Digital Health in Australia
27.7 M
inhabitants (2025)
10.1%
of GDP spent on health (2023–2024)
6 states
and 2 territories in a federal system
Over 1,000
digital health companies
Australian healthcare system
Australia operates a hybrid system that combines universal public health insurance (Medicare) with a strong private sector.
Medicare, funded through taxation and a specific levy, covers most general practice consultations, specialist care and public hospital treatment, while the Pharmaceutical Benefits Scheme (PBS) subsidises prescription medicines and protects patients from high out‑of‑pocket costs.
Responsibilities are shared across levels of government: the Commonwealth sets national strategy, funds Medicare and the PBS and regulates private health insurance; states and territories manage public hospitals and local health services; local governments deliver public health and community services.
Around half of the population holds private health insurance to complement Medicare and access some services more quickly or more broadly.
Digital Health Strategy and Infrastructure
Australia is implementing the National Digital Health Strategy 2023–2028, led by the Australian Digital Health Agency (ADHA), which aims to build a more connected, person‑centred, inclusive and data‑driven health system. The strategy is supported by a 2023–2028 Delivery Roadmap and a 2023–2025 Action and Impact Report that track progress on around 80 initiatives, over 30 of which are led or co‑led by ADHA.
The core national infrastructure is My Health Record, a shared electronic health record to which almost all residents are automatically registered, accessed by healthcare providers through the National Authentication Service for Health (NASH) and integrated with a wide range of clinical information systems. However, the coexistence of many private electronic medical record systems and practice software still leads to fragmentation and strong interoperability needs.
In February 2025, the Modernising My Health Record Act introduced a “sharing by default” principle for specific categories of health information, to strengthen continuity of care and safe data sharing. The national strategy also emphasises the roll‑out of interoperability standards (FHIR®, SNOMED CT and national terminologies), the broader Health Connect Australia ecosystem and extensive digital literacy and training programmes for both clinicians and consumers.
A market in rapid expansion
The Australian digital health market is experiencing rapid growth, rising from USD 8.9 billion in 2025 to a projected USD 31.1 billion by 2034, driven by a CAGR of 14.92%. This momentum is supported by three major factors:
- Widespread smartphone usage (23.6 million users expected by 2026),
- The expansion of telehealth, crucial for rural and Indigenous populations,
- Personalised chronic disease management through wearables and health apps.
Australia is also investing heavily in AI driven healthcare : 10% of the population already uses tools like ChatGPT for health information, and a new National Clinical Governance Committee for Digital Health (established in March 2026) now oversees AI safety and the expansion of virtual care services.
At the same time, the ANZ preventive digital wellness market has surpassed USD 250 billion, driven by the growth of wearables and personalised health monitoring.
Finally, a 2023–2033 Digital Health Blueprint sets a long-term vision for connected and sustainable health systems, extending beyond the initial 2023–2028 strategy.
How to access the Australian market ?
Market access for digital health solutions combines medical device regulation, listing in the national register and, where relevant, access to public reimbursement.
1. Comply with medical device regulations
The Therapeutic Goods Administration (TGA) regulates medical devices, including software as a medical device (SaMD).
Software is considered a medical device when it is intended to diagnose, prevent, monitor or treat disease, support clinical decision‑making or control another device.
Software is classified using risk‑based classes (Class I, IIa, IIb, III), with increasing requirements for clinical evidence and conformity, while some low‑risk functions are excluded or exempted to avoid unnecessary regulation.
2. Obtain listing in the national registry (ARTG)
Inclusion in the Australian Register of Therapeutic Goods (ARTG) requires an appropriate conformity assessment (quality management system based on ISO 13485, technical documentation, clinical evidence where needed), either conducted by the TGA or based on approvals from comparable regulators such as CE marking.
Medical devices are defined in Section 41BD of the Therapeutic Goods Act (1989) / TGA classification rules.
Use the TGA Business Services (TBS) website to submit your medical device application.
Visit this link to manage your application for ARTG entry.
Access the official application here and follow the procedure.
3. Secure access to public reimbursement
For public funding, digital technologies that support or are integral to a clinical service can be submitted to the Medical Services Advisory Committee (MSAC) for possible listing on the Medicare Benefits Schedule (MBS), through standard, expedited or direct pathways.
4. Strengthen credibility through voluntary assessment
In addition, the ADHA has developed a voluntary mobile health assesslent framework for wellness, health and SaMD apps.
It includes four phases (triage, assessment against 13 criteria, publication in an apps library, and periodic reassessment) and complements, but does not replace, the TGA’s regulatory requirements.
Government agencies and public bodies
Industry organizations and professional networks
Innovation hubs and clusters
Training
Further information
Australia’s National Digital Health Strategy Action and Impact Report 2023–2025, which provides an assessment of progress towards delivering Australia’s National Digital Health Strategy 2023–2028 and associated Delivery Roadmap.
Why Australia for medical technology, devices and diagnostics?: Overview of Australia’s advanced digital health sector has the proven capability and readiness to deliver scalable, secure, and effective healthcare solutions for markets worldwide. (See PDF document below)
The Australian Digital and Connected Health Industry Report, developed in collaboration with ANDHealth and Austrade, showcases Australia is a world-leader in national digital health infrastructure with a proven track record in digital health innovation. (See PDF document below)