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Gov't finalizes plan to create medical big data pool for use by drug firms, researchers

TOKYO -- The government on April 10 finalized the basic policy for the implementation of the "medical big data act," allowing the collection and anonymization of patients' medical histories and conditions for use by researchers and drug firms.

The basic policy must now get approval from the ruling parties by the time the law enters force on May 11.

Under the policy, medical institutions will have to get written consent from patients for their information, including detailed receipts for their care and the results of physical examinations, to be added to the data pool. The information is then to be anonymized by a national government-approved private firm, before being made available to research institutions, universities and pharmaceutical companies for big data analysis. The hope is that the pool of patient data will help spur the development of new drugs and treatments.

The basic policy also states that medical institutions should inform patients that they can refuse to provide their medical information to the data pool at the beginning of an examination or at any time thereafter. Furthermore, the choice to provide data must be made by a parent or guardian for any individual considered to lack sufficient decision-making ability, including children under 16.

Meanwhile, the policy also demands the private firms handling the information be structured stably and be able to continue in the business for a long period. Furthermore, they must have a high degree of technical expertise in the medical research sector and in data security. After the information has been received, at a patient's request the firm must also be able to erase to the greatest extent possible any content that could be used to identify that person.

(Japanese original by Masahiro Sakai, Business News Department)

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