[Secondary Use of Electronic Medical Record Data from Primary Health Care is Feasible: Report from RADAR Project]. / Sekundäre Nutzung von hausärztlichen Routinedaten ist machbar ­ Bericht vom RADAR Projekt.

Objectives It is difficult to obtain longitudinal 'real world' data from ambulatory medical care in Germany in a systematic way. Our vision is a large German research data repository featuring representative, anonymized patient and outpatient health care data, longitudinal, continuously updated and across different providers, offering a perspective of linking secondary care data or additional data obtained from research cohorts, for example patient reported data or biodata, and will be accessible for other researchers. Here we report specific methods and results from the RADAR project.Methods Survey of legislation, design of technical processes and organisational solutions, with a feasibility study to evaluate technical and content functionality, acceptability and performance fitness for health services research questions.Results In 2016, a multi-disciplinary scientific team initiated the development of a privacy protection and IT security concept for data exported from the electronic medical records (EMR) of physicians' practices in line with the European General Data Protection Regulation. Technical and organisational requirements for lawful research infrastructure were developed and executed for use in a specific case, namely ̒oral anticoagulation'. In 7 Lower Saxonian general practices, 100 patients were selected by their physician and their data - reduced to 40 essential data fields - extracted from EMR via a mandatory software interface after informed consent. Still in the practice, the data were split into identifying or medical data. These were encrypted and transferred either to a trusted third party (TTP) or to a data repository, respectively. 75 patients who met our inclusion criteria (minimum of one year of oral anticoagulation treatment) received a quality-of-life questionnaire via the TTP. Of the 66 returns, 63 responses were then linked to the EMR data in the repository.Conclusion Results from RADAR project proved the technical and organisational feasibility of lawful, pseudonymised data acquisition and the linkage of questionnaires to EMR data. The protecting concepts privacy by design and data minimization (Art. 25 GDPR with Recital 78) were implemented. Without informed consent, secondary use of routine data from ambulatory care which are sufficiently anonymized but still meaningful is all but impossible under current German law.

Designing and piloting a generic research architecture and workflows to unlock German primary care data for secondary use.

BACKGROUND: Medical data from family doctors are of great importance to health care researchers but seem to be locked in German practices and, thus, are underused in research. The RADAR project (Routine Anonymized Data for Advanced Health Services Research) aims at designing, implementing and piloting a generic research architecture, technical software solutions as well as procedures and workflows to unlock data from family doctor's practices. A long-term medical data repository for research taking legal requirements into account is established. Thereby, RADAR helps closing the gap between the European countries and to contribute data from primary care in Germany. METHODS: The RADAR project comprises three phases: (1) analysis phase, (2) design phase, and (3) pilot. First, interdisciplinary workshops were held to list prerequisites and requirements. Second, an architecture diagram with building blocks and functions, and an ordered list of process steps (workflow) for data capture and storage were designed. Third, technical components and workflows were piloted. The pilot was extended by a data integration workflow using patient-reported outcomes (paper-based questionnaires). RESULTS: The analysis phase resulted in listing 17 essential prerequisites and guiding requirements for data management compliant with the General Data Protection Regulation (GDPR). Based on this list existing approaches to fulfil the RADAR tasks were evaluated-for example, re-using BDT interface for data exchange and Trusted Third Party-approach for consent management and record linkage. Consented data sets of 100 patients were successfully exported, separated into person-identifying and medical data, pseudonymised and saved. Record linkage and data integration workflows for patient-reported outcomes in the RADAR research database were successfully piloted for 63 responders. CONCLUSION: The RADAR project successfully developed a generic architecture together with a technical framework of tools, interfaces, and workflows for a complete infrastructure for practicable and secure processing of patient data from family doctors. All technical components and workflows can be reused for further research projects. Additionally, a Trusted Third Party-approach can be used as core element to implement data privacy protection in such heterogeneous family doctor's settings. Optimisations identified comprise a fully-electronic consent recording using tablet computers, which is part of the project's extension phase.

[The risk of re-identification when analyzing electronic health records: a critical appraisal and possible solutions]. / Das Risiko von Re-Identifizierung bei der Auswertung medizinischer Routinedaten ­ Kritische Bewertung und Lösungsansätze.

BACKGROUND AND OBJECTIVES: The use of primary care data gathered from electronic health records in local practices could be an important building block for the future of health services research. However, the risks and reservations associated with using this data for research purposes should not be underestimated. We show the data protection and privacy problems that may arise through secondary analysis of routine primary care data and describe the technical solutions that are available to address these concerns - as a trust-building measure. METHODS: We screened 40 variables that are deemed important for documentation in the electronic health records of primary care physicians and rated the risk of patient re-identification when using these records from routine medical data for research purposes. The criteria used to rate the risk of re-identification were "expert perception" (inferences of a professional observer of phenotypical characteristics which are documented in the 40 variables), "researchable additional knowledge" (knowledge of characteristics of a person through publicly available information and social media networks), and "statistic frequency" according to diagnosis and medication statistics. RESULTS: Diagnoses and reasons for contacting a general practitioner can contain particularly identifiable characteristics such as "obesity" (ICD-10 E66) and "nicotine dependence" (F17). About half of all ICD codes documented in primary care fall below a critical threshold value in their absolute frequency; this is all the more problematic if diagnoses allow for re-identification due to phenotypical characteristics. Medication information holds little potential risk of re-identification of a person. However, the application of medications could be a source of re-identification, e. g., self-injections of insulin or use of inhalators. Information about times and dates are especially sensitive for the re-identification of a person. Sex and age of a patient generally pose no problems, except in the case of very young or very old individuals when these age groups are seldom represented in the practice. DISCUSSION: Routine health data are, in principle, sensitive data. Knowledge about the variables in primary care data gathered from electronic health records in local practices and the evaluation of this data allow us to more accurately estimate the risk of re-identification for the persons concerned. In particular, chronic diagnoses and/or diagnoses in long text, calendar dates for patient contacts and therapies bear a high risk of re-identification. Technical measures such as removing data, masking values and coding should make re-identification considerably more difficult. There will always be a remaining risk of re-identification which should be openly discussed to counteract concerns about a lack of data protection or a sweeping critique of digitization in healthcare.

Novel bifunctional cap for simultaneous electroencephalography and transcranial electrical stimulation.

Neuromodulation induced by transcranial electric stimulation (TES) exhibited promising potential for clinical practice. However, the underlying mechanisms remain subject of research. The combination of TES and electroencephalography (EEG) offers great potential for investigating these mechanisms and brain function in general, especially when performed simultaneously. In conventional applications, the combination of EEG and TES suffers from limitations on the electrode level (gel for electrode-skin interface) and the usability level (preparation time, reproducibility of positioning). To overcome these limitations, we designed a bifunctional cap for simultaneous TES-EEG applications. We used novel electrode materials, namely textile stimulation electrodes and dry EEG electrodes integrated in a flexible textile cap. We verified the functionality of this cap by analysing the effect of TES on visual evoked potentials (VEPs). In accordance with previous reports using standard TES, the amplitude of the N75 component was significantly decreased post-stimulation, indicating the feasibility of using this novel flexible cap for simultaneous TES and EEG. Further, we found a significant reduction of the P100 component only during TES, indicating a different brain modulation effect during and after TES. In conclusion, the novel bifunctional cap offers a novel tool for simultaneous TES-EEG applications in clinical research, therapy monitoring and closed-loop stimulation.