엠디웍스코리아

New Health Technology Assessment (nHTA)

Scientifically, health technologies include not only drugs, treatment materials and internal medicinal/surgical operations used in healthcare, but also all of the organizational and supportive systems involved in the process of providing healthcare services. Health technology assessment looks not only at the safety, effectiveness and
cost effectiveness of relevant technologies but also all the social, ethical and legal effects of the technologies.
The subjects of health technology assessment in Korea are internal medicinal/surgical operations and related tests; assessment areas are divided into
safety/effectiveness assessment pursuant to the Medical Services Act and the suitability of benefits and cost-effectiveness pursuant to the National Health Insurance Act.

Conditional Approval for Evidence Development

This is the system where the Minister of Health and Welfare approves the technology - that is not recognized as a new health technology due to lack of study and\
is for disease or illness without alternative health technology, rare disease, or end-stage or severe chronic diseases with no alternative technology and needs to
enter the clinical environment hastily - at certain medical institutions to collect and analyze the outcome to produce a clinical evidence for the technology.
The health care institutions over hospital-level by Article 3 of the Medical Service Act may request for an approval, and if the technology is determined
as a ‘ conditional health technology’, the institution may use the technology as non-reimbursement item for the duration notified by the Minister of Health and
Welfare. Once the duration is over, the technology must undergo the nHTA based on the clinical evidence collected at the clinical environment.

Postponement of nHTA

This system is implemented to postpone nHTA for 2 years for earlier use of the technology at clinical environment if it uses a medical device approved by the
Ministry of Food and Drug Safety (MFDS) and meets the falling clauses.

Innovative Health Technology assessment

Other than the assessment of effectiveness through scholarly works, potential value of the emerging technology, etc. are considered, providing an opportunity
for a safe innovative health technology to be utilized in practice.
The technology may be temporarily used for 3 ~ 5 years on clinical uses if the related conditions, such as purpose and target of use, duration, treatment (examination) method, etc., are met. Once the period of use is over, nHTA is made based on the clinical evidence collected in the clinical environment to prove the effectiveness.