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Call for tenders' details

Title:
Primary Healthcare Databases – Lot 1: Primary Healthcare Database in France; Lot...
Contracting authority:
European Medicines Agency (EMA)
TED publication date:
13/03/2023
Time limit for receipt of tenders:
24/04/2023
Status:
Closed
Status
12/04/2023
17/04/2023
English (en)
Question details
French data set with extended data points
The EMA requests for primary health care data from France. In France there’s a possibility to link the primary care data with 6 months of historical lookback claims data which is collected during a patient visit to his/her HCP, in order to avoid drug/drug interaction and in general provide better patient history. This data use/linkage would need formal approval from CNIL. We assume that for this tender and the response this claims data will not be included in the proposed data set unless explicit CNIL approval is obtained by tenderer at EMA’s request. Is this a correct assumption?
17/04/2023
Please refer to the section 3.1 of the technical specifications that describes the desired characteristics of the primary healthcare database. It is for the tenderer to ensure compliance to the requirements described in the technical specifications and to propose elements to EMA that it considers appropriate. Any information of the proposed database should be duly described. From a data protection perspective, any proposed database shall be in compliance with the legal framework applicable to the personal data available in the database. The tenderers are reminded that the proposed database should be available to EMA within 90 (ninety) calendar days from the entry into force of the contract (see section 3.1.9 of the technical specifications).