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Decree 96/2023/ND-CP guiding the Law on Medical Examination and Treatment

On December 30, 2023, the Government issued Decree 96/2023/ND-CP to update detailed regulations on several articles in the Law on Medical Examination and Treatment 2023 and amend some contents of Decree 98 /2021/ND-CP on medical equipment management. Viet An Law Firm will present the outstanding new features of Decree 96/2023/ND-CP in the article below.

Basic information about Decree 96/2023/ND-CP guiding the Law on Medical Examination and Treatment

  • Date of issue: December 30, 2023
  • Effective date: January 1, 2024.
  • Issuing agency: Government.
  • Signed by: Tran Hong Ha.

Highlights in Decree 96/2023/ND-CP guiding the Law on Medical Examination and Treatment

Scope of regulation of Decree 96/2023/ND-CP

The Decree details several articles of the Law on Medical Examination and Treatment regarding:

  • Issuing licenses to practice medical examination and treatment;
  • Issuing licenses for medical examination and treatment activities;
  • Applying new techniques, new methods, and clinical trials in medical examination and treatment;
  • Management of medical equipment at medical examination and treatment facilities;
  • Mobilizing and mobilizing medical examination and treatment facilities to participate in medical examination and treatment activities in case of natural disasters, catastrophes, group A infectious diseases and emergencies;
  • Conditions to ensure medical examination and treatment activities;
  • Guidance on regulations on implementation roadmap; Transitional regulations related to professional licenses and operating licenses.

Regarding time and practice content for granting medical examination and treatment practice licenses

A new point in this Decree is to change the form of granting a “practicing certificate” to a “practicing license” for medical examination and treatment. Conditions for granting practice licenses corresponding to each title of doctor, nurse, etc. are specified in Article 8.

In Article 3 of Decree 96/2023/ND-CP, the regulations on time as a condition for granting a practice license have changed compared to the provisions in Article 24 of the Law on Medical Examination and Treatment 2009, which shortens the practice time as follows:

Title Law on Medical Examination and Treatment 2009 Decree 96/2023/ND-CP
Doctor 18 months 12 months
Medico 12 months 09 months
Midwives 09 months 06 months
Nursing 09 months 06 months

Also in Article 3, Decree 96 has added the medical examination and treatment practice time of new positions such as 6 months for the clinical nutritionist position,  6 months for the outpatient emergency paramedic position, and 9 months for clinical psychology positions.

Regarding dossiers and procedures for granting new practice licenses

Documents for new issuance, re-issuance, extension, and adjustment of professional licenses in this Decree are also reduced and simplified, in which, criminal records have been removed from the dossier, replacing personal records with a self-narrative curriculum vitae without confirmation by the commune-level People’s Committee.

In Article 14, for professional titles such as doctor, nurse, midwife, medical technician, clinical nutritionist, outpatient paramedic, and clinical psychologist, the application file for a new grant requires a practice license in the case of a person applying for a practice license for the first time as prescribed in Point a, Clause 1, Article 30 of the Law on Medical Examination and Treatment and in the cases specified in Point dd, Clause 1, Article 13 of this Decree including:

  • Application according to Form 08, Appendix I issued with Decree 96/2023/ND-CP;
  • Original or valid copy of one of the following documents:
  • Written confirmation of successful results in the examination to assess the capacity to practice medical examination and treatment;
  • The practice license has been recognized according to the provisions of Article 37 of Decree 96/2023/ND-CP.
  • Original or valid copy of health certificate issued by a qualified medical examination and treatment facility or valid copy of work permit in cases where a work permit is required according to the provisions of the Labor Code;
  • Curriculum vitae of the practitioner according to Form 09, Appendix I issued with Decree 96/2023/ND-CP;
  • 02 portrait photos size 04cm x 06 cm, taken on a white background within no more than 06 months up to the time of applying for a new practice license;
  • Valid copies of one or more of the following documents for the cases specified in Point a, Clause 6, Article 10 of Decree 96/2023/ND-CP:
  • Certificate of herbal medicine;
  • Certificate of traditional medicine;
  • Certificate of traditional healing method.

Regarding licensing conditions for medical examination and treatment facilities

An amendment and supplement to Decree 96/2023/ND-CP compared to Decree 109/2016/ND-CP regulating the issuance of practice certificates to practitioners and operating licenses for medical examination and treatment facilities, as amended and supplemented by Decree 155/2018/ND-CP on general conditions of medical examination and treatment facilities are shown in the following table:

Criteria Decree 96/2023/ND-CP Decree 109/2016/ND-CP
Infrastructure Have a fixed location that meets the provisions of law on load-bearing safety, fire prevention and fighting, infection control, environmental protection, and radiation safety (if any); b Ensure adequate electricity and water to serve the operations of medical examination and treatment facilities. There are signs, diagrams, and signs leading to faculties, departments, and professional and administrative departments. Have a fixed location (except for mobile medical examination and treatment organizations). Ensure radiation and room safety conditions during fire fighting according to the provisions of the law. A sterilization area must be arranged to process reused medical instruments, except in cases where there are no instruments that need to be re-sterilized or there is a contract with another medical facility to sterilize the instruments.
Medical equipment Have medical equipment consistent with the list of technical expertise and scope of registered activities. There is enough medical equipment suitable to the scope of professional activities of the facility.
Organization

Personnel

There must be enough clinical and paraclinical examination departments, human resources, and necessary medical equipment to examine and detect health status according to health standards and a health examination form is issued along with the requirements. Medical examination guidance document. Each medical examination and treatment facility must have a person responsible for technical expertise. In addition to the person responsible for the technical expertise of the medical examination and treatment facility, he or she must have a practicing certificate and may only perform medical examination and treatment within the scope of assigned work.
Health examination facility There are enough clinical and paraclinical examination departments, human resources, and medical equipment necessary to examine and detect health status according to health standards and a health examination form is issued along with the requirements. written instructions for health examination;

 

Has been granted an operating license according to the provisions of law. There must be enough clinical and paraclinical examination departments, human resources, and necessary medical equipment to examine and detect health status according to health standards and a health examination form is issued along with the requirements. Written instructions for health examination according to the provisions of law.

Regarding conditions for remote medical examination and treatment

Conditions for performing remote medical examination and treatment are specified in Clause 1, Article 87 of Decree 96/2023/ND-CP as follows:

  • Performed by practitioners of medical examination and treatment establishments in one of the organizational forms specified in Article 39 of this Decree;
  • Have a scope of professional activities consistent with the facility’s remote medical examination and treatment content;
  • There are enough practitioners within the facility’s scope of remote medical examination and treatment;
  • Having technical infrastructure, information technology equipment, specialized equipment, and information technology software suitable for the type of service provided and ensuring the transmission, display, processing, and storage of data is safe and secure. Ensure data storage and backup time meet legal regulations.

The scope of remote medical examination and treatment is as prescribed in Point a, Clause 1, Article 80 of the Law on Medical Examination and Treatment. For remote medical examination and treatment, the medical examination and treatment facility must meet the conditions specified in Clause 1, Article 87 and carry out procedures for declaring eligibility to perform remote medical examination and treatment as prescribed in Clause 2, Clause 3, Article 87 of this Decree. In case of piloting remote medical examination and treatment for diseases and conditions that are not on the prescribed list, it must be submitted to the operating licensing agency for consideration and approval.

Regarding the process that allows the application of new techniques

Decree 96/2023/ND-CP also regulates the order related to the application of new techniques and new methods in medical examination and treatment according to the Law on Medical Examination and Treatment 2023, specifically in Article 96 as follows :

Step 1. When some techniques or methods are not included in the list of technical expertise issued by the Minister of Health, the medical examination and treatment facility applies to identify new techniques and methods for the Ministry of Health.

Step 2. After receiving the dossier, the Ministry of Health returns to the facility requesting the determination of new techniques and new methods in the dossier receipt form according to Form 0 2 Appendix I of this Decree.

Step 3. In case there is no request to amend or supplement the dossier, the dossier-receiving agency will respond in writing within 30 days from the date recorded on the dossier receipt, which must clearly state the new technique or new method that the establishment proposes to identify falls into one of the following cases:

  • New techniques and new methods must be clinically tested;
  • New techniques and new methods do not require clinical trials but must be piloted;
  • New techniques and new methods are not subject to clinical trials and do not have to be piloted.

Step 4. Within 60 days from the date of receipt of the documents specified in Point c, Clause 4 of this Article, the Ministry of Health is responsible for approving the technical process of new techniques and new methods; Approving economic and technical norms of new techniques and new methods; Approve prices of new techniques and new methods; Classification of new techniques, new methods; Issue documents allowing medical examination and treatment facilities to implement new techniques and new methods.

Step 5. After the Ministry of Health has approved the technical process and technical classification, other medical examination and treatment facilities must follow the following process:

  • For techniques belonging to the special category of techniques:
  • Prepare documents requesting pilot implementation;
  • After completing the pilot, prepare a dossier requesting official approval.
  • For techniques not included in the list of special techniques: comply with the procedure for adjusting the scope of operation of medical examination and treatment facilities according to the provisions of this Decree.

Clients who need advice on legal regulations on medical examination and treatment, civil law, criminal law, and related amended decrees, please contact Viet An Law Firm for the best support.

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