Section 1 Measures for Ensuring Safety in Medical Care
第一節 医療の安全の確保のための措置
第六条の九
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.
国並びに都道府県、保健所を設置する市及び特別区は、医療の安全に関する情報の提供、研修の実施、意識の啓発その他の医療の安全の確保に関し必要な措置を講ずるよう努めなければならない。
第六条の十
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.
第六条の十一
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.
医療事故調査等支援団体は、前項の規定により支援を求められたときは、医療事故調査に必要な支援を行うものとする。
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.
第六条の十二
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.
第六条の十三
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.
都道府県等は、前項の規定により医療安全支援センターを設けたときは、その名称及び所在地を公示しなければならない。
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.
都道府県等は、一般社団法人、一般財団法人その他の厚生労働省令で定める者に対し、医療安全支援センターにおける業務を委託することができる。
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.
医療安全支援センターの業務に従事する職員（前項の規定により委託を受けた者（その者が法人である場合にあつては、その役員）及びその職員を含む。）又はその職にあつた者は、正当な理由がなく、その業務に関して知り得た秘密を漏らしてはならない。
第六条の十四
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.
国は、医療安全支援センターにおける事務の適切な実施に資するため、都道府県等に対し、医療の安全に関する情報の提供を行うほか、医療安全支援センターの運営に関し必要な助言その他の援助を行うものとする。
Section 2 Medical Accident Investigation and Support Center
第二節 医療事故調査・支援センター
第六条の十五
The Minister of Health, Labour and Welfare, upon application, may designate as a medical accident investigation and support center a general incorporated association or general incorporated foundation whose purpose is to contribute to ensuring the safety of medical care by conducting medical accident investigations and providing support for medical accident investigations conducted by the administrators of hospitals, etc. in which medical accidents have occurred, and which is found to be capable of appropriately and reliably performing the services prescribed in the following Article.
When the Minister of Health, Labour and Welfare has made a designation under the provisions of the preceding paragraph, the minister must make public the name, address, and office location of the relevant medical accident investigation and support center.
When a medical accident investigation and support center intends to change its name, address, or the location of its office, the center must notify the Minister of Health, Labour and Welfare to that effect in advance.
医療事故調査・支援センターは、その名称、住所又は事務所の所在地を変更しようとするときは、あらかじめ、その旨を厚生労働大臣に届け出なければならない。
When the Minister of Health, Labour and Welfare has received a notification under the preceding paragraph, the minister must make public the particulars pertaining to the relevant notification.
厚生労働大臣は、前項の規定による届出があつたときは、当該届出に係る事項を公示しなければならない。