Maximizing Financial Growth: Insights on HSAs and Smart Investment Strategies with Shaun Eddy
New Developments in Health Information Policy
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 220: Healthcare Regulation Under the Trump Administration with Bob Coble of Maynard Nexsen
Podcast - Rewriting the Narrative of Private Equity in Healthcare
Hospice Insights Podcast - A Year in Review: Reflections and Hopes for the Future
Key Takeaways From the OIG's New Compliance Guidance for Nursing Facilities — Assisted Living and the Law Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 219: The Evolving Nursing Industry with Terry McDonnell of Duke University Health System
AGG Talks: Healthcare Insights Podcast - Episode 7: National MultiPlan Litigation: A Guide for Healthcare Providers
Podcast — The Growth Rocketship: How BridgeBio’s Hub and Spoke Portfolio Strategy Set the Market for the Future of Biotech — Then, Now, and What’s Next?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 218: Artificial Intelligence in Drug Development with John Van Hoy of PPD & Thermo Fisher
Podcast — Drug Pricing: How Might the Trump Administration Transform FDA Enforcement Activities?
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
Podcast — Drug Pricing: What’s in the New CMS Medicaid Final Rule?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 217: Japanese Investment in North Carolina’s Life Sciences Industry with David Robinson of Maynard Nexsen
12 Days of Regulatory Insights: Day 3 - State AG Oversight in the Health Care Industry — Regulatory Oversight Podcast
Hospice Insights Podcast - What a Difference No Deference Makes: Courts No Longer Bow to Administrative Agencies
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 216: Patient Advocacy and Healthcare Policy Change with Melissa Horn of the Arthritis Foundation
AGG Talks: Home Health & Hospice Podcast - Episode 7: OIG Report Reveals Gaps in Hospice PRF Compliance: What Providers Need to Know
Health Policy Update: Impact of the 2024 U.S. Elections – Diagnosing Health Care
Updating the Research Compliance Handbook
As the New Year begins, questions surrounding how recent election results will impact technology regulation across industries loom large. It’s hardly a bold prediction that artificial intelligence (“AI”) and the regulation...more
House Committees Organize, Senate Committees Begin Nomination Hearings. House healthcare committees held organizing meetings and announced subcommittee assignments, while Senate committees held nomination hearings for...more
On January 15, 2025, the U.S. Department of Justice (DOJ) issued a press release announcing its fiscal year (FY) 2024 False Claims Act (FCA) recoveries and reported that settlements and judgments exceeded $2.9 billion in...more
This case examines the application of trademark functionality doctrine in the medical device industry, specifically addressing whether the pink color of ceramic hip components can be protected as a trademark. The case...more
The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-12 (the “Opinion”) to a pharmaceutical manufacturer (the...more
The Office for Civil Rights (“OCR”) under the U.S. Department of Health and Human Services (“HHS”) recently issued a Notice of Proposed Rulemaking (the “Proposed Rule”) to modify the Health Insurance Portability and...more
At the close of 2024, US Congress passed a short-term extension of Medicare telehealth flexibilities as part of the American Relief Act, 2025 (ARA). The Medicare telehealth waivers, originally enacted as part of the COVID-19...more
The California Attorney General published two legal advisories this week: Legal Advisory on the Application of Existing California Laws to Artificial Intelligence. Legal Advisory on the Application of Existing California Law...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include ...more
The US Food and Drug Administration (FDA) has released its proposed rule on front-of-package (FOP) nutrition labeling. Announced on January 14, 2025, the proposed rule would add a requirement to include an informational box...more
On January 15, 2025, FDA announced an order revoking the listings providing for the use of the color additive FD&C Red No. 3 in both foods (including dietary supplements) and ingested drugs. The order is in response to a 2022...more
On January 13, 2025, California Attorney General (“AG”) Rob Bonda issued an advisory describing providers’ and businesses’ obligations related to the development, sale, and use of artificial intelligence (“AI”) and automated...more
The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting requirements for a nonprescription drug product with an “additional condition for...more
This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more
The American Relief Act, 2025, signed into law on December 21, included a short-term extension of certain telehealth waivers that went into effect in the early days of the COVID-19 Public Health Emergency. These waivers, for...more
Private equity sponsors and their healthcare portfolio companies are expected to ride the tailwind of an M&A rebound. Long-term capital gains tax rates will likely remain unchanged, or possibly drop. As a result, sellers may...more
Recent enforcement actions, audit activity, proposed rulemakings, and guidance issued by the U.S. Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) highlight the agency’s focus on health data...more
On January 7, 2025, FDA announced the availability of a final guidance document titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...more
If you are looking for a high-level summary of California laws regulating artificial intelligence (AI), check out the two legal advisories issued by California Attorney General Rob Bonta. The first advisory is directed at...more
The qui tam provisions of the False Claims Act allow individuals to file suit on behalf of the United States and to receive a share of the resulting financial settlement or judgment. Filing a qui tam case is not just a formal...more
On January 1, 2025, Amgen launched the first interchangeable biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab), Wezlana™ (ustekinumab-auub), as a private label product through Optum Health’s Nuvaila....more
When considering the health care enforcement landscape in 2024 and where it might be headed in 2025, we would be remiss if we did not address the enforcement activities of state and federal agencies beyond those typically...more
Earlier this month, the U.S. Food and Drug Administration (FDA) announced a public meeting entitled “Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act”...more
The HHS Office of Inspector General (OIG), in connection with its enforcement responsibilities, must exclude a party from the federal health care programs if the party is found to have violated certain federal laws. This type...more
The US Department of Health and Human Services (HHS) on January 6, 2025 issued a notice of proposed rulemaking (NPRM) seeking feedback on proposed updates to the Security Standards for the Protection of Electronic Protected...more
