2014-643 EMS - UNC Heart and Vascular Center - Data Use Agreement

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DATA USE AGREEMENT This data use agreement(the"Agreement"), effective as of the 15 th day of January,2014(the"Effective Date"),by and between Orange County EMS("Orange")and The University of North Carolina at Chapel Hill for its Heart and Vascular Center("Recipient"),establishes the terms and conditions under which Recipient will access and use certain data described below(the"Data"). Orange and Recipient are sometimes referred to in this Agreement singularly as a"Party"and collectively as the"Parties." WHEREAS, Recipient acknowledges that Orange is a"covered entity,"as such term is defined under the Administrative Simplification regulations codified at 45 C.F.R. Parts 160 and 164, promulgated pursuant to the Health Insurance Portability and Accountability Act of 1996, as amended(collectively, "HIPAA"), and as such, is required to protect the privacy of Protected Health Information, as that term is defined at 45 C.F.R. 160.103,maintained by covered entity; WHEREAS,pursuant to 45 C.F.R. § 164.512(i), Orange is permitted to disclose Protected Health Information to Recipient for research purposes,where Orange receives documentation that an Institutional Review Board("MM")of competent jurisdiction, or other privacy board as defined at 45 C.F.R. § 164.512(i)(1)(i)(B),has approved an alteration to or waiver of the authorization otherwise required by 45 C.F.R. § 164.508; and WHEREAS,this Agreement is intended to meet the requirements of 45 C.F.R. § 164.512(i)and to otherwise secure adequate assurances from Recipient that Recipient will restrict use or disclosure of the Data received pursuant to this Agreement according to the terms and conditions herein; NOW THEREFORE, in consideration of the mutual promises and covenants herein, and for other good and valuable consideration,the receipt and sufficiency of which is hereby acknowledged,the Parties agree as follows: 1. Description of Data. Recipient may obtain from Orange specific clinical data from selected Orange EMS patients. Recipient acknowledges that Orange may provide Data to Recipient pursuant to a waiver of authorization granted by an IRB of competent jurisdiction or by a privacy board as defined at 45 C.F.R. § 164.512(i), in accordance with 45 C.F.R. § 164.512(i)("Waiver"). 2. Recipient's Use of Data. Except as otherwise specified herein, Orange grants Recipient the right to use and disclose the Data solely in fulfillment of its professional obligations for determining cause of sudden unexpected death, provided such use is consistent with the terms, conditions and purposes stated in the relevant Waiver. Recipient acknowledges and agrees that,prior to Orange's release of Data to Recipient,Recipient shall provide evidence of the Waiver and a copy of such Waiver shall be attached to this Agreement as Exhibit A. 3. Restrictions on Recipient's Use of Data. 3.1 Recipient agrees to comply with all applicable federal and state laws and regulations concerning the privacy and confidentiality of Protected Health Information and to use or disclose the Data exclusively for the purposes set forth in Section 2 above or as required by law. Without limiting the generality of the foregoing,Recipient agrees to use or disclose the Data solely as permitted by the Waiver. 3.2 Recipient agrees to use appropriate safeguards to protect the Data from misuse and unauthorized access or disclosure, including,without limitation,(i)maintaining adequate physical controls and password protections for any server or system on which the Data may reside; (ii)ensuring that Data is not stored on any mobile device(e.g. laptop, smartphone)or 1