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Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.
Haynes Boone

The FDA Opens a Wider Door for Wellness Wearables

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As Americans kick off the new year with resolutions to get fit, sleep better, and take better care of themselves, the FDA has broadened access to the wearable wellness device market to a greater number of products. In a...more

Robinson+Cole Health Law Diagnosis

DEA Extends Tele-Prescribing Flexibilities Yet Again – Now Through December 31, 2026 – to Avoid Telemedicine Cliff

On December 31, 2025, the federal Drug Enforcement Administration (DEA) extended current regulatory flexibilities related to tele-prescribing of controlled substances for another year. The DEA issued a fourth temporary...more

Burr & Forman

How Should Medical Professionals Respond to ICE Agent Seeking Patient Access and/or Information

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On January 20, 2025, the President signed Executive Order 14148, titled “Initial Rescission of Harmful Executive Orders and Actions.” A significant aspect of this Executive Order is the removal of previous protections against...more

Epstein Becker & Green

Governing Health AI Development and Adoption: Insights from HHS’s Recently Announced Strategy to Promote AI in Healthcare

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The Trump Administration continues to pursue a policy of AI dominance, which began with its January 23, 2025 executive order to remove “barriers” to Artificial Intelligence (“AI”) innovation to promote “human flourishing,...more

Haynes Boone

Biotech Insights - December 2025

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A client calls and says, “We’re cooking up a bispecific antibody. We want to mix and match binding sequences like a molecular gastronomy tasting menu. Some will go into CAR-T dishes. And of course, we want patents...more

Haynes Boone

Enforcement of West Virginia’s Food Dye Ban Temporarily Halted

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To the relief of food manufacturers rushing to find natural substitutes for synthetic food dyes, a federal court has temporarily halted the enforcement of West Virginia’s House Bill 2354 (HB 2354). HB 2354 banned several...more

Holland & Knight LLP

Holland & Knight Health Dose: January 13, 2026

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The U.S. House of Representatives has passed a bill to extend the enhanced advanced premium tax credits (APTCs) for three years following a 230-196 vote, with 17 Republicans voting with Democrats to support its passage. The...more

McDermott+

Healthcare Preview for the Week of: January 12, 2026

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Last week, the House passed a three-year clean extension of the enhanced advanced premium tax credits (APTCs), which expired December 31, 2025. While 17 Republicans supported the bill, it appears to be dead on arrival in the...more

Health Care Compliance Association (HCCA)

OCR Director Stannard: Enforcement Widening To Encompass Risk Management, Parents’ Access

Paula Stannard, the newish director of the HHS Office for Civil Rights (OCR), plans to continue two enforcement initiatives with which covered entities (CEs) and business associates (BAs) likely are familiar—but she’s...more

Bradley Arant Boult Cummings LLP

Medical Cannabis Finally Rolling in Alabama

In a monumental decision almost five years in the making, the Alabama Medical Cannabis Commission on Thursday issued medical cannabis dispensary licenses to three applicants: GP6 Wellness LLC, RJK Holdings LLC and CCS of...more

Bass, Berry & Sims PLC

2026 Healthcare Private Equity Outlook & Trends

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As we step into 2026, the healthcare private equity landscape is defined by both powerful momentum and meaningful constraints. Record levels of dry powder and a growing pipeline of high‑quality assets suggest increased deal...more

Morgan Lewis

Straight to the Source: What Direct Drug Models Mean for Employer Plan Sponsors in 2026

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Alternative prescription drug access models—including direct-to-employer (DTE) and direct-to-consumer (DTC)—are gaining traction as employers reassess traditional pharmacy benefit manager (PBM)-based pricing structures. As...more

Jackson Lewis P.C.

NYC Expands Construction Safety Training to Include Mental Health

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New York City recently enacted a local law to address growing mental health concerns within the construction industry, reflecting increased attention on suicide prevention and substance abuse. The new law amends the New York...more

Spilman Thomas & Battle, PLLC

Common HIPAA Pitfalls

All readers of The Health Record understand the importance of complying with HIPAA’s Privacy, Security and Breach notification rules. But where do violations most often occur?...more

Holland & Knight LLP

DEA and HHS Extend Telemedicine Prescribing Flexibilities Through 2026

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The U.S. Drug Enforcement Administration (DEA), jointly with the U.S. Department of Health and Human Services (HHS), issued a fourth temporary rule extending the full set of COVID‑19 telemedicine flexibilities for prescribing...more

Morgan Lewis - Health Law Scan

CMS Expands Hospice Oversight to Georgia and Ohio as DEA Extends Telemedicine Flexibilities

Recent regulatory actions by the Centers for Medicare and Medicaid Services (CMS), the US Drug Enforcement Administration (DEA), and the US Department of Health and Human Services (HHS) highlight heightened federal scrutiny...more

MG+M The Law Firm

FDA PFAS Cosmetics Report Flags One Chemical for Potential Safety Concern

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On December 29, 2025, the US Food and Drug Administration (FDA) published its Report on the Use of PFAS in Cosmetic Products and Associated Risks (Report). The Report, as required under the Modernization of Cosmetics...more

Husch Blackwell LLP

DEA Extends Telemedicine Flexibilities for Ketamine Prescribing: What Clinics Need to Know in 2026

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In my November 2025 blog post, I discussed the uncertainty surrounding the DEA’s then-pending telemedicine rule and its implications for ketamine clinics. At that time, the future of pandemic-era telehealth prescribing...more

Quarles & Brady LLP

Utah Authorizes AI-Based Prescription Renewals

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Utah has issued a policy, through the Utah Department of Commerce and its Office of Artificial Intelligence Policy, authorizing a pilot program that allows an artificial intelligence (AI) system to autonomously renew certain...more

Poyner Spruill LLP

DOL Issues Six New Opinion Letters

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Following up on its re-opening of the Opinion Letter program, the United States Department of Labor, Wage and Hour Division (“DOL”) issued six new opinion letters on January 5, 2026. These letters are helpful guidance for...more

BakerHostetler

There’s a New Sheriff in Town (and It’s HHS OCR): Time To Refocus on Part 2 Compliance Before February 2026

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The Department of Health and Human Services (HHS) previously finalized sweeping changes to 42 CFR Part 2 (Part 2), the federal rules protecting the confidentiality of substance use disorder (SUD) records....more

Pietragallo Gordon Alfano Bosick & Raspanti,...

Amniotic Allograft Fraud: Is It Legitimate Wound Care or Expensive Snake Oil?

Takeaway: Wound care fraud is now one of the key enforcement priorities of the Department of Justice. An aging population, combined with Medicare’s pricing policies, nurtured an opportunity for Amniotic Allograft Fraud to...more

Bergeson & Campbell, P.C.

ECHA Survey on Nanomaterials Used as or Integrated into Flame Retardants Open until January 31, 2026

As part of the activities of the European Union (EU) Observatory for Nanomaterials (EUON), the European Chemicals Agency (ECHA) has commissioned a study on “Nanomaterials used as or integrated into flame retardants.”...more

Kilpatrick

Building a Strong Patent Portfolio: What to Protect

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Happy New Year, Founders! As we enter 2026, I encourage pharmaceutical innovators to approach intellectual property with energy and intention. The start of the year is the perfect time to step back and review your patent...more

Harris Beach Murtha

Ultra-Processed Food Regulations: 5 Things Food Companies Should Know

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Ultra-processed foods are a staple of diets throughout the nation. For many, these foods are more accessible, affordable and convenient due to their long shelf lives and ready-to-eat nature....more

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