Accepted for/Published in: JMIR Formative Research
Date Submitted: Oct 30, 2025
Open Peer Review Period: Oct 30, 2025 - Dec 25, 2025
Date Accepted: Feb 2, 2026
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
From “black box” to learning system: a formative viewpoint on digital health governance for childhood cancer information in Japan
ABSTRACT
Background:
Background:
Japan has universal coverage and designated pediatric oncology centers, yet the childhood cancer information ecosystem remains a “black box.” Incidence is measurable, but treatment exposure and long-term follow-up are not reliably linked across hospitals, registries, and survivorship services. WHO’s CureAll framework highlights information governance as a lever for equity.
Objective:
Objective:
To propose a formative design for national digital governance connecting registries, clinical systems, and survivorship in Japan.
Methods:
Methods:
We synthesized international guidance and Japanese statutes, plans, and registry reports. Drawing on operational experience, we specified a minimal pediatric dataset, an HL7 FHIR–based interoperability architecture, and governance to align standards, consent, and data use. No new empirical data were collected.
Results:
Results:
We outline a four-layer architecture. Source systems (electronic health records, laboratory and radiology systems, pathology, and cooperative-group databases) feed an HL7 FHIR gateway. A national Pediatric Data Steward governs standards/interoperability (FHIR profiles/APIs), terminology/coding (ICD-O/ICCC with mappings to SNOMED CT/LOINC), privacy/consent, data-use agreements, data quality, and audit. Outputs flow to the National and Hospital-based Cancer Registries and a patient-facing digital survivorship passport, with bidirectional clinic updates and linkage to the resident registry and vital statistics. Security, audit, and public reporting span all layers. We define pediatric indicators and a staged roadmap.
Conclusions:
Conclusions:
Transforming Japan’s pediatric oncology information into a learning system is chiefly a governance task. A Pediatric Data Steward, a harmonized pediatric data dictionary via FHIR, and a portable survivorship passport with layered consent can improve timeliness, completeness, follow-up, and transparency.
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.