21 Jul 2020
Healthcare is a people business; delivered by caring health professionals to their patients. It is often delivered during periods of health compromise, sickness or medical uncertainty. In this time of COVID-19, it is arguably the most important and respected service of any sector.
On the surface, artificial intelligence (AI) may seem counterintuitive as a form of healthcare – given It is also known as machine intelligence. As that name suggests, AI has software, algorithms and machine learning at its heart. Yet, it is fast becoming one of the most exciting and effective developments in healthcare services and delivery.
"A comprehensive governance framework for any AI strategy in a healthcare setting needs to start from the position that healthcare is centred on the consumer.”
AI has the ability to help deliver some health services more quickly, efficiently, at lower cost and with greater accuracy. But, like any new technology or therapeutic intervention that is introduced in a healthcare setting, AI must be properly regulated.
Those who are accountable for managing risk and regulatory compliance within organisations should have assurance the implementation and use of any AI tool will be safe and cost effective, produce better outcomes, with an improved experience, for all stakeholders.
Legal and regulatory frameworks can have difficulty keeping up with the rapid technological advancements and uptake of AI in the healthcare sector. The regulatory requirements for medical devices arise under the Therapeutic Goods Act 1989 and associated regulations provides guidance for regulating AI. Software as a medical device (SaMD) is specifically included under this regime but is subject to ongoing consultation, with refinements expected in the next 12 to 18 months.
Organisations intending to implement AI tools for health-related purposes must implement a governance and risk management framework which goes beyond those minimum legal and regulatory requirements.
A comprehensive governance framework for any AI strategy in a healthcare setting needs to start from the position that healthcare is centred on the consumer. Introduction of market leading technology can create an edge in a crowded industry, however it is important to keep in mind the end user - not only the health team of clinicians but the patient, aged care resident, person with a disability or other consumer.
A governance and risk management framework for AI may include the following elements;
The COVID-19 pandemic has accelerated changes in models of healthcare by many years, with increased expectations from the consumer that is centred around outcomes, experience and delivery of care directly to them where possible.
Considering these matters at the very start of any AI journey and asking if AI in each instance will achieve a better outcome and provide a better experience, will ensure the end-product meets expectations and will be adopted by consumers, within a governance framework that appropriately balances and manages risk.
Shane Evans is Partner and Health Industry Lead at MinterEllison
The views and opinions expressed in this communication are those of the author and may not necessarily state or reflect those of ANZ.
21 Jul 2020
09 Jun 2020