Digital Medicine in Viet Nam: Frequently Asked Questions on Definitions, Evidence, Regulation and Implementation (2026)
EVIDENCE BRIEFS
Digital Medicine in Viet Nam: Frequently Asked Questions on Definitions, Evidence, Regulation and Implementation (2026)
Last reviewed: 23 September 2026
Digital Medicine is becoming increasingly relevant in Viet Nam as healthcare organizations expand their use of electronic medical records, connected technologies, artificial intelligence, remote care and other digital tools. At the same time, the regulatory environment has changed substantially. New laws governing artificial intelligence, personal data protection, cybersecurity and digital transformation are now in effect alongside existing healthcare, health-data and medical-device regulations.
This creates understandable questions for hospitals, clinics, healthcare professionals, researchers and health technology companies. What exactly is Digital Medicine? How is it different from digital health? What evidence should be required before adopting a technology? When might software or artificial intelligence be considered a medical device? What does Viet Nam’s new AI framework mean for healthcare? And what should an organization actually do before introducing a technology into clinical practice?
The following frequently asked questions provide a practical overview of these issues as of September 2026. They are intended to clarify concepts and support responsible decision-making rather than replace product-specific legal, regulatory or clinical assessment.
Definitions and scope
1. What is Digital Medicine?
Digital Medicine describes a field concerned with the use of digital technologies as tools for measurement, intervention and enhancing human health. The Digital Medicine Society describes its products as being driven by hardware, software and, increasingly, artificial intelligence that can support medicine broadly, including treatment, recovery, disease prevention and health promotion. As a discipline, Digital Medicine also places strong emphasis on evidence generation and the responsible use of these technologies.[1]
This emphasis on evidence is important. A technology does not become meaningful in healthcare simply because it is digital, innovative or technically sophisticated. The more useful questions are whether it measures or intervenes reliably, whether its intended use is clearly defined, whether appropriate evidence supports that use and whether it can be integrated safely and effectively into real healthcare practice.
2. How is Digital Medicine different from digital health?
Digital health is the broader concept. It can include electronic medical records, hospital information systems, patient portals, telemedicine, mobile health applications, administrative systems, connected devices, artificial intelligence, digital public infrastructure and many other uses of technology across health and healthcare.
Digital Medicine is more focused on evidence-based technologies used to measure and/or intervene in the service of human health. The Evidence DEFINED framework, for example, describes Digital Medicine products as evidence-based software and/or hardware products that measure and/or intervene in human health.[2]
The distinction is useful, but it should not be treated as a rigid legal boundary. In Viet Nam, “Digital Medicine” is not currently a statutory product classification. A product described professionally as Digital Medicine may legally fall under one or several different regulatory frameworks depending on its intended use and characteristics.
3. Is Digital Medicine the same as digital therapeutics?
No. Digital therapeutics are a more specific category. They deliver evidence-based therapeutic interventions intended to prevent, manage or treat a medical disorder or disease. Digital Medicine is broader and can also include digital measurement products, monitoring technologies, clinical decision-support tools and other evidence-based technologies that do not themselves deliver a therapeutic intervention.[2]
A connected technology that measures a physiological parameter, for example, may be part of Digital Medicine without being a digital therapeutic. Likewise, software that assists a clinician in detecting or interpreting an abnormality may support clinical decision-making without directly delivering treatment.
4. Are healthcare AI, wearable devices and health apps automatically Digital Medicine?
Not necessarily. The technology alone does not determine whether something should be considered Digital Medicine. A wearable used primarily for general fitness tracking may sit within the broader digital health or consumer wellness space, while a sensor validated for a defined clinical measurement and integrated into healthcare decision-making may play a Digital Medicine role.
The same principle applies to artificial intelligence and mobile applications. An AI tool used to schedule appointments is very different from an AI system that analyzes clinical images or contributes to treatment decisions. The relevant factors are intended use, the nature of the measurement or intervention, the supporting evidence and how the output is actually used in healthcare.
5. Are electronic medical records and telemedicine Digital Medicine?
Electronic medical records and telemedicine are better understood primarily as parts of the broader digital health environment, although both can enable Digital Medicine.
Electronic medical records provide important infrastructure for clinical care, information exchange, monitoring and evaluation. Viet Nam is continuing to expand their implementation under Circular 13/2025/TT-BYT and the Ministry of Health’s 2026–2030 plan, which aims for healthcare facilities nationwide to implement electronic medical records without maintaining paper medical records by 2030.[3,4]
Telemedicine is similarly a mode or channel of healthcare delivery rather than automatically a Digital Medicine intervention. Viet Nam’s Law on Medical Examination and Treatment recognizes remote medical examination and treatment, while Circular 30/2023/TT-BYT prescribes the list of diseases and medical conditions eligible for remote medical examination and treatment.[5,6] A Digital Medicine component may be embedded within that care model, such as a validated connected blood-pressure monitor, a remote cardiac monitoring system or an algorithm designed to identify deterioration.
Evidence and evaluation
6. Why does evidence matter so much in Digital Medicine?
Technical performance is not the same as clinical value. A technology may successfully process an image, detect a signal or generate a prediction and still fail to improve healthcare. The measurement may not be sufficiently reliable in the intended population, clinicians may misunderstand the output, false positives may create unnecessary testing, false negatives may delay care, or workflow disruption may offset expected efficiencies. Performance may also change when a system encounters different equipment, patient populations or clinical environments.
Digital Medicine therefore requires organizations to look beyond whether a technology technically “works” and ask whether sufficient evidence supports its reliability, safety, clinical relevance and value for the particular way it is intended to be used. The Evidence DEFINED framework was developed to support more systematic and rigorous assessment of evidence for digital health interventions.[2]
7. What evidence should a healthcare organization ask for?
There is no single evidence package appropriate for every technology. Evidence should be proportionate to the product’s intended use, claims and potential consequences of failure.
Depending on the technology, an organization may need to consider technical or analytical performance, clinical validity, clinical effectiveness, safety, usability and human factors, performance across relevant patient groups, cybersecurity, workflow impact and real-world implementation outcomes. For artificial intelligence, additional considerations can include the characteristics of development and validation datasets, external validation, handling of missing or poor-quality data, performance after deployment, software or model updates and performance across clinically relevant subgroups.
An accuracy figure in a sales presentation is therefore rarely sufficient by itself. Decision-makers need to understand what was measured, in whom, under what conditions, against what reference standard and how closely those conditions resemble the intended use environment.
8. Does every Digital Medicine technology require a randomized controlled trial?
No. Requiring the same study design for every Digital Medicine technology would be neither practical nor scientifically appropriate. A relatively low-consequence digital measurement tool does not necessarily require the same evidence as software influencing cancer detection, medication dosing or treatment selection. Technologies used only for administrative purposes may fall outside Digital Medicine altogether.
Randomized controlled trials may be appropriate when causal evidence of clinical effectiveness is important, but other study designs can also provide valuable evidence depending on the technology and the question being asked. The underlying principle is proportionality: the greater a technology’s influence on clinical decisions and the greater the potential consequences if it performs incorrectly, the stronger the evidence and controls that should generally be expected.
9. Is regulatory approval in another country enough to adopt a technology in Viet Nam?
No. Authorization, registration or regulatory clearance in another jurisdiction can provide important information about a product, but it does not automatically establish legal compliance or implementation readiness in Viet Nam.
A healthcare organization still needs to understand the product’s intended use, applicable Vietnamese regulatory pathway, data-processing arrangements, supporting evidence and compatibility with local clinical workflows. Population characteristics, disease prevalence, language, equipment, clinical practices and data quality can also influence real-world performance.
International regulatory status should therefore be treated as an important input into evaluation, not as a substitute for Vietnamese regulatory assessment and implementation governance.
10. Does every technology need to be clinically validated in Viet Nam before it can be used?
There is no universal rule requiring every Digital Medicine product to undergo a new Vietnamese clinical validation study simply because it is introduced into Viet Nam. Legal requirements depend on the specific product, its claims, regulatory classification, intended use and applicable pathway.
However, legal permission and evidentiary confidence are different questions. Even when a new local clinical study is not legally required, healthcare organizations may still need to determine whether evidence generated elsewhere is applicable to their own patients, equipment and workflows. For higher-consequence applications, a controlled local evaluation, prospective pilot or structured post-implementation study may be appropriate before wider deployment.
Viet Nam is already beginning to generate this type of evidence. A 2024 narrative review described several locally developed AI applications in gastrointestinal endoscopy and reported preliminary research dating from 2019.[23] More recently, a 2026 single-center before-and-after study involving 2,329 patients at University Medical Center Ho Chi Minh City found a modest improvement in overall gastric lesion detection and in the detection of lesions measuring 5 mm or smaller after the introduction of real-time AI assistance, together with a reduction in biopsy rates.[24] These findings are useful, but the study design and single-center setting also illustrate why results from one implementation should not automatically be generalized to the entire Vietnamese health system.
Regulation in Viet Nam
11. Does Viet Nam have a specific Digital Medicine law?
No. There is currently no single Vietnamese law regulating “Digital Medicine” as one unified legal category.
Digital Medicine technologies are regulated according to their actual functions, claims, data processing and implementation context. A single product may potentially involve healthcare regulation, medical-device regulation, artificial intelligence law, personal data protection, health-data rules, cybersecurity requirements and other legislation.
Regulatory assessment should therefore begin with a product’s intended use and actual function, rather than the commercial label used to describe it.
12. What are the main Vietnamese laws and regulations relevant to Digital Medicine in 2026?
The applicable framework depends on the product and use case, but several instruments are particularly relevant. These include the Law on Medical Examination and Treatment No. 15/2023/QH15 and relevant Ministry of Health regulations; the Data Law No. 60/2024/QH15 and Decree 102/2025/NĐ-CP on health-data management; the Law on Personal Data Protection No. 91/2025/QH15 and Decree 356/2025/NĐ-CP; the Law on Artificial Intelligence No. 134/2025/QH15 and Decree 142/2026/NĐ-CP; the Law on Cybersecurity No. 116/2025/QH15 and its implementing framework; and the Law on Digital Transformation No. 148/2025/QH15 together with Decree 224/2026/NĐ-CP.[5,7–19]
The cybersecurity framework became more detailed in August 2026. Decree 331/2026/NĐ-CP regulates cybersecurity protection for information systems, while Decree 333/2026/NĐ-CP provides details and implementation measures under the Cybersecurity Law. Decree 330/2026/NĐ-CP, also effective from 19 August 2026, establishes administrative penalties in the fields of cybersecurity and personal data protection.[15–17]
Where a technology meets the definition of a medical device, Decree 98/2021/NĐ-CP on medical-device management, as amended, and relevant Ministry of Health regulations also become important. Circular 24/2026/TT-BYT, effective from 1 July 2026, addresses risk determination and management measures for products and goods that are medical devices.[20,21]
This framework is not exhaustive, and not every instrument will apply to every product. Digital Medicine regulation therefore needs to be assessed according to the specific technology, intended use and implementation context rather than through a single generic checklist.
13. Can software or artificial intelligence be considered a medical device in Viet Nam?
Yes, depending on its intended use and characteristics. Decree 98/2021/NĐ-CP expressly includes software within the definition of a medical device when it satisfies the relevant criteria and is intended for specified medical purposes such as diagnosis, prevention, monitoring, treatment or alleviation of disease, among other purposes.[20]
This does not mean that every health application or AI system is automatically a medical device. A scheduling application, an administrative chatbot and software analyzing diagnostic images may all use software or AI, but they perform fundamentally different functions and may follow different regulatory pathways.
There is also an important distinction in Decree 98 between software that itself meets the definition of a medical device and software used for medical devices. The latter is specifically exempted from certain requirements under the Decree, including provisions on classification, circulation numbers and declaration of eligibility for trading.[20] That exemption should not be interpreted as meaning that all standalone medical software is outside the medical-device framework. Classification needs to be based on the software’s intended purpose, functionality and product configuration.
14. How does Viet Nam’s new AI Law affect healthcare AI?
The Law on Artificial Intelligence No. 134/2025/QH15 took effect on 1 March 2026, followed by Decree 142/2026/NĐ-CP on 1 May 2026. Together, they establish a risk-based framework for AI development, provision, deployment and use.[11,12]
Decision 33/2026/QĐ-TTg, effective from 15 August 2026, established the current official list of high-risk AI systems. In healthcare, the list is presently relatively narrow and contains two entries concerning AI-assisted surgery and surgical robotic systems under specified conditions. These include systems integrated into robots that directly participate in interventions or guide procedures, as well as specified systems that directly execute therapeutic actions without healthcare personnel confirming each change in parameters.[13]
Decision 33 also contains transitional provisions for high-risk systems already operating or introduced during the initial implementation period. Organizations using systems that may fall within the formal high-risk categories should therefore review the applicable compliance timetable rather than assume that existing use is automatically exempt.
15. If a healthcare AI system is not on the current high-risk list, does that mean it is low risk?
No. This is an important distinction. Decision 33 establishes a formal legal list of high-risk AI systems for purposes of the AI regulatory framework. It should not be interpreted as a comprehensive clinical-risk classification of every possible healthcare AI application.
An AI system that supports endoscopy, imaging interpretation, deterioration prediction or diagnostic reasoning may not fall within the two healthcare entries currently listed, but its real-world clinical consequences can still be significant. It may also remain subject to other parts of the AI framework, healthcare law, medical-device regulation where applicable, personal data protection, cybersecurity requirements and professional responsibilities.
Decision 33 also makes clear that using AI does not remove or transfer the legal authority and responsibilities of competent organizations and individuals and that human supervision, control and the ability to intervene must be maintained.[13] Healthcare organizations therefore still need their own clinical and organizational risk assessment, even when a system does not appear on the formal high-risk list.
16. How is personal health information regulated?
The Law on Personal Data Protection No. 91/2025/QH15 took effect on 1 January 2026 together with Decree 356/2025/NĐ-CP.[9,10] Article 26 of the Law specifically addresses personal data relating to health information and insurance activities. Among other provisions, it requires consent for the collection and processing of personal health data except where a statutory exception under Article 19 applies. It also restricts specified disclosures by organizations and individuals operating in the health sector to third-party healthcare, health-insurance and life-insurance providers, and requires organizations and individuals developing health applications to comply with personal data protection requirements.[9]
Health-data governance therefore involves considerably more than adding a consent box or privacy notice to an application. Organizations need to understand what data they collect, why they need them, the applicable legal basis and processing purpose, who can access the information, how long it is retained, how it is protected, whether it is shared and what happens when information is reused for another purpose.
Cross-border arrangements also require attention. Decree 356 provides a more detailed implementation framework under the Personal Data Protection Law, including requirements relevant to personal-data protection impact assessment and cross-border data transfers.[10] For healthcare organizations using overseas cloud services, international technology vendors or multinational research arrangements, these questions should be considered at the design stage rather than after implementation.
17. Can a hospital use existing patient data to train an AI model simply because the data are already in its system?
A hospital should not assume that it can. Data originally collected for clinical care may later be valuable for research, algorithm development, quality improvement or commercial product development, but the existence of those data does not by itself resolve the legal or ethical questions surrounding secondary use.
The organization needs to identify the new purpose, applicable legal basis, consent requirements or statutory exceptions where relevant, personal-data protection obligations, research-governance requirements, contractual arrangements, access controls and cybersecurity safeguards. Responsibilities between the healthcare organization, technology developer, research partner and any other party receiving or processing the data also need to be defined.
De-identification can materially affect the legal analysis. The Personal Data Protection Law provides that personal data are no longer personal data after they have been de-identified so that they no longer identify or help identify a specific individual.[9] Whether a dataset has actually reached that threshold requires careful technical and legal assessment. Simply removing a patient’s name or replacing a direct identifier should not automatically be assumed to constitute effective de-identification.
18. Who is responsible when artificial intelligence is used in healthcare?
Artificial intelligence should not be treated as an independent transfer of clinical or organizational responsibility. Decision 33 states that the use of AI does not alter, transfer or exclude the authority and responsibilities of competent organizations and individuals and requires human supervision, control and the ability to intervene.[13]
For healthcare organizations, this means responsibilities should be defined before implementation. Who is the clinical owner of the system? Who reviews its output? When may the output be ignored or overridden? Who responds when the technology fails? Who reviews incidents? Who authorizes software updates or changes in intended use? Who is responsible for vendor oversight and ongoing performance monitoring?
“Human in the loop” should therefore mean more than simply having a clinician somewhere in the process. Meaningful human oversight requires clear authority, sufficient information, appropriate training and a practical ability to challenge, override or stop the system when necessary.
Implementation in Viet Nam
19. Is Viet Nam ready for Digital Medicine?
There is no useful single yes-or-no answer. Viet Nam’s digital foundation has become substantially stronger. Electronic medical records are expanding, the Ministry of Health maintains a national electronic medical record implementation platform, and Decision 965/QĐ-BYT sets the goal of electronic medical records without paper medical records across healthcare facilities nationwide by 2030.[4] Viet Nam also now has much more developed legal frameworks governing health data, personal data protection, artificial intelligence, cybersecurity and digital transformation.
Implementation maturity, however, remains uneven. A 2025 cross-sectional assessment of five major Vietnamese public hospitals found widespread adoption of hospital, laboratory and radiology information systems but variable maturity in electronic medical records, clinical data repositories and clinical decision support. None of the hospitals in the study reported sharing clinical data with other organizations using Health Level Seven standards, although two reported that their systems had adopted those standards internally.[22]
The sample was small and should not be interpreted as a national estimate of current digital maturity. It also preceded some of the major implementation efforts during 2025 and 2026. Nevertheless, it illustrates an important point: having digital systems is not the same as having interoperable, implementation-ready infrastructure. Readiness is therefore more usefully assessed at the level of the specific organization and specific use case.
20. Which Digital Medicine applications appear most practical in Viet Nam today?
Under current conditions, Digital Medicine applications that augment existing healthcare while maintaining meaningful professional oversight may be more practical to integrate responsibly than technologies designed to replace professional decision-making entirely.
Examples may include validated digital measurement technologies, clinician-supervised remote monitoring, AI used as a second reader or decision-support tool, digital systems supporting follow-up and continuity of care, and technologies that help healthcare organizations identify risk or variation while keeping final decisions within an appropriate clinical workflow.
This does not mean that these technologies are inherently safe. Each still requires appropriate evidence, regulatory assessment, data governance, workflow integration and monitoring. Higher-consequence applications, such as autonomous diagnosis or treatment, automated changes to therapy or generative AI providing high-stakes clinical recommendations, deserve correspondingly stronger scrutiny.
A useful practical principle is that evidence and governance should be proportionate to the consequences if the technology is wrong.
21. What should a healthcare organization do before implementing Digital Medicine?
The most useful starting point is the healthcare problem rather than the technology. An organization should first define the need it is trying to address and the intended use of the proposed technology. It should then assess the applicable regulatory pathway, supporting evidence, intended patient population, data requirements, privacy and cybersecurity implications, interoperability, clinical workflow, human oversight, training requirements, vendor responsibilities and financial sustainability.
Before go-live, the organization should also define what success will look like and establish appropriate baseline measures so that outcomes can be compared after implementation. Depending on the intended purpose, these might include clinical outcomes, process measures, safety indicators, workload, patient experience, utilization, cost or other relevant measures.
A pilot can be valuable, but only when it is designed to answer meaningful questions. Installing a technology in a small number of patients and reporting that clinicians found it useful provides relatively limited evidence about safety, effectiveness or scalability.
22. What should be monitored after implementation?
Implementation should continue beyond go-live. Healthcare organizations need to monitor whether the system continues to perform as expected, whether clinicians use it as intended, whether unexpected errors or safety issues occur and whether the outcomes that justified adoption are actually improving.
Depending on the technology, relevant measures may include false positives and false negatives, overrides, incidents, workflow delays, patient outcomes, utilization, staff workload, patient engagement and performance across relevant subgroups. Monitoring should be linked to a defined process for escalation and corrective action rather than simply collecting data.
Artificial intelligence adds further considerations because performance can change when software or models are updated, patient populations change, equipment changes or the underlying data environment shifts. Organizations therefore need mechanisms to identify deterioration in performance, including model or data drift where relevant, and to determine when re-evaluation or additional validation is necessary.
Post-implementation monitoring is not only a safety function. It is also how an organization determines whether a technology is delivering the value that justified adopting it.
23. What should health technology companies prepare before approaching Vietnamese healthcare organizations?
A credible implementation discussion should go beyond a product demonstration, international certification or headline accuracy figure. Companies should be able to explain clearly what their technology is intended to do, what it is not intended to do, what evidence supports its claims and how it fits within the relevant Vietnamese regulatory framework.
They should also understand where data are processed and stored, whether data cross organizational or national borders, how privacy and cybersecurity are managed, how the technology integrates with hospital systems, what training is required, what responsibilities remain with clinicians and healthcare organizations, and how incidents, software updates and performance monitoring will be handled.
For technologies intended for clinical use, a credible implementation package should connect evidence, regulation, data governance, workflow, patient safety, technical integration and post-deployment monitoring. Localization should also mean more than translating an interface into Vietnamese. Clinical terminology, workflows, user behavior, data structures, patient characteristics and organizational capacity can all affect implementation.
24. What is the most important principle for Digital Medicine in Viet Nam in 2026?
The next stage should be evidence-led, risk-proportionate implementation. Viet Nam has made significant progress in building the digital and regulatory foundations needed for Digital Medicine. The challenge is increasingly shifting from whether healthcare can become more digital to whether digital technologies can be selected, governed, implemented and monitored in ways that produce measurable healthcare value.
The World Health Organization similarly emphasizes that sustainable digital health transformation requires the integration of financial, organizational, human and technological resources rather than technology alone.[25]
For healthcare organizations, this means moving away from the question, “What new technology should we adopt?” and toward a more useful sequence of questions: What healthcare problem are we trying to solve? What is the technology intended to do? What evidence supports it? What risks does it create? What regulation applies? Are we ready to implement it? And how will we know whether it actually improves care?
That is the difference between adopting digital technology and building responsible Digital Medicine.
References and further reading
Digital Medicine Society. Defining Digital Medicine.
Digital Medicine Society. Evidence DEFINED: Evidence in Digital Health for Effectiveness of Interventions with Evaluative Depth. See also Silberman J, Wicks P, Patel S, et al. Rigorous and rapid evidence assessment in digital health with the Evidence DEFINED framework. npj Digital Medicine. 2023;6:101. doi:10.1038/s41746-023-00836-5.
Ministry of Health of Viet Nam. Circular No. 13/2025/TT-BYT dated 6 June 2025, guiding implementation of electronic medical records. Effective 21 July 2025.
Ministry of Health of Viet Nam. Decision No. 965/QĐ-BYT dated 10 April 2026, approving the Plan for Implementation of Electronic Medical Records at Healthcare Facilities Nationwide for 2026–2030.
National Assembly of Viet Nam. Law on Medical Examination and Treatment No. 15/2023/QH15.
Ministry of Health of Viet Nam. Circular No. 30/2023/TT-BYT dated 30 December 2023, prescribing the list of diseases and medical conditions eligible for remote medical examination and treatment. Effective 1 January 2024.
National Assembly of Viet Nam. Law on Data No. 60/2024/QH15. Effective 1 July 2025.
Government of Viet Nam. Decree No. 102/2025/NĐ-CP dated 13 May 2025 on management of health data. Effective 1 July 2025.
National Assembly of Viet Nam. Law on Personal Data Protection No. 91/2025/QH15. Effective 1 January 2026.
Government of Viet Nam. Decree No. 356/2025/NĐ-CP dated 31 December 2025, detailing provisions and measures for implementation of the Law on Personal Data Protection. Effective 1 January 2026.
National Assembly of Viet Nam. Law on Artificial Intelligence No. 134/2025/QH15. Effective 1 March 2026.
Government of Viet Nam. Decree No. 142/2026/NĐ-CP dated 30 April 2026, detailing provisions and measures for implementation of the Law on Artificial Intelligence. Effective 1 May 2026.
Prime Minister of Viet Nam. Decision No. 33/2026/QĐ-TTg dated 30 June 2026, promulgating the List of High-Risk Artificial Intelligence Systems. Effective 15 August 2026.
National Assembly of Viet Nam. Law on Cybersecurity No. 116/2025/QH15. Effective 1 July 2026.
Government of Viet Nam. Decree No. 331/2026/NĐ-CP dated 19 August 2026 on cybersecurity protection for information systems. Effective 19 August 2026.
Government of Viet Nam. Decree No. 333/2026/NĐ-CP dated 19 August 2026, detailing a number of articles and measures for implementation of the Law on Cybersecurity. Effective 19 August 2026.
Government of Viet Nam. Decree No. 330/2026/NĐ-CP dated 19 August 2026 on administrative penalties in the fields of cybersecurity and personal data protection. Effective 19 August 2026.
National Assembly of Viet Nam. Law on Digital Transformation No. 148/2025/QH15. Effective 1 July 2026.
Government of Viet Nam. Decree No. 224/2026/NĐ-CP dated 24 June 2026, detailing provisions and measures for implementation of the Law on Digital Transformation. Effective 1 July 2026.
Government of Viet Nam. Decree No. 98/2021/NĐ-CP on medical-device management, as amended by subsequent regulations.
Ministry of Health of Viet Nam. Circular No. 24/2026/TT-BYT dated 30 June 2026 on risk determination and management measures for products and goods that are medical devices and amendments to Circular No. 05/2022/TT-BYT. Effective 1 July 2026.
Tran DM, Thanh Dung N, Minh Duc C, et al. Status of Digital Health Technology Adoption in 5 Vietnamese Hospitals: Cross-Sectional Assessment. JMIR Formative Research. 2025;9:e53483. doi:10.2196/53483.
Dao HV, Nguyen BP, Nguyen TT, et al. Application of artificial intelligence in gastrointestinal endoscopy in Vietnam: a narrative review. Therapeutic Advances in Gastrointestinal Endoscopy. 2024;17:26317745241306562. doi:10.1177/26317745241306562.
Lee H, Huynh CB, Cho S, et al. Impact of real-time artificial intelligence integration on detection of gastric lesions: an exploratory single-center before-and-after study using low-definition routine endoscopy. Clinical Endoscopy. 2026;59(3):408–416. doi:10.5946/ce.2025.272.
World Health Organization. Global Strategy on Digital Health 2020–2027. World Health Organization; 2025.
National Assembly of Viet Nam. Law No. 20/2026/QH16 dated 24 August 2026, amending and supplementing provisions of the Law on Radio Frequency, Law on Telecommunications, Law on Electronic Transactions and Law on Technology Transfer. Effective 1 March 2027.
Regulatory and educational note
This FAQ provides a general overview of Digital Medicine in Viet Nam as of 23 September 2026. “Digital Medicine” is used here as a professional and scientific concept and should not be interpreted as a standalone legal classification under Vietnamese law. The regulatory status and obligations applicable to a specific product depend on factors including its intended use, functionality, technical characteristics, data processing, claims and implementation context. A technology may fall simultaneously within healthcare, medical-device, artificial intelligence, personal data protection, health-data, cybersecurity and other regulatory frameworks. Product-specific legal and regulatory assessment should therefore be undertaken where appropriate.
The Vietnamese regulatory environment continues to evolve. For example, Law No. 20/2026/QH16 was enacted on 24 August 2026 and includes amendments to the Law on Electronic Transactions, but it does not take effect until 1 March 2027.[26] It is therefore relevant to future regulatory planning but is not treated in this FAQ as part of the legal framework currently in force on the review date.
This article is educational and does not constitute legal, regulatory or clinical advice.