A survey on the current status and future perspective of informed consent management in the MIRACUM consortium of the German Medical Informatics Initiative

Abstract

Background The consent management is an essential component for supporting the implementation of consents and withdrawals and thus, the realisation of patient’s rights. In MIRACUM, one of the four consortia of the Medical Informatics Initiative (MII), ten university hospitals intend to integrate the generic Informed Consent Service® (gICS) in their Data Integration Center (DIC). To provide a tool that supports the local workflows of the MIRACUM sites, the gICS should be improved. Methods We used three standardised questionnaires with 46 questions to elicit requirements from the ten sites. Each site answered the questions from the current and the desired future perspective. This made it possible to understand the individual processes at each site and it was possible to identify features and improvements that were generally necessary. Results The results of the survey were classified according to their impact on the gICS. Feature requests of new functionalities, improvements of already implemented functionalities and conceptual support for implementing processes were identified. This is the basis for an improved gICS release to support the ten sites’ individual consent management processes. Conclusions A release plan for the feature requests and improvements was coordinated with all sites. All sites have confirmed that the implementation of these features and enhancements will support their software-based consent management processes.

A FHIR® has been lit on gICS® – Facilitating the standardized exchange of informed consents in a large network of university medicine (NUM) in pandemic research

“…In the Medical Informatics Initiative (MII) the BMBF funded the four consortia, MIRACUM [7], HiGHmed [8], SMITH [9] and DIFUTURE [10]. The aim of the MII, which started before NUM, is, among others, "to improve medical research and patient care with innovative data architectures and software solutions" [11]. This project is primarily based on decentralised infrastructures and is not limited to COVID-19 or pandemic research, but shall support a very broad approach of medical research based on patient data from diagnostic and therapeutic clinical routine in all University Hospitals in Germany, and their cooperation partners.…”

“…Moreover, the WG Consent has successfully coordinated this broad consent, which was approved by all the data protection authorities at both all federated states and the national level in Germany. It shall "be used over all sites in the four consortia" [11].…”

“…network zones, authentication, various local IT-security measures), but also human resources for su cient information of the patient, retrieval and documentation of consent, as well as for quality control of consent information. gICS® supports digital-and paper-based consent processes and follows the principles of "privacy by design" [11]. Based on consent policies and consent modules gICS® allows to automatically determine and query the detailed consent status for each patient at any time.…”

“…The correct consideration and implementation of the patient's rights, in particular the handling of consents and the implementation of patient withdrawals, require a reliable consent management [11].…”

Secondary use of health care data and left-over biosamples within the ‘Medical Informatics Initiative’ (MII): a quasi-randomized controlled evaluation of patient perceptions and preferences regarding the consent process

“…The project is of great importance to the digitisation of medicine and the networking of University Hospitals in Germany by using innovative data architectures and software solutions. In the MII, the University Medicine Greifswald (UMG) provides tools for establishing General Data Protection Regulation (GDPR)-compliant trust centre solutions [ 4 ], implementing record linkage [ 5 ], pseudonymization [ 4 ], and for consent management [ 6 , 7 ].…”