Data Governance Arrangements for Real-world Evidence in Japan

Article by: Marina Rodes Sanchez, Adrian Towse

A new OHE Consulting Report describes the current status of real-world data in Japan, including core legislation and governance arrangements. The authors sought to understand how real-world data is accessed or generated and used to produce or generate real-world evidence, and to see whether use is aligned with international standards.

A 2015 OHE Consulting Report explored data governance arrangements for real-world evidence (RWE) in eight countries: Australia, France, Germany, Italy, Sweden, the Netherlands, the UK, and the US. The objective was to understand and develop a view on the core principles that should govern how real-world data (RWD) is accessed or generated and used credibly to produce or generate RWE, working toward a set of ‘international standards’. In 2017, Lilly commissioned a second report, on South Korea, following the same method and structure as the original.

For our latest report, information was collected by the Japanese co-authors Hideo Yasunaga and Hayato Yamana using the same pro-forma as for the previous reports. The report outlines the current arrangements for the collection, sharing, and use of RWD, and assesses how these compare with an ‘ideal’, facilitative framework for data governance.

The report briefly introduces the Japanese health system before presenting in more detail the arrangements behind the collection and management of patient data. In Japan, as well as other countries, academic studies using RWD have been increasing in number, and academic societies are using RWE to revise guidelines and to create medical decision tools useful in clinical practice. The Ministry of Health, Labour, and Welfare (MHLW) also uses RWD to support decisions on inclusion in universal healthcare coverage. The Pharmaceuticals and Medical Devices Agency has just started using RWD and RWE to monitor adverse drug events and to make regulatory decisions. Pharmaceutical companies are using commercially available RWD for post-marketing studies and for studies to better understand patients in order to improve drug development.

At present, various types of RWD are regularly collected by insurers and/or hospitals. Different entities – public or private, non-commercial or commercial – gather the data to create their own bigger, anonymised databases, which are made available to various recipients (some limited to selected academic researchers, others open to private companies). Sources of RWD include, but are not limited to, administrative claims data for healthcare services, national health check-up data, the Diagnosis Procedure Combination (DPC) data, and Electronic Medical Records.

In Japan, the legal framework for using personal data includes the Act on the Protection of Personal Information (APPI) and related government guidelines. The governance arrangements cover two important aspects. Firstly, patient consent for collecting and using routinely collected data. Under current conditions, most Japanese RWD are open only to academic researchers and societies, who don’t need to obtain prior individual patient consent, and are closed to the private sector (e.g. pharmaceutical companies and consulting companies), except for several commercially available databases which use de-identified patient data. Secondly, requirements for de-identification of routinely collected data. An option that allows more flexibility within the APPI is to obtain data through a de-identification process undertaken within the medical institution itself, so that patient data are no longer deemed to be personal information and are therefore no longer subject to the Act.

Japan is still facing some challenges in developing a clear set of nationally agreed and implemented standard rules to optimise interoperability of health system records. These limit the ability to fully benefit from achievements in the areas of de-identification, privacy rules, data control, and access. New legislation, the Next-generation Healthcare Infrastructure Act (NHIA), was put into force in 2018 with the potential to fundamentally change the governance arrangements for RWD in Japan. According to this law, “certified operators for de-identifying medical data” are allowed to collect patients’ personal information directly from healthcare providers, link all the data at the individual level, and provide de-identified data to academic researchers. The implication of this being that NHIA can improve individual-level data linkage which has the potential to enhance RWD studies. However, the MHLW is still searching for candidates to act as the certified operators, and thus the issue of data accessibility has not been fully addressed. It is unclear whether this new development will help deal with the asymmetry of the position of commercial and non-commercial researchers in getting access to RWD to conduct research.


Yasunaga, H., Yamana, H., Rodes Sanchez, M. and Towse, A., 2019. Data Governance Arrangements for Real-World Evidence in Japan. OHE Consulting Report, London: Office of Health Economics.

Related research

Hampson, G., Towse, A., Dreitlein, W.B., Henshall, C. and Pearson, S.D., 2018. Real-world Evidence for Coverage Decisions: Opportunities and Challenges. Journal of Comparative Effectiveness Research, 7(12), pp.1133-43. DOI. RePEc.

Lee,E.K., Park,J.A., Cole,A. and Mestre-Ferrandiz,J., 2017. Data Governance Arrangements for Real-World Evidence in South Korea. OHE Consulting Report, London: Office of Health Economics. RePEc.

Cole, A., Garrison, L., Mestre-Ferrandiz, J. and Towse, A. 2015. Data Governance Arrangements for Real-World Evidence. OHE Consulting Report, London: Office of Health Economics. RePEc.

Posted in Drug Development/R&D, Health Care Systems, OHE Consulting | Tagged Consulting Reports