Medical Care Act

When a prefectural governor, the mayor of a city with a public health center, or the mayor of a special ward of Tokyo finds it necessary, the governor or mayor may order the establisher or administrator of a hospital, clinic, or birthing center, or the founder of a facility for receiving online medical care, to report as necessary, and may have the relevant officials enter the relevant hospital, clinic, birthing center or facility for receiving online medical care and inspect the personnel or the state of cleanliness, its buildings, and equipment, its medical records, birth records, books and documents, and other articles.

When a prefectural governor, the mayor of a city with a public health center, or the mayor of a special ward of Tokyo suspects that the operation of a hospital, clinic, birthing center or facility for receiving online medical care is in violation of laws and regulations or a disposition based on laws and regulations, or suspects that the management thereof is significantly unsuitable, the governor or mayor may order the establisher or administrator of the relevant hospital, clinic, or birthing center, or the founder of the relevant facility for receiving online medical care, to submit medical records, birth records, books and documents, and other articles, or have the relevant officials enter the office of the establisher of the relevant hospital, clinic or birthing center or of the founder of the relevant facility for receiving online medical care, or other places related to the operation of the relevant hospital, clinic, birthing center or facility for receiving online medical care, and inspect books and documents, and other articles to the extent necessary for the enforcement of this Act.

When the Minister of Health, Labour and Welfare finds it necessary, the minister may order the establisher or administrator of an advanced treatment hospital, etc. to report as necessary, and may have the relevant officials enter the advanced treatment hospital, etc. and inspect the personnel or the state of cleanliness, its buildings and equipment, medical records, birth records, books and documents, and other articles.

When the Minister of Health, Labour and Welfare suspects that the operation of an advanced treatment hospital, etc. is in violation of laws and regulations or a disposition based on laws and regulations, or suspects that the management thereof is significantly unsuitable, the minister may order the establisher or administrator of the relevant advanced treatment hospital, etc. to submit medical records, birth records, books and documents, or other articles.

The provisions set forth in Article 6-8, paragraph (3) apply mutatis mutandis pursuant to entry and inspection as set forth in paragraph (1) through paragraph (3), and the provisions set forth in paragraph (4) of the same Article apply mutatis mutandis pursuant to the authority set forth in each of the preceding paragraphs.

The mayors of cities with a public health center and the mayors of special wards of Tokyo must, as provided by Order of the Ministry of Health, Labour and Welfare, give notice to the prefectural governor of the particulars specified by Order of the Ministry of Health, Labour and Welfare concerning clinics, birthing centers and facilities for receiving online medical care.

The Minister of Health, Labour and Welfare, prefectural governors, mayors of cities with public health centers, and mayors of special wards of Tokyo are to appoint medical care inspectors from among the officials of the Ministry of Health, Labour and Welfare, prefecture, city with the public health center, or special ward of Tokyo, to be entrusted with the authority of the relevant officials provided for in Article 25, paragraphs (1) and (3).

Beyond the provisions of the preceding paragraph, necessary particulars concerning medical care inspectors are to be as prescribed by an Order of the Ministry of Health, Labour and Welfare.

A hospital, clinic with in-patient facilities, or birthing center with admission facilities must not use its buildings and equipment without first undergoing inspection by the prefectural governor with jurisdiction over their location and receiving a license.

When the establisher or administrator of a hospital or clinic fails to comply with the conditions attached to the permission granted under the provisions of Article 7, paragraph (5) or (6) without justifiable grounds, the prefectural governor may recommend that the relevant establisher or administrator comply with the relevant conditions by a set deadline, after hearing the opinions of the Prefectural Council on Medical Service Facilities.

When the establisher or administrator of a hospital or clinic who has received a recommendation pursuant to the provisions of the preceding paragraph fails to take measures pertaining to the relevant recommendation without justifiable grounds, the prefectural governor may order the relevant establisher or administrator to take measures pertaining to the relevant recommendation by a set deadline, after hearing the opinions of the Prefectural Council on Medical Service Facilities.

If a prefectural governor has issued an order under the preceding paragraph, and the establisher or administrator of a hospital or clinic who has received the relevant order fails to comply with it, the prefectural governor may make a public announcement to that effect.

When the prefectural governor finds the administrator of a hospital, clinic, or birthing center to have committed a criminal act, to have committed an unlawful act related to medical practice, or to be unfit to manage, the governor may order the establisher of the relevant hospital, clinic, or birthing center to replace the relevant administrator by a set deadline.

The prefectural governor may rescind permission for establishment of a hospital, clinic, or birthing center, or may order the establisher of the hospital, clinic or birthing center or the founder of the facility for receiving online medical care to close it by a period that the governor prescribes, if it falls under any of the following items:

when operation has not commenced six months or more after permission was received for its establishment, without justifiable grounds;

when the operation of a hospital, clinic (excluding where notification and establishment have taken place as set forth in Article 8, paragraph (1)), birthing center (excluding where notification and establishment have taken place as set forth in the same paragraph), or facility for receiving online medical care has not re-commenced one year or more after it was suspended, without justifiable grounds;

when the establisher has violated an order or disposition based on the provisions of Article 6-3, paragraph (8), Article 6-12-2, paragraph (5), Article 24, paragraph (1), or the preceding Article; or

when the establisher or founder has violated an order based on the provisions of Article 24-2, paragraph (2).

when the establisher or founder has committed a criminal act or an unlawful act related to medical practice.

The prefectural governor may, when operation related to the permission pursuant to the provisions of Article 7, paragraph (2) or (3) has not commenced six months or more after the relevant permission was received without justifiable grounds, rescind the relevant permission.

The prefectural governor may rescind the approval for a regional medical care support hospital if it falls under any of the following items:

when the regional medical care support hospital has failed to meet the requirements listed in each item of Article 4, paragraph (1);

when the establisher of the regional medical care support hospital has violated provisions of Article 12-2, paragraph (1);

when the establisher of the regional medical care support hospital has violated an order based on the provisions of Article 24, paragraph (1), Article 30-13, paragraph (5), Article 30-18-2, paragraph (2) or Article 30-18-4, paragraph (6);

when the administrator of a regional medical care support hospital has violated the provisions of Article 16-2, paragraph (1);

when the administrator of a regional medical care support hospital fails to comply with an instruction under Article 30-12-6, paragraph (9);

when the establisher or administrator of the regional medical care support hospital has violated an order under the provisions of Article 7-2, paragraph (8), Article 27-2, paragraph (2), or Article 30-15, paragraph (6);

when the establisher or administrator of the regional medical care support hospital fails to comply with a recommendation under the provisions of Article 30-12, paragraph (2) or Article 30-17; or

when the establisher or administrator of the regional medical care support hospital fails to comply with an instruction under the provisions of Article 30-16, paragraph (1).

when the administrator of a regional medical care support hospital fails to comply with an instruction under Article 36-4, paragraph (1) or (3) of the Act on the Prevention of Infectious Diseases and Medical Care for Patients with Infectious Diseases.

The Minister of Health, Labour and Welfare may rescind their approval for an advanced treatment hospital, if it falls under any of the following items:

when the advanced treatment hospital has failed to meet the requirements listed in each of the items of Article 4-2, paragraph (1);

when the establisher of the advanced treatment hospital has violated the provisions of Article 10-2, Article 12-3, paragraph (1), or Article 19-2;

when the establisher of the advanced treatment hospital has violated an order based on the provisions of Article 24, paragraph (2), Article 30-13, paragraph (5), Article 30-18-2, paragraph (2) or Article 30-18-4, paragraph (6);

when the administrator of the advanced treatment hospital has violated the provisions of paragraph (1) or (2) of Article 16-3;

when the administrator of the advanced treatment hospital fails to comply with an instruction under Article 30-12-6, paragraph (9);

when the establisher or administrator of the advanced treatment hospital has violated an order under the provisions of Article 7-2, paragraph (8), Article 27-2, paragraph (2), or Article 30-15, paragraph (6);

when the establisher or administrator of the advanced treatment hospital fails to comply with a recommendation under the provisions of Article 30-12, paragraph (2) or Article 30-17; or

when the establisher or administrator of the advanced treatment hospital fails to comply with an instruction under the provisions of Article 30-16, paragraph (1).

when the administrator of the advanced treatment hospital fails to comply with an instruction under Article 36-4, paragraph (1) or (3) of the Act on the Prevention of Infectious Diseases and Medical Care for Patients with Infectious Diseases.

The Minister of Health, Labour and Welfare may revoke the approval for a core hospital for clinical research, if it falls under any of the following items:

when the core hospital for clinical research has failed to meet the requirements listed in each of the items of Article 4-3, paragraph (1);

when the establisher of the core hospital for clinical research has violated the provisions of Article 12-4, paragraph (1);

when the establisher of the core hospital for clinical research has violated an order under the provisions of Article 24, paragraph (2); or

when the administrator of the core hospital for clinical research has violated the provisions of Article 16-4.

In revoking the approval for a regional medical care support hospital pursuant to the provisions of paragraph (3), the prefectural governor must hear the opinions of the Prefectural Council on Medical Service Facilities in advance.

In revoking the approval for an advanced treatment hospital, etc. pursuant to the provisions of paragraph (4) or (5), the Minister of Health, Labour and Welfare must hear the opinions of the Social Security Council in advance.

If the Minister of Health, Labour and Welfare finds an urgent necessity to protect the health of the citizens, the minister may instruct a prefectural governor to render a disposition pursuant to the provisions of Article 28, and paragraph (1) and paragraph (2) of the preceding Article.

When a disposition has been rendered pursuant to the provisions of Article 23-2, Article 24, paragraph (1), Article 24-2, Article 28, or Article 29, paragraph (1) or (3) in advance of an opportunity for explanation being granted or a hearing being undertaken pursuant to Article 13, paragraph (2), item (i) of the Administrative Procedure Act (Act No. 88 of 1993), the prefectural governor must grant an opportunity for explanation to parties subject to the relevant disposition within three days of the relevant disposition.

Beyond those provided for in this Chapter, the necessary particulars concerning the establishment and management of hospitals, clinics and birthing centers, and the establishment of facilities for receiving online medical care, are to be as specified by Cabinet Order.