Tag: final rule

final rule

Regulatory/FDA

FTC Issues Final Version of Revised Health Breach Notification Rule

FTC Issues Final Version of Revised Health Breach Notification Rule

The Federal Trade Commission (FTC) issued a final rule on April 26, 2024 that updates its Health Breach Notification Rule (HBNR). The final rule definitions now encompass health apps and other technologies not covered by the Health Insurance Portability and Accountability Act (HIPAA). It also specifies what the FTC considers a breach of security, new […]

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Regulatory/FDA

New Federal Overtime Rule to Impact Agencies

New Federal Overtime Rule to Impact Agencies

The U.S. Department of Labor (DOL) recent released a modified employee overtime pay rules. The new rules which take effect on July 1, 2024 (with a secondary deadline of January 1, 2025) will have a material impact on many U.S. businesses including marketing service companies. Background  The federal Fair Labor Standards Act (FLSA) guarantees minimum wages […]

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Regulatory/FDA

Current FDA Voluntary Pre-Publication Rx Ad Review Processes

Current FDA Voluntary Pre-Publication Rx Ad Review Processes

As run-up to FDA’s DTC Prescription Advertising Rule that goes into effect on May 20, 2024, CHC is working with FDA staff to help reinforce current ad review processes available to healthcare marketers and how review of ads will change in May and later this year with its November enforcement date. Watch for our planned […]

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Regulatory/FDA

FDA Issues Long-Awaited Final Rule for DTC Prescription Drug Ads

FDA Issues Long-Awaited Final Rule for DTC Prescription Drug Ads

The FDA’s final rule for Direct-to-Consumer Prescription Drug Advertisements (released on November 21, 2023) will certainly impact the creative decisions agencies will make about how to structure the agency refers to as the “major statement” or the dual modality of presenting in a balanced or “neutral” manner the drug’s benefits and risks in visually clear, […]

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DTC Advertising

CMS Final Rule Requiring List Prices in DTC TV Ads Virtually the Same as Original Proposal

CMS Final Rule Requiring List Prices in DTC TV Ads Virtually the Same as Original Proposal

May 9, 2019 — The Centers for Medicare & Medicaid Services (CMS) has announced its final rule requiring that drug companies include list prices in direct-to-consumer (DTC) television ads – “the single most significant step any administration has taken toward a simple commitment: American patients deserve to know about the prices of the healthcare they […]

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