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
                              300-Does HIPAA's public health provision permit covered entities to disclose information without authorization


    

    

    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

                    




Does the HIPAA Privacy Rule's public health provision permit covered entities to disclose protected health information without authorization to a manufacturer of a product regulated by the Food and Drug Administration (FDA) for use by the manufacturer to assess the effectiveness of its marketing campaign?








  
  
    

  
      





Answer:

No. The public health provision is intended to facilitate the flow of information that is essential to the FDA’s public health mission. The provision does not permit covered entities to disclose protected health information to a manufacturer for the manufacturer’s commercial purposes, or for any other non-public health purpose.
For example, the Rule does not permit a covered entity to provide a drug manufacturer with a list of persons who prefer a different flavored cough syrup over the flavor of the manufacturer’s product. Rather, this provision permits covered entities to disclose protected health information as necessary to continue current voluntary reporting of adverse events and similar reports that are necessary to ensure the quality, safety, or effectiveness of an FDA-regulated product.
For instance, a covered entity would be permitted to report a concern to a drug manufacturer that its cough syrup might be unsafe based on the belief that a difference in the taste could be due to drug tampering or a manufacturing problem. Likewise, a covered health care provider would be permitted to disclose protected health information to a drug manufacturer to report that the failure of a patient’s medical condition to improve may be due to the drug’s ineffectiveness. In making such a report, the covered entity may disclose the protected health information that is reasonably necessary to achieve the purpose of the report.
Learn more about public health uses and disclosures and the minimum necessary standard.

Date Created: 12/20/2002

                    
  


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​