SummaryThis article is part of the Focus Theme of Methods of Information in Medicine on the German Medical Informatics Initiative. The Medical Informatics Initiative (MII) was launched within the scope of the German Federal Ministry of Education and Research’s (BMBF) Medical Informatics Funding Scheme, with the goal of developing infrastructure for the integration of clinical data from patient care and medical research in Germany. Its work is to be performed over the course of a decade (2016–2025) across three funding phases, with the first two concentrating on university hospitals. During the conceptual phase (now concluded), a central supporting project ensured coordination – and laid the ground for standardised solutions for all the initiative’s sites and scientific consortia that will enable effective data use and exchange, both for health care as well as research. The conceptual phase focused on the following: a) interoperability, through the consistent use of international standards (from an early stage, i.e. primary IT systems in patient care); b) standardised templates for patient consent and harmonised data protection; and c) standard rules for data use and access (monitoring and safeguarding access to data). On this basis, the initiative aims in the long term to improve medical research (particularly health care research, using data from treatments), to accelerate the transfer of knowledge from research to patient care – and to provide important impetus for the digitalization of medicine in Germany.

Making routine clinical-care-data available for medical research requires adequate consent to legitimize use and exchange. While, public interest in supporting medical research is increasing, individuals often find it difficult to actively enable researchers to access their data. In addition to broad consent, the idea of (consent-free) data donation has been brought into play as another way to legitimize secondary research use of medial data. However, flanking the implementation of broad consent policies or data donation, the attitude of patients, and the general public toward different aspects of these approaches needs to be assessed. We conducted two empirical studies to this end among Dutch patients (n = 7430) and representative German citizens (n = 1006). Wide acceptance of broad consent was observed among Dutch patients (92.3%), corroborating previous findings among German patients (93.0%). Moreover, 28.8% of the Dutch patients generally approved secondary data-use for non-academic research, 42.3% would make their decision dependent upon the type of institution in question. In the German survey addressing the general population, 78.8% approved data donation without explicit consent as an alternative model of legitimization, the majority of those who approved (96.7%) would allow donated data to be used by universities and public research institutions. This willingness to support contrasted sharply with the fact that only 16.6% would allow access to the data by industry. Our findings thus not only add empirical evidence to the debate about broad consent and data donation, but also suggest that widespread public discussion and education about the role of industry in medical research is necessary in that context.

The complexity and size of the trial master file requires new solutions. Though ODM provides effective means to archive the study database, it shows still deficiencies, especially for the joint archiving of data and the complex documentation of the trial master file. A concept was developed in which the ODM standard is part of an integrated archiving of the trial data and documents. ODM archiving of the study database enables long-term storage which is GCP-compliant. Archiving of documents of the trial master file in PDF/A, including links and electronic signatures, as well as the storage of selected study data in a data warehouse at the sponsor site in SDTM are the other components of the concept.

COVID-19 has challenged the healthcare systems worldwide. To quickly identify successful diagnostic and therapeutic approaches large data sharing approaches are inevitable. Though organizational clinical data are abundant, many of them are available only in isolated silos and largely inaccessible to external researchers. To overcome and tackle this challenge the university medicine network (comprising all 36 German university hospitals) has been founded in April 2020 to coordinate COVID-19 action plans, diagnostic and therapeutic strategies and collaborative research activities. 13 projects were initiated from which the CODEX project, aiming at the development of a Germany-wide Covid-19 Data Exchange Platform, is presented in this publication. We illustrate the conceptual design, the stepwise development and deployment, first results and the current status.

Zusammenfassung Hintergrund Die Notfallversorgung befindet sich im Umbruch. In Notaufnahmen werden Patienten ausgehend von Symptomen und Dringlichkeit versorgt; dies bildet sich jedoch in den etablierten Routinedaten der gesetzlichen Sozialversicherung nicht ab. Ziel des AKTIN-Projekts war der Aufbau einer datenschutzkonformen Registerinfrastruktur zur Nutzung von klinischen Routinedaten aus Notaufnahmen. Methoden Über eine standardisierte Schnittstelle werden aus den verschiedenen Dokumentationssystemen kontinuierlich Daten der Notaufnahmebehandlung in ein lokales Data Warehouse exportiert. Dort stehen sie sowohl für lokale Nutzungen, wie interne Berichte und Qualitätsmanagement, als auch gleichzeitig datenschutzkonform für multizentrische Auswertungen zur Verfügung. Anhand der Registerpopulation wird die Ersteinschätzung sowie die Erhebung von Vitalparametern in Abhängigkeit von Vorstellungsgründen für einen 12-Monats-Zeitraum analysiert. Ergebnisse Für den Zeitraum 04/2018 bis 03/2019 wurden 436.149 gültige Fälle aus 15 Notaufnahmen übermittelt. In 86,0 % der Fälle ist eine Ersteinschätzung dokumentiert. Diese fand in 70,5 % innerhalb von 10 min nach Ankunft des Patienten statt. In 10 Kliniken wird regelhaft (82,3 %) ein Vorstellungsgrund erfasst. Die Erfassung von Vitalparametern variiert plausibel zwischen den Vorstellungsgründen. Schlussfolgerung Das AKTIN-Notaufnahmeregister bietet einen zeitnahen Einblick in das Versorgungsgeschehen der Notaufnahmen ohne zusätzlichen Dokumentationsaufwand und unabhängig vom primären IT-System, Kostenträger, Fallart und Abrechnungsmodus. Die Vorgaben des Gemeinsamen Bundesausschusses zur Ersteinschätzung werden weitgehend umgesetzt. Durch die Etablierung von standardisierten Vorstellungsgründen werden symptombasierte Analysen und Gesundheitssurveillance ermöglicht.