaking and proposed regulatory changes that would, effectively, cause many federal healthcare regulations to disappear...more