DATA USE AGREEMENT FOR RESEARCH
45 CFR 164.514(e)
This data use agreement (“Agreement”) between [Hospital] (“Covered Entity”) and , the Limited Data Set recipient (“Recipient”), is effective as of the date approved by the Covered Entity (“Effective Date”).
The Covered Entity is willing to provide Recipient with a Limited Data Set of Protected Health Information (“PHI”) as defined by 45 CFR 164.514(e)(2) for research purposes; and
The Recipient warrants that it shall use or disclose the Limited Data Set exclusively for the purposes set forth herein:
1. Permitted uses and Disclosures: Recipient agrees to use and disclose Limited Data Set solely for the research protocol entitled:
Protocol Number:
Additionally, Recipient agrees that it and all other “Permitted Users” of the Limited Data Set as defined in section 2, shall not use or further disclose the information other than as permitted by this agreement or as required by law.
2. Permitted users: In addition to the Recipient, the following individuals or class of individuals are permitted to use/receive the Limited Data Set:
3. Recipient Responsibilities:
3.1 Safeguards: Recipient and all Permitted Users shall use appropriate administrative, physical and technical safeguards to prevent use or disclosure of the information other than as provided by this Agreement.
3.2 Reporting: Recipient agrees to report in writing to the Privacy Officer of the Covered Entity any unauthorized use or disclosure of the Limited Data Set that it becomes aware of within three (3) business days.
3.3 Agents and Subcontractors: Recipient ensures that its agents and subcontractors to whom it provides the Limited Data Set shall agree in writing to adhere to the same restrictions and conditions contained herein to its use and disclosure.
3.4 Contact/Identification: Recipient agrees and shall ensure that all Permitted Users shall agree not to identify the information in the Limited Data Set or contact the individual who is the subject of the Limited Data Set or his/her relatives, employers or household members.
3.5 Indemnification: Recipient shall indemnify, hold harmless, and defend Covered Entity from and against all claims, losses, liabilities, costs and other expenses resulting from or relating to the acts or omissions of Recipient in connection with the representations, duties and obligations of Recipient under this agreement.
4. Term: This agreement shall become effective on the Effective Date of the Agreement and shall continue in effect until all obligations of the Parties have been met, and all PHI in the Limited Data Set provided to the Recipient is destroyed or returned to the holder. The terms and conditions of this Agreement shall survive the expiration or termination of the Agreement.
5. Termination: Covered Entity may terminate this Agreement immediately in the event that Recipient is in material breach of its terms and shall report the problem to the Secretary of the Department of Health and Human Services or its Designee.
6. No Third Party Beneficiaries: Nothing expressed or implied in this Agreement is intended or shall be deemed to confer on any person other than the Covered Entity and Recipient, and their respective successors and assigns, any rights, obligations, remedies or liabilities.
AGREED AND ACCEPTED:
Recipient:
By: Investigator Name: Title:
______
Investigator Signature Date
Covered Entity:
By: Andrea Eklund, Privacy Officer
______
Signature Date
Form DUA Rev. 11/14 - 2 -