Law on Medical Examination and Treatment 2023, Law No. 15/2023/QH15

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ATTRIBUTE Law on Medical Examination and Treatment 2023

Law on Medical Examination and Treatment, No. 15/2023/QH15 dated January 09, 2023 of the National Assembly
Issuing body: National Assembly of the Socialist Republic of VietnamEffective date:
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Official number:15/2023/QH15Signer:Vuong Dinh Hue
Type:LawExpiry date:Updating
Issuing date:09/01/2023Effect status:
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Fields:Medical - Health

SUMMARY

3 more professional titles subject to practice licenses from 2024

Law on Medical Examination and Treatment, No. 15/2023/QH15 is issued on January 09, 2023 by the National Assembly.

In accordance with the new Law, patients are entitled to make petitions about existence, inadequacies, difficulties, problems and other issues in the medical examination and treatment process. Noticeably, they will be entitled to claim compensation upon occurrence of medical complications, except for the cases where the practitioner makes no professional and technical mistakes when he/she is determined by a professional council to fall into either of the following cases:

Firstly, having complied with regulations on responsibilities for care for and treatment of patients and observed professional and technical regulations in medical examination and treatment but medical complications still occur to patients;

Secondly, cases of emergency in which medical complications occur to patients due to an unsolvable lack of medical means and equipment, drugs and practitioners or the unavailability of professional and technical guidance on a disease, resulting in such medical complications; etc.

Besides, the Law also additionally provide 3 professional titles requiring practice licenses, including clinical dietitian; out-of-hospital emergency provider; and clinical psychologist. A practice license’s validity duration is 05 years. In addition, there are 3 more organizational forms of medical examination and treatment establishments: Infirmary of People's Armed Force; Paraclinical service establishment; Out-of-hospital emergency establishment.

Instead of organizing a healthcare system into 4 levels (central, provincial, district and commune levels), the National Assembly agrees to organize the healthcare system into 3 technical and professional levels, including initial, basic and intensive medical examination and treatment.

This Law takes effect on January 01, 2024.

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Effect status: Known

THE NATIONAL ASSEMBLY

 

THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness

No. 15/2023/QH15

 

 


LAW ON MEDICAL EXAMINATION AND TREATMENT[1]

Pursuant to the Constitution of the Socialist Republic of Vietnam;

The National Assembly promulgates the Law on Medical Examination and Treatment.

 

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

This Law prescribes the rights and obligations of patients; medical examination and treatment practitioners; medical examination and treatment establishments; technical expertise in medical examination and treatment; medical examination and treatment by traditional medicine and combination of traditional medicine with modern medicine; medical examination and treatment for humanitarian and not-for-profit purposes; transfer of professional techniques in medical examination and treatment; application of new techniques, new methods and clinical trials; professional and technical errors; conditions to ensure medical examination and treatment activities; mobilization and transfer of resources for medical examination and treatment in case of disasters, catastrophes, group-A infectious diseases or state of emergency.

Article 2. Interpretation of terms

In this Law, the terms below are construed as follows:

1. Medical examination means the use of professional knowledge, methods and techniques by medical examination and treatment practitioners to evaluate patients’ health status, health risks and health care needs.

2. Medical treatment means the use of professional knowledge, methods and techniques by medical examination and treatment practitioners to solve a disease condition, prevent the occurrence and progression of a disease, or meet health care needs of patients on the basis of medical examination results.

3. Patient means a user of medical examination and treatment services.

4. Medical examination and treatment practitioner means a person who has been granted by a competent Vietnamese agency a license to practice medical examination and treatment (below referred to as practitioner).

5. License to practice medical examination and treatment means a document issued by a competent Vietnamese agency to a person who is fully qualified to practice medical examination and treatment in accordance with this Law (below referred to as a practicing license).

6. Medical examination and treatment establishment means an establishment that has been granted a medical examination and treatment operation license by a competent Vietnamese agency to provide medical examination and treatment services.

7. Medical examination and treatment operation license is a document issued by a competent Vietnamese agency to an establishment that is fully qualified for medical examination and treatment operation in accordance with this Law (below referred to as operation license).

8. Traditional herbal remedy or traditional healing method means a remedy or healing method based on experience handed down by a family line or family which effectively treats one or several disease(s) and is therefore recognized by the specialized health agency of a provincial-level People’s Committee.

9. Owner of a traditional herbal remedy or traditional healing method means a person who holds the right to own a remedy or healing method defined in Clause 8 of this Article.

10. Patient without relative means a person who falls into one of the following cases:

a/ A patient who is in an emergency status without any personal identification papers, accompanying relative and information to contact his/her relatives;

b/ A patient who by the time of admission to a medical examination and treatment establishment is unable or difficult to cognize or control his/her behavior and has no personal identification papers, accompanying relative and information to contact his/her relatives;

c/ A patient whose identity has been identified but by the time of admission to a medical examination and treatment establishment is unable or difficult to cognize or control his/her behavior and has no accompanying relative and information to contact his/her relatives;

d/ A child under 6 months old who is abandoned at a medical examination and treatment establishment.

11. Patient’s relative means a person who falls into one of the following cases:

a/ Wife or husband; natural parent, adoptive parent, parent-in-law; offspring, adopted child, daughter-in-law, or son-in-law of the patient or another family member as defined in the Law on Marriage and Family;

b/ The patient’s representative;

c/ A person who directly cares for the patient in the period of medical examination and treatment at a medical examination and treatment establishment but is not a practitioner.

12. Patient’s representative means a person who replaces the patient in exercising and performing the patient’s rights and obligations under this Law within the scope of representation.

13. Person in charge of professional expertise of a medical examination and treatment establishment means the at-law representative of a medical examination and treatment establishment for all of its professional activities.

14. Continuous updating of medical knowledge means the supplementation of medical knowledge and skills relevant to the scope of practice as prescribed by the Minister of Health.

15. Emergency status means a health status or behavior of a person which appears suddenly and, unless monitored and intervened in time, is likely to lead to declining bodily function, serious and long-term harm to a bodily organ or part, or death to that person, or cause a serious threat to the health or life of another person.

16. Consultation means a discussion between a group of practitioners about a patient’s disease condition in order to diagnose and put forth a treatment method in an appropriate and timely manner.

17. Medical record means a collection of data of a patient, including personal information, medical examination results, subclinical results, functional investigation results, and process of diagnosis, treatment and care, and other relevant information collected in the process of medical treatment of the patient at a medical examination and treatment establishment.

18. Rehabilitation is a set of interventions, including medical methods, rehabilitation techniques, assistive technologies, and educational, career orientation, social and environmental improvement measures, for patients to develop, achieve and maintain maximum functional activities, and prevent and reduce the disability status in conformity with their living environment.

19. Telehealth means a form of medical examination and treatment which is carried out without direct contact between practitioners and patients but through equipment and information technology.

20. Health check-up means medical examination to determine the health status, classify health or detect and manage diseases.

21. Medical assessment means medical examination to determine the health status and degree of bodily harm caused by injury, disease, illness, abnormality or deformity or at the demand or request of an agency, organization or individual.

22. Adverse event means an undesirable or unusual situation that occurs during the process of medical examination and treatment due to objective or subjective factors.

23. Medical complication means an adverse event that causes harm to the health and life of a patient for one of the following reasons:

a/ Undesirable risks although the practitioner has complied with professional and technical regulations in medical examination and treatment;

b/ Professional and technical errors.

Article 3. Principles of medical examination and treatment

1. Respect for, protection, equal treatment of and non-discrimination against patients.

2. Prioritization of medical examination and treatment for patients in emergency status, children under 6 years old, pregnant women, people with extremely severe disabilities, people with severe disabilities, people aged full 75 years and older, and people with meritorious services to the revolution as suitable to the characteristics of medical examination and treatment establishments.

3. Respect for, cooperation with and protection of practitioners and other persons performing duties at medical examination and treatment establishments.

4. Timely implementation and compliance with professional and technical regulations.

5. Compliance with the code of professional ethics in medical examination and treatment practice issued by the Minister of Health.

6. Equality and fairness among medical examination and treatment establishments.

Article 4. The State’s policies on medical examination and treatment

1. The State shall play a leading role in the development of medical examination and treatment activities; and mobilize social resources for medical examination and treatment activities.

2. The state budget funds shall be allocated with priority for the following activities:

a/ Developing medical examination and treatment establishments of the grassroots healthcare system, and the pre-hospital emergency care system; concentrating investment in medical examination and treatment establishments in border areas, on islands, and in ethnic minority and mountainous areas, areas with difficult socio-economic conditions and areas with extremely difficult socio-economic conditions;

b/ Providing medical examination and treatment for people with meritorious services to the revolution; children, the elderly, people with disabilities, people from poor households, people from near-poor households; people living in border areas, on islands, in areas with difficult socio-economic conditions and areas with extremely difficult socio-economic conditions; people suffering mental illness or leprosy; people suffering group-A infectious diseases; and people suffering group-B infectious diseases on the list issued by the Minister of Health;

c/ Promoting the development of human resources for the health sector, especially in the fields of infectious diseases, psychiatry, anatomic pathology, forensic medicine, forensic psychiatry, and intensive care medicine and emergency, and other specialized fields of priority to meet the needs and suit the conditions of socio-economic development in each period according to the Government’s regulations;

d/ Researching and applying science and technology, and carrying out digital transformation in medical examination and treatment.

3. To promote public-private partnership; to implement investment incentives in the field of medical examination and treatment. Medical examination and treatment establishments will be entitled to credit incentives to invest in improving the quality of medical examination and treatment; and to exemption from enterprise income tax for the income amount that is undivided and retained for investment in development of the establishments.

4. To invest in medical examination and treatment establishments in areas with difficult socio-economic conditions and areas with extremely difficult socio-economic conditions, and medical examination and treatment establishments operating for not-for-profit purposes in the sectors and trades eligible for special investment incentives on the List of sectors and trades eligible for investment incentives.

5. To implement a definite-time rotation regime for practitioners between state-run medical examination and treatment establishments.

6. To adopt special treatment policies for practitioners.

7. To adopt policies to develop human resources for hospital management and governance.

8. To bring into play the role of socio-professional organizations engaged in medical examination and treatment in medical examination and treatment activities.

9. To inherit and promote traditional medicine; to combine traditional medicine with modern medicine.

10. To combine military medicine and civil medicine in medical examination and treatment.

Article 5. State management of medical examination and treatment

1. Contents of state management in medical examination and treatment:

a/ Formulating, promulgating, and organizing the implementation of, legal documents on medical examination and treatment; promulgating a system of standards and technical regulations on medical examination and treatment;

b/ Formulating, promulgating, and organizing the implementation of, strategies, policies, programs, schemes and plans on medical examination and treatment;

c/ Formulating, promulgating, and organizing the implementation of, the master plan on the system of medical examination and treatment establishments in accordance with the planning law;

d/ Prescribing technical expertise, criteria, standards and technical regulations in medical examination and treatment;

dd/ Organizing, building and managing the system of medical examination and treatment establishments; evaluating the quality of medical examination and treatment establishments;

e/ Granting practicing licenses, suspending practice and revoking practicing licenses for practitioners, and operation licenses for medical examination and treatment establishments;

g/ Training, further training and developing human resources for medical examination and treatment activities; educating and disseminating knowledge and laws on medical examination and treatment; guiding the implementation of the definite-term rotation regime for practitioners;

h/ Organizing scientific and technological research and development, and technology application and transfer in medical examination and treatment;

i/ Building, managing and operating an information system on management of medical examination and treatment activities;

k/ Performing the state management of medical examination and treatment service charges in accordance with this Law and the law on price;

l/ Carrying out international cooperation in the field of medical examination and treatment;

m/ Carrying out inspection and examination, settling complaints and denunciations, and handling violations of the law on medical examination and treatment.

2. Responsibilities for state management of medical examination and treatment:

a/ The Government shall perform the unified state management of medical examination and treatment;

b/ The Ministry of Health shall be held answerable to the Government for performing the state management of medical examination and treatment;

c/ The Ministry of National Defense and Ministry of Public Security shall, within the ambit of their tasks and powers, perform the state management of medical examination and treatment and organize the medical examination and treatment system and activities under their respective management in accordance with this Law;

d/ Ministries and ministerial-level agencies shall, within the ambit of their tasks and powers, coordinate with the Ministry of Health in performing the state management of medical examination and treatment;

dd/ People’s Committees at all levels shall perform the state management of medical examination and treatment in localities under their management.

Article 6. Socio-professional organizations engaged in medical examination and treatment

Socio-professional organizations engaged in medical examination and treatment established and operating in accordance with the law on associations have the following responsibilities:

1. To protect their members’ lawful rights and interests in accordance with law;

2. To participate in the formulation of policies and laws on medical examination and treatment;

3. To participate in professional councils, compile textbooks, teaching materials, and professional and technical documents, and participate in testing for evaluation of practicing capacity and supervision of practice and continuous updating of medical knowledge at the request of competent agencies or organizations;

4. To disseminate, educate and further train in professional knowledge and policies and laws on medical examination and treatment for their members in accordance with law;

5. To implement programs, projects and research topics, provide consultancy, and participate in social supervision and criticism on medical examination and treatment in accordance with law;

6. To participate in the formulation and organize the implementation of the code of professional ethics; to mobilize their members, and organizations and individuals engaged in medical examination and treatment activities to abide by law;

7. To mobilize social resources to carry out medical examination and treatment activities in accordance with law;

8. To propose competent state agencies to handle violations of the law on medical examination and treatment.

Article 7. Prohibited acts in medical examination and treatment activities

1. Infringing upon a patient’s rights.

2. Refusing or deliberately delaying emergency care to a patient, except the case specified in Article 40 of this Law.

3. Providing medical examination and treatment without satisfying the conditions specified in Article 19 of this Law.

4. Providing medical examination and treatment beyond the scope of practice or scope of operation licensed by a competent agency, except the case of providing emergency care or medical examination and treatment as mobilized or assigned by competent agencies in case of a disaster, catastrophe, group-A infectious disease or state of emergency.

5. Practicing medical examination and treatment outside the time and place already registered for medical examination and treatment practice (below referred to as practice registration), except the cases specified in Clause 3, Article 36 of this Law.

6. Failing to comply with professional and technical regulations; applying professional methods and techniques or using medical equipment that have/has not been approved by a competent agency.

7. Prescribing, or giving instructions for the use of, drugs that have not been licensed for circulation in accordance with the law on pharmacy in medical examination and treatment.

8. Committing acts of harassment in medical examination and treatment.

9. Prescribing drugs, assigning performance of technical services or use of medical equipment, suggesting transferring patients to other medical examination and treatment establishments, or committing other acts for self-seeking purposes.

10. Erasing or tampering with medical records in order to falsify information about medical examination and treatment, or creating fake medical records, or making false medical records and other false papers on medical examination and treatment results.

11. Practitioners selling drugs in any form, except the following cases:

a/ Traditional medicine doctors, traditional medicine assistant doctors, and herb doctors selling traditional medicines;

b/ Owners of a traditional herbal remedy selling drugs according to the remedy already registered.

12. Using alcohol, beer and other alcoholic beverages, narcotics or tobacco at medical examination and treatment establishments or during medical examination and treatment.

13. Using forms of superstition in medical examination and treatment.

14. Refusing to participate in medical examination and treatment activities upon occurrence of a disaster, catastrophe, group-A infectious disease or state of emergency under mobilization or assignment decisions of competent agencies or persons, except the cases specified at Points a and b, Clause 3, Article 47 of this Law.

15. Medical examination and treatment establishments providing medical examination and treatment services in one of the following cases:

a/ Having no operation license;

b/ Being suspended from operation;

c/ Operating outside the licensed scope of professional activities, except cases of providing emergency care or providing medical examination and treatment under mobilization or assignment decisions of competent agencies or persons upon occurrence of a disaster, catastrophe, group-A infectious disease or state of emergency.

16. Renting, borrowing, leasing or lending a practicing license or an operation license.

17. Taking advantage of a practitioner’s image and status to speak, mobilize and encourage patients to use unrecognized medical examination and treatment methods.

18. Infringing upon life and health, or offending the honor and dignity of practitioners and other persons working at medical examination and treatment establishments or destroying property of medical examination and treatment establishments.

19. Preventing patients who are subject to compulsory medical treatment from entering medical examination and treatment establishments or intentionally performing compulsory medical treatment for persons who are not subject to compulsory medical treatment.

20. Advertising beyond the scope of practice or scope of professional activities approved by a competent agency; taking advantage of medical knowledge to falsely advertise medical examination and treatment.

21. Posting information alleging the responsibilities of practitioners and medical examination and treatment establishments upon occurrence of adverse events although there are not yet any conclusions from competent agencies.

Article 8. Patients’ representatives

1. A patient may have only one representative at a time.

2. A patient’s representative must have full civil act capacity, who may be:

a/ A person chosen by the patient himself/herself, in case the patient is an adult;

b/ A person chosen by a family member of the patient in case the patient is an adult but cannot choose a representative for himself/herself and does not make authorization before falling into a state of being unable or having difficulty in cognition or behavior control;

c/ The authorized representative or at-law representative of the patient as prescribed in the Civil Code;

d/ The at-law representative of the legal person as prescribed in the Civil Code or a person assigned by the legal person which is responsible for the management, care and nurturing of the patient in accordance with the Civil Code;

dd/ A person other than that defined at Point a, b, c or d of this Clause who voluntarily performs the patient’s obligations in accordance with the Civil Code.

3. The replacement of a representative is specified as follows:

a/ In case of replacing the representative defined at Point a, Clause 2 of this Article, certification by the patient is required;

b/ In case of replacing the representative defined at Point b, Clause 2 of this Article, certification by the patient or a member of the patient’s family is required;

c/ If the representative is the parent with respect to a minor child, certification by the patient is not required when replacing the representative;

d/ If the representative is a guardian, a person appointed by the court, the at-law representative of a legal person or a person assigned by a legal person, the replacement of the representative must comply with a decision of a competent agency or organization;

dd/ If the representative is an authorized representative, the replacement of the representative must comply with a written authorization as prescribed.

4. Rights and obligations of representatives, legal consequences of the act of representation, duration of representation, and scope of representation must comply with the Civil Code and relevant laws.

 

 

Chapter II

RIGHTS AND OBLIGATIONS OF PATIENTS

Section 1

RIGHTS OF PATIENTS

Article 9. The right to medical examination and treatment

1. To receive information and explanations about health status; methods and services of medical examination and treatment, and charges of medical examination and treatment services; to be guided on how to self-monitor, take care of health and prevent complications.

2. To receive medical examination and treatment by safe methods suitable to patients’ diseases and health status and actual conditions of medical examination and treatment establishments.

Article 10. The right to respect for honor, protection of health and respect for privacy in medical examination and treatment

1. To be respected in terms of age, gender, ethnicity, religion, belief, health status, economic conditions, and social status.

2. To be entitled to confidentiality of information in medical records and other information about private life, which the patients have provided to the practitioner in the course of medical examination and treatment, unless the patients agree to share information in accordance with law or except the cases specified in Clauses 3 and 4, Article 69 of this Law.

3. Not to be stigmatized, discriminated against, mistreated, physically abused or sexually abused in the course of medical examination and treatment.

4. Not to be forced to receive medical examination and treatment, except the cases of compulsory medical treatment specified in Clause 1, Article 82 of this Law.

Article 11. The right to choose in medical examination and treatment

1. To choose a method of medical examination and treatment after being provided with sufficient information, explanation and advice on the disease condition, results and possible risks, except the case specified in Clause 4, Article 40 of this Law.

2. To accept or refuse to participate in biomedical research on medical examination and treatment.

Article 12. The right to be provided with information about medical records and medical examination and treatment expenses

1. To read, view, copy and take notes on medical records and be provided with summaries of medical records as prescribed at Point d, Clause 4, Article 69 of this Law.

2. To be provided with information and explained in detail about payments for medical examination and treatment services upon request.

Article 13. The right to refuse medical examination and treatment and leave medical examination and treatment establishments

1. To refuse medical examination and treatment while having to give a written commitment to taking self-responsibility for their refusal after being advised by a practitioner, except the cases of compulsory medical treatment specified in Clause 1, Article 82 of this Law.

2. To leave the medical examination and treatment establishment before the completion of medical treatment against the practitioner’s instructions while having to give a written commitment to taking self-responsibility for leaving the medical examination and treatment establishment, except the cases of compulsory medical treatment specified in Clause 1, Article 82 of this Law.

Article 14. The right to petition and compensation

1. To make petitions on shortcomings, shortcomings, difficulties, problems and other matters in the course of medical examination and treatment.

2. To receive compensations in accordance with Article 102 of this Law.

Article 15. The exercise of rights of patients who have lost civil act capacity, have difficulties in cognition or behavior control, or have civil act capacity restricted, or are minors and have no relatives

1. In case the patient is an adult and falls into a state of having lost civil act capacity, having difficulties in cognition or behavior control, or having civil act capacity restricted, but has previously made a document expressing his/her lawful wish for medical examination and treatment, the patient’s wish shall be followed.

2. In case the patient is an adult and falls into a state of having lost civil act capacity, having difficulties in cognition or behavior control, or having civil act capacity restricted but has previously made no document expressing his/her lawful wish for medical examination and treatment:

a/ If the patient has a representative as defined at Point a, b, c or d, Clause 2, Article 8 of this Law, the representative’s decision shall be followed;

b/ If the patient has no representative as defined at Point a, b, c or d, Clause 2, Article 8 of this Law, the decision of the person in charge of professional expertise or the on-duty manager of the medical examination and treatment establishment shall be followed.

3. In case the patient is a minor:

a/ If the patient has a representative as defined at Point c or d, Clause 2, Article 8 of this Law, the representative’s decision shall be followed;

b/ If the patient has no representative as defined at Point c or d, Clause 2, Article 8 of this Law, the decision of the person in charge of professional expertise or the on-duty manager of the medical examination and treatment establishment shall be followed.

Section 2

OBLIGATIONS OF PATIENTS

Article 16. The obligation to respect practitioners and other persons working at medical examination and treatment establishments

To respect practitioners; to refrain from threatening, infringing on the life and health, or offending the honor and dignity of practitioners and other persons working at medical examination and treatment establishments.

Article 17. The obligation to comply with regulations in medical examination and treatment

1. To provide truthful information and take responsibility for information related to patients’ personal records and health status, and fully cooperate with practitioners and other persons working at medical examination and treatment establishments.

2. To comply with the practitioner’s instructions on diagnosis and treatment methods.

3. To abide by and request their relatives and visitors to abide by the rules of medical examination and treatment establishments, and the law on medical examination and treatment.

Article 18. The obligation to pay medical examination and treatment expenses

1. Patients participating in health insurance are obliged to pay medical examination and treatment expenses outside the scope of insurance benefits and the level of benefits in accordance with the law on health insurance.

2. Patients not participating in health insurance are obliged to pay medical examination and treatment expenses in accordance with law.

 

Chapter III

MEDICAL EXAMINATION AND TREATMENT PRACTITIONERS

Section 1

PRACTICE CONDITIONS

Article 19. Conditions for individuals to be allowed to provide medical examination and treatment

1. Individuals shall be allowed to practice medical examination and treatment in Vietnam when fully satisfying the following conditions:

a/ Possessing a valid practicing license;

b/ Having registered to practice, except the cases specified in Clause 3, Article 36 of this Law;

c/ Satisfying the requirements on language use in medical examination and treatment specified in Article 21 of this Law;

d/ Being physically fit to practice as prescribed by the Minister of Health;

dd/ Not falling into the cases specified in Article 20 of this Law.

2. Individuals may provide medical examination and treatment without having to satisfy the conditions specified at Points a, b and c, Clause 1 of this Article in the following cases:

a/ Trainees, students and pupils studying at training institutions in the health specialty, persons who are in the period of medical examination and treatment internship in order to be granted a practicing license, and those who are awaiting grant of a practicing license and only allowed to provide medical examination and treatment under the supervision of a practitioner;

b/ Village health workers, village midwives or health workers working in healthcare divisions of agencies, units or organizations without medical examination and treatment establishments may only provide medical examination and treatment within the permitted scope of operation and after having completed a training program according to the professional contents prescribed by the Minister of Health;

c/ The subjects specified in Clause 1, Article 115 of this Law;

d/ Other subjects participating in the process of medical examination and treatment according to the Government’s regulations.

3. Foreigners and overseas Vietnamese who possess a practicing license granted by a foreign authority may provide humanitarian medical examination and treatment under campaigns and cooperate in medical training involving medical examination and treatment internship or transfer professional techniques in medical examination and treatment in accordance with this Law without having to satisfy the conditions specified at Points a and b, Clause 1 of this Article.

4. Persons participating in community-based emergency care who are not pre-hospital emergency care providers are not required to satisfy the conditions specified in Clause 1 of this Article.

Article 20. Cases in which a person is banned from practicing medical examination and treatment

1. Being examined for penal liability for law-breaking acts related to technical expertise.

2. Currently serving a suspended sentence or non-custodial reform sentence for law-breaking acts related to technical expertise.

3. Being in the probation period, for a person sentenced to imprisonment for technical expertise but eligible for early conditional release.

4. Currently serving a prison sentence or being subject to an administrative handling measure of being confined to a compulsory education institution or a compulsory drug rehabilitation establishment.

5. Being banned from practicing medical examination and treatment under a legally effective criminal judgment of a court or restricted from performing medical examination and treatment activities under a competent agency’s decision.

6. Having lost civil act capacity or having difficulties in cognition or behavior control or having civil act capacity restricted.

Article 21. Use of languages in medical examination and treatment

1. The language used in medical examination and treatment must be Vietnamese, except the cases specified in Clause 2 of this Article.

2. A practitioner being a foreigner or an overseas Vietnamese (below referred to as foreign practitioner) may use a language other than Vietnamese to provide medical examination and treatment for a patient in one of the following cases:

a/ The patient has the same native language as the practitioner; the patient is able to use the same language as registered by the practitioner;

b/ The patient is a foreigner and does not fall into the case specified at Point a of this Clause;

c/ Humanitarian medical examination and treatment is carried out under campaigns; transfer of professional techniques in medical examination and treatment according to cooperation agreements between Vietnamese medical examination and treatment establishments and foreign health establishments.

3. The use of languages in the cases specified in Clause 2 of this Article is prescribed as follows:

a/ In the cases of providing medical examination and treatment specified at Points b and c, Clause 2 of this Article, an interpreter is required;

b/ Medical examination and treatment information shall be recorded in the registered language of the foreign practitioner and translated into Vietnamese.

4. The Government shall detail this Article; specify criteria for interpreters in the case specified at Point a, Clause 3 of this Article; and prescribe the use of languages in medical examination and treatment for ethnic minority people who cannot use Vietnamese, people with language impairment, and foreign patients.

Article 22. Continuous updating of medical knowledge

1. Practitioners holding one of the titles of doctor, assistant doctor, nurse, midwife, laboratory technician, clinical nutritionist, pre-hospital emergency care provider and clinical psychologist shall update their medical knowledge continuously as suitable to the scope of practice.

2. Forms of continuous updating of medical knowledge:

a/ Participating in short-term training and further training courses, and medical conferences and seminars suitable to the scope of practice;

b/ Participating in the compilation of textbooks, teaching materials and professional documents on medical examination and treatment;

c/ Carrying out scientific research and teaching in medicine within the scope of practice;

d/ Self-updating medical knowledge, and other forms.

3. Medical examination and treatment establishments shall create conditions for practitioners to continuously update medical knowledge.

4. The Minister of Health shall detail this Article.

Section 2

ORGANIZATION OF TESTING FOR EVALUATION OF MEDICAL EXAMINATION AND TREATMENT PRACTICING CAPACITY

Article 23. Medical examination and treatment internship

1. An applicant for a license to practice in the capacity as one of the titles of doctor, assistant doctor, nurse, midwife, laboratory technician, clinical nutritionist, pre-hospital emergency care provider and clinical psychologist shall undergo medical examination and treatment internship in adherence to the principles specified in Clause 2 of this Article, except the following cases:

a/ Having completed a specialized training program;

b/ Having been granted a practicing license by a foreign authority and recognized under Article 29 of this Law.

2. Medical examination and treatment internship shall be carried out in adherence to the following principles:

a/ Conforming to the internts’ granted professional diplomas;

b/ Being performed at medical examination and treatment establishments whose scope of professional activities is suitable to the internship contents;

c/ Having an internship period suitable for each professional title;

d/ The internship-instructing establishment shall assign an internship instructor, register the list of interns at the establishment on the information system on management of medical examination and treatment activities and issue a written certification of internship for the interns;

dd/ An internship instructor must be a practitioner whose scope of practice is consistent with the contents of internship instruction and shall take responsibility for professional activities of the interns during the internship period, unless the interns intentionally violate the law;

e/ The interns shall comply with the assignment and instructions of the internship instructors and respect the rights and obligations of patients.

3. The Government shall detail this Article.

Article 24. Testing for evaluation of medical examination and treatment practicing capacity

1. The testing for evaluation of medical examination and treatment practicing capacity before the application for a practicing license shall apply to the titles of doctor, assistant doctor, nurse, midwife, laboratory technician, clinical nutritionist, pre-hospital emergency care provider and clinical psychologist.

2. To take a test for evaluation of medical examination and treatment practicing capacity, a person must satisfy the following conditions:

a/ Possessing a diploma relevant to each professional title specified in Clause 1 of this Article;

b/ Having completed the medical examination and treatment internship in accordance with Article 23 of this Law.

3. The testing for evaluation of medical examination and treatment practicing capacity shall be organized by the National Medical Council.

4. Persons taking tests for evaluation of medical examination and treatment practicing capacity shall pay testing and evaluation expenses.

5. The Government shall detail this Article.

Article 25. The National Medical Council

1. The National Medical Council is an organization established by the Prime Minister, having the function of conducting independent evaluation of medical examination and treatment practicing capacity; and has its own seal and head office.

2. The National Medical Council has the following tasks:

a/ To assume the prime responsibility for, and coordinate with socio-professional organizations engaged in medical examination and treatment and other related agencies and organizations in, developing a set of tools for evaluation of medical examination and treatment practicing capacity;

b/ To promulgate a set of tools for evaluation of medical examination and treatment practicing capacity;

c/ To assume the prime responsibility for organizing tests for evaluation of medical examination and treatment practicing capacity;

d/ To receive and settle petitions and complaints or coordinate with state management agencies in settling complaints and denunciations about results of testing and evaluation of medical examination and treatment practicing capacity;

d/ To perform other tasks as prescribed by the Prime Minister.

3. The Prime Minister shall provide for the organization and operation of the National Medical Council.

 

Section 3

PRACTICING LICENSES

Article 26. Professional titles requiring a practicing license

1. Professional titles requiring a practicing license include:

a/ Doctor;

b/ Assistant doctor;

c/ Nurse;

d/ Midwife;

dd/ Laboratory technician;

e/ Clinical nutritionist;

g/ Pre-hospital emergency care provider;

h/ Clinical psychologist;

i/ Herb doctor;

k/ Owner of traditional herbal remedy or traditional healing method.

2. The Government shall specify professional titles and conditions for grant, re-grant, extension and modification of practicing licenses, suspension from practice, and revocation of practicing licenses, for professional titles other than those specified in Clause 1 of this Article as suitable to the country’s socio-economic development situation in each period after reporting thereon to the National Assembly Standing Committee.

3. The Minister of Health shall provide for the scope of practice for each professional title.

Article 27. Practicing licenses

1. Each practitioner may be granted only 1 practicing license which is valid nationwide.

2. A practicing license is valid for 5 years.

3. A practicing license must have the following basic information:

a/ Full name, date of birth and personal identification number, for Vietnamese practitioners; and passport number and citizenship, for foreign practitioners;

b/ Professional title of the practitioner;

c/ Scope of practice of the practitioner;

d/ Validity period of the license.

4. A person requesting grant, re-grant, extension or modification of a practicing license shall pay a charge in accordance with the law on charges and fees, unless such request is made due to the fault of an agency competent to grant practicing licenses.

5. The Minister of Health shall detail this Article and issue the form of practicing license.

Article 28. Competence to grant, re-grant, extend and modify practicing licenses, suspend practice or revoke practicing licenses

1. The competence to grant, re-grant, extend and modify practicing licenses is as follows:

a/ The Ministry of Health shall grant, re-grant, extend and modify practicing licenses for doctors, assistant doctors, nurses, midwives, laboratory technicians, clinical nutritionists, pre-hospital emergency care providers and clinical psychologists, for persons working at medical examination and treatment establishments under its management;

b/ The Ministry of National Defense shall grant, re-grant, extend and modify practicing licenses for doctors, assistant doctors, nurses, midwives, laboratory technicians, clinical nutritionists, pre-hospital emergency care providers and clinical psychologists, for persons working at medical examination establishments under its management;

c/ The Ministry of Public Security shall grant, re-grant, extend and modify practicing licenses for doctors, assistant doctors, nurses, midwives, laboratory technicians, clinical nutritionists, pre-hospital emergency care providers and clinical psychologists, for persons working at medical examination establishments under its management;

d/ Specialized health agencies under provincial-level People’s Committees shall grant, re-grant, extend and modify practicing licenses for the professional titles specified in Clause 1, Article 26 of this Law, except the cases specified at Points a, b and c of this Clause.

2. The competence to suspend practice and revoke practicing licenses is as follows:

a/ The Ministry of Health shall suspend practice for practitioners working at medical examination and treatment establishments nationwide; and revoke practicing licenses for practitioners working at medical examination and treatment establishments under its management;

b/ The Ministry of National Defense shall suspend practice and revoke practicing licenses for practitioners working at medical examination and treatment establishments under its management;

c/ The Ministry of Public Security shall suspend practice and revoke practicing licenses for practitioners working at medical examination and treatment establishments under its management;

d/ Specialized health agencies under provincial-level People’s Committees shall suspend practice for practitioners working at medical examination and treatment establishments in localities under their management; and revoke practicing licenses for practitioners under their management.

Article 29. Recognition of practicing licenses granted by foreign authorities

1. A practicing license granted by a foreign authority shall be considered for recognition when fully satisfying the following conditions:

a/ Being recognized under a treaty to which the Socialist Republic of Vietnam is a contracting party or under an international agreement to which Vietnam is a signatory; being granted by a foreign authority which is evaluated by the Ministry of Health for recognition under Clause 3 of this Article;

b/ Remaining valid at the time of request for recognition;

c/ Containing information about the professional title that must be equivalent to one of the professional titles specified at Points a, b, c, d, dd, e, g and h, Clause 1, Article 26 of this Law.

2. Procedures for recognition of practicing licenses:

a/ The holder of a practicing license shall send a dossier of request for recognition of the practicing license to the Ministry of Health, which must comprise a request for recognition of the practicing license and a valid copy of the granted practicing license;

b/ Within 30 days after receiving the dossier of request for recognition of the practicing license, the Ministry of Health shall issue a written reply on recognition or refusal of recognition of the practicing license;

c/ In case it is necessary to verify the practitioner’s overseas training, the time limit for recognition of the practicing license is 30 days from the date of issuance of verification results.

3. Contents of evaluation for recognition of a foreign authority granting practicing licenses cover:

a/ Evaluating the training system;

b/ Evaluating the system, process and procedures for grant of practicing licenses and regulations on professional titles and scope of practice.

4. Holders of practicing licenses granted by foreign authorities and recognized in Vietnam are not required to undergo medical examination and treatment internship under Article 23 of this Law and to take tests for evaluation of medical examination and treatment practicing capacity under Article 24 of this Law.

5. The Government shall detail this Article.

Article 30. Grant of practicing licenses

1. Grant of a practicing license applies to the following cases:

a/ Persons applying for a practicing license for the first time;

b/ Practitioners whose professional title stated in their practicing license is changed;

c/ Practitioners whose practicing license is revoked fall into the case of grant of practicing licenses under the Government’s regulations;

d/ Other cases as prescribed by the Government.

2. Conditions for grant of a practicing license for a doctor, an assistant doctor, a nurse, a midwife, a laboratory technician, a clinical nutritionist, a pre-hospital emergency care provider or a clinical psychologist:

a/ Being evaluated as fully qualified to practice after taking a test for evaluation of medical examination and treatment practicing capacity under Article 24 of this Law or possessing a practicing license recognized under Article 29 of this Law;

b/ Being physically fit to practice;

c/ Satisfying the requirement on Vietnamese language proficiency under the Government’s regulations, for foreigners;

d/ Not falling into one of the cases specified in Article 20 of this Law, or being administratively sanctioned for the act of providing medical examination and treatment without a practicing license while the period for being regarded as not having been administratively sanctioned has not expired.

3. Conditions for grant of a practicing license for an herb doctor or an owner of traditional herbal remedy or traditional healing method:

a/ Possessing an herb doctor certificate or a certificate of an owner of traditional herbal remedy or a certificate of an owner of traditional healing method;

b/ Satisfying the conditions specified at Points b, c and d, Clause 2 of this Article.

4. A dossier of application for a practicing license must comprise:

a/ An application for a practicing license;

b/ Documents proving the applicant’s satisfaction of the conditions specified in Clause 2 or 3 of this Article for each professional title.

5. Procedures for grant of a practicing license:

a/ An applicant for a practicing license shall submit a dossier specified in Clause 4 of this Article to an agency competent to grant practicing licenses;

b/ The agency competent to grant practicing licenses shall grant a practicing license within 30 days after receiving a complete dossier; in case of refusal to grant a practicing license, such agency shall issue a written reply, clearly stating the reason;

c/ In case it is necessary to verify documents with foreign elements in the dossier of application, the time limit for grant of a practicing license is 30 days from the date of issuance of verification results.

6. The Government shall detail this Article.

Article 31. Re-grant of practicing licenses

1. Re-grant of a practicing license applies to the following cases:

a/ The practicing license is lost or damaged;

b/ There is a change in the information specified at Point a, Clause 3, Article 27 of this Law or there is an error in the information specified in Clause 3, Article 27 of this Law;

c/ The practitioner whose practicing license is revoked falls into the case of re-grant of practicing licenses under the Government’s regulations;

d/ The practicing license is granted ultra vires;

dd/ Other cases as prescribed by the Government.

2. Conditions for a practitioner to be re-granted a practicing license:

a/ Having been granted a practicing license;

b/ Satisfying the conditions set for the contents requested for re-grant of the license;

c/ Not falling into one of the cases specified in Article 20 of this Law.

3. A dossier of request for re-grant of a practicing license must comprise:

a/ A request for re-grant of a practicing license;

b/ Documents proving the requester’s satisfaction of the conditions specified in Clause 2 of this Article.

4. Procedures for re-grant of a practicing license:

a/ A requester for re-grant of a practicing license shall submit a dossier specified in Clause 3 of this Article to an agency competent to grant practicing licenses;

b/ The agency competent to grant practicing licenses shall re-grant a practicing license within 15 days after receiving a complete dossier; in case of refusal to re-grant a practicing license, such agency shall issue a written reply, clearly stating the reason;

c/ In case it is necessary to verify documents with foreign elements in the dossier of request for re-grant of a practicing license, the time limit for re-grant of a practicing license is 15 days from the date of issuance of verification results.

5. The Government shall detail this Article.

Article 32. Extension of practicing licenses

1. Extension of practicing licenses applies to cases in which practicing licenses expire.

2. Conditions for extension of a practicing license for a doctor, an assistant doctor, a nurse, a midwife, a laboratory technician, a clinical nutritionist, a pre-hospital emergency care provider, a clinical psychologist or an herb doctor:

a/ Meeting the requirement on continuous updating of medical knowledge as specified in Article 22 of this Law;

b/ Being physically fit to practice;

c/ Carrying out extension procedures at least 60 days before the expiration of the practicing license, except other cases as prescribed by the Government;

d/ Not falling into one of the cases specified in Article 20 of this Law.

3. Conditions for extension of a practicing license for an owner of traditional remedy or traditional healing method are those specified at Points b, c and d, Clause 2 of this Article.

4. A dossier of request for extension of a practicing license must comprise documents proving the requester’s satisfaction of the conditions specified in Clause 2 or 3 of this Article.

5. Procedures for extension of a practicing license:

a/ A requester for extension of a practicing license shall submit a dossier specified in Clause 4 of this Article to an agency competent to grant practicing licenses;

b/ Within the period from the date of receipt of a complete dossier to the expiry date stated in the practicing license, the agency competent to grant practicing licenses shall extend the practicing license or shall, if refusing to extend the practicing license, issue a written reply, clearly stating the reason; if no reply is issued by the expiry date stated in the practicing license, the practicing license will continue to be valid under Clause 2, Article 27 of this Law;

c/ In case it is necessary to verify the practitioner’s continuous updating of medical knowledge under programs organized by foreign authorities, the time limit for extension of a practicing license is 15 days from the date of issuance of verification results.

6. The Government shall detail this Article.

Article 33. Modification of practicing licenses

1. Practicing licenses shall be modified for doctors, assistant doctors, nurses, midwives, laboratory technicians, clinical nutritionists, pre-hospital emergency care providers and clinical psychologists when the scope of their medical examination and treatment practice is changed.

2. Conditions for modification of a practicing license for a practitioner:

a/ Having completed a professional and technical training program relevant to the scope of practice to be modified, which is organized by a training institution or hospital;

b/ Satisfying the requirements on medical examination and treatment internship for a number of professional fields;

c/ Not falling into one of the cases specified in Article 20 of this Law.

3. A dossier of request for modification of a practicing license must comprise:

a/ A request for modification of a practicing license;

b/ Documents proving the requester’s satisfaction of the conditions specified in Clause 2 of this Article.

4. Procedures for modification of a practicing license:

a/ A requester for modification of a practicing license shall submit a dossier specified in Clause 3 of this Article to an agency competent to grant practicing licenses;

b/ The agency competent to grant practicing licenses shall modify the practicing license within 15 days after receiving a complete dossier; in case of refusal to modify the practicing license, such agency shall issue a written reply, clearly stating the reason;

c/ In case it is necessary to verify documents with foreign elements in the dossier of request for modification of a practicing license, the time limit for modification is 15 days from the date of issuance of verification results.

5. The Government shall detail this Article.

Article 34. Suspension from practice

1. A practitioner shall be suspended from practice in the following cases:

a/ Being evaluated by the professional council specified in Article 101 of this Law as committing professional and technical errors that are serious enough for suspension from practice but not serious enough for revocation of practicing license;

b/ Receiving a competent agency’s conclusion stating his/her violation of professional ethics but such violations are not serious enough for revocation of practicing license;

c/ Not being physically fit to practice.

2. Depending on the nature and severity of their professional and technical errors or violations of professional ethics and their health conditions, practitioners shall be suspended from practice for between 1 month and 24 months.

3. After being suspended from practice, depending on the nature and severity of professional and technical errors, practitioners shall update their medical knowledge according to the conclusions of the professional councils specified in Article 101 of this Law.

4. The Government shall detail this Article.

Article 35. Revocation of practicing licenses

1. A practicing license of a practitioner shall be revoked in the following cases:

a/ The dossier of application for the practicing license has been made in contravention of regulations;

b/ Documents in the dossier of application for the practicing license are forged;

c/ The granted practicing license states the wrong professional title or scope of practice as compared to the dossier of application for the practicing license;

d/ The practitioner has not practiced for 24 consecutive months, unless he/she attends specialized training programs;

d/ The practitioner falls into one of the cases banned from practice specified in Clauses 1, 2, 3, 4 and 6, Article 20 of this Law;

e/ The practitioner is concluded by the professional council specified in Article 101 of this Law as committing professional and technical errors that are serious enough for revocation of practicing license;

g/ The practitioner has for the second time been concluded by the professional council specified in Article 101 of this Law as committing professional and technical errors that are serious enough for suspension from practice during the validity period of his/her practicing license;

h/ The practitioner has for the second time been concluded by a competent state agency as committing breaches of professional ethics that are serious enough for suspension from practice during the validity period of his/her practicing license;

i/ The practitioner himself/herself requests revocation of his/her practicing license;

k/ Other cases as prescribed by the Government after being reported to the National Assembly Standing Committee.

2. After having his/her practicing license revoked, the practitioner shall, if wishing to continue practicing, apply for a practicing license under Point c, Clause 1, Article 30 of this Law or request re-grant of a practicing license under Point c, Clause 1, Article 31 of this Law.

3. The Government shall detail this Article.

 

 

Section 4

PRACTICE REGISTRATION

Article 36. Principles of practice registration

1. Practitioners may register to practice at multiple medical examination and treatment establishments but shall ensure that their working time of medical examination and treatment at these medical examination and treatment establishments does not coincide.

2. Practitioners may register to work in one or more of the following professional positions in the same medical examination and treatment establishment but shall ensure the quality of work in their assigned positions:

a/ Providing medical examination and treatment according to their practicing licenses;

b/ Taking charge of a specialized division;

c/ Taking charge of professional expertise of the medical examination and treatment establishment.

3. A practitioner may provide medical examination and treatment without having to register practice in the following cases:

a/ Carrying out emergency care activities outside medical examination and treatment establishments, except pre-hospital emergency care providers;

b/ Participating in medical examination and treatment activities as mobilized or assigned by competent agencies or persons in case of disasters, catastrophes, group-A infectious diseases or state of emergency;

c/ Providing humanitarian medical examination and treatment under campaigns;

d/ Providing medical examination and treatment in the process of transferring professional techniques or providing professional and technical assistance at other medical examination and treatment establishments in a short term;

dd/ Other cases as prescribed by the Minister of Health.

Article 37. Contents of practice registration for a practitioner

1. Full name, and number of the practicing license, of the practitioner.

2. Professional title and position of the practitioner.

3. Place of practice, including name and address of the medical examination and treatment establishment where the practice is registered.

4. Duration of practice.

5. Language used by the foreign practitioner in medical examination and treatment, for the cases specified at Points a and b, Clause 2, Article 21 of this Law.

Article 38. Responsibilities in practice registration

1. A medical examination and treatment establishment shall register practice for practitioners working at the establishment as follows:

a/ Sending a list of practice-registering practitioners together with the establishment’s application for an operation license to an agency competent to grant operation licenses;

b/ In case there is a change in practitioner pending the grant of the operation license or in the course of operation, sending the request for practice registration to an agency competent to grant operation licenses.

2. An agency competent to grant operation licenses shall publicly announce the list of practitioners on the information system on management of medical examination and treatment activities as follows:

a/ Simultaneously with the grant of operation licenses, for the case specified at Point a, Clause 1 of this Article and in case there is a change in practitioner pending the grant of the operation license under Point b, Clause 1 of this Article;

b/ Within 5 working days after receiving the request for practice registration, in case of change in practitioner in the course of operation of the medical examination and treatment establishment under Point b, Clause 1 of this Article.

3. The Government shall provide in detail practice registration mentioned in Section 4, Chapter III of this Law.

Section 5

RIGHTS OF PRACTITIONERS

Article 39. The right to practice

1. To practice medical examination and treatment within the permitted scope of practice.

2. To decide on diagnosis and treatment methods within the permitted scope of practice.

3. To practice medical examination and treatment at different medical examination and treatment establishments while complying with this Law’s provisions on practice registration.

4. To join socio-professional organizations engaged in medical examination and treatment.

Article 40. The right to refuse to provide medical examination and treatment

A practitioner may refuse to provide medical examination and treatment in the following cases:

1. It is predicted that the patient’s disease condition falls beyond the practitioner’s capability or falls beyond his/her scope of practice, provided that the practitioner refers the patient to another practitioner or another medical examination and treatment establishment as appropriate for medical examination and treatment and provides first aid, emergency care, monitoring, care and treatment for the patient until the latter is received by another practitioner or admitted to another medical examination and treatment establishment;

2. Medical examination and treatment is contrary to the law or professional ethics;

3. The patient or the patient’s relative commits acts of infringing upon the body, health or life of the practitioner on duty, unless such patient or relative suffers a mental illness or another disease making him/her unable to cognize or control his/her behaviors;

4. The patient requests a method of medical examination and treatment that does not comply with professional and technical regulations;

5. The patient or the patient’s representative specified at Point a, Clause 2, or Point a, Clause 3, Article 15 of this Law fails to comply with the practitioner’s instructions on diagnosis and treatment method after being advised and persuaded by the practitioner and such failure is likely to harm the health or life of the patient.

Article 41. The right to improve professional capacity

1. To be trained for development of professional capacity.

2. To be continuously updated with medical knowledge suitable to the scope of practice.

3. To attend further training courses and information exchange seminars on medical expertise and legal knowledge.

Article 42. The right to protection upon occurrence of adverse events

1. To be protected by law and not be held responsible when having complied with regulations but adverse events still occur.

2. To request agencies, organizations and socio-professional organizations engaged in medical examination and treatment to protect their lawful rights and interests upon occurrence of adverse events.

Article 43. The right to safety assurance when practicing medical examination and treatment

1. To be entitled to assurance of occupational safety and health at work in accordance with the law on occupational safety and health.

2. To have their honor, dignity, health and life protected.

3. To temporarily leave the workplaces in case of having their health or life threatened by others while having to immediately report such to the person in charge of professional expertise or the on-duty manager of the medical examination and treatment establishment and to the public security agency or local administration of the nearest place.

Section 6

OBLIGATIONS OF PRACTITIONERS

Article 44. Obligations toward patients

1. To promptly provide first aid, emergency care and medical examination and treatment to patients, except the cases specified in Clauses 2, 3, 4 and 5, Article 40 of this Law.

2. To respect the rights of patients, and adopt considerate and gentle attitudes toward patients.

3. To provide counseling and information under Clause 1, Article 9 of this Law.

4. To treat patients equally, not letting personal interests or discrimination affect their professional decisions.

5. To only request patients to pay medical examination and treatment expenses in accordance with law.

Article 45. Profession-related obligations

1. To comply with professional and technical regulations.

2. To take responsibility for their medical examination and treatment.

3. To regularly study and continuously update medical knowledge.

4. To show dedication in the process of medical examination and treatment.

5. To ensure confidentiality of patients’ disease condition, information provided by patients and medical records, except the cases in which the patients agree to share information and the cases specified in Clauses 3 and 4, Article 69 of this Law.

6. To notify competent persons of practitioners who deceive patients or violate this Law.

Article 46. Obligations toward colleagues

1. To cooperate with colleagues in medical examination and treatment.

2. To respect the honor and prestige of colleagues.

Article 47. Obligations toward the society

1. To participate in community-based emergency care, health protection and health education activities.

2. To participate in supervising the professional capacity and professional ethics of other practitioners.

3. To abide by definite-term rotation decisions of managing agencies; and mobilization and assignment decisions of competent agencies or persons on participation in medical examination and treatment activities in case of disasters, catastrophes, group-A infectious diseases or a state of emergency, except the following cases:

a/ A practitioner who is pregnant or nursing a child under 24 months old, unless such person voluntarily participates in medical examination and treatment activities;

b/ A practitioner who is highly prone to epidemics, and other cases as prescribed by the Minister of Health.

 

Chapter IV

MEDICAL EXAMINATION AND TREATMENT ESTABLISHMENTS

Section 1

LICENSES FOR MEDICAL EXAMINATION AND TREATMENT ACTIVITIES

Article 48. Organizational forms of medical examination and treatment establishments

1. Organizational forms of medical examination and treatment establishments include:

a/ Hospital;

b/ Infirmary in the people’s armed forces;

c/ Maternity hospital;

d/ Clinic;

dd/ Traditional medicine clinic;

e/ Subclinical service establishment;

g/ Health station;

h/ Pre-hospital emergency care establishment;

i/ Family medicine establishment;

k/ Other organizational forms of medical examination and treatment establishments as prescribed by the Government.

2. In case medical assessment establishments, forensic examination establishments, forensic psychiatric establishments, medical centers, institutes with patient beds, health divisions of agencies, units and organizations, or establishments with other names provide medical examination and treatment, the grant of operation licenses shall be based on one of the organizational forms of medical examination and treatment establishments specified in Clause 1 of this Article.

3. The Government shall detail this Article.

Article 49. Conditions on operation of a medical examination and treatment establishment

1. Having been granted an operation license by a competent agency.

2. Satisfying the basic quality standards specified at Point a, Clause 1, Article 57 of this Law in the course of operation.

Article 50. Operation licenses of medical examination and treatment establishments

1. Each medical examination and treatment establishment shall be granted one operation license with an indefinite term. In case a medical examination and treatment establishment has additional medical examination and treatment establishments in other locations, each of these establishments must have a separate operation license.

2. Contents of an operation license of a medical examination and treatment establishment must have the following basic information:

a/ Name of the medical examination and treatment establishment;

b/ Organizational form;

c/ Operation address;

d/ Scope of professional activities;

dd/ Daily working hours.

3. A medical examination and treatment establishment requesting grant, re-grant or modification of an operation license shall pay a charge in accordance with the law on charges and fees, unless such request is made due to the fault of the agency competent to grant operation licenses.

4. Within 5 working days from the date of grant, re-grant or modification of an operation license, the agency competent to grant operation licenses shall update information relating to the grant, re-grant or modification of the operation license onto the information system on management of medical examination and treatment activities.

5. The Government shall provide in detail cases, conditions, dossiers and procedures for grant, re-grant and modification of operation licenses for each organizational form of medical examination and treatment establishments specified in Article 48 of this Law; and provide for forms of operation licenses of medical examination and treatment establishments and specific conditions for medical examination and treatment establishments in the people’s armed forces.

Article 51. Competence to grant, re-grant and modify operation licenses, suspend operation and revoke operation licenses for medical examination and treatment establishments

1. The Ministry of Health shall grant, re-grant and modify operation licenses, suspend operation and revoke operation licenses for medical examination and treatment establishments under its management; and suspend operation of other medical examination and treatment establishments nationwide.

2. The Ministry of National Defense shall grant, re-grant and modify operation licenses, suspend operation and revoke operation licenses for medical examination and treatment establishments under its management.

3. The Ministry of Public Security shall grant, re-grant and modify operation licenses, suspend operation and revoke operation licenses for medical examination and treatment establishments under its management.

4. Specialized health agencies under provincial-level People’s Committees shall grant, re-grant, modify and revoke operation licenses for medical examination and treatment establishments in localities under their management, except the cases specified in Clauses 1, 2 and 3 of this Article; and suspend operation for medical examination and treatment establishments operating in localities under their management.

Article 52. Grant of operation licenses

1. Grant of operation licenses applies to the following cases:

a/ Medical examination and treatment establishments applying for operation licenses for the first time;

b/ Medical examination and treatment establishments having their operation licenses revoked, except the case specified at Point d, Clause 1, Article 56 of this Law;

c/ Medical examination and treatment establishments already possessing operation licenses changing their organizational forms or locations of operation;

d/ Medical examination and treatment establishments already possessing operation licenses undergoing splitting, consolidation or merger;

dd/ Other cases as prescribed by the Government.

2. Conditions for a medical examination and treatment establishment to be granted an operation license:

a/ Being established in accordance with law;

b/ Having an organizational structure suitable to each organizational form of medical examination and treatment establishments;

c/ Having a location of operation;

d/ Having physical foundations suitable to the scope of professional activities and the size of the medical examination and treatment establishment, in which information technology infrastructure must be connected with the information system on management of medical examination and treatment activities as specified in Clause 1, Article 112 of this Law;

dd/ Having sufficient medical equipment and facilities suitable to the scope of professional activities and the size of the medical examination and treatment establishment;

e/ Having sufficient practitioners suitable to the scope of professional activities and the size of the medical examination and treatment establishment; the medical examination and treatment establishment must have a person in charge of professional expertise, ensuring that each medical examination and treatment establishment has only one person in charge of professional expertise.

3. A dossier of application for an operation license must comprise:

a/ An application for an operation license;

b/ Documents proving the medical examination and treatment establishment’s satisfaction of the conditions specified in Clause 2 of this Article.

4. Procedures for grant of an operation license:

a/ A dossier of application for an operation license shall be submitted to an agency competent to grant operation licenses;

b/ The agency competent to grant operation licenses shall appraise the dossier. The time limit for appraisal must not exceed 60 days from the date of receipt of a complete dossier. The appraisal results shall be recorded in an appraisal report, which must clearly state the contents required for modification and supplementation (if any) and must bear signatures of the parties participating in the appraisal and of a representative of the appraised establishment;

c/ Within 10 working days after issuing the appraisal report, the agency competent to grant operation licenses shall grant an operation license; in case the establishment is required to make modifications and supplementations as stated in the appraisal report, within 10 working days from the date of completion of the modification and supplementation, the agency competent to grant operation licenses shall grant an operation license.

5. The Government shall detail this Article; and provide for the grant of operation licenses for medical examination and treatment establishments in the people’s armed forces.

Article 53. Re-grant of operation licenses

1. Re-grant of an operation license applies to the following cases:

a/ The operation license is lost;

b/ The operation license is damaged;

c/ The operation license contains erroneous information.

2. A dossier of request for re-grant of an operation license must comprise:

a/ A request for re-grant of an operation license;

b/ The original operation license, except the case specified at Point a, Clause 1 of this Article;

c/ Supporting documents, for the case specified at Point c, Clause 1 of this Article.

3. Procedures for re-grant of an operation license:

a/ A dossier of request for re-grant of an operation license shall be submitted to an agency competent to grant operation licenses;

b/ Within 20 days after receiving a complete dossier, the agency competent to grant operation licenses shall re-grant an operation license. In case it is necessary to carry out appraisal at the establishment, the procedures specified at Points b and c, Clause 4, Article 52 of this Law shall apply.

4. The Government shall detail this Article; and provide for the re-grant of operation licenses for medical examination and treatment establishments in the people’s armed forces.

Article 54. Modification of operation licenses

1. An operation license of a medical examination and treatment establishment may be modified in the following cases:

a/ There is a change in the scope of professional activities;

b/ There is a change in the scale of operation;

c/ There is a change in the working time;

d/ The medical examination and treatment establishment changes its name and address but does not change its location of operation;

dd/ The medical examination and treatment establishment which is subject to partial operation suspension fails to complete the remediation of the contents required in the suspension document after the suspension period expires.

2. Conditions for modification of an operation license of a medical examination and treatment establishment:

a/ The establishment’s operation license remains valid;

b/ The establishment satisfies the conditions suitable to the contents requested for modification as prescribed by law.

3. A dossier for modification of an operation license must comprise:

a/ A request for modification of an operation license;

b/ The original operation license and supporting documents for the change specified at Point b, Clause 2 of this Article.

4. Procedures for modification of an operation license:

a/ A dossier of request for modification of an operation license shall be submitted to an agency competent to grant operation licenses;

b/ Within 20 days after receiving a complete dossier, the agency competent to grant operation licenses shall modify an operation license. In case it is necessary to carry out appraisal at the establishment, the procedures specified at Points b and c, Clause 4, Article 52 of this Law shall apply.

5. The Government shall detail this Article; and provide for the modification of operation licenses for medical examination and treatment establishments in the people’s armed forces.

Article 55. Operation suspension for medical examination and treatment establishments

1. A medical examination and treatment establishment shall be subject to suspension of part or the whole of its operation in the following cases:

a/ There occurs an adverse event at the medical examination and treatment establishment that is serious enough for operation suspension;

b/ Failing to satisfy one of the conditions specified in Article 49 of this Law;

c/ Failing to satisfy one of the conditions specified in Clause 2, Article 52 of this Law.

2. The operation suspension period is between 1 month and 24 months.

3. The suspension of part or the whole of operation of a medical examination and treatment establishment and the suspension period shall be based on the causes, nature, severity and consequences of adverse events or the part of operation conditions that are no longer satisfied.

4. During the operation suspension period, if the medical examination and treatment establishment has completed the remediation of the contents required in the suspension document, the agency competent to suspend the operation of the medical examination and treatment establishment shall decide to permit the establishment to resume its operation.

5. The Government shall detail this Article.

Article 56. Revocation of operation licenses of medical examination and treatment establishments

1. The operation license of a medical examination and treatment establishment shall be revoked in the following cases:

a/ The dossier of application for the operation license has been made in contravention of regulations;

b/ Papers in the dossier of application for the operation license are forged;

c/ The operation license is granted ultra vires;

d/ The operation license contains erroneous information;

dd/ The operation license specifies a wrong organizational form and scope of professional activities;

e/ The medical examination and treatment establishment fails to operate after 24 months from the date it is granted the operation license;

g/ The medical examination and treatment establishment suspends its operation for 24 consecutive months or more or terminates its operation;

h/ The medical examination and treatment establishment which is subject to suspension of the whole of its operation fails to complete the remediation of the contents required in the suspension document after the suspension period expires;

i/ The medical examination and treatment establishment fails to fully maintain the conditions specified in Article 49 or Clause 2, Article 52 of this Law;

k/ The medical examination and treatment establishment itself requests revocation of its operation license.

2. The Government shall detail this Article. In case it is necessary to add cases of revocation of operation licenses, the Government shall report such to the National Assembly Standing Committee before making the addition.

Section 2

EVALUATION OF QUALITY OF MEDICAL EXAMINATION AND TREATMENT ESTABLISHMENTS

Article 57. Quality standards for medical examination and treatment establishments

1. Quality standards are standards and requirements on management and technical expertise which are used as a basis for evaluating the quality of technical services or of each specialty or of the entire medical examination and treatment establishment which has been granted an operation license, including:

a/ Basic quality standards for medical examination and treatment establishments, issued by the Ministry of Health;

b/ Advanced quality standards for medical examination and treatment establishments, issued by the Ministry of Health;

c/ Quality standards for each specialty or technical service, issued by the Ministry of Health;

d/ Quality standards for medical examination and treatment establishments or each specialty or technical service, issued by domestic or foreign organizations and recognized by the Ministry of Health.

2. Medical examination and treatment establishments are encouraged to apply the quality standards specified at Points b, c and d, Clause 1 of this Article.

3. The quality standards specified at Point d, Clause 1 of this Article must suit Vietnam’s conditions, not be lower than the quality standards specified at Point a, Clause 1 of this Article, and meet at least the following requirements:

a/ Ensuring scientificity and effectiveness;

b/ Ensuring the overall evaluation of quality characteristics and quality components;

c/ Being recognized by international organizations on quality of medical examination and treatment and having been applied around the world.

4. The Minister of Health shall provide for the recognition of the quality standards specified at Point d, Clause 1 of this Article.

Article 58. Quality evaluation and certification for medical examination and treatment establishments

1. Quality evaluation and certification aim to:

a/ Maintain and improve the operation quality of medical examination and treatment establishments;

b/ Provide information for patients and payers to select appropriate medical examination and treatment establishments;

c/ Serve as a basis for proposing the handling of violations and commendation for evaluation results based on basic quality standards.

2. Principles for evaluating the quality of medical examination and treatment establishments:

a/ Ensuring independence, objectivity, honesty, publicity, transparency and lawfulness;

b/ Ensuring conformity with medical examination and treatment quality standards issued or recognized by the Ministry of Health;

c/ Conducting quality evaluation after at least full 12 months from the date a medical examination and treatment establishment is granted the operation license;

d/ Ensuring that quality evaluation and certification agencies and organizations take responsibility before law for their evaluation results.

3. Annually, medical examination and treatment establishments shall conduct quality self-evaluation under Point a, Clause 1, Article 57 of this Law.

4. Organizations conducting quality evaluation and certification of medical examination and treatment establishments that have been granted certificates of registration of conformity assessment activities in accordance with law shall conduct quality evaluation at the request of state management agencies in charge of medical examination and treatment or at the request of medical examination and treatment establishments.

5. Quality evaluation results shall be made public at medical examination and treatment establishments and posted on the information system on management of medical examination and treatment activities.

6. Based on the evaluation results specified in Clauses 3 and 4 of this Article, state management agencies in charge of medical examination and treatment shall examine the quality evaluation results for medical examination and treatment establishments under their management on the principles of risk management.

7. The Government shall detail this Article.

Section 3

RIGHTS AND RESPONSIBILITIES OF MEDICAL EXAMINATION AND TREATMENT ESTABLISHMENTS

Article 59. Rights of medical examination and treatment establishments

1. To carry out medical examination and treatment activities in accordance with this Law.

2. To refuse to provide medical examination and treatment in the following cases:

a/ Cases falling beyond their professional capacity or outside the scope of their professional activities, except emergencies specified in Article 61 of this Law.

b/ One of the cases specified in Clauses 3, 4 and 5, Article 40 of this Law.

3. To collect expenses related to medical examination and treatment activities in accordance with law.

4. To enjoy preferential regimes when carrying out medical examination and treatment activities in accordance with law.

5. To enter into contracts on provision of health insurance-covered medical examination and treatment with social insurance agencies in accordance with the law on health insurance; to enter into contracts on provision of medical examination and treatment with other insurance organizations in accordance with the law on insurance business.

6. To coordinate with domestic and foreign organizations and individuals in medical examination and treatment activities.

7. To provide care and support services at the request of patients and patients’ representatives.

8. For private medical examination and treatment establishments, to participate in bidding or receive orders placed by the State to provide a number of medical examination and treatment services on the list of public non-business services of which expenses are wholly or partially covered by the state budget.

Article 60. Responsibilities of medical examination and treatment establishments

1. To provide first aid, emergency care, and medical examination and treatment in a timely manner for patients.

2. To comply with professional and technical regulations and relevant laws; to take responsibility for results of medical examination and treatment provided by practitioners under their management.

3. To make public information on the working time and list of practitioners of the establishments, and working time of each practitioner at their establishments.

4. To post medical examination and treatment service charge rates and on-demand care and support service charge rates at the establishments and on the information system on management of medical examination and treatment activities.

5. To ensure the exercise of rights and performance of obligations by patients and practitioners in accordance with this Law.

6. To ensure necessary conditions for practitioners to provide medical examination and treatment.

7. To conduct self-evaluation of quality and publicize quality evaluation results according to Clauses 3 and 5, Article 58 of this Law.

8. To abide by mobilization or assignment decisions of competent agencies and persons in case of disasters, catastrophes, group-A infectious diseases or state of emergency.

9. To organize security forces, satisfy conditions on physical foundations to ensure security and order in conformity with the organizational form and size of the establishments; to coordinate with competent public security agencies in organizing the implementation of measures to ensure security and order at the establishments; to notify local competent public security agencies for coordination in implementing measures to protect patients who are victims of violence or abuse.

10. To refer and transfer patients to other medical examination and treatment establishments suitable to their disease condition and at their request in the following cases:

a/ The patients’ disease condition falls beyond the professional capacity or outside the scope of professional activities of the establishments;

b/ The patients or patients’ representatives so request and the attending practitioners or on-duty clinical personnel so agree;

c/ The establishments suspend their operation or are subject to suspension from operation or revocation of operation licenses.

d/ The establishments encounter a force majeure event and are no longer able to admit and provide treatment to patients.

11. To participate in preventive medicine activities in accordance with law.

12. To buy professional liability insurance in medical examination and treatment activities according to the Government’s regulations.

Chapter V

TECHNICAL EXPERTISE

Article 61. Emergency care

1. Emergency care activities include:

a/ Emergency care at medical examination and treatment establishments;

b/ Pre-hospital emergency care.

2. Emergency care shall be performed on the basis of evaluation, classification and application of professional and technical measures suitable to patients’ condition. When it is necessary to apply urgent emergency measures while not yet obtaining the consent of patients’ representatives, the persons in charge of professional expertise or on-duty managers of medical examination and treatment establishments may make decision.

3. For emergencies that require professional and technical assistance, medical examination and treatment establishments shall, on a case-by-case basis, carry out one or several of the following activities:

a/ Holding consultation in accordance with Article 64 of this Law;

b/ Requesting other medical examination and treatment establishments to render support;

c/ Providing support for telehealth activities;

d/ Transferring emergency patients to appropriate medical examination and treatment establishments.

4. Medical examination and treatment establishments shall create the best conditions in terms of human resources, medical equipment and drugs for providing emergency care to patients and for transferring emergency patients to appropriate medical examination and treatment establishments.

5. Pre-hospital emergency care activities include:

a/ First-aid activities carried out by persons who have knowledge of, or have been trained in, pre-hospital emergency care;

b/ Emergency care activities carried out by pre-hospital emergency providers or practitioners.

6. The pre-hospital emergency care system shall be organized based on the following basic criteria:

a/ Being suitable with the population size;

b/ Being suitable with the geographical characteristics of each locality;

c/ Ensuring the ability to admit and transport patients to medical examination and treatment establishments in the shortest time.

7. Funds for pre-hospital emergency care activities:

a/ The state budget shall allocate funds for investment in setting up the system of state-run pre-hospital emergency care facilities and the medical emergency information and coordination system; expenses for transportation and use of medical examination and treatment services in the course of emergency transport in case of accidents, disasters, catastrophes, and especially dangerous infectious disease outbreaks likely to transmit very quickly or spread widely with a high mortality rate or unknown causative agent; and expenses for management and operation of state-run pre-hospital emergency care establishments;

b/ Users of pre-hospital medical emergency care services shall pay expenses for using the services in accordance with Articles 18 and 110 of this Law, except the cases specified at Point a of this Clause.

8. Provincial-level People’s Committees shall organize the state-run pre-hospital emergency care system in the localities under their management.

9. The Government shall provide in detail the allocation of funds for emergency care activities specified at Point a, Clause 7 of this Article.

Article 62. Medical examination, designation of treatment methods and prescription of drugs

1. Medical examination, designation of treatment methods and prescription of drugs must comply with professional and technical regulations issued or recognized by the Minister of Health.

2. Practitioners assigned the task of providing medical examination and treatment have the following responsibilities:

a/ To provide medical examination, designate treatment methods and prescribe drugs in a timely and accurate manner and take responsibility for their decisions;

b/ To base themselves on patients’ disease condition to decide to apply outpatient treatment, day treatment or inpatient treatment. In case patients must undergo inpatient treatment but medical examination and treatment establishments do not have inpatient beds, to refer the patients to other appropriate medical examination and treatment establishments.

Article 63. Use of drugs in treatment

1. The use of drugs in medical examination and treatment must adhere to the following principles:

a/ Drugs shall be prescribed only in really necessary cases in a proper, safe, reasonable and effective manner;

b/ The prescription of drugs must be consistent with disease diagnosis and disease condition of patients;

c/ Drugs shall be stored, dispensed and used according to regulations.

2. When prescribing drugs, practitioners must fully and clearly write in the prescriptions or medical records information about the drug name, content, dosage, administration and duration of use; and may not prescribe supplements in prescriptions.

3. When dispensing drugs to patients, practitioners assigned to dispense drugs have the following responsibilities:

a/ To check prescriptions, drug receipts, drug name, concentration, content, dosage, and administration;

b/ When receiving drugs, to check and collate the prescriptions with information on the drug name, content, concentration, expiry date and quantity;

c/ To check and collate the patients’ full names, drug name, drug form, concentration, content, dosage, administration, and duration of use before dispensing drugs to patients;

d/ For patients undergoing inpatient treatment, to record the time of dispensing drugs to patients, monitor and promptly detect medical complications and notify such to the attending practitioners.

4. Patients have the responsibility to use drugs according to practitioners’ instructions. Patients or patients’ representatives shall promptly inform practitioners or medical examination and treatment establishments of abnormal signs occurring after the patients take the drugs.

Article 64. Consultation

1. The consultation shall be carried out in case the patient’s disease falls beyond the diagnosis and treatment capacity of the practitioner or medical examination and treatment establishment or in case the disease has been treated but does not become better or gets worse. The consultation results shall be written down and kept in the patient’s medical records.

2. Forms of consultation include:

a/ Consultation within a department, consultation with the participation of several departments and consultation with the participation of all departments of the medical examination and treatment establishment;

b/ Consultations between domestic medical examination and treatment establishments; consultation between domestic and foreign medical examination and treatment establishments;

c/ Other forms of consultation.

3. Methods of consultation include:

a/ In-person consultation;

b/ Remote consultation.

4. Based on consultation results, the attending practitioner shall make decisions on appropriate diagnosis and treatment for patients.

Article 65. Performance of invasive surgery or intervention

1. Invasive surgery or intervention for a patient may only be performed after obtaining the consent of the patient or the patient’s representative specified at Point a, b, c or d, Clause, 2 Article 8 of this Law.

2. Invasive surgery or intervention for a patient who has lost civil act capacity, has difficulties in cognition or behavior control, or has civil act capacity restricted, or a minor, or a patient without relatives must comply with Article 15 of this Law.

Article 66. Patient care

1. Patient care means the performance of professional and assistive intervention techniques to care for patients during medical examination and treatment as prescribed by practitioners.

2. Contents of patient care include:

a/ Determining care needs, making nursing diagnoses, and assigning patient care interventions;

b/ Assigning patient care levels;

c/ Performing professional and assistive intervention techniques to care for patients, and guide patients or patients’ relatives to perform a number of care activities;

d/ Monitoring patients’ condition and evaluate the results of care interventions.

Article 67. Nutrition in medical examination and treatment

1. Nutrition in medical examination and treatment means clinical nutrition activities and nutritional counseling and guidance in medical examination and treatment.

2. Contents of nutrition activities in medical examination and treatment include:

a/ Examining, evaluating and classifying the degrees of malnutrition, providing professional counseling and guidance on pathological nutrition and monitoring the nutritional status of patients;

b/ Conducting education and communication on nutrition.

Article 68. Rehabilitation

1. Principles of performing rehabilitation activities include:

a/ Preventing and reducing the impacts of disabilities; examining for detection and early rehabilitation intervention;

b/ Evaluating the need for rehabilitation intervention measures in the course of examination and treatment for patients;

c/ Implementing intervention measures in a continuous and comprehensive manner according to the stages of the disease;

d/ Implementing coordination between the rehabilitation specialty with other specialties; between medical examination and treatment establishments and individuals, families, communities and other agencies and organizations; implementing community-based rehabilitation.

2. Rehabilitation activities include:

a/ Examining, diagnosing, and determining patients’ needs for rehabilitation;

b/ Using techniques of movement therapy, physical therapy, occupational therapy, speech therapy, psychotherapy, orthopedics, medical equipment, rehabilitation tools and other intervention measures;

c/ Providing patients and their families with counseling on rehabilitation, psychology, education, career orientation and community integration;

d/ Adjusting and improving access to the living environment suitable to health status;

d/ Conducting communication on prevention of disabilities and diseases.

Article 69. Medical records

1. It is required to make and update medical records for patients undergoing inpatient treatment, day treatment and outpatient treatment in medical examination and treatment establishments.

Medical records shall be made in paper form or electronic form which are of the same legal validity. The form of medical record and form of summary of medical record shall be issued by the Minister of Health.

2. Medical records shall be stored and kept confidential in accordance with law; in case the medical records are classified as state secrets, the provisions of the law on protection of state secrets shall apply. The storage of medical records must comply with the law on archives.

3. The exploitation of the medical record of a patient undergoing treatment is specified as follows:

a/ Pupils, students, trainees, and researchers of research institutions and training institutions, practitioners, persons directly involved in the treatment of the patient at the medical examination and treatment establishment may read and copy the medical record only after getting the consent of the medical examination and treatment establishment;

b/ Practitioners of other establishments may read and copy the medical record after getting the consent of the medical examination and treatment establishment.

4. The exploitation of the stored medical record of a patient who has completed the treatment process is specified as follows:

a/ Representatives of state management agencies in charge of health, investigation bodies, procuracies, courts, specialized health inspectorates, forensic examination organizations, and forensic psychiatry organizations, and the patient’ lawyers may access and get the medical record to serve the performance of their tasks in accordance with relevant laws;

b/ Pupils, students, trainees, researchers of research institutions and training institutions, and practitioners in the medical examination and treatment establishment may borrow the medical record in order to read or copy it on the premises to serve their research or professional activities after getting the consent of the medical examination and treatment establishment;

c/ Representatives of social insurance agencies or state compensation settlement agencies may borrow the medical record in order to read or take notes on the premises or request the provision of a copy of the medical record to serve the performance of their assigned tasks after getting the consent of the medical examination and treatment establishment;

d/ The patient or patient’s representative specified at Points c and d, Clause 2, Article 8 of this Law may read, view, copy and take notes of the medial record and shall be provided with a summary of the medical record if he/she so requests in writing;

dd/ The patient’s representative specified at Points a and d, Clause 2, Article 8 of this Law shall be provided with a summary of the medical record if he/she so requests in writing.

5. The subjects specified in Clauses 3 and 4 of this Article shall, when using the information in the medical record, keep it secret and may only use it for the proper purposes as stated in the request submitted to the medical examination and treatment establishment.

Article 70. On-duty medical staff

1. Medical examination and treatment establishments with inpatient beds and beds for patient monitoring and treatment and pre-hospital emergency care facilities shall arrange on-duty medical staff who shall work continuously according to the working time stated in their operation licenses, including also holidays, New Year festivals and rest days, in order to promptly provide emergency care and maintain other medical examination and treatment activities.

2. On-duty medical staff includes the following personnel:

a/ On-duty managers;

b/ On-duty clinical personnel;

c/ On-duty subclinical personnel;

d/ On-duty logistics and administration personnel.

3. The on-duty medical staff at hospitals must include all personnel specified in Clause 2 of this Article; the on-duty medical staff at medical examination and treatment establishments specified in Clause 1 of this Article that are not hospitals must comply with the Minister of Health’s regulations.

4. Heads of the medical examination and treatment establishments specified in Clause 1 of this Article have the following responsibilities:

a/ To assign on-duty staff;

b/ To ensure the availability of adequate means of emergency transport in conformity with the form of organization of medical examination and treatment at their establishments; medical equipment and essential drugs used in emergencies;

c/ To ensure compliance with the reporting regime for each duty shift.

Article 71. Prevention of adverse events at medical examination and treatment establishments

1. The prevention of adverse events shall be carried out on the basis of identifying, reporting, and analyzing to find the causes, giving recommendations and solutions to prevent and avoid the recurrence of adverse events to improve the quality of medical examination and treatment services and ensure safety for patients.

Recommendations and solutions to prevent adverse events shall be published on the information system on management of medical examination and treatment activities.

2. The prevention of adverse events at medical examination and treatment establishments is the responsibility of the heads of and persons working at the medical examination and treatment establishments.

Article 72. Admission and handling of patients without relatives

1. When admitting and performing medical examination and treatment for patients without relatives, medical examination and treatment establishments shall inventory, make records of and store patients’ belongings.

2. Within 48 hours after admitting a patient, if the medical examination and treatment establishment cannot identify his/her relatives, it shall:

a/ Notify the case to the commune-level People’s Committee of the locality where the establishment is located for the latter to make an announcement in the mass media to find the patient’s relatives;

b/ Make a dossier of request for admission of social protection policy beneficiaries in extremely difficult circumstances to social assistance establishments in accordance with the law on social protection, for under-6-month children abandoned at medical examination and treatment establishments.

3. In case the patient has been treated and his/her condition has become stable but it remains impossible to identify his/her relatives, if the patient falls into the case of having lost civil act capacity, having difficulties in cognition or behavior control or having civil act capacity restricted, the medical examination and treatment establishment shall make a dossier of request for admission of social protection policy beneficiaries in extremely difficult circumstances to social assistance establishments in accordance with the law on social assistance.

4. In case the patient dies, the medical examination and treatment establishment shall handle the case according to Article 73 of this Law.

5. The medical examination and treatment establishment shall nurture, care for, and provide medical examination and treatment to the patient during the period from the time of admitting the patient until completing procedures for transferring the patient to a social assistance establishment or until the patient dies.

6. The Government shall prescribe the payment of expenses for nurturing, caring and providing medical examination and treatment for the subjects specified in this Article and the handling of foreign patients without relatives.

Article 73. Handling of cases of death

1. The handling of cases in which a person is taken to a medical examination and treatment establishment but dies before arriving at the medical examination and treatment establishment is specified as follows:

a/ In case such person has personal identification papers and it is possible to contact his/her relatives, the medical examination and treatment establishment shall notify such person’s death to his/her relatives for receipt of the body;

b/ In case such person has no personal identification papers or has personal identification papers but it is impossible to contact his/her relatives, the medical examination and treatment establishment shall notify such person’s death to the commune-level People’s Committee of the locality where the medical examination and treatment establishment is located within 24 hours after receiving the body.

The commune-level People’s Committee of the locality where the medical examination and treatment establishment is located shall receive the body and organize the burial within 48 hours after receiving the notice.

2. The handling of cases of death at a medical examination and treatment establishment is specified as follows:

a/ Medical examination and treatment establishments shall issue death notices; conduct death case reviews; complete and store dead patients’ medical records; take and store body samples to serve the identification of patients’ identity, for the case specified at Point b, Clause 1 of this Article; and notify the patients’ death to their relatives for organizing burial;

b/ A medical examination and treatment establishment shall notify the commune-level People’s Committee of the locality where the establishment is located within 24 hours after a patient dies, in case such patient has no relatives or his/her relatives refuse to receive the body.

The commune-level People’s Committee of the locality where the medical examination and treatment establishment is located shall receive the body and organize the burial within 48 hours after receiving the notice from the medical examination and treatment establishment as specified at Point b of this Clause.

3. The Government shall prescribe the handling of cases of death of foreigners without relatives and the payment of burial expenses for the cases specified at Point b, Clause 1 and Point b, Clause 2 of this Article.

Article 74. Infection control at medical examination and treatment establishments

1. Infection control at medical examination and treatment establishments includes the following measures:

a/ Supervision of infection at medical examination and treatment establishments and diseases at risk of causing epidemics;

b/ Supervision of the compliance with infection control practices;

c/ Standard precautions, transmission-based precautions;

d/ Infection control of medical instruments and equipment;

dd/ Hand hygiene;

e/ Environmental sanitation;

g/ Prevention and treatment of infections related to microorganisms;

h/ Food safety;

i/ Other infection control measures.

2. Medical examination and treatment establishments have the following responsibilities:

a/ To implement infection control measures at medical examination and treatment establishments as specified in Clause 1 of this Article;

b/ To ensure physical foundations, equipment, protective clothing, and personal hygiene conditions for persons working at medical examination and treatment establishments, patients and other persons who come to medical examination and treatment establishments in conformity with requirements for infection control at medical examination and treatment establishments;

c/ To provide counseling on infection control measures to patients and patients’ relatives;

d/ To organize infection control systems at medical examination and treatment establishments.

Article 75. Medical waste management and environmental protection in medical examination and treatment establishments

Medical examination and treatment establishments shall manage medical wastes and protect the environment in medical examination and treatment establishments in accordance with the law on environmental protection.

Article 76. Outpatient treatment

Outpatient treatment shall be applied to cases that do not require inpatient treatment at medical examination and treatment establishments.

Article 77. Inpatient treatment

1. Inpatient treatment shall be applied to cases in which the patient needs to stay at a medical examination and treatment establishment for medical examination and treatment as prescribed by the practitioner.

2. Depending on each specialty and operating conditions, medical examination and treatment establishments may organize inpatient treatment. Private polyclinics in areas with difficult socio-economic conditions, areas with extremely difficult socio-economic conditions or border areas, or on islands, state-run regional polyclinics, maternity hospitals and commune health stations may arrange beds for patient monitoring and treatment for at most 72 hours, except in case of force majeure events due to disasters, catastrophes or epidemics.

3. The transfer of a patient from one department to another is specified as follows:

a/ In case it is discovered that medical examination and treatment for the patient at another specialty is more suitable to the patient’s disease condition;

b/ The department from which the patient is transferred shall complete the medical record, and transfer the patient and the medical record to the new department.

4. In case of transferring a patient to a new medical examination and treatment establishment, the medical examination and treatment establishment from which the patient is transferred shall complete the medical record and refer the patient to the new medical examination and treatment establishment.

In case of transferring a patient to a new medical examination and treatment establishment at the request of the patient or the patient’s representative, for the patients specified in Article 15 of this Law, the patient or the patient’s representative shall make a written commitment to take responsibility for such transfer.

5. A patient may leave the medical examination and treatment establishment in one of the following cases:

a/ When the patient has recovered or his disease condition has become stable;

b/ The patient or the patient’s representative, in case the patient has lost civil act capacity, has difficulties in cognition or behavior control, or has civil act capacity restricted, or is a minor, files a request to leave the medical examination and treatment establishment and commits to take responsibility for his/her decision.

6. When a patient leaves the medical examination and treatment establishment, the medical examination and treatment establishment shall:

a/ Complete the patient’s medical record;

b/ Provide self-care instructions to the patient;

c/ Designate outpatient treatment in case of necessity;

d/ Conduct account-finalization of medical examination and treatment expenses;

d/ Issue a hospital discharge paper for the patient.

Article 78. Day treatment

1. Day treatment shall be applied to patients who need to undergo inpatient treatment but do not need to stay overnight at medical examination and treatment establishments according to the practitioners’ prescription.

2. Day treatment must comply with Article 77 of this Law.

Article 79. Mobile medical examination and treatment activities

1. Mobile medical examination and treatment activities include:

a/ Mobile medical examination and treatment activities carried out by medical examination and treatment establishments outside locations of medical examination and treatment stated in their operation licenses;

b/ Home-based medical examination and treatment, health check-ups at agencies, organizations and units;

c/ Humanitarian medical examination and treatment under campaigns.

2. Conditions for carrying out mobile medical examination and treatment activities:

a/ Mobile medical examination and treatment activities in the cases specified at Points a and b, Clause 1 of this Article shall be carried out by medical examination and treatment establishments that have sufficient practitioners, medical equipment, physical foundations and other conditions suitable to the scale and scope of the mobile medical examination and treatment services provided, except home-based medical examination and treatment activities carried out by village health workers or village midwives;

b/ Mobile medical examination and treatment activities in the case specified at Point c, Clause 1 of this Article must satisfy the conditions specified in Clause 2, Article 88 of this Law;

c/ Mobile medical examination and treatment activities shall be approved by the specialized health agencies under the provincial-level People’s Committees of the localities where the mobile medical examination and treatment activities are to be carried out, for the cases specified at Points a and c, Clause 1 of this Article, except cases in which medical examination and treatment establishments in the armed forces organize mobile medical examination and treatment for subjects under their management.

3. The Government shall detail this Article.

Article 80. Telehealth and telehealth support

1. Telehealth between practitioners and patients shall be implemented as follows:

a/ Telehealth between practitioners and patients shall be implemented within the scope of practitioners’ practice; telehealth shall be applied to the list of diseases and disease status promulgated by the Minister of Health;

b/ Practitioners shall bear responsibility for their disease diagnosis results, designation of treatment methods and prescription of drugs.

2. Telehealth support between medical examination and treatment establishments is prescribed as follows:

a/ Practitioners performing medical examination and treatment at supported medical examination and treatment establishments shall be held responsible for their medical examination and treatment results;

b/ Supported medical examination and treatment establishments shall pay telehealth support costs to medical examination and treatment establishments that provide telehealth support at their agreed rates.

3. The Government shall provide in detail telehealth and telehealth support.

Article 81. Medical examination and treatment after the model of family medicine

1. Medical examination and treatment activities after the model of family medicine shall be carried out by medical examination and treatment establishments specialized in family medicine or other medical examination and treatment establishments with the scope of professional expertise covering family medicine.

2. The medical examination and treatment establishments specified in Clause 1 of this Article shall perform the following tasks:

a/ To manage and provide primary health care in the localities they operate;

b/ To provide counseling on disease and illness prevention and health improvement;

c/ To provide emergency care and primary medical examination and treatment;

d/ To provide medical examination and treatment, rehabilitation, palliative care, and end-of-life care services at home;

dd/ To decide on the transfer of patients under their management to other medical examination and treatment establishments; to receive patients transferred from medical examination and treatment establishments and manage their health;

e/ To perform other tasks assigned by competent agencies.

Article 82. Compulsory medical treatment

1. Cases subject to compulsory medical treatment under this Law include:

a/ People suffering group-A infectious diseases as prescribed in the law on prevention and control of infectious diseases;

b/ People suffering depression with suicidal ideation and behavior; people suffering mental illness who are in an agitated state and likely to self-harm or commit acts of causing harms to others or destroying property;

c/ Other law-prescribed cases.

2. The Government shall prescribe compulsory medical treatment measures for the cases prescribed in Clause 1 of this Article.

Article 83. Health check-ups

1. Forms of health check-ups include:

a/ Periodic health check-ups;

b/ Health check-ups for the purpose of health classification for school admission or recruitment;

c/ Health check-ups for pupils and students;

d/ Health check-ups based on requirements of specific occupations and jobs;

dd/ Health check-ups to detect occupational diseases;

e/ On-demand health check-ups;

g/ Other forms of health check-ups.

2. The Minister of Health shall prescribe health standards and health check-ups specified in Clause 1 of this Article, except the case specified in Clause 3 of this Article.

3. The Minister of National Defense and Minister of Public Security shall prescribe specific health standards and health check-ups for subjects under their management.

Article 84. Medical assessment

1. Medical assessment includes first-time medical assessment, medical re-assessment, re-assessment of deformity and final assessment.

2. Assessment conclusions must comply with the contents of the assessment solicited or requested by agencies, organizations or individuals. Agencies and persons making assessment conclusions shall bear responsibility before law for such conclusions.

 

Chapter VI

TRADITIONAL MEDICINE-BASED MEDICAL EXAMINATION AND TREATMENT AND COMBINATION OF TRADITIONAL MEDICINE WITH MODERN MEDICINE

Article 85. Development of traditional medicine-based medical examination and treatment

1. State-run general hospitals shall provide traditional medicine-based medical examination and treatment; to encourage traditional medicine establishments to provide general medical services if fully meeting the law-specified conditions.

2. To inherit and develop traditional medicine-based herbal remedies and healing methods; to encourage the use of herbal medicinal products , traditional drugs made from domestically grown materials that are clinically effective in disease prevention and treatment. To encourage and support the development of traditional medicine-based life-nourishing methods in the community.

3. To encourage the following scientific and technological researches in traditional medicine:

a/ Discovery of, and research on, herbal medicinal products and traditional drugs;

b/ Research on tastes and medical properties according to traditional medicine of traditional Vietnamese medicinal materials, folk medicines and medicaments, which are identified in traditional medicine and modern medicine as having effects in disease prevention and treatment;

c/ Research on the safety and effect of traditional medicine diagnosis and treatment methods and non-drug treatment methods in disease prevention and treatment;

d/ Research on the selection and development of safe and highly effective herbal medicinal products and traditional drugs for use in disease treatment;

dd/ Research on the safety and effect of herbal medicinal products and traditional drugs combined with chemical medicinal products in different stages of diseases;

e/ Research on the combination of traditional medicine and modern medicine in disease diagnosis so as to develop a set of criteria for diagnosis of diseases and disease status based on traditional medicine;

g/ Research on the application of advanced technologies to the preparation of herbal medicinal products and traditional drugs in modern dosage forms.

4. To encourage the registration of intellectual property rights for traditional herbal remedies and traditional healing methods.

Article 86. Development of human resources in service of traditional medicine-based medical examination and treatment

1. To incorporate traditional medicine knowledge in training programs of training institutions in the health specialty; to diversify types and forms of training in traditional medicine-based medical examination and treatment personnel at different levels.

2. Herb doctors and owners of traditional herbal remedies and traditional healing methods may attend training courses to update and improve their knowledge of modern medicine and traditional medicine.

3. Owners of traditional herbal remedies and traditional healing methods are encouraged to register with specialized health agencies of provincial-level People’s Committees of the localities where they practice in case of handing down their traditional herbal remedies and traditional healing methods to others.

4. The Minister of Health shall prescribe the issuance of the herb doctor’s certificate, certificate of owner of traditional herbal remedies and certificate of traditional healing methods.

Article 87. Combination of traditional medicine with modern medicine at medical examination and treatment establishments

1. The combination of traditional medicine and modern medicine may only be carried out at medical examination and treatment establishments and must comply with the following regulations:

a/ To combine professional methods and techniques of traditional medicine with those of modern medicine in medical examination and treatment and monitor and evaluate treatment results;

b/ Only qualified practitioners may designate treatment methods and give prescriptions that combine traditional medicine and modern medicine.

2. The Minister of Health shall detail this Article.

 

Chapter VII

HUMANITARIAN MEDICAL EXAMINATION AND TREATMENT, NOT-FOR-PROFIT MEDICAL EXAMINATION AND TREATMENT; TRANSFER OF PROFESSIONAL TECHNIQUES IN MEDICAL EXAMINATION AND TREATMENT

Section 1

HUMANITARIAN MEDICAL EXAMINATION AND TREATMENT, NOT-FOR-PROFIT MEDICAL EXAMINATION AND TREATMENT

Article 88. Humanitarian medical examination and treatment activities, not-for-profit medical examination and treatment activities

1. Domestic and foreign organizations and individuals may request provision of humanitarian medical examination and treatment and not-for-profit medical examination and treatment in Vietnam.

2. Conditions for carrying out humanitarian medical examination and treatment under campaigns:

a/ Being performed by practitioners or the persons prescribed in Clause 3, Article 19 of this Law;

b/ Being carried out by medical examination and treatment establishments or organizations licensed to operate in Vietnam;

c/ Having financial sources for carrying out humanitarian medical examination and treatment and exempting all medical examination and treatment charges for people eligible for humanitarian medical examination and treatment;

d/ Having obtained competent agencies’ approval in accordance with the Government’s regulations.

3. Conditions for granting operation licenses to humanitarian medical examination and treatment establishments and not-for-profit medical examination and treatment establishments:

a/ Having satisfied the requirements for grant of an operation license under this Law;

b/ Having financial sources for carrying out humanitarian medical examination and treatment activities and exempting all medical examination and treatment charges for people eligible for humanitarian medical examination and treatment, for humanitarian medical examination and treatment establishments;

c/ Making commitments to operate for not-for-profit purposes and not to withdraw capital, using annual income under undivided co-ownership for investment in development of the establishments, for not-for-profit medical examination and treatment establishments. The commitments must be inscribed in the establishment decision or decision on transformation of the type of medical examination and treatment establishments.

4. The Government shall detail this Article.

Article 89. Incentives for humanitarian medical examination and treatment establishments and not-for-profit medical examination and treatment establishments

1. Humanitarian medical examination and treatment establishments and not-for-profit medical examination and treatment establishments may, upon establishment, enjoy preferential regimes prescribed by law.

2. Humanitarian medical examination and treatment establishments and not-for-profit medical examination and treatment establishments shall comply with financial, accounting, auditing, tax, asset valuation and financial publicity regulations, particularly the incomes under undivided co-ownership of not-for-profit medical examination and treatment establishments will be eligible for tax exemption.

Section 2

TRANSFER OF PROFESSIONAL TECHNIQUES IN MEDICAL EXAMINATION AND TREATMENT

Article 90. Transfer of professional techniques in medical examination and treatment

1. Medical examination and treatment establishments may cooperate with domestic and foreign organizations and individuals in the transfer of professional techniques in medical examination and treatment in Vietnam.

2. The training in transfer of professional techniques in medical examination and treatment shall be provided by lawful practitioners or medical examination and treatment establishments.

3. The Government shall detail this Article.

Article 91. Incentives for transfer of professional techniques in medical examination and treatment

The transfer of professional techniques in medical examination and treatment will be eligible for preferential regimes under the laws on technology transfer, intellectual property, and science and technology.

 

Chapter VIII

APPLICATION OF NEW TECHNIQUES AND METHODS IN MEDICAL EXAMINATION AND TREATMENT AND CLINICAL TRIALS IN MEDICAL EXAMINATION AND TREATMENT

Section 1

APPLICATION OF NEW TECHNIQUES AND METHODS IN MEDICAL EXAMINATION AND TREATMENT

Article 92. New techniques and methods in medical examination and treatment

1. New techniques and methods are techniques and methods which are applied in Vietnam for the first time.

2. New techniques and methods include:

a/ New techniques and methods researched in Vietnam or overseas;

b/ New techniques and methods licensed for application by foreign authorities.

Article 93. Conditions for application of a new technique or method in medical examination and treatment

1. A medical examination and treatment establishment requesting the application of a new technique or method must satisfy the following conditions:

a/ Possessing an operation license with the scope of professional operations conformable to the new technique or method requested for application;

b/ Having physical foundations, medical equipment, human resources and other conditions meeting the requirements for application of the new technique or method.

2. The application of a new technique or method is specified as follows:

a/ The medical examination and treatment establishment shall formulate a scheme to request the licensing of pilot application of the new technique or method;

b/ The Ministry of Health shall appraise or delegate the appraisal of the scheme for licensing the pilot application of the new technique or method;

c/ Upon the completion of the pilot phase, the medical examination and treatment establishment shall summarize the pilot application result and request the Ministry of Health to organize a pre-acceptance test;

d/ In case the result of the pre-acceptance test is satisfactory, the Ministry of Health shall issue a document licensing the application of the new technique or method.

3. The Government shall detail this Article.

Section 2

CLINICAL TRIALS IN MEDICAL EXAMINATION AND TREATMENT

Article 94. Cases of clinical trials in medical examination and treatment

1. New techniques and methods in medical examination and treatment.

2. Medical equipment with medium-high or high degree of risk as stipulated by the Government, before being registered for sale in Vietnam.

Article 95.  Conditions for participating in clinical trials in medical examination and treatment

1. Persons who satisfy professional requirements of clinical trials of new techniques and methods and medical equipment in medical examination and treatment (below referred to as clinical trial) and voluntarily participate in clinical trial.

2. In case clinical trial participants are those who have lost civil act capacity, have difficulties in cognition or behavior control, or have civil act capacity restricted; or are minors, the consent of their representatives or guardians as provided by the civil law shall be required.

3. In case clinical trial participants are those specified in Clause 2 of this Article, or pregnant or breastfeeding women, the dossiers of research must clearly state reasons for selection of, and appropriate measures to protect, clinical trial participants as well as fetuses and infants breastfed by the mothers being the clinical trial participants.

Article 96. Rights and obligations of clinical trial participants

1. A clinical trial participant has the following rights:

a/ To be provided with sufficient and truthful information on the clinical trial and potential risks before the clinical trial is conducted;

b/ To receive compensation for damage (if any) caused by the clinical trial;

c/ To have his/her personal information relating to the clinical trial kept confidential;

d/ To be exempt from liability when unilaterally terminating his/her participation in the clinical trial;

dd/ To lodge a complaint or denunciation or initiate a lawsuit against the violation of law committed by the organization or individual that possesses the new technique or method subject to clinical trials.

2. Clinical trial participants have the obligation to abide by instructions under the approved clinical trial dossiers.

Article 97. Rights and obligations of organizations and individuals possessing new techniques or methods subject to clinical trials

 1. An organization or individual possessing a new technique or method or medical equipment subject to clinical trials has the following rights:

a/ To select an establishment that meets requirements on physical foundations and human resources for conducting the clinical trial;

b/ To possess all outcomes of the clinical trial.

2. An organization or individual possessing a new technique or method or medical equipment subject to clinical trials has the following responsibilities:

a/ To compensate for damage caused to clinical trial participants in accordance with law for risks occurring in the clinical trial, if any;

b/ To enter into written clinical trial contracts with clinical trial-hosting establishments;

c/ To be held responsible before law for the quality and safety of the new technique or method or new medical equipment it provides.

Article 98. Rights and responsibilities of clinical trial-hosting establishments

1. A clinical trial-hosting establishment has the following rights:

a/ To host the clinical trial according to regulations;

b/ To import and purchase chemicals, reference materials, drug specimens and medical equipment serving the clinical trial;

c/ To use the outcomes of the clinical trial as agreed upon with the organization or individual possessing the new technique or method subject to clinical trials.

2. A clinical trial-hosting establishment has the following responsibilities:

a/ To be held responsible for the completeness, accuracy and truthfulness of the outcomes of the clinical trial;

b/ To be held responsible for the safety of clinical trial participants and compensate for damage caused to clinical trial participants in accordance with law for risks occurring due to their faults.

c/ To ensure truthfulness and objectivity of the clinical trial.

Article 99. Principles and competence for approval of clinical trials

1. Clinical trials shall be conducted before a new technique or method is licensed for application or a medical equipment is registered for sale, except cases exempt from clinical trial or exempt from several phases of clinical trials.

2. A clinical trial shall be conducted only after the clinical trial dossier is evaluated regarding the scientific and ethical aspects by a Council of Ethics in Biomedical Research specified in Clause 3 of this Article and approved in writing by a competent agency.

3. A Council of Ethics in Biomedical Research is an independent council established to protect the rights, safety and health of clinical trial participants.

4. Clinical trials, scientific and ethical evaluation of clinical trial dossiers and approval of clinical trials must adhere to the following fundamental principles:

a/ To respect, protect and ensure clinical trial participants’ self-determination rights;

b/ To ensure that the benefits of the research outweigh potential risks in the clinical trial process;

c/ To ensure the equality between benefits and responsibilities; and ensure that potential risks are equally distributed to clinical trial participants;

d/ To ensure that all clinical trial phases are carried out and clinical trials comply with good clinical practices according to the Minister of Health’s regulations.

5. The Government shall specify the following contents:

a/ Phases of clinical trials;

b/ Cases of exemption from clinical trials or exemption from several phases of clinical trials;

c/ Requirements for new techniques and methods, and medical equipment subject to clinical trials;

d/ Requirements for clinical trial-hosting establishments;

dd/ Dossiers, order and procedures for licensing clinical trials;

e/ Establishment of the councils of ethics in biomedical research.

 

Chapter IX

PROFESSIONAL AND TECHNICAL ERRORS

Article 100. Determination of practitioners committing professional and technical errors

1. A practitioner shall be considered having committed professional and technical errors when he/she is determined by a professional council specified in Article 101 of this Law as having committed at least either of the following acts:

a/ Violating regulations on responsibilities in patient care and treatment;

b/ Violating professional and technical regulations.

2. A practitioner shall be considered not having committed professional and technical errors when he/she is determined by a professional council specified in Article 101 of this Law as falling into one of the following cases:

a/ Cases in which practitioners have properly performed their responsibilities in patient care and treatment and observed professional and technical regulations in medical examination and treatment but medical complications still occur to patients;

b/ Cases of emergencies which cannot be handled due to lack of technical means, medical equipment, drugs and practitioners; or cases of diseases for which professional and technical guidance is not yet available, resulting in occurrence of medical complications to patients;

c/ Cases of force majeure events or other external obstacles or objective causes, resulting in occurrence of medical complications to patients;

d/ Cases in which medical complications are caused by patients themselves.

Article 101. Professional councils

1. When a medical complication occurs to a patient and leads to a dispute that needs to be solved, the concerned medical examination and treatment establishment shall, at the request of the patient or the patient’s representative or the involved practitioner, establish a professional council to determine whether or not the practitioner has committed professional and technical errors.

2. A professional council shall be composed of the following members:

a/ Experts in relevant specialties;

b/ Experts in other specialties and fields related to the medical complication.

3. The invitation of experts to join the professional council must ensure objectivity and no conflict of interests in accordance with law.

4. A professional council shall be established in the following cases:

a/ A medical examination and treatment establishment shall establish a professional council by itself under Clause 1 of this Article. In case the medical examination and treatment establishment cannot establish a professional council by itself, it shall propose its managing competent state agency in charge of health to establish a council.

b/ A competent state agency in charge of health that directly manages a medical examination and treatment establishment shall establish a professional council in case the latter files a request therefor under Point a of this Clause or in case a disputing party files a written request therefor as he/she disagrees with the conclusion of the professional council established by the medical examination and treatment establishment;

c/ The Ministry of Health shall establish a profession council in case a disputing party files a request therefor as he/she disagrees with the conclusion of the professional council established by the competent state agency in charge of health that directly manages the medical examination and treatment establishment.

5. Professional councils shall adhere to the following principles:

a/ Professional councils operate on the principles of conducting collective discussion, making decisions by majority rule and taking responsibility before law for their conclusions.

b/ Professional councils’ conclusion serves as a basis for settlement of disputes upon occurrence of medical complications and a ground for competent state agencies in charge of health or heads of medical examination and treatment establishments to make decisions on application of measures for handling practitioners according to their competence;

c/ Conclusion of professional councils established by the Ministry of Health is the final conclusion on whether or not practitioners have committed professional and technical errors.

6. The Minister of Health shall provide for the regulation on organization and operation of professional councils, and order and procedures for settlement of disputes over occurrence of medical complications.

Article 102. Compensation upon occurrence of medical complications

In case of occurrence of a medical complication to a patient, the concerned medical examination and treatment establishment shall compensate to the patient in accordance with law, except the cases specified in Clause 2, Article 100 of this Law.

Article 103. Professional liability insurance in medical examination and treatment

1. Professional liability insurance in medical examination and treatment is a type of insurance used to pay damages for medical complications occurring in the course of medical examination and treatment within the insurance contract period, and costs for legal actions related to these medical complications, except the case specified at Point d, Clause 2, Article 100 of this Law.

2. Insurance enterprises shall pay damages under Clause 1 of this Article to medical examination and treatment establishments under the signed insurance contracts.

3. Professional liability insurance in medical examination and treatment must comply with the law on insurance business.

4. The Government shall detail this Article.

 

Chapter X

CONDITIONS FOR ASSURANCE OF MEDICAL EXAMINATION AND TREATMENT

Section 1

PROFESSIONAL AND TECHNICAL ASSURANCE CONDITIONS

Article 104. Professional and technical levels in medical examination and treatment

1. State-run and private medical examination and treatment establishments shall be divided into 3 professional and technical levels as follows:

a/ Primary medical examination and treatment, which is assigned to perform medical examination, outpatient treatment and primary healthcare; and disease management and community-based rehabilitation;

b/ Basic medical examination and treatment, which is assigned to perform medical examination, and general outpatient and inpatient treatment; and provide training in general medical practice and continuous updating of medical knowledge for practitioners;

c/ Intensive medical examination and treatment, which is assigned to perform medical examination, and intensive outpatient and inpatient treatment; provide training in intensive practice; conduct continuous intensive research and training; and carry out technology transfer in medical examination and treatment.

2. Professional and technical levels in medical examination and treatment shall be organized in a way that ensures continuousness and transferability in provision of medical examination and treatment services based on disease status and severity, adhering to the following principles:

a/ One medical examination and treatment establishment may only be classified into one professional and technical level; in case a medical examination and treatment establishment performs the tasks of 3 professional and technical levels, it shall be classified into the intensive level; in case a medical examination and treatment establishment performs the tasks of the primary and basic medical examination and treatment levels, it shall be classified into the basic level;

b/ Medical examination and treatment establishments shall focus on performing the task of the level into which they are classified, and may perform the professional and technical tasks of other levels if satisfying the conditions specified by the Minister of Health; and shall perform the tasks of other professional and technical levels which are suitable to the characteristics of their specialties or fields according to the Government’s regulations.

3. A medical examination and treatment establishment shall be classified into a professional and technical level based on the following criteria:

a/ The capacity of providing medical examination and treatment services and scope of professional operations;

b/ The capacity for participating in training of medical practice;

c/ The capacity for providing technical support for other medical examination and treatment establishments;

d/ The capacity of conducting scientific researches on medicine.

4. The Government shall detail this Article.

Article 105. Training and further training of practitioners

1. Medical examination and treatment establishments shall organize, and create conditions for practitioners to participate in training and continuous updating of medical knowledge, and further training in professional and technical skills and professional ethics.

2. The State shall adopt policies on scholarships as follows:

a/ To grant study promotion scholarships to learners of state-run health discipline-training institutions who major in psychiatry, anatomical pathology, forensic medicine, forensic psychiatry, infectious diseases and intensive care medicine and have their academic results qualified for scholarships;

b/ To grant policy scholarships to learners majoring in psychiatry, anatomical pathology, forensic medicine, forensic psychiatry, infectious diseases and intensive care medicine who are working at medical examination and treatment establishments in areas with difficult socio-economic conditions and areas with extremely difficult socio-economic conditions.

3. The State shall subsidy learners majoring in psychiatry, anatomical pathology, forensic medicine, forensic psychiatry, infectious diseases and intensive care medicine as follows:

a/ To subsidy all tuition fees and cost-of-living expenses for the entire course for learners of state-run health discipline-training institutions;

b/ To subsidy all tuition fees and cost-of-living expenses for the entire course equivalent to the amounts specified at Point a of this Clause, for learners of private health discipline-training institutions.

4. The State shall encourage organizations and individuals to grant scholarships or subsidy to learners.

5. The Government shall detail this Article.

Section 2

FINANCIAL CONDITIONS

Article 106. Financial sources for medical examination and treatment

1. Financial sources for medical examination and treatment include:

a/ The state budget;

b/ The health insurance fund;

c/ Expenses paid by patients;

d/ Aid, donations and supports from domestic and foreign organizations and individuals in accordance with law;

dd/ Other lawful financial sources in accordance with law.

2. Medical examination and treatment establishment shall perform the financial, accounting, auditing and tax regimes, and carry out asset valuation and financial publicization in accordance with law.

Article 107. State budget funds for medical examination and treatment

1. To allocate funds to medical examination and treatment establishments that provide medical examination and treatment services on the list of medical examination and treatment services funded by the state budget in accordance with law, and perform the tasks placed or assigned by competent state agencies.

2. To provide support to state-run medical examination and treatment establishments in accordance with the laws on the state budget and financial autonomy regime applicable to public non-business units, covering also funds for assurance of recurrent expenditures in case they are unable to balance recurrent expenditures.

3. To cover expenses for development investment of medical examination and treatment establishments in accordance with law.

4. To wholly or partially pay health insurance premiums for those who are eligible for whole or partial payment of health insurance premiums by the State in accordance with the law on health insurance.

Article 108. Regulations on autonomy for state-run medical examination and treatment establishments

1. State-run medical examination and treatment establishments shall be funded by the State to perform the functions and tasks assigned by competent state agencies; and responsible for effectively using financial resources in accordance with law, and bringing into full play their potential and strength and improving the quality of medical examination and treatment.

2. Medical examination and treatment mechanisms practicing autonomy may enjoy autonomy in making decisions on their organization and human resources, performing the tasks of, and developing professional activities and other activities serving, medical examination and treatment in accordance with this Law and other relevant laws.

3. Medical examination and treatment establishments shall practice financial autonomy in accordance with law and for the following contents:

a/ To decide on the contents and levels of payments for goods and services related to medical examination and treatment activities and provided to patients and patients’ relatives in accordance with law, except goods and services valuated by the State;

b/ To decide on the use of their lawful revenues to invest in projects on implementation of medical examination and treatment activities in accordance with law;

c/ To decide on the contents and levels of spending from the sources of revenues from provision of medical examination and treatment services, non-business revenues, and orders placed by the State according to their internal spending regulations in accordance with law and in conformity with the establishments’ financial capacity;

d/ To decide on the use of public assets in accordance with law for development of medical examination and treatment activities in adherence to the principles of conservation and development; to receive, manage, exploit and use assets given or donated by organizations and individuals on the principles of publicity and transparency and non-binding interests among involved parties to serve medical examination and treatment work;

dd/ Medical examination and treatment establishments that cover by themselves investment expenses and recurrent expenditures may decide on prices of their medical examination and treatment services which, however, must not exceed the equivalent service prices specified by the Minister of Health, except prices of on-demand medical examination and treatment services and prices of medical examination and treatment services formed from activities of cooperation in the form of public-private partnership under Clauses 7 and 9, Article 110 of this Law.

4. The Government shall detail this Article.

Article 109. Socialization of medical examination and treatment activities

1. Organizations, families and individuals shall take care of their health, early detect diseases for members of their organizations and families and for themselves; participate in providing emergency care and support in case of accidents and injuries occurring in the community, and participate in medical examination and treatment activities when being mobilized by competent agencies or persons.

2. The State shall diversify forms of medical examination and treatment services. Organizations and individuals participating in the construction of medical examination and treatment establishments are entitled to preferential policies in accordance with regulations on socialization activities, ensuring adherence to the principles of publicity, transparency, equality, sustainability, efficiency, and harmony of the interests of the State, investors, patients and the community. Private medical examination and treatment establishments are encouraged to provide humanitarian and not-for-profit medical examination and treatment. It is encouraged to establish funds for medical examination and treatment support.

3. Forms of attracting social resources for medical examination and treatment activities:

a/ Investment in establishment of private medical examination and treatment establishments;

b/ Investment in the form of public-private partnership to establish medical examination and treatment establishments;

c/ Borrowing loans to invest in infrastructure works and medical equipment;

d/ Rent and lease of property, clinical services, subclinical services, non-medical services and pharmacy services, and management and operation of medical examination and treatment establishments;

dd/ Purchase of medical equipment on deferred or installment payment; rent and borrowing of medical equipment;

e/ Donation or aid from domestic and foreign organizations and individuals;

g/ Other forms in accordance with the law on management and use of public property and other relevant laws.

4. The attraction of social resources for medical examination and treatment activities of state-run medical examination and treatment establishments must comply with law.

5. The Government shall detail this Article.

Article 110. Medical examination and treatment service charges

1. Medical examination and treatment service charges include the following constituents:

a/ Total cost of medical examination and treatment services as specified in Clause 2 of this Article;

b/ Accumulations or expected profits (if any);

c/ Financial obligations prescribed by law.

2. The total cost of medical examination and treatment services consists of:

a/ Labor cost, including salary and wage suitable to the type of services provided, salary-based contributions and allowances as prescribed;

b/ Direct expenses, including expenses for drugs, chemicals, blood, and blood products, expenses for raw materials, materials, instruments, tools, fuel, and energy used for medical examination and treatment, and other direct expenses;

c/ Expenses for amortization of medical equipment and fixed assets;

d/ Administrative expenses, including expenses for maintenance and servicing of medical equipment and fixed assets, expenses for environmental protection and infection control, expenses for training, scientific research and information technology, expense for professional liability insurance, expense for quality control, loan interests (if any), and other expenses related to medical examination and treatment activities.

3. The determination of medical examination and treatment service charges must be consistent with the types of provided medical examination and treatment services and adhere to the following principles:

a/ Covering costs of provision of medical examination and treatment in accordance with Points b and c, Clause 4 of this Article;

b/ Ensuring the harmony of interests of the State and lawful rights and interests of medical examination and treatment establishments and patients;

c/ Reviewing constituents of charges for the adjustment of medical examination and treatment service charges in case of necessity. The adjustment of medical examination and treatment service charges must be based on the grounds for determination of charges specified in Clause 4 of this Article.

4. The determination of medical examination and treatment service charges shall be based on the following grounds:

a/ The constituents of medical examination and treatment service charges specified in Clause 1 of this Article at the time of determination of charges;

b/ The supply-demand relationship of medical examination and treatment services and patients’ solvency;

c/ Guidelines, policies and laws on autonomy mechanism applicable to public non-business units in each period, and the State’s socio-economic development guidelines and policies in each period according to the Government-prescribed roadmap for correct and adequate calculation of medical examination and treatment service charges.

5. The Minister of Health shall:

a/ Assume the prime responsibility for, and coordinate with the Minister of Finance in, prescribing methods of determination of medical examination and treatment service charges;

b/  Set specific charge rates for medical examination and treatment services on the list of medical examination and treatment services covered by the health insurance fund, specific charge rates for medical examination and treatment services covered by the state budget, and specific charge rates for medical examination and treatment services not on the list of medical examination and treatment services covered by the health insurance fund that are not on-demand medical examination and treatment services, for medical examination and treatment establishments under the Ministry of Health and other ministries.

6. Provincial-level People’s Councils shall set specific charge rates for the medical examination and treatment services specified at Point b, Clause 5 of this Article, for state-run medical examination and treatment establishments in the localities as assigned to them, which, however, must not exceed the corresponding medical examination and treatment service charges set by the Minister of Health.

7. State-run medical examination and treatment establishments shall apply specific charge rates for medical examination and treatment services for patients without health insurance cards who use services on the list of medical examination and treatment services covered by the health insurance fund that are not on-demand medical examination and treatment services; may decide on charges for on-demand medical examination and treatment services, and shall declare and publicly display such charges.

8. Private medical examination and treatment establishments may decide on medical examination and treatment service charges and shall declare and publicly display such charges.

9. Medical examination and treatment establishments invested in the form of public-private partnership may decide on medical examination and treatment service charges in accordance with the law on investment in the form of public-private partnership.

10. The Government shall detail this Article.

Article 111. Funds for medical examination and treatment support

1. A fund for medical examination and treatment support shall be established to cover part of medical examination and treatment expenses for patients meeting with difficulties or unable to pay such expenses; pay medical examination and treatment expenses for persons facing occupational accidents; and for other activities serving medical examination and treatment.

2. Funds for medical examination and treatment support include:

a/ Funds for medical examination and treatment support established by organizations or individuals, which shall be organized and managed and operate in accordance with regulations on social funds and charity funds;

b/ Funds for medical examination and treatment support established by medical examination and treatment establishments with donations and aid from organizations and individuals, funding sources of medical examination and treatment establishments (if any) and other funding sources prescribed by law, which shall be organized and managed and operate in accordance with internal spending regulations of medical examination and treatment establishments in accordance with law.

Section 3

OTHER CONDITIONS

Article 112. The information system on management of medical examination and treatment activities

1. The information system on management of medical examination and treatment activities includes information on the following major contents:

a/ Patients and their health information;

b/ Practitioners;

c/ Medical examination and treatment establishments;

 d/ Technical expertise;

dd/ Charges for medical examination and treatment services, and charges for on-demand care and support services;

e/ Medical examination and treatment expenses, including also those covered by the health insurance fund.

2. The information system on management of medical examination and treatment activities shall be uniformly and centrally managed by the Ministry of Health, must meet the law-specified conditions for information safety and confidentiality assurance, and shall be connected to the relevant national databases.

3. Medical examination and treatment establishments shall provide information in an adequate, accurate and prompt manner to the information system on management of medical examination and treatment activities.

4. Social insurance agencies shall provide in an adequate, accurate and prompt manner information about payment of medical examination and treatment expenses covered by the health insurance fund to the information system on management of medical examination and treatment activities.

5. The Minister of Health shall provide for:

a/ Output data format standards applicable to the information system on management of medical examination and treatment activities specified in Clause 1 of this Article;

b/ Building, management, exploitation and use of the information system on management of medical examination and treatment activities.

Article 113. Medical equipment

1. Medical equipment used in medical examination and treatment establishments shall be licensed for sale in Vietnam.

2. The use, inspection, servicing, maintenance, repair and replacement of supplies and components, and the verification and calibration of medical equipment must comply with their manufacturers’ regulations, unless otherwise required under regulations on verification and calibration.

3. Medical examination and treatment establishments shall make, manage and keep medical equipment records in an adequate manner.

4. The Government shall detail this Article.

Article 114. Assurance of security and order at medical examination and treatment establishments

1. Measures to ensure security and order for medical examination and treatment establishments and ensure safety for practitioners and other persons working at medical examination and treatment establishments:

a/ Setting up systems for security and order-related risk monitoring and warning;

b/ Imposing time- or area-based restrictions on entry into and leaving from medical examination and treatment establishments;

c/ Applying hi-tech solutions for managing patients, patients’ relatives and practitioners to enhance security and order for medical examination and treatment establishments;

d/ Taking appropriate measures to protect property of patients and patients’ relatives during medical examination and treatment at medical examination and treatment establishments;

dd/ Not allowing the bringing of substances, means, tools and items that are likely to affect security and order at medical examination and treatment establishments into these establishments;

e/ Other measures to ensure security and order as prescribed by law.

2. In case patients, patients’ relatives or other persons commit any act of disturbing public order, harming the life, health or safety of patients, practitioners, other persons working at medical examination and treatment establishments, or persons entering and leaving medical examination and treatment establishments, the medical examination and treatment establishments may:

a/ Apply deterrent measures in accordance with law and notify such to police offices, except cases in which the violators are patients in emergency status;

b/ Impose restrictions on entry into and leaving from areas suffering or in danger of suffering security and order risks at the medical examination and treatment establishments.

3. Heads of medical examination and treatment establishments shall, in pursuance to this Law and other relevant laws, provide for, and organize the implementation of, measures to ensure security and order for the medical examination and treatment establishments and ensure safety for practitioners, other persons working at the medical examination and treatment establishments, and persons entering and leaving the medical examination and treatment establishments.

4. Persons who commit any act of harming the body, health or life or hurting the honor or dignity of practitioners and other persons working at medical examination and treatment establishments shall, depending on the nature and severity of their violations, be administratively handled or examined for penal liability in accordance with law.

 

Chapter XI

MOBILIZATION OF RESOURCES TO SERVE MEDICAL EXAMINATION AND TREATMENT IN CASE OF DISASTERS, CATASTROPHES, GROUP-A INFECTIOUS DISEASES OR STATE OF EMERGENCY

Article 115. Mobilization and assignment of persons to participate in medical examination and treatment in case of disasters, catastrophes, group-A infectious diseases or state of emergency

1. Competent agencies and persons may mobilize or assign the following persons to participate in medical examination and treatment in case of disasters, catastrophes, group-A infectious diseases or state of emergency without requiring modification or grant of practicing licenses:

a/ Practitioners, including also foreigners practicing in Vietnam;

b/ Foreigners and overseas Vietnamese granted practicing licenses by foreign authorities;

c/ Trainees, students and pupils studying at training institutions in the health specialty; persons eligible for grant of practicing licenses but having not been granted such licenses.

2. The assignment of tasks to the subjects specified in Clause 1 of this Article must ensure suitability to the professional qualifications of mobilized or assigned persons and ensure safety for patients.

3. In the course of task performance, the mobilized or assigned persons specified in Clause 1 of this Article are not required to take responsibility for medical complications in one of the cases specified in Clause 2, Article 100 of this Law.

 4. The Minister of Health shall provide for the mobilization of and assignment of tasks to the subjects specified in Clauses 1 and 2 of this Article.

Article 116. Mobilization and assignment of medical examination and treatment establishments to participate in medical examination and treatment in case of disasters, catastrophes, group-A infectious diseases or state of emergency

1. To establish state-run medical examination and treatment establishments in one of the forms specified in Clause 1, Article 48 of this Law to provide medical examination and treatment in case of disasters, catastrophes, group-A infections diseases or state of emergency without having to fully satisfy the conditions specified in this Law and without requiring grant of operation licenses.

2. Upon being mobilized or assigned to participate in medical examination and treatment in case of disasters, catastrophes, group-A infectious diseases or state of emergency, medical examination and treatment establishments are not required to have their operation licenses modified, even in case the medical examination and treatment is different from their scope of professional operations.

3. The Government shall detail this Article.

Article 117. Financial mechanism applicable to medical examination and treatment in case of disasters, catastrophes, group-A infectious diseases or state of emergency

1. The state budget funds shall be allocated under regulations on state budget management decentralization for:

a/ Salaries, wages, allowances, contributions prescribed by law and other regimes (if any), for persons working at the medical examination and treatment establishments specified in Clause 1, Article 116 of this Law who currently receive salaries or wages in accordance with law and are mobilized or assigned to support medical examination and treatment in case of disasters, catastrophes, group-A infectious diseases or state of emergency;

b/ Allowances and other regimes (if any), for persons mobilized or assigned to support medical examination and treatment in case of disasters, catastrophes, group-A infectious diseases or state of emergency who do not receive salaries or wages in accordance with law.

2. Funds for recurrent expenditures of the mobilized or assigned medical examination and treatment establishments specified in Clause 1, Article 116 of this Law include those from the state budget, the health insurance fund, payments by service users and other lawful revenues as prescribed by law, of which:

a/ The central budget funds shall be allocated for medical examination and treatment establishments established by central agencies. In case local budgets have covered part of funds for the operation of medical examination and treatment establishments established by central agencies and based in localities, the central budget is not required to cover such part of funds;

b/ Local budget funds shall be allocated for medical examination and treatment establishments established by localities. In case a locality has used up its resources under regulations but remains unable to allocate funds for such establishments, support from the central budget shall be considered.

3. The state budget funds shall be allocated for mobilized or assigned medical examination and treatment establishments that carry out activities serving prevention, control, and remediation of consequences, of disasters, catastrophes, group-A infectious diseases or state of emergency.

4. The Government shall detail this Article.

Article 118. Competence to assign participation in medical examination and treatment in case of disasters, catastrophes, group-A infectious diseases or state of emergency

1. The Minister of Health may assign human resources and medical examination and treatment establishments to participate in medical examination and treatment in case of disasters, catastrophes, group-A infectious diseases or state of emergency nationwide at the request of agencies, organizations or localities, except human resources and medical examination and treatment establishments in the people’s armed forces.

2. Heads of other ministries and sectors and chairpersons of provincial-level People’s Committees may assign human resources under their management to participate in medical examination and treatment in case of disasters, catastrophes, group-A infectious diseases or state of emergency.

 

Chapter XII

IMPLEMENTATION PROVISIONS

Article 119. To amend and supplement a number of articles of a number of laws concerning medical examination and treatment

1. To amend and supplement Clause 10, Article 4 of Law No. 14/2008/QH12 on Enterprise Income Tax, which had a number of articles amended and supplemented under Law No. 32/2013/QH13, Law No. 71/2014/QH13 and Law No. 61/2020/QH14, as follows:

“10. Undistributed incomes of medical examination and treatment establishments, which are retained for investment in the development of these establishments; undistributed incomes of health establishments practicing socialization that are not medical examination and treatment establishments, and undistributed incomes of establishments practicing socialization in the field of education and training and other fields, which are retained for investment in the development of these establishments in accordance with specialized laws concerning the fields of education and training and health and other fields; and incomes constituting undistributed assets of cooperatives established and operating under the Law on Cooperatives.”

2. To replace the phrase “Law No. 40/2009/QH12 on Medical Examination and Treatment” at Point 26 of Appendix II on the List of technical and specialized master plans to Planning Law No. 21/2017/QH14 with the phrase “Law No. 15/2023/QH15 on Medical Examination and Treatment”.

Article 120. Effect

1. This Law takes effect on January 1, 2024, except the cases specified in Clauses 3, 4, 5, 6, 7, 8 and 9 of this Article.

2. Law No. 40/2009/QH12 on Medical Examination and Treatment, which had a number of articles amended and supplemented under Law No. 21/2017/QH14, ceases to be effective on the date this Law takes effect.

3. The National Medical Council shall carry out testing for evaluation of medical examination and treatment practicing capacity:

a/ From January 1, 2027, for doctors;

b/ From January 1, 2028, for assistant doctors, nurses and midwifes;

c/ From January 1, 2029, for laboratory technicians, clinical nutritionists, pre-hospital emergency care providers and clinical psychologists.

4. The conditions on Vietnamese language proficiency applicable to foreigners as specified at Point c, Clause 1, Article 19 and Point c, Clause 2, Article 30 of this Law shall apply from January 1, 2032.

5. The condition on information technology infrastructure specified at Point d, Clause 2, Article 52 of this Law shall apply:

a/ From January 1, 2027, in case of submission of dossiers of application for operation licenses on or after January 1, 2027;

b/ No later than January 1, 2029, for medical examination and treatment establishments granted operation licenses before January 1, 2027.

6. The quality standards specified at Point a, Clause 1, Article 57 of this Law shall apply:

a/ From January 1, 2025, for hospitals;

b/ From January 1, 2027, for medical examination and treatment establishments in other organizational forms.

7. The provisions on professional and technical levels in medical examination and treatment of Article 104 of this Law shall apply from January 1, 2025.

8. The establishment and operation of the information system on management of medical examination and treatment activities shall be completed before January 1, 2027.

9. Specialized health agencies under provincial-level People’s Committees shall grant, re-grant, modify and revoke operation licenses for private hospitals from January 1, 2027.

Article 121. Transitional provisions

1. Practicing certificates granted before January 1, 2024, shall be converted into practicing licenses according to the Government-set roadmap and extended every 5 years from the date of conversion in accordance with this Law.

2. The grant of practicing certificates for application dossiers submitted before January 1, 2024, must comply with Law No. 40/2009/QH12 on Medical Examination and Treatment, which had a number of articles amended and supplemented under Law No. 21/2017/QH14.

3. Practicing certificates granted under Clause 2 of this Article shall be converted into practicing licenses and extended under Clause 1 of this Article.

4. The provisions on languages used in licensing and practice of medical examination and treatment applicable to foreigners and overseas Vietnamese of Law No. 40/2009/QH12 on Medical Examination and Treatment, which had a number of articles amended and supplemented under Law No. 21/2017/QH14, shall apply through December 31, 2031.

5. The suspension from practice or revocation of practicing certificates granted under Law No. 40/2009/QH12 on Medical Examination and Treatment, which had a number of articles amended and supplemented under Law No. 21/2017/QH14, must comply with this Law’s provisions on suspension from practice and revocation of practicing licenses.

6. Persons who apply from January 1, 2024, through December 31, 2026, for practicing licenses to practice in the capacity as doctors are not required to undergo testing for evaluation of practicing capacity under this Law.

7. Persons who apply from January 1, 2024, through December 31, 2027, for practicing licenses to practice in the capacity as assistant doctors, nurses or midwifes are not required to undergo testing for evaluation of practicing capacity under this Law.

8. Persons who apply from January 1, 2024, through December 31, 2028, for practicing licenses to practice in the capacity as laboratory technicians, clinical nutritionists, pre-hospital emergency care providers or clinical psychologists are not required to undergo testing for evaluation of practicing capacity under this Law.

9. Persons granted practicing licenses under Clauses 1, 2, 6, 7 and 8 of this Article shall comply with practice-related provisions of this Law.

10. For persons who are granted assistant doctor diplomas at intermediate level after December 31, 2026, practicing licenses to practice in the capacity as assistant doctors shall not be granted.

11. Medical examination and treatment establishments already granted operation licenses under Law No. 40/2009/QH12 on Medical Examination and Treatment, which had a number of articles amended and supplemented under Law No. 21/2017/QH14, may continue operating without having to request re-grant of operation licenses.

12. Dossiers of application for operation licenses that are submitted before January 1, 2024, may continue to be processed in accordance with Law No. 40/2009/QH12 on Medical Examination and Treatment, which had a number of articles amended and supplemented under Law No. 21/2017/QH14.

13. The grant of operation licenses for application dossiers that are submitted from January 1, 2024, through December 31, 2026, must comply with this Law’s provisions on organizational forms, conditions, procedures and competence, except the provision on condition of Point d, Clause 2, Article 52 and the provision on competence of Clause 9, Article 120 of this Law. The Minister of Health shall grant, re-grant, modify and revoke operation licenses for private hospitals from January 1, 2024, through December 31, 2026.

14. The suspension from operation and revocation of operation licenses granted under Law No. 40/2009/QH12 on Medical Examination and Treatment, which had a number of articles amended and supplemented under Law No. 21/2017/QH14, must comply with this Law’s provisions on suspension from operation and revocation of operation licenses.

15. The Government shall detail this Article; and provide for conditions for grant of practicing licenses specified in Clauses 6, 7 and 8 of this Article.

This Law was passed on January 9, 2023, by the XVth National Assembly of the Socialist Republic of Vietnam at its 2nd extraordinary session.- 

Chairman of the National Assembly
VUONG DINH HUE

 

[1] Công Báo Nos 489-490 (19/02/2023)

 

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