Towards a comprehensive and interoperable representation of consent-based data usage permissions in the German medical informatics initiative.

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  • Additional Information
    • Affiliation:
      Technical University of Munich, School of Medicine, Institute of Medical Informatics, Statistics and Epidemiology, Ismaninger Str. 22, 81675, Munich, Germany
      Institute for Community Medicine, Department Epidemiology of Health Care and Community Health, University Medicine Greifswald, Ellernholzstr 1-2, 17487, Greifswald, Germany
      TMF - Technology, Methods, and Infrastructure for Networked Medical Research, Charlottenstraße 42, 10117, Berlin, Germany
      Heinrich-Lanz-Center for Digital Health, University Medicine Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany
      Department of Medicine, Hematology/Oncology, Goethe University, Theodor-Stern-Kai 7, 60590, Frankfurt am Main, Germany
      Interdisciplinary Bank of Biomaterials and Data Würzburg, University and University Hospital Würzburg, Straubmühlweg 2a, 97078, Würzburg, Germany
      Department of Medical Information Systems, Heidelberg University Hospital, Im Neuenheimer Feld 130.3, 69120, Heidelberg, Germany
      Institute for Medical Informatics and Statistics, University Hospital Schleswig-Holstein and Kiel University, Arnold-Heller-Str. 3, 24105, Kiel, Germany
      Institute for Medical Informatics, Statistics and Epidemiology, Universität Leipzig, Härtelstraße 16-18, 04107, Leipzig, Germany
      Staff Unit for Medical & Scientific Technology Development & Coordination, Commercial Directorate, University Hospital Bonn, Bonn, Germany
      Department Of Anesthesiology & Intensive Care Medicine, University Hospital Bonn, Bonn, Germany
      Institute for Medical Biometrics, Informatics & Epidemiology, University of Bonn, Venusbergcampus 1, 53127, Bonn, Germany
      Charité - Universitätsmedizin Berlin, Charitéplatz 1, 10117, Berlin, Germany
      Berlin Institute of Health (BIH), Anna-Louisa-Karsch-Str. 2, 10178, Berlin, Germany
    • Abstract:
      Background: The aim of the German Medical Informatics Initiative is to establish a national infrastructure for integrating and sharing health data. To this, Data Integration Centers are set up at university medical centers, which address data harmonization, information security and data protection. To capture patient consent, a common informed consent template has been developed. It consists of different modules addressing permissions for using data and biosamples. On the technical level, a common digital representation of information from signed consent templates is needed. As the partners in the initiative are free to adopt different solutions for managing consent information (e.g. IHE BPPC or HL7 FHIR Consent Resources), we had to develop an interoperability layer.Methods: First, we compiled an overview of data items required to reflect the information from the MII consent template as well as patient preferences and derived permissions. Next, we created entity-relationship diagrams to formally describe the conceptual data model underlying relevant items. We then compared this data model to conceptual models describing representations of consent information using different interoperability standards. We used the result of this comparison to derive an interoperable representation that can be mapped to common standards.Results: The digital representation needs to capture the following information: (1) version of the consent, (2) consent status for each module, and (3) period of validity of the status. We found that there is no generally accepted solution to represent status information in a manner interoperable with all relevant standards. Hence, we developed a pragmatic solution, comprising codes which describe combinations of modules with a basic set of status labels. We propose to maintain these codes in a public registry called ART-DECOR. We present concrete technical implementations of our approach using HL7 FHIR and IHE BPPC which are also compatible with the open-source consent management software gICS.Conclusions: The proposed digital representation is (1) generic enough to capture relevant information from a wide range of consent documents and data use regulations and (2) interoperable with common technical standards. We plan to extend our model to include more fine-grained status codes and rules for automated access control.
    • Journal Subset:
      Biomedical; Computer/Information Science; Europe; UK & Ireland
    • ISSN:
      1472-6947
    • MEDLINE Info:
      PMID: NLM32503529 NLM UID: 101088682
    • Grant Information:
      01ZZ1803A-R//Bundesministerium für Bildung und Forschung/; 01ZZ1801A-M//Bundesministerium für Bildung und Forschung/; 01ZZ1804A-I//Bundesministerium für Bildung und Forschung/; 01ZZ1601//Bundesministerium für Bildung und Forschung/; 01ZZ1802A-X//Bundesministerium für Bildung und Forschung/
    • Publication Date:
      In Process
    • Publication Date:
      20200611
    • DOI:
      http://dx.doi.org/10.1186/s12911-020-01138-6
    • Accession Number:
      143611935
  • Citations
    • ABNT:
      BILD, R. et al. Towards a comprehensive and interoperable representation of consent-based data usage permissions in the German medical informatics initiative. BMC Medical Informatics & Decision Making, [s. l.], v. 20, n. 1, p. 1–9, 2020. DOI 10.1186/s12911-020-01138-6. Disponível em: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=rzh&AN=143611935. Acesso em: 6 ago. 2020.
    • AMA:
      Bild R, Bialke M, Buckow K, et al. Towards a comprehensive and interoperable representation of consent-based data usage permissions in the German medical informatics initiative. BMC Medical Informatics & Decision Making. 2020;20(1):1-9. doi:10.1186/s12911-020-01138-6
    • APA:
      Bild, R., Bialke, M., Buckow, K., Ganslandt, T., Ihrig, K., Jahns, R., Merzweiler, A., Roschka, S., Schreiweis, B., Stäubert, S., Zenker, S., & Prasser, F. (2020). Towards a comprehensive and interoperable representation of consent-based data usage permissions in the German medical informatics initiative. BMC Medical Informatics & Decision Making, 20(1), 1–9. https://doi.org/10.1186/s12911-020-01138-6
    • Chicago/Turabian: Author-Date:
      Bild, Raffael, Martin Bialke, Karoline Buckow, Thomas Ganslandt, Kristina Ihrig, Roland Jahns, Angela Merzweiler, et al. 2020. “Towards a Comprehensive and Interoperable Representation of Consent-Based Data Usage Permissions in the German Medical Informatics Initiative.” BMC Medical Informatics & Decision Making 20 (1): 1–9. doi:10.1186/s12911-020-01138-6.
    • Harvard:
      Bild, R. et al. (2020) ‘Towards a comprehensive and interoperable representation of consent-based data usage permissions in the German medical informatics initiative’, BMC Medical Informatics & Decision Making, 20(1), pp. 1–9. doi: 10.1186/s12911-020-01138-6.
    • Harvard: Australian:
      Bild, R, Bialke, M, Buckow, K, Ganslandt, T, Ihrig, K, Jahns, R, Merzweiler, A, Roschka, S, Schreiweis, B, Stäubert, S, Zenker, S & Prasser, F 2020, ‘Towards a comprehensive and interoperable representation of consent-based data usage permissions in the German medical informatics initiative’, BMC Medical Informatics & Decision Making, vol. 20, no. 1, pp. 1–9, viewed 6 August 2020, .
    • MLA:
      Bild, Raffael, et al. “Towards a Comprehensive and Interoperable Representation of Consent-Based Data Usage Permissions in the German Medical Informatics Initiative.” BMC Medical Informatics & Decision Making, vol. 20, no. 1, June 2020, pp. 1–9. EBSCOhost, doi:10.1186/s12911-020-01138-6.
    • Chicago/Turabian: Humanities:
      Bild, Raffael, Martin Bialke, Karoline Buckow, Thomas Ganslandt, Kristina Ihrig, Roland Jahns, Angela Merzweiler, et al. “Towards a Comprehensive and Interoperable Representation of Consent-Based Data Usage Permissions in the German Medical Informatics Initiative.” BMC Medical Informatics & Decision Making 20, no. 1 (June 5, 2020): 1–9. doi:10.1186/s12911-020-01138-6.
    • Vancouver/ICMJE:
      Bild R, Bialke M, Buckow K, Ganslandt T, Ihrig K, Jahns R, et al. Towards a comprehensive and interoperable representation of consent-based data usage permissions in the German medical informatics initiative. BMC Medical Informatics & Decision Making [Internet]. 2020 Jun 5 [cited 2020 Aug 6];20(1):1–9. Available from: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=rzh&AN=143611935