Governance
DHSCA is committed to ensuring its own governance arrangements are robust, and meets the same expectations of the organisations and products it assesses.
DHSCA's External Advisory Council is in the process of being established to steer strategy, standards, assessment and future accreditation work. The Council will operate under published terms of reference.
DHSCA will announce its membership and formalise the Council's arrangements later in 2026.
Independence
DHSCA funds its own work. We do not receive funding from any other source.
Assessment and accreditation decisions are held separate from any readiness engagement that DHSCA conducts with a health service organisation or vendor.
Participation in a readiness engagement confers no advantage in a later assessment. Clinical and technical assessors who support readiness activities must declare conflicts of interest, and cannot assess an organisation for which they have contributed advice to for a period of 5 years.
What DHSCA is not
An assessment by DHSCA is not a Therapeutic Goods Administration (TGA) approval and does not substitute for one.
We are not a regulatory body and where a product is a regulated medical device, the sponsor's and manufacturer's obligations under the Therapeutic Goods Act 1989 are unchanged.
Our assessments are designed to sit alongside existing regulatory compliance, in the substantial space where no existing regulation applies. Where we reasonably believe a product may require Software as a Medical Device regulation, we will refer you to the TGA