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The Agency Clinical Governance Framework helps everyone, including our partners, understand the responsibility to demonstrate clinical governance in the way we work throughout the delivery lifecycle of all products and services.  

At the Agency, we do this under our 5 clinical governance principles: 

  • Person-centredness 
  • Partnerships 
  • Leading with our people 
  • Systems safety and quality improvement 
  • Evidence-based practice. 

The Agency is accountable to the Australian community to improve health care and care by providing health technology solutions through the delivery of products and services. Clinical governance promotes clinical safety, quality and continuous improvement in the delivery of health care and care, including through health technologies. It comprises a culture of safety and quality that is supported by clinical input and a set of relationships and responsibilities established within the Agency, together with our partners, our workforce and consumers.  

We acknowledge that Agency products and services form part of broader connected systems and capabilities (both technical and non-technical) that deliver care across the healthcare and care sectors in Australia, through a complex network of participants, perspectives and interdependencies. The clinical safety, quality and continuous improvement of all our products and services matter to us. Consumers’ experiences are impacted by all health technology initiatives, and we recognise that their lived experiences are diverse.  

Effective clinical governance by the Agency ensures that we operate within a structured, open, transparent, and blame-free environment, led by the Agency Board and delivered by our workforce. This visibility builds trust in the Agency and increases confidence in the Australian community that we are supporting connected, person-centred products and services, in a way that is evidence-based and values health outcomes for our diverse range of consumers.  

The Agency Clinical Governance Framework provides the structure that supports everyone in the Agency, including our partners, to be accountable for ensuring the clinical safety and quality of our products and services and for continually improving them. It is consistent with, and supports, the Agency’s functions under the Public Governance, Performance and Accountability Rule 2016 (Establishing the Australian Digital Health Agency) 2016 (PGPA Rule), Part 2, section 9(1)(d) that is ‘to develop, implement and operate comprehensive and effective clinical governance, using a whole-of-system approach, to ensure clinical safety in the delivery of the national digital health work program’. 

The Framework advocates for the active management and monitoring of risks, with a strong and effective focus on clinical governance measures. While the Agency has a high appetite for responsible innovation wherever possible, clinical safety, security and privacy will not be compromised to achieve this. Effectively implementing clinical governance helps ensure clinical safety, security and privacy are always managed to a very low risk level.  

The Agency acknowledges that trust in health technologies can be lost through inadequate consideration of clinical governance, clinical use cases, workflow and user requirements in the design, development and delivery of our products and services. Accordingly, the Agency Framework drives collaboration and promotes conformance with evidence-based standards to maintain and increase trust in health technologies. 

For more information, contact the Clinical Governance Branch via [email protected]