The "Genome Era", a term that has been used to describe the period following the sequencing of the human genome, has heralded significant changes in biomedical research and clinical practice. Personalised medicine aims to use this increased genetic knowledge base to identify predisposition to disease and to tailor treatment to the individual based on an analysis of their genome. In 2003, the Australian Law Reform Commission and the Australian Health Ethics Committee released a report recommending regulatory reform to ensure adequate protection of genetic information. There have been significant developments in this area since that report was released, and the authors argue that it is time to reconsider the regulatory framework of personalised medicine in Australia. The authors identify a number of ethical concerns that need to be addressed if the promise of personalised medicine is to be fully realised.