Declaration on the collection of data
The “Screentime” app, henceforth called “App” is used to collect data that provide information on the duration of use of display devices from patients in the context of a scientific research study, named “Screentime”. The research study is a collaboration between the following institutions:
The University of North Carolina at Chapel Hill (coordinator)
Hahn Schickard
The collection and processing of the data obtained by the App is performed fully pseudonymous and encrypted by Hahn-Schickard. The pseudonymous data is sent encrypted by the App to a secured Bexome gateway. From the gateway, another encrypted connection is used to transfer data to the research organisations participating in the study (see research study partner list). The pseudonymised data will be stored for at least 10 years by the project coordinators and the study participant managers.
Pseudomisation is performed using an participant identification number (PID) without specifying the name of the study participants. Pseudonymous means that the data cannot be used to identify a participant, without an additional coding list that links PIDs to the participant names. Coding lists exist that link the respective name to the PID. The coding lists are only accessible to the study managers of the respective institutions, i.e. only the study managers can assign the collected data to the respective participant name. All other collaborating institutions do not have access to coding lists. Coding lists will be destroyed after completion of the study. As long as a coding list exist, the respective patients can request deletion of all collected data. However, once the coding list is deleted, participant data can no longer be identified. The data is then anonymised. Therefore, requests for data deletion can be implemented as long as the coding list exist.
Data access is secured and personalised. Only designated study managers of the partner institution, who serves as study participant manager, as well as study researchers of each collaborating institution are granted access to the pseudonymous patient data.
The research study had been assessed and approved by a Medical-Ethical Committee according to the rules of good scientific practice. Study participants will fully informed about the data collection, transfer, and storage. Each study participant must sign the study-related consent form before participating.
Types of data collected
The devices connected via Bluetooth LE record and transmit information about the composition of the light in the subject’s field of vision, their head movement and the distance to the nearest object to infer the duration of use of screen devices.
To realize the Bluetooth connection to the recording devices, the app also needs access to the location of the smartphone.
The app only uses the smartphone camera to scan a QR code, which contains the proband ID, the MAC addresses of the recording devices that can be connected via Bluetooth LE and the access data for the cloud server.
Privacy and confidentiality
All data collected in studies with the Screentime app are published fully anonymised and kept confidential in accordance with the European Union (EU) General Data Protection Regulation (GDPR). Subsequent use of data is subject to standard data use policies that protect the complete anonymity of participating individuals. In all cases, the use of data is subject to the General Data Protection Regulation. Employees of the research institutes who are not involved in the studies do not have access to the raw data or protocols. This precaution is intended to prevent any negative impact from individual comments made by study participants. As with any publication or online activity, the risk of a breach of confidentiality always exists. In accordance with the GDPR, researchers will inform participants if a data confidentiality breach has been identified.
Responsible for the research study
- Prof. Dr. Oliver Amft and Dr. Mario Cypko
- Hahn-Schickard-Gesellschaft für angewandte Forschung e.V.
– IES Lab Freiburg
- Georges-Köhler-Allee 302
- 79110 Freiburg im Breisgau
- [email protected]
- [email protected]
- Hahn-Schickard-Gesellschaft für angewandte Forschung e.V.
Data Protection Officer of Hahn-Schickard
- Ralf Heimburger
- Datenschutz Südwest
- Achauerstraße 8
- 78647 Trossingen
- Phone number: +49 07425 9400050
- [email protected]