Digital health is rapidly evolving across Asia and transforming what patients, healthcare providers, and health authorities think about care delivery. The emergence of AI, reimbursement frameworks, and pandemic-era changes has caused regulators to implement policy changes. Health authorities across Asia are beginning to encourage innovation while being mindful of the risks, such as privacy violations, safety lapses, and inequities in access to care.
China: Significant Growth Boosted by AI
Few places illustrate this better than China. In 2024, the country already accounted for about one-fifth of the Asia-Pacific digital health market, and momentum is only building. The rollout of new AI models like Qwen2.5-Max, Kimi k1.5, and DeepSeek v3 shows how far domestic companies have come. Alibaba Cloud has even claimed its system outperforms major global competitors, including Llama-3.1-405B.
These tools are not just academic achievements. They are being built into diagnostic platforms, personalized treatment programs, and systems that help physicians communicate more effectively with patients. If the next versions of these AI engines continue to improve, China could find itself setting global standards in medical AI.
But the environment is not without headwinds. Patient data protection is a pressing concern, and public trust could be shaken if rules are not clear or strongly enforced. Doctors also worry about technology weakening the human side of care, and the country still lacks enough professionals with both AI expertise and medical training to fully integrate these systems safely.
Japan: A Slower, Careful Expansion
Japan offers a different picture. Digital health here is far less entrenched than in Western countries, yet recent years have seen important steps forward. The first major milestone occurred in 2020 when the digital therapeutic startup Cure Up was granted approval for a digital therapeutic aimed at nicotine addiction. International partnerships in late 2020 included a collaboration between Welldoc and Astellas Pharma to assist patients with diabetes, and Akili partnered with Shionogi to create video game-based tools for ADHD.
Digital health products are now getting Japanese medical device reimbursement, which is essential to a product’s market success in Japan. However, cultural conservatism in healthcare somewhat leads to slower adoption of digital health products in Japan compared to the West.
Singapore: Tightening Rules for Software Devices
Singapore’s Health Sciences Authority (HSA) takes a very precise approach. At the end of 2021, it clarified its requirements on software that is classified as a medical device. The smallest change – whether that is changing an algorithm, the operating system, or adding a new feature – must be reported. Developers must notify the regulator within 6 months and keep records of all changes to their software.
The message is clear: digital health products evolve constantly, but patient safety cannot be compromised by an unchecked software patch. By insisting on oversight of incremental updates, Singapore is building a regulatory model that other markets may look to as software becomes central to healthcare.
Hong Kong: Catching Up After the Pandemic
Since the pandemic, Hong Kong has expedited digital health initiatives that had long been talked about but never widely adopted. Since 2021, hospitals and clinics have initiated telehealth consultations, developed mobile apps for appointments, established digital record systems, and used navigation and location services to smooth patient flow.
These moves are significant, but Hong Kong still trails neighbors like Singapore in terms of depth and coordination. Much of the progress remains fragmented across providers. Turning pandemic-era improvisations into durable, system-wide frameworks will be the city’s next challenge.
Korea: Leading on Fast-Track Innovation
Korea’s approach to digital health can be characterized by its speed of adoption. In November 2024, regulators unveiled the “Immediate Market Entry Medical Technology System.” For eligible products such as AI-driven diagnostics, digital therapeutics, and medical robots, the approval timeline has been cut from well over a year to as little as 80 days.
What makes this reform stand out is its dual-track design. As soon as clinical evaluation begins, the reimbursement review by the Health Insurance Review and Assessment Agency runs in parallel. This means manufacturers no longer have to wait a long time for regulatory approval to receive Korean medical device reimbursement.
There are safeguards – some products with new technologies will have 3 years of post-market surveillance. Products that are proven to perform well during this period can receive better reimbursement. The Ministry of Health and Welfare has even established the Digital Health Promotion Agency to coordinate the national strategy, manage R&D, and integrate emerging technologies within the healthcare provision system.
Looking Across the Region
Despite their differences, all these Asian countries are wrestling with similar questions: How should regulators handle the constant updates that define digital tools? How can systems reward innovation while protecting patients and keeping care affordable? And how can public trust be maintained when technologies advance faster than the rules? Asia’s answers to these questions will not just shape local markets. Given the region’s size and diversity, policies in Asia are likely to influence global standards as well.
