Skip to main content


U.S. flag
      An official website of the United States government
              Here’s how you know
        Here’s how you knowDot gov**Official websites use .gov**
                 A **.gov** website belongs to an official government organization in the United States.
                  HTTPS**Secure .gov websites use HTTPS**
                 A **lock** (A locked padlock) or **https://** means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites. 
  Menu Close
          Enter the terms you wish to search for.
    Search
        








  
  
    

  
      

                                      About HHS
    
                        
                              
      
      
      Programs & Services
    
                        
                              
      
      
      Grants & Contracts
    
                        
                              
      
      
      Laws & Regulations                  
Health Information Privacy
  HIPAA for Individuals
    
                        
                                            
      
      
      Filing a Complaint
    
                        
                                            
      
      
      HIPAA for Professionals
    
                        
                                            
      
      
      Newsroom

              

    



Breadcrumb
    HHS
                              HIPAA Home
                              For Professionals
                              FAQ
                              1526-Are pharmaceutical manufacturer-funded communications to patients concerning a prescribed drug considered marketing


    

    

    Navigate to:
  Authorizations (30)
          Business Associates (41)
          Compliance Dates (2)
          Covered Entities (14)
          Decedents (9)
          Disclosures for Law Enforcement Purposes (5)
          Disclosures for Rule Enforcement (1)
          Disclosures in Emergency Situations (2)
          Disclosures Required by Law (6)
          Disclosures to Family and Friends (28)
          Disposal of Protected Health Information (6)
          Facility Directories (7)
          Family Medical History Information (3)
          FERPA and HIPAA (10)
          Group Health Plans (3)
          Incidental Uses and Disclosures (10)
          Judicial and Administrative Proceedings (8)
          Minimum Necessary (14)
          Notice of Privacy Practice (20)
          Preemption of State Law (10)
          Privacy Rule: General Topics (12)
          Protected Health Information (2)
          Public Health Uses and Disclosures (13)
          Research Uses and Disclosures (20)
          Right to an Accounting of Disclosures (8)
          Right to File a Complaint (1)
          Right to Request a Restriction (4)
          Safeguards (13)
          Security Rule (24)
          Smaller Providers and Businesses (145)
          Student Immunizations (8)
          Transition Provisions (3)
          Treatment, Payment, and Health Care Operations Disclosures (30)
          Workers Compensation Disclosures (5)
          Limited Data Set (6)
          Marketing (17)
          Marketing - Refill Reminders (16)
          Personal Representatives and Minors (12)
          Right to Access and Research (58)
          Mental Health (35)
          Health Information Technology (41)
          Telehealth (11)Text resize icon

                    




Are pharmaceutical manufacturer-funded communications to patients concerning a prescribed drug considered marketing under the Privacy Rule if they are required by a Risk Evaluation and Mitigation Strategy (REMS)?








  
  
    

  
      





Answer:

No. If the Food and Drug Administration (FDA) determines that a particular drug can only be approved with additional measures, beyond labeling, to mitigate a serious risk posed by the drug, and one or more of those measures take the form of patient communications about the drug, then such communications are not marketing, even if the communication is funded by the drug manufacturer. Government-mandated communications to individuals are not considered marketing under the Privacy Rule, even if such communications are paid for by a third party whose product or service is being described. As with communications to individuals concerning government and government-sponsored programs, government-mandated communications to individuals are not commercial in nature. Thus, a covered entity may use or disclose an individual’s protected health information without the individual’s authorization to send the individual educational or other information concerning a prescribed drug that is required by a REMS, even if the communication is funded by the drug manufacturer.

Created 9/19/13

                    
  


Content created by Office for Civil Rights (OCR) Content last reviewed February 8, 2023Back to top
    Contact HHS
    
                        
                                            
      
      
      Careers
    
                        
                                            
      
      
      HHS FAQs
    
                        
                                            
      
      
      Nondiscrimination NoticeHHS Archive
    
                        
                                            
      
      
      Accessibility Statement
    
                        
                                            
      
      
      Privacy Policy
    
                        
                                            
      
      
      Viewers & PlayersBudget/Performance
    
                        
                                            
      
      
      Inspector General
    
                        
                                            
      
      
      Web Site Disclaimers
    
                        
                                            
      
      
      EEO/No Fear ActFOIA
    
                        
                                            
      
      
      The White House
    
                        
                                            
      
      
      USA.gov
    
                        
                                            
      
      
      Vulnerability Disclosure Policy
        Sign Up for Email Updates

Receive the latest updates from the Secretary, Blogs, and News Releases.

Sign Up
  HHS Headquarters
          200 Independence Avenue, S.W.
                  Washington, D.C. 20201
                  Toll Free Call Center: 1-877-696-6775​