Act on Assurance of Medical Care for Elderly People

A prefecture, pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare, in the fiscal year following the fiscal year that includes the last day of the period of the Prefectural Plan for Regulating Medical Expenses, is to investigate and analyze the status of achievement of the objectives of the plan and the status of implementation of measures, hear the opinions of the Council of Insurers, and evaluate the performance of the plan.

When the prefectural government has conducted the evaluation referred to in the preceding paragraph, the prefectural government is to endeavor to make the results public and report them to the Minister of Health, Labour and Welfare pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare.

In the fiscal year following the fiscal year that includes the last day of the period of the National Plan for Regulating Medical Expenses, the Minister of Health, Labour and Welfare is to investigate and analyze the status of the achievement of the objectives of the plan and the status of the implementation of measures, and evaluate the results of the plan, as well as evaluate the results of the Prefectural Plan for Regulating Medical Expenses in each prefecture by hearing the opinions of the prefectures concerned based on the report set forth in the preceding paragraph, as specified by Order of the Ministry of Health, Labour and Welfare.

When the Minister of Health, Labour and Welfare conducts the evaluation referred to in the preceding paragraph, the Minister is to publicize the results of the evaluation.

If a prefecture finds it necessary for achieving the goals set forth in Article 9, paragraph (2), item (ii) as a result of the evaluation referred to in paragraph (1) of the preceding Article, the prefecture may submit to the Minister of Health, Labour and Welfare its opinions on the provisions under Article 76, paragraph (2) of the Health Insurance Act, the provisions under Article 88, paragraph (4) of the same Act, the standards for calculating the amount of expenses required for benefits for medical treatment provided in Article 71, paragraph (1), and the standards specified by the Minister of Health, Labour and Welfare provided in Article 78, paragraph (4) (referred to as "medical fees" in the following paragraph and paragraph (1) of the following Article).

When the prefectural government submits its opinions pursuant to the provisions of the preceding paragraph, the Minister of Health, Labour and Welfare must endeavor to determine the medical fees in consideration of the opinions.

If, as a result of the evaluation referred to in Article 12, paragraph (3), the Minister of Health, Labour and Welfare finds it necessary for achieving the goals set forth in Article 8, paragraph (4), item (ii) and in Article 9, paragraph (2), item (ii) in each prefecture and for promoting the optimization of medical expenses, the Minister may specify medical fees in the areas of one prefecture that are different from those in the areas of other prefectures, within a scope that is found to be reasonable from the viewpoint of providing appropriate medical care fairly among the prefectures, while taking into account the actual conditions of the area.

In establishing the provisions of the preceding paragraph, the Minister of Health, Labour and Welfare is to consult with the relevant prefectural governors in advance.

If the Minister of Health, Labour and Welfare or the prefectural governor finds it necessary to make public the status of progress referred to in Article 11, paragraph (1) or (5) or the results referred to in paragraph (2) or (6) of the same Article, or to make the evaluation referred to in Article 12, paragraph (1) or (3), the Minister or the governor may request cooperation from insurers, Association of Medical Care Systems for the Elderly Aged 75 and older, medical institutions, and other relevant persons for the submission of necessary materials.

The Minister of Health, Labour and Welfare and the prefectural governor may provide necessary advice or assistance to insurers, Association of Medical Care Systems for the Elderly Aged 75 and older, or medical institutions based on the progress made public pursuant to the provisions of Article 11, paragraph (1) or paragraph (5), the results referred to in paragraph (2) or paragraph (6) of the same Article, or the results of the evaluation referred to in Article 12, paragraph (1) or paragraph (3).

The Minister of Health, Labour and Welfare is to investigate and analyze data concerning the following particulars (hereinafter referred to as "medical insurance-related data"), and publicize the results thereof, for the purpose of contributing to the preparation, implementation, and evaluation of the national plan for regulating medical expenses and the prefectural plan for regulating medical expenses:

the status of expenses required for medical care by area, age group, or disease, and other particulars specified by Order of the Ministry of Health, Labour and Welfare;

the status of changes in the number of beds concerning the provision of medical care by area and other particulars specified by the Order of the Ministry of Health, Labour and Welfare.

Insurers and Associations of Medical Care Systems for the Elderly Aged 75 and older must provide the Minister of Health, Labour and Welfare with medical insurance-related information by the method specified by Order of the Ministry of Health, Labour and Welfare.

The Minister of Health, Labour and Welfare, when finding it necessary, may request a prefecture, municipality, or any other person specified by Order of the Ministry of Health, Labour and Welfare to provide medical insurance-related information by a method specified by Order of the Ministry of Health, Labour and Welfare.

The Minister of Health, Labour and Welfare may, in order to contribute to the improvement of national health, use anonymized medical data (meaning medical insurance-related information processed in accordance with the standards specified by Order of the Ministry of Health, Labour and Welfare so as to make it impossible to identify a specific insured or other person specified by Order of the Ministry of Health, Labour and Welfare pertaining to the medical insurance-related information (referred to as "the person themselves" in the following Article) and to restore the medical insurance-related information used to prepare it; the same applies hereinafter), or may provide it, as specified by Order of the Ministry of Health, Labour and Welfare, to a person listed in the following items who conducts the business specified respectively in those items as business found to have considerable public interest in being conducted upon receiving the provision of anonymized medical data.

other national administrative organs and local governments:surveys concerning the planning and drafting of policies that contribute to the provision of appropriate health and medical services;

universities and other research institutes:research on the causes of diseases and methods of prevention, diagnosis, and treatment of diseases, and other research on the improvement and promotion of public health;

private business operators and other persons specified by Order of the Ministry of Health, Labour and Welfare:analyses that contribute to research and development in the medical field and other services specified by Order of the Ministry of Health, Labour and Welfare (excluding those carried out for the purpose of using them in the advertisement or promotion of specific goods or services).

The Minister of Health, Labour and Welfare, when using or providing information pursuant to the provisions of the preceding paragraph, may use the anonymized medical data, etc. in a way that links it to anonymized medical data, etc. provided for in Article 150-2, paragraph (1) of the Health Insurance Act, anonymized long-term care insurance data, etc. provided for in Article 118-3, paragraph (1), Long-Term Care Insurance Act, and other data specified by Order of the Ministry of Health, Labour and Welfare, or provide the anonymized medical data, etc. in a way that allows it to be used in a way that links it to other data.

If the Minister of Health, Labour and Welfare intends to provide anonymized medical data pursuant to the provisions of paragraph (1), the Minister must hear the opinion of the Social Security Council in advance.

A person who receives and uses anonymized medical data, etc. pursuant to the provisions of paragraph (1) of the preceding Article (hereinafter referred to as a "user of anonymized medical data, etc. related information"), in handling the anonymized medical data, etc. related information, in order to identify the principal pertaining to the medical insurance related information used to prepare the anonymized medical data, etc. related information, must not obtain information on descriptions, etc. (meaning any and all matters stated or recorded in a document, drawing, or electronic or magnetic record (meaning a record made in an electronic or magnetic form (meaning an electronic form, a magnetic form, or any other form that cannot be recognized by human perception)), or expressed by using sound, motion, or any other method) deleted from the medical insurance related information or information on the processing method used to prepare the anonymized medical data, etc. related information, or cross-check the anonymized medical data, etc. related information with other information.

When a user of anonymized medical data, etc. no longer needs to use the provided anonymized medical data, etc., the user must delete the anonymized medical data, etc. without delay.

Users of anonymized medical data must take measures specified by Order of the Ministry of Health, Labour and Welfare as necessary and appropriate for the security control of the anonymized medical data, such as the prevention of leakage, loss, or damage to the anonymized medical data.

A person who is or was a user of anonymized medical data related to medical insurance, etc. must not disclose the anonymized medical data related to medical insurance, etc. acquired in relation to the use of the anonymized medical data related to medical insurance, etc. to other persons without justifiable grounds or use the anonymized medical data related to medical insurance, etc. for an unjust purpose.

To the extent necessary for the enforcement of the provisions of this Section, the Minister of Health, Labour and Welfare may order users of anonymized medical data (excluding other administrative organs of the national government; hereinafter the same applies in this paragraph and the following Article) to make a report or submit or present books and documents, or have the relevant officials question the relevant persons or enter the offices or other places of business of the users of anonymized medical data to inspect the books, documents, and any other articles of the users of anonymized medical data.

When carrying out questioning or on-site inspections under the provisions of the preceding paragraph, the relevant officials must carry an identification card and present it when requested by any person concerned.

The authority under the provisions of paragraph (1) must not be construed as being granted for the purpose of criminal investigation.

When the Minister of Health, Labour and Welfare finds that a user of anonymized medical data is in violation of any of the provisions of Articles 16-3 through 16-6, the Minister of Health, Labour and Welfare may order the person to take necessary measures to rectify the violation.

The Minister of Health, Labour and Welfare may entrust the investigation and analysis prescribed in Article 16, paragraph (1) and the affairs pertaining to the use or provision under Article 16-2, paragraph (1), in whole or in part, to the Medical Information Infrastructure and Medical Fee Examination and Payment Organization under the Medical Information Infrastructure and Medical Fee Examination and Payment Organization Act (Act No. 129 of 1948) (hereinafter referred to as the "Organization"), the Federation of National Health Insurance Associations prescribed in Article 45, paragraph (5) of the National Health Insurance Act (hereinafter referred to as the "NHI federation"), or other persons specified by Order of the Ministry of Health, Labour and Welfare (referred to as the "Organization, etc." in the following Article).

Users of anonymized medical data must pay a fee in the amount specified by Cabinet Order in consideration of the actual costs to the national government (when the Organization, etc. conducts all of the affairs related to the provision of anonymized medical data under Article 16-2, paragraph (1) upon entrustment from the Minister of Health, Labour and Welfare pursuant to the provisions of the preceding Article, the Organization, etc.).

If a person who intends to pay the fee set forth in the preceding paragraph is a prefecture or any other person specified by Cabinet Order as a person who plays particularly important roles in improving the health of the people, the Minister of Health, Labour and Welfare may grant the person a reduction of or exemption from the fee pursuant to the provisions of Cabinet Order.

A fee paid to the Organization, etc. pursuant to the provisions of paragraph (1) is to be the revenue of the Organization, etc.