Why Medical Data Sharing Is Stagnating in Japan — Why Patient-Centric Data Governance Must Come Before EHR Standardization
Background: Japan’s Current Push for EHR Standardization
In February 2026, the Japanese government released draft standard specifications for Electronic Health Records (EHRs) and medical billing systems, targeting clinics and small-to-medium hospitals, and opened them for public consultation.
This initiative is part of Japan’s broader “Medical DX” (digital transformation) agenda, which aims to modernize healthcare IT systems, promote data sharing, and improve efficiency across the healthcare sector.
At first glance, this approach appears reasonable. However, Japan’s experience over the past decade shows that technical standardization alone does not lead to meaningful medical data sharing.
The Core Argument
To enable effective medical data sharing, EHR standardization should not be the starting point.
What Japan needs first is:
-
A clear definition of patients’ rights and responsibilities
-
A patient-centric data governance framework
-
A legal obligation for healthcare providers to submit standardized data
-
Only then, EHR standardization
Japan is currently attempting to start from step 4 — and that is the fundamental reason why progress has been slow.
The Recommended Order for Medical Data Sharing
From a governance perspective, the logical sequence should be:
-
Establish patients’ rights and responsibilities regarding their medical data
-
Design patient-centric data governance (who controls access, under what conditions, and with what transparency)
-
Mandate data provision by healthcare institutions
-
Standardize EHR systems
Japan’s current policy emphasis reverses this order, prioritizing system standardization before governance and legal enforcement.
Why API Connectivity and FHIR Compliance Are Not Enough
The draft specifications strongly emphasize:
-
Standard APIs
-
FHIR-based interfaces
-
Cloud compatibility
-
Interoperability with national services (e-prescriptions, insurance eligibility checks, shared EHR platforms)
As a result, EHR systems that comply with these specifications can technically connect to national data-sharing services.
However, technical connectivity does not guarantee that data will actually be shared.
At this stage, Japan’s standards focus primarily on:
-
API connectivity
-
Data migration compatibility
-
Infrastructure modernization
They do not enforce full semantic interoperability — meaning that differences in data meaning and structure across vendors remain largely unaddressed.
The Structural Failure of “Voluntary Participation”
Japan’s approach relies heavily on:
-
Voluntary participation
-
Financial incentives
-
“Best effort” data provision
This model has repeatedly failed.
A clear example is Japan’s electronic prescription system, where adoption remained low for years despite financial incentives. The same pattern risks repeating itself:
Low participation → insufficient shared data → low usefulness → declining incentives to participate
Without mandatory data provision, medical data sharing is unlikely to reach critical mass.
Why Mandatory Data Submission Solves Interoperability
A crucial but often overlooked point is this:
Mandatory data provision is the most effective way to achieve semantic interoperability.
If healthcare providers are legally required to submit data in government-defined standardized formats (e.g., FHIR profiles specified by the Ministry of Health), then:
-
Vendors may retain internal proprietary data models
-
But output data must conform strictly to legal standards
This effectively neutralizes vendor-specific differences.
As long as the exported data is standardized, semantic interoperability emerges automatically, regardless of how internal systems are designed.
This is the same logic used in:
-
Electronic tax filing
-
Digital financial reporting
Different accounting software systems vary widely internally, yet interoperability is achieved because submission formats are legally enforced.
The Role of Patients in Data Governance
Mandatory data provision cannot function without patient-centric data governance.
In healthcare, data governance means a structured framework governing:
-
Data collection
-
Data use
-
Data protection
-
Accountability and transparency
At its core, this framework must clearly define patients’ rights and responsibilities.
Patients’ Rights
-
Right to access their own medical data
-
Right to see who accessed their data and when
-
Right to control or restrict data sharing in specific cases
These rights increase transparency and trust, reducing resistance to data sharing.
Patients’ Responsibilities
-
Cooperation with data sharing as a default
-
Ensuring accuracy of personal health information
This does not require absolute coercion.
A default sharing model with opt-out rights strikes a realistic balance between public benefit and individual autonomy.
Learning from Estonia
This governance model is not theoretical. It has been implemented successfully in Estonia.
Key features include:
-
Government-guaranteed data integrity (authoritative records)
-
Full transparency of access logs
-
Patients can see who accessed their data, when, and for what purpose
-
Fine-grained controls (e.g., restricting mental health records while allowing general access)
-
A special emergency data module that cannot be blocked in life-threatening situations
According to public reporting, fewer than 0.2% of the population exercises full opt-out rights, indicating high trust in the system.
The lesson is clear:
Strong obligations and strong trust mechanisms reinforce each other.
What This Means for Japan
Japan can avoid a prolonged period of partial, ineffective data sharing by:
-
Adopting default data sharing with opt-out
-
Making access logs fully visible to patients
-
Legally mandating standardized data submission
-
Strengthening patients’ rights alongside responsibilities
Continuing with standardization first and voluntary participation will almost certainly fail to meet Japan’s 2030 goals for nationwide medical data sharing.
However, with targeted legal reforms and reimbursement-linked enforcement, a functional, patient-centric data-sharing ecosystem is achievable.
Final Note
Japan’s challenge is not a lack of technology.
It is a governance sequencing problem.
Once governance is designed correctly, technology standardization will finally deliver the results policymakers expect.
