Advancing Personal Health Data Spaces: Governance, Interoperability, and Real-World Evidence for Learning Healthcare Systems
Abstract
Background
Healthcare systems increasingly generate large volumes of clinical, imaging, genomic, wearable and real-world healthcare data. However, fragmentation across healthcare infrastructures continues to limit interoperability, integrated evidence generation and coordinated patient management.
Objective
This commentary examines how Personal Health Data Spaces (PHDS) may support interoperable, patient-centred, and evidence-informed healthcare through the integration of governance, real-world evidence (RWE), artificial intelligence (AI) and health data infrastructures. APPROACH: Drawing on regulatory science, digital health policy, interoperability frameworks and RWE practice, this commentary proposes a conceptual framework for PHDS that distinguishes them from existing health data initiatives and presents an implementation-oriented roadmap for their adoption within learning healthcare systems.
Discussion
Personal Health Data Spaces may support continuity of care, multimodal evidence generation, regulatory science, AI-enabled analytics and personalised medicine across increasingly interconnected healthcare environments. However, their successful implementation depends on interoperable infrastructures, harmonised governance, methodological transparency, cybersecurity, workforce capability and meaningful multi-stakeholder collaboration to avoid reinforcing existing healthcare inequities and operational fragmentation.
Conclusion
Personal Health Data Spaces represent a patient-centred operational framework for integrating healthcare data across clinical care, research, and regulatory decision-making, supporting the transition towards interoperable and continuously learning healthcare systems. Their long-term success will depend not only on technological capability, but also on trustworthy governance, scalable implementation strategies, and sustained public trust.