Medical Care Act

The Minister of Health, Labour and Welfare must establish, by Order of the Ministry of Health, Labour and Welfare, standards for the appropriate implementation of online medical care.

The standards set forth in the preceding paragraph are to be prescribed with regard to the following matters:

matters concerning the facilities and equipment necessary in a hospital or clinic for providing online medical care, and the distribution of personnel;

matters concerning the place where a patient receives online medical care;

matters concerning the explanation given to a patient when providing online medical care;

matters concerning cooperation with other hospitals or clinics and otherwise ensuring a system for providing appropriate treatment in the case where a patient's condition suddenly changes;

other matters necessary for the appropriate implementation of online medical care.

Online medical care must be provided in accordance with the standards set forth in paragraph (1).

The administrator of a hospital or clinic at which a physician or dentist who provides online medical care works (referred to as a "hospital, etc. providing online medical care" in the following Article) must take the measures necessary to bring the online medical care provided by that physician or dentist into conformity with the standards set forth in paragraph (1) of the preceding Article, as provided by Order of the Ministry of Health, Labour and Welfare.

The founder of a facility for receiving online medical care must, as provided by Order of the Ministry of Health, Labour and Welfare, make public that the facility for receiving online medical care conforms to the standards set forth in Article 14-3, paragraph (1) in relation to the matters listed in paragraph (2), item (ii) of that Article, and other matters specified by Order of the Ministry of Health, Labour and Welfare as contributing to the selection of facilities for receiving online medical care by the administrator of a hospital, etc. providing online medical care.

The administrator of a hospital or clinic must supervise the physicians, dentists, pharmacists, and other employees working at the relevant hospital or clinic, and must take other necessary precautions for the management and operation of the relevant hospital or clinic, so that they can fulfill their responsibilities prescribed in this Act.

The administrator of a birthing center must supervise the midwives and other employees working at the relevant birthing center, and must take other necessary precautions for the management and operation of the relevant birthing center, so that they can fulfill their responsibilities prescribed in this Act.

The administrator of a hospital or clinic must notify the prefectural governor of the area in which the hospital or clinic is situated, pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare, where the relevant hospital or clinic has an x-ray unit for medical treatment, or in other cases prescribed by an Order of the Ministry of Health, Labour and Welfare.

The administrator of a hospital, clinic or birthing center, when performing specimen testing prescribed in Article 2 of the Act on Clinical Laboratory Technicians (Act No. 76 of 1958) (hereinafter referred to as "specimen testing" in this Article and paragraph (1) of the following Article) in the relevant hospital, clinic or birthing center, must ensure that the buildings and equipment of the facilities where specimen testing is performed, management organization, methods for ensuring the accuracy of specimen testing and other particulars conform to the standards specified by an Order of the Ministry of Health, Labour and Welfare as necessary for the proper performance of specimen testing.

When the administrator of a hospital, clinic or birthing center wishes to entrust specimen testing, the administrator must do so to the following persons:

an establisher of a sanitary laboratory registered under Article 20-3, paragraph (1) of the Act on Clinical Laboratory Technicians.; and

a person who performs specimen testing in a hospital, clinic or other places specified by an Order of the Ministry of Health, Labour and Welfare, and the buildings and equipment of the facilities where the person performs specimen testing, management organization, methods for ensuring the accuracy of specimen testing and other particulars conform to the standards specified by an Order of the Ministry of Health, Labour and Welfare as necessary for the proper performance of specimen testing.

Beyond what is provided for in the preceding paragraph, when the administrator of a hospital, clinic, or birthing center wishes to entrust the operation of the hospital, clinic, or birthing center that are prescribed by Cabinet Order as having a significant influence on physicians' or dentists' diagnoses, on the services of midwives, or on the hospitalization or admission of patients, pregnant women, women in labor, or women resting after childbirth, the administrator must entrust the relevant operations to a party who conforms to the requirements prescribed by an Order of the Ministry of Health, Labour and Welfare as a party with the ability to properly undertake its operation, in accordance with the type of operation undertaken at the relevant hospital, clinic, or birthing center.

The administrator of a hospital that carries out a medical practice must have a physician on night duty in the hospital; provided, however, that this does not apply to the case where the physicians of the relevant hospital stand by at a place adjacent to the relevant hospital or other cases specified by an Order of the Ministry of Health, Labour and Welfare as those where a system is in place which ensures that the physicians of the relevant hospital promptly provide medical treatment in the event of a sudden change in the medical condition of an inpatient of the relevant hospital.

The administrator of a regional medical care support hospital must undertake the following particulars, pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare:

allowing all or part of the buildings, equipment, instruments, or tools of the relevant hospital to be used by medical care professionals who do not work at the relevant hospital for their practices, research, or training;

providing emergency medical care;

carrying out training for ensuring primary care functions in the community and other training to enhance the quality of community medical care professionals;

systematically managing records as listed in Article 22, items (ii) and (iii);

when a request to view records listed in Article 22, item (ii) or (iii) has been received from a physician who wishes to refer a patient to the relevant regional medical care support hospital or from other persons as prescribed by an Order of the Ministry of Health, Labour and Welfare, making available for inspection the records which are prescribed by an Order of the Ministry of Health, Labour and Welfare as having no risk of harming patient confidentiality, except where there are justifiable grounds for not doing so;

providing medical care to patients referred from other hospitals or clinics; and

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

The administrator of a regional medical care support hospital must provide necessary support concerning the promotion of in-home medical care provision by medical institutions providing in-home medical care, designated in-home service providers pursuant to the provisions of Article 41, paragraph (1) of the Long-Term Care Insurance Act who undertake in-home nursing under Article 8, paragraph (4) of the same Act, and other persons providing in-home medical care (hereinafter referred to as "in-home medical care providers, etc." in this paragraph), such as supporting close coordination with in-home medical care providers, etc., and providing information concerning in-home medical care providers, etc. to recipients of medical care or medical institutions in the area.

The administrator of an advanced treatment hospital must undertake the following particulars pursuant to the provisions of an Order of the Ministry of Health, Labour and Welfare:

providing advanced medical care;

carrying out development and evaluation of advanced medical care techniques;

carrying out training in advanced medical care;

ensuring a high level of medical safety;

systematically managing the records listed under Article 22-2, items (iii) and (iv);

when a request to view the records listed in Article 22-2, item (iii) or (iv) has been received from a physician who wishes to refer a patient to the relevant advanced treatment hospital or from other persons as prescribed by an Order of the Ministry of Health, Labour and Welfare, making available for inspection the records that are prescribed by an Order of the Ministry of Health, Labour and Welfare as having no risk of harming patient confidentiality, except where there are justifiable grounds for not doing so;

providing medical care to patients referred from other hospitals or clinics; and

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

The administrator of an advanced treatment hospital, when carrying out particulars specified by an Order of the Ministry of Health, Labour and Welfare as important particulars concerning the management and operation of the advanced treatment hospital, must do so based on a resolution of a council composed of the relevant administrator and physicians, dentists, pharmacists, nurses and other persons working in the relevant advanced treatment hospital, pursuant to an Order of the Ministry of Health, Labour and Welfare.

The administrator of an advanced treatment hospital must make arrangements so that a medical care coordination system as provided for in Article 30-4, paragraph (2), item (ii) is properly constructed.

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, 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 Ordinances of the Prefecture (or, in the case of a clinic situated in a city or special ward with a public health center, the relevant city or special ward with a public health center); provided, however, that this does not apply where permitted by the prefectural governor of the area in which the hospital or clinic is situated.