JMIR Publications

ABSTRACT

Background:

The German Health Data Utilization Act and the Digital Act aim to enhance health data sharing for healthcare and research in Germany and beyond, while ensuring robust data protection. A key prerequisite is patients’ willingness to share their data for primary use (PU), eg for medical care and secondary use (SU), eg for research. There is a lack of qualitative research to determine patients’ perspectives regarding data sharing under the new legal framework, especially in vulnerable groups like those with mental health diseases.

Objective:

This study qualitatively examines the factors influencing German patients’ willingness to share their digital health data for PU and SU, exploring similarities and differences between patients with somatic and mental health diseases.

Methods:

In 2024, two focus groups (FGs) were conducted with 13 outpatients: seven with somatic (FG1) and six with mental health diseases (FG2). Participants were recruited from the University Hospital in Dresden, Germany, based on predefined inclusion criteria. The FG discussions followed a topic guide with open-ended questions based on an overview of reviews and pretests. Data were qualitatively analyzed by two researchers independently according to Kuckartz’ approach. The findings are reported according to the COREQ checklist.

Results:

Ten main categories with 32 subcategories were identified as influencing factors: previous experience with data sharing, individual usefulness for medical care, public benefit, personal and privacy concerns, data security concerns, consent management preferences, technical safety measures, legal and ethical framework conditions and requirements, informational self-determination and social involvement and influence. Both FGs highlighted individual usefulness and public benefits despite various personal experiences. Fears of discrimination and stigmatization and data security concerns about automatic data sharing were more relevant in FG2. Technical safety measures of anonymization and pseudonymization were discussed in detail in FG1, while FG2 debated data protection intensively. There were concerns that data protection in Germany could potentially pose a greater health risk than the sharing of personal health data. The category consent management preferences yielded the most statements, but no clear consensus emerged. Social influence and involvement, including family, peers, and healthcare professionals, were more relevant in FG2. Both FGs explicitly opposed the use of health data by companies like Google.

Conclusions:

Our study qualitatively compared the perspectives of patients with somatic and mental health diseases. While it revealed similarities, patients with mental health diseases viewed their data as highly sensitive due to experiences of stigmatization and fear of misuse, emphasizing the need for tailored consent management. Involving family, peers, and healthcare professionals can increase acceptance. Healthcare professionals and targeted outreach can ensure transparency, raising awareness about data sharing policies to build trust, especially when commercial interests are involved. Knowledge deficits, even among tech-savvy patients, indicated the need for broad and understandable public relations efforts.