Are Traditional Registries Becoming Obsolete in the Modern Digital Health Ecosystem?

Clinical Snapshot

Key Findings

• P Value: Not applicable — no statistical testing performed

• Effect Size: Not applicable — no quantitative effect size reported

• Primary Outcome: Conceptual argument that traditional stand-alone registries will become obsolete unless redesigned as dynamic, service-oriented software stacks embedded within interoperable digital health ecosystems

• Nnt Or Sensitivity: Not applicable — viewpoint article; no NNT, sensitivity, specificity, or hazard ratio calculable. Key conceptual propositions include: (1) EHRs will evolve into primary health data hubs; (2) TEFCA and EHDS signal a paradigm shift toward cross-network health information exchange; (3) next-generation registries should leverage FHIR-based common data infrastructure; (4) digital twins and learning health systems represent the logical endpoint of registry evolution

• Confidence Interval: Not applicable — no confidence intervals reported

Clinical Application

The conceptual framework is feasible in principle but implementation is highly context-dependent. Transition to embedded, interoperable registry architectures requires substantial investment in EHR infrastructure, FHIR-compliant data standards, workforce capability, and governance frameworks. Feasibility will vary significantly between large academic health systems and smaller community or rural providers. The authors do not provide implementation guidance, cost estimates, or transition roadmaps. Australia presents a partially receptive environment for the proposed framework. The Australian Digital Health Agency (ADHA) My Health Record system provides a national EHR infrastructure that could theoretically support embedded registry functions. The National Digital Health Strategy 2023–2028 aligns with interoperability goals described by the authors. However, Australia lacks a direct equivalent to TEFCA or EHDS, and My Health Record adoption and data completeness remain variable. The Australian Institute of Health and Welfare (AIHW) maintains numerous national disease registries (e.g., Australian Cancer Database, National Diabetes Services Scheme) that would need significant re-engineering to align with the proposed model. PBS and TGA pharmacovigilance registries represent additional stakeholders. RACGP's position on digital health integration and the pending National Health Information Agreement reforms are relevant policy levers. The authors' framework would benefit from explicit engagement with these Australian-specific structures. Healthcare organisations, clinical researchers, health informaticians, registry administrators, and policymakers involved in the design, maintenance, or utilisation of patient and clinical registries across all disease domains

Abstract

Registries have long been a cornerstone of medical research and public health, providing systematically collected data on diseases, treatments, and health outcomes. However, in the era of digital health, we argue that the traditional model of stand-alone registries needs reconsideration, given the context of increasingly digitized and interoperable health data ecosystems. Unless registries evolve to embrace embedded, standards-based data services, operating across interoperable infrastructure, they will become obsolete while digitalization is reshaping how data can be collected, shared, and used. In this viewpoint, we recount how the present health data ecosystem came to be and what role registries have come to play therein. Following that, we show how recent regulatory initiatives such as the Trusted Exchange Framework and Common Agreement in the United States or the European Health Data Space Regulation signal a shift toward cross-network health information exchange, promoting patient-centric data integration within electronic health record systems. We further illustrate how electronic health records are consequently set to evolve into information hubs, acting as the primary gateway for individuals through which they may access and control their personal health data spread throughout increasingly connected health data ecosystems. This, in turn, might stimulate the creation of digital twins and continuous learning health systems in practice. Following this line of thought, we discuss the opportunities and challenges of interconnected health data ecosystems. Ultimately, we propose that next-generation registries need to be designed as dynamic, service-oriented software stacks for research, leveraging the common data infrastructures that are currently being established around the world. Given the points raised in this viewpoint, we invite health care professionals and researchers alike to equally rethink the role that registries should play within the globally emerging interconnected health data ecosystems and contribute their findings. References included in this viewpoint were identified through searches of PubMed and Google Scholar with various search terms and combinations thereof pertinent to the topics touched on, for example, "patient registry," "clinical registry," "digital twin," "healthcare," "clinical research," "virtual twin," "TEFCA," or "EHDS." Only papers in English were reviewed. The final reference list was generated on the basis of originality and relevance to the broad scope of topics covered in this viewpoint, aiming to present a balanced overview of topic-related findings and arguments.

References

1. 1.Wenk, J., Inojosa, H., Voigt, I., Gilbert, S., & Ziemssen, T. (2026). Are traditional registries becoming obsolete in the modern digital health ecosystem? Journal of Medical Internet Research. https://doi.org/10.2196/92696