On February 8th, 2023, our Director of Public Affairs, Van Nguyen, joined the “Health Talk – Data Management in the Health Sector” organized by CCI France Vietnam – CCIFV and the EuroCham Vietnam Digital Sector Committee to discuss health regulation and policy in Vietnam.
Vietnam is a rapidly growing market in the health sector, with primary digital health segments comprising Health Information Technology, Telemedicine, Consumer Health Electronics, and Healthcare Big Data & AI-based products and services.
The government is taking active steps to streamline healthcare administration, promote accessible and affordable healthcare services, and digitize medical records and health information. In 2021, the Ministry of Health (MOH) proposed a Draft Decree on the national medical database (electronic medical records, electronic health records, and other health information). However, Circular 46/2018/TT-BYT, which prescribed electronic medical records, is outdated and no longer fits with the government’s vision for digitalizing the health sector.
The Ministry of Information and Communications (MIC) enacted The Law on Cyber Information Security 2015 to protect personal data and online activities. The Ministry of Public Security (MPS) The Law on Cybersecurity 2018 was passed and came into effect on January 1st, 2019. The Draft Law on Digital Technology Industry by MIC will be presented to the National Assembly for further review in 2023, and Decree 53/2022/ND-CP, which implements the Law on Cybersecurity 2018 by MPS, has been in effect since October 1st, 2022. Additionally, the Ministry of Public Security proposes to upgrade the Draft Decree on Personal Data Protection (PDP) into an official law.
The policy roadmap for medical data management outlines a series of milestones to achieve the complete digitization of health data. By 2028, all healthcare establishments will have completed the system for electronic medical records (Circular 46). Between 2019 and 2023, Category-1 healthcare establishments are required to upgrade their IT infrastructure to meet the conditions for the deployment of electronic medical records.
Integrating electronic health information with the national population database is coordinated by MOH and MPS under the Prime Minister’s Decision 06/2022/QD-TTg. The government is promoting digital health platforms as part of the national digital transformation and promulgating telemedicine to expand healthcare coverage.
Despite the progress made in medical regulation, some regulatory challenges still need to be addressed. These include patient rights to privacy and confidentiality, the legal basis for data sharing and processing, ownership and access to the National Medical Database, the classification of health-related personal data, and the number of government stakeholders involved.
There needs to be more consistency between health and data privacy and cybersecurity regulations, particularly regarding patient rights to confidentiality and privacy, principles of consent, and public disclosure. Pharmaceutical and healthcare technology companies are not subject to data localization regulations, except for data processors appointed to perform data processing. However, critical infrastructure gaps and a shortage of IT workers at healthcare facilities could pose barriers to the complete digitization of health data and information. MOH is setting a low priority for the national medical database. However, there is still time and opportunity to refine the legal framework and data infrastructure for a better future of data sharing.