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Table 1 List of prerequisites and requirements (referred to in the following text as “REQ”)

From: Designing and piloting a generic research architecture and workflows to unlock German primary care data for secondary use

REQ No. Prerequisite/Requirement
1 As FD practices focus on every-day primary health care of walk-in patients, additional (research) activities, time and workload for the practice staff must be reduced to a strict minimum. This means, daily or continuous operation of processes to support the RADAR project must be avoided wherever possible
2 Practice staff may not have the necessary technical knowledge and may need local support and direct assistance by IT-staff from the RADAR project
3 Data should be extracted from the patient’s health record as automatedly as possible
4 Data source is the FP’s PMS, i.e. so-called routine data. As a result, FD practices that work mostly paper-based are excluded from the RADAR project
5 No hardware or any additional software may be implemented into or reconfigured in the PMS. If the PMS is adjusted in any way, the FP may lose warranty or product support by the PMS or hardware supplier in case of problems with the PMS
6 Data extraction from the PMS should not be scheduled during peak office hours. Rather, data extraction, transformation and loading must be done during time periods without or with minimum patient traffic
7 The PMS’s export interface must be accessible for use
8 Compound data sets including person-identifying data [IDAT] and medical data [MDAT] must not leave the practice. Rather, data must be split into IDAT and MDAT within the practice before being transferred to the RADAR research domain
9 The RADAR data transfer solution should deal with as-is internet access availability of the practices
10 The RADAR data export should deal with local practice-internal network availability
11 Patient’s consent and release of obligation to maintain confidentiality is basis for legal data processing, and must be a design element for the operations model
12 The RADAR project team should provide a RADAR-specific consent, patient information and release of obligation to maintain confidentiality
13 The RADAR project team manages processes with ethics committees and provides a positive vote
14 The RADAR consent recording must be (a) convenient for practice staff as well as (b) patients but still (c) digitalised as early as possible in the process
15 RADAR project provides a data protection concept based on the guidelines of the TMF. This includes the integration of a TTP for the administration of identifying data and assigned pseudonyms
16 RADAR work packages and building blocks of the solution must (a) map to the number and expertise of project partners and still provide a setup that (b) complies with GDPR requirements
17 RADAR solution should allow to select and export data subsets from the research database in a web-based, easy-to-manage way for subsequent analysis