Setting up a Governance Framework for Secondary Use of Routine Health Data in Nursing Homes: Development Study Using Qualitative Interviews

Background: In the nursing home sector, reusing routinely recorded EHR data for knowledge development and quality improvement is in its infancy. A data governance framework (who may access the data, under what conditions, and for what purposes) can help obtaining trust in appropriate and responsible data reuse. Little guidance is available on development and implementation of data governance frameworks in practice.

Objective: To describe the development process of a governance framework for the  "Registry Learning from Data in Nursing Homes" – a Dutch national registry for EHR data on care delivered by nursing home physicians.

Methods: Interviews were conducted with stakeholders representing practices, policies, and research in the nursing home sector. Main aim was to explore perspectives regarding the Registry's aim, data access criteria, and governing bodies' tasks and composition. Interview topics and analyses were guided by 8 health data governance principles. Interview results, together with legal advice and consensus discussions were used to shape the rules, regulations, and governing bodies of the framework.

Results: Stakeholders saw the involvement of nursing home residents, nursing home physicians, boards of directors, and scientists as a prerequisite for a trustworthy data governance framework. For the Registry, their involvement can be achieved through a consent procedure, transparency, and a position in a governing body. In addition, a data request approval procedure indicates that data reuse by third parties aligns with the aims of the Registry, benefits the nursing home sector, and protects the privacy of data subjects.

Conclusions: Stakeholders' views, expertise, and knowledge of other frameworks and relevant legislation serve to inform the application of governance principles to the contexts of both the nursing home sector and the Netherlands. Engagement of the full range of stakeholders in an early stage of governance framework development is important to generate trust in appropriate and responsible data reuse.