Amgen Activities; Permitted Data Elements. Amgen represents, warrants, covenants and agrees that (i) absent the express written consent from Dialysis Center and other than linking with fields of information that contain only Permitted Data Elements (as defined below), Amgen will not link the Data with any other data elements; (ii) Amgen will delete, purge or eliminate from any database that will hold the Data, all data elements identified in the safe harbor at 45 C.F.R. Section 164.514(b)(2)(i), other than any data element that constitutes a Permitted Data Element, and (iii) Amgen will not create any reports that contain Patient Level Data (as defined below) or permit access to the Data by any person who otherwise has access to Patient Level Data for patients of Dialysis Center. For purposes of the foregoing and this Agreement, the following definitions shall apply: (A) ”Patient Level Data” shall mean any data elements attributable to a particular patient; and (B) ”Permitted Data Element” shall mean the data elements comprising the Data, together with any other data element that identifies dates of service (including admission dates and discharge dates), gender, age or ICD-9 diagnosis and procedure codes for any individual patient. Furthermore, Amgen represents, warrants, covenants and agrees that throughout the term of this Agreement it will maintain and enforce such policies, standards or procedures, including those regarding various physical, technical and procedural safeguards, as necessary for Amgen to comply with the restrictions on use and disclosure of the Data by Amgen that are set forth herein. To the extent that Amgen desires to link with any data element not included in the list of Permitted Data Elements, Amgen shall so inform Dialysis Center in writing and identify the additional data elements desired to be included as a Permitted Data Element hereunder. Upon receipt of such notice, Dialysis Center will promptly engage, at Xxxxx’s expense, a Statistician to render a written Certification to Dialysis Center with respect to the Data, taking into account the desired linking of the additional data to be included as a Permitted Data Element hereunder. In connection with the foregoing, such Statistician shall provide a timeline to both Dialysis Center and Amgen setting forth the required time and any additional information necessary for such Statistician to conduct an appropriate review of such new desired Permitted Data Elements, and inform the parties whether a Certification can be render...
Amgen Activities; Permitted Data Elements. Subject to the requirements of any Certification, Amgen represents, warrants, covenants and agrees that (a) absent the express written consent of Dialysis Center, and other than linking with fields of
