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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},
}