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Section 1 Foundation

第一節 開設等

Article 7

第七条

When a person wishes to establish a hospital, when a person who is neither a person registered pursuant to the provisions of Article 16-6, paragraph (1) of the Medical Practitioners' Act (Act No. 201 of 1948) (for a person who has been issued an order by the Minister of Health, Labour and Welfare pursuant to the provisions of Article 7-2, paragraph (1) of that Act, limited to a person registered pursuant to the provisions of paragraph (2) of that Article; hereinafter referred to as a "clinically trained physician") nor a person registered pursuant to the provisions of (for a person who has been issued an order by the Minister of Health, Labour and Welfare pursuant to the provisions of , limited to a person registered pursuant to the provisions of ; hereinafter referred to as a "clinically trained dentist") wishes to establish a clinic, or when a person who is not a midwife (for a person who has been issued an order by the Minister of Health, Labour and Welfare pursuant to the provisions of , limited to a person registered pursuant to the provisions of ; hereinafter the same applies in this Article, Article 8, paragraph (1) and Article 11) wishes to establish a birthing center, the person must first acquire permission to do so from the prefectural governor for the location of the relevant facility (the mayor of the city with a public health center or the mayor of the special ward in the case that the location of the relevant clinic or birthing center is within such a city with a public health center or a special ward; the same applies in Article 8, paragraph (1), Article 12, Article 15, Article 18, Article 24, Article 27, Article 28 and Article 29, paragraph (2)).

病院を開設しようとするとき、医師法(昭和二十三年法律第二百一号)第十六条の六第一項の規定による登録を受けた者(同法第七条の二第一項の規定による厚生労働大臣の命令を受けた者にあつては、同条第二項の規定による登録を受けた者に限る。以下「臨床研修等修了医師」という。)及びの規定による登録を受けた者(の規定による厚生労働大臣の命令を受けた者にあつては、の規定による登録を受けた者に限る。以下「臨床研修等修了歯科医師」という。)でない者が診療所を開設しようとするとき、又は助産師(の規定による厚生労働大臣の命令を受けた者にあつては、の規定による登録を受けた者に限る。以下この条、第八条第一項及び第十一条において同じ。)でない者が助産所を開設しようとするときは、開設地の都道府県知事(診療所又は助産所にあつては、その開設地が保健所を設置する市又は特別区の区域にある場合においては、当該保健所を設置する市の市長又は特別区の区長。第八条第一項、第十二条、第十五条、第十八条、第二十四条、第二十七条、第二十八条及び第二十九条第二項において同じ。)の許可を受けなければならない。

When a person who has established a hospital wishes to alter the number of beds, the classification of beds described in each of the following items (hereinafter referred to as "bed classifications"), or other particulars prescribed by an Order of the Ministry of Health, Labour and Welfare, when a person who is neither a clinically trained physician nor a clinically trained dentist but has established a clinic or a person who is not a midwife but has established a birthing center, wishes to alter the number of beds or other particulars prescribed by an Order of the Ministry of Health, Labour and Welfare, the same applies as in the preceding paragraph, except where prescribed by an Order of the Ministry of Health, Labour and Welfare:

病院を開設した者が、病床数、次の各号に掲げる病床の種別(以下「病床の種別」という。)その他厚生労働省令で定める事項を変更しようとするとき、又は臨床研修等修了医師及び臨床研修等修了歯科医師でない者で診療所を開設したもの若しくは助産師でない者で助産所を開設したものが、病床数その他厚生労働省令で定める事項を変更しようとするときも、厚生労働省令で定める場合を除き、前項と同様とする。

psychiatric hospital beds (meaning hospital beds for the hospitalization of persons with psychiatric disorders; the same applies hereinafter):

精神病床(病院の病床のうち、精神疾患を有する者を入院させるためのものをいう。以下同じ。)

infectious disease hospital beds (meaning hospital beds for the hospitalization of patients (including persons regarded as patients with category 1 infectious diseases, category 2 infectious diseases, pandemic influenza or similar infectious diseases, or designated infectious diseases pursuant to the provisions of (including as applied mutatis mutandis pursuant to )) with category 1 infectious diseases provided for in , category 2 infectious diseases provided for in (except tuberculosis), pandemic influenza or similar infectious diseases provided for in , and designated infectious diseases provided for in (limited to those infectious diseases to which the provisions of or apply mutatis mutandis under the provisions of ), and persons found to have new infectious diseases provided for in ; the same applies hereinafter):

感染症病床(病院の病床のうち、に規定する一類感染症、に規定する二類感染症(結核を除く。)、に規定する新型インフルエンザ等感染症及びに規定する指定感染症(の規定により又はの規定を準用するものに限る。)の患者((において準用する場合を含む。)の規定により一類感染症、二類感染症、新型インフルエンザ等感染症又は指定感染症の患者とみなされる者を含む。)並びにに規定する新感染症の所見がある者を入院させるためのものをいう。以下同じ。)

tuberculosis hospital beds (meaning hospital beds for the hospitalization of tuberculosis patients; the same applies hereinafter):

結核病床(病院の病床のうち、結核の患者を入院させるためのものをいう。以下同じ。)

long-term care beds (meaning hospital or clinic beds other than those described in the above three items that are primarily for the hospitalization of patients requiring long-term recuperation; the same applies hereinafter): or

療養病床(病院又は診療所の病床のうち、前三号に掲げる病床以外の病床であつて、主として長期にわたり療養を必要とする患者を入院させるためのものをいう。以下同じ。)

general beds (meaning hospital or clinic beds other than those described in each of the above items; the same applies hereinafter).

一般病床(病院又は診療所の病床のうち、前各号に掲げる病床以外のものをいう。以下同じ。)

When a person wishes to provide beds in a clinic, or when the person wishes to alter the number of beds in a clinic, the bed classifications, or other particulars prescribed by an Order of the Ministry of Health, Labour and Welfare, the person must first acquire permission to do so from the prefectural governor of the area in which the relevant clinic is situated, except where prescribed by an Order of the Ministry of Health, Labour and Welfare.

診療所に病床を設けようとするとき、又は診療所の病床数、病床の種別その他厚生労働省令で定める事項を変更しようとするときは、厚生労働省令で定める場合を除き、当該診療所の所在地の都道府県知事の許可を受けなければならない。

Where there has been an application for permission as set forth in the preceding three paragraphs, the prefectural governor, mayor of a city with a public health center or mayor of a special ward must grant permission as set forth in the preceding three paragraphs if the buildings, equipment, and personnel of the facility pertaining to the relevant application comply with the requirements prescribed by the Order of the Ministry of Health, Labour and Welfare set forth in Article 21 and Article 23 and the Prefectural Ordinance set forth in Article 21.

都道府県知事又は保健所を設置する市の市長若しくは特別区の区長は、前三項の許可の申請があつた場合において、その申請に係る施設の構造設備及びその有する人員が第二十一条及び第二十三条の規定に基づく厚生労働省令並びに第二十一条の規定に基づく都道府県の条例の定める要件に適合するときは、前三項の許可を与えなければならない。

A prefectural governor, when granting permission on an application for permission to establish a hospital, to increase the number of beds or alter bed classifications of a hospital, to set up beds in a clinic, or to increase the number of beds or alter bed classifications of a clinic, may attach to that permission the condition of providing, in the beds pertaining to the relevant application, medical care pertaining to those of the functional classifications of beds prescribed in Article 30-13, paragraph (1) (hereinafter referred to as "functional classification of beds" in this paragraph) for which the number of existing beds according to the functional classification of beds in the vision area (meaning the "vision area" prescribed in Article 30-4, paragraph (2), item (vii), which is specified in a medical care plan prescribed in Article 30-4, paragraph (1) (hereinafter referred to as "medical care plan" in this Article, the following Article and Article 7-3, paragraph (1)); the same applies in Article 7-3, paragraph (1)) including the location of the hospital or clinic pertaining to the relevant application has not reached the future requirements for the number of beds prescribed in Article 30-4, paragraph (2), item (vii), (a) in the relevant vision area specified in the medical care plan, or any other condition specified by an Order of the Ministry of Health, Labour and Welfare as necessary for the promotion of the achievement of the regional medical care vision prescribed in Article 30-4, paragraph (2), item (vii) specified in the medical care plan.

都道府県知事は、病院の開設の許可若しくは病院の病床数の増加若しくは病床の種別の変更の許可又は診療所の病床の設置の許可若しくは診療所の病床数の増加若しくは病床の種別の変更の許可の申請に対する許可には、当該申請に係る病床において、第三十条の十三第一項に規定する病床の機能区分(以下この項において「病床の機能区分」という。)のうち、当該申請に係る病院又は診療所の所在地を含む構想区域(第三十条の四第一項に規定する医療計画(以下この条、次条及び第七条の三第一項において「医療計画」という。)において定める第三十条の四第二項第七号に規定する構想区域をいう。第七条の三第一項において同じ。)における病床の機能区分に応じた既存の病床数が、医療計画において定める当該構想区域における同号イに規定する将来の病床数の必要量に達していないものに係る医療を提供することその他の医療計画において定める同号に規定する地域医療構想の達成の推進のために必要なものとして厚生労働省令で定める条件を付することができる。

In the case where a prefecture conducts the affairs relating to the permission set forth in paragraphs (1) to (3) pursuant to the provisions of Article 30-4, paragraph (10), or conducts the affairs relating to those permissions pursuant to the provisions of paragraph (11) of that Article, when it is found that the circumstances specified by the Cabinet Order set forth in paragraph (10) of that Article have ceased to exist, or when operations relating to beds are no longer carried out in the beds specified by the Order of the Ministry of Health, Labour and Welfare set forth in paragraph (11) of that Article, conditions may be attached to those permissions, namely taking measures to change the permission, the content of which is to reduce the number of specially permitted beds within the range of the number of beds that exceeds the target number of beds, and other conditions specified by Order of the Ministry of Health, Labour and Welfare as necessary for ensuring the medical care delivery system prescribed in Article 30-3, paragraph (1); here, the number is the number of hospital or clinic beds corresponding to the bed classifications of the beds to which the relevant permission relates (where the specially permitted beds are long-term care beds, etc. only, the number of long-term care beds and general beds in that area) in the area that includes the location of the hospital or clinic to which the relevant permission relates (where the beds to which the relevant permission relates (hereinafter referred to as "specially permitted beds" in this paragraph) are long-term care beds or general beds (hereinafter referred to as "long-term care beds, etc." in this paragraph, the following Article and Article 7-3, paragraph (1)) only, this is to be the area provided for in Article 30-4, paragraph (2), item (xiv) as prescribed by the medical care plan; where the specially permitted beds are psychiatric hospital beds, infectious disease hospital beds or tuberculosis hospital beds (hereinafter referred to as "psychiatric hospital beds, etc." in this paragraph and paragraph (1) of the following Article) only, this is to be the area of the prefecture; and where the specially permitted beds are long-term care beds, etc. and psychiatric hospital beds, etc., this is to be the area provided for in that item and the area of the prefecture), and the target number of beds is the target number of beds for that area corresponding to the bed classifications of the beds to which the relevant permission relates (where the specially permitted beds are long-term care beds, etc. only, the target number of beds for long-term care beds and general beds in that area) as prescribed in the medical care plan in accordance with the standards specified by Order of the Ministry of Health, Labour and Welfare set forth in Article 30-4, paragraph (8).

都道府県が第三十条の四第十項の規定により第一項から第三項までの許可に係る事務を行う場合又は同条第十一項の規定によりこれらの許可に係る事務を行う場合におけるこれらの許可には、同条第十項の政令で定める事情がなくなつたと認められる場合又は同条第十一項の厚生労働省令で定める病床において当該病床に係る業務が行われなくなつた場合には、当該許可に係る病院又は診療所の所在地を含む地域(当該許可に係る病床(以下この項において「特例許可病床」という。)が療養病床又は一般病床(以下この項、次条及び第七条の三第一項において「療養病床等」という。)のみである場合は医療計画において定める第三十条の四第二項第十四号に規定する区域とし、特例許可病床が精神病床、感染症病床又は結核病床(以下この項及び次条第一項において「精神病床等」という。)のみである場合は当該都道府県の区域とし、特例許可病床が療養病床等及び精神病床等である場合は同号に規定する区域及び当該都道府県の区域とする。)における病院又は診療所の病床の当該許可に係る病床の種別に応じた数(特例許可病床が療養病床等のみである場合は、その地域における療養病床及び一般病床の数)のうち、第三十条の四第八項の厚生労働省令で定める基準に従い医療計画において定めるその地域の当該許可に係る病床の種別に応じた基準病床数(特例許可病床が療養病床等のみである場合は、その地域における療養病床及び一般病床に係る基準病床数)を超えている病床数の範囲内で特例許可病床の数を削減することを内容とする許可の変更のための措置をとることその他の第三十条の三第一項に規定する医療提供体制の確保のために必要なものとして厚生労働省令で定める条件を付することができる。

Notwithstanding the provisions of paragraph (4), the permission set forth in paragraph (1) may be refused to a person who wishes to establish a hospital, clinic or birthing center for profit.

営利を目的として、病院、診療所又は助産所を開設しようとする者に対しては、第四項の規定にかかわらず、第一項の許可を与えないことができる。

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