This page outlines the importance of clinical governance and the responsibilities of industry partners to implement clinical governance in the design, development and delivery of digital health products and services. The Agency's Clinical Governance Framework for Digital Health (the Framework) provides guidance to assist industry partners to understand their responsibility to demonstrate clinical governance throughout the design, development and delivery lifestyle.
The Framework outlines 5 clinical governance principles which promote clinical safety, quality and continuous improvement in digital health:
- Person-centredness – the end users, clinicians and consumers (patients), should be involved and considered in the design and delivery of products and services to ensure they are safe and fit for purpose.
- Partnerships - collaboration with industry partners, peak bodies, consumers and government agencies is vital to ensuring a whole-of-system approach to digital health
- Leading with our people - A culture of clinical safety, quality, and continuous improvement is fostered through effective leadership and workforce engagement
- Systems safety and quality improvement - Clinical safety and high-quality products and services are achieved through systems and processes that promote systems thinking and continuous improvement
- Evidence-based practice – Data, evidence and standards should be used to inform the development and delivery of products and services to ensure they are safe, secure and interoperable
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 the lowest possible risk level.
To access the Framework in full, please click here: Clinical Governance Framework
For more information, please contact the Clinical Governance Section of the Agency via [email protected]