Section 1 Providing Information on Medical Care
第一節 医療に関する情報の提供等
第六条の二
National government and local governments must endeavor to undertake the necessary measures to enable medical care recipients to easily acquire the necessary information for choosing a hospital, clinic, or birthing center.
Establishers and administrators of medical institutions must endeavor to provide accurate and well-suited information on the medical care provided thereby, and to appropriately respond to queries from patients or their families, to enable medical care recipients to choose appropriate health and medical services.
医療提供施設の開設者及び管理者は、医療を受ける者が保健医療サービスの選択を適切に行うことができるように、当該医療提供施設の提供する医療について、正確かつ適切な情報を提供するとともに、患者又はその家族からの相談に適切に応ずるよう努めなければならない。
In order to contribute to the efficient provision of high-quality and appropriate medical care, citizens must endeavor to deepen their understanding of the importance of the sharing of functions and the coordination of operations among medical institutions, and to choose and receive medical care appropriately according to the functions of medical institutions.
国民は、良質かつ適切な医療の効率的な提供に資するよう、医療提供施設相互間の機能の分担及び業務の連携の重要性についての理解を深め、医療提供施設の機能に応じ、医療に関する選択を適切に行い、医療を適切に受けるよう努めなければならない。
第六条の三
The administrator of a hospital, clinic, or birthing center (hereinafter referred to as "hospital, etc." in this Article) must report the particulars prescribed by an Order of the Ministry of Health, Labour and Welfare as necessary information for enabling medical care recipients to choose an appropriate hospital, etc. with a sufficient understanding of the functions of hospitals, etc., including the function of providing day-to-day medical care in familiar communities, measures to prevent illness and other medical care (hereinafter referred to as "primary care function"), to the prefectural governor of the location of the relevant hospital, etc., pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare, and must make documents describing such particulars available for inspection within the relevant hospital, etc.
If a change arises with regard to particulars reported pursuant to the provisions of the preceding paragraph, the administrator of a hospital, etc. must promptly report to the prefectural governor of the location of the relevant hospital, etc., and amend the details of the documents provided for in the preceding paragraph, pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare.
In lieu of making documents pursuant to the provisions of paragraph (1) available for inspection, the administrator of a hospital, etc., pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare, may provide the particulars that should be stated in the relevant documents by electronic or magnetic means (which means a method using an electronic data processing system or other information communication technology; the same applies hereinafter) specified by an Order of the Ministry of Health, Labour and Welfare.
If a prefectural governor finds it necessary in order to confirm the details of a report pursuant to the provisions of paragraph (1) or paragraph (2), the governor may request the necessary information concerning a hospital, etc. situated within the boundaries of the relevant prefecture from a municipality or other public agency.
A prefectural governor, upon receiving a report pursuant to the provisions of paragraph (1) or paragraph (2), is to report the contents of the report to the Minister of Health, Labour and Welfare and make them public, pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare.
If the administrator of a hospital, etc. has made a report pursuant to the provisions of paragraph (1) or paragraph (2) by electronic or magnetic means that enables the administrator, the prefectural governor of the location of the relevant hospital, etc. and the Minister of Health, Labour and Welfare to view its contents, the prefectural governor who received the report is deemed to have made the report pursuant to the provisions of the preceding paragraph.
Upon receiving a report pursuant to the provisions of paragraph (5), the Minister of Health, Labour and Welfare is to take necessary measures such as advice and recommendations concerning the publication by prefectural governors pursuant to the provisions of that paragraph, for the provision of information required from a cross-regional perspective that extends beyond prefectural boundaries.
If the administrator of a hospital, etc. fails to report pursuant to the provisions of paragraph (1) or paragraph (2) or has made a false report, the prefectural governor may order the establisher of the relevant hospital, etc. to have the relevant administrator give the relevant report or correct the details of the relevant report within a period that the governor prescribes.
第六条の四
When a patient has been admitted, the administrator of a hospital or clinic must have the physician or dentist responsible for their treatment prepare documents describing the following information, deliver them to the relevant patient or their family, and give an appropriate explanation thereof, pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare; provided, however, that this does not apply where the patient is expected to be discharged from the hospital in a short period of time or where prescribed by an Order of the Ministry of Health, Labour and Welfare:
the name, date of birth, and gender of the patient;
患者の氏名、生年月日及び性別
the name of the physician or dentist primarily responsible for the relevant patient's treatment;
当該患者の診療を主として担当する医師又は歯科医師の氏名
the name of the illness and major symptoms leading to hospitalization;
入院の原因となつた傷病名及び主要な症状
a plan for examinations, surgeries, medication, and other treatments to be undertaken during hospitalization (including nursing and dietary management during hospitalization); and
入院中に行われる検査、手術、投薬その他の治療(入院中の看護及び栄養管理を含む。)に関する計画
other particulars as prescribed by an Order of the Ministry of Health, Labour and Welfare.
その他厚生労働省令で定める事項
In lieu of delivering the documents as set forth in the preceding paragraph, the administrator of a hospital or clinic, pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare, may provide the particulars that should be stated in the relevant documents by electronic or magnetic means specified by an Order of the Ministry of Health, Labour and Welfare, with the consent of the patient or their family.
When a patient is being discharged from the hospital, the administrator of the relevant hospital or clinic must endeavor to have documents that describe the particulars related to health and medical services or welfare services that will be necessary for their treatment after being discharged from the hospital prepared, delivered, and appropriately explained.
In preparing the documents as set forth in paragraph (1), the administrator of a hospital or clinic must endeavor to properly reflect the opinions of the physicians, dentists, pharmacists, nurses, and other employees who work at the relevant hospital or clinic, and to appropriately provide medical care during hospitalization through organic coordination between these parties, based on the contents of the relevant documents.
In preparing the documents set forth in paragraph (3), the administrator of a hospital or clinic must endeavor to seek cooperation with providers of the health and medical services or welfare services that are necessary for the relevant patient's treatment after the patient is discharged from the hospital.
第六条の四の二
The administrator of a hospital or clinic that has received confirmation pursuant to the provisions of Article 30-18-4, paragraph (2) and has a system that meets the requirements specified by an Order of the Ministry of Health, Labour and Welfare under that paragraph (including where it ensures the relevant function prescribed in that paragraph in mutual cooperation with another hospital or clinic) must endeavor to ensure that, in the case where it provides necessary medical care at home, etc. to a person requiring continuous medical care prescribed in paragraph (1) of that Article, or in any other case specified by an Order of the Ministry of Health, Labour and Welfare as a case in which an explanation is particularly necessary in providing outpatient medical care, and a request has been made by the person requiring continuous medical care or their family, the physician or dentist in charge of the person's care gives the person requiring continuous medical care or their family an appropriate explanation of the following particulars, by electronic or magnetic means or any other method specified by an Order of the Ministry of Health, Labour and Welfare, unless there is a justifiable reason:
第三十条の十八の四第二項の規定による確認を受けた病院又は診療所であつて、同項の厚生労働省令で定める要件に該当する体制を有するもの(他の病院又は診療所と相互に連携して同項に規定する当該機能を確保する場合を含む。)の管理者は、同条第一項に規定する継続的な医療を要する者に対して居宅等において必要な医療の提供をする場合その他外来医療を提供するに当たつて説明が特に必要な場合として厚生労働省令で定める場合であつて、当該継続的な医療を要する者又はその家族からの求めがあつたときは、正当な理由がある場合を除き、電磁的方法その他の厚生労働省令で定める方法により、その診療を担当する医師又は歯科医師により、当該継続的な医療を要する者又はその家族に対し、次に掲げる事項の適切な説明が行われるよう努めなければならない。
the name of the disease;
疾患名
the plan for treatment;
治療に関する計画
other particulars prescribed by Order of the Ministry of Health, Labour and Welfare.
その他厚生労働省令で定める事項
第六条の四の三
The administrator of a birthing center (or in the case of a midwife who only does house calls, the relevant midwife; the same applies in the following paragraph), when the administrator has promised to provide midwifery services to a pregnant woman or a woman in labor (hereinafter referred to as "pregnant woman, etc." in this Article and Article 19, paragraph (2)), must ensure, pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare that the midwife in charge of providing midwifery services to the relevant pregnant woman, etc. delivers a document stating the following information and provides appropriate explanation to the relevant pregnant woman, etc. or her family:
the name and date of birth of the pregnant woman, etc.;
妊婦等の氏名及び生年月日
the name of the midwife who is in charge of providing midwifery services to the relevant pregnant woman, etc.;
当該妊婦等の助産を担当する助産師の氏名
policies concerning midwifery and health guidance for the relevant pregnant woman, etc.;
当該妊婦等の助産及び保健指導に関する方針
the name, address and contact information of the relevant birthing center;
当該助産所の名称、住所及び連絡先
the name, address and contact information of the hospital or clinic that responds to the abnormality of the relevant pregnant woman, etc.; and
other particulars prescribed by Order of the Ministry of Health, Labour and Welfare.
その他厚生労働省令で定める事項
In lieu of delivering the documents as set forth in the preceding paragraph, the administrator of a birthing center, pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare, provide the particulars that should be stated in the relevant documents by electronic or magnetic means specified by an Order of the Ministry of Health, Labour and Welfare, with the consent of the pregnant woman, etc. or her family.
第六条の四の四
If the supply of pharmaceuticals, medical device or regenerative medicine products (meaning the pharmaceuticals, medical device and regenerative medicine products prescribed respectively in Article 2, paragraphs (1), (4) and (9) of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Act No. 145 of 1960), excluding those intended to be used exclusively for animals; the same applies hereinafter in this paragraph and paragraph (3)) is short or is likely to become short due to a decrease in production or other circumstances, and there is therefore a risk that the interests of medical care recipients will be significantly harmed, the Minister of Health, Labour and Welfare may request a person who has obtained approval for marketing prescribed in Article 14, paragraph (1) of that Act, a person who has obtained approval for marketing prescribed in Article 23-2-5, paragraph (1) of that Act, or a person who has obtained approval for marketing prescribed in Article 23-25, paragraph (1) of that Act (hereinafter referred to as "marketing authorization holder" in this Article) to report on the status of production, import, sale or lending of those pharmaceuticals, medical device or regenerative medicine products.
厚生労働大臣は、医薬品、医療機器又は再生医療等製品(医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律(昭和三十五年法律第百四十五号)第二条第一項、第四項及び第九項にそれぞれ規定する医薬品、医療機器及び再生医療等製品をいい、専ら動物のために使用されることが目的とされているものを除く。以下この項及び第三項において同じ。)について、生産の減少その他の事情によりその供給が不足し、又は不足するおそれがあるため、医療を受ける者の利益が大きく損なわれるおそれがある場合には、当該医薬品、医療機器又は再生医療等製品について、同法第十四条第一項に規定する製造販売の承認を受けた者、同法第二十三条の二の五第一項に規定する製造販売の承認を受けた者又は同法第二十三条の二十五第一項に規定する製造販売の承認を受けた者(以下この条において「製造販売業者」という。)に対して、当該医薬品、医療機器又は再生医療等製品の生産、輸入、販売又は貸付けの状況について報告を求めることができる。
A marketing authorization holder must comply with a request from the Minister of Health, Labour and Welfare pursuant to the provisions of the preceding paragraph.
If the Minister of Health, Labour and Welfare has received a report from a marketing authorization holder, based on the provisions of paragraph (1), on the status of production, import, sale or lending of pharmaceuticals, medical device or regenerative medicine products, the Minister is to make public information on that status.