Medical Care Act

The national government, prefectures, cities with public health centers and special wards of Tokyo must endeavor to undertake the necessary measures to ensure safety in medical care, including the provision of information on safety in medical care, training, and raising awareness on compliance.

The administrator of a hospital, clinic, or birthing center (hereinafter referred to as "hospital, etc." in this Chapter), when a medical accident (meaning a death or stillbirth caused or suspected to be caused by medical care provided by medical care professionals working in the relevant hospital, etc. and determined by an Order of the Ministry of Health, Labour and Welfare as a death or stillbirth which the relevant administrator did not expect; the same applies hereinafter in this Chapter) has occurred, the administrator must immediately report the date, time, place and circumstances of the relevant medical accident and other particulars specified by an Order of the Ministry of Health, Labour and Welfare to the medical accident investigation and support center set forth in Article 6-15, paragraph (1), pursuant to an Order of the Ministry of Health, Labour and Welfare.

Prior to the submission of a report pursuant to the provision of the preceding paragraph, the administrator of the hospital, etc. must explain to the bereaved family of the deceased pertaining to the medical accident or the parents of the stillborn baby pertaining to the medical accident and other persons specified by an Order of the Ministry of Health, Labour and Welfare (hereinafter simply referred to as "bereaved family" in this Chapter) about the particulars specified by an Order of the Ministry of Health, Labour and Welfare; provided, however, that this does not apply when there is no bereaved family or the whereabouts of the bereaved family are unknown.

In the event of a medical accident, the administrator of a hospital, etc., pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare, must immediately conduct an investigation necessary to clarify the cause of the accident (hereinafter referred to as "medical accident investigation" in this Chapter).

The administrator of a hospital, etc. is to seek the support necessary for conducting medical accident investigations from an academic organization related to medicine and medical science or any other organization specified by the Minister of Health, Labour and Welfare (in the case of an organization that is not a corporation, it is to be limited to an organization with a designated representative or administrator; referred to as "medical accident investigation support organization" in the following paragraph and Article 6-22).

When a medical accident investigation support organization is requested to provide support in accordance with the provisions of the preceding paragraph, it is to provide the necessary support for medical accident investigation.

When the administrator of a hospital, etc. has completed a medical accident investigation, the administrator must immediately report the results to the medical accident investigation and support center set forth in Article 6-15, paragraph (1), pursuant to an Order of the Ministry of Health, Labour and Welfare.

Prior to the submission of a report pursuant to the provisions of the preceding paragraph, the administrator of the hospital, etc. must explain to the bereaved family about the particulars specified by an Order of the Ministry of Health, Labour and Welfare; provided, however, that this does not apply when there is no bereaved family or the whereabouts of the bereaved family are unknown.

Beyond what is provided for in the preceding two Articles, the administrator of a hospital, etc., pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare, must take measures to ensure the safety of medical care in the relevant hospital, etc., such as formulating guidelines to ensure the safety of medical care and providing training for employees.

The administrator of a hospital or clinic specified by an Order of the Ministry of Health, Labour and Welfare that provides medical procedures, surgery and other treatment for cosmetic purposes to cleanse or beautify a person's skin or teeth, to shape the body, or to reduce weight must, as prescribed by an Order of the Ministry of Health, Labour and Welfare, report the status of the measures prescribed in the preceding Article and other particulars specified by an Order of the Ministry of Health, Labour and Welfare as information necessary for ensuring safety in medical care, to the prefectural governor of the prefecture where the relevant hospital or clinic is located (in the case of a clinic whose location is within the area of a city with a public health center or a special ward of Tokyo, the mayor of the relevant city with a public health center or the mayor of the special ward of Tokyo; the same applies hereinafter in this Article, Article 15, paragraph (3) and Article 18).

The administrator of a hospital or clinic that has made a report pursuant to the provisions of the preceding paragraph must, when there has been a change to the particulars reported pursuant to the provisions of that paragraph, promptly report to the prefectural governor of the prefecture where the relevant hospital or clinic is located, as prescribed by an Order of the Ministry of Health, Labour and Welfare.

When the prefectural governor finds it necessary in order to confirm the details of a report pursuant to the provisions of the preceding two paragraphs, the governor may request the necessary information concerning a hospital or clinic prescribed in paragraph (1) that is situated within the boundaries of the relevant prefecture (in the case of a clinic whose location is within the area of a city with a public health center or a special ward of Tokyo, the relevant city with a public health center or special ward of Tokyo; the same applies in Article 18) from a municipality or other public agency.

The prefectural governor must, as prescribed by an Order of the Ministry of Health, Labour and Welfare, publish, among the particulars reported pursuant to the provisions of paragraph (1), those specified by an Order of the Ministry of Health, Labour and Welfare as particularly necessary for ensuring safety in medical care.

When the administrator of a hospital or clinic prescribed in paragraph (1) has failed to make a report pursuant to the provisions of that paragraph or paragraph (2) or has made a false report, the prefectural governor may order the establisher of the relevant hospital or clinic to have the relevant administrator make a report or correct the contents of the report, by setting a period of time.

Prefectures, cities with public health centers, and special wards (hereinafter referred to as "prefectures, etc." in this Article and the following Article) must endeavor to provide facilities (hereinafter such a facility is referred to as a "medical care safety support center") for the implementation of the following operations, in order to undertake the measures provided for in Article 6-9:

handling complaints and responding to queries from patients or their families concerning medical care at the hospitals, etc. situated within the boundaries of the relevant prefecture, etc., and giving advice as required to the relevant patients or their families and the administrators of the relevant hospitals, etc.;

providing information as required to ensure safety in medical care to the establishers, administrators, and employees of the hospitals, etc. situated within the boundaries of the relevant prefecture, etc., patients or their families, or citizens;

implementing training on safety in medical care for the administrators and employees of the hospitals, etc. situated within the boundaries of the relevant prefecture, etc.; or

providing support beyond that listed in the preceding three items as required to ensure safety in medical care within the boundaries of the relevant prefecture, etc.

When a medical care safety support center has been established pursuant to the provisions of the preceding paragraph, the prefecture, etc. must provide public notice of its name and location.

A prefecture, etc. may entrust the operations of a medical care safety support center to a general incorporated association, general incorporated foundation, or to another party prescribed by an Order of the Ministry of Health, Labour and Welfare.

Personnel (including parties to whom operations have been entrusted pursuant to the provisions of the preceding paragraph (and their officers in the case that such a party is a corporation) and their personnel) who are or have been engaged in the operations of a medical care safety support center must not divulge any secret acquired in relation to the relevant operations without justifiable grounds.

The national government, beyond providing information on safety in medical care, provide advice and other support on the management of medical care safety support centers to prefectures, etc., to contribute to the appropriate implementation of operations in medical care safety support centers.