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Fusion42 · 7 September 2026 · Fusion42 review
The Digital Health Standards Council of Australasia (DHSCA) launched as a clinically led assurance body for digital health and AI-enabled healthcare technologies in the ANZ region, aiming to provide additional governance beyond existing regulatory frameworks. DHSCA plans to accredit services against national standards and assess AI tools below medical device thresholds starting in 2027.
This Wire brief sits within Fusion42's coverage of Digital Health.
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You now face a new regulatory assurance gateway in Australia and New Zealand that targets health tech not covered by current rules. Build your compliance path early to avoid market access delays when DHSCA accreditation begins.
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1 source · 7 Sep 2026
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