Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 243: HIPAA Compliance and Potential Changes with Shannon Lipham of Maynard Nexsen
HHS OIG’s Nursing Facility: Industry Segment-Specific Compliance Program Guidance
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
On July 31, the U.S. Department of Justice (DOJ) announced a settlement in United States ex rel. Lenore v. Illumina, Inc, the first case in which underlying cybersecurity issues formed the basis of a settlement under the...more
The past six months at the US Department of Health and Human Services and the US Food and Drug Administration’s Center for Devices and Radiological Health have seen a fluctuating workforce size, a slew of new executive...more
On June 24, 2025, in a hearing before the U.S. House of Representatives Committee on Energy and Commerce, the Secretary of Health and Human Services (HHS), Robert F. Kennedy Jr. revealed that his department plans to soon...more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more
On May 30, 2025, the Department of Health and Human Services released additional information regarding the Trump administration’s Fiscal Year (FY) 2026 budget request. The release of these FY26 budget materials is timely as...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
News Briefs - States, D.C., File Lawsuit to Block Trump's HHS Restructuring - A coalition of 20 attorneys general is suing to block what they say is the Trump administration's "dangerous dismantling" of the federal health...more
Companies that interact with FDA are likely to find that the layoff of 3,500 employees on April 1, 2025, affects their dealings in a variety of ways....more
Since returning to office for a second term, President Trump has taken steps to reshape federal agencies. Here, we discuss the significant changes that have occurred at the Food and Drug Administration (FDA or Agency) during...more
With the rapidly evolving regulatory landscape, staying on top of the latest updates is crucial for companies in biopharma and medical devices. In this briefing, we highlight recent regulatory and legislative developments...more
As spring arrived in the mid-Atlantic region, the Department of Health and Human Services (HHS) under Robert F. Kennedy, Jr. followed through with a previously announced Reduction in Force (RIF) that reduced the department’s...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
On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA (“ACLA v. FDA”), a closely watched case...more
There has been a flurry of activity at the Food and Drug Administration (FDA) since the start of the Trump administration. Day-to-day operations at FDA are already significantly altered, and we expect the trickle-down effects...more
News Briefs - Hospital, Device Makers Seeking Exemptions on Tariffs - Medical device makers, hospitals, and other key health industries are pressing to gain exemptions under the Trump administration's new tariff regime with...more
Last Monday, the U.S. District Court for the Eastern District of Texas (the “District Court”) issued a highly anticipated – and unsurprising – opinion invalidating the U.S. Food & Drug Administration’s (“FDA’s” or the...more
A court has struck down the Food and Drug Administration’s attempt to extend its regulatory authority to clinical laboratory testing services. On March 31, 2025, in the consolidated cases American Clinical Laboratory...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
On March 3, 2025, the U.S. Department of Health and Human Services (HHS) published a policy statement rescinding a decades-old administrative exemption for notice-and-comment rulemaking known as the Richardson Waiver. Written...more
Clinical laboratories still face uncertainty and the difficult decision of whether to start the work needed to comply with the with Phase 1 expectations under FDA’s Laboratory Developed Tests Final Rule (the “LDT Final...more
In recent weeks, the FDA has faced significant cuts, including the layoffs of probationary employees. These employees, many of whom had been hired to fill roles left by retirees or to bolster the agency’s staffing during the...more
On January 6, 2025, the US Food and Drug Administration (FDA) published final guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...more
DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more