Medical Care Act

The administrator of a core hospital for clinical research, pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare, must carry out the following particulars:

to develop and implement a plan concerning specified clinical research;

when conducting specified clinical research jointly with other hospitals or clinics, to play a leading role in the implementation of specified clinical research;

to provide consultation, necessary information, advice and other assistance to other hospitals or clinics concerning the implementation of specified clinical research;

to provide training on specified clinical research;

to systematically manage the various records listed in items (iii) and (iv) of Article 22-3; and

other particulars specified by an Order of the Ministry of Health, Labour and Welfare.

Beyond the provisions of Article 6-10 through Article 6-12-2, Article 13 through Article 14-2, Article 14-4, and Article 15 through the preceding Article, particulars that should be observed by the administrator of a hospital, clinic, or birthing center in the management of their buildings and equipment, pharmaceuticals, and other articles, and in the hospitalization or admission of patients, pregnant women, women in labor, and women resting after childbirth, are to be as prescribed by an Order of the Ministry of Health, Labour and Welfare.

The establisher of a hospital or clinic must provide an exclusive pharmacist in the relevant hospital or clinic in accordance with the standards specified by an Order of the Ministry of Health, Labour and Welfare and in accordance with a Prefectural Ordinance; provided, however, that this does not apply where permitted by the prefectural governor of the area in which the hospital or clinic is situated.

The establisher of a birthing center must provide for contract physicians and hospitals or clinics pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare.

When a midwife who only does house calls enters into a contract which provides that she will give midwifery services to a pregnant woman, etc., she must specify the hospital or clinic that responds to the abnormality of the relevant pregnant woman, etc., pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare.

The establisher of an advanced treatment hospital, pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare, must take the following measures to ensure that the administrator of the relevant advanced treatment hospital properly executes the management and operation of the relevant advanced treatment hospital:

to clarify the authority that the relevant administrator has for the management and operation of the relevant advanced treatment hospital;

to set up an audit committee for ensuring the safety of medical care.;

to establish a system to ensure that the execution of the duties of the relevant administrator complies with laws and regulations, a system pertaining to the supervision of the business of the relevant advanced treatment hospital by the relevant establisher, and other systems specified by an Order of the Ministry of Health, Labour and Welfare as necessary to ensure the appropriateness of the business of the relevant advanced treatment hospital: and

other measures specified by an Order of the Ministry of Health, Labour and Welfare as necessary for the proper execution of the management and operation of the relevant advanced treatment hospital by the relevant administrator.

A hospital, clinic, or birthing center is to be maintained in a clean state, and its buildings and equipment must be recognizable as being safe in terms of sanitation, fire safety, and security.

A hospital is to have the following personnel and facilities and must prepare the following records, pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare (in the case of employees listed in item (i) (excluding physicians and dentists) and facilities listed in item (xii), Prefectural Ordinances):

beyond physicians, dentists in the numbers prescribed by an Order of the Ministry of Health, Labour and Welfare, nurses, and other employees in the numbers prescribed by prefectural ordinances, in accordance with the classifications of the beds at the relevant hospital;

a consultation room for each clinical department;

an operating room;

treatment rooms;

a diagnostic laboratory;

an X-ray unit;

a dispensary;

food service facilities;

records concerning medical treatment;

delivery rooms and neonatal bathing facilities in hospitals that have a gynecology and obstetrics department or an obstetrics department;

functional training rooms in hospitals that have long-term care beds; and

other facilities as prescribed by prefectural ordinances.

A clinic with long-term care beds must have the following personnel and facilities, pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare (in the case of employees listed in item (i) (excluding physicians and dentists) and facilities listed in item (iii), Prefectural Ordinances):

beyond physicians, dentists in the numbers prescribed by an Order of the Ministry of Health, Labour and Welfare, nurses, and other employees, including those engaged in nursing support, in the numbers prescribed by Prefectural Ordinances;

functional training rooms; and

other facilities as prescribed by Prefectural Ordinances.

When formulating the ordinances set forth in the preceding two paragraphs, prefectures is to determine the employees and the number of employees of hospitals and clinics with long-term care beds (limited to those specified by an Order of the Ministry of Health, Labour and Welfare) in accordance with the standards specified by an Order of the Ministry of Health, Labour and Welfare, and other particulars with reference to the standards specified by an Order of the Ministry of Health, Labour and Welfare.

Beyond the provisions of paragraph (1) of the preceding Article (excluding item (ix)), a regional medical care support hospital is to have the following facilities and must prepare the following records, pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare:

an intensive care unit;

records concerning medical treatment;

records concerning the management and operation of the hospital;

chemical, bacteriological, and pathological inspection facilities;

an autopsy room;

a laboratory;

a lecture room;

a library; and

other facilities as prescribed by an Order of the Ministry of Health, Labour and Welfare.

Beyond the provisions of Article 21, paragraph (1) (excluding items (i) and (ix)), an advanced treatment hospital is to have the following personnel and facilities and must prepare the following records, pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare:

physicians, dentists, pharmacists, nurses, and other employees in the numbers prescribed by an Order of the Ministry of Health, Labour and Welfare;

an intensive care unit;

records concerning medical treatment;

records concerning the management and operation of the hospital;

the facilities listed in item (iv) through item (viii) of the preceding Article; and

other facilities as prescribed by an Order of the Ministry of Health, Labour and Welfare.

Beyond the provisions of Article 21, paragraph (1) (excluding items (i) and (ix)), a core hospital for clinical research is to have the following personnel and facilities and must prepare the following records, pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare:

physicians, dentists, pharmacists, nurses, and other employees involved in clinical research in the numbers prescribed by an Order of the Ministry of Health, Labour and Welfare;

an intensive care unit;

records concerning medical treatment and clinical research;

records concerning the management and operation of the hospital;

the facilities listed in item (iv) through item (viii) of Article 22; and

other facilities as prescribed by an Order of the Ministry of Health, Labour and Welfare.

Beyond the provisions of Article 21 through the preceding Article, the necessary standards for ensuring satisfactory ventilation, lighting, illumination, damp proofing, security, emergency evacuation, cleanliness, and other sanitary conditions with regard to the buildings and equipment of a hospital, clinic or birthing center, is to be prescribed by an Order of the Ministry of Health, Labour and Welfare.

Regulations may be established by Cabinet Order to sentence persons who have violated the provisions of the Order of the Ministry of Health, Labour and Welfare as set forth in the provisions of the preceding paragraph to a fine of up to 200,000 yen.

When the distribution of personnel in a hospital or in a clinic with long-term care beds is significantly lacking in terms of the standards prescribed by the Order of the Ministry of Health, Labour and Welfare or prefectural ordinances set forth in Article 21, paragraph (1) (limited to the parts pertaining to item (i)) or paragraph (2) (limited to the part pertaining to item (i)), and falls under cases prescribed by an Order of the Ministry of Health, Labour and Welfare as cases that cause a significant impediment to the suitable provision of medical care, the prefectural governor may order the establisher to increase the number of personnel by a set deadline, or may suspend all or a part of its operations for a period that the governor prescribes.

When a hospital, clinic, or birthing center is lacking in cleanliness, or when its buildings and equipment violate the provisions of Article 21, paragraph (1) or (2), or Article 22, or violate the provisions of an Order of the Ministry of Health, Labour and Welfare that is based on the provisions set forth in Article 23, paragraph (1), or are found to be a sanitation hazard or safety risk, the prefectural governor may prescribe a period of time and order the establisher to fully or partially limit or prohibit the use thereof, or may order repairs or reconstruction to be carried out by a set deadline.

When the buildings and equipment of an advanced treatment hospital or core hospital for clinical research (hereinafter referred to as "advanced treatment hospital, etc." in this Section) violate the provisions of Article 22-2 or Article 22-3, the Minister of Health, Labour and Welfare may order their repair or reconstruction to be carried out by the establisher of the relevant advanced treatment hospital, etc. by a set deadline.

When a prefectural governor finds that the business of a hospital, clinic, birthing center or facility for receiving online medical care violates laws and regulations or dispositions under laws and regulations, or that the operation thereof is extremely inappropriate (excluding the cases prescribed in Article 23-2 or paragraph (1) of the preceding Article), the governor may, to the extent necessary for the enforcement of this Act, order the establisher of the relevant hospital, clinic or birthing center or the founder of the relevant facility for receiving online medical care to take necessary measures by a set deadline.

In the event that the establisher or founder set forth in the preceding paragraph does not comply with the order as prescribed in the same paragraph, the prefectural governor may order the relevant establisher or founder to suspend all or part of the business of the hospital, clinic, birthing center or facility for receiving online medical care that they establish, for a specified period of time.