CIRCULAR

ON FORMULATION, MANAGEMENT, AND OPERATION OF THE INFORMATION SYSTEM FOR MANAGEMENT OF MEDICAL EXAMINATION AND TREATMENT ACTIVITIES

Pursuant to the Law on Medical Examination and Treatment dated January 09, 2023;

Pursuant to Decree No. 95/2022/ND-CP dated November 15, 2022 of the Government on functions, tasks, powers and organizational structure of the Ministry of Health of Vietnam;

Pursuant to Decree No. 47/2020/ND-CP dated April 09, 2020 of the Government on management, connection and share of digital data of state authorities;

Pursuant to Decree No. 13/2023/ND-CP dated April 17, 2023 of the Government on protection of personal data;

At the request of the Director General of the Department of Medical Service Administration;

The Minister of Health promulgates the Circular on formulation, management, and operation of the information system for management of medical examination and treatment activities.

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GENERAL REGULATIONS

Article 1. Scope

This Circular promulgates regulations on formulation, management, and operation of the information system for management of medical examination and treatment activities.

Article 2. Principles for formulation, management, and operation of the information system for management of medical examination and treatment activities

1. The information system for management of medical examination and treatment activities is formulated, jointly managed, and synchronized from central to local authorities.

2. The information system for management of medical examination and treatment activities is formulated and updated in order to provide comprehensive, accurate, and timely information about medical examination and treatment activities to meet the state management requirements for managing medical examination and treatment activities.

3. The information system for management of medical examination and treatment activities shall operate continuously, stably, and smoothly. Its data shall be stored for the long term for operations of organizations, individuals, and agencies in accordance with the law.

4. The formulation, management, and operation of the information system for management of medical examination and treatment activities shall comply with the laws on information technology, electronic transactions, cybersecurity, access to information; regulations on management, connection and share of digital data of state authorities; regulations on protection of personal data and privacy in accordance with the law.

5. The identification numbers issued by national databases and other specialized databases shall be used to manage the entities in the system.

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FORMULATION AND MANAGEMENT OF THE INFORMATION SYSTEM FOR MANAGEMENT OF MEDICAL EXAMINATION AND TREATMENT ACTIVITIES

Article 3. Basic features of the information system for management of medical examination and treatment activities

1. Input data on examination and treatment activities using the form for management of medical examination and treatment activities via structured data formats or application programming interface (API).

2. Formulate dynamic reports combining different methods such as tables, diagrams, charts and graphs.

3. Disclose and update the following information on the website in accordance with the Law on Medical Examination and Treatment in 2023: licenses to provide medical services; results of evaluation of quality of medical licenses; office hours, list of practitioners and office hours of each practitioner at the facility; prices of medical services, prices of medical care and support services upon request; cautions and solutions to prevent medical incidents.

4. Manage the discharge information of each outpatient, inpatient, day treatment cases; calculate the incidence rate, mortality rate, distribution of each disease group by age, gender, occupation, ethnicity, geographical location, and calculate the morbidity structure index of each case.

5. Manage the causes of deaths at the medical facilities, deaths in transit, and manage information of critically ill patients requesting for discharge.

6. Manage the following information related to licenses to practice medicine: scope of practice; registration information and information on medical continuing professional development.

7. Manage the following information related to licenses to provide medical services: medical directors, list of practitioners, list of medical interns, information on the scope of practice, list of medical services, and number of patient beds.

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9. Calculate morbidity structure index of each medical facility.

10. Record medical costs by each service or by each disease group at each healthcare facility.

11.  Manage inventory and depreciation of medical assets and equipment.

11. Report on medical examination and treatment activities based on professional, total number of treatment days and average length of treatment, financial aspects, human resources, pharmacy and medication use, nursing care, occupational therapy, and infection control.

12. Manage results of evaluation of quality of medical facilities and results of evaluation of quality of laboratory test.

13. Manage results of satisfaction surveys of patients, patients’ family and medical staff.

14. Manage treatment protocols, technical procedures, and care processes at each medical facility.

15. Manage patients’ feedbacks on the quality of services provided at medical facilities.

16. Manage registration information and approval of the list of medical services.

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18. Connect data to other systems.

Article 4. Formulation and update of data to the information system for management of medical examination and treatment activities

1. Creation and collection of data: medical facilities are responsible to standardize, collect and provide comprehensive, accurate, timely information on medical examination and treatment activities to the information system for management of medical examination and treatment activities.

2. Update of data: medical facilities shall notify to the management authority of the information system for management of medical examination and treatment activities when there is any change, update, or incorrectness of data to ensure the accuracy and timeliness of data on the system.

3. Provision of data in special cases: Medical facilities are responsible for providing medical data as requested by the relevant state authorities in emergency situations such as disease outbreaks, natural disasters, or other public emergencies. State authorities shall specify the type of data to be provided, the purpose of data usage, and the appropriate time limit for data usage to meet the requirements of the emergency situation.

Article 5. Data sources of the information system for management of medical examination and treatment activities

Data of the information system for management of medical examination and treatment activities is collected from the following sources:

1. Periodic report on medical examination and treatment activities including medical facilities, patient beds; medical personnel; number of inpatients; outpatients; surgeries, medical procedures; paraclinical; morbidity and mortality pattern according to ICD-10, and other professional activities.

2. Results of evaluation of quality of medical facilities including information on medical facilities, patient beds, professional activities, finance, human resources, results of self-evaluation of quality of medical facilities, results of evaluation of quality made by the inspectorate, results of satisfaction surveys of patients, patients’ family and medical staff.

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4. Submission of report on the admission and treatment of cases of Group-A infectious diseases including the disease situation, number of patients, outbreak progression, and disease prevention measures to the Ministry of Health upon request.

5. Report on traffic accidents, injuries according to the prescribed form including the number of emergency cases, the condition of the patients, and preliminary accident causes according to ICD-10 for statistical purposes based on information provided by the patients, their family, or medical staff through injury assessment.

6. On-duty report on emergency care and treatment activities during holidays, summary report after holidays.

7. Discharge information of all cases.

8. Report on information about deceased cases including death declaration, underlying causes in the disease, causes of deaths with ICD-10 codes, and the time from symptom onset to death in the Cause of Death Diagnosis Form.

9. Report on information of critically ill patients requesting for discharge in the Request for discharge of critically ill patients.

10. Information on issuance of licenses to practice medicine and information registered for practicing medicine.

11. Public health information including information on the license to provide medical services of medical facilities; list of practitioners; details on professional competence; prices of medical services; results of evaluation of quality of medical facilities.

12. Information on registration, approval of medical services, and levels of professional and technical expertise of medical facilities by the Ministry of Health, Department of Health.

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14. Data on requests for payment of health insurance-covered medical costs of medical facilities shared by the Social Insurance of Vietnam.

15. National database on management of prescribing and dispensing prescription drugs.

16. Database on Electronic Health Record on the VNeID application.

17. Database on basic healthcare information on the National Database on Social Insurance.

18. Data on investigation on healthcare related to medical examination and treatment activities carried out by the Ministry of Health or other ministries.

Article 6. Output data format standards

Output data format standards as prescribed in point a clause 5 Article 112 of the Law on Medical Examination and Treatment in 2023 shall be designed based on regulations in Chapter II of this Circular following output data format standards that the Ministry of Health issued to serve state management activities regarding medical examination and treatment and payment of costs of health insurance-covered medical care.

Article 7. Protection of the information system

A proposal for classification of cybersecurity levels and implementation of measures for cybersecurity for the information system for management of medical examination and treatment activities shall be formulated in accordance with regulations on cybersecurity at different levels.

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INFORMATION FOR MANAGEMENT OF MEDICAL EXAMINATION AND TREATMENT ACTIVITIES

Article 8. Information on the patients and personal health information

Information on the patients after the treatment used for state management purposes related to medical examination and treatment, disease prevention, recording costs and resources in medical examination and treatment.

1. Discharge information of all patients:

a) Population data information: full name, date of birth, gender, ethnicity, occupation, personal identification number, or health insurance card number;

b) Address information: permanent residence address, current address according to the ID card/citizen identification card, phone number;

c) Information on hospital admission, discharge, and transfer: date and time of admission, date and time of discharge, discharge status, treatment result, weight of children, number of days in emergency or intensive care unit, name of the transferring medical facility, name of the receiving medical facility.

d) Performed surgeries and procedures with ICD-9 CM codes (if any) including surgeries and procedures covered by health insurance, and paid by the patient;

dd) Definitive diagnosis before discharge including primary diagnosis, complications, comorbidities, causes, other related health conditions with ICD-10 codes;

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2. Detailed information on pharmaceuticals and medical services: list of pharmaceuticals, used quantity, unit of measurement including pharmaceuticals covered by health insurance and paid by the patient.

3. Results of some clinical and paraclinical indicators that are valuable in diagnosis, prognosis, and monitoring.

4. Summary of the treatment process for inpatients, transferred patients, and other relevant individuals to integrate data into electronic health records to support medical care:

a) Medical history (allergies, chronic diseases, surgical history, obstetric history, artificial implants), medical history, condition upon admission;

b) Clinical progression during the treatment process;

c)  Condition upon discharge, result of the treatment;

d) Summary of paraclinical results, indicators that are valuable in diagnosis, monitoring, and prognosis;

dd) Summary of the treatment methods including internal medicine, surgery, occupational therapy, or traditional medicine;

e) Following treatment plan, prescriptions for outpatients, doctor's instructions, follow-up appointment schedule;

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Article 9. Information on the practitioners, medical interns

1. Information on practitioners include full name, date of birth, gender, personal identification number, license number (including practicing certificate number or license to practice medicine, place of issuance, date of issuance), academic degree, qualification, scope of practice, professional techniques assigned to perform outside the scope of practice on the practicing certificate or license to practice medicine, number of the decision on adjusting the scope of practice, date of issuance of the license to practice medicine, validity period of the license to practice medicine.

2. Information on registration for practicing medicine: position, duration of practice (specific time, medical facility for the main registration, and other facilities for after-hours practice).

3. Information on medical continuing professional development including the name of training courses, conferences, conferences with scores for medical knowledge updates, development of textbooks, teaching materials, professional documents, scientific research, teaching, number of professional development, name of continuous training facility, starting time, ending time.

4. Information on the medical interns includes full name, date of birth, gender, personal identification number, academic degree, academic degree, qualification, scope of internship, starting and ending time of the internship, internship registration place.

Article 10. Information on the medical facilities

1. Information on license to provide medical services and relevant information:

a) Names and codes of the medical facilities;

b) License to provide medical services, date of issuance, issuing authority, scope of practice, person responsible for medical director;

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d) Level, rank of the medical facility, medical specialty, supervisory authority;

dd) Determination if the medical facility is a the medical facility accepting medical interns, health insurance-covered facilities, public or private medical facility;

e) Daily office hours, medical director, year of establishment and operation.

2. Information on infrastructure and patient beds:

a) Planned bed capacity, registered bed capacity for private hospitals, actual bed capacity.

b) Number of ICU beds, negative pressure beds, operating tables, delivery tables;

c) List of medical equipment and current utilization status;

d) List and quantity of imported, exported, and remaining pharmaceuticals, chemicals, biological products made every 6 and 12 months.

3. Information on organization and personnel:

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b) List of practitioners including information of the person responsible for professional accountability.

4. Information on the quality of services of the medical facilities:

a) Result of the valuation of the quality of services of the medical facilities;

b) Results of evaluation of quality of the lab;

c) Results of satisfaction surveys of patients, patients’ family and medical staff;

d) Management of medical incidents and prevention of medical incidents.

5. Information on the operations of the medical facilities (every 6 and 12 months):

a) Information on professional activities, total number of treatment days, average treatment days, personnel, hospital pharmacy, mortality pattern, mortality at the medical facilities, nursing work, occupational therapy, infection control, support for inferior level and transfer of professional techniques;

b) Information on financial activities: details of revenues, expenditures, establishment of funds, financial risk alerts; details of proposed items and results of payment and statement of health insurance-covered medical care costs;

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a) List of professional technique services approved by competent authorities;

b) The number of each provided professional technique service covered by health insurance and paid by patients;

c) List of diagnostic guidelines, treatment protocols, technical procedures, and care processes of the medical facilities;

7. Information on prices of medical services:

a) Prices of medical services covered by health insurance and paid by patients, and on-demand services;

b) Prices of medical care and support services and costs for diagnosis, treatment, and monitoring.

8. a) Information on medical costs and accounting of prices of services based on professional techniques, and each case;

a) Costs for personnel: employee ID, department, total annual income (salary, allowances, social insurance, health insurance, occupational insurance, others).

d) Depreciation of assets and medical equipment: equipment code, equipment name, department of use, year of commissioning, original cost, source;

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d) Regular expenses (management expenses): power costs, infection control, materials, communication expenses, other expenses;

dd) Direct treatment costs by episode of care: consultation fee, hospitalization day, medication cost, supplies, blood, intravenous fluids, laboratory tests, imaging diagnostics, surgery, procedures, and transportation.

Chapter IV

OPERATION OF THE INFORMATION SYSTEM FOR MANAGEMENT OF MEDICAL EXAMINATION AND TREATMENT ACTIVITIES

Article 11. Operation of the information system for management of medical examination and treatment activities

1. Ministries, ministerial authorities, assigned state authorities shall operate the information system for management of medical examination and treatment activities for planning policies, state management in medical examination and treatment, and other duties in accordance with the law.

2. Medical facilities, training institutions in the healthcare sector, and healthcare business establishments have the right to access and use data from the system to serve their operations including training, research, quality improvement in medical services, and enhancing the effectiveness of medical services.

3. Authorities, organizations, and individuals accessing and using data from the information system for management of medical examination and treatment activities shall comply with the registered purposes of use, and ensure the legality and accuracy of data utilization to prevent misuse or unauthorized use.

4. The Ministry of Health is the governing body of the information system for management of medical examination and treatment activities, and responsible for building, maintaining, updating, and sharing data from this system to support state management, develop healthcare policy strategies, and serve the data utilization needs of organizations and individuals in accordance with the law.

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1. The connection and sharing of medical data between medical databases must comply with the regulations in Article 42 of the Law on Electronic Transactions in 2023, Decree No. 47/2020/ND-CP dated April 09, 2020 of the Government on management, connection and share of digital data of state authorities, legislative documents on data management and protection.

2. All connections and sharing of medical data shall be secured, available throughout the transmission and utilization process.

3. The connection and sharing of data shall be in accordance with requirements for cybersecurity and personal data protection as prescribed by the law including measures to prevent unauthorized access, leakage, or tampering of personal information and medical data of the system.

4. Authorities, organizations, and units are responsible for ensuring that medical data shared between information systems is used for the intended purposes, securely, and only for activities permitted by law.

Chapter V

IMPLEMENTATION

Article 13. Effect

This Circular comes into force from January 01, 2027.

Article 14. Transitional provision

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Article 15. Implementation

1. The Department of Medical Service Administration shall take charge, and cooperate with authorities, relevant organizations in leading, inspecting, conducting preliminary review, review of the implementation of this Circular nationwide.

2. The authorities, departments of the Ministry of Health shall organize the implementation of this Circular within their jurisdiction.

3. The Social Insurance of Vietnam shall fully, accurately, and promptly connect and share data on payment of costs of health insurance-covered medical care on the information system for management of medical examination and treatment activities.

4. The Departments of Health of provinces and central-affiliated cities; health units of Ministries and central authorities shall:

a)  Lead, provide instructions, inspect, review the implementation of this Circular of medical facilities within their jurisdiction;

b) conducting preliminary review, review, report on the implementation to the Ministry of Health (Department of Medical Service Administration) and to immediately supervisory authorities.

3. The medical facilities shall fully, accurately, and promptly share the data on the information system for management of medical examination and treatment activities.

Authorities, organizations, individuals shall report any issues arise during the implementation to the Ministry of Health (Department of Medical Service Administration) for consideration and resolution./.

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PP. MINISTER
DEPUTY MINISTER




Tran Van Thuan

Thông tư 38/2024/TT-BYT quy định xây dựng, quản lý, khai thác, sử dụng Hệ thống thông tin về quản lý hoạt động khám bệnh, chữa bệnh do Bộ trưởng Bộ Y tế ban hành