The Executive Yuan today (May 15) approved the draft of the "National Health Insurance Data Management Act", proposed by the Ministry of Health and Welfare (MOHW), and will submit it to the Legislative Yuan for deliberation. The National Health Insurance (NHI) data covers comprehensive health information of all citizens and is highly beneficial for policy-making and pharmaceutical development. The government aims to promote the reasonable use of NHI data on the foundation of protecting personal data privacy, in order to enhance public health and well-being.

According to the MOHW, following the Constitutional Court’s Judgment No. 13 in 2022, this draft has gone through collaborative efforts from administrative agencies, legal experts, and stakeholders. It is designed to fulfill the constitutional requirements by enhancing personal information protection while balancing the need to improve medical quality, public health, social welfare, and academic research. This dedicated law establishes mechanisms for the use and management of NHI data, marking a new milestone in institutionalizing health data governance and building public trust in Taiwan.

The draft establishes organizational and procedural oversight mechanisms for the use and management of NHI data beyond its originally collected purposes. It clearly defines the eligibility, purposes, and review procedures for data access applications to ensure reasonable and secure use of the data. A strict supervisory framework will be set up, including the creation of a National Health Insurance Data Advisory Council to enhance data security during database construction, management, and transmission processes. Additionally, the draft introduces a withdrawal mechanism, granting individuals the right to request cessation of non-original-purpose data use, with exceptions clearly outlined to safeguard personal autonomy over data.

The draft Act consists of 27 articles, with the key points as follows:

1. Legislative purpose, competent authority, and definitions (Articles 1 to 3)

2. Formation of the NHI Data Advisory Council, along with its tasks and composition (Articles 4 and 5)

3. Construction, management, evaluation of relevant databases, and methods for data transmission by insurers to the competent authority (Article 6)

4. Authorities responsible for managing the use of data beyond its original purpose, and provisions for outsourcing to professional institutions or legal entities (Article 7)

5. Restrictions on usage purposes, applicant qualifications, application procedures, and appeals for non-official applicants dissatisfied with review results (Articles 8 to 12)

6. Execution procedures after application approval; competent authority and insurers must establish secure operating environments (Article 13)

7. Regulations on the outcomes derived from using NHI data (Article 14)

8. Benefit-sharing mechanisms for industry gains resulting from data use (Article 15)

9. Subjects, reasons, procedures, and effects related to requests to stop using personal NHI data, including exceptions (Articles 16 to 19)

10. Penalties for violations of the Act (Articles 20 to 24)

11. Transitional provisions for previously approved data uses to continue under the new law (Article 25)

The MOHW emphasized that in response to population aging, increasing chronic disease burden, and healthcare financing challenges, it is essential to not only protect personal data privacy and autonomy but also recognize the public value of data sharing. By enacting a dedicated law, Taiwan aims to establish a comprehensive legal framework for the use and management of NHI data, enhancing its effectiveness and value. The MOHW calls on all sectors to support this initiative for mutual benefit.