Clinical Governance in a digital world
It’s almost impossible to think about clinical governance these days without also thinking about digital health. But what does clinical governance mean in this digitised age? A good starting point is to remember that clinical governance ‘includes patient safety, risk management and quality improvement.’1 Therefore this should also apply in digital health, as in any context.
The Australian Digital Health Agency (ADHA) refers to clinical governance as ‘the set of relationships and responsibilities established by a healthcare service between its executive, workforce (clinical and non-clinical) and stakeholders (including patients/clients). It provides a system through which clinicians and managers are jointly accountable for patient safety and quality care.’2 This definition aligns with that described by the Australian Commission on Safety and Quality (ACSQHC) in Health Care, in its National Model Clinical Governance Framework.3
Clinical governance in digital health is no different but operates in an environment where we have the benefit of technology to support it.
An important aspect of clinical governance, highlighted by both the ADHA and ACSQHC, is its necessary integration with corporate governance. In other words, safety, quality and risk management must be a component of corporate governance – described by the ACSQHC as ‘the establishment of systems and processes that shape, enable and oversee the management of an organisation’ which includes ‘formulating strategy, setting policy delegating responsibility, overseeing management, and ensuring that appropriate risk management and accountability arrangements are in place throughout the organisation.’4 Clinical governance should be inherent to corporate governance processes in any organisation which has an impact on care – being healthcare, aged care, disability services – or digital health.
Does digital health present any specific challenges? Most certainly, and clinical governance approaches should never be generic.
Firstly, digital health is stemmed from health informatics,5 and data governance has particular importance when it comes to the digitisation of care. Secondly, the factors that make any information system successful should be considered in digital health.6 As such, clinical governance in digital health might be analysed across two broad domains; what happens with/in the system itself, and how it translates to the point of care:
- System design, usability and operation. What is the quality of the input, and how is it integrated in the system? Is it easy and efficient to use, or prone to error? What other risks are associated with the system itself (eg. cyber-risks)?
- Outputs and outcomes. Does the system do what it purports to do? How do system inputs and outputs translate to point of care? Do the outputs and outcomes align with the intended benefits? How is the system viewed by those who seek to rely on it, and their beneficiaries? Are there any emerging risks?7
Clinical governance in a digital world, as in any context, is multilayered. It requires not only the application of first principles, but an understanding of health informatics and systems thinking – all integrated with corporate governance – and data governance.
5. Which may be defined as ‘the science and practice around information in health that leads to informed and assisted health care. ‘Informed’ here means ‘that the right information about the subject (consumer, patient or population) together with relevant health knowledge, is available at the right time and in a form that allows it to be used. ‘Assisted’ here means ‘that the job of the health care worker is made safer and easier and that the health consumer is supported in their decisions and actions’. See HISA, at https://www.hisa.org.au/health-informatics/
6. S Petter, W DeLone & E McLean (2008). ‘Measuring information systems success: models, dimensions, measures, and interrelationships.’ European Journal of Information Systems, 17:3, 236-263, DOI: 10.1057/ejis.2008.15. Accessible at: https://www.tandfonline.com/doi/full/10.1057/ejis.2008.15?scroll=top&needAccess=true
7. These questions are not exhaustive and the issues will be further explored in articles to follow.