Milliman Becomes Second Private Company in Japan to Earn Certified Pseudonymized Medical Information User Status
核心洞察
Milliman, Inc. (搜索) has obtained Type II certification as a "Certified Pseudonymized Medical Information User" in Japan, becoming only the second private company to achieve this designation.
The certification, granted under Japan's Next Generation Medical Infrastructure Act amended in April 2024, enables secure utilization of pseudonymized medical information including rare disease data.
This capability will enhance the quality of health economics and outcomes research, including safety, efficacy, and cost-effectiveness studies for pharmaceuticals and medical devices.
Milliman, Inc. (搜索), a leading global actuarial consulting firm, announced on August 10, 2026, that it has obtained Type II certification as a "Certified Pseudonymized Medical Information User" in Japan, becoming only the second private company in the country to achieve this regulatory milestone.
The certification is granted under Japan's "Act on Anonymized and Pseudonymized Medical Information for Research and Development in the Medical Field," also known as the Next Generation Medical Infrastructure Act, which was amended and enacted in April 2024. This legislative framework governs the secure handling and utilization of medical data for research purposes.
Enhanced Data Access for Rare Disease Research
The Type II certification enables Milliman to safely utilize pseudonymized medical information within a secure environment. Critically, this includes access to data containing unique test values or rare disease names that would otherwise necessitate processing or deletion when using only anonymized medical information. This distinction is particularly significant for epidemiological studies focused on rare diseases, where data granularity is essential for meaningful analysis.
Milliman consultants bring extensive experience in analyses utilizing data from Japan's National Database and the Long-Term Care Database. The firm has also previously worked with "Anonymized Processed Medical Information" within the certified operator database under the Next Generation Medical Infrastructure Act. The addition of "Pseudonymized Processed Medical Information" access represents a substantial expansion of the firm's analytical capabilities.
Advancing Health Economics and Outcomes Research
By leveraging pseudonymized data, Milliman aims to enhance the quality of research on the safety, efficacy, and cost-effectiveness of pharmaceuticals and medical devices. The firm also plans to strengthen cross-sectional and longitudinal epidemiological studies on various diseases, with particular emphasis on rare diseases where comprehensive data access is often a limiting factor.
Kosuke Iwasaki, Leader of Milliman's Healthcare Practice in Tokyo, emphasized the strategic importance of the certification: "With the acquisition of Type II certification as a certified pseudonymized medical information user, we have established a framework to utilize real-world data in a safer and more advanced manner."
Supporting Evidence-Based Healthcare Decision-Making
Iwasaki further outlined the practical applications of this expanded data access, noting that the firm will provide solutions "directly applicable to practice—such as visualizing disease burden, evaluating the value of early diagnosis and treatment, analyzing healthcare cost optimization, and designing outcome-based policies—while ensuring security and governance."
The certification positions Milliman to support a diverse range of stakeholders, including pharmaceutical and medical device companies, insurers, local governments, and research institutions. As discussions advance on linking and utilizing data from public databases and the insurance and medical fields, the firm intends to integrate data science with actuarial methods to achieve more precise predictive analysis and value assessment.
Through these contributions, Milliman stated it will strive to further advance healthcare in Japan and extend healthy life expectancy, working toward the construction of a sustainable healthcare system under strict management of pseudonymized medical information.