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National Institutes of Health HIPAA Privacy Rule - Information for Researchers
This website is currently in the process of being updated. For guidance on the HIPAA Privacy Rule in research, please see:

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HIPAA Privacy Rule Booklet for Research

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Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule

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Table of Contents

  1. Preface
  2. Table of Contents
  3. Why Should Researchers Be Aware of the HIPAA Privacy Rule?
  4. What Are the Purpose and Background of the Privacy Rule?
  5. How Do Other Privacy Protections Interact With the Privacy Rule?
    1. State Laws and Regulations
    2. Federal Laws and Regulations
    3. Certificates of Confidentiality
  6. To Whom Does the Privacy Rule Apply and Whom Will It Affect?
    1. Covered Entities
    2. Hybrid Entities
    3. Business Associates
    4. Determining Your Status Under the Privacy Rule
  7. What Health Information Is Protected by the Privacy Rule?
  8. How Can Covered Entities Use and Disclose Protected Health Information for Research and Comply with the Privacy Rule?
    1. De-identifying Protected Health Information Under the Privacy Rule Other Issues Relating to De-identification
    2. Authorization for Research Uses and Disclosures Elements of an Authorization
    3. Waiver or Alteration of the Authorization Requirement
    4. Limited Data Set and Data Use Agreement
    5. Activities Preparatory to Research
    6. Research on Decedents’ Protected Health Information
    7. Other Uses and Disclosures of Protected Health Information
    8. Minimum Necessary Restriction
    9. How Are Research Subjects’ Rights Affected by the Privacy Rule?
    10. Access to Protected Health Information
    11. Accounting of Disclosures of Protected Health Information
  9. What Is the Effect of the Privacy Rule on Research Started Before the Compliance Date?
  10. Conclusion
  11. Sources of Information About the Privacy Rule
  12. Glossary

Department of Health and Human Services National Institutes of Health USAGov The HIPAA Privacy Rule