30 May 2023
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.
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.
Practical Guidance Updates
Featuring the latest updates from your Practical Guidance account.
- Access our new Generative Artificial Intelligence (AI) Resource Kit, which provides a collection of current practical guidance on generative AI, ChatGPT, and similar tools.
- Legal Developments provide the latest updates and analyses of emerging topics impacting healthcare. Visit the Legal Developments page to see breaking healthcare legal news—notably on the U.S. Supreme Court’s Dobbs decision—and related Practical Guidance content.
- Listen Up! The Practical Guidance and Law360 Podcasts Resource Kit features interviews with industry-leading attorneys on cutting edge issues in the law: NFTs, Cannabis, COVID-19, and more.
- The Practical Guidance Journal Second Edition 2023 includes legal developments on generative AI, bank failure impacts, and the risks created by crypto-assets.
- Check out the new Practical Guidance Author Center! Learn about the 1750+ leading attorney authors contributing to our 23 practice areas and find out how you can Become a Practical Guidance Author.
- Document alerts allow you to stay current on legal developments that affect your practice. Find out how to set up your document alerts.
PRACTICAL GUIDANCE CUSTOMER EMAIL EDITION ON THE WEB
Experience results today with practical guidance, legal research, and data-driven insights—all in one place.
Experience Lexis+