igitalization across various segments of the healthcare value chain continues to grow more prevalent and accessible around the world. This rise in popularity had made regulatory policies for digital health (DH) essential in guiding digital health companies’ provision of safer (and better) DH services. Digital health technologies empower consumers to make more informed choices about their own healthcare and provide healthcare professionals with new options in terms of disease prevention, diagnosis, and management. Digital health can help low- and middle-income countries (LMICs) in particular overcome traditional barriers to better healthcare.

Digital Health and Digital Medicine

The new discipline of digital medicine has emerged from new combinations of modern medicine with digital technology and encompasses medicine, computer science, mathematics, informatics, electronics, and mechanical engineering. Digital medicine applies software and hardware to the field of evidence-based tools that measure, diagnose, and/or intervene to support the practice of medicine, including treatment, recovery, disease prevention, and health promotion for individual patients and patient populations. Digital medicine also seems to hold promise for improved patient care, cost-effectiveness, and transparency.

Digital health acts as the umbrella entity that encompasses digital medicine, as broadly illustrated below.

• Clinical confirmation: Digital health is not evidence-based (no clinical trials). However, digital medicine can include improving the care that patients receive based on information/updates from randomized clinical trials and is therefore evidence-based.
• Regulatory oversight: Regulatory oversight is required for digital medicine products that are classified or defined as medical devices by the responsible health authorities or regulatory agencies. Digital medicine products used as tools to develop other drugs, devices, or medical products also require regulatory review and approval. However, other digital health products that do not meet these definitions do not require regulatory oversight.
• Product examples: Mobile health (mHealth) apps and devices, health information technology (IT), wearable devices, telehealth, telemedicine, and lifestyle apps, and products that capture, store, and display data and information come under digital health. Measurement and intervention products, digital companions, and ingestible sensors come under digital medicine.

Digitalization of Healthcare Systems in Asia Pacific: Projected Scope

Unmet demand for digital healthcare in Asia continues to grow due to reasons of economy and care. Economic issues include the general lack of high-end infrastructure, monetary constraints, and a shortage of medical equipment and medical professionals in rural areas. Therapeutic issues include the region’s high incidence of chronic, noncommunicable diseases such as diabetes, hypertension, obesity, and chronic obstructive pulmonary disease. For example, chronic disease is responsible for more than 75% of deaths in parts of the Asia-Pacific region and has led to self-care programs such as Remote Care Management (RCM). Different levels of healthcare provision and regulatory expertise also contribute to wide variation in how DH solutions are brought to this market.

Aging is another urgent driver for digital health in the region. Cumulative healthcare expenditures on geriatric populations in Asia Pacific from 2015 to 2030 are expected to exceed $20T (US), leading experts to project that the region’s digital health market will grow by 34.2% CAGR over the next five years. The United Nations Economic and Social Commission for Asia and the Pacific estimates that by 2050, more than a quarter of the population in Asia Pacific will be over the age of 60, strong motivation for researchers, industry, and regulators to advance healthcare digitalization in the region.

Singapore, South Korea, and Australia are generally considered the region’s top three role models for digital health due to their respective governments’ progressive approach toward the value of digital health technologies. In other countries, the unique geography and geology of Southeast Asia calls for establishing and strengthening technology infrastructures that will support digital health and medicine. Southeast Asia is home to more than half a billion people spread across highly diverse countries, from economic powerhouses like Singapore to relatively minor economies such as Cambodia, Laos, and Myanmar. The region’s high susceptibility to earthquakes and resultant tsunamis, along with seasonal typhoons and floods, makes strengthening these infrastructures an urgent healthcare priority, especially in its most remote or vulnerable locations.

Digitalization of Healthcare Systems in Asia Pacific: Regulation

Harmonization is also a technology issue. Interoperability gaps in national healthcare systems continue to challenge implementation of digital healthcare platforms and technologies. Patient/consumer privacy and protection, IT security, cybersecurity, data privacy, and related issues remain top of mind, adding one more layer of complexity to the highly heterogenous healthcare and regulatory networks that reach throughout Asia Pacific.