Einstellungen von Herzinsuffizienzpatient*innen gegenüber Datenerhebung mit digitalen, mobilen Messgeräten im Rahmen von gesundheitlicher Selbstdokumentation vor dem Hintergrund datenbasierter medizinischer Forschung – eine empirisch-ethische Studie

Background: In recent years, there has been an increased growth in usage of digital measuring devices, also known as “wearables”, for tracking and documenting personal health information. In the context of the tremendous increase in “Big Data”-associated medical research, the data collected by those wearables become increasingly valuable for medical research. This applies specifically to cardiovascular diseases, such as chronic heart failure. From an ethical point of view, very few studies have yet evaluated the patient’s perspective on wearables used for self-documentation in the context of medical research. Methods: A cross-sectional survey of chronic heart failure patients was conducted at a German university medical center (N=105) in 2020 (March to July). At the core of this study, through a carefully developed literature search, was the patient’s perspective on collecting and sharing personal digital health data, integrating medical-ethical aspects throughout the survey. Eligibility criteria for participation included: 1. German-speaking adults, 2. confirmed chronic heart failure, and 3. treatment at the German medical center. A corresponding questionnaire was sent to the patients by mail. Results: Most participants reported a positive response on self-documentation and digital measuring devices. Almost two thirds of participants had usage experiences with digital measuring devices. The digital recording devices were largely positively perceived as a tool for documenting the personal health status but also as a data source for their treating physicians to better understand their patients’ individual health conditions. In general, more than 90% of the participants felt highly comfortable with sharing their personal health data with their physicians and government-sponsored research organizations, albeit only under certain conditions. Some participants raised their concerns for implementing stricter regulations on data control and information sharing regarding scientific research projects that are based on their personal health data. Discussion and conclusion: The mainly positive perception of patients with chronic heart failure using digital devices for recording and documenting their personal health data offers a solid foundation for advancing this technology more broadly into the clinical arena both for patient care but also for scientific purposes. It has to be noted, however, that an honest and transparent communication between the treating physician and the patients is key to building the trust it requires to share delicate health information gathered by the digital measuring devices among all stake holders. Patients’ needs regarding research information and data control runs at the forefront of this endeavour and needs to be met to make them equal advocates for their own health when using digital devices and sharing digital device data with the medical research community. This work therefore hopes to set the stage for understanding the medical-ethical aspects when patients are starting to share their digital health data with medical researchers.