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Author: Sven Zenker4
Data protection-compliant broad consent for secondary use of health care data and human biosamples for (bio)medical research: Towards a new German national standard
SMITH - Smart Medical Information Technology for Healthcare

Abstract (Expand)

BACKGROUND: The secondary use of deidentified but not anonymized patient data is a promising approach for enabling precision medicine and learning health care systems. In most national jurisdictions … (e.g., in Europe), this type of secondary use requires patient consent. While various ethical, legal, and technical analyses have stressed the opportunities and challenges for different types of consent over the past decade, no country has yet established a national consent standard accepted by the relevant authorities. METHODS: A working group of the national Medical Informatics Initiative in Germany conducted a requirements analysis and developed a GDPR-compliant broad consent standard. The development included consensus procedures within the Medical Informatics Initiative, a documented consultation process with all relevant stakeholder groups and authorities, and the ultimate submission for approval via the national data protection authorities. RESULTS: This paper presents the broad consent text together with a guidance document on mandatory safeguards for broad consent implementation. The mandatory safeguards comprise i) independent review of individual research projects, ii) organizational measures to protect patients from involuntary disclosure of protected information, and iii) comprehensive information for patients and public transparency. This paper further describes the key issues discussed with the relevant authorities, especially the position on additional or alternative consent approaches such as dynamic consent. DISCUSSION: Both the resulting broad consent text and the national consensus process are relevant for similar activities internationally. A key challenge of aligning consent documents with the various stakeholders was explaining and justifying the decision to use broad consent and the decision against using alternative models such as dynamic consent. Public transparency for all secondary use projects and their results emerged as a key factor in this justification. While currently largely limited to academic medicine in Germany, the first steps for extending this broad consent approach to wider areas of application, including smaller institutions and medical practices, are currently under consideration.

Authors: Sven Zenker, Daniel Strech, Kristina Ihrig, Roland Jahns, Gabriele Müller, Christoph Schickhardt, Georg Schmidt, Ronald Speer, Eva Winkler, Sebastian Graf von Kielmansegg, Johannes Drepper

Date Published: 1st Jul 2022

Publication Type: Journal article

Algorithmic surveillance of ICU patients with acute respiratory distress syndrome (ASIC): protocol for a multicentre stepped-wedge cluster randomised quality improvement strategy
SMITH - Smart Medical Information Technology for Healthcare

Abstract (Expand)

INTRODUCTION: The acute respiratory distress syndrome (ARDS) is a highly relevant entity in critical care with mortality rates of 40%. Despite extensive scientific efforts, outcome-relevant therapeutic … measures are still insufficiently practised at the bedside. Thus, there is a clear need to adhere to early diagnosis and sufficient therapy in ARDS, assuring lower mortality and multiple organ failure. METHODS AND ANALYSIS: In this quality improvement strategy (QIS), a decision support system as a mobile application (ASIC app), which uses available clinical real-time data, is implemented to support physicians in timely diagnosis and improvement of adherence to established guidelines in the treatment of ARDS. ASIC is conducted on 31 intensive care units (ICUs) at 8 German university hospitals. It is designed as a multicentre stepped-wedge cluster randomised QIS. ICUs are combined into 12 clusters which are randomised in 12 steps. After preparation (18 months) and a control phase of 8 months for all clusters, the first cluster enters a roll-in phase (3 months) that is followed by the actual QIS phase. The remaining clusters follow in month wise steps. The coprimary key performance indicators (KPIs) consist of the ARDS diagnostic rate and guideline adherence regarding lung-protective ventilation. Secondary KPIs include the prevalence of organ dysfunction within 28 days after diagnosis or ICU discharge, the treatment duration on ICU and the hospital mortality. Furthermore, the user acceptance and usability of new technologies in medicine are examined. To show improvements in healthcare of patients with ARDS, differences in primary and secondary KPIs between control phase and QIS will be tested. ETHICS AND DISSEMINATION: Ethical approval was obtained from the independent Ethics Committee (EC) at the RWTH Aachen Faculty of Medicine (local EC reference number: EK 102/19) and the respective data protection officer in March 2019. The results of the ASIC QIS will be presented at conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: DRKS00014330.

Authors: Gernot Marx, Johannes Bickenbach, Sebastian Johannes Fritsch, Julian Benedict Kunze, Oliver Maassen, Saskia Deffge, Jennifer Kistermann, Silke Haferkamp, Irina Lutz, Nora Kristiana Voellm, Volker Lowitsch, Richard Polzin, Konstantin Sharafutdinov, Hannah Mayer, Lars Kuepfer, Rolf Burghaus, Walter Schmitt, Joerg Lippert, Morris Riedel, Chadi Barakat, André Stollenwerk, Simon Fonck, Christian Putensen, Sven Zenker, Felix Erdfelder, Daniel Grigutsch, Rainer Kram, Susanne Beyer, Knut Kampe, Jan Erik Gewehr, Friederike Salman, Patrick Juers, Stefan Kluge, Daniel Tiller, Emilia Wisotzki, Sebastian Gross, Lorenz Homeister, Frank Bloos, André Scherag, Danny Ammon, Susanne Mueller, Julia Palm, Philipp Simon, Nora Jahn, Markus Loeffler, Thomas Wendt, Tobias Schuerholz, Petra Groeber, Andreas Schuppert

Date Published: 1st Apr 2021

Publication Type: Journal article

Towards a comprehensive and interoperable representation of consent-based data usage permissions in the German medical informatics initiative
SMITH - Smart Medical Information Technology for Healthcare

Abstract (Expand)

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.

Authors: Raffael Bild, Martin Bialke, Karoline Buckow, Thomas Ganslandt, Kristina Ihrig, Roland Jahns, Angela Merzweiler, Sybille Roschka, Björn Schreiweis, Sebastian Stäubert, Sven Zenker, Fabian Prasser

Date Published: 1st Jun 2020

Publication Type: Journal article

Integrating heterogeneous data sources for cross-institutional data sharing: Requirements elicitation and management in SMITH
SMITH - Smart Medical Information Technology for Healthcare

Abstract (Expand)

The digitization of health records and cross-institutional data sharing is a necessary precondition to improve clinical research and patient care. The SMITH project unites several university hospitals … and medical faculties in order to provide medical informatics solutions for health data integration and cross-institutional communication. In this paper, we focus on requirements elicitation and management for extracting clinical data from heterogeneous subsystems and data integration based on eHealth standards such as HL7 FHIR and IHE profiles.

Authors: Kais Tahar, Christoph Müller, Andreas Dürschmid, Silke Haferkamp, Kutaiba Saleh, Patrick Jürs, Sebastian Stäubert, Jan Erik Gewehr, Sven Zenker, Danny Ammon, Thomas Wendt

Date Published: 1st Aug 2019

Publication Type: Journal article

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