Online access to clinical notes for outpatients - OpenNOTES study

About Open Notes

The term "Open Notes" has become internationally accepted for sharing clinical notes with patients. It originates from a US research initiative called "OpenNotes" at Harvard University (Boston, USA). The aim of shared clinical notes is to provide patients with digital access to personal health information and their individual, case-related medical documentation. In many other countries, patients can already access Open Notes via digital patient portals. This is not yet common practice in Germany. However, patients in Germany also have a right to access medical records (informational self-determination), which is enshrined in the Patients' Rights Act (§§ 630 A BGB FF). According to German law, access can only be denied if there is a risk of significant damage to health (e.g. self-harm).

About the OpenNOTES study

OpenNOTES stands for: "Online access to clinical treatment notes for outpatients". The project is being conducted by the Brandenburg Medical School (MHB) in collaboration with the University of Cologne and the Brandenburg University of Applied Sciences (THB) (study duration 03/2025 - 02/2028). The study is funded by the Innovation Fund (Gemeinsamer Bundesausschuss).

The aim of the OpenNotes study is to investigate the impact of digital patient access to outpatient clinical notes on patient empowerment. The influence of Open Notes on patient-relevant outcomes such as self-efficacy and patient satisfaction will be examined. Furthermore, it will be investigated whether and how Open Notes can be established in standard health care. The project is divided into various modules:

Following a mixed methods approach, qualitative and quantitative methods are combined during data collection at the participating clinics.

The OpenNOTES study follows a participatory approach based on Patient and Public Involvement (PPI) and current recommendations of participatory health research. Patients and patient representatives from the study sites are involved in the study design and key project decisions from the outset through participatory workshops and a participatory committee.

To date, none of the studies conducted in Germany on Open Notes have provided evidence of effectiveness for an evidence-based decision on the regular introduction of Open Notes in Germany. It is also unclear which factors influence the adoption of Open Notes and how its integration into the national telematics infrastructure could be specifically designed. The OpenNOTES study provides for the first time a solid evidence base as well as recommendations for action and implementation in order to implement Open Notes on a broad scale in Germany.

The study has been registered with the German Clinical Trials Register (DRKS). Further details regarding the study design can be found on the DRKS homepage.

Study Centers

The OpenNOTES study is expected to be conducted at the following university outpatient clinics of the Immanuel Hospital Rüdersdorf and Berlin (IKR):

Name Institution Field of Expertise Contact
Prof. Dr. Martin Heinze Immanuel Hospital Rüdersdorf Psychiatry martin.heinze@immanuelalbertinen.de
Prof. Dr. Jens Schmidt Immanuel Hospital Rüdersdorf Neurology jens.schmidt@immanuelalbertinen.de
Prof. Dr. Andreas Michalsen Immanuel Hospital Berlin Naturopathy andreas.michalsen@immanuelalbertinen.de
Prof. Dr. Kerstin Stahlhut Polyclinic Rüdersdorf General medicine N.N.

Team and contact

Name Institution Responsibility Contact
Dr. Julian Schwarz Brandenburg Medical School Consortium leadership, project leadership julian.schwarz@mhb-fontane.de
Eva Meier-Diedrich Brandenburg Medical School Research assistant eva.meier-diedrich@mhb-fontane.de
Pelin Özkara Brandenburg Medical School Research assistant (Modul D) N.N.
Justin Speck Brandenburg Medical School Research assistant; Technical implementation justin.speck@mhb-fontane.de
PD Dr. Ute Karbach University of Cologne Management Modul A and C ute.karbach@uk-koeln.de
Dr. Ibrahim Demirer University of Cologne Responsible for quantitative methodology ibrahim.demirer@uk-koeln.de
Florian Wurster University of Cologne Research assistant florian.wurster1@uk-koeln.de
Prof. Dr. Anne-Maria Purohit Brandenburg University of Applied Sciences Management Modul D and E purohit@th-brandenburg.de
Gefördert durch: Gemeinsamer Bundesausschuss

Legal Notice

Dr. Julian Schwarz
Department of Psychiatry and Psychotherapy
Center for Mental Health
Immanuel Hospital Rüdersdorf
University Hospital of the Brandenburg Medical School
Seebad 82/83, 15562 Rüdersdorf
GERMANY

Phone: 033638 83-561
Mail: julian.schwarz@mhb-fontane.de