Software as a Medical Device (SaMD) refers to software intended for medical purposes that meets the Therapeutic Goods Administration (TGA) definition of a medical device and performs its function independently of dedicated hardware. Examples include diagnostic algorithms, treatment planning software, and certain clinical decision support tools.In Australia, SaMD is regulated by the TGA and is subject to regulatory assessment based on its intended use and risk classification, with higher-risk software requiring more rigorous evaluation.From an insurance perspective, the development and use of SaMD may give rise to a range of risk considerations, depending on the role of the insured. These can include issues relating to software performance, regulatory compliance, and the impact of software outputs on clinical decision-making. Relevant considerations may include the regulatory status and classification of the software, post-market surveillance obligations, software updates and version control, and clear labelling of intended use and limitations. Healthcare professionals remain responsible for patient care, and coverage is subject to the terms, conditions, and exclusions of the applicable policy.

Software as a Medical Device (SaMD) refers to software intended for medical purposes that meets the Therapeutic Goods Administration (TGA) definition of a medical device and performs its function independently of dedicated hardware. Examples include diagnostic algorithms, treatment planning software, and certain clinical decision support tools.In Australia, SaMD is regulated by the TGA and is subject to regulatory assessment based on its intended use and risk classification, with higher-risk software requiring more rigorous evaluation.From an insurance perspective, the development and use of SaMD may give rise to a range of risk considerations, depending on the role of the insured. These can include issues relating to software performance, regulatory compliance, and the impact of software outputs on clinical decision-making. Relevant considerations may include the regulatory status and classification of the software, post-market surveillance obligations, software updates and version control, and clear labelling of intended use and limitations. Healthcare professionals remain responsible for patient care, and coverage is subject to the terms, conditions, and exclusions of the applicable policy.