Exploring Taiwan’s AI Applications in Healthcare

Taiwan is globally recognised as a leader in the semiconductor industry, renowned not only for its advanced manufacturing capabilities but also for its comprehensive integrated supply chain, from design and fabrication to packaging and testing. Recently, the rapid emergence of artificial intelligence technologies, particularly those using generative AI, have triggered an unprecedented surge in demand for advanced semiconductor chips. The cutting-edge applications made possible by AI require increasingly sophisticated and high-performance chips. At present, Taiwan’s fully developed and sophisticated local supply chain gives its semiconductor industry a distinct competitive advantage over those of other regions.

Similarly, the high standards of medical care in Taiwan have earned it significant worldwide recognition in recent years. The global quality-of-life database Numbeo has ranked Taiwan number one in the world in its Health Care Index for the past seven years. The Health Care Index evaluates multiple factors, including the technical skills and competencies of medical personnel, the efficiency with which medical examinations and reports are completed, the quality of medical equipment and software, and the accuracy of medical reports that collectively reflect the overall quality of healthcare services. Moreover, Taiwan’s performance during the COVID-19 pandemic reinforced Taiwan’s standing as a worldwide leader in medical standards and public health management.

Taiwan’s competitiveness in both the semiconductor and medical sectors has positioned the island as an ideal location for developing AI applications within the healthcare industry.

Taiwan’s National Health Insurance system

The medical system in Taiwan is structured by a comprehensive insurance framework known as National Health Insurance (NHI), which is a compulsory social insurance programme designed to provide universal health coverage to Taiwanese citizens.

Under the National Health Insurance Act, NHI is exclusively managed by a single governmental agency, the National Health Insurance Administration (NHIA). This centralised management structure is a key factor in the system’s overall efficiency and adaptability. As of the most recent data, approximately 99.9% of the Taiwanese population is enrolled in NHI. Benefiting from the NHI system, Taiwanese citizens enjoy affordable access to high-quality medical treatment.

However, demographic trends are likely to bring new challenges to the NHI system in the near future. Like many countries around the world, Taiwan is experiencing a rapidly ageing population. Societal shifts, including delayed marriage and low fertility rates, have contributed to a significant demographic transformation within Taiwan, with the island being classified as an “aged society” (in which 14% of the population is aged 65 or over) starting in 2018, and projected to be classified as a “super-aged society” (in which more than 20% of the population is aged 65 or over) by 2025.

As the proportion of elderly individuals rises, the demand for healthcare services is expected to increase correspondingly. As such, Taiwan’s healthcare system is currently confronted with a critical shortage of humanpower, which complicates efforts to meet the escalating needs of its ageing population. In response, Taiwan is exploring a range of strategies, including integration of advanced technologies, enhancement of workforce training programmes, and implementation of policy reforms aimed at optimising resource allocation.

AI applications in healthcare development in Taiwan

In the context of healthcare development in Taiwan, AI applications have been frequently integrated into assistance and alert functionalities. These foundational uses leverage AI’s inherent capabilities to analyse complex datasets of medical data, thereby enabling tailored applications to address specific clinical needs.

Medical management, diagnosis and prediction-based diagnosis

More recently, AI’s role in healthcare has expanded to encompass medical management, diagnosis, and prediction-based diagnosis. In the area of medical management, AI has been applied to optimise resource utilisation and enhance the organisation of outpatient services. In diagnostic applications, AI-powered identification systems have been employed to facilitate faster and more precise image analyses, thereby supporting clinicians in achieving more accurate diagnoses. Regarding prediction-based diagnosis, by aggregating and analysing extensive datasets including patient histories, genetic information, and real-time health indicators, AI can generate risk assessments and recommend precautionary measures to individual patients.

In Taiwan, leading medical institutions such as National Taiwan University Hospital and Taipei Veterans General Hospital have begun integrating AI-assisted outpatient services into their clinical offerings. These services span various specialties, including orthopedics, cardiology, and neuroimaging interpretation. Through these applications, AI supports clinicians in delivering more accurate diagnoses and personalised treatment plans.

Clinical care

In the area of clinical care, AI systems can aggregate and analyse vast amounts of patient biodata, including medical histories, imaging data, and real-time physiological measurements. Through continuous monitoring, AI can detect subtle changes or emerging risks in a patient’s condition. Such uninterrupted surveillance facilitates timely identification of potential complications, allowing for proactive interventions that lead to better patient outcomes.

Beyond individual patient monitoring, AI-based analysis of large-scale datasets enables the detection of non-compliance or deviations from established medical standards. Through comparison monitoring, AI can identify instances where a patient may not be following prescribed instructions, or where clinical practices diverge from accepted standards. Corresponding alerts could serve as safeguards to prevent avoidable clinical errors.

A practical example of AI applications in clinical care is demonstrated by technologies developed at National Cheng Kung University Hospital, where AI-driven tools calculate muscle composition ratios based on CT scans. This innovation enables early warning of potential side effects associated with chemotherapy.

Legal Framework Governing Healthcare & AI in Taiwan

With the rapid advancement of AI technologies in recent years, society has witnessed unprecedented convenience brought about by AI. Alongside such benefits, however, growing concern has arisen regarding potential ethical and legal challenges posed by AI. To ensure that AI development proceeds in a responsible manner, several countries have initiated establishment of legal frameworks aimed at managing AI. Among these efforts, the EU’s Artificial Intelligence Act, passed in 2024, stands out as a milestone regulatory initiative.

Concurrently, Taiwan has recognised the need for local AI regulations. Starting in 2019, the government began drafting the Artificial Intelligence Development Fundamental Act, with ongoing refinement continuing since then. However, due to the rapid advancement of artificial intelligence technologies and applications, as well as the many differing opinions and discussions from experts, scholars, and various industries regarding this draft bill, it is still uncertain when this law will be passed by the congress and whether there will be any major revisions to its content.

As a result, Taiwan does not currently have a comprehensive, AI-specific legal framework. Instead, regulatory oversight is primarily exercised through sector-specific guidelines. For instance, the AI Technology R&D Guidelines were promulgated by the National Science and Technology Council in 2019, and the Core Principles and Policies for Artificial Intelligence (AI) Applications in the Financial Industry were promulgated by the Financial Supervisory Commission in 2024.

With respect to AI applications within the healthcare sector, relevant regulations are dispersed across multiple legal frameworks, such as the Medical Devices Act and the Data Protection Act, rather than consolidated into a single regulation.

Management of medical devices

Across the healthcare industry, AI applications are increasingly being integrated into various diagnostic, therapeutic and monitoring tools. In Taiwan, such AI-driven healthcare solutions meeting specific requirements will be classified as medical devices.

The Medical Devices Act provides primary regulations governing medical devices in Taiwan. Management of AI applications in the context of healthcare is likely to fall under the purview of the Medical Devices Act. According to the Medical Devices Act, the term “medical device” refers to instruments, machines, apparatuses, materials, software, reagents for in vitro use and related articles thereof, whose design and use achieve one of the following primary intended actions in or on the human body by means other than pharmacological, immunological, metabolic or chemical means:

• diagnosis, treatment, alleviation or direct prevention of human diseases;
• modification or improvement of the structure and function of the human body; and
• control of conception.

The Ministry of Health and Welfare (MOHW) is the competent authority overseeing the matters related to healthcare, products and industries. Under the MOHW, the Food and Drug Administration (TFDA) supervises the regulation of food, drugs, medical devices, and cosmetics to ensure their safety and quality. The TFDA is responsible for granting product registrations and approving clinical trials, and monitoring manufacturing processes and imports. From a legal standpoint in Taiwan, the manufacture or import of medical devices is permitted only after the MOHW has issued a medical device permit licence which grants registration and market approval.

Further, to accommodate emerging and advanced categories of medical devices, the TFDA issued the Guidance for the Inspection and Registration of Medical Software of AI/ML-based Technologies (the “Guidance”) in August 2021. The Guidance describes the inspection and registration requirements for medical software and medical devices that use AI/ML-based (artificial intelligence/machine learning-based) technologies. Based on the list of AI/ML-based medical devices approved as of December 2024, approximately 50 domestically manufactured AI/ML-based medical devices and approximately 116 imported AI/ML-based medical devices had been authorised by the TFDA for manufacture or import into Taiwan. Such AI/ML-based medical devices include ultrasound devices with AI-assisted interpretation, complementary diagnosis software, and X-ray photography systems.

It is foreseeable that the integration of AI into healthcare, including diagnostics and treatment, will continue to expand significantly. These advancements promise to enhance the accuracy and personalisation of healthcare delivery. However, the proliferation of AI applications in this sector also introduces complexities in regulatory oversight and will present additional challenges at both national and international levels.

Personal data protection

In addition to the management of medical devices, the protection of personal data has emerged as a key concern in the deployment of AI within the healthcare field. As AI technologies rely on vast amounts of sensitive patient information to enhance diagnostic accuracy and treatment personalisation, important issues regarding the protection of personal data have arisen.

The Personal Data Protection Act

The Personal Data Protection Act (PDPA), last amended in May 2023, serves as the core legislation for personal data protection in Taiwan. Under the PDPA, “personal data” encompasses any information capable of directly or indirectly identifying an individual, such as name, date of birth, national identification card number, passport number, physical characteristics, fingerprints, marital status, family information, educational background, occupation, medical records, healthcare data, genetic data, sexual history, records of physical examination, criminal record, contact information, financial conditions, and social activities.

The PDPA outlines the responsibilities of data controllers and processors in the collection, processing, and use of personal data, ensuring that such activities are conducted in accordance with the regulations, such as acquiring the consent of the data subject prior to the use and collection of personal data. The PDPA also prescribes requirements for personal data security, mandates timely notification in the event of data breaches, and provides mechanisms for individuals to exercise their rights regarding their personal data.

Additionally, the scope of personal data is further delineated to include a distinct category of “sensitive personal data”, which encompasses information such as medical records, healthcare details, genetic data, sexual history, physical examination results, and criminal record. Due to the nature of such data, the PDPA imposes more stringent regulatory requirements, mandating that such sensitive personal data may be collected, processed, and used only under specific conditions, such as where the collection, processing, and/or use is/are expressly required by law, or after provision of the data subjects’ written consent.

In the context of the healthcare sector, the personal data processed by AI largely encompass medical records and healthcare-related information, which are classified as sensitive personal data under the PDPA and are subject to more stringent regulatory requirements. Moreover, the deployment of AI within healthcare frequently entails cross-border transfer of personal data, thereby introducing additional compliance requirements in data protection laws. Consequently, the collection, processing, and use of personal data in AI-driven healthcare applications will be subject to multiple layers of legal considerations and require more diligence in implementing data compliance mechanisms to mitigate risks and protect personal data.

Initiatives regarding personal health data

Since its inception in 1995, Taiwan’s NHI system has been managed by the NHIA, which oversees a large volume of personal data. From 2000 to 2016, the NHIA entrusted data management to the National Health Research Institute, which created the National Health Insurance Research Database for external research. In 2012, amid rising concerns about personal data privacy, seven individuals objected to the NHIA’s disclosure of their personal data to third parties, resulting in petitions and administrative lawsuits that were ultimately unsuccessful. In 2017, the plaintiffs pursued a constitutional interpretation to determine the legality of such personal data release.

In August 2022, Taiwan’s Constitutional Court ruled in the Judgment of Constitutional Court (111) Sian-Pan-Zi No 13, mandating that laws must be revised within three years to strengthen protection of personal data under the PDPA. Key requirements included establishing an independent oversight mechanism, defining clear regulations for NHI data usage, and permitting individuals to opt out of personal data usage.

To comply, the PDPA was amended in May 2023, designating the Personal Data Protection Commission (PDPC) as the authority overseeing the relevant data protection regulations. A Preparatory Office for the PDPC was accordingly established in December 2023 for the purpose of formulating organisational laws and regulations of the PDPC and revising and interpreting the PDPA. In light of the time constraint imposed by the Constitutional Court, the PDPC is expected to be officially established by the end of 2025.

In May 2025, draft legislation, titled the National Health Insurance Data Management Act, was published by the Executive Yuan, introducing comprehensive measures to enhance the governance of health insurance data. The draft Act would mandate the establishment of an advisory council tasked with providing expert counsel and overseeing the implementation of related policies. It further defines a framework for the construction, management, and evaluation of pertinent data repositories, as well as standardised procedures for transmission of data by insurers to competent authorities. Moreover, the draft Act would also entitle data subjects to opt out of data usage.

Since 9 June 2025, the Legislative Yuan (congress) has convened to review the draft legislation of the National Health Insurance Data Management Act. It is expected that the legislation will be completed by the deadline set by the Constitutional Court (ie, 12 August 2025).

Conclusion

Given that healthcare inherently involves human dimensions and places significant emphasis on ethical considerations, it is imperative to differentiate the application of AI within this sector from its use in other fields. As AI technologies continue to advance, the healthcare sector faces increasingly complex legal and ethical challenges. Among these, the lack of transparency in AI decision-making processes raises concerns regarding accountability and the attribution of responsibility. Consequently, existing legal frameworks may be inadequate to address the issues arising from AI integration in healthcare. In light of the above, the development of regulatory frameworks governing AI deployment in healthcare must proceed with diligence and specificity, ensuring that considerations of patient safety, personal privacy, and ethical standards remain paramount.