The Digital Health Standards Council of Australasia (DHSCA) commenced operations today, 24 August 2026, as a new body for assurance and assessment of digital health and AI-enabled healthcare technologies. Its model serves vendors, clinicians, boards, and health service organisations and their executives with assurance for digitally enabled tools and services.

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DHSCA operates across three areas:

• Capability work supporting boards, clinical and technical governance leads, and executives build internal readiness to confidently govern healthcare technologies

• Accreditation of services against national safety and quality standards will follow pending relevant approval, which DHSCA intends to seek in 2027

• Assessment of tools falling below the Software as a Medical Device (SaMD) threshold, following external validation and piloting of GUARDS; a six-domain clinical and technical safety framework for assessing AI-enabled tools.

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Only some digital health and AI tools sit within existing regulatory arrangements. The Therapeutic Goods Administration (TGA) oversees products meeting the SaMD threshold, and the Australian Commission on Safety and Quality in Health Care (the Commission) administers voluntary national safety and quality standards for digital mental health services. Many technologies are not captured under these arrangements which leaves an opening for independent assurance and support. DHSCA Chief Executive Chris Boyd-Skinner, said:

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"The TGA regulates medical devices, and it does that exceptionally well. But most of the AI turning up in Australian health services isn't classed as a medical device. A chatbot triaging a patient, or an app carrying someone's mental health information, doesn't clear the SaMD threshold, so health services are left to work it out themselves, one procurement at a time."

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"We're not aiming to replicate the work of governments, jurisdictions or regulators in any way. This is about an additional unmet need and supporting organisations that want to build, deploy and scale health technologies safely."

 

Central to its own governance arrangements, DHSCA's External Advisory Council is in the final stages of being established. On the Council, Mr Boyd-Skinner said:

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"An organisation committed to supporting health services to mature their governance has to hold itself to the same standards. The Council will advise DHSCA on both strategy and direction, and I look forward to announcing the inaugural Chair and membership within the coming months."

 

DHSCA is already working with health services, technology developers and peak bodies, with current engagements spanning Aboriginal Community Controlled Health Organisations, Primary Care Networks and private hospital groups on their AI governance. Organisations can register their interest via: contact@dhsca.com.au 

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Mr Boyd-Skinner added: "Developers have wanted a way to show a product is safe, and when I work in the intensive care unit I hear time and again how buyers want something independent to point to. Neither side has had a straightforward path, so everything we're working towards over the next twelve months is aimed at closing that gap."

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- ENDS