Sorry, but you do not have permission to view this content.
Read more 
Tag: final rule
final rule Regulatory/FDA
FTC Revised Health Breach Notification Rule Goes into Effect
FTC Revised Health Breach Notification Rule Goes into Effect
Agencies with healthcare clients in pharmaceuticals, healthcare services, digital health apps, or health-related connected devices such as wearables should take note that the Federal Trade Commission (FTC) final rule updating its Health Breach Notification Rule (HBNR) that took effect on July 29, 2024. The FTC considers a breach to include a covered entity’s unauthorized disclosure […]
Read more 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 […]
Read more
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 […]
Read more
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 […]
Read more DTC Advertising
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, […]
Read more
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 […]
Read more