Chương VI Luật khám bệnh, chữa bệnh 2009: Áp dụng kỹ thuật, phương pháp mới trong khám bệnh, chữa bệnh

Chapter VI

APPLICATION OF NEW TECHNIQUES AND METHODS TO MEDICAL EXAMINATION AND TREATMENT

Article 69. New techniques and methods in medical examination and treatment

New techniques and methods in medical examination and treatment include:

1. Techniques and methods which arc studied in Vietnam or overseas, recognized In competent Vietnamese state agencies and applied in Vietnam for the first time:

2. Techniques and methods which have been licensed for application by overseas competent state agencies but are applied in Vietnam for the first time:

3. Techniques and methods which have been licensed by competent state agencies and applied in Vietnam, but are applied for the lirst time at a medical examination and treatment establishment.

Article 70. Conditions on application of new techniques and methods to medical examination and treatment in Vietnam

1. To fully meet the conditions on human resources, physical foundations and equipment to apply new techniques and methods.

2. To be licensed for application by the Minister of Health or the Director of a provincial-level Health Department.

Article 71. Competence to license application of new techniques and methods

1. The Minister of Health shall evaluate and license a medical examination and treatment establishment to apply for the first time new techniques and methods specified in Clauses 1 and 2. Article 69 of this Law.

2. The Director of a provincial-level Health Department shall evaluate and license a medical examination and treatment establishment under his/her management to apply for the first time new techniques and methods specified in Clause 3. Article 69 of this Law according to the Ministry of Health's classification of professional and technical operations.

Article 72. Dossiers and procedures for licensing medical examination and treatment establishments to apply new techniques and methods

1. A dossier of request to apply a new technique or method comprises:

a/ An application for application of a new technique or method;

b/ Documents evidencing the legality, clinical proofs and effects of the new technique or method in medical examination and treatment, for the case specified in Clause 2, Article 69 of this Law;

c/  A plan to apply the new technique or method, which describes the medical examination and treatment establishment's capacity in terms of physical foundations, human resources and equipment, economic efficiency of the technique or method, the technical process to be applied and the implementation scheme;

d/ Copies of professional diplomas and certificates of practitioners related to the new technique or method;

e/ The contract signed with the domestic or foreign agency, organization or individual transferring the new technique or method.

2. Procedures to license the application of a new technique or method are as follows:

a/ A medical examination and treatment establishment shall submit a dossier of request to apply a new technique or method under Clause 1 of this Article to the Ministry of Health or a provincial-level Health Department:

b/ Within 10 working days after receiving a complete dossier, the Minister of Health or the provincial-level Health Department director shall appraise the dossier and issue a document allowing the medical examination and treatment establishment to test the new technique or method on a pilot basis. In case of refusal, he/she shall issue a written reply clearly stating the reason:

c/ The medical examination and treatment establishment shall apply the new technique or method on a pilot scale as licensed by the Minister of Health or the provincial-level Health Department director:

d/ After completing the pilot application, the medical examination and treatment establishment shall submit a report on application results and a complete technical process to the Ministry of Health or the provincial-level Health Department for appraisal:

e/ Within 20 days after receiving such report and technical process, the Minister of Health or the provincial-level Health Department director shall set up a professional council to appraise pilot application results and the technical process proposed by the medical examination and treatment establishment for advice to the Minister of Health or the provincial-level Health Depart­ment director for consideration and licensing;

f/ Within 5 working days after receiving an advisory report of the professional council, the Minister of Health or the provincial-level Health Department director shall issue a decision allowing the medical examination and treatment establish­ment to apply the new technique or method and approving the technical process. Technical processes with the same equipment and implemen­tation steps shall be applied nationwide while those with different equipment and implementation steps shall be approved on a case-by-case basis. When disallowing such application, he/she shall issue a written reply clearly stating the reason.

3. The Minister of Health shall detail conditions and procedures to license the application of new techniques and methods in medical examination and treatment.