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@ARTICLE{Bialke:137628,
author = {M. Bialke and T. Bahls and L. Geidel and H. Rau and A.
Blumentritt and S. Pasewald and R. Wolff and J. Steinmann
and T. Bronsch and B. Bergh and G. Tremper$^*$ and M.
Lablans$^*$ and F. Ückert$^*$ and S. Lang and T. Idris and
W. Hoffmann},
title = {{MAGIC}: once upon a time in consent management-a {FHIR}®
tale.},
journal = {Journal of translational medicine},
volume = {16},
number = {1},
issn = {1479-5876},
address = {London},
publisher = {BioMed Central},
reportid = {DKFZ-2018-01508},
pages = {256},
year = {2018},
abstract = {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.},
cin = {G230},
ddc = {610},
cid = {I:(DE-He78)G230-20160331},
pnm = {317 - Translational cancer research (POF3-317)},
pid = {G:(DE-HGF)POF3-317},
typ = {PUB:(DE-HGF)16},
pubmed = {pmid:30217236},
pmc = {pmc:PMC6137912},
doi = {10.1186/s12967-018-1631-3},
url = {https://inrepo02.dkfz.de/record/137628},
}