Medical Care Act

The medical accident investigation and support center are to perform the following services:

organize and analyze the information collected through the report under the provisions of Article 6-11, paragraph (4):

report the results of the organization and analysis of the information under the preceding item to the administrators of hospitals, etc. that have made a report under the provisions of Article 6-11, paragraph (4):

conduct the investigation set forth in paragraph (1) of the following Article and report the results to the administrator and the bereaved family set forth in the same paragraph:

provide training on knowledge and skills pertaining to medical accident investigation to those engaged in medical accident investigation:

provide consultation on the implementation of medical accident investigation and provide necessary information and support:

promote dissemination of information and awareness-raising about prevention of recurrence of medical accidents: and

beyond what is listed in each of the preceding items, to perform services necessary to ensure the safety of medical care.

The medical accident investigation and support center may conduct necessary investigations when the administrator of a hospital, etc. where a medical accident has occurred or a bereaved family requests an investigation of the relevant medical accident.

When the medical accident investigation and support center finds it necessary to conduct the investigation set forth in the preceding paragraph, it may request the administrator set forth in the same paragraph to provide written or oral explanations or submit materials or other forms of necessary cooperation.

The administrator prescribed in paragraph (1) must not refuse a request made by the medical accident investigation and support center pursuant to the preceding paragraph.

When the administrator prescribed in paragraph (1) refuses a request under the provisions of paragraph (2), the medical accident investigation and support center may make a public announcement to that effect.

When the medical accident investigation and support center has completed the investigation under paragraph (1), it must report the results of the investigation to the administrator and the bereaved family prescribed in the same paragraph.

When the medical accident investigation and support center performs the services listed in each item of Article 6-16 (hereinafter referred to as "investigation services, etc."), prior to performance of such services, the center must establish rules for investigation services, etc. covering particulars concerning the implementation method of investigation services, etc. and other particulars specified by an Order of the Ministry of Health, Labour and Welfare (referred to as the "service rules" in the following paragraph and Article 6-26, paragraph (1), item (iii)), and obtain approval from the Minister of Health, Labour and Welfare. The same applies when the medical accident investigation and support center intends to change the relevant rules.

When the Minister of Health, Labour and Welfare finds that the service rules approved under the preceding paragraph have become inappropriate for the proper and reliable implementation of the investigation services, etc., the minister may order that the relevant service rules be changed.

Each business year, the medical accident investigation and support center, pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare, must prepare a business plan and a budget for income and expenditure with respect to the investigation services, etc. and obtain the approval from the Minister of Health, Labour and Welfare. The same applies when the medical accident investigation and support center intends to change the relevant business plan and budget.

The medical accident investigation and support center, pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare, must prepare and submit to the Minister of Health, Labour and Welfare a business report and a statement of income and expenditure with respect to the investigation services, etc. after the end of each business year.

The medical accident investigation and support center must not suspend or abolish all or part of the investigation services, etc. without obtaining approval from the Minister of Health, Labour and Welfare.

No officer or employee of the medical accident investigation and support center, or any former officer or employee thereof must divulge any secret obtained in connection with the investigation services, etc. without justifiable grounds.

The medical accident investigation and support center may entrust a part of the investigation services, etc. to a medical accident investigation support organization.

An officer or employee of a medical accident investigation support organization entrusted with the investigation services, etc. under the preceding paragraph, or a person who used to be such an officer or employee must not divulge any secret obtained in connection with the relevant investigation services, etc. entrusted to them without justifiable grounds.

The medical accident investigation and support center, pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare, must keep books, describe particulars specified by an Order of the Ministry of Health, Labour and Welfare concerning the investigation services, etc. therein, and store them.

When the Minister of Health, Labour and Welfare finds it necessary in order to ensure the proper operation of investigation services, etc., the minister may order the medical accident investigation and support center to make necessary reports on the status of the investigation services, etc. or assets, or have the relevant officials enter the office of the medical accident investigation and support center and inspect the status of the investigation services, etc. or books, documents or other objects.

The official who enters and inspects under the provisions of the preceding paragraph must carry a certificate for identification and present it to the persons concerned.

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

The Minister of Health, Labour and Welfare, to the extent necessary to enforce the provisions of this Section, may issue to the medical accident investigation and support center orders necessary for the supervision of the investigation services, etc.

When the medical accident investigation and support center falls under any of the following items, the Minister of Health, Labour and Welfare may rescind the designation under the provisions of Article 6-15, paragraph (1) (hereinafter referred to as "designation" in this Article):

when the medical accident investigation and support center is found to be unable to perform investigation services, etc. appropriately and reliably;

when there has been a wrongful act with regard to the designation; or

when the medical accident investigation and support center has violated the provisions of this Section or an order or disposition thereunder, or has performed investigation services, etc. without complying with the service rules approved under Article 6-18, paragraph (1).

When the Minister of Health, Labour and Welfare has rescinded a designation pursuant to the provisions of the preceding paragraph, the minister must make a public announcement to that effect.

Beyond what is provided for in this Section, necessary particulars concerning the medical accident investigation and support center are to be specified by an Order of the Ministry of Health, Labour and Welfare.