# 医療法 / Medical Care Act — 第四条の三 (Article 4-3) - Law: 医療法 (Medical Care Act), 昭和二十三年法律第二百五号 - English title "Medical Care Act": Ministry of Justice translation - Kind: Act — the distinction between 法律 (Act), 政令 (Cabinet Order), 省令 (Ministerial Order) and 条例 (local ordinance) decides who may issue it and what it may say. - Provision: 第四条の三 (Article 4-3) — address `art-4-3` - Text in force since: 2026-10-01 - URL (the page that opens at this provision): https://japanlaw.org/ja/medical-care-act/art-4-3 - Permanent URL (e-Gov law ID, never renamed): https://japanlaw.org/l/323AC0000000205/art-4-3 - Every provision below carries its address and both URLs on the line under it. - Japanese text: e-Gov 法令検索, Digital Agency (デジタル庁). English: as marked on each line below. Only the Japanese as published by the government has legal effect; the text below is a copy of it. Every English rendering below is a translation and says which kind: the Ministry of Justice's translation, or this site's machine translation, whose model and date the Sources list names. They are never merged and never substituted for one another. --- ### 第四条の三 art-4-3 · https://japanlaw.org/ja/medical-care-act/art-4-3 · https://japanlaw.org/l/323AC0000000205/art-4-3 **第一項** 病院であつて、臨床研究の実施の中核的な役割を担うことに関する次に掲げる要件に該当するものは、厚生労働大臣の承認を得て臨床研究中核病院と称することができる。 art-4-3/par-1 · https://japanlaw.org/ja/medical-care-act/art-4-3/par-1 · https://japanlaw.org/l/323AC0000000205/art-4-3/par-1 A hospital that meets the following requirements for playing a central role in the implementation of clinical research may bear the name "core hospital for clinical research", with the approval of the Minister of Health, Labour and Welfare: Ministry of Justice translation — Japanese Law Translation Database System **一** 特定臨床研究（厚生労働省令で定める基準に従つて行う臨床研究をいう。以下同じ。）に関する計画を立案し、及び実施する能力を有すること。 art-4-3/par-1/item-1 · https://japanlaw.org/ja/medical-care-act/art-4-3/par-1/item-1 · https://japanlaw.org/l/323AC0000000205/art-4-3/par-1/item-1 having the capability of planning and implementing a project on specified clinical research (meaning clinical research conducted in accordance with the standards specified by an Order of the Ministry of Health, Labour and Welfare; the same applies hereinafter); Ministry of Justice translation — Japanese Law Translation Database System **二** 他の病院又は診療所と共同して特定臨床研究を実施する場合にあつては、特定臨床研究の実施の主導的な役割を果たす能力を有すること。 art-4-3/par-1/item-2 · https://japanlaw.org/ja/medical-care-act/art-4-3/par-1/item-2 · https://japanlaw.org/l/323AC0000000205/art-4-3/par-1/item-2 having the capability of playing a leading role in the implementation of the specified clinical research, in the case where specified clinical research is to be implemented jointly with other hospitals or clinic; Ministry of Justice translation — Japanese Law Translation Database System **三** 他の病院又は診療所に対し、特定臨床研究の実施に関する相談に応じ、必要な情報の提供、助言その他の援助を行う能力を有すること。 art-4-3/par-1/item-3 · https://japanlaw.org/ja/medical-care-act/art-4-3/par-1/item-3 · https://japanlaw.org/l/323AC0000000205/art-4-3/par-1/item-3 having the capability of providing consultation, necessary information, advice and other assistance to other hospitals or clinics concerning the implementation of specified clinical research; Ministry of Justice translation — Japanese Law Translation Database System **四** 特定臨床研究に関する研修を行う能力を有すること。 art-4-3/par-1/item-4 · https://japanlaw.org/ja/medical-care-act/art-4-3/par-1/item-4 · https://japanlaw.org/l/323AC0000000205/art-4-3/par-1/item-4 having the capability of providing training on specified clinical research; Ministry of Justice translation — Japanese Law Translation Database System **五** その診療科名中に厚生労働省令で定める診療科名を有すること。 art-4-3/par-1/item-5 · https://japanlaw.org/ja/medical-care-act/art-4-3/par-1/item-5 · https://japanlaw.org/l/323AC0000000205/art-4-3/par-1/item-5 having the names of clinical departments amongst its clinical departments, as prescribed by an Order of the Ministry of Health, Labour and Welfare; Ministry of Justice translation — Japanese Law Translation Database System **六** 厚生労働省令で定める数以上の患者を入院させるための施設を有すること。 art-4-3/par-1/item-6 · https://japanlaw.org/ja/medical-care-act/art-4-3/par-1/item-6 · https://japanlaw.org/l/323AC0000000205/art-4-3/par-1/item-6 having facilities to hospitalize more patients than prescribed by an Order of the Ministry of Health, Labour and Welfare; Ministry of Justice translation — Japanese Law Translation Database System **七** その有する人員が第二十二条の三の規定に基づく厚生労働省令で定める要件に適合するものであること。 art-4-3/par-1/item-7 · https://japanlaw.org/ja/medical-care-act/art-4-3/par-1/item-7 · https://japanlaw.org/l/323AC0000000205/art-4-3/par-1/item-7 the personnel meet the requirements prescribed by the Order of the Ministry of Health, Labour and Welfare set forth in Article 22-3; Ministry of Justice translation — Japanese Law Translation Database System **八** 第二十一条第一項第二号から第八号まで及び第十号から第十二号まで並びに第二十二条の三第二号、第五号及び第六号に規定する施設を有すること。 art-4-3/par-1/item-8 · https://japanlaw.org/ja/medical-care-act/art-4-3/par-1/item-8 · https://japanlaw.org/l/323AC0000000205/art-4-3/par-1/item-8 having facilities provided for in Article 21, paragraph (1), items (ii) through (viii) and (x) through (xii), and Article 22-3, items (ii), (v) and (vi); Ministry of Justice translation — Japanese Law Translation Database System **九** その施設の構造設備が第二十一条第一項及び第二十二条の三の規定に基づく厚生労働省令並びに同項の規定に基づく都道府県の条例で定める要件に適合するものであること。 art-4-3/par-1/item-9 · https://japanlaw.org/ja/medical-care-act/art-4-3/par-1/item-9 · https://japanlaw.org/l/323AC0000000205/art-4-3/par-1/item-9 the buildings and equipment of the facility meet the requirements prescribed by the Order of the Ministry of Health, Labour and Welfare set forth in Article 21, paragraph (1) and Article 22-3 and Prefectural Ordinances set forth therein; and Ministry of Justice translation — Japanese Law Translation Database System **十** 前各号に掲げるもののほか、特定臨床研究の実施に関する厚生労働省令で定める要件に適合するものであること。 art-4-3/par-1/item-10 · https://japanlaw.org/ja/medical-care-act/art-4-3/par-1/item-10 · https://japanlaw.org/l/323AC0000000205/art-4-3/par-1/item-10 beyond what is listed in each of the preceding items, the requirements specified by an Order of the Ministry of Health, Labour and Welfare concerning the implementation of specified clinical research are met. Ministry of Justice translation — Japanese Law Translation Database System **第二項** 厚生労働大臣は、前項の承認をするに当たつては、あらかじめ、社会保障審議会の意見を聴かなければならない。 art-4-3/par-2 · https://japanlaw.org/ja/medical-care-act/art-4-3/par-2 · https://japanlaw.org/l/323AC0000000205/art-4-3/par-2 In granting approval as set forth in the preceding paragraph, the Minister of Health, Labour and Welfare must hear the opinions of the Social Security Council in advance. Ministry of Justice translation — Japanese Law Translation Database System **第三項** 臨床研究中核病院でないものは、これに臨床研究中核病院又はこれに紛らわしい名称を称してはならない。 art-4-3/par-3 · https://japanlaw.org/ja/medical-care-act/art-4-3/par-3 · https://japanlaw.org/l/323AC0000000205/art-4-3/par-3 A facility that is not a core hospital for clinical research is not to bear the name "core hospital for clinical research" or a name that may cause it to be mistaken for such. Ministry of Justice translation — Japanese Law Translation Database System --- ## Cites - art-4-3/par-1/item-7: 第二十二条の三 → 医療法 第二十二条の三 (Article 22-3), art-22-3 — https://japanlaw.org/ja/medical-care-act/art-22-3 · https://japanlaw.org/l/323AC0000000205/art-22-3 - art-4-3/par-1/item-8: 第二十一条第一項第二号から第八号まで → 医療法 第二十一条第一項第二号 (Article 21, paragraph (1), item (ii)), art-21/par-1/item-2 — https://japanlaw.org/ja/medical-care-act/art-21/par-1/item-2 · https://japanlaw.org/l/323AC0000000205/art-21/par-1/item-2 - art-4-3/par-1/item-8: 第二十一条第一項第二号から第八号まで → 医療法 第二十一条第一項第三号 (Article 21, paragraph (1), item (iii)), art-21/par-1/item-3 — https://japanlaw.org/ja/medical-care-act/art-21/par-1/item-3 · https://japanlaw.org/l/323AC0000000205/art-21/par-1/item-3 - art-4-3/par-1/item-8: 第二十一条第一項第二号から第八号まで → 医療法 第二十一条第一項第四号 (Article 21, paragraph (1), item (iv)), art-21/par-1/item-4 — https://japanlaw.org/ja/medical-care-act/art-21/par-1/item-4 · https://japanlaw.org/l/323AC0000000205/art-21/par-1/item-4 - art-4-3/par-1/item-8: 第二十一条第一項第二号から第八号まで → 医療法 第二十一条第一項第五号 (Article 21, paragraph (1), item (v)), art-21/par-1/item-5 — https://japanlaw.org/ja/medical-care-act/art-21/par-1/item-5 · https://japanlaw.org/l/323AC0000000205/art-21/par-1/item-5 - art-4-3/par-1/item-8: 第二十一条第一項第二号から第八号まで → 医療法 第二十一条第一項第六号 (Article 21, paragraph (1), item (vi)), art-21/par-1/item-6 — https://japanlaw.org/ja/medical-care-act/art-21/par-1/item-6 · https://japanlaw.org/l/323AC0000000205/art-21/par-1/item-6 - art-4-3/par-1/item-8: 第二十一条第一項第二号から第八号まで → 医療法 第二十一条第一項第七号 (Article 21, paragraph (1), item (vii)), art-21/par-1/item-7 — https://japanlaw.org/ja/medical-care-act/art-21/par-1/item-7 · https://japanlaw.org/l/323AC0000000205/art-21/par-1/item-7 - art-4-3/par-1/item-8: 第二十一条第一項第二号から第八号まで → 医療法 第二十一条第一項第八号 (Article 21, paragraph (1), item (viii)), art-21/par-1/item-8 — https://japanlaw.org/ja/medical-care-act/art-21/par-1/item-8 · https://japanlaw.org/l/323AC0000000205/art-21/par-1/item-8 - art-4-3/par-1/item-8: 第十号から第十二号まで → 医療法 第二十一条第一項第十号 (Article 21, paragraph (1), item (x)), art-21/par-1/item-10 — https://japanlaw.org/ja/medical-care-act/art-21/par-1/item-10 · https://japanlaw.org/l/323AC0000000205/art-21/par-1/item-10 - art-4-3/par-1/item-8: 第十号から第十二号まで → 医療法 第二十一条第一項第十一号 (Article 21, paragraph (1), item (xi)), art-21/par-1/item-11 — https://japanlaw.org/ja/medical-care-act/art-21/par-1/item-11 · https://japanlaw.org/l/323AC0000000205/art-21/par-1/item-11 - art-4-3/par-1/item-8: 第十号から第十二号まで → 医療法 第二十一条第一項第十二号 (Article 21, paragraph (1), item (xii)), art-21/par-1/item-12 — https://japanlaw.org/ja/medical-care-act/art-21/par-1/item-12 · https://japanlaw.org/l/323AC0000000205/art-21/par-1/item-12 - art-4-3/par-1/item-8: 第二十二条の三第二号 → 医療法 第二十二条の三第一項第二号 (Article 22-3, paragraph (1), item (ii)), art-22-3/par-1/item-2 — https://japanlaw.org/ja/medical-care-act/art-22-3/par-1/item-2 · https://japanlaw.org/l/323AC0000000205/art-22-3/par-1/item-2 - art-4-3/par-1/item-8: 第五号 → 医療法 第二十二条の三第一項第五号 (Article 22-3, paragraph (1), item (v)), art-22-3/par-1/item-5 — https://japanlaw.org/ja/medical-care-act/art-22-3/par-1/item-5 · https://japanlaw.org/l/323AC0000000205/art-22-3/par-1/item-5 - art-4-3/par-1/item-8: 第六号 → 医療法 第二十二条の三第一項第六号 (Article 22-3, paragraph (1), item (vi)), art-22-3/par-1/item-6 — https://japanlaw.org/ja/medical-care-act/art-22-3/par-1/item-6 · https://japanlaw.org/l/323AC0000000205/art-22-3/par-1/item-6 - art-4-3/par-1/item-9: 第二十一条第一項 → 医療法 第二十一条第一項 (Article 21, paragraph (1)), art-21/par-1 — https://japanlaw.org/ja/medical-care-act/art-21/par-1 · https://japanlaw.org/l/323AC0000000205/art-21/par-1 - art-4-3/par-1/item-9: 第二十二条の三 → 医療法 第二十二条の三 (Article 22-3), art-22-3 — https://japanlaw.org/ja/medical-care-act/art-22-3 · https://japanlaw.org/l/323AC0000000205/art-22-3 - art-4-3/par-1/item-10: 前各号 → 医療法 第四条の三第一項第一号 (Article 4-3, paragraph (1), item (i)), art-4-3/par-1/item-1 — https://japanlaw.org/ja/medical-care-act/art-4-3/par-1/item-1 · https://japanlaw.org/l/323AC0000000205/art-4-3/par-1/item-1 - art-4-3/par-1/item-10: 前各号 → 医療法 第四条の三第一項第二号 (Article 4-3, paragraph (1), item (ii)), art-4-3/par-1/item-2 — https://japanlaw.org/ja/medical-care-act/art-4-3/par-1/item-2 · https://japanlaw.org/l/323AC0000000205/art-4-3/par-1/item-2 - art-4-3/par-1/item-10: 前各号 → 医療法 第四条の三第一項第三号 (Article 4-3, paragraph (1), item (iii)), art-4-3/par-1/item-3 — https://japanlaw.org/ja/medical-care-act/art-4-3/par-1/item-3 · https://japanlaw.org/l/323AC0000000205/art-4-3/par-1/item-3 - art-4-3/par-1/item-10: 前各号 → 医療法 第四条の三第一項第四号 (Article 4-3, paragraph (1), item (iv)), art-4-3/par-1/item-4 — https://japanlaw.org/ja/medical-care-act/art-4-3/par-1/item-4 · https://japanlaw.org/l/323AC0000000205/art-4-3/par-1/item-4 - art-4-3/par-1/item-10: 前各号 → 医療法 第四条の三第一項第五号 (Article 4-3, paragraph (1), item (v)), art-4-3/par-1/item-5 — https://japanlaw.org/ja/medical-care-act/art-4-3/par-1/item-5 · https://japanlaw.org/l/323AC0000000205/art-4-3/par-1/item-5 - art-4-3/par-1/item-10: 前各号 → 医療法 第四条の三第一項第六号 (Article 4-3, paragraph (1), item (vi)), art-4-3/par-1/item-6 — https://japanlaw.org/ja/medical-care-act/art-4-3/par-1/item-6 · https://japanlaw.org/l/323AC0000000205/art-4-3/par-1/item-6 - art-4-3/par-1/item-10: 前各号 → 医療法 第四条の三第一項第七号 (Article 4-3, paragraph (1), item (vii)), art-4-3/par-1/item-7 — https://japanlaw.org/ja/medical-care-act/art-4-3/par-1/item-7 · https://japanlaw.org/l/323AC0000000205/art-4-3/par-1/item-7 - art-4-3/par-1/item-10: 前各号 → 医療法 第四条の三第一項第八号 (Article 4-3, paragraph (1), item (viii)), art-4-3/par-1/item-8 — https://japanlaw.org/ja/medical-care-act/art-4-3/par-1/item-8 · https://japanlaw.org/l/323AC0000000205/art-4-3/par-1/item-8 - art-4-3/par-1/item-10: 前各号 → 医療法 第四条の三第一項第九号 (Article 4-3, paragraph (1), item (ix)), art-4-3/par-1/item-9 — https://japanlaw.org/ja/medical-care-act/art-4-3/par-1/item-9 · https://japanlaw.org/l/323AC0000000205/art-4-3/par-1/item-9 - art-4-3/par-2: 前項 → 医療法 第四条の三第一項 (Article 4-3, paragraph (1)), art-4-3/par-1 — https://japanlaw.org/ja/medical-care-act/art-4-3/par-1 · https://japanlaw.org/l/323AC0000000205/art-4-3/par-1 ## Cited by 6 provisions cite this one. No official source publishes this direction. - 健康保険法 第六十三条第四項（療養の給付） — https://japanlaw.org/ja/health-insurance-act/art-63/par-4 · https://japanlaw.org/l/211AC0000000070/art-63/par-4 - 医療法 第四条の三第一項第十号 — https://japanlaw.org/ja/medical-care-act/art-4-3/par-1/item-10 · https://japanlaw.org/l/323AC0000000205/art-4-3/par-1/item-10 - 医療法 第四条の三第二項 — https://japanlaw.org/ja/medical-care-act/art-4-3/par-2 · https://japanlaw.org/l/323AC0000000205/art-4-3/par-2 - 医療法 第二十九条第五項第一号 — https://japanlaw.org/ja/medical-care-act/art-29/par-5/item-1 · https://japanlaw.org/l/323AC0000000205/art-29/par-5/item-1 - 医療法 第八十九条第一項第一号 — https://japanlaw.org/ja/medical-care-act/art-89/par-1/item-1 · https://japanlaw.org/l/323AC0000000205/art-89/par-1/item-1 - 高齢者の医療の確保に関する法律 第六十四条第四項（療養の給付） — https://japanlaw.org/ja/elderly-medical-care-act/art-64/par-4 · https://japanlaw.org/l/357AC0000000080/art-64/par-4 --- ## Sources - e-Gov 法令検索, Digital Agency (デジタル庁) — 医療法 — the text in force from 2026-10-01 (https://laws.e-gov.go.jp/law/323AC0000000205/20261001_507AC0000000087), retrieved 2026-10-19 - Japanese Law Translation Database System, Ministry of Justice (法務省) — Medical Care Act — Ministry of Justice translation (https://www.japaneselawtranslation.go.jp/en/laws/view/4006/tb), retrieved 2026-10-19 - This site's parser, version 210 — 医療法 — structure, counts, cross-references and defined terms, computed 2026-10-19