GP Data and Electronic Clinical Decision Support – Response to the Consultation Regulatory Impact Statement

This submission to the Department of Health and Aged Care responds to its Consultation Regulatory Impact Statement on general practice (GP) data and electronic clinical decision support (eCDS). Research Australia agrees with the consultation paper that current processes for sharing and accessing GP data are complex, disjointed and inconsistent, and supports measures to improve the quality of data captured in GP practice management systems and researchers’ access to it, including linkage with sources such as the Pharmaceutical Benefits Scheme. It cites a study that used practice management system data to track blood glucose levels in 76,341 patients of 960 GPs over nine years, and the Department of Veterans’ Affairs Veterans’ MATES program, which has used claims data to send tailored medicines advice to more than 300,000 clients and 33,000 GPs. It maintains that data fed back to GPs must first be analysed and offers to convene an expert group to help. On eCDS, it submits that the Therapeutic Goods Administration is the most appropriate body to regulate the safety of eCDS software, that the Australian Government’s eight Artificial Intelligence Ethics Principles should underpin any regulatory framework, and that research is needed into the outcomes, effectiveness and evidence base of eCDS systems, possibly feeding into an accreditation or ratings framework. It offers to work with the Department on such a research program.