Medical data accumulated in the course of care (real-world data) is a valuable resource for research and quality improvement. One framework supporting this "secondary use" is said to be the Next-Generation Medical Infrastructure Act.
This article organizes what secondary use is, its balance with privacy protection, the thinking behind the Next-Gen Act, and what hospitals can prepare day-to-day, so administrators and IT staff can grasp the overview.
How to make use of dormant data
Hospitals accumulate vast clinical data daily, yet much of it is merely stored as care records and not sufficiently used for research or analysis. Making use of it could lead to quality improvement and new insights.
At the same time, providing data containing patients' personal information to external research requires protecting individuals and proper procedures. Balancing the hope for use with the demand for protection is the central issue of secondary use.
What is secondary use?
Secondary use refers to applying data collected for care to research or analysis apart from its original purpose. Gathering large volumes of real clinical data is expected to help verify treatment effectiveness and improve care quality.
Because it handles patients' personal information, processing that prevents identification and appropriate consent or procedures are indispensable. Through anonymization or pseudonymization, mechanisms are arranged to balance utility and protection.
The role and points of the Next-Gen Act
The Next-Gen Act is described as a law establishing a framework for the safe secondary use of medical data. To grasp the overall picture, the following points are worth noting — hold them on the premise that details may be revised.
- A framework where certified operators aggregate and process data
- Providing data for research after processing so individuals are not identifiable
- Rules on how notification to and consent from patients are handled
- Arrangements on scope of use and security at the recipient
A practical checklist hospitals can prepare
In preparing for secondary use, keeping data organized day-to-day forms the base. Looking to future research collaboration, confirming and arranging the following across IT and related departments is advisable.
- Whether clinical data is accumulated in standard form
- Internal rules on patient explanation and consent handling
- Status of personal-data management and access controls
- Clarifying procedures and contacts for external provision
Common misconceptions and how to avoid them
Beware the misconception that "anonymizing lets you use data freely." Processing methods and provision procedures have defined rules, and deviating from them can raise privacy-protection concerns. Avoid hasty judgments.
Also avoid assuming "the law exists, so the hospital need do nothing." Future use and coordination go smoothly only with day-to-day data preparation and internal rules. The earlier the preparation, the better.
Confirm the framework with primary sources
The requirements, operation, and treatment of anonymized/pseudonymized processing under the Next-Gen Act may be revised. This article aims at a conceptual overview; always confirm specific requirements and the latest details with primary sources such as the MHLW and Cabinet Office.
Also, when using generative AI in-house to analyze or organize data, confirm whether patient data may be transmitted externally or used for training, and define a scope of use per internal rules to prevent leakage.
Data use and the foundation going forward
In preparing for secondary use, keeping data organized in standard form forms the base. A standards-compliant cloud base like the Sakigake Platform makes it easier to prepare for future research collaboration and data use.
The key is to see protection and use as compatible rather than opposed. Advancing use atop a proper management structure leads to contributing to medical progress while keeping patients' trust.
What to arrange day-to-day for secondary use
Opportunities for secondary use can arrive suddenly; to avoid scrambling, arranging data and procedures day-to-day helps. Accumulating clinical data in standard form and reducing missing items and inconsistent notation makes it easier to begin processing and provision when a research or analysis request comes.
Also, deciding in-house on patient explanation and consent handling, and the contact and decision flow for external provision, lets you judge feasibility quickly. Share the following across departments and advance preparation. Since rules may be revised, always confirm requirements with primary sources.
- Accumulate clinical data in standard form and check quality periodically
- Organize operational rules for patient explanation and consent
- Clarify the contact and decision flow for external provision
- Review personal-data management and access rights, keeping records
Summary
Secondary use of medical data contributes to progress but presumes balancing privacy protection. Understand the Next-Gen Act's framework, confirm requirements with primary sources, and keep data organized in standard form with internal rules prepared day-to-day.
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