Chương III Nghị định 96/2023/NĐ-CP: Cấp giấy phép hoạt động khám bệnh, chữa bệnh

Chapter III

ISSUANCE OF OPERATING LICENSES

Section 1. FORMS OF ORGANIZATION AND LICENSING CONDITIONS FOR HEALTH FACILITIES

Article 39. Forms of organization of health facilities

1. Hospitals, including:

a) General hospitals;

b) Traditional medicine hospitals;

c) Odonto-stomatology hospitals;

d) Specialty hospitals. 

2. Clinics, including:

a) Polyclinics;

b) Specialty clinics;

c) Interspecialty clinics;

d) Medical doctor’s clinics;

dd) Traditional medicine clinics;

e) Odonto-stomatology clinics;

g) Nutrition clinics;

h) General physician assistant's clinics.

3. Health stations.

4. Maternity wards.

5. Traditional medicine diagnosis and treatment centers.

6. Subclinical service facilities, including:

a) Testing facilities;

b) Medical imaging facilities;

c) Testing and medical imaging facilities.

7. Family medicine facilities.

8. Dental technology facilities.

9. Rehabilitation facilities.

10. Clinical psychology facilities.

11. Nursing service facilities.

12. Maternity service facilities.

13. Palliative care facilities.

14. Out-of-hospital emergency care facilities.

15. Corrective spectacle stores performing refraction tests.

16. Blood purification facilities.

Article 40. General licensing conditions

Each health facility is required to meet the following general licensing conditions:
1. Scale: The health facility's scale must be appropriate to its form of organization.

2. Material facilities:

a) The health facility must have a fixed location which must meet regulations of law on bearing safety, fire prevention and fighting, bacterial contamination control, environmental protection, and radiation safety (if any); and must be equipped with electrical and water systems capable of serving its operation;

b) It must have a signboard, patient flowchart and wayfinding signs to professional and administrative wards, departments and sections;

c) If the health facility establishes a venue outside its precinct, this venue must be also required to meet the specific conditions for the relevant form of organization as prescribed in Article 39 of this Decree.

3. Its medical devices must be appropriate to the list of professional techniques and its registered scope of operation.

4. Personnel:

a) The health facility must employ sufficient medical practitioners according to its scale and list of professional techniques, and ensure the medical practitioner ratio set by the Minister of Health of Vietnam (including medical practitioners who have been issued with practicing licenses by licensing authorities in people’s armed forces, stop working in people’s armed forces but still use their issued practicing licenses);

b) The person in charge of professional practices of the health facility must be its full-time medical practitioner whose scope of practice is appropriate to its scope of professional activities, and who has practiced within such scope of professional activities for at least 36 months, except a medical practitioner who is a herbalist, folk remedy holder or folk therapy holder.

In case the health facility has different specialties, the scope of practice on the practicing license of its person in charge of professional practices must be appropriate to one of its registered specialties;

c) The manager of a professional department or unit of the health facility must possess a practicing license appropriate to his/her in-charge specialty and must be its full-time medical practitioner;

d) Medical practitioners must be vested with tasks appropriate to their scope of practice approved by competent authorities;

dd) Medical technicians whose scope of practice involves medical laboratory and who possess bachelor’s degrees may read and sign test reports. In case the health facility does not have any medical practitioner who is granted a practicing license for the title of doctor specializing in medical laboratory technology or medical technician possessing bachelor’s degree whose scope of practice involves medical laboratory, the doctor giving prescription for testing shall read and sign such test report.

e) Medical technicians whose scope of practice involves medical imaging and who possess bachelor’s degrees may read and describe diagnostic images. In case the health facility does not have any medical practitioner who is granted a practicing license for the title of doctor specializing in medical imaging technique or medical technician possessing bachelor’s degree whose scope of practice involves medical laboratory, the doctor giving prescription for medical imaging technique shall read and sign such medical imaging report;

g) Other persons engaging in medical examination and treatment without holding practicing licenses as prescribed in point d clause 2 Article 19 of the Law on Medical Examination and Treatment (such as medical physics engineers, radiotherapy engineers, biotechnology engineers, biotechnology bachelors and other persons (hereinafter referred to as “employees”) may perform professional activities as assigned by the health facility’s person in charge of professional practices. This assignment must be appropriate to professional qualification and capacity of the assigned employee.

h) If a medical practitioner who is a lecturer of a training institution in healthcare sector is working at a health facility that acts as an instructing facility accepting medical interns from that training institution, he/she may hold the position of manager of a professional department, department or ward of that health facility.

5. A health facility that provides health checks must be a hospital or polyclinic, and meet the following conditions:

a) It must have sufficient clinical and subclinical departments, personnel and medical devices necessary for examination, screening and detection of health conditions according to health standards and templates of health check forms enclosed with guiding documents on health checks;

b) Data on health check forms for drivers must be connected with the healthcare management information system or national healthcare database or data receipt portal of health insurance assessment information system.

6. A health facility that provides HIV/AIDS diagnosis and treatment must be a hospital or clinic, and meet the following conditions:

a) Material facilities: It has a minimum area of at least 18m² (excluding waiting area), which is divided into two rooms used for providing medical examination and consulting for patients;

b) Personnel: the person in charge of professional practices of the HIV/AIDS diagnosis and treatment department must be a medical practitioner who holds the professional title of doctor and possesses a certificate of completion of training course in HIV/AIDS diagnosis and treatment issued by a lawful training institution;

c) It must be equipped with anaphylaxis kits and adequate emergency medicines for different specialties within its scope of professional activities.

7. A health facility that provides examination and treatment for occupational diseases must be a hospital, polyclinic, interspecialty clinic, specialty clinic or medical doctor’s clinic and meet the following conditions:

a) It is capable of performing biochemical testing techniques in conformity with diagnostic guidelines for occupational diseases it will adopt.

b) Its medical devices must be appropriate to the list of professional techniques and the list of occupational diseases registered.

c) The person that provides examination and treatment for occupational diseases must hold a practicing license for the title of doctor whose scope of practice involves medicine and possess a certificate of completion of training course in occupational diseases or doctor whose scope of practice involves preventive medicine and possess a certificate of completion of training course in occupational diseases.

d) In case it is an independent facility in charge of providing medical examination and treatment for occupational diseases, its person in charge of professional practices must meet the following conditions:

- He/she is a doctor holding a practicing license for occupational disease specialty or a doctor holding a practicing license on which the scope of practice involves either a particular specialty or medicine and possessing a certificate of completion of training courses in occupational diseases;

- He/she has practiced medicine for at least 36 months after obtaining a practicing certificate or practicing license.

8. A health facility that provides HIV/AIDS testing services must be a hospital, polyclinic, interspecialty clinic, specialty clinic, medical doctor’s clinic or subclinical service facility and meet the conditions set out in the Government’s Decree No. 75/2016/ND-CP dated July 01, 2016 prescribing eligibility conditions for conduct of HIV tests.

9. A health facility that provides in-vitro fertilization and altruistic surrogacy services must be a hospital and meet the conditions set out in the Government’s Decree No. 10/2015/ND-CP dated January 28, 2015 prescribing giving birth with in-vitro fertilization and conditions for altruistic surrogacy.

10. The health facilities prescribed in clauses 1, 2, 3, 4 and 7 Article 39 of this Decree may provide preventive examination, consulting and treatment services.

11. A health facility that has been issued with an operating license for one of the forms of organization specified in Article 39 of this Decree may provide services in another form of organization or health checks or medical examination and treatment for HIV/AIDS or occupational diseases if it meets the conditions for operating in such another form of organization or for providing such services.

In case a health facility meets conditions for providing services in another form of organization or conditions for providing health checks or HIV/AIDS examination and treatment when it applies for an operating license, it may apply for appraisal of its satisfaction of such conditions together with its application for operating license.

It such conditions are met after a practicing license has been issued, procedures for modification of the practicing license shall be followed. Particularly, health checks or HIV/AIDS examination and treatment services may be provided without following such procedures for modification of the practicing license, provided that procedures for announcement of its eligibility must be followed as prescribed in Article 69 of this Decree.

If family medicine is delivered, there must be a medical practitioner holding the title of doctor and meeting the following conditions:

- The scope of practice on his/her practicing license involves family medicine;

- He/she must hold a certificate of completion of training or refresher course in family medicine whose duration is not shorter than 03 months;

- There is documentary evidence that the total duration of family medicine training in the training program is at least 03 months.

12. A health facility that provides the following cosmetic services or uses products with pharmacological effects must be a hospital, polyclinic or specialty clinic:

a) Cosmetic services that use drugs, substances and equipment to intervene in the human body (surgery, procedures, interventions involving injections, injections, pumps, irradiation, waves, burning or other invasive interventions) that:

- change skin color, shape or weight (including reduce fat);

- correct defects or create desired shapes of body parts (skin, nose, eyes, lips, face, chest, abdomen, buttocks and other parts of the human body);

- regenerate or restore cells or parts or functions of body parts.

b) Tattooing, spraying and skin embroidery using injectable anesthetics.

13. Apart from the conditions set out in clauses 1 through 12 of this Article, a humanitarian or not-for-profit healthcare facility must also meet the following:

a) Other specific conditions corresponding to its form of organization.

b) Finance for its humanitarian healthcare is available.

c) The phrase “humanitarian healthcare facility” or “not-for-profit healthcare facility” must be shown on its signboard.

Article 41. Licensing conditions for hospitals

In addition to the general licensing conditions set out in Article 40 of this Decree, a hospital is also required to meet the following:

1. Scale:

a) For a general hospital: at least 30 hospital beds;

b) For a traditional medicine hospital or an odonto-stomatology hospital: at least 20 hospital beds;

c) For a specialty hospital: at least 20 hospital beds; particularly, an ophthalmology hospital must have at least 10 hospital beds.

2. Material facilities:

a) Professional departments are assigned according to their functions to facilitate medical examination and treatment activities;

b) Construction requirements must be met as prescribed by laws. To be specific: there must be a minimum construction floor area of 50 m² per hospital bed; the hospital façade must be at least 10 m; ambulances must be given way to emergency care unit; any clinics located within the hospital must meet minimum area requirements for corresponding types of clinics set out in Articles 42, 43, 45, 46, points b, c clause 1 Article 47, Article 53 of this Decree;

c) If the hospital establishes a professional department outside its precinct, it must ensure transport infrastructure connection between its departments to ensure the safety of patients, their families and health workers.

3. Mean of transport: there must be sufficient emergency vehicles for transporting patients in and out of the hospital. If emergency vehicles providing out-of-hospital treatment are not available, the hospital must enter into a contract with a local health facility that functions as emergency care/patient transport service provider.

4. Organization:

a) Management or executive board of the hospital.

b) Professional departments:

The hospital is composed of the following professional departments, including: outpatient department, clinical department, subclinical department, pharmaceutical department and auxiliary department. To be specific:

- The outpatient department must be composed of a reception area, emergency room, patient stay room, medical examination room, and technical/minor surgery rooms (if techniques/minor surgery operations are performed);

- Clinical departments of a general hospital include at least two of the following: internal medicine department, surgery, obstetrics and pediatrics; a specialty hospital, traditional medicine hospital or odonto-stomatology hospital must establish a clinical department appropriate to its scope of professional activities;

- The subclinical department is composed of at least a laboratory and a medical imaging room. If the ophthalmology hospital does not establish any medical imaging department, it must enter into a professional assistance agreement with a health facility that has been issued with an operating license and has a medical imaging department;

- Pharmaceutical department;

- A hospital that has a scale of at least 100 hospital beds must establish a nutrition department; there must be at least a person in charge of nutrition for each 100 hospital beds. A hospital that has a scale of less than 100 hospital beds shall establish a clinical nutrition section or appoint a person in charge of nutrition; the person in charge of nutrition must be a bachelor of nutrition or a medical practitioner who holds the title of doctor and possesses a certificate of completion of training course in clinical nutrition whose duration is 06 months or longer, or a nurse who holds a bachelor’s degree and possesses a certificate of completion of training course in clinical nutrition whose duration is 06 months or longer;

- A hospital that has a scale of at least 150 hospital beds must establish an infection control department; there must be at least a person in charge of infection control for each 150 hospital beds. A hospital that has a scale of less than 150 hospital beds shall establish an infection control section; the person in charge of infection control must hold a bachelor’s degree or higher in healthcare sector and possess a certification or certificate or diploma of graduation from a training course in infection control;

- Other professional departments of the hospital must be appropriate to its scale, tasks and functions.

c) There must be departments or sections performing the following tasks, including general planning, organization and personnel, quality control, nursing, finance and accounting, information technology, medical devices, and other necessary tasks.

d) Depending on its material facilities and personnel, the head of the health facility may decide to establish professional departments in the form of inter-specialty departments; the person in charge of professional practices of a specialty must possess a practicing license on which the scope of practice is appropriate to at least one of such other specialties. In case the hospital is unable to establish separate departments, it may establish units affiliated to clinical departments; the person in charge of professional practices of a unit must possess a practicing license on which the scope of practice is appropriate to its specialty.

dd) Professional departments which are institutes or centers affiliated to and located within the precinct of a hospital are not eligible to operating licenses; persons in charge of professional practices of these institutes or centers and their professional units must meet relevant conditions set out in this Decree.

5. Personnel:

a) The number of full-time medical practitioners of a department must be accounted for at least 70% of total medical practitioners of such department;

b) The head of each professional department of the hospital must be a full-time medical practitioner of that hospital, possess a practicing license appropriate to the specialty of his/her in-charge professional department, and have practiced such specialty for at least 36 months. If a medical practitioner who is a lecturer of a training institution in healthcare sector is working at a health facility that acts as an instructing facility accepting medical interns from that training institution, he/she may hold the position of manager or head of a department or ward of that health facility;

c) The head of a professional department who is not eligible for a practicing license must possess a bachelor’s degree in a major appropriate to his/her assigned tasks and be a full-time employee of the hospital.

6. The hospital must provide inpatient treatment and adequate staff on duty at all times (i.e. 24 hours per day and 7 days per week) to provide professional care.

Article 42. Licensing conditions for polyclinics

In addition to the general licensing conditions set out in Article 40 of this Decree, a polyclinic is also required to meet the following:

1. Scale and organizational structure of the polyclinic:

a) It must have at least three specialties which include at least two of the following: internal medicine, surgery, obstetrics and pediatrics; establish subclinical departments (medical laboratory and medical imaging); and have emergency room, minor surgery room (if minor surgery operations are performed) and patient stay room;

b) In case a polyclinic meets corresponding conditions for another form of organization of health facility as prescribed in Article 39 of this Decree (except hospital), its scope of professional activities may include professional activities of such form of organization of health facility.

2. Material facilities and personnel:

a) Medical examination rooms of a polyclinic must meet the following minimum area requirements:

- The minimum area of the emergency room is 12 m²;

- The patient stay room has a minimum area of 15 m², and has at least 02 hospital beds. If there are at least 03 hospital beds in the patient stay room, the minimum area of at least 05 m² per hospital bed must be ensured;

- The minimum area of each specialty-specific medical examination room is 10 m²;

- If techniques and minor surgery operations are performed, in addition to specialty-specific medical examination rooms, a technical and minor surgery room with a minimum area of at least 10 m² must be available; if motor therapy is provided, the technical and minor surgery room must have a minimum area of at least 20 m².

b) A sterilization area for treating reusable medical devices must be available, unless there are no medical devices to be sterilized or the polyclinic has entered into a contract for sterilization of medical devices with another health facility.

c) If traditional drugs are prepared or made up, standards for preparation of traditional drugs adopted by the Minister of Health of Vietnam must be met.

3. The polyclinic must be equipped with anaphylaxis kits and adequate emergency medicines for different specialties within its scope of professional activities.

Article 43. Licensing conditions for specialty clinics

In addition to the general licensing conditions set out in Article 40 of this Decree, a specialty clinic is also required to meet the following:

1. Scale and organizational structure of the specialty clinic:

a) It has at least a specialty;

b) In case a specialty clinic meets corresponding conditions for another form of organization of health facility as prescribed in Article 39 of this Decree (except hospital), its scope of professional activities may include professional activities of such form of organization of health facility, provided that activities of no more than 03 forms of organization of health facility are added.

2. Material facilities:

a) The specialty clinic must provide adequate area for receiving patients. The minimum area of its medical examination room is 10 m²;

b) If techniques and minor surgery operations are performed, in addition to medical examination room(s), a technical and minor surgery room with a minimum area of at least 10 m² must be available; if motor therapy is provided, the technical and minor surgery room must have a minimum area of at least 20 m².

c) A sterilization area for treating reusable medical devices must be available, unless there are no medical devices to be sterilized or the clinic has entered into a contract for sterilization of medical devices with another health facility.

3. The clinic must be equipped with anaphylaxis kits and adequate emergency medicines for different specialties within its scope of professional activities.

Article 44. Licensing conditions for interspecialty clinics

In addition to the general licensing conditions set out in Article 40 of this Decree, an interspecialty clinic is also required to meet the following:

1. Scale and organizational structure of the interspecialty clinic:

a) It has at least two specialties (excluding internal medicine department, surgery, obstetrics and pediatrics);

b) In case an interspecialty clinic meets corresponding conditions for another form of organization of health facility as prescribed in Article 39 of this Decree (except hospital), its scale and scope of professional activities may include professional activities of such form of organization of health facility, provided that activities of no more than 03 forms of organization of health facility are added.

2. Material facilities:

Each specialty-specific medical examination department of the interspecialty clinic must meet the conditions set out in clause 2 Article 43 of this Decree.

3. The clinic must be equipped with anaphylaxis kits and adequate emergency medicines for different specialties within its scope of professional activities.

4. The person in charge of each specialty-specific medical examination department of the interspecialty clinic must be a full-time medical practitioner of the clinic, have a licensed scope of practice appropriate to the specialty of his/her in-charge medical examination department, and have practiced such specialty for at least 36 months.

Article 45. Licensing conditions for medical doctor’s clinics

In addition to the general licensing conditions set out in Article 40 of this Decree, a medical doctor’s clinic is also required to meet the following:

1. Scale and organizational structure of the medical doctor’s clinic: A medical doctor’s clinic is a clinic owned by a person holding a practicing license for the title of doctor whose scope of practice involves medicine or a specific specialty.

2. Material facilities:

a) The medical doctor’s clinic must provide adequate area for receiving patients. The minimum area of its medical examination room is 10 m²;

b) A sterilization area for treating reusable medical devices must be available, unless there are no medical devices to be sterilized or the clinic has entered into a contract for sterilization of medical devices with another health facility;

c) If techniques and minor surgery operations are performed, in addition to its medical examination room(s), a technical and minor surgery room with a minimum area of at least 10 m² must be available; if motor therapy is provided, the technical and minor surgery room must have a minimum area of at least 20 m².

3. The clinic must be equipped with anaphylaxis kits and adequate emergency medicines for different specialties within its scope of professional activities.

Article 46. Licensing conditions for traditional medicine clinics

In addition to the general licensing conditions set out in Article 40 of this Decree, a traditional medicine clinic is also required to meet the following:

1. Material facilities:

a) The traditional medicine clinic must provide adequate area for receiving patients. The minimum area of its medical examination room is 10 m².

b) Depending on its registered scope of professional activities, the traditional medicine clinic must also meet the following conditions:

- If techniques and minor surgery operations are performed, in addition to its medical examination room(s), a technical and minor surgery room with a minimum area of at least 10 m² must be available; if motor therapy is provided, the technical and minor surgery room must have a minimum area of at least 20 m²;

- In case of medical sauna, a closed but well-illuminated sauna room with a minimum area of at least 02 m² must be available.

- If traditional drugs are prepared or made up, standards for preparation of traditional drugs adopted by the Minister of Health of Vietnam must be met.

2. Equipment used for performing medical examination and treatment activities;

a) If medical examination, drug prescription and drug preparation are performed:

- Drug cabinets must be available; prepared traditional medicinal materials must be kept in drawers or in glass or white plastic bottles with caps, and have their names clearly written on such drawers or bottles;

- Scales must be equipped for weighing and dividing prepared traditional medicinal materials into small doses or packing them in wrapper.

b) In case acupuncture, massage and acupressure are provided, the clinic must be equipped with the following:

- Beds for performing acupuncture, massage and acupressure activities;

- Adequate devices or tools for performing acupuncture, massage and acupressure activities;

- Adequate devices and instructions for dealing with needle shock (also known as vasovagal syncope, a common adverse event of acupuncture treatment).

c) In case of medical sauna, there must be a medicinal steam system that has control valves, sauna instructions and emergency alert system.

d) The clinic must be equipped with anaphylaxis kits and adequate emergency medicines for different specialties within its scope of professional activities.

3. Personnel:

The person in charge of professional practices of the traditional medicine clinic must be a medical practitioner holding the title of:

a) a doctor whose scope of practice involves traditional medicine; or

b) a doctor whose scope of practice specializes in traditional medicine.

Article 47. Licensing conditions for odonto-stomatology clinics

In addition to the general licensing conditions set out in Article 40 of this Decree, an odonto-stomatology clinic is also required to meet the following:

1. Material facilities:

a) The odonto-stomatology clinic must provide adequate area for receiving patients. The minimum area of its medical examination room is 10 m²;

b) There must be at least 01 dental unit; the minimum area for each dental unit is 05 m²;

c) In case dental implant technique is performed, a separate room for performing such implant technique with a minimum area of at least 10 m² must be provided.

2. Personnel:

The person in charge of professional practices of the odonto-stomatology clinic must be a medical practitioner holding the title of:

a) a doctor whose scope of practice involves odonto-stomatology; or

b) a doctor whose scope of practice specializes in odonto-stomatology.

3. The clinic must be equipped with anaphylaxis kits and adequate emergency medicines for different specialties within its scope of professional activities.

Article 48. Licensing conditions for nutrition clinics

In addition to the general licensing conditions set out in Article 40 of this Decree, a nutrition clinic is also required to meet the following:

1. It is organized as an internal medicine clinic or medical doctor’s clinic.

2. The person in charge of professional practices of the clinic must be a medical practitioner holding the title of a doctor whose scope of practice involves clinical nutrition or the title of clinical nutritionist.

Article 49. Licensing conditions for general physician assistant's clinics

In addition to the general licensing conditions set out in Article 40 of this Decree, a general physician assistant's clinic is also required to meet the following:

1. It is located in an extremely socioeconomically disadvantaged area as defined by the Minister of Labour, War Invalids and Social Affairs of Vietnam.

2. The person in charge of professional practices of the clinic must be a medical practitioner holding the title of a physician assistant whose scope of practice involves general medicine.

3. The clinic must be equipped with anaphylaxis kits and adequate emergency medicines for different specialties within its scope of professional activities.

Article 50. Licensing conditions for health stations

In addition to the general licensing conditions set out in Article 40 of this Decree, a health station is also required to meet the following:

1. Personnel:

a) The person in charge of professional practices of the health station must be a medical practitioner holding the title of a doctor or physician assistant;

b) The number of medical practitioners working at the health station must comply with regulations of law on payroll of state-owned health facilities;

c) Village health workers shall provide primary healthcare according to assignment and professional directions given by the person in charge of professional practices of the health station.

2. The health station must be equipped with anaphylaxis kits and adequate emergency medicines for different specialties within its scope of professional activities.

Article 51. Licensing conditions for maternity wards

In addition to the general licensing conditions set out in Article 40 of this Decree, a maternity ward is also required to meet the following:

1. Material facilities:

a) Departments, wards or rooms are assigned according to their functions to facilitate medical examination and treatment activities;

b) It must have antenatal care room, gynecological examination room, labour room, patient stay department with less than 20 beds where prenatal and postnatal monitoring and care are given, and nursery room.

2. There must be sufficient emergency vehicles for transporting patients in and out of the maternity ward. If emergency vehicles providing care and treatment out of the maternity ward are not available, the maternity ward must enter into a contract with a health facility that has been licensed to operate and provide emergency care/patient transport services.

3. The person in charge of professional practices of the maternity ward must be a medical practitioner holding the title of:

a) a doctor whose scope of practice involves obstetrics; or

b) a midwife possessing a bachelor’s degree or higher.

4. The maternity ward must provide adequate staff on duty at all times (i.e. 24 hours per day and 7 days per week) to provide professional care.

Article 52. Licensing conditions for traditional medicine diagnosis and treatment centers

In addition to the general licensing conditions set out in Article 40 and Article 46 of this Decree, a traditional medicine diagnosis and treatment center is also required to meet the following requirement regarding its person in charge of professional practices:

He/she must be a medical practitioner who has been issued with a practicing license for any of the titles of:

1. Doctor whose scope of practice involves traditional medicine.

2. Doctor whose scope of practice specializes in traditional medicine.

3. Physician assistant whose scope of practice involves traditional medicine.

4. Herbalist.

5. Folk remedy holder.

6. Folk therapy holder.

Article 53. Licensing conditions for subclinical service facilities, dental technology facilities, and rehabilitation facilities

In addition to the general licensing conditions set out in Article 40 of this Decree, a subclinical service facility, dental technology facility, or rehabilitation facility is also required to meet the following:

1. Testing facility:

a) Material facilities:

- Waiting area for specimen collection, and areas for receiving specimens and cleaning tools must be available;

- If any of the following testing types, including blood tests, biochemical tests, genetic tests and immunologic tests, is performed, the minimum area of the laboratory is 10 m²;

- If 02 or 03 of the following testing types, including blood tests, biochemical tests, genetic tests and immunologic tests, are performed, the minimum area of the laboratory is 15 m²;

- If all of the following testing types, including blood tests, biochemical tests, genetic tests and immunologic tests, are performed, the minimum area of the laboratory is 20 m²;

- If anatomic pathology and cytological pathology are performed, the laboratory must have a minimum area of at least 20 m² and be separated from blood, biochemical, genetic and immunologic laboratories and other laboratories;

- If microbiological tests are performed, the laboratory must have a minimum area of at least 20 m² and be separated from blood, biochemical, genetic and immunologic laboratories and other laboratories;

- Wall surfaces in the laboratory must be covered with waterproof material from the floor to the ceiling;

- The floor surface of the laboratory must be waterproof, smooth and level without stagnant water;

- Laboratory workbench must be constructed of waterproof and anti-corrosive material, with sink and faucet installed thereon.

b) Personnel:

The person in charge of professional practices of the testing facility must be a medical practitioner holding the title of:

- a doctor whose scope of practice specializes in medical laboratory; or

- a medical technician who possesses a bachelor’s degree or higher, and whose scope of practice involves medical laboratory.

2. Medical imaging facility:

The person in charge of professional practices of the medical imaging facility must be a medical practitioner holding the title of:

a) a doctor whose scope of practice specializes in medical imaging technique; or

b) a medical technician who possesses a bachelor’s degree or higher, and whose scope of practice involves medical imaging technique.

3. Dental technology facility:

The person in charge of professional practices of the dental technology facility must be a medical practitioner holding the title of a medical technician who possesses a bachelor’s degree or higher, and whose scope of practice involves dental technology.

4. Rehabilitation facility:

The person in charge of professional practices of the rehabilitation facility must be a medical practitioner holding the title of:

a) a doctor whose scope of practice specializes in rehabilitation; or

b) a medical technician who possesses a bachelor’s degree or higher, and whose scope of practice involves rehabilitation.

5. In addition to the conditions set out in this Decree, a health facility that performs HIV confirmatory tests must also meet the relevant conditions set out in the Government’s Decree No. 75/2016/ND-CP dated July 01, 2016.

6. In addition to the conditions set out in point a clause 1 of this Article, the person in charge of professional practices of a testing and medical imaging facility must meet the conditions in point b clause 1 or clause 2 of this Article.

Article 54. Licensing conditions for clinical psychology facilities

In addition to the general licensing conditions set out in Article 40 of this Decree, the person in charge of professional practices of a clinical psychology facility must be a medical practitioner holding the title of:

1. a clinical psychologist; or

2. a doctor whose scope of practice specializes in psychiatry and who possesses a certificate of completion of basic training course in clinical psychology as prescribed in clause 2 Article 128 of this Decree.

Article 55. Licensing conditions for nursing service facilities, maternity service facilities, and palliative care facilities

In addition to the general licensing conditions set out in Article 40 of this Decree, a nursing service facility, maternity service facility, or palliative care facility is also required to meet the following:

1. Material facilities: If techniques and minor surgery operations are performed, in addition to its medical examination room(s), a technical and minor surgery room with a minimum area of at least 10 m² must be available.

2. It must be equipped with anaphylaxis kits.

3. Personnel:

a) Nursing service facility:

The person in charge of professional practices of the nursing service facility must be a medical practitioner holding the title of:

- Doctor;

- Physician assistant;

- Nurse; or

- Midwife.

b) Maternity service facility:

The person in charge of professional practices of the maternity service facility must be a medical practitioner holding the title of a midwife.

c) Palliative care facility:

The person in charge of professional practices of the palliative care facility must be a medical practitioner holding the title of a doctor whose scope of practice involves:

- Medicine;

- Traditional medicine;

- Preventive medicine; or

- a specific specialty, except odonto-stomatology.

Article 56. Licensing conditions for out-of-hospital emergency care facilities

In addition to the general licensing conditions set out in Article 40 of this Decree, an out-of-hospital emergency care facility is also required to meet the following:

1. Material facilities:

a) There must be an area for disinfection of ambulances with adequate decontamination devices and facilities, or the out-of-hospital emergency care facility must enter into a service contract with a qualified health facility to perform disinfection of its ambulances in accordance with regulations adopted by the Minister of Health of Vietnam.

b) 24/7 service room, personnel and hotline are available at its head office.

c) Its head office is exclusive of parking area for emergency vehicles.

d) Emergency vehicles:

- The out-of-hospital emergency care facility must be equipped with at least 02 ambulances;

- Its ambulances must meet relevant quality standards.

dd) It must be equipped with anaphylaxis kits and adequate emergency medicines to ensure safety and hygienic conditions for patients.

2. Personnel:

The person in charge of professional practices of the out-of-hospital emergency care facility must be a medical practitioner holding the title of:

a) a doctor; or

b) an out-of-hospital paramedic.

Article 57. Licensing conditions for corrective spectacle stores performing refraction tests

1. Material facilities: The minimum area of the refraction room is 10 m².

2. Refraction equipment is available.

3. The person in charge of professional practices must be a medical practitioner holding the title of:

a) a doctor specializing in ophthalmology; or

b) a medical technician whose scope of practice involves ophthalmic refraction.

Article 58. Licensing conditions for blood purification facilities

In addition to the general licensing conditions set out in Article 40 of this Decree, a blood purification facility is also required to meet the following:

1. Material facilities:

a) Area for receiving patients, waiting area, dry and wet storage areas, and dialyzer reprocessing room (if dialyzer reprocessing is performed) must be available;

b) The blood purification room must provide a minimum area of at least 4,5m² per dialysis machine; separate blood purification and dialyzer reprocessing areas must be provided for patients with infectious diseases;

c) There must be a system supplying R.O water for dialysis machine and dialyzer reprocessing (if dialyzer reprocessing is performed);

d) It must enter into a professional assistance contract with a local hospital whose scope of professional activities includes hemodialysis;

dd) Emergency vehicles must be available. If emergency vehicles are not available, it must enter into a contract for emergency transport.

2. Personnel:

a) The person in charge of professional practices of the blood purification facility must be a medical practitioner holding the title of a doctor whose scope of practice involves medicine, internal medicine, or intensive care, and possessing a certificate of completion of a professional training course in hemodialysis as prescribed in clause 3 Article 12 of this Decree;

b) The medical practitioner holding the title of nurse must possess a certificate of completion of a professional training course in hemodialysis as prescribed in clause 3 Article 12 of this Decree.

Section 2. ISSUANCE OF OPERATING LICENSES

Article 59. Cases of issuance of operating licenses

1. An operating license may be issued to:

a) a health facility that applies for operating license for the first time;

b) a health facility whose operating license is revoked, except as defined in point d clause 1 Article 56 of the Law on Medical Examination and Treatment;

c) a health facility that has been issued with an operating license if it changes its form of organization;

d) a health facility that has been issued with an operating license if it changes its operating location;

dd) a health facility that has been issued with an operating license if it undergoes a split-up, split-off, consolidation or merger process;

e) a health facility that has been issued with an operating license if its affiliated health facilities are established outside the precinct of the licensed one; or

g) a health facility that has been issued with an operating license if it applies for delivery of humanitarian healthcare or not-for-profit healthcare.

2. If a health facility that has been issued with an operating license changes its owner but its name, scale, scope of operation and location, it must not follow procedures for issuance of a new operating license.

Article 60. Application package for operating license

1. An application package for issuance of operating license in the case prescribed in point a, b, c, d, dd or e clause 1 Article 59 of this Decree is composed of:

a) An application form (made using Form 02 in Appendix II enclosed herewith);

b) a legitimate copy of an establishment decision or a document containing name of the health facility (applicant) issued by a competent authority, if the applicant is a state-owned health facility, or enterprise registration certificate, if the applicant is a private health facility, or investment certificate, if the applicant is a foreign-invested health facility;

c) legitimate copies of the practicing license and certificate of practicing period, which is made using Form No. 11 in Appendix I enclosed herewith, of the person in charge of professional practices of the health facility (applicant) (not required if these documents have been shared or published on the healthcare management information system or national healthcare database);

d) legitimate copies of the practicing license and certificate of practicing period, which is made using Form No. 11 in Appendix I enclosed herewith, of the manager of professional department of the health facility (applicant) (not required if these documents have been shared or published on the healthcare management information system or national healthcare database);

dd) Declaration of material facilities, list of medical devices and list of personnel meeting licensing conditions for the corresponding form of organization, made using Form No. 08 in Appendix II enclosed herewith, and documents proving or certifying such declaration;

e) The list of medical practitioners who have registered for practice at the health facility (applicant), which is made using Form No. 01 in Appendix II enclosed herewith, and in which name and number of practicing license of each medical practitioner must be indicated;

g) A competent authority’s written approval of functions, tasks and organizational structure of the state-owned hospital or of the charter on organization and operation of a private hospital, which is made using Form No. 03 in Appendix II enclosed herewith;

h) The list of professional techniques to be performed by the health facility (applicant) which is made on the basis of the list of professional techniques issued by the Minister of Health of Vietnam;

i) In case the health facility delivering humanitarian healthcare or not-for-profit healthcare applies for an operating license for the first time, documents proving the funding for humanitarian healthcare or not-for-profit healthcare must be submitted.

2. An application package for issuance of operating license submitted by a health facility that has been issued with an operating license but changes its operating location as prescribed in point d clause 1 Article 59 of this Decree is composed of:

a) An application form (made using Form 02 in Appendix II enclosed herewith);

b) a legitimate copy of an establishment decision or a document containing name of the health facility (applicant) issued by a competent authority, if the applicant is a state-owned health facility, or enterprise registration certificate, if the applicant is a private health facility, or investment certificate, if the applicant is a foreign-invested health facility;

c) Declaration of material facilities meeting licensing conditions at the new location, and documents proving or certifying such declaration;

d) A legitimate copy of the issued operating license.

3. An application package for issuance of operating license submitted by a health facility that has been issued with an operating license but applies for delivery of humanitarian healthcare or not-for-profit healthcare without charging patients for medical costs as prescribed in point g clause 1 Article 59 of this Decree is composed of:

a) An application form (made using Form 02 in Appendix II enclosed herewith);

b) Documents proving funding for humanitarian healthcare activities.

Article 61. Procedures for issuance of operating license

1. The health facility (applicant) shall submit an application package and application fee, as defined by the Law on Fees and Charges, to the authority competent to issue operating license (hereinafter referred to as "licensing authority").

2. Upon receipt of the application package, the receiving authority shall give a receipt note using Form No. 02 in Appendix I enclosed herewith to the applicant.

3. If the application is satisfactory:

a) The licensing authority shall carry out verification of operating conditions and list of professional techniques to be performed by the applicant, and issue a verification record within 60 days from the date specified in the receipt note;

b) If there are no matters that need to be modified, the licensing authority shall issue an operating license and a decision approving the list of professional techniques to be performed by the applicant within 10 working days from the date of the verification record;

c) Any matters that need to be modified must be clearly described in the verification record.

Within 10 working days from its receipt of a written notice and documents proving finished modification from the applicant, the licensing authority may conduct a physical inspection of items or matters modified by the applicant, where necessary, or issue an operating license. If an application is refused, a written response indicating reasons for refusal must be given.

4. If the modification of the application is required:

a) The licensing authority shall send a written request for modification of the application, which must clearly indicate the documents and/or contents that need to be modified, to the applicant within 10 days from the date of the receipt note.

b) Upon its completion of modification, the applicant shall send a written notice and documents proving its finished modification to the licensing authority.

c) After receiving modified application documents, the licensing shall:

- follow procedures in clause 3 of this Article if the application is satisfactory; or

- follow procedures in points a, b of this clause if the application is still unsatisfactory.

5. Within 05 working days from the day on which an operating license is issued, the licensing authority shall publish the following information on its web portal and on the healthcare management information system, including: name and address of the licensed health facility; full name and number of practicing license of the person in charge of professional practices of the licensed health facility; number of the issued operating license; scope of professional activities and opening hours.

6. An operating license will be made using Form No. 06 in Appendix II enclosed herewith in 02 copies of which 01 copy is delivered to the applicant and the other is kept by the licensing authority, unless application processing results are returned electronically.

7. When issuing an operating license to a health facility in the form of a hospital, the licensing authority shall also issue a document to temporarily classify the hospital into the basic level. This document on temporary classification of the hospital shall be valid for 02 years from the date thereon. At least 60 days before the expiry date of this document, the hospital must submit an application for classification of its professional and technical expertise as prescribed in Article 90 of this Decree.

Article 62. Application package for re-issuance of operating license

1. An application form (made using Form 02 in Appendix II enclosed herewith).

2. In case the operating license is lost or damaged: a copy of the lost license or the original of the damaged license (if available).

3. In case there is any technical error in information: documents proving the contents or information that needs to be modified.

Article 63. Procedures for re-issuance of operating license

1. The health facility (applicant) shall submit an application package for re-issuance of operating license and application fee, as defined by the Law on Fees and Charges, to the licensing authority.

2. When receiving the application, the licensing authority shall give a receipt note to the applicant.

3. Within 20 days from the date of the receipt note, the licensing authority shall re-issue the requested operating license and update information on such re-issued license on its website or web portal and on the healthcare management information system.

Article 64. Application package for modification of an operating license

1. In case the name, address (without relocation) or opening hours of a health facility are changed, an application package for modification of its operating license is composed of:

a) An application form (made using Form 02 in Appendix II enclosed herewith);

b) Documentary evidence of such a change.

2. In case the health facility changes its scale or scope of professional activities, or makes changes in its list of professional techniques, an application package for modification of its operating license is composed of:

a) An application form (made using Form 02 in Appendix II enclosed herewith);

b) The original operating license;

c) Declaration of material facilities, medical devices and personnel corresponding to the new scale or scope of professional activities or the modified list of professional techniques and documentary evidence of such a change.

Article 65. Procedures for modification of an operating license in case of changes in health facility’s opening hours, name or address (without relocation)

1. The health facility (applicant) shall submit an application package for change in its name, address or opening hours as prescribed in clause 1 Article 64 of this Decree and application fee, as defined by the Law on Fees and Charges, to the licensing authority.

2. Upon receipt of the application package, the licensing authority shall give a receipt note using Form No. 02 in Appendix I enclosed herewith to the applicant.

3. In case the application package is satisfactory, the licensing authority shall make changes to the requested operating license within 20 days from the date of the receipt note prescribed in clause 2 of this Article.

4. If the application package needs to be modified, within 05 working days from the date of the receipt note prescribed in clause 2 of this Article, the licensing authority shall send a written request for modification, which must clearly indicate the documents and/or contents that need to be modified, to the applicant.

Within 06 months from the date of the written request for modification given by the licensing authority, the applicant must make requested modifications. If the applicant fails to make requested modifications by the aforementioned deadline, their submitted application documents will be invalidated.

5. Upon receipt of a modified application package, the licensing authority shall give a receipt note using Form No. 02 in Appendix I enclosed herewith to the applicant, and take the following actions:

a) In case the modified application package is still unsatisfactory, the licensing authority shall continue sending a written request for modification to the applicant as prescribed in clause 4 of this Article.

Within 06 months from the date of the written request for modification given by the licensing authority, the applicant must make requested modifications. If the applicant fails to make requested modifications by the aforementioned deadline, or after 12 months counting from the date of the initial submission of the application for modification of operating license, the modified application package is still unsatisfactory, the submitted application documents will be invalidated.

b) In case the modified application package is satisfactory, the licensing authority shall take actions as prescribed in clause 3 of this Article.

6. Within 05 working days after a modified operating license is issued, the licensing authority shall publish or update information on modified contents on its web portal and on the healthcare management information system.

7. A modified operating license will be issued in 02 copies of which 01 copy is delivered to the applicant and the other is kept by the licensing authority, unless application processing results are returned electronically.

Article 66. Procedures for modification of operating license in case of changes in health facility’s scale, scope of professional activities, or list of professional techniques

1. The health facility (applicant) shall submit an application package as prescribed in clause 2 Article 64 of this Decree and application fee, as defined by the Law on Fees and Charges, to the licensing authority.

2. Upon receipt of the application package, the licensing authority shall give a receipt note to the applicant.

3. If the application package needs to be modified, within 07 working days from the date of the receipt note, the licensing authority shall send a written request for modification, which must clearly indicate the documents and/or contents that need to be modified, to the applicant.

Within 06 months from the date of the written request for modification given by the licensing authority, the applicant must make requested modifications. If the applicant fails to make requested modifications by the aforementioned deadline, their submitted application documents will be invalidated.

4. Upon receipt of a modified application package, the licensing authority shall give a receipt note to the applicant and take the following actions:

In case the modified application package is still unsatisfactory, the licensing authority shall continue sending a written request for modification to the applicant as prescribed in clause 3 of this Article.

Within 06 months from the date of the written request for modification given by the licensing authority, the applicant must make requested modifications.

If the applicant fails to make requested modifications by the aforementioned deadline, or after 12 months counting from the date of the initial submission of the application for modification of operating license, the modified application package is still unsatisfactory, the submitted application documents will be invalidated.

5. In case the application package is satisfactory or modifications to the submitted application package are satisfactory as prescribed in clauses 3, 4 of this Article, the licensing authority shall:

a) issue a written approval of changes in scale or scope of professional activities or addition or removal of techniques to or from the list of professional techniques within 20 days from the date of the receipt note, if the physical inspection to the applicant’s premises is deemed unnecessary; or

b) conduct a physical inspection to the applicant’s premises and issue an inspection record within 60 days from the date of the receipt note, if such a physical inspection is deemed necessary. Any matters that need to be modified must be indicated in the inspection record.

6. Upon completion of the physical inspection, the licensing authority shall:

a) issue a written approval of changes in scale or scope of professional activities or addition or removal of techniques to or from the list of professional techniques within 10 working days from the date of the inspection record, if no matters need to be modified;

b) issue a notice of contents that need to be modified within 05 working days from the date of the inspection record, if there are matters that need to be modified.

Within 06 months from the date of the written notice of contents that need to be modified given by the licensing authority, if the applicant fails to make requested modifications, their submitted application documents will be invalidated.

7. Within 10 working days from the receipt of written notice of finished modifications and documentary evidence thereof from the applicant, the licensing authority shall:

a) issue a written approval of changes in scale or scope of professional activities or addition or removal of techniques to or from the list of professional techniques, if a physical inspection to the applicant’s premises is deemed unnecessary.

b) conduct a physical inspection to the applicant’s premises, if such physical inspection is deemed necessary, and:

- issue a written approval of changes in scale or scope of professional activities or addition or removal of techniques to or from the list of professional techniques, in case the applicant has completely made modifications; or

- give a written response indicating reasons for its refusal to approve changes in scale or scope of professional activities or addition or removal of techniques to or from the list of professional techniques, if the applicant has completely made modifications.

8. Within 05 working days after giving approval of the health facility’s addition of its professional techniques, the licensing authority shall publish or update information on modified contents on its web portal or website and on the healthcare management information system.

9. A written approval of addition of professional techniques is given in 02 copies of which 01 copy is delivered to the applicant and the other is kept by the licensing authority, unless application processing results are returned electronically.

10. Regarding addition of a technique included in the list of special-type techniques:

a) The health facility shall submit an application package as prescribed in clause 2 Article 64 of this Decree to the Ministry of Health of Vietnam for consideration of its capacity to perform such special-type technique.

b) Within 05 working days from its receipt of application package, the Ministry of Health of Vietnam shall carry out inspection and assessment to decide whether to experiment on that special-type technique or whether the health facility is capable of performing that special-type technique.

c) In case an experiment on the special-type technique should be conducted, procedures in Article 97 of this Decree will be followed.

d) In case the health facility has completed the experiment on the special-type technique and made a report on experimental results which includes proposal for official application of that special-type technique, the following procedures shall be followed:

- The health facility shall submit an application package which includes the report on results of the experiment conducted as prescribed in point c of this clause and procedures for performing that special-type technique proposed by the health facility;

- Within 15 days from its receipt of adequate application documents, the Ministry of Health of Vietnam shall carry out an appraisal of experimental results and technical procedures proposed by the health facility;

- Within 05 working days from the day on which an appraisal record is issued, the Ministry of Health of Vietnam shall issue a decision to allow the health facility to officially apply that special-type technique. If an application is refused, a written response indicating reasons for such refusal shall be given;

- The health facility shall follow procedures prescribed in clause 1 through 9 of this Article for adding the special-type technique which it is allowed to officially apply to its scope of professional activities.

dd) In case an experiment on the special-type technique is deemed unnecessary, the following procedures will be followed:

- Within 05 working days, the Ministry of Health of Vietnam shall issue a decision to allow the health facility to officially apply that special-type technique without conducting experiment thereon. If an application is refused, a written response indicating reasons for such refusal shall be given;

- The health facility shall follow procedures prescribed in clauses 1 through 9 of this Article for adding the special-type technique which it is allowed to officially apply to its scope of professional activities.

Article 67. Authority to issue, re-issue and modify operating licenses

1. The Minister of Health shall have authority to:

a) issue and re-issue operating licenses to health facilities under its management;

c) modify operating licenses of health facilities under its management if their scope of professional activities are changed: addition or removal of techniques to or from their scope of professional activities.

c) modify operating licenses of health facilities under its management if their scale is changed. To be specific:

- There is an increase or decrease in number of professional departments or wards of the health facility, including the case specified in point dd clause 1 Article 54 of the Law on Medical Examination and Treatment;

- The number of hospital beds of the health facility is increased or decreased by at least 10% or by less than 10% but more than 30 hospital beds;

- The number of hospital beds of the health facility is changed as prescribed in clause 4 of this Article.

d) modify operating licenses of health facilities under its management if their opening hours are changed.

dd) modify operating licenses of health facilities under its management if there are changes in their names or addresses (without relocation).

2. Health authorities affiliated to provincial People's Committees shall have authority to:

a) issue or re-issue operating licenses to health facilities located in their provinces, except those under the management of the Ministry of Health of Vietnam, the Ministry of National Defence of Vietnam, or the Ministry of Public Security of Vietnam.

b) modify operating licenses of health facilities located in their provinces, except those under the management of the Ministry of Health of Vietnam, the Ministry of National Defence of Vietnam, or the Ministry of Public Security of Vietnam, if their scope of professional activities are changed: addition or removal of techniques to or from their scope of professional activities.

c) modify operating licenses of health facilities located in their provinces, except those under the management of the Ministry of Health of Vietnam, the Ministry of National Defence of Vietnam, or the Ministry of Public Security of Vietnam, if their scale is changed. To be specific:

- There is an increase or decrease in number of professional departments or wards of the health facility, including the case specified in point dd clause 1 Article 54 of the Law on Medical Examination and Treatment;

- The number of hospital beds of the health facility is increased or decreased by at least 10% or by less than 10% but more than 30 hospital beds;

- The number of hospital beds of the health facility is changed as prescribed in clause 4 of this Article.

d) modify operating licenses of health facilities located in their provinces, except those under the management of the Ministry of Health of Vietnam, the Ministry of National Defence of Vietnam, or the Ministry of Public Security of Vietnam, if their opening hours are changed.

dd) modify operating licenses of health facilities located in their provinces, except those under the management of the Ministry of Health of Vietnam, the Ministry of National Defence of Vietnam, or the Ministry of Public Security of Vietnam, if there are changes in their names or addresses (without relocation).

3. A hospital may increase or decrease the number of hospital beds of its departments or wards by less than 10% of its total number of hospital beds specified in its operating license but not more than 30 hospital beds, and must send a written report on such change to its supervisory authority. Such report must indicate:

a) The number of hospital beds of its departments or wards to be increased or decreased;

b) Declaration of its material facilities, medical devices and personnel proving its satisfaction of conditions for making change in number of its hospital beds.

4. If a hospital wishes to change the number of its hospital beds after it has completed procedures for increase or decrease of the number of its hospital beds by less than 10%, it shall be required to follow procedures for modification of its operating license as prescribed in Article 66 of this Decree. The hospital shall send an application package for modification of its operating license to:

a) The Ministry of Health of Vietnam, if it is affiliated to the Ministry of Health of Vietnam; or

b) The health authority affiliated to the People’s Committee of province or city where it is located, unless it is affiliated to the Ministry of Health of Vietnam, the Ministry of National Defence of Vietnam, or the Ministry of Public Security of Vietnam.

5. If a hospital wishes to change the number of its hospital beds after it has completed procedures for modification of its operating license as prescribed in clause 4 of this Article, it shall follow corresponding guidelines in clause 3 and clause 4 of this Article.

Article 68. Documentation for declaration of eligibility to provide health checks or HIV/AIDS examination and treatment

1. Written declaration of eligibility to provide health checks or HIV/AIDS examination and treatment (which is made using Form No. 04 in Appendix II enclosed herewith).

2. A legitimate copy of the health facility’s operating license accompanied with its list of professional techniques.

3. List of personnel and medical devices meeting conditions for providing health checks or HIV/AIDS examination and treatment, which is made using Form No. 05 in Appendix II enclosed herewith.

4. A legitimate copy of a contract for provision of professional assistance of the health facility (if any).

Article 69. Procedures for declaration of eligibility to provide health checks or HIV/AIDS examination and treatment

1. Before its provision of initial health check, the health facility must submit 01 set of required documents for declaration of its eligibility to provide health checks or HIV/AIDS examination and treatment as prescribed in Article 68 of this Decree to the competent health authority. To be specific:

a) For health facilities affiliated to the Ministry of Health of Vietnam and other ministries and central-government authorities (except the Ministry of National Defence of Vietnam and the Ministry of Public Security of Vietnam): required documents shall be sent to the Ministry of Health of Vietnam;

b) For health facilities under the management of the Ministry of National Defence of Vietnam: required documents shall be sent to the Ministry of National Defence of Vietnam;

c) For health facilities under the management of the Ministry of Public Security of Vietnam: required documents shall be sent to the Ministry of Public Security of Vietnam;

d) For health facilities under the management of health authorities affiliated to provincial People's Committees (health facilities do not fall in the cases specified in points a, b, c of this clause): required documents shall be sent to the health authority affiliated to the People's Committee of province where the health facility is headquartered.

2. Procedures for considering a document package for declaration of eligibility to provide health checks or HIV/AIDS examination and treatment:

a) Upon receipt of a document package for declaration of eligibility to provide health checks or HIV/AIDS examination and treatment, the health authority as defined in clause 1 of this Article (hereinafter referred to “receiving authority”) shall give a receipt note, which is made using Form No. 02 in Appendix I enclosed herewith, to the health facility that declares its eligibility to provide health checks or HIV/AIDS examination and treatment (hereinafter referred to “declaring facility”).

In case the received documents are inadequate or invalid as prescribed in Article 68 of this Decree, the receiving authority shall send a written request for modification to the declaring facility. Upon receipt of modified documents from the declaring facility, the receiving authority shall also give a receipt note, which is made using Form No. 02 in Appendix I enclosed herewith, to the declaring facility;

b) In case the received documents are adequate and valid as prescribed in Article 68 of this Decree and no written request for modification is given by the receiving authority, after 15 working days from the date of the receipt note, the declaring facility may initiate provision of health checks or HIV/AIDS examination and treatment within its declared scope of professional activities;

c) In case a health facility that has successfully completed procedures for declaration of its eligibility to provide health checks or HIV/AIDS examination and treatment changes its name, address, material facilities, personnel and declared scope of professional activities, it shall send a written notice of such a change to the authority that has received its document package for eligibility declaration.

Article 70. Signboards of health facilities

A health facility that has been issued with an operating license must have a signboard which is designed in accordance with regulations of law on signboards, does not bear the red cross symbol, and must adequately contain the following basic information:

1. Full name of the health facility.

2. Form of organization.

3. Number of operating license.

4. Address of the health facility as written in its operating license; telephone number.

5. Opening hours.

Section 3. HEALTHCARE QUALITY ASSESSMENT AND CERTIFICATION

Article 71. Assessment of basic quality standards

1. Every year, health facilities shall carry out quality self-assessment as prescribed in clause 3 Article 58 of the Law on Medical Examination and Treatment, and send assessment results to regulatory authorities.

2. Quality assessment results must openly be posted on web portals of health authorities and on the healthcare management information system.

3. Based on the assessment results published by health facilities, regulatory authorities shall randomly select the health facilities whose quality will be re-assessed according to risk management principles.

Article 72. Assessment of advanced quality standards of health facilities, quality standards of a particular specialty or technical services

1. Quality assessment and certification which are based on advanced quality standards, or quality standards of a particular specialty or technical services promulgated by the Ministry of Health of Vietnam shall be carried out as follows:

a) Healthcare quality certification bodies shall carry out assessment of quality of health facilities according to advanced quality standards, or quality standards of a particular specialty or technical services promulgated by the Ministry of Health of Vietnam, and their internal procedures;

b) Quality assessment results must be reported to competent health authorities, and openly be posted on web portals of health authorities and on the healthcare management information system;

c) Competent health authorities may randomly select health facilities for re-assessment according to risk management principles.

2. Quality assessment and certification which are based on advanced quality standards, or quality standards of a particular specialty or technical services recognized by the Ministry of Health of Vietnam shall be carried out as follows:

a) Healthcare quality certification bodies shall carry out assessment of quality of health facilities according to advanced quality standards, or quality standards of a particular specialty or technical services recognized by the Ministry of Health of Vietnam, and their internal procedures;

b) Quality assessment results must be reported to competent health authorities, and openly be posted on web portals of health authorities and on the healthcare management information system.

Article 73. Operating rules of healthcare quality certification bodies

1. Ensure compliance with provisions of clauses 1 and 2 Article 58 of the Law on Medical Examination and Treatment.

2. Carry out quality assessment and certification in conformity with quality standards promulgated or recognized by the Ministry of Health of Vietnam.

3. Voluntarily carry out quality assessment and certification on the basis of service contracts signed with health facilities.

4. Keep confidentiality of information collected or obtained during quality assessment and certification.

Article 74. Functions and tasks of healthcare quality certification bodies

1. Give advice and instructions to health facilities to apply quality standards to improve their healthcare quality.

2. Issue fixed-term quality certificates to health facilities that satisfy quality standards or give notices of refusal to issue new quality certificates to health facilities that fail to maintain their satisfaction of quality standards as certified.

3. Supervise health facilities granted quality certificates to ensure their maintenance of healthcare quality according to certified quality standards.

4. Submit periodical reports or ad hoc reports at the request of competent health authorities, and bear inspection of such competent health authorities.

Article 75. Eligibility requirements for healthcare quality certification bodies

In order to provide healthcare quality assessment and certification services, an entity or organization must meet the following requirements:
1. It is lawfully established.

2. It runs an appropriate organizational structure according to quality standards in order to perform:

a) Professional techniques; and

b) Data management.

3. There are at least 05 assessment specialists who are its full-time employees and meet the following conditions:

a) The person in charge of professional practices must:

- hold a bachelor’s degree or higher;

- have at least 05 years of working experience in managing professional activities of health facilities or health authorities that directly manage health facilities; and

- have attended and been issued with a certificate of completion of training course in healthcare quality assessment skills by a training institution announced or accredited by the Ministry of Health of Vietnam in accordance with regulations of law.

b) Each assessor must:

- hold a bachelor’s degree or higher;

- have attended and been issued with a certificate of completion of training course in healthcare quality assessment skills by a training institution announced or accredited by the Ministry of Health of Vietnam in accordance with regulations of law; and

- have at least 03 years of working experience in providing healthcare at health facilities or health authorities that directly manage health facilities;

Article 76. Application package for certificate of registration for provision of healthcare quality assessment and certification services

In addition to the required documents included in an application package for certificate of registration for provision of certification services for products and management systems as prescribed in the Government’s Decree No. 107/2016/ND-CP dated July 01, 2016, as amended by the Decree No. 154/2018/ND-CP dated November 09, 2018, an application package for certificate of registration for provision of healthcare quality assessment and certification services must also include:

1. A personnel list.

2. Legitimate copies of certificates of completion of training course in healthcare quality assessment skills of the applicant’s assessors.

3. Documents proving that the applicant’s organizational structure is conformable with assessment quality standards.

Article 77. Procedures for issuance, suspension and revocation of certificate of registration for provision of healthcare quality assessment and certification services

Procedures for issuance, suspension and revocation of certificate of registration for provision of healthcare quality assessment and certification services shall be followed in accordance with regulations of law on conformity assessment.

Section 4. SUSPENSION AND REVOCATION OF OPERATING LICENSES

Article 78. Procedures for revocation of operating licenses and suspension of operation of health facilities

1. Suspension of part or all of professional activities of a health facility:

a) Within 05 working days from the day on which by the Expert Council as defined in Article 101 of the Law on Medical Examination and Treatment or a competent authority draws their conclusion or inspection record asserting that the health facility has committed a violation to an extent that it is subject to suspension of part or all of its operation as prescribed in clause 1 Article 55 of the Law on Medical Examination and Treatment, the competent authority defined in Article 51 of the Law on Medical Examination and Treatment shall issue a decision to suspend operation of that health facility.

b) A suspension decision shall, inter alia, include:

- Name of the health facility;

- Reasons for suspension;

- Scope of activities suspended: part or all of licensed activities, depending on the nature and severity of the violation;

- Suspension period;

- Conditions for restoring operation.

c) Within 03 working days from the day on which a decision to suspend part or all of operation of the health facility is issued, the issuing authority shall:

- publish information on the suspension and make limitations on scope of professional activities of the suspended health facility on the healthcare management information system, if that health facility is under its management;

- send the suspension decision to the authority that has issued operating license to that health facility.

d) Within 03 working days from its receipt of the suspension decision as prescribed in point d of this clause, the authority that has issued operating license to the health facility shall publish information on the suspension and make limitations on scope of professional activities of the suspended health facility on the healthcare management information system.

dd) Suspension of operating license of a health facility that is found to have committed an administrative violation shall be carried out in accordance with regulations of law on penalties for administrative violations.

2. Revocation of an operating license:

a) Within 05 working days from the day on which by the Expert Council as defined in Article 101 of the Law on Medical Examination and Treatment or a competent authority draws their conclusion or inspection record asserting that the health facility has committed a violation to an extent that its operating license is revoked as prescribed in clause 1 Article 56 of the Law on Medical Examination and Treatment, or the health facility applies for revocation at its discretion, the authority that has issued operating license to the health facility shall issue a decision to revoke operating license of that health facility.

b) A revocation decision shall, inter alia, include:

- Name of the health facility;

- Reasons for revocation of operating license;

- Post-revocation actions and legal liabilities.

c) Within 03 working days from the issue date of the revocation decision, the licensing authority shall publish information on the revocation on its web portal or website.

Article 79. Actions taken after revocation of operating license or suspension of part or all of professional activities of a health facility

1. In case an operating license is revoked according to clause 1 Article 56 of the Law on Medical Examination and Treatment: the health facility whose operating license is revoked shall follow procedures for issuance of a new operating license in accordance with provisions of this Decree.

2. In case a health facility has part or all of its professional activities suspended as prescribed in clause 1 Article 55 of the Law on Medical Examination and Treatment, the authority issuing the suspension decision must clearly specify contents and period of suspension in its issued decision.

3. Upon its fulfillment of remedial obligations, the health facility subject to suspension decision shall submit a report on remedial measures to its licensing authority.

4. Upon receipt of the report, the licensing authority shall give a receipt note to the health facility.

5. In case no request for modification is made, the licensing authority shall:

a) issue a decision to terminate suspension period within 15 days from the date of the receipt note, if the report on remedial measures is satisfactory; or

b) carry out a physical inspection at the health facility’s premises within 30 days from the date of the receipt note, if necessary.

6. If the report on remedial measures needs to be modified, within 10 working days from the date of the receipt note, the licensing authority shall send a written request for modification, which must clearly indicate documents and/or contents that need to be modified, to the health facility.

Within 06 months from the date of the written request for modification given by the licensing authority, the health facility must submit a modified report as requested. If the health facility fails to make the requested modifications, its submitted report will be invalidated.

7. Upon receipt of the modified report, the licensing authority shall give a receipt note to the health facility, and take the following actions:

a) In case the modified report is still unsatisfactory, the licensing authority shall continue sending a written request for modification to the health facility as prescribed in clause 6 of this Article.

Within 06 months from the date of the written request for modification given by the licensing authority, the health facility must submit a modified report as requested. If the health facility fails to make the requested modifications by the aforementioned deadline, or after 12 months counting from the date of the initial submission of the report, the modified report is still unsatisfactory, the submitted reports will be invalidated.

b) In case the modified report is satisfactory, the licensing authority shall follow the procedures in clause 5 of this Article.

8. Upon completion of the physical inspection to the health facility’s premises, the licensing authority shall:

a) issue a decision to terminate suspension period within 15 days after completion of the physical inspection, if results of remedial measures taken by the health facility are satisfactory; or

b) give a written notice of contents that need to be remedied or modified within 05 working days after completion of the physical inspection, if there are still contents that need to be remedied or modified.

If the health facility fails to fulfill its remedial obligations within 06 months from the date of the licensing authority’s written notice of contents that need to be remedied or modified, its submitted documents will be invalidated.

9. Within 20 days from its receipt of a written notice and documents proving the health facility’s fulfillment of remedial obligations, the licensing authority shall follow the procedures in clause 5 of this Article.

Section 5. HUMANITARIAN HEALTHCARE AND MOBILE HEALTHCARE

Article 80. Humanitarian healthcare activities

1. Forms of humanitarian healthcare:

a) Humanitarian healthcare facilities, that are organized in any of the forms of organization defined in Article 48 of the Law on Medical Examination and Treatment and in Article 39 of this Decree;

b) Humanitarian healthcare delegations;

c) Humanitarian healthcare individuals.

2. Humanitarian healthcare activities prescribed in clause 1 of this Article must be performed without collecting any fees or amounts of money from patients.

Article 81. Conditions, application package and procedures for issuance, re-issuance, modification, suspension and revocation of operating license of humanitarian healthcare facilities

Conditions, application package and procedures for issuance, re-issuance, modification, suspension and revocation of operating license of humanitarian healthcare facilities shall comply with the provisions of Chapter III of this Decree.

Article 82. Conditions for provision of humanitarian outreach healthcare campaigns at intervals, provision of humanitarian healthcare by individuals, and mobile healthcare (including health checks)

1. Humanitarian outreach healthcare campaigns at intervals must be organized by health facilities holding operating licenses.

2. Humanitarian healthcare activities of individuals must be performed by medical practitioners who have been issued with practicing licenses on which the scope of practice must be appropriate to humanitarian healthcare activities to be performed.

3. Mobile healthcare must be delivered by health facilities that have been issued with operating licenses and whose scope of professional activities must be appropriate to mobile healthcare activities.

4. In case an intervals-based humanitarian outreach healthcare campaign or mobile healthcare is organized at a location other than that specified in the operating license, material facilities at this location must meet the following conditions:

a) There are areas for receiving patients and performing medical examination and treatment activities meeting the following conditions:

- Regulations of law on contamination control, radiation safety, biomedical waste management, and fire fighting and prevention must be observed;

- Water, electricity, and other conditions must be adequately supplied to serve healthcare.

b) There are adequate medical practitioners, medical devices and other conditions in conformity with the scale and scope of healthcare services to be provided.

5. When organizing humanitarian outreach healthcare campaigns at intervals or mobile healthcare activities or providing health checks in the form of healthcare delegations, the following personnel conditions must be satisfied:

a) The person in charge of professional practices of the humanitarian healthcare delegation or mobile healthcare delegation must have an unexpired practicing license at the time of application for permission to provide humanitarian or mobile healthcare, on which the scope of practice must be appropriate to the list of professional techniques registered by the delegation, and have at least 36 months, up to the date of application for permission to provide humanitarian or mobile healthcare, of experience in providing healthcare;

b) Other persons directly engaging in healthcare process must possess practicing licenses. If a person directly engaging in healthcare process is exempt from practicing license as prescribed by the Law on Medical Examination and Treatment, he/she must possess qualifications or certificates appropriate to his/her assigned activities;

c) In case drugs are dispensed, the person in charge of dispensing activities must possess a diploma of pharmacist assistant or hold a practicing license for the title of a doctor;

d) If a person delivering humanitarian healthcare is a foreigner, a language interpreter shall be required, unless such foreigner is proficient in Vietnamese.

6. A medical practitioner who delivers humanitarian healthcare as an independent individual shall be required to meet personnel conditions set out in clause 2 of this Article. He/she may make up drug prescriptions but shall not be allowed to dispense drugs.

7. Medical devices and drugs:

a) Medical devices, anaphylaxis kits, emergency drugs and drugs for medical treatment must be adequately equipped in conformity with the registered scope of healthcare activities;

b) Medical devices must have clearly known origin; drugs used in humanitarian healthcare activities must be included in the list of drugs to be sold in Vietnam and unexpired. If any drug which is not yet granted marketing authorization in Vietnam is used, a written commitment that such drug has been lawfully sold in a foreign country shall be required (only applicable for foreign humanitarian healthcare delegations).

Article 83. Application package and procedures for granting permission for humanitarian outreach healthcare campaigns at intervals, mobile healthcare as prescribed in clause 1 Article 79 of Law on Medical Examination and Treatment or humanitarian healthcare delivered by individuals

1. An application package for permission for humanitarian outreach healthcare campaigns at intervals or mobile healthcare as prescribed in clause 1 Article 79 of Law on Medical Examination and Treatment is composed of:

a) An application form which is made using Form No. 01 in Appendix IV enclosed herewith;

b) List of persons engaging in humanitarian or mobile healthcare process which is made using Form No. 02 in Appendix IV enclosed herewith, and must clearly state the person in charge of professional practices of the healthcare delegation; a legitimate copy of the practicing license of this person must be also accompanied with the list;

c) Legitimate copies of professional qualifications/certificates of persons who directly deliver healthcare but are exempt from practicing licenses as prescribed by the Law on Medical Examination and Treatment (if any);

d) A humanitarian or mobile healthcare plan which is made using Form No. 03 in Appendix IV enclosed herewith;

dd) Written approval given by the health facility or the head of the location where healthcare activities are to be performed.

2. An application package for permission for humanitarian healthcare delivered by an individual is composed of:

a) An application form which is made using Form No. 01 in Appendix IV enclosed herewith;

b) A legitimate copy of the applicant’s practicing license;

c) A humanitarian healthcare plan which is made using Form No. 03 in Appendix IV enclosed herewith;

d) Written approval given by the health facility or the head of the location where humanitarian healthcare activities are to be performed.

3. An application package for permission for a humanitarian outreach healthcare campaign at intervals or mobile healthcare shall be submitted to:

a) the Ministry of Health of Vietnam, if:

- a foreign organization or individual organizes a humanitarian outreach healthcare campaign at intervals or mobile healthcare in 02 provinces or central-affiliated cities or more; or

- the humanitarian outreach healthcare campaign at intervals or mobile healthcare is organized at a health facility affiliated to the Ministry of Health of Vietnam or another Ministry, except the Ministry of National Defence of Vietnam and the Ministry of Public Security of Vietnam.

b) the Ministry of National Defence of Vietnam, if the humanitarian outreach healthcare campaign at intervals or mobile healthcare is organized at a health facility, agency or unit affiliated to this Ministry.

c) the Ministry of Public Security of Vietnam, if the humanitarian outreach healthcare campaign at intervals or mobile healthcare is organized at a health facility, agency or unit affiliated to this Ministry.

d) a health authority affiliated to the relevant provincial People's Committee, for humanitarian outreach healthcare campaign at intervals or mobile healthcare activities other than those specified in points a, b and c of this clause.

4. Procedures for granting permission for a humanitarian outreach healthcare campaign at intervals or mobile healthcare:

Within 10 days from its receipt of an adequate application package, the receiving authority as defined in clause 3 of this Article shall give its written permission for the humanitarian outreach healthcare campaign at intervals or mobile healthcare. If an application is refused, a written response which clearly states reasons for refusal shall be given.

Section 6. TRANSFER OF PROFESSIONAL TECHNIQUES IN HEALTHCARE OR COOPERATION IN PROVISION OF TRAINING COURSES ON MEDICINE INVOLVING MEDICAL INTERNSHIP

Article 84. Cases and conditions for transfer and receipt of transfer of professional techniques between health facilities

1. Only techniques included in the list of techniques promulgated by the Ministry of Health of Vietnam may be transferred between domestic health facilities. In case a technique is transferred to a foreign country, it must not be subject to prohibition from transfer to foreign countries as prescribed by the Law on Technology Transfer.

2. Conditions to be satisfied by the health facility that transfers a professional technique (hereinafter referred to as “transferring facility”):

a) The technique to be transferred must fall within its scope of professional activities approved by a competent authority;

b) The person in charge of technique transfer must have experience in performing the technique to be transferred and have been assigned in writing by the person in charge of professional practices of the transferring facility to carry out such technique transfer.

3. Conditions to be satisfied by the health facility that receives transfer of a professional technique (hereinafter referred to as “receiving facility”):

a) Its scope of professional activities must be appropriate to the technique received;

b) Its personnel, material facilities and medical devices are adequate and suitable for receipt of the technique to be transferred.

Article 85. Technique transfer process

1. Do surveys for determining the demand for technique transfer.

2. Formulate a technique transfer protocol.

3. Enter into a technique transfer contract, in which the transferring facility and the person in charge of technique transfer must assume responsibility for medical examination and treatment results.

Where a technique included in the list of special-type techniques is transferred, the receiving facility must also follow the procedures in clause 10 Article 66 of this Decree before entering into a technique transfer contract.

4. Carry out the transfer of technique, including the following steps:

a) Provide theoretical and practical training for the person in charge of technique receipt. Upon completion of the training, the transferring facility shall issue a written certification of completion of technical training to the trainee.

Where the transferring facility is a continuous training provider, the written certification of completion of technical training mentioned in this point shall be also used as certification of continuous training;

b) Carry out transfer of technique at the receiving facility;

c) Carry out acceptance test and assessment of the transferred technique, liquidate contract and issue certificate of competence to perform the technique.

5. Upon completion of the technique transfer process, relevant health facilities shall follow procedures for modification of their scope of professional activities in accordance with provisions of this Decree.

Article 86. Conditions, application package and procedures for granting permission to foreigners entering Vietnam for transfer of professional techniques in healthcare or cooperation in provision of training courses on medicine involving medical internship

1. Conditions for granting permission to foreigners entering Vietnam for transfer of professional techniques in healthcare or cooperation in provision of training courses on medicine involving medical internship (hereinafter referred to as “provision of healthcare at intervals”):

a) The foreigner must possess a practicing license issued by a competent authority of a foreign country which is still valid at the application date;

b) The foreigner meets conditions for foreigners entering Vietnam for study or working set out in laws;

c) Language interpreter(s) must be employed as prescribed in clause 2 Article 35 of this Decree, unless a foreigner is proficient in Vietnamese;

d) Drugs and medical devices used must be conformable with the scope of professional activities of the applicant; must have clearly known origin and been granted marketing authorization by competent authorities of foreign countries or a competent authority of Vietnam; must be unexpired and usable;

dd) A consent given by an authority, organization or health facility of Vietnam to receive foreigners is available.

2. An application package for permission to foreigners entering Vietnam for transfer of professional techniques in healthcare or cooperation in provision of training courses on medicine involving medical internship is composed of:

a) An application form for permission for foreigners entering Vietnam for provision of healthcare at intervals, made by the Vietnamese authority or organization receiving such foreigners;

b) List of foreigners that will enter Vietnam for provision of healthcare which must bear the seal of the Vietnamese authority or organization receiving such foreigners and contain the following information: full name; passport’s number; professional title; tasks performed in Vietnam and commitment to assume responsibility for quality of healthcare services provided by foreigners of the Vietnamese authority or organization receiving such foreigners, and be enclosed with legitimate copy of practicing license of each foreigner;

c) List of interpreters of foreigners entering Vietnam for provision of healthcare at intervals which must bear certification of the Vietnamese authority or organization receiving such foreigners and contain the following information: full name; ID number, passport’s number, citizen identity card’s number or personal identification number; professional qualifications and commitment to assume responsibility for interpretation quality of the Vietnamese authority or organization receiving such foreigners, and be enclosed with legitimate copy of professional qualification of each interpreter;

d) List of medical devices which must bear certification of the Vietnamese authority or organization receiving such foreigners (if any), and contain the following information: name and origin of the device, and commitment that the device is still in good use.

If medical devices of a Vietnamese health facility are used, the written agreement to provide medical devices of the authority or organization where healthcare services will be provided shall be required.

If foreigners who enter Vietnam for provision of healthcare at intervals donate medical devices to the Vietnamese authority or organization upon completion of their healthcare provision, the Vietnamese authority or organization must follow procedures for receiving such medical devices in accordance with the Government’s regulations.

dd) List of drugs (if any) which must contain the following information: name of drug, active ingredient, expiry date, marketing authorization number and commitment that the drug is lawfully placed on the market of at least a foreign country;

e) The written agreement on provision of healthcare at intervals between the Vietnamese authority or organization and the foreigner or the foreign authority or organization.

3. An application package for permission to foreigners entering Vietnam for transfer of professional techniques in healthcare or cooperation in provision of training courses on medicine involving medical internship shall be sent to:

a) The Ministry of Health of Vietnam, if foreigners will work at a health facility affiliated to the Ministry of Health of Vietnam or another ministry, except the Ministry of National Defence of Vietnam and the Ministry of Public Security;

b) The Ministry of National Defence of Vietnam, if foreigners will work at a health facility affiliated to this Ministry;

c) The Ministry of Public Security of Vietnam, if foreigners will work at a health facility affiliated to this Ministry;

d) The health authority affiliated to a provincial People's Committee, if foreigners will work at a health facility affiliated to this health authority or within this province.

4. Procedures for granting permission to foreigners entering Vietnam for transfer of professional techniques in healthcare or cooperation in provision of training courses on medicine involving medical internship:

Within 15 days from its receipt of an adequate application package, the receiving authority as defined in clause 3 of this Article shall give its written permission to foreigners entering Vietnam for provision of healthcare. If an application is refused, a written response indicating reasons for such refusal shall be given.

Section 7. TELEHEALTH AND TELEHEALTH SUPPORT

Article 87. Telehealth

1. Conditions for carrying out telehealth:

a) Telehealth must be provided by medical practitioners of any of the health facilities defined in Article 39 of this Decree;

b) The health facility’s scope of professional activities must be appropriate to the telehealth contents;

c) The health facility has adequate medical practitioners according to its scope of telehealth;

d) Technical infrastructure, IT equipment, specialized equipment and IT software programs must be suitable for the type of services to be provided and be capable of transmitting, displaying, processing and storing data in a safe and confidential manner. Data storage and backup periods must comply with regulations of law.

2. Application for declaration of eligibility to carry out telehealth:

a) An application form for approval of telehealth, which must clearly state the start date of telehealth;

b) A legitimate copy of the operating license of the health facility (not required if such operating license has been shared or published on the healthcare management information system or national healthcare database);

c) List of registered medical practitioners in which their practicing license numbers must be indicated (in case the health facility's operating license has been shared or published on the healthcare management information system or national healthcare database). If the health facility’s operating license has not yet been shared or published on the healthcare management information system or national healthcare database, a legitimate copy of the practicing license of each medical practitioner who will provide telehealth shall be required.

d) List of telehealth services to be provided;

dd) Documentary evidence of satisfaction of the conditions set out in Point d Clause 1 of this Article.

3. Procedures for declaring eligibility to carry out telehealth:

a) The health facility shall send an application package for declaration of eligibility to carry out telehealth as prescribed in clause 2 of this Article to:

- The Ministry of Health of Vietnam, if it is under this Ministry's management;

- The health authority affiliated to the People's Committee of province or city where this health facility is located (event if it is a private health facility), except health facilities under management of the Ministry of Health of Vietnam, the Ministry of National Defence of Vietnam or the Ministry of Public Security of Vietnam.

b) Upon receipt of the application package for declaration of eligibility to carry out telehealth, the receiving authority shall give a receipt note using the Form No. 02 in Appendix I enclosed herewith to the applicant.

c) Within 10 days from the date specified on the receipt note which is given according to clause 2 of this Article, the receiving authority shall publish information on the health facility that is eligible to carry out telehealth on its website or web portal and on the healthcare management information system.

If the received application is not satisfactory, the receiving authority shall send a written response indicating reasons therefor to the applicant.

Information to be published shall, inter alia, include: name and address of the health facility providing telehealth, and list of telehealth services to be provided.

d) After 10 days from the date specified in the receipt note, if the receiving authority neither sends a document to the health facility on its eligibility to carry out telehealth nor publishes information as prescribed in point c of this clause, the health facility may start providing telehealth.

dd) During its provision of telehealth, if any changes in the information published as prescribed in clause 2 of this Article occur, the health facility shall repeat procedures for declaring its eligibility to carry out telehealth as prescribed in this clause.

4. The scope of telehealth shall comply with point a clause 1 Article 80 of the Law on Medical Examination and Treatment.

5. If a health facility's scope of telehealth includes the diseases or health conditions which are not included in this list specified in clause 4 of this Article, the health facility must meet the conditions set out in clause 1 of this Article and send an application for permission to pilot telehealth as prescribed in clause 6 of this Article to the authority that has issued the operating license for approval.

6. Procedures for approval of pilot provision of telehealth:

a) The health facility that applies for approval of its pilot provision of telehealth shall submit an application which includes the following documents to the authority that has issued its operating license (hereinafter referred to as “licensing authority”):

- An application form which must clearly state the start date of telehealth;

- The operating license of the health facility (not required if such operating license has been shared or published on the healthcare management information system or national healthcare database);

- List of telehealth services to be provided;

- Documentary evidence of satisfaction of the conditions set out in Point d Clause 1 of this Article;

- List of medical practitioners who will engage in pilot provision of telehealth, in which full name and number of practicing license of each medical practitioner must be indicated;

- Other documentary evidences of its satisfaction of conditions.

b) Upon receipt of the application, the licensing authority shall give a receipt note to the applicant.

c) In case the application package is satisfactory, the licensing authority shall carry out an appraisal within 30 days from the date specified in the receipt note. A physical inspection may be conducted at the applicant’s premises if it is deemed necessary.

d) Within 15 days from the date of the appraisal record, the licensing authority shall give a written approval of pilot provision of telehealth, in which the number of cases to be performed must be clearly indicated. If an application is refused, a written response which specifies reasons for refusal shall be given to the applicant.

dd) If an application package needs to be modified, within 15 working days from the date specified in the receipt note, the licensing authority shall send a written request for modification, which must clearly indicate the documents and/or contents that need to be modified, to the applicant.

e) After receiving the modified application, the licensing authority shall provide a receipt note for the applicant and follow the procedures specified in Point c and Point d co this Clause.

g) In case the modified application package is still unsatisfactory, the licensing authority shall send a written notification to the applicant in accordance with Point dd of this Clause.

h) Within 06 months from the date of the written request for modification given by the licensing authority, the applicant must make requested modifications. If the applicant fails to make requested modifications by the aforementioned deadline, or after 12 months from the day on which the application is submitted for the first time, the modified application package is still unsatisfactory, the submitted application documents will be invalidated.

7. Upon the end of the pilot period, the health facility shall send a report on pilot results to the licensing authority for reporting to the Ministry of Health of Vietnam.

8. Prices of telehealth services, which shall also be applied during pilot period:

a) Prices of medical examination shall be the prices of medical examination services provided by the health facility that carries out telehealth as approved by a competent authority, including the prices of on-demand healthcare services (if any);

b) The price of hospital bed services per day and prices of technical services provided shall be the prices, approved by competent authorities, of the health facility that receives the patient (hereinafter referred to as “receiving health facility”), including the prices of on-demand services (if any);

c) Prices of drugs, medical devices, whole blood and blood products to be used for the patient shall be reasonable costs incurred during provision of the service (if any) as prescribed.

9. If a patient comes a health facility to receive telehealth provided by another health facility, the receiving health facility shall receive payment of costs of healthcare services from the patient as prescribed in clause 8 of this Article and make payment to the health facility providing telehealth as agreed upon in the contract for provision of telehealth services between these health facilities as prescribed in clause 11 of this Article.

If a patient holds a health insurance card, costs of covered medical services shall be paid by the health insurance fund in accordance with regulations of law on health insurance. The patient shall themself make the prescribed co-payment and payment of other costs and expenses greater than the maximum coverage percentages (if any).

Costs shall not be covered by the health insurance fund in case of pilot provision of telehealth as prescribed in clause 5 of this Article.

The patient that does not hold a valid health insurance care shall themself pay costs of telehealth services according to the prices of healthcare services approved by competent authorities.

10. If a patient receives telehealth services not through any other health facility, costs of healthcare services shall be paid as agreed upon between the parties.

11. A contract for provision of telehealth services shall, inter alia, include the following contents:

a) Responsibilities, rights and benefits of the health facility providing telehealth towards the receiving health facility;

b) Technical infrastructure, IT equipment, specialized equipment and IT software programs for ensuring safety and security of information which must be suitable for telehealth services;

c) Data storage and backup which must meet information safety and security requirements as laid down in laws;

d) Costs of telehealth services;

dd) Costs of healthcare services agreed upon between health facilities.

Article 88. Telehealth support

1. Conditions for providing telehealth support:

a) Telehealth support provided must be appropriate to the licensed scope of professional activities of the supporting health facility.

b) A contract for provision of telehealth support must be available. This contract shall, inter alia, include the following contents:

- Responsibilities, rights and benefits of the supporting health facility and the supported health facility;

- Technical infrastructure, IT equipment, specialized equipment and IT software programs for ensuring safety and security of information which must be suitable for telehealth support services;

- Data storage and backup which must meet information safety and security requirements as laid down in laws;

- Costs of telehealth support services;

- Costs of telehealth support services agreed upon between health facilities.

2. Patients are provided with information on telehealth support services during their medical examination and treatment.

3. Health facilities providing telehealth support assume responsibility to strictly comply with the signed contracts for provision of telehealth support, and submit annual reports thereon to supervisory authorities.

4. Rules for payment of costs of telehealth support services:

a) Prices of healthcare services are those at the supported health facility with approval of a competent authority;

b) The supported heath facility must pay costs of telehealth support services to the supporting health facility at the rates agreed upon between them and under terms and conditions of the signed contract for provision of telehealth support services.

Section 8. LEVELS OF PROFESSIONAL TECHNIQUES IN HEALTHCARE

Article 89. Classification of health facilities by levels of professional techniques

1. Primary healthcare level includes health facilities that do not provide inpatient treatment, commune health stations and regional polyclinics that have hospital beds.

2. Basic and intensive healthcare levels include hospital (health centers that have hospital beds).

3. Classification of a health facility into a basic or intensive healthcare level shall comply with provisions of Appendix V enclosed herewith.

Article 90. Application and procedures for classification of health facilities by professional technique levels

1. An application for classification of a health facility by professional technique level includes:

a) An application form;

b) The scoring results according to the assessment criteria and contents specified in Appendix V enclosed herewith;

c) Documents and statistical figures proving the given score;

d) Other relevant documents.

2. Procedures for classification of a health facility by professional technique levels:

a) The hospital (applicant) shall submit an application as prescribed in clause 1 of this Article to the authority defined in clause 3 of this Article.

b) Upon receipt of the application, the receiving authority shall give a receipt note using Form No. 02 in Appendix I enclosed herewith to the applicant.

c) In case the application is satisfactory, the authority defined in clause 3 of this Article shall issue a document to classify the health facility by professional technique level within 60 days from the date specified in the receipt note.

d) If the application needs to be modified, within 10 days from the date specified in the receipt note, the authority defined in clause 3 of this Article shall send a written request for modification, which must clearly indicate the documents and/or contents that need to be modified, to the applicant.

dd) Upon its completion of modifications, the applicant shall give a written notice, accompanied with documents proving its completion of modifications.

e) Upon receipt of modified application, the authority defined in clause 3 of this Article shall:

- follow procedures in point c of this clause if the application is satisfactory; or

- follow procedures in points d, dd of this clause if the application is still unsatisfactory.

g) Within 05 working days from the day on which the health facility is classified, the authority defined in clause 3 of this Article shall publish the name and address of the classified health facility and its professional technique level on its web portal and on the healthcare management information system.

3. Authority to classify health facilities by professional technique levels:

a) The Ministry of Health shall classify hospitals affiliated to this Ministry;

b) The health authority affiliated to a provincial People’s Committee shall classify hospitals located in that province or city and private hospitals that have been issued with operating licenses by the Ministry of Health of Vietnam, except hospitals affiliated to the Ministry of Health of Vietnam, the Ministry of National Defence of Vietnam, or the Ministry of Public Security of Vietnam.

Section 9. INVOLUNTARY TREATMENT

Article 91. Patient cases subject to involuntary treatment

1. Patient cases subject to the involuntary treatment requirements in accordance with this Decree shall be defined as follows:

a) Persons suffering from group-A infectious diseases that are defined in laws on prevention and control of infectious diseases (hereinafter referred to as “group-A infectious disease patients”);

b) Persons with depression susceptible to suicidal thoughts and behaviors; persons with mental illness in an agitated state that is likely to harm himself or with behaviors harming other persons, or destroying property (hereinafter referred to as “mental patients”).

2. The involuntary treatment for a person who violates the law or is suspected of violating the criminal law and suffers from mental illness as prescribed in point b clause 1 of this Article shall comply with provisions of the criminal code, the criminal procedure code, and regulations of law on judgment enforcement.

3. In consideration of actual status, the Ministry of Health of Vietnam shall request the Government to consider and decide other patient cases subject to involuntary treatment as prescribed in point c clause 1 Article 82 of the Law on Medical Examination and Treatment.

Article 92. Involuntary treatment for group-A infectious disease patients

1. In case a person with a confirmed diagnosis is undergoing home quarantine or quarantine at a non-healthcare setting (hereinafter referred to as “at home”):

a) If the patient's condition can be treated at home or according to guidelines on home care treatment given by the Steering Committee for epidemic prevention, the Chairperson of the People’s Committee of commune where the patient is residing shall issue a decision on involuntary treatment at home which must clearly state the health facility that is responsible for instructing and supporting the patient during his/her treatment at home as proposed by the at the health authority of the same level;

b) If the patient’s condition cannot be treated at home, the Chairperson of the People’s Committee of commune where the patient is residing shall issue a decision on involuntary treatment and organize the transfer of the patient from his/her home to a suitable health facility for getting involuntary treatment;

c) If the patient requires treatment but cannot be moved to a health facility, the Chairperson of the People’s Committee of commune where the patient is residing shall issue a decision on involuntary treatment at home which must clearly state the reasons for failure to transfer the patient to a health facility and information on the health facility that is responsible for instructing and supporting the patient during his/her treatment at home as proposed by the at the health authority of the same level.

2. In case a person with a confirmed diagnosis is undergoing quarantine at a quarantine setting with healthcare services:

a) If the patient’s condition can be treated at the quarantine setting with healthcare services, the head of this quarantine setting shall issue a decision on involuntary treatment at the quarantine setting and provide treatment for the patient;

b) If the patient’s condition cannot be treated at the quarantine setting, the head of this quarantine setting shall issue a decision on involuntary treatment and organize the transfer of the patient from the quarantine setting to a suitable health facility for getting involuntary treatment;

c) If the patient’s condition cannot be treated at the quarantine setting but the patient cannot be transferred to any health facility, the head of the quarantine setting shall issue a decision on involuntary treatment which must clearly state the reasons for failure to transfer the patient to a health facility, and contact and ask another health facility for guidance and support in treatment for the patient.

3. In case a person is diagnosed with a group-A infectious disease when he/she is receiving medical examination and treatment at a health facility:

a) If the patient's condition can be treated at the health facility where the patient is receiving medical examination and treatment, the head of this health facility or his/her authorized person (hereinafter referred to as “the health facility’s head”) shall issue a decision on involuntary treatment and provide treatment for the patient;

b) If the patient’s condition cannot be treated at the health facility, the health facility’s head shall issue a decision on involuntary treatment and organize the transfer of the patient to another health facility capable of treating the patient’s condition for getting involuntary treatment;

c) If the patient’s condition cannot be treated at the health facility but the patient cannot be transferred to another health facility, the health facility's head shall issue a decision on involuntary treatment which must clearly state the reasons for failure to transfer the patient to another health facility, and contact and ask another health facility for guidance and support in treatment for the patient.

Article 93. Involuntary treatment for mental patients

1. If any person in the community is found to have the signs mentioned in point b clause 1 Article 91 of this Decree:

a) The People’s Committee of commune where that person is found shall adopt measures for transferring him/her to a health facility for carrying out confirmatory diagnosis;

b) In case that person is diagnosed with mental illness and requires involuntary treatment, the health facility shall provide involuntary treatment or transfer him/her to a mental health facility for getting involuntary treatment, and inform his/her family for cooperating in managing and caring for him/her.

c) In case the patient’s family cannot be identified or refuses to accept the patient, a request for management, caring and provision of benefits for the patient shall be prepared and sent to a competent authority in charge of labour, war invalids and social affairs in accordance with regulations of law on social protection.

2. If any person is found to have the signs mentioned in point b clause 1 Article 91 of this Decree during delivery of medical examination and treatment:

a) The health facility shall provide involuntary treatment or transfer the patient to a suitable mental health facility for getting treatment. The patient’s family must also be informed for cooperation in managing and caring for the patient;

b) In case the patient’s family cannot be identified or refuses to accept the patient, a request for management, caring and provision of benefits for the patient shall be prepared and sent to a competent authority in charge of labour, war invalids and social affairs in accordance with regulations of law on social protection.

Section 10. HANDLING PROCEDURES FOR FOREIGN PATIENTS WITHOUT FAMILIES AND DECEASED PATIENTS WHO ARE FOREIGNERS WITHOUT FAMILIES

Article 94. Foreign patients without families

1. Provision of medical examination and treatment for patients who are foreigners without families shall comply with the provisions of Article 15 of the Law on Medical Examination and Treatment.

2. Death of patients who are foreigners without families shall be handled in accordance with provisions of Article 95 of this Decree.

Article 95. Deceased patients who are foreigners without families

1. Health facilities shall manage death of patients who are foreigners without families and whose nationality cannot be defined in accordance with the provisions of Article 73 of the Law on Medical Examination and Treatment.

2. If the deceased patient is a foreigner without family but has his/her nationality defined, the health facility shall notify the death case to the People’s Committee of district where it is headquartered for management in accordance with regulations of the law on civil status.

The health facility shall directly embalm or employ another facility to embalm the body of the deceased patient pending response from the People’s Committee.

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