Public and patient involvement in health data governance (DATAGov): protocol of a people-centred, mixed-methods study on data use and sharing for rare diseases care and research

Introduction International policy imperatives for the public and patient involvement in the governance of health data coexist with conflicting cross-border policies on data sharing. This can challenge the planning and implementation of participatory data governance in healthcare services locally. Engaging with local stakeholders and understanding how their needs, values and preferences for governing health data can be articulated with policies made at the supranational level is crucial. This paper describes a protocol for a project that aims to coproduce a people-centred model for involving patients and the public in decision-making processes about the use and sharing of health data for rare diseases care and research. Methods and analysis This multidisciplinary project draws on an explanatory sequential mixed-methods study. A hospital-based survey with patients, informal carers, health professionals and technical staff recruited at two reference centres for rare diseases in Portugal will be conducted first. The qualitative study will follow consisting of semi-structured interviews and scenario-based workshops with a subsample of the participant groups recruited at baseline. Quantitative data will be analysed using descriptive and inferential statistics. Inductive and deductive approaches will be combined to analyse the qualitative interviews. Data from scenario-based workshops will be iteratively compared using the constant comparison method to identify cross-cutting themes and categories. Ethics and dissemination The Ethics Committee for Health from the University Hospital Centre Sao Joao/Faculty of Medicine of University of Porto approved the study protocol (Ref. 99/19). Research findings will be disseminated at academic conferences and science promotion events, and through public meetings involving patient representatives, practitioners, policy-makers and students, a project website and peer-reviewed journal publications.

Automated summary

International policies require public and patient involvement in health data governance, but conflicting cross-border policies on data sharing can pose challenges. This project aims to develop a people-centered model for patient and public involvement in decision-making processes regarding health data for rare diseases. The study will involve a hospital-based survey, qualitative interviews, and scenario-based workshops to understand stakeholder needs and preferences for governing health data.