If it wasn’t for us, there would be no data: stakeholders’ perspectives on patient involvement in the use of health data in Ireland

Legislative reform in Ireland and Europe, including the introduction of a Health Information Bill in Ireland and the European Health Data Space (EHDS) Regulation, promote strong governance of health data, including control over how health data is used for different purposes, such as individual care, research, planning and policy-making. The aim of this study was to explore key stakeholders’ perspectives on the role of patients in enabling inclusive and ethical use of health data for primary and secondary purposes in Ireland. This was a cross-sectional qualitative study with focus group design. Thirty-five participants were evenly distributed across five groups: Academics and Researchers; Data Controllers, Data Protection Officers and Ethics Experts; Patients and Public; Healthcare Professionals and the Industry Group. A semi-structured approach guided by a topic guide was used, and thematic data analysis was conducted. This study identified strong support for increased patient involvement. However, contradictions in participants’ views within and across groups were found particularly around patient control over health data and data ownership and embedding Patient and Public Involvement (PPI) in research. Most of the participants agreed that patient autonomy over health data is of ‘vital’ importance; yet they advocated for staged and delayed patient access. Similarly, the participants believed that PPI was required to drive the direction of research and funding allocation; however, patients’ lack of understanding of research areas was a challenge. Concerns were expressed around informed consent required for sharing of patient data, particularly with the industry, and around the timing of consent when patients are at their most vulnerable. Participants expressed strong support for increased patient involvement in the use of health data in Ireland; however, there were contrasting views in relation to data control and ownership, consent processes and PPI. These findings have implications for policy development in the implementation of the EHDS in Europe, and the establishment of the Health Data Access Body in Ireland. This study emphasises the importance of patient involvement to support successful implementation of new health information systems and data access infrastructure. New legal and regulatory frameworks are being introduced across Europe, including the European Health Data Space Regulation, which will make it easier to use and exchange electronic patient health records for care in the European Union. This regulation also promotes strong control over how health data is managed and used for different purposes, including health research. Data that is used for individual health care is referred to as primary use, and if it is used for other purposes, for example in research, it is referred to as secondary use. This study aims to explore the perspectives of key people on the role of patients in how their health data is used for primary and secondary purposes in Ireland. The study involved focus groups with academics and researchers; data and ethics experts; healthcare professionals; patients and public; and the industry. Focus groups involve meetings with participants with different backgrounds to discuss specific topics to help explore different perspectives. The findings suggested strong support for increased patient involvement in decisions around how their data is used, although views were inconsistent around who should have control over, or who owns health data, and how to incorporate Patient and Public Involvement (PPI) in research. This study emphasises the importance of increased patient involvement to support successful implementation of new health information systems and policies in all European Union (EU) Member States.