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
          HHS Search (hipaa)
    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
                              Privacy
                              Guidance Materials
                              Research


    

    

    Navigate to:
  HIPAA for Professionals
    
                                    
                                            
            
      
      
      
      Regulatory Initiatives
    
                                                  
                                                                  
            
      
      
      
      Privacy
                                            
            
            Summary of the Privacy Rule
    
                                                  
                                            
            
      
      
      
      Guidance
    
                                                  
                                            
            
      
      
      
      Combined Text of All Rules
    
                                                  
                                            
            
      
      
      
      HIPAA Related Links
    
                                                  
                                                                  
            
      
      
      
      Security
                                            
            
            Summary of the Security Rule
    
                                                  
                                            
            
      
      
      
      Security Guidance
    
                                                  
                                            
            
      
      
      
      Cyber Security Guidance
    
                                                  
                                                                  
            
      
      
      
      Breach Notification
                                            
            
            Breach Reporting
    
                                                  
                                            
            
      
      
      
      Guidance
    
                                                  
                                            
            
      
      
      
      Reports to Congress
    
                                                  
                                            
            
      
      
      
      Regulation History
    
                                                  
                                                                  
            
      
      
      
      Compliance & Enforcement
                                            
            
            Enforcement Rule
    
                                                  
                                            
            
      
      
      
      Enforcement Process
    
                                                  
                                            
            
      
      
      
      Enforcement Data
    
                                                  
                                            
            
      
      
      
      Resolution Agreements
    
                                                  
                                            
            
      
      
      
      Case Examples
    
                                                  
                                            
            
      
      
      
      Audit
    
                                                  
                                            
            
      
      
      
      Reports to Congress
    
                                                  
                                            
            
      
      
      
      State Attorneys General
    
                                                  
                                                                  
            
      
      
      
      Special Topics
                                            
            
            HIPAA and Part 2
    
                                                  
                                            
            
      
      
      
      Change Healthcare Cybersecurity Incident FAQs
    
                                                  
                                            
            
      
      
      
      HIPAA and COVID-19
    
                                                                
                                                                  
            
      
      
      
      HIPAA and Reproductive Health
                          
            
            HIPAA and Final Rule Notice
    
                                                  
                                            
            
      
      
      
      HIPAA and Telehealth
    
                                                  
                                            
            
      
      
      
      HIPAA and FERPA
    
                                                  
                                            
            
      
      
      
      Research
    
                                                  
                                            
            
      
      
      
      Public Health
    
                                                  
                                            
            
      
      
      
      Emergency Response
    
                                                  
                                            
            
      
      
      
      Health Information Technology
    
                                                  
                                            
            
      
      
      
      Health Apps
    
                                                  
                                                                  
            
      
      
      
      Patient Safety
                                            
            
            Statute & Rule
                          
            
            PSQIA Statute
    
                                                  
                                            
            
      
      
      
      Patient Safety Rule
    
                                                  
                                            
            
      
      
      
      Enforcement
    
                                                  
                                            
            
      
      
      
      Guidance
    
                                                  
                                                                  
            
      
      
      
      Covered Entities & Business Associates
                                            
            
            Business Associate Contracts
    
                                                  
                                            
            
      
      
      
      Business Associates
    
                                    
                                            
            
      
      
      
      Training & Resources
    
                                    
                                            
            
      
      
      
      FAQs for Professionals
    
                                    
                                            
            
      
      
      
      Other Administrative Simplification RulesText resize icon

                    




Research








  
  
    

  
      





45 CFR 164.501, 164.508, 164.512(i) (See also 45 CFR 164.514(e), 164.528, 164.532)   (Download a copy in PDF)
Background
The HIPAA Privacy Rule establishes the conditions under which protected health information may be used or disclosed by covered entities for research purposes. Research is defined in the Privacy Rule as, “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” See 45 CFR 164.501. A covered entity may always use or disclose for research purposes health information which has been de-identified (in accordance with 45 CFR 164.502(d), and 164.514(a)-(c) of the Rule) without regard to the provisions below.
The Privacy Rule also defines the means by which individuals will be informed of uses and disclosures of their medical information for research purposes, and their rights to access information about them held by covered entities. Where research is concerned, the Privacy Rule protects the privacy of individually identifiable health information, while at the same time ensuring that researchers continue to have access to medical information necessary to conduct vital research. Currently, most research involving human subjects operates under the Common Rule (45 CFR Part 46, Subpart A) and/or the Food and Drug Administration’s (FDA) human subject protection regulations (21 CFR Parts 50 and 56), which have some provisions that are similar to, but separate from, the Privacy Rule’s provisions for research. These human subject protection regulations, which apply to most Federally-funded and to some privately funded research, include protections to help ensure the privacy of subjects and the confidentiality of information. The Privacy Rule builds upon these existing Federal protections. More importantly, the Privacy Rule creates equal standards of privacy protection for research governed by the existing Federal human subject regulations and research that is not.
How the Rule Works
In the course of conducting research, researchers may obtain, create, use, and/or disclose individually identifiable health information. Under the Privacy Rule, covered entities are permitted to use and disclose protected health information for research with individual authorization, or without individual authorization under limited circumstances set forth in the Privacy Rule. Research Use/Disclosure Without Authorization. To use or disclose protected health information without authorization by the research participant, a covered entity must obtain one of the following:
Documented Institutional Review Board (IRB) or Privacy Board Approval. Documentation that an alteration or waiver of research participants’ authorization for use/disclosure of information about them for research purposes has been approved by an IRB or a Privacy Board. See 45 CFR 164.512(i)(1)(i). This provision of the Privacy Rule might be used, for example, to conduct records research, when researchers are unable to use de-identified information, and the research could not practicably be conducted if research participants’ authorization were required. A covered entity may use or disclose protected health information for research purposes pursuant to a waiver of authorization by an IRB or Privacy Board, provided it has obtained documentation of all of the following:
		Identification of the IRB or Privacy Board and the date on which the alteration or waiver of authorization was approved;
			A statement that the IRB or Privacy Board has determined that the alteration or waiver of authorization, in whole or in part, satisfies the three criteria in the Rule;
			A brief description of the protected health information for which use or access has been determined to be necessary by the IRB or Privacy Board;
			A statement that the alteration or waiver of authorization has been reviewed and approved under either normal or expedited review procedures; and
			The signature of the chair or other member, as designated by the chair, of the IRB or the Privacy Board, as applicable.The following three criteria must be satisfied for an IRB or Privacy Board to approve a waiver of authorization under the Privacy Rule:
The use or disclosure of protected health information involves no more than a minimal risk to the privacy of individuals, based on, at least, the presence of the following elements:
		an adequate plan to protect the identifiers from improper use and disclosure;
			an adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers or such retention is otherwise required by law; and
			adequate written assurances that the protected health information will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research for which the use or disclosure of protected health information would be permitted by this subpart;
	The research could not practicably be conducted without the waiver or alteration; and
	The research could not practicably be conducted without access to and use of the protected health information.Preparatory to Research. Representations from the researcher, either in writing or orally, that the use or disclosure of the protected health information is solely to prepare a research protocol or for similar purposes preparatory to research, that the researcher will not remove any protected health information from the covered entity, and representation that protected health information for which access is sought is necessary for the research purpose. See 45 CFR 164.512(i)(1)(ii). This provision might be used, for example, to design a research study or to assess the feasibility of conducting a study.
	Research on Protected Health Information of Decedents. Representations from the researcher, either in writing or orally, that the use or disclosure being sought is solely for research on the protected health information of decedents, that the protected health information being sought is necessary for the research, and, at the request of the covered entity, documentation of the death of the individuals about whom information is being sought. See 45 CFR 164.512(i)(1)(iii).
	Limited Data Sets with a Data Use Agreement. A data use agreement entered into by both the covered entity and the researcher, pursuant to which the covered entity may disclose a limited data set to the researcher for research, public health, or health care operations. See 45 CFR 164.514(e). A limited data set excludes specified direct identifiers of the individual or of relatives, employers, or household members of the individual. The data use agreement must:
		Establish the permitted uses and disclosures of the limited data set by the recipient, consistent with the purposes of the research, and which may not include any use or disclosure that would violate the Rule if done by the covered entity;
			Limit who can use or receive the data; and
			Require the recipient to agree to the following:
				Not to use or disclose the information other than as permitted by the data use agreement or as otherwise required by law;
					Use appropriate safeguards to prevent the use or disclosure of the information other than as provided for in the data use agreement;
					Report to the covered entity any use or disclosure of the information not provided for by the data use agreement of which the recipient becomes aware;
					Ensure that any agents, including a subcontractor, to whom the recipient provides the limited data set agrees to the same restrictions and conditions that apply to the recipient with respect to the limited data set; and
					Not to identify the information or contact the individual.
	Research Use/Disclosure With Individual Authorization. The Privacy Rule also permits covered entities to use or disclose protected health information for research purposes when a research participant authorizes the use or disclosure of information about him or herself. Today, for example, a research participant’s authorization will typically be sought for most clinical trials and some records research. In this case, documentation of IRB or Privacy Board approval of a waiver of authorization is not required for the use or disclosure of protected health information. To use or disclose protected health information with authorization by the research participant, the covered entity must obtain an authorization that satisfies the requirements of 45 CFR 164.508. The Privacy Rule has a general set of authorization requirements that apply to all uses and disclosures, including those for research purposes. However, several special provisions apply to research authorizations:
		Unlike other authorizations, an authorization for a research purpose may state that the authorization does not expire, that there is no expiration date or event, or that the authorization continues until the “end of the research study;” and
			An authorization for the use or disclosure of protected health information for research may be combined with a consent to participate in the research, or with any other legal permission related to the research study.
	Accounting for Research Disclosures. In general, the Privacy Rule gives individuals the right to receive an accounting of certain disclosures of protected health information made by a covered entity. See 45 CFR 164.528. This accounting must include disclosures of protected health information that occurred during the six years prior to the individual’s request for an accounting, or since the applicable compliance date (whichever is sooner), and must include specified information regarding each disclosure. A more general accounting is permitted for subsequent multiple disclosures to the same person or entity for a single purpose. See 45 CFR 164.528(b)(3). Among the types of disclosures that are exempt from this accounting requirement are:
		Research disclosures made pursuant to an individual’s authorization;
			Disclosures of the limited data set to researchers with a data use agreement under 45 CFR 164.514(e).In addition, for disclosures of protected health information for research purposes without the individual’s authorization pursuant to 45 CFR164.512(i), and that involve at least 50 records, the Privacy Rule allows for a simplified accounting of such disclosures by covered entities. Under this simplified accounting provision, covered entities may provide individuals with a list of all protocols for which the patient’s protected health information may have been disclosed under 45 CFR 164.512(i), as well as the researcher’s name and contact information. Other requirements related to this simplified accounting provision are found in 45 CFR 164.528(b)(4).
Transition Provisions. Under the Privacy Rule, a covered entity may use and disclose protected health information that was created or received for research, either before or after the compliance date, if the covered entity obtained any one of the following prior to the compliance date
An authorization or other express legal permission from an individual to use or disclose protected health information for the research;
	The informed consent of the individual to participate in the research; or
	A waiver of informed consent by an IRB in accordance with the Common Rule or an exception under FDA’s human subject protection regulations at 21 CFR 50.24. However, if a waiver of informed consent was obtained prior to the compliance date, but informed consent is subsequently sought after the compliance date, the covered entity must obtain the individual’s authorization as required at 45 CFR 164.508. For example, if there was a temporary waiver of informed consent for emergency research under the FDA’s human subject protection regulations, and informed consent was later sought after the compliance date, individual authorization would be required before the covered entity could use or disclose protected health information for the research after the waiver of informed consent was no longer valid. The Privacy Rule allows covered entities to rely on such express legal permission, informed consent, or IRB-approved waiver of informed consent, which they create or receive before the applicable compliance date, to use and disclose protected health information for specific research studies, as well as for future unspecified research that may be included in such permission.Please review the Frequently Asked Questions about the Privacy Rule.
OCR HIPAA Privacy
	December 3, 2002 Revised April 3, 2003
Back to Top

                    
  


Content created by Office for Civil Rights (OCR) Content last reviewed July 26, 2013Back 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​Disclaimer Policy: Links with this icon () mean that you are leaving the HHS website.
              The Department of Health and Human Services (HHS) cannot guarantee the accuracy of a non-federal website.
                  Linking to a non-federal website does not mean that HHS or its employees endorse the sponsors, information, or products presented on the website. HHS links outside of itself to provide you with further information.
                  You will be bound by the destination website's privacy policy and/or terms of service when you follow the link.
                  HHS is not responsible for Section 508 compliance (accessibility) on private websites.For more information on HHS's web notification policies, see Website Disclaimers.
              Continue
                  Go back