Making healthcare provider interests explicit in Use & Access decision-making on the secondary use of health data: a concep-tual framework with illustrative use cases

Secondary use of health data usually depends on governance systems that seek to enable socially valu-able research while protecting legitimate stakeholder interests. Existing policies and frameworks for Use & Access decisions in secondary use of health data mainly focus on the criteria of scientific quality, legal and data protection compliance, and the interests of patients and the public. Much less explicit attention has been given to the interests of healthcare providers, even though they generate data, are often represented in Use & Access Committees, and may be reluctant to share data when they anticipate risks. Against this backdrop, we have developed a simple conceptual framework for managed-access settings that distinguishes three steps: a Threshold Criteria Review, a Stakeholder Interest (Risk-Benefit) Assessment, and a selection of Management Strategies. Within this framework, Healthcare Provider (Data Holder) Interests are explicitly specified as Economic / Liability Risks and Academic Competition. It also organises management strategies for these risks as Upstream Risk Reduction, In-Process Risk Balancing, and Downstream Risk Mitigation. Five hypothetical yet realistic use cases have been developed as supplementary materials to test the framework’s plausibility and to illustrate different constellations of healthcare provider interests, privacy concerns, and public value. The framework does not replace existing governance criteria. Rather, it adds an explicit and structured approach to addressing provider interests that are already influential in practice but often remain implicit. In this way, it can support more transparent, consistent, and proportionate Use & Access decisions in secondary use of health data.