TY  - JOUR
AU  - Bialke, Martin
AU  - Bahls, Thomas
AU  - Geidel, Lars
AU  - Rau, Henriette
AU  - Blumentritt, Arne
AU  - Pasewald, Sandra
AU  - Wolff, Robert
AU  - Steinmann, Jonas
AU  - Bronsch, Tobias
AU  - Bergh, Björn
AU  - Tremper, Galina
AU  - Lablans, Martin
AU  - Ückert, Frank
AU  - Lang, Stefan
AU  - Idris, Tarik
AU  - Hoffmann, Wolfgang
TI  - MAGIC: once upon a time in consent management-a FHIR® tale.
JO  - Journal of translational medicine
VL  - 16
IS  - 1
SN  - 1479-5876
CY  - London
PB  - BioMed Central
M1  - DKFZ-2018-01508
SP  - 256
PY  - 2018
AB  - The use of medical data for research purposes requires an informed consent of the patient that is compliant with the EU General Data Protection Regulation. In the context of multi-centre research initiatives and a multitude of clinical and epidemiological studies scalable and automatable measures for digital consent management are required. Modular form, structure, and contents render a patient's consent reusable for varying project settings in order to effectively manage and minimise organisational and technical efforts.Within the DFG-funded project 'MAGIC' (Grant Number HO 1937/5-1) the digital consent management service tool gICS was enhanced to comply with the recommendations published in the TMF data protection guideline for medical research. In addition, a structured exchange format for modular consent templates considering established standards and formats in the area of digital informed consent management was designed. Using the new FHIR standard and the HAPI FHIR library, the first version for an exchange format and necessary import-/export-functionalities were successfully implemented.The proposed exchange format is a 'work in progress'. It represents a starting point for current discussions concerning digital consent management. It also attempts to improve interoperability between different approaches within the wider IHE-/HL7-/FHIR community. Independent of the exchange format, providing the possibility to export, modify and import templates for consents and withdrawals to be reused in similar clinical and epidemiological studies is an essential precondition for the sustainable operation of digital consent management.
LB  - PUB:(DE-HGF)16
C6  - pmid:30217236
C2  - pmc:PMC6137912
DO  - DOI:10.1186/s12967-018-1631-3
UR  - https://inrepo02.dkfz.de/record/137628
ER  -