HIPAA-Compliant Data Use Agreement

Adopt this data use agreement to ensure HIPAA compliance when conducting clinical research. Consult with your healthcare clients when they are considering disclosing protected health information (PHI) for research purposes. Although the HIPAA Privacy Rule, 45 C.F.R. § 164.514(e), requires that covered entity healthcare organizations meet certain conditions to use or disclose PHI, the rule permits covered entities to enter into data use agreements to use or disclose a limited data set when obtaining authorization of the research participant is not possible or practical. Use this template agreement to disclose limited PHI (without participant consent) to third parties for research, public health, or healthcare operations.

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Related Content

• HIPAA Authorization to Use and Disclose PHI in Clinical Research
  Stay compliant with the HIPAA Privacy Rule when using or disclosing a patient’s PHI (other than a limited data set) for purposes of clinical research. Get the patient to execute this authorization before sharing PHI as part of a clinical trial. Rely on this template to capture or disclose all information required by the Privacy Rule.
• HIPAA Enforcement and Penalties
  Learn how the HIPAA Privacy Rule, Security Rule, Breach Notification Rule, and the Transaction Rule (known collectively as the HIPAA administrative simplification rules) are enforced, including the responsible enforcement bodies and how violations are investigated, resolved, and appealed. Understand the penalties assessed and get up to speed on HIPAA compliance best practices to avoid adverse actions.
• Privacy and Confidentiality in Clinical Research
  Differentiate how the HIPAA Privacy Rule applies to healthcare provider covered entities and the research organizations with which they work. Review this practice note also to understand the Privacy Rule exceptions applicable to clinical trials.

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