Circular No. 38/2024/TT-BYT stipulates the construction, management, operation, and use of the Information System for Managing Medical Examination and Treatment Activities issued by the Minister of Health.

CIRCULAR

Regulations on the construction, management, exploitation, and use of

The information system for managing medical examination and treatment activities

On the basis of Law on Medical Examination and Treatment dated January 9, 2023;

Decree No. Decree No. 95/2022/NĐ-CP dated November 15, 2022 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

Decree No. Decree No. 47/2020/NĐ-CP dated April 9, 2020 of the Government on management, connection, and sharing of digital data of state agencies;

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

At the proposal of the Director of the Department of Medical Examination and Treatment;

The Minister of Health issues this Circular to regulate the construction, management, exploitation, and use of the information system for managing medical examination and treatment activities.

PART I
GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular regulates the construction, management, exploitation, and use of the information system for managing medical examination and treatment activities.

Article 2. Principles for constructing, managing, exploiting, and using the information system for managing medical examination and treatment activities

1. The information system for managing medical examination and treatment activities shall be constructed, managed centrally, uniformly, and synchronously from central to local levels.

2. The information system for managing medical examination and treatment activities shall be constructed and updated to provide comprehensive, accurate, and timely information about medical examination and treatment activities, meeting the requirements of state management over medical examination and treatment activities.

3. The information system for managing medical examination and treatment activities shall maintain continuous, stable, and uninterrupted operation, and be stored long-term, meeting the needs for exploitation and use by agencies, organizations, and individuals as prescribed by law.

4. The construction, updating, management, exploitation, and use of the information system for managing medical examination and treatment activities shall comply with legal provisions on information technology, electronic transactions, information security, cybersecurity, access to information; regulations on management, connection, and sharing of digital data of state agencies; and regulations on personal data protection and privacy rights as currently prescribed.

5. Use identification codes assigned by national databases or other specialized databases.

Chapter II
CONSTRUCTION AND MANAGEMENT OF THE INFORMATION SYSTEM FOR MANAGING MEDICAL EXAMINATION AND TREATMENT ACTIVITIES

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

1. Inputting information on medical examination and treatment activities according to the management form for medical examination and treatment activities and structured data or through application programming interfaces (APIs).

2. Generating dynamic reports combining various formats such as tables, diagrams, charts, and visual graphs.

3. Publicizing and updating information as prescribed by the Law on Medical Examination and Treatment 2023: operating licenses; quality assessment results of medical examination and treatment facilities; working hours and lists of practitioners at each facility; prices for medical examination and treatment services, care and support services upon request, and recommendations and preventive measures against medical accidents.

4. Managing discharge information for outpatient, inpatient, and day-care patients; allowing calculation of morbidity rates, mortality rates, distribution of disease groups by age, gender, occupation, ethnicity, administrative location, and calculating the morbidity structure index for each patient.

5. Managing causes of death for cases of death at medical examination and treatment facilities, deaths en route to medical examination and treatment facilities, and managing information on seriously ill patients requesting discharge.

6. Managing updates to practitioner practice licenses: scope of expertise; registration and continuous medical knowledge update information.

7. Managing updates to medical examination and treatment facility operating licenses: responsible professional personnel information, practitioner lists, medical examination and treatment trainee lists, scope of professional activities, technical catalogues, bed capacity.

8. Assigning unified codes to medical examination and treatment facilities nationwide.

9. Calculating the morbidity structure index for each medical examination and treatment facility.

10. Accounting for medical examination and treatment costs by service type or disease group at each medical examination and treatment facility.

11. Managing inventory, depreciation of assets, and medical equipment.

12. Statistical reporting on medical examination and treatment activities by specialty, total number of treatment days, average treatment days, finance, human resources, pharmaceutical work and drug use, nursing, rehabilitation, and infection control.

13. Managing quality assessment results for medical examination and treatment facilities and laboratory testing.

14. Managing patient satisfaction measurement results, family satisfaction, and healthcare worker satisfaction.

15. Managing treatment protocols, technical procedures, and care procedures for each medical examination and treatment facility.

16. Managing patient feedback on the quality of services provided by medical examination and treatment facilities.

17. Managing registration and approval of technical catalogues.

18. Managing admission and treatment of certain specific diseases, monitoring dangerous epidemics.

19. Interconnecting data with other systems.

Article 4. Creation and updating of data in the Information System for Management of Medical Examination and Treatment Activities

1. Creation and collection of data: medical examination and treatment establishments shall be responsible for standardizing, collecting, and providing complete data on medical examination and treatment activities at their units to the Information System for Management of Medical Examination and Treatment Activities, ensuring that the data is accurate, complete, and timely.

2. Updating data: medical examination and treatment establishments must immediately notify the management agency of the Information System for Management of Medical Examination and Treatment Activities of any changes, additions, or errors discovered in their unit's data in order to ensure the accuracy and timeliness of the data in the system.

3. Provision of data in special cases: in emergency situations such as epidemics, natural disasters, or other public emergencies, medical examination and treatment establishments shall be responsible for providing health data according to the requirements of state agencies with competent authority. State agencies must clearly specify the type of data to be provided, the purpose of using the data, and the duration of use to ensure compliance with the requirements of the emergency situation.

Article 5. Sources of Data for the Information System for Management of Medical Examination and Treatment Activities

Data provided to the Information System for Management of Medical Examination and Treatment Activities is sourced from the following data sources:

1. Regular statistical reports on medical examination and treatment activities including: medical examination and treatment establishments, hospital beds; medical personnel; number of inpatients; outpatients; surgeries, procedures; clinical laboratory tests; disease models, deaths according to ICD-10, and other specialized activities.

2. Reports on the results of quality assessment inspections of hospitals including: information on medical examination and treatment establishments, hospital beds, specialized activities, finance, human resources, self-assessment quality scorecards by medical examination and treatment establishments, quality scorecards of hospitals assessed by inspection teams, patient satisfaction measurement results, family members' satisfaction, and healthcare staff satisfaction.

3. Reports on the results of quality assessment inspections of laboratory testing according to criteria issued by the Ministry of Health, self-assessed by medical examination and treatment establishments and evaluated by inspection teams.

4. Reports on epidemic containment and treatment in dangerous group A epidemics regarding the epidemic situation, number of patients, epidemic trends, and preventive measures reported to the Ministry of Health upon request.

5. Traffic accident and injury reports according to prescribed formats including: number of emergency rescues, patient conditions, and preliminary causes of accidents according to ICD-10 for statistical purposes based on information reported by patients, family members, or determined by healthcare staff through injuries.

6. Continuous reports during holidays and festivals on emergency rescue and treatment activities, summary reports after holiday and festival periods.

7. Patient discharge information for all discharge cases.

8. Reports on death case information including: death certificate information, chain of pathological causes leading to death, events leading to death accompanied by ICD-10 codes and time from occurrence to death in the Death Cause Diagnosis Form.

9. Reports on seriously ill patients requesting discharge based on information in the Seriously Ill Patient Discharge Information Form.

10. Information on issuance and registration of practice licenses.

11. Public health information as prescribed: information on the operating license of medical examination and treatment establishments; list of practitioners; information on professional capacity; information on medical examination and treatment service prices; evaluation results of medical examination and treatment establishment quality.

12. Information on registration and approval of technical services, classification of technical specialties of medical examination and treatment establishments by the Ministry of Health and Provincial Health Departments.

13. Information on issuance of operating licenses by the Ministry of Health and Provincial Health Departments.

14. Data for requesting payment of medical examination and treatment costs under health insurance by medical examination and treatment establishments connected and shared by the Vietnam Social Security.

15. National database on prescription drug management and sale.

16. Electronic Health Record database on the VNeID application.

17. Basic health information group database in the National Social Insurance Database.

18. Data from health surveys related to medical examination and treatment activities conducted by the Ministry of Health or other ministries.

Article 6. Data Output Format Standards

The data output format standards prescribed in point a, Clause 5, Article 112 of the Medical Examination and Treatment Law 2023 are designed based on the contents stipulated in Chapter II of this Circular, following the principle of inheriting the output standards previously issued by the Ministry of Health to serve state management of medical examination and treatment and health insurance payment for medical expenses.

Article 7. Ensuring Information System Security

The information system for managing medical examination and treatment activities must establish a file to propose the level of information system security and implement measures to ensure information system security according to the regulations on ensuring information system security by level.

Chapter III
CONTENTS OF INFORMATION FOR MANAGING MEDICAL EXAMINATION AND TREATMENT ACTIVITIES

Article 8. Patient Information and Personal Health Information

Patient information after completing a period of medical examination and treatment is aimed at serving state management of medical examination and treatment, disease prevention, cost accounting, and resource utilization in medical examination and treatment.

1. Discharge patient information (for all patient categories):

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

b) Address information: place of permanent residence, current address according to identity card/residence card, contact phone number;

c) Admission and discharge information: admission time, discharge time, discharge status, treatment outcome, weight of children, number of days in intensive care or critical care beds, name of medical examination and treatment facility (where transferred from), name of medical examination and treatment facility (where will be transferred to);

d) Surgical and procedural information performed with ICD-9 CM codes (if applicable) including both procedures covered by health insurance and those paid out-of-pocket by patients;

đ) Final diagnosis upon discharge, including primary disease, complications, accompanying diseases, cause, other related health conditions according to ICD-10 codes;

e) Primary cause of death (for deceased cases) according to guidelines on creating disease chains and events leading to death.

2. Detailed information about medications and technical services: list of medications, quantity, units used, including both those covered by health insurance and those paid out-of-pocket by patients.

3. Results of certain clinical and paraclinical indices valuable for diagnosis, prognosis, and monitoring.

4. Summary of the treatment process for inpatients, transferred patients, and other relevant parties to link data into electronic health records for continuous care:

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

b) Clinical course during treatment;

c) Condition upon discharge, treatment outcome;

d) Summary of paraclinical results, diagnostic, monitoring, and prognostic indices;

đ) Summary of implemented treatment methods, internal medicine, surgery, rehabilitation, traditional medicine;

e) Next treatment plan, outpatient prescription, doctor's instructions, follow-up appointment schedule;

g) Contact information for treating physician or medical examination and treatment facility.

Article 9. Information on Practitioners and Medical Examination and Treatment Practitioners

1. Information on practitioners includes: full name, date of birth, gender, personal identification number, practice license number (including the number of the practice certificate or practice permit, issuing authority, issuance date), professional qualifications, level of education, scope of practice, specialized techniques outside the scope of practice on the practice certificate or permit, decision adjusting the scope of practice, issuance date of the practice permit, validity period of the practice permit.

2. Information on registration for practice includes: position, time of practice (specify time, medical examination and treatment facility where the main practice is registered and other facilities outside regular hours).

3. Information on training and continuous medical knowledge updating includes: name of training courses, conferences, seminars with points for updating medical knowledge, textbook compilation, teaching materials, professional literature, scientific research, teaching, number of hours for knowledge updating, continuous training institution, start time, end time.

4. Information on medical examination and treatment practitioners includes: full name, date of birth, gender, personal identification number, professional qualifications, level of education, scope of practice, start time and expected end time of practice, registration facility.

Article 10. Information on Medical Examination and Treatment Facilities

1. Information on operating permits and related information:

a) Name and code of the medical examination and treatment facility; facility code;

b) Operating permit number, issuance date, issuing authority, professional scope, person responsible for professional matters;

c) Full address, organizational form, technical level;

d) Management level, classification of medical examination and treatment facility, specialty, supervising agency;

đ) Training practice facility, medical examination and treatment facility under health insurance, public or private;

e) Daily working hours, person responsible for professional matters, year of establishment and operation.

2. Information on infrastructure and beds:

a) Planned bed number, registered bed number for private hospitals, actual bed number;

b) Intensive care unit bed number, negative pressure bed number, operating table number, delivery table number;

c) List of medical equipment and current usage status;

d) List and quantity of drugs, chemicals, biological products imported, exported, and stockpiled periodically every six months and twelve months.

3. Information on organization and human resources:

a) List of departments, rooms, centers;

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

4. Information on the quality of services provided by the medical examination and treatment facility:

a) Quality assessment results of the medical examination and treatment facility;

b) Quality assessment results of the laboratory;

c) Patient satisfaction measurement results, patient family satisfaction, and healthcare staff satisfaction;

d) Management and prevention of medical incidents.

5. Information on the activities of the medical examination and treatment facility (periodically every six months and twelve months):

a) Professional activity information, total number of treatment days, average number of treatment days, human resources, hospital pharmacy, disease model, mortality at the medical examination and treatment facility, nursing work, rehabilitation, infection control, guidance and technology transfer;

b) Financial activity information: detailed income and expenditure items, establishment of funds, financial risk warning information; detailed requests and settlement results for medical examination and treatment under health insurance.

6. Information on the capability to perform specialized technical procedures:

a) List of specialized technical services approved by the competent authority;

b) Number of each specialized technical service performed covered by health insurance and paid by patients;

c) Guidelines for diagnosis, treatment protocols, technical procedures, and care applied at the medical examination and treatment facility.

7. Information on the price of medical examination and treatment services:

a) Price of medical examination and treatment services covered by health insurance, paid by patients, and requested services;

b) Price of supportive care services and costs related to diagnosis, treatment, and follow-up.

8. Information on the cost of medical examination and treatment and accounting for service prices based on specialized technical procedures and per case:

a) Labor costs: employee code, department/room, annual gross income (salary, allowances, social insurance, health insurance, occupational insurance, other contributions);

b) Depreciation of assets and medical equipment: equipment code, equipment name, using department/room, year put into use, original value, source;

c) Building depreciation: building code, usable area, construction cost, using department/room;

d) Regular expenses (management costs): energy costs, infection control costs, material costs, communication costs, other costs;

đ) Direct costs per treatment episode: consultation fee, bed day fee, drug fee, supplies fee, blood fee, transfusion fee, testing fee, imaging diagnosis fee, surgery fee, procedure fee, and transportation fee.

Chapter IV
EXPLOITATION AND USE OF DATA FROM THE INFORMATION SYSTEM FOR MANAGING MEDICAL EXAMINATION AND TREATMENT ACTIVITIES

Article 11. Exploitation and use of data from the Information System for Managing Medical Examination and Treatment Activities

1. Ministries, ministerial-level agencies, and state management agencies related to such activities have the authority to exploit and use data from the Information System for Managing Medical Examination and Treatment Activities to serve policy planning work, state management of medical examination and treatment activities, and other public service tasks as prescribed by law.

2. Healthcare facilities, educational institutions in the healthcare sector, and businesses operating in the healthcare sector have the right to exploit and use data from the System to serve their operations, including purposes such as training, research, improving the quality of medical examination and treatment, and enhancing the effectiveness of health care services.

3. Agencies, organizations, and individuals exploiting and using data from the Information System for Managing Medical Examination and Treatment Activities must ensure compliance with the intended use registered with the direct managing agency of the System, while also ensuring the legality and accuracy in the exploitation and use of data, avoiding misuse or improper use.

4. The Ministry of Health is the main managing agency for the Information System for Managing Medical Examination and Treatment Activities, responsible for building, maintaining, updating, and sharing data from this System to serve state management, developing health policy strategies, and serving the exploitation needs of organizations and individuals within the framework of the law.

Article 12. Connection and Sharing of Data from the Information System for Managing Medical Examination and Treatment Activities

1. The connection and sharing of healthcare data between healthcare databases must comply with the provisions set forth in Article 42 of the Electronic Transactions Law 2023, Decree No. 47/2020/NĐ-CP dated April 9, 2020 of the Government on the management, connection, and sharing of digital data of state agencies, and other regulatory legal documents on data management and protection.

2. All connections and sharing of healthcare data must ensure the confidentiality, integrity, and availability of data throughout the transmission and usage process.

3. The connection and sharing of data must comply with requirements for cybersecurity and personal data protection as stipulated by current laws, including measures to prevent unauthorized access, leakage, or falsification of personal information and healthcare data in the system.

4. Agencies, organizations, and units are responsible for ensuring that healthcare data shared between information systems are for the intended purpose, are confidential, and are only used for permitted activities as prescribed by law.

Chapter V
IMPLEMENTATION

Article 13. Effective Date

This Circular takes effect from January 1, 2027.

Article 14. Transitional Provisions

In cases where the referenced documents in this Circular are amended, supplemented, replaced, or abolished, they shall be applied according to the amended, supplemented, replaced, or abolished documents.

Article 15. Implementation Organization

1. The Department of Medical Examination and Treatment Management shall take the lead and coordinate with relevant agencies and organizations to direct, inspect, review, and summarize the implementation of this Circular nationwide.

2. Departments and Bureaus under the Ministry of Health shall be responsible for organizing the implementation of this Circular within their assigned functions and tasks.

3. The Vietnam Social Security shall be responsible for fully, accurately, and promptly connecting and sharing data on health insurance medical examination and treatment cost payments with the Information System for Managing Medical Examination and Treatment Activities.

4. Provincial Departments of Health under centrally governed cities and departments of health under ministries and sectors:

a) Direct, guide, inspect, and audit the implementation of the regulations stipulated in this Circular for medical examination and treatment facilities under their management authority;

b) Conduct reviews, summaries, and report results of implementation to the Ministry of Health (Department of Medical Examination and Treatment Management) and to the direct managing agency.

3. Medical examination and treatment facilities provide full, accurate, and timely data to the Information System for Managing Medical Examination and Treatment Activities.

During the implementation process, if there are difficulties or obstacles, agencies, organizations, and individuals are requested to reflect these issues to the Ministry of Health (Department of Medical Examination and Treatment Management) for consideration and resolution./.