MAGIC: once upon a time in consent management-a FHIR® tale

被引：16

作者：

Bialke, Martin ^{[1
]}

Bahls, Thomas ^{[1
]}

Geidel, Lars ^{[1
]}

Rau, Henriette ^{[1
]}

Blumentritt, Arne ^{[1
]}

Pasewald, Sandra ^{[2
]}

Wolff, Robert ^{[1
]}

Steinmann, Jonas ^{[3
]}

Bronsch, Tobias ^{[4
,5
]}

Bergh, Bjoern ^{[4
,5
]}

Tremper, Galina ^{[6
]}

Lablans, Martin ^{[6
]}

Ueckert, Frank ^{[6
]}

Lang, Stefan ^{[7
]}

Idris, Tarik ^{[8
]}

Hoffmann, Wolfgang ^{[1
]}

机构：

[1] Univ Med Greifswald, Dept Epidemiol Hlth Care & Community Hlth, Inst Community Med, Ellernholzstr 1-2, D-17475 Greifswald, Germany

[2] Univ Med Greifswald, Independent Trusted Party 3, Ellernholzstr 1-2, D-17475 Greifswald, Germany

[3] Technol Methods & Infrastruct Networked Med Res T, Charlottenstr 42 Dorotheenstr, D-10117 Berlin, Germany

[4] Univ Kiel, Inst Med Informat & Stat, Campus Kiel,Arnold Heller Str 3, D-24105 Kiel, Germany

[5] Univ Med Ctr Schleswig Holstein, Campus Kiel,Arnold Heller Str 3, D-24105 Kiel, Germany

[6] German Canc Res Ctr, Dept Med Informat Translat Oncol, Neuenheimer Feld 280, D-69120 Heidelberg, Germany

[7] HL7 Deutschland eV, Tech Comm FHIR, Anna Louisa Karsch Str 2, D-10178 Berlin, Germany

[8] InterComponentWare AG ICW, Altrottstr 31, D-69190 Walldorf, Germany

来源：

JOURNAL OF TRANSLATIONAL MEDICINE | 2018年 / 16卷

关键词：

Medical data management; Informed consent; General data protection regulation; FHIR; IHE; APPC; Research network; Web application; gICS; Clinical trials; Patient rights; Hospital information systems; CARE; DESIGN;

D O I：

10.1186/s12967-018-1631-3

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

Background: 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. Results: 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. Conclusions: 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.

引用

页数：11

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