Overview
Vietnam moved from a decree-level personal data protection regime to a dedicated primary law on 1 January 2026, when Law 91/2025/QH15 — Personal Data Protection Law — and its implementing Decree 356/2025/ND-CP entered into force. The new Law and its implementing decree expressly repealed the prior Decree 13/2023/ND-CP, which had governed personal data protection from 1 July 2023 to 31 December 2025. There is no parallel operation: from 1 January 2026 controllers and processors apply the new Law and Decree alone.
Why this matters for digital health:
- Telemedicine platforms (Law 15/2023/QH15 Article 53; Decree 96/2023/ND-CP Article 87) process sensitive health data at scale.
- Electronic medical records and the inter-facility connectivity required under Law 15/2023 put patient health data into shared infrastructure.
- E-prescription with the 14-character national prescription code (Circular 11/2025/TT-BYT amending Circular 02/2018 GPP) routes patient identifiers and drug-dispensing data through the national pharmacy system.
- The drug-traceability system links manufacturer, wholesaler, retailer and patient records.
- Processing of health-insurance claims involves diagnosis and treatment data.
- Clinical trials process detailed health and sometimes genetic data of trial subjects.
Scope of this page:
- What changed on 1 January 2026.
- Definitions: personal data vs. sensitive personal data; why health data is sensitive.
- Data subject rights under Article 4 of the Law.
- Lawful bases and consent — including specific consent for sensitive health data.
- Controller / processor duties: DPIA filing, DPO, security, breach notification.
- Cross-border transfer of personal data — the mandatory 60-day filing with Ministry of Public Security / A05 using Form 09.
- Data localisation — Law on Cybersecurity + Decree 53/2022/ND-CP for in-scope online services.
- Healthcare-sector cross-cutting rules (Law 15/2023, Decree 96/2023, Circular 11/2025).
- Sanctions — administrative (Article 8 of the Law) and criminal (Article 288 of Penal Code).
- Practical compliance checklist for telemedicine, EMR, e-prescription, drug-traceability and clinical-trial operators.
Legal stack at a glance:
- Law 91/2025/QH15 — primary law, 5 chapters and 39 articles, passed 26 June 2025 by the 15th National Assembly at the 9th session, effective 1 January 2026.
- Decree 356/2025/ND-CP — 31 December 2025, effective 1 January 2026, 5 chapters and 42 articles, with 10 annexed forms (notably Form 09 — cross-border transfer impact-assessment report).
- Law on Cybersecurity 24/2018/QH14 + Decree 53/2022/ND-CP — data localisation regime, unchanged by the 2025 reform.
- Penal Code Article 288 — criminal liability for unauthorised disclosure or trade of personal information on computer networks.
- Law on Medical Examination and Treatment 15/2023/QH15 Article 69 — patient rights including confidentiality of medical-record information and the right to access and copy one’s own record.
- Decree 96/2023/ND-CP Article 87 — IT security and data-protection conditions for telemedicine operating facilities.
- Circular 11/2025/TT-BYT (amending Circular 02/2018 GPP) — pharmacy software connectivity to the national pharmacy / e-prescription system and the 14-character electronic prescription code.
Definitions you need:
- "Personal data" — any information attached to or identifying a natural person.
- "Sensitive personal data" — a defined sub-set that includes health data, biometric data, genetic data, sexual orientation, religious belief, political opinion, financial account, criminal record and other categories listed in the Law and Decree. Health-sector controllers must notify the data subject in advance and in writing that the data being collected is sensitive — a specific obligation not present for ordinary personal data.
- The "controller" and the "processor" carry distinct duties; joint controllers must enter into a written allocation of responsibilities.
- "Cross-border transfer of personal data" — replacing the 2023 terminology of "transfer of personal data abroad" and covering both transfers to overseas servers and access from overseas to data stored in Vietnam.
Data subject rights (Article 4 of Law 91/2025/QH15): Right to be informed of the processing, to consent or refuse, to withdraw consent at any time, to access, view and rectify, to request provision or deletion, to restrict processing, to object to processing, to complain, to denounce, to sue, to claim damages, and to demand protective measures from the controller and from authorities. Decree 356/2025/ND-CP sets a 2-working-day initial response window for receipt and logging of subject requests, with a longer substantive deadline for action.
Lawful bases and consent for health data:
- Consent is the default basis, and for sensitive health data the consent must be specific, informed and separately documented.
- Article 19 of the Law provides narrow exceptions in emergencies, public-interest defence, life-saving circumstances and certain statutory obligations — including treating emergencies under Law 15/2023.
- A healthcare controller MUST NOT transfer patient data to a third-party health, life or social-insurance service provider without a written request from the patient, except where Article 19 applies.
Controller / processor duties:
- DPIA: every controller processing sensitive personal data must compile a personal-data processing impact assessment and file it with Department of Cybersecurity and High-Tech Crime Prevention and Control (A05) of Ministry of Public Security within 60 days of starting processing. Telemedicine, EMR, e-prescription, drug-traceability, clinical-trial sponsor / CRO and health-insurance-data-handling controllers all fall within this trigger because of the sensitive-data definition.
- DPO — a dedicated personal-data-protection unit or officer: mandatory for organisations processing sensitive personal data, which captures the healthcare sector by default. The DPO is the point of contact for data subjects and for A05.
- Security: technical and organisational measures commensurate with the risk — encryption, access controls, segregation, retention controls, audit logging.
- Breach notification: within 72 hours to A05 of Ministry of Public Security, with detailed records retained at least 5 years. Where the breach involves biometric data or location data, notification to the affected data subject within 72 hours or as soon as possible is also required.
- Children’s data: processing requires consent of the parent or legal guardian; for children aged 7+ the child’s assent must also be obtained.
Cross-border transfer of personal data:
- Terminology under the 2025 Law: "cross-border transfer of personal data".
- Mandatory cross-border data transfer impact assessment report filed with A05 within 60 days of starting the transfer; the report must include the transfer contract or commitments and evidence of protective controls in the receiving jurisdiction.
- Narrow exemptions: international shipping or payment contracts, overseas study, emergency medical treatment abroad, and a 5-year delayed-filing window for small enterprises whose business does not involve data.
- Foreign telemedicine providers serving Vietnamese patients from overseas servers fall within scope and must either route via a Vietnamese-licensed facility (see Medibase Telemedicine reference page) or file the cross-border transfer dossier.
- Extraterritorial application: Law 91/2025/QH15 applies to foreign organisations processing personal data of Vietnamese residents from abroad.
Data localisation under Law on Cybersecurity + Decree 53/2022/ND-CP:
- Law 91/2025/QH15 itself does not impose a blanket localisation mandate; localisation continues to be governed by the Cybersecurity Law and Decree 53/2022.
- In-scope online services storing Vietnamese-user personal data must store that data in Vietnam for a minimum period. Foreign-invested telemedicine and EMR platforms should run a separate localisation assessment in parallel to the DPIA.
Sanctions:
- Article 8 of Law 91/2025/QH15 codifies the administrative penalty caps directly in the Law itself — a significant change from the 2023 framework which relied on the general Decree 15/2020/ND-CP on sanctions in telecoms and IT.
- Unlawful sale of personal data: fine up to 10 times the illegal revenue.
- Violations of cross-border personal-data transfer rules: fine up to 5 % of prior-year revenue of the violating organisation.
- Other violations: fine up to VND 3 billion for organisations; individuals face half the organisational cap.
- A dedicated administrative-penalty decree on cybersecurity and personal data protection was in public consultation by Ministry of Public Security in early 2026 and will set the procedural detail; until it is promulgated, A05 enforces under the Law’s direct penalty provisions.
- Criminal liability: Penal Code Article 288 ("Offence of unlawfully posting or using information on computer networks or telecommunications networks") — fine VND 30–200 million, or imprisonment up to 3 years, with aggravated penalties up to 7 years.
- Healthcare-sector administrative penalties under Decree 117/2020/ND-CP remain in force for non-data healthcare violations and may be cumulated with data-protection penalties.
Healthcare-sector cross-cutting rules:
- Law 15/2023/QH15 Article 69 — patient confidentiality and right to access / copy own medical record. The controller of an EMR system must be able to deliver a copy of the record to the patient on request.
- Decree 96/2023/ND-CP Article 87 (clause 1) — telemedicine facilities must guarantee safe transmission, display, processing and storage of clinical data and enter contractual data-protection terms with technology suppliers.
- Circular 11/2025/TT-BYT — pharmacy software must connect to the national pharmacy / e-prescription system; dispensing is only against electronic prescriptions carrying the 14-character national code; patient identifiers flowing through this pipe are sensitive health data, and pharmacy operators inherit DPIA, DPO and breach-notification duties.
- Law 15/2023/QH15 Article 112 — the chapter establishing the personal health information system and the requirement for facilities to deploy EMR and e-prescription and to connect to the national healthcare-activity management information system .
Practical compliance checklist (telemedicine, EMR, e-prescription, traceability, clinical-trial operators): 1. Map the data flows: classify every category as personal data, sensitive personal data, or non-personal data. Health data is sensitive by default. 2. Update consent forms: separate, specific consent for sensitive-data processing, with the express notice that data is sensitive. 3. Compile and file the DPIA dossier with A05 within 60 days of starting processing; update on material change. 4. Designate a DPO (or DPO team) and publish the contact channel. 5. Cross-border transfer: scope all overseas recipients (cloud regions, parent-company analytics, foreign CROs, foreign sponsors), file Form 09 with A05, and put in place transfer contracts with protective controls in the receiving jurisdiction. 6. Data localisation: run a separate Cybersecurity Law / Decree 53/2022 assessment for in-scope online services and provision Vietnam-region storage where required. 7. Breach playbook: 72-hour notification window to A05; biometric / location breaches additionally notify subjects. 8. Records retention: at least 5 years for breach records and processing logs. 9. Vendor contracts: data-processor terms with specific allocation of duties, sub-processor controls, audit rights, deletion at termination. 10. Cross-link governance: align with Law 15/2023 patient-rights workflows (Article 69), Decree 96/2023 telemedicine controls (Article 87), and Circular 11/2025 pharmacy-software connectivity.
- Reference only, not legal advice. Always verify against the consolidated text of Law 91/2025/QH15 and Decree 356/2025/ND-CP on vanban.chinhphu.vn and against current Ministry of Public Security / A05 guidance.
Key documents
Foundational law:
- Law 91/2025/QH15 — Personal Data Protection Law, passed 26 June 2025, effective 1 January 2026. 5 chapters, 39 articles. Article 4 (data subject rights), Article 8 (administrative penalty caps), Article 19 (lawful processing exceptions).
- Law on Cybersecurity 24/2018/QH14 — cybersecurity, data-localisation hook.
- Law on Medical Examination and Treatment 15/2023/QH15 Article 69 (patient confidentiality and record access); Article 112 (personal health information system) .
- Penal Code Article 288 — unauthorised disclosure or trade of personal information on computer networks.
Decree:
- Decree 356/2025/ND-CP — 31 December 2025, effective 1 January 2026, implements Law 91/2025/QH15. 5 chapters, 42 articles, 10 annexed forms (Form 09 — cross-border transfer impact assessment report).
- Decree 53/2022/ND-CP — data localisation under the Cybersecurity Law.
- Decree 96/2023/ND-CP Article 87 — telemedicine IT security and data protection.
- Decree 117/2020/ND-CP (amended by Decree 124/2021/ND-CP) — administrative sanctions in healthcare.
Circular:
- Circular 11/2025/TT-BYT — pharmacy software connectivity to the national pharmacy / e-prescription system; 14-character electronic prescription code.
- Circular 18/2026/TT-BYT — special-control medicines, including prohibition on remote prescribing of narcotic, psychotropic and precursor substances (cross-cuts data protection).
Superseded:
- Decree 13/2023/ND-CP — repealed by Decree 356/2025/ND-CP from 1 January 2026.
Sanctions and enforcement authority:
- Department of Cybersecurity and High-Tech Crime Prevention and Control (A05) — Ministry of Public Security. Primary enforcement body for Law 91/2025/QH15 and Decree 356/2025/ND-CP.
- A dedicated administrative-penalty decree on cybersecurity and personal data protection is in public consultation.
Source documents
Direct links to the official text on government portals.
Law and decree:
- Law 91/2025/QH15 — https://vanban.chinhphu.vn/?pageid=27160&docid=214590
- Law 91/2025/QH15 (original text via vbpl.vn) — https://vbpl.vn/TW/Pages/vbpq-van-ban-goc.aspx?ItemID=179252
- Decree 356/2025/ND-CP — https://vanban.chinhphu.vn/?pageid=27160&docid=216387
- Decree 13/2023/ND-CP (repealed 1/1/2026) — https://vanban.chinhphu.vn/?pageid=27160&docid=207759
- Law on Medical Examination and Treatment 15/2023/QH15 — https://vanban.chinhphu.vn/?pageid=27160&docid=207396
- Decree 96/2023/ND-CP — https://vanban.chinhphu.vn/?pageid=27160&docid=209491
- Penal Code Article 288 — https://thuvienphapluat.vn/hoi-dap-phap-luat/dieu-288-bo-luat-hinh-su-quy-dinh-ve-toi-dua-hoac-su-dung-trai-phep-thong-tin-mang-may-tinh-mang-vi-138065165.html
Sectoral guidance:
- Ministry of Public Security — sectoral notes on personal data protection — https://bocongan.gov.vn/chinh-sach-phap-luat/bai-viet/bao-ve-du-lieu-ca-nhan-trong-mot-so-hoat-dong-1754989261
- Cross-border transfer Form 09 procedural note (VDPC) — https://vdpc.vn/thu-tuc-thong-bao-danh-gia-tac-dong-chuyen-du-lieu-ca-nhan-ra-nuoc-ngoai/
- Penalty draft decree (Ministry of Public Security public consultation 2026) — https://thuvienphapluat.vn/chinh-sach-phap-luat-moi/vn/ho-tro-phap-luat/chinh-sach-moi/107459/
Operational portals:
- Ministry of Public Security / A05 — https://bocongan.gov.vn
- Ministry of Health — https://moh.gov.vn
- Medical Services Administration — https://kcb.vn
- Vietnam Social Security (health insurance — VSS) — https://baohiemxahoi.gov.vn
Medibase cross-references:
- Reference — Telemedicine — /practice/telemedicine/
- Reference — Medical Practice Licensing — /practice/practice-licensing/
- Reference — Healthcare Facility Licensing — /practice/facility-licensing/
- Reference — Drug Distribution & Retail (e-prescription pipeline) — /medicine/distribution-retail/
- Reference — Special-Control Medicines — /medicine/special-control/
Recent updates
17 April 2023 — Government issues Decree 13/2023/ND-CP, Vietnam’s first comprehensive data-protection decree (effective 1 July 2023).
12 June 2018 — National Assembly passes Law on Cybersecurity 24/2018/QH14, providing the data-localisation hook.
15 August 2022 — Government issues Decree 53/2022/ND-CP detailing data-localisation rules.
26 June 2025 — the 15th National Assembly passes Law 91/2025/QH15 at the 9th session — first dedicated primary law on personal data protection in Vietnam.
31 December 2025 — Government issues Decree 356/2025/ND-CP implementing Law 91/2025/QH15 and expressly repealing Decree 13/2023/ND-CP.
1 January 2026 — Law 91/2025/QH15 and Decree 356/2025/ND-CP enter into force. Healthcare controllers must have DPIA, DPO and breach-notification machinery in place; cross-border transfers require Form 09 filings.
Early 2026 — Ministry of Public Security publishes draft administrative-penalty decree on cybersecurity and personal data protection for public consultation .
Resources & links
Operational portals:
- Ministry of Public Security / A05 — https://bocongan.gov.vn
- Ministry of Health — https://moh.gov.vn
- Medical Services Administration — https://kcb.vn
- Vietnam Social Security (health insurance — VSS) — https://baohiemxahoi.gov.vn
Legal-text portals:
- Government Portal — legal documents — https://vanban.chinhphu.vn
- Official Gazette (online) — https://congbao.chinhphu.vn
- National Legal Portal — https://vbpl.vn
- Thu Vien Phap Luat — https://thuvienphapluat.vn
Medibase cross-references:
- Reference — Telemedicine — /practice/telemedicine/
- Reference — Medical Practice Licensing — /practice/practice-licensing/
- Reference — Healthcare Facility Licensing — /practice/facility-licensing/
- Reference — Drug Distribution & Retail — /medicine/distribution-retail/
- Reference — Special-Control Medicines — /medicine/special-control/
- Reference — Clinical Trials & BE — /medicine/clinical-trials-be/
Legal basis
- 124/2021/ND-CP — Amending Decree 117/2020 on health-sector administrative penalties
- 117/2020/ND-CP — Administrative penalties in the health sector
- 96/2023/ND-CP — Second amendment of Decree 98/2021 on the management of medical devices
- 15/2023/QH15 — Law on Medical Examination and Treatment
- 11/2025/TT-BYT
- 18/2026/TT-BYT — Rules on narcotic, psychotropic, precursor and radioactive medicines
- 02/2018/TT-BYT — On Good Pharmacy Practice for drug retail establishments
- 13/2023/ND-CP
- 53/2022/ND-CP
- 91/2025/QH15
- 356/2025/ND-CP
- 15/2020/ND-CP
Frequently asked questions
- What changed for healthcare on 1 January 2026?
Law 91/2025/QH15 (the Personal Data Protection Law) and Decree 356/2025/ND-CP entered into force, replacing the prior Decree 13/2023/ND-CP. Healthcare controllers — telemedicine platforms, EMR operators, e-prescription pharmacies, drug-traceability operators, health-insurance data processors and clinical-trial sponsors — must have DPIA, DPO and breach-notification machinery in place because health data is classified as sensitive personal data.
- Is health data sensitive personal data?
Yes. The 2025 Law and Decree 356 classify health data — including biometric and genetic data — as sensitive personal data, requiring specific informed consent and an express advance notice to the subject that the data is sensitive.
- When must I file a DPIA?
Within 60 days of starting the processing, with A05 of Ministry of Public Security. The DPIA must be updated when material changes occur.
- Do I have to appoint a DPO?
Yes. Organisations processing sensitive personal data are required to designate a personal-data protection officer or team; healthcare is in scope by default.
- Can I host telemedicine or EMR data on overseas cloud regions?
Possibly, but you must (i) file the cross-border transfer impact-assessment report with A05 within 60 days, (ii) put in place a transfer contract with protective controls in the receiving jurisdiction, and (iii) run a separate Law on Cybersecurity + Decree 53/2022 localisation assessment for in-scope online services. Foreign telemedicine platforms serving Vietnamese patients from overseas servers also fall in scope.
- How quickly must I notify a breach?
Within 72 hours to A05 of Ministry of Public Security. If the breach involves biometric or location data, also notify the affected subjects within 72 hours or as soon as possible. Records must be retained at least 5 years.
- What are the headline penalties?
Article 8 of Law 91/2025/QH15 codifies penalty caps directly in the Law: up to 10× illegal revenue for unlawful sale of personal data, up to 5 % of prior-year revenue for cross-border transfer violations, up to VND 3 billion for other violations (individuals: half the organisational cap). Criminal liability is under Penal Code Article 288.
- Does Law 91/2025/QH15 mandate data localisation?
No — localisation continues to be governed by Law on Cybersecurity 24/2018/QH14 and Decree 53/2022/ND-CP. Run that assessment in parallel to the DPIA for any in-scope online service.
- How does this interact with the e-prescription pipeline?
Circular 11/2025/TT-BYT requires pharmacy software to connect to the national pharmacy / e-prescription system and to dispense only against the 14-character electronic prescription code. The patient identifiers and dispensing data flowing through this pipe are sensitive health data; pharmacy operators inherit DPIA, DPO and breach-notification duties.
Page changelog
2026-06-28: Initial publication. Reflects Law 91/2025/QH15 (effective 1 January 2026), Decree 356/2025/ND-CP (implementing decree, effective 1 January 2026, replacing Decree 13/2023/ND-CP), Law on Cybersecurity 24/2018/QH14 + Decree 53/2022/ND-CP (data localisation), Penal Code Article 288 (criminal liability), Law on Medical Examination and Treatment 15/2023/QH15 Articles 69 and 112, Decree 96/2023/ND-CP Article 87, and Circular 11/2025/TT-BYT (e-prescription). Items marked await primary-source confirmation.
- Effective from:
- 2026-01-01
- Last reviewed:
- 2026-06-28
- Page updated:
- 2026-10-27