Provision of medical big data to be greatly expanded in Japan

Yomiuri Shimbun file photo
People wait at a COVID-19 vaccination center in Tokyo in October.

The Cabinet Office has decided to greatly expand the provision of medical big data — personal medical records mainly held by medical institutions — to research entities and pharmaceutical companies in a bid to promote research and development of new drugs and treatments based on such data.

Efforts to utilize medical big data for drug development and other purposes have been advancing in Japan and abroad in recent years.

In Japan, a law on anonymized medical data that is meant to contribute to research and development in the medical field was enacted in 2018. Under the law, a system for providing personal medical information to research institutions and pharmaceutical companies was established.

The government designates an entity specializing in collecting and processing data based on the law. The entity gathers medical records, health checkup test results and treatment fee statements among other information. The data is then anonymized so that individuals cannot be identified before being used for research for such purposes as confirming the effectiveness of cancer treatments.

Cases of symptoms among an extremely small number of patients were previously excluded from the data provided. Such data and test results that show significantly high levels will also be included in the data to be provided.

The expansion will also allow the provision of exact figures for age and weight, which were previously given as approximate numbers such as “in their 30s.”

The details will be finalized by the end of the year.

In a bid to protect personal information, a large amount of data was not provided previously, and many pharmaceutical companies and other entities said the data was not was useful for research and development purposes.

Patients and others can refuse the collection and provision of their data under the current rules. With the expansion of the provision, the designated entity will be required to manage the information even more strictly.

As of August, the data of 2.47 million people was collected by the designated entity but was provided in only 22 cases.

With more information becoming available, the data is expected to be used to identify side effects of drugs that were not detected in pre-approval clinical trials and to verify the safety and efficacy of new vaccines.

Israel, one of the first countries to begin COVID-19 inoculation rollouts, quickly gathered and analyzed vaccination information and provided the data to pharmaceutical companies, thereby contributing to proving the effectiveness of a vaccine.

As the promotion of medical big data is growing, the European Union is considering sharing data among research institutes in member countries.