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Healthcare › Regulatory Requirements › Marketing

Buchalter

9th Circ. Decisions Help Clarify Scope Of Legal Lab Marketing

Buchalter on

The Eliminating Kickbacks in Recovery Act, enacted in 2018, was a bombshell for the addiction treatment and diagnostic laboratory industries. For the first time, paying commissions for sales and marketing services was...more

BakerHostetler

In Case of First Impression, Looking to AKS Precedent, Ninth Circuit Affirms EKRA Conviction for Improper Payments to Marketers

BakerHostetler on

In one of the few prosecutions based on the Eliminating Kickbacks in Recovery Act (EKRA), and in an even rarer Court of Appeals opinion interpreting the statute, the Ninth Circuit in United States v. Schena, No. 23-2989, 2025...more

Klein Moynihan Turco LLP

Let’s Be Real: AI TCPA Lawsuits Are on the Rise

Klein Moynihan Turco LLP on

Recently, an Artificial Intelligence (“AI”) Telephone Consumer Protection Act (“TCPA”) lawsuit was filed against a healthcare marketer in the United States District Court for the Northern District of Illinois. In Finley v....more

Sheppard Mullin Richter & Hampton LLP

If You Are Uptight About AI, This May Relax You

Sheppard Mullin Richter & Hampton LLP on

While AI has many people uptight, Aescape has developed technology to help you relax – AI robotic massage. Aescape touts that it combines the timeless art of massage with robotics and artificial intelligence to deliver an...more

Ropes & Gray LLP

FDA Finalizes Guidance on Communication of Scientific Information on Unapproved Uses and Releases Updated First Amendment Analysis

Ropes & Gray LLP on

On January 7, 2025, FDA published a final guidance entitled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products - Questions and Answers...more

Husch Blackwell LLP

Legal Insights for Manufacturing: Outlook for 2025

Husch Blackwell LLP on

Intensifying international crises, increasing regulatory burdens, and uncertain macroeconomic conditions have led to an era of caution for manufacturers, but hidden among those challenges are exciting opportunities for...more

Sheppard Mullin Richter & Hampton LLP

FDA Clarifies Labeling Expectations for Prescription Drug Use-Related Software

Sheppard Mullin Richter & Hampton LLP on

On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) which adds a piece to the...more

Gardner Law

State Registration Enforcement

Gardner Law on

Are you licensed to sell in these states? Most U.S. states require manufacturers to register, and gain a state-issued licensure, to sell or manufacture products within state boundaries. In fact, the following states...more

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