The Digital Health Standards Council of Australasia will help vendors, clinicians, boards, and health service organisations build, deploy, and scale digital health tech safely.
A new body for assurance and assessment of digital health and AI-enabled healthcare technologies has launched, to provide vendors, clinicians, boards, and health service organisations and their executives with assurance for digitally enabled tools and services.
The Digital Health Standards Council of Australasia (DHSCA) would operate 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 would follow pending relevant approval, which DHSCA intended 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.
DHSCA chief executive Chris Boyd-Skinner said there was a need for such a body as currently only some digital health and AI tools sat within current regulatory arrangements.
“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.”
”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.”
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There would be a DHSCA’s External Advisory Council which was in the final stages of being established. The council would advise DHSCA on strategy and direction with the appointment of the inaugural chair and membership, yet to be announced.
DHSCA was self-funded and independent. It was 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.
“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 12 months is aimed at closing that gap,” Mr Boyd-Skinner added.