GOVERNMENT OF VIETNAM |
THE SOCIALIST REPUBLIC OF VIETNAM |
No. 102/2025/ND-CP |
Hanoi, May 13, 2025 |
DECREE
ON MANAGEMENT OF DATA ON HEALTH SECTOR
Pursuant to the Law on Government Organization dated February 18, 2025;
Pursuant to the Law on Data dated November 30, 2024;
Pursuant to the Law on Electronic Transactions dated June 22, 2023;
Pursuant to the Law on Medical Examination and Treatment dated January 09, 2023;
Pursuant to the Law on amendment to some articles of the Law on Pharmacy dated November 21, 2024;
Pursuant to the Law on Cybersecurity dated June 12, 2018;
Pursuant to the Law on Cybersecurity dated April 06, 2016;
Pursuant to the Law on Cybersecurity dated November 19, 2015;
Pursuant to the Law on Information Technology dated June 29, 2006;
At the request of the Minister of Health;
The Government promulgates the Decree on management of data on health sector.
Chapter I
GENERAL REGULATIONS
Article 1. Scope
1. This Decree regulates the digital data on health sector including formulation, development, protection, administration, handling, and use of the digital data on health sector, national database on health sector; responsibilities of relevant authorities, organizations, and individuals involved in management of digital data on health sector.
2. This Decree does not apply to the data on health sector related to state secrets.
Article 2. Regulated entities
1. Vietnamese authorities, organizations, and individuals.
2. Foreign authorities, organizations, and individuals in Vietnam.
3. Foreign authorities, organizations, and individuals involved in or related to the digital data on health sector in Vietnam.
Article 3. Definitions
For the purposes of this Decree, the terms below shall be construed as follows:
1. Digital data on health sector means digital data on all aspects of the health sector (hereinafter referred to as “health sector data”).
2. Database on heath sector means a collection of health sector data that is arranged and organized for access, use, sharing, management and update.
3. Electronic health record (hereinafter referred to as “e-Health record”) means an application or software for updating, displaying, searching, storing summarized information on the process of disease prevention, diagnosis, treatment, and healthcare for individuals.
Article 4. General principles
1. Health sector data is used for protection, care, and improvement of public health; state management; simplification of administrative procedures; development of e-Government, digital Government; socio-economical development.
2. The formulation, update, maintenance, development, protection, administration, handling, use of health sector data, national database on health sector shall comply with this Decree and the laws on data, information technology, electronic transactions, cybersecurity, information access, personal data protection; regulations on management, connection and sharing of digital data of state authorities; regulations on formulation, update, maintenance, use of national database.
Chapter II
FORUMATION, DEVELOPMENT, PROTECTION, ADMINISTRATION, HANDLING AND USE OF HEALTH SECTOR DATA
Article 5. Scope of health sector data
Health sector data demonstrates data on all aspects of the health sector including:
1. Data on preventive medicine.
2. Data on environmental protection in health sector.
3. Data on medical examination and treatment, and functional rehabilitation.
4. Data on medical assessment, forensic medicine, forensic psychiatry.
5. Data on traditional medicine and pharmacy.
6. Data on pharmacy.
7. Data on cosmetic products.
8. Data on food safety under management of the health sector.
9. Data on medical devices.
10. Data on medical infrastructures.
11. Data on population.
12. Data on health of mothers – children, and reproductive health.
13. Data on health insurance.
14. Data on health communication and education in health sector.
15. Data on science and technology in health sector.
16. Data on international cooperation in health sector.
17. Data on technology application and digital transformation in health sector.
18. Data on finance in health sector.
19. Data on inspection in health sector.
20. Data on health personnel.
21. Data on training for health personnel.
22. Data on administrative procedures in heath sector.
23. Data on legislative documents, documents for management and administration in health sector.
24. Data on medical facilities.
Article 6. Personal health identification number
The personal identification number of Vietnamese and foreigners who have e-ID accounts in accordance with the law on identification shall be used for personal health identification number.
Article 7. Databases on health sector
1. Databases on health sector
2. Databases on health sector include:
a) Databases on health sector of the Ministry of Health, ministries, ministerial authorities, Governmental authorities, political organizations, socio-political organizations including one or multiple group of data prescribed in Article 5 of this Decree;
b) Databases on health sector of the provincial People’s Committees including one or multiple group of data prescribed in Article 5 of this Decree;
3. Databases on health sector of authorities at other levels of the Government, medical facilities having health sector data within their jurisdiction.
4. Common database on health sector includes national database on health sector and specialized database on health sector.
Article 8. Formulation and development of health sector data
The Ministry of Health, ministries, ministerial authorities, Governmental authorities, political organizations, socio-political organizations, People’s Committees at all levels, medical facilities shall formulate, develop health sector data as prescribed in Articles 11 and 12 of the Law on Data, and other regulations in this Decree.
Article 9. Handling of health sector data
1. The handling of health sector data shall comply with Articles 22, 23, 24, 25 and 26 of the Law on Data and this Decree.
2. Conditional access of data
a) Data related to business secret in groups of information as prescribed in clauses 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 13, 15, 17, 18, 19 and 24, Article 5 of this Decree is allowed to be accessed if the owner of that business secret agrees;
b) Data related to private life secrets, personal secrets, health status, genetic characteristics, physical attributes, individual biological characteristics, sexual life, sexual orientation of individuals in groups of information prescribed in clauses 1, 3, 4, 5, 6, 11, 12, 13, 15, 19, and 20, Article 5 of this Decree is allowed to be accessed if the owner of that secret agrees in accordance with the law personal data protection;
c) Data related to family secrets in groups of information as prescribed in clauses 11, 3, 4, 5, 6, 11, 12, 13, 15 and 19, Article 5 of this Decree is allowed to be accessed if it is allowed by members of family;
d) During the execution of functions, responsibilities and powers, heads of state authorities shall decide the provision of information related to business secrets, private life, personal secrets, and family secrets in cases where it is deemed necessary for the public interest, community health without obtaining consent from the owner of the secret as prescribed in points a, b and c, clause 2 of this Article.
Article 10. Use of health sector data
1. The use of health sector data shall comply with Articles 16, 17 and 21 of the Law on Data and this Decree.
2. Entities using health sector data include:
a) Authorities of Communist Party of Vietnam, the State, Vietnam Fatherland Front Central Committee and political organizations, socio-political organizations shall use health sector data in conformity with their functions, responsibilities;
b) The subject in the data is allowed to use their health sector data;
c) Organizations and individuals that are not prescribed in points and b of this clause have the freedom to access and use open healthcare data; shall access and use personal data with the consent of the entity managing, maintaining data, and the data subject; access and use other data with the consent of the entity managing, maintaining the data.
3. The master data of the national databases on health sector shall be used as an official paper document provided by the competent authority.
4. The master data of the national databases on health sector of ministries, central authorities and local authorities shall be used as an official paper document provided by prescribed authorities.
5. The health sector data shall be used for implementation of e-Health record
a) Health sector data on disease prevention, medical examination and treatment, healthcare, and relevant data shall be used for implementation of e-Health record.
b) Medical facilities legally operating in Vietnam shall connect, share, link relevant health sector data to e-Health record which is integrated in VNeID application;
c) Medical facilities legally operating in Vietnam, Vietnamese citizens or foreigners that have e-ID accounts are allowed to use e-Health record integrated in VNeID application instead of relevant documents during medical examination and treatment, and healthcare as prescribed by law.
Article 11. Administration and protection of health sector data
The administration and protection of health sector data shall comply with Articles 15 and 27 of the Law on Data and this Decree.
Chapter III
NATIONAL DATABASE ON HEALTH SECTOR
Article 12. Governing bodies of the national database on health sector
The Ministry of Health is the governing body of the national database on health sector.
Article 13. Purposes of formulation of the national database on health sector
1. Serve the state management tasks of the health sector; share with other relevant ministries, central authorities, and local authorities to support policy planning, formulate socio-economical development strategies; serve handling of administrative procedures, administrative reform; simplify administrative procedures for citizens, enterprises; serve the needs of the use and application of data of organizations, individuals, and socio-economical development targets.
2. Serve the tasks of protecting, caring for, and improving the health of the people; serve the people in managing their own health.
Article 14. Scope of the national database on health sector
1. The following data on authorities, organizations operating in medical examination and treatment, traditional medicine and pharmacy; functional rehabilitation; medical assessment; forensic medicine assessment; forensic psychiatry assessment; preventive medicine and biosafety in laboratory medicine; population; health of mothers – children, and reproductive health; health insurance; medical devices; medicine; medicine materials; functional food; micronutrient-fortified food; environmental protection in health sector; science and technology in health sector; education and training in health sector; pharmacy production and trading; cosmetic products production and trading; medical devices production and trading; functional food production and trading; production and trading of chemical substances, insecticides, antibacterial products used at home and in health sector:
a) Data on electronic identity of authorities or organizations.
b) Organization structures;
c) Data on scope of operations, services in health sector.
2. Data on health personnel
a) Personal basic data;
b) Data on training and refresher training;
c) Data on professional qualifications.
3. Basic data on pharmacy, medical devices
a) Identification data;
b) Circulation data;
c) Data on export permit;
d) Data on import permit;
4. Personal health data
a) Personal health identification number;
b) Personal basic data;
c) Data on birth certification paper/birth certificate;
d) Data on health insurance;
dd) Data on disease prevention, medical examination and treatment, healthcare;
e) Data on death declaration.
Article 15. Stored and shared master data
1. Data on scope of operations, services in health sector as prescribed in point c clause 1 Article 14 of this Decree.
2. Data on professional qualifications as prescribed in point c clause 2 Article 14 of this Decree.
3. Identification and circulation data as prescribed in points a and b, clause 3, Article 14 of this Decree.
4. Data on birth certificate; data on disease prevention, medical examination and treatment, healthcare; data on death declaration as prescribed in points c, dd and e, clause 4, Article 14 of this Decree.
Article 16. Sources of data for formulation and update of the national database on health sector
1. The data of national database on health sector shall be collected, updated and synchronized from the following sources:
a) Data from the Ministry of Health and state management authorities in health sector;
b) Data from databases on health sector managed by the Ministry of Health;
c) Data shared, synchronized from national databases, databases managed by ministries, central authorities, provinces, central-affiliated cities, Vietnam Fatherland Front Central Committee and political organizations, socio-political organizations as prescribed in Article 14 of this Decree;
d) Data from databases managed by medical facilities;
dd) Data on the result of administrative procedures, public services in health sector;
e) Data digitized, provided, integrated by individuals and organizations.
2. Governing bodies, managing authorities of national databases and databases related to scope of data in the National database in health sector shall update, adjust data as prescribed in Article 14 of this Decree, ensure the completeness, accuracy, consistency, and quality of the updated and shared data.
Article 17. Use of the national database on health sector
1. The use of the national database on health sector shall comply with Article 10 of this Decree.
2. Methods for use of the national database on health sector
a) Connect and share data of national databases; specialized databases; databases; other information system with the national database in health sector;
b) National portal, national public service portal, website of the Ministry of Health, information system for handling administrative procedures of the Ministry of Health;
c) Electronic identification and authentication platforms;
d) National identification application;
dd) Devices, equipment, software provided by units managing and maintaining the data;
e) Other methods approved by the Ministry of Health.
Chapter IV
RESPONSIBILITIES OF AUTHORITIES, UNITS, ORGANIZATIONS, INDIVIDUALS
Article 18. Responsibilities of the Ministry of Health
1. Take charge and cooperate with competent authorities to integrate the national database on health sector into the list of national databases in accordance with the law; develop a roadmap for implementing the national database on health sector; organize the construction, management, administration, and maintenance of the national database on health sector.
2. Formulate and issue the national technical regulation on the national database on health sector, specialized database on health sector within jurisdiction.
3. Formulate and the list of national databases on health sector; disclose open data on health sector within jurisdiction.
4. Formulate and carry out the plan and measures to ensure quality health sector data.
Article 19. Responsibilities of the Ministry of Public Security
1. Ensure infrastructure and cybersecurity to store the national database on health sector in the National data center.
2. Connect, share and synchronize electronic identity information of authorities, organizations, and basic personal data from the national database on population into the national database on health sector.
3. Cooperate with the Ministry of Health and relevant authorities, units in using health sector data to formulate and operate the e-Health record system on VNeID application.
Article 20. Responsibilities of the Office of Government
Connect, share and synchronize data from the national public service portal, national information system for reporting, other systems of the Office of Government into the national database on health sector as prescribed by law.
Article 21. Responsibilities of ministries, ministerial authorities, Governmental authorities
1. Governing bodies of the national databases on enterprise registration; officials, public employees in state authorities; insurance; export permits, import permits, medicine prices, medical devices shall connect, share and synchronize data into the national database on health sector.
2. Formulate, update, connect, share, synchronize data related to health sector managed by managing authorities into the national database on health sector, specialized databases on health sector as prescribed by law.
3. Ensure resources for collecting, updating, managing and using health sector data within jurisdiction.
Article 22. Responsibilities of People’s Committees of provinces and central-affiliated cities
1. Formulate and collect health sector data to formulate databases on health sector to serve management and use of data of local authorities.
2. Formulate and update the list of national databases on health sector, open data on health sector within jurisdiction.
3. Connect, update and synchronize data related to health sector managed by local authorities into the national database on health sector, specialized databases on health sector as prescribed by law.
4. Formulate and implement e-Health record to serve protection, healthcare and improvement of People's health within their jurisdiction.
Article 23. Responsibilities of medical facilities
1. Formulate, collect, standardize data, and formulate databases of units.
2. Connect, share and synchronize data of units into the national database on health sector, database of the Ministry of Health, databases on health sector of provinces and e-Health record in VNeID application.
3. Ensure cybersecurity for databases and data connection, sharing, synchronization.
Article 24. Responsibilities of authorities, units, organizations, individuals
1. Promptly notify governing bodies of the database on health sector when there is any adjustment, supplementation or wrong data related to them.
2. Use the data of databases on health sector as prescribed by law.
Chapter V
IMPLEMENTATION CLAUSE
Article 25. Effect
This Decree comes into force from July 01, 2025.
Article 26. Implementation
1. The Minister of Health shall instruct, inspect, and urge the implementation of this Decree.
2. Ministers, Heads of ministerial authorities, Heads of governmental authorities, Presidents of People's Committees of provinces and central-affiliated cities, relevant authorities, units, organizations and individuals are responsible to implement this Decree.
|
ON THE BEHALF OF THE GOVERNMENT |
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