Navigating the healthcare provider’s data dilemma: stakeholder perspectives on provider risks and benefits of health data reuse. A qualitative interview study

Background: Reusing health data has far-reaching potential for improving health and healthcare. Current ethical discussions on developing health data platforms (e.g. the German Medical Informatics Initiative, MII) have primarily addressed patient-related benefits and risks. Less is known about the perspectives of healthcare providers. However, the risks they perceive and a resulting reluctance to share data, along with the lack of strategies for managing these risks, could significantly impede research with health data. In this exploratory qualitative study, we investigated the interests and risks relevant to healthcare providers in the secondary use of health data, and strategies to address these risks (pre-registration: https://osf.io/uxds).Methods: Online expert interviews (N=21) were conducted between May and August 2023 with German representatives of different stakeholder groups (e.g. healthcare providers, researchers, patient representatives, data protection officers). Data was analysed using the deductive-inductive approach of qualitative content analysis. Results: Although the interviewees attributed several potentials to the reuse of health data, they also pointed to risks, including their causes and consequences for providers’ reputation, economic and existential situation. Risks included a) biased results and interpretation of data analyses due to inadequate data validity and inappropriate analytical approaches, b) questionable reuse purposes, c) liability risks due to a lack of control over shared data and unresolved legal questions, and d) improved transparency that may reveal challenges and misconduct in healthcare. Suggested strategies for risk mitigation related to use and access decisions on secondary use requests. These include a) developing risk-reducing policies, b) ensuring transparent decision-making processes by involving all relevant stakeholders and applying structured risk-benefit assessments, and c) measures to improve the validity of secondary analyses. In addition, the interviewees identified further need for action to be addressed by providers, researchers and policymakers. Conclusion: These findings point to needs and opportunities for action to manage risks that providers associate with health data reuse. Ensuring fair decision-making processes on secondary use requests and improving reuse quality, safety, and trust are key. These recommendations should be taken up by responsible stakeholders in initiatives such as the MII, among researchers and policymakers to reduce reluctance and promote research with health data.