The NHIA is actively promoting digital transformation. The introduction of the FHIR format will help integrate patient data from screening to diagnosis, treatment, and follow-up. The NHIA hopes that combining structured patient data with the FHIR format will support the development of smart preview mechanisms, shorten patients’ waiting time for access to medicines, and accelerate the overall treatment process.

In Taiwan, the NHIA is responsible for granting prior approval for the use of cancer drugs. The purpose of this process is to ensure the appropriate use of expensive medications, especially new drugs and targeted therapies, and to support the effective allocation of NHI resources.

Dr. Chen Liang-Yu, Director-General of the NHIA, noted that Taiwan’s NHI digital governance is internationally recognized. The NHIA introduced NHI cards in 2004 and launched cloud-based medication records in 2013.

In 2025, the NHIA introduced the FHIR format into the prior-approval process for cancer drug uses, shortening the review time to just one day. So far, 69 hospitals have implemented the FHIR format, and more than 20 of them have already begun making digital submissions. 

For certain expensive cancer drugs with complicated reimbursement conditions, the NHIA requires prior approval for their use. Only uses that receive approval are eligible for NHIA reimbursement.

Hospitals help patients submit the required evidence, such as the patient’s condition, diagnosis, gene test reports, and other relevant information, to the NHIA for approval. This process used to rely on paper-based submissions.

As part of the NHIA’s digital transformation efforts, the FHIR format has been introduced to shorten the review time from one or two weeks to just one day. So far, many hospitals have joined this initiative, which helps accelerate patients’ access to needed medications.

The Pharmaceutical Benefit and Reimbursement Scheme (PBRS) clearly specifies the conditions under which prior approval is required, as well as the reimbursement criteria, for example, PD-L1 expression levels, specific gene variants, and other clinical indicators.

The NHIA also grants certain qualified hospitals the authority to conduct autonomous prior reviews for selected cancer drug cases, in order to speed up the internal review process.

Taiwan already has a well-established cloud-based NHI system and continues to improve its data structures. For example, the NHIA has launched new functions for graphical queries of test results and lung cancer screening results, and it has introduced an AI-assisted interface for reviewing and querying imaging reports. These advancements support clinical decision-making and enhance the integration of patient treatment and care.

Dr. Chen Liang-Yu noted that, as of October, about 25% of prior approval submissions were made using the FHIR format. She expects that by the end of next year, the FHIR format will be implemented in all medical centers. Looking ahead, she hopes that regional and district hospitals will follow suit, promoting the sharing of patient records across hospitals and enhancing the safety and quality of care.

【2025-12-02 /HEHO News】