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Government eyes new law to help compile medical big data


Aiming to compile personal medical information as big data, the government is considering creating a system under which it will designate certified organizations and allow them to collect information about patients’ treatment and medication from hospitals and pharmacies, it has been learned.

Under the new system, the certified organizations will include medical academic societies and organizations engaged in the development of new drugs and other activities, according to sources. They would make the collected information anonymous and provide it to research institutes such as universities.

By consolidating personal medical information as big data, the government aims to utilize it to establish future treatment methods and develop new drugs. The government will submit a bill centering on the envisaged system to the ordinary Diet session to be convened on Jan. 20, aiming to implement the law in 2018.

According to the sources, the legislation is tentatively called a “bill to facilitate the provision of medical information contributing to medical research and development.” The government likely believes that consolidating medical big data will make it possible to analyze a variety of cases and treatment procedures, and that this will help verify the results of treatment and discover side effects.

It could also be possible to identify such things as connections between multiple diseases that have yet to be clarified, and the effects of administered drugs.

With regard to cancer, lifestyle-related and other diseases affecting many people, the big data is also expected to help find measures to prevent such diseases or slow their progression that are suited to each individual’s physical condition.

Under the envisaged system, the certified organizations will urge mainly hospitals and pharmacies to provide patients’ information in such areas as treatment histories, examination results, medication histories and side effects, the sources said. Since the request is not legally binding, whether to provide such information will be left to the respective medical institutions and others, the sources said.

Cooperating medical organizations and others will have to inform affected patients in writing about the provision of their information. After collecting such information, the certified organizations will work to identify individuals who go to multiple hospitals, pharmacies and other facilities, based on names, with cooperation from a support organization to be newly established by the government, according to the sources.

The certified organizations will delete names and other identifying details from the aggregated information to prevent individuals from being identified, and allow research institutes and others that file the necessary application to use the big data.

The Personal Information Protection Law stipulates that when personal medical information is provided to a third party, the person’s consent must be obtained. Under the revised law that will take full effect in May, people’s history of illness will be considered “sensitive personal information,” as is their race, beliefs and criminal record. Strict handling will be required.

Focusing on the usefulness of medical big data, the government is considering creating a system under which the certified organizations will not be required to obtain the consent of an affected person “as an exception,” and only when a patient refuses the provision of their information will it not be provided.

The government plans to designate several certified organizations across the country. To prevent information leaks, the system used by the certified organizations will be separated from external networks, and people who can use the system will be limited, the sources said.

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