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Medical Care Act

医療法(いりょうほう)

Chapter II Supporting Choices in Medical Care (Articles 6-2 to 6-4-4)

The law as Act Partially Amending the Medical Care Act, etc. (Act No. 87 of 2025) leaves it, with the words it changes marked.

The main text is read a page at a time: a chapter to a page, and a long chapter in runs of articles. The whole main text, and the supplementary provisions and appended tables this amendment changes. Those it leaves untouched are on the page for the text in force.

Chapter II Supporting Choices in Medical Care第二章 医療に関する選択の支援等

Section 1 Providing Information on Medical Care第一節 医療に関する情報の提供等

Article 6-2第六条の二

Article 6-2, paragraph (1)

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.

国及び地方公共団体は、医療を受ける者が病院、診療所又は助産所の選択に関して必要な情報を容易に得られるように、必要な措置を講ずるよう努めなければならない。

Article 6-2, paragraph (2)

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。

Article 6-2, paragraph (3)

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。

Article 6-3第六条の三

Article 6-3, paragraph (1)

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.

病院、診療所又は助産所(以下この条において「病院等」という。)の管理者は、厚生労働省令で定めるところにより、医療を受ける者が身近な地域における日常的な診療、疾病の予防のための措置その他の医療の提供を行う機能(以下「かかりつけ医機能」という。)その他の病院等の機能についての十分な理解の下に病院等の選択を適切に行うために必要な情報として厚生労働省令で定める事項を当該病院等の所在地の都道府県知事に報告するとともに、当該事項を記載した書面を当該病院等において閲覧に供しなければならない。

Article 6-3, paragraph (2)

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.

病院等の管理者は、前項の規定により報告した事項について変更が生じたときは、厚生労働省令で定めるところにより、速やかに、当該病院等の所在地の都道府県知事に報告するとともに、同項に規定する書面の記載を変更しなければならない。

Article 6-3, paragraph (3)

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.

病院等の管理者は、第一項の規定による書面の閲覧に代えて、厚生労働省令で定めるところにより、当該書面に記載すべき事項を電磁的方法(電子情報処理組織を使用する方法その他の情報通信の技術を利用する方法をいう。以下同じ。)であつて厚生労働省令で定めるものにより提供することができる。

Article 6-3, paragraph (4)

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.

都道府県知事は、第一項又は第二項の規定による報告の内容を確認するために必要があると認めるときは、市町村その他の官公署に対し、当該都道府県の区域内に所在する病院等に関し必要な情報の提供を求めることができる。

Article 6-3, paragraph (5)

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.

都道府県知事は、第一項又は第二項の規定による報告を受けたときは、厚生労働省令で定めるところにより、その報告の内容を厚生労働大臣に報告するとともに、公表しなければならない。

Article 6-3, paragraph (6)

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.

病院等の管理者が、第一項又は第二項の規定による報告を、電磁的方法であつてその内容を当該管理者、当該病院等の所在地の都道府県知事及び厚生労働大臣が閲覧することができるものにより行つたときは、当該報告を受けた都道府県知事は、前項の規定による報告を行つたものとみなす。

Article 6-3, paragraph (7)

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.

厚生労働大臣は、第五項の規定による報告を受けたときは、都道府県の区域を超えた広域的な見地から必要とされる情報の提供のため、都道府県知事による同項の規定による公表に関し必要な助言、勧告その他の措置を行うものとする。

Article 6-3, paragraph (8)

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.

都道府県知事は、病院等の管理者が第一項若しくは第二項の規定による報告をせず、又は虚偽の報告をしたときは、期間を定めて、当該病院等の開設者に対し、当該管理者をしてその報告を行わせ、又はその報告の内容を是正させることを命ずることができる。

Article 6-4第六条の四

Article 6-4, paragraph (1)

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:

病院又は診療所の管理者は、患者を入院させたときは、厚生労働省令で定めるところにより、当該患者の診療を担当する医師又は歯科医師により、次に掲げる事項を記載した書面の作成並びに当該患者又はその家族への交付及びその適切な説明が行われるようにしなければならない。ただし、患者が短期間で退院することが見込まれる場合その他の厚生労働省令で定める場合は、この限りでない。

Article 6-4, paragraph (1), item (i)

the name, date of birth, and gender of the patient;

患者の氏名、生年月日及び性別

Article 6-4, paragraph (1), item (ii)

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

Article 6-4, paragraph (1), item (iii)

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

Article 6-4, paragraph (1), item (iv)

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

Article 6-4, paragraph (1), item (v)

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

Article 6-4, paragraph (2)

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.

病院又は診療所の管理者は、患者又はその家族の承諾を得て、前項の書面の交付に代えて、厚生労働省令で定めるところにより、当該書面に記載すべき事項を電磁的方法であつて厚生労働省令で定めるものにより提供することができる。

Article 6-4, paragraph (3)

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.

病院又は診療所の管理者は、患者を退院させるときは、退院後の療養に必要な保健医療サービス又は福祉サービスに関する事項を記載した書面の作成、交付及び適切な説明が行われるよう努めなければならない。

Article 6-4, paragraph (4)

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.

病院又は診療所の管理者は、第一項の書面の作成に当たつては、当該病院又は診療所に勤務する医師、歯科医師、薬剤師、看護師その他の従業者の有する知見を十分に反映させるとともに、当該書面に記載された内容に基づき、これらの者による有機的な連携の下で入院中の医療が適切に提供されるよう努めなければならない。

Article 6-4, paragraph (5)

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.

病院又は診療所の管理者は、第三項の書面の作成に当たつては、当該患者の退院後の療養に必要な保健医療サービス又は福祉サービスを提供する者との連携が図られるよう努めなければならない。

Article 6-4-2第六条の四の二

Article 6-4-2, paragraph (1)

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。

Article 6-4-2, paragraph (1), item (i)

the name of the disease;

疾患名

Article 6-4-2, paragraph (1), item (ii)

the plan for treatment;

治療に関する計画

Article 6-4-2, paragraph (1), item (iii)

the name, address and contact information of the relevant hospital or clinic; and

当該病院又は診療所の名称、住所及び連絡先

Article 6-4-2, paragraph (1), item (iv)

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

Article 6-4-3第六条の四の三

Article 6-4-3, paragraph (1)

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:

助産所の管理者(出張のみによつてその業務に従事する助産師にあつては当該助産師。次項において同じ。)は、妊婦又は産婦(以下この条及び第十九条第二項において「妊婦等」という。)の助産を行うことを約したときは、厚生労働省令で定めるところにより、当該妊婦等の助産を担当する助産師により、次に掲げる事項を記載した書面の当該妊婦等又はその家族への交付及びその適切な説明が行われるようにしなければならない。

Article 6-4-3, paragraph (1), item (i)

the name and date of birth of the pregnant woman, etc.;

妊婦等の氏名及び生年月日

Article 6-4-3, paragraph (1), item (ii)

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

Article 6-4-3, paragraph (1), item (iii)

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

Article 6-4-3, paragraph (1), item (iv)

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

Article 6-4-3, paragraph (1), item (v)

the name, address and contact information of the hospital or clinic that responds to the abnormality of the relevant pregnant woman, etc.; and

当該妊婦等の異常に対応する病院又は診療所の名称、住所及び連絡先

Article 6-4-3, paragraph (1), item (vi)

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

Article 6-4-3, paragraph (2)

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.

助産所の管理者は、妊婦等又はその家族の承諾を得て、前項の書面の交付に代えて、厚生労働省令で定めるところにより、当該書面に記載すべき事項を電磁的方法であつて厚生労働省令で定めるものにより提供することができる。

Article 6-4-4第六条の四の四

Article 6-4-4, paragraph (1)

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。

Article 6-4-4, paragraph (2)

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.

製造販売業者は、厚生労働大臣から前項の規定による求めがあつたときは、その求めに応じなければならない。

Article 6-4-4, paragraph (3)

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.

厚生労働大臣は、第一項の規定に基づき製造販売業者から医薬品、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受けた場合には、当該状況に関する情報を公表するものとする。

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