Search for:
Product Regulation & Liability

Vietnam: Draft decree on medical data management

By , , and 3 Mins Read

In brief

The Ministry of Health (MOH) is drafting a decree on medical data management (“Draft Decree“) to establish a legal framework for (i) medical data management and development, (i) the establishment of the National Medical Database, and (iii) detailing the implementation of electronics health records and health books.

The Draft Decree is currently open for public consultation until 3 August 2024.

In details

  • Overview of the Draft Decree: The Draft Decree has four chapters with 29 articles. The draft currently open for public consultation is the third draft.
  • Medical data: Medical data is defined as information on medical fields, including: medical examination, treatment and rehabilitation, medical examination, forensic examination, and forensic psychiatric examination; preventive medicine; traditional medicine and pharmacy; pharmaceuticals and cosmetics; medical equipment and medical works; food safety; population and reproductive health; health insurance; environmental protection in medical activities; training of medical human resources and science and technology in the medical field.
  • National Medical Database: The National Medical Database will include, among others, (i) information on facilities established or licensed to operate in medical related fields; (ii) information on human resources in medical related fields; (iii) information on medical devices; (iv) information on pharmaceuticals; and (iv) information on personal health. The MOH will be the management agency of the National Medical Database.
  • Collecting, updating, altering, maintaining, using, connecting and sharing medical data: The Draft Decree provides the rights and obligations of state agencies, data subjects and other related organizations/individuals in collecting, updating, altering, maintaining, using, connecting and sharing medical data. Notably, relevant organizations and individuals shall be entitled to exploit and use medical data in accordance with the functions, tasks, authorizations and purposes registered with the MOH. The Draft Decree does not provide any further registration details.
  • Effective date: The Draft Decree is proposed to take effect within 2024. However, no specific date has been officially announced just yet.

In conclusion

The Draft Decree is an effort of the MOH to realize Decision No. 749/QD-TTg dated 3 June 2020 of the Prime Minister approving the “National Digital Transformation Program to 2025, with a vision to 2030”, in which the MOH was assigned to take charge of digital transformation in the medical fields, including the establishment of the National Medical Database.

We are closely monitoring its progress, and we will keep you informed of any related developments. If you have any questions or need advice on how this proposed change might impact your business, please feel free to contact us.

Categories:
Author

Hung Tran is the practice group leader of the Intellectual Property (IP) and Technology Practice Groups of Vietnam offices. For years, he has been constantly ranked as a leading IP lawyer by numerous researchers such as Chambers Global and Chambers Asia.
He regularly writes articles concerning pressing legal issues in both English and Vietnamese, and his works have been published regularly in various reputable publications. He has assisted the government in reviewing and revising the IP Law, the IP provisions under the country’s criminal code, the draft e-Transaction Law, and the first draft Personal Data Protection Decree, etc.
He is also a respected presenter in the area of IP, Franchising, Data Privacy, and Entertainment Laws. In addition to authoring many publications, Mr. Tran has lectured at Waseda University School of Law (Japan), Vietnam-German University, Hanoi Law University, Diplomatic Academy of Vietnam, Foreign Trade University, an international MBA Program (CFVG) and IP laws for the Professional Training School of the Ministry of Industry and Trade. He used to serve as the Chairman of the Legal Committee of Hanoi American Chamber of Commerce.

Author

Minh Tan Dang is an Associate in Baker McKenzie, Ho Chi Minh City office.

Author

Huu Tuan Nguyen is an Associate in BMVN International LLC, Ho Chi Minh City office.

Author

Tuan Linh Nguyen is a Government Affairs Manager in in BMVN International LLC, Hanoi office.

Related Posts

Write A Comment