[Nationally standardized broad consent in practice: initial experiences, current developments, and critical assessment].

Abstract

The digitalization in the healthcare sector promises asecondary use of patient data in the sense of alearning healthcare system. For this, the Medical Informatics Initiative's (MII) Consent Working Group has created an ethical and legal basis with standardized consent documents. This paper describes the systematically monitored introduction of these documents at the MII sites. The monitoring of the introduction included regular online surveys, an in-depth analysis of the introduction processes at selected sites, and an assessment of the documents in use. In addition, inquiries and feedback from alarge number of stakeholders were evaluated. The online surveys showed that 27of the 32sites have gradually introduced the consent documents productively, with acurrent total of 173,289 consents. The analysis of the implementation procedures revealed heterogeneous organizational conditions at the sites. The requirements of various stakeholders were met by developing and providing supplementary versions of the consent documents and additional information materials. The introduction of the MII consent documents at the university hospitals creates auniform legal basis for the secondary use of patient data. However, the comprehensive implementation within the sites remains challenging. Therefore, minimum requirements for patient information and supplementary recommendations for best practice must be developed. The further development of the national legal framework for research will not render the participation and transparency mechanisms developed here obsolete.