Mental Health Dear Chair Thank you for your correspondence regarding Petition EN9586 on governance and regulation of digital mental health tools (DMHTs). The Australian Government agrees that innovation in mental health care must be underpinned by robust safeguards, clear regulatory settings and a strong focus on safety and clinical quality. There are a range of existing regulatory and assurance mechanisms in place that apply to DMHTs and services. These include the regulation of products by the Therapeutic Goods Administration (TGA), and oversight of service providers by the Australian Commission on Safety and Quality in Health Care (Commission). The Commission administers the National Safety and Quality Digital Mental Health Standards, which support safe and high quality care through a voluntary accreditation scheme for service providers. Users are supported to make choices about their digital mental health services by looking for accredited services, facilitated by the Medicare Mental Health website (www.medicarementalhealth.gov.au). The Commission also has resources for clinicians and users in identifying digital mental health services that are safe. DMHTs are generally regulated by the TGA where they meet the definition of a medical device. However, certain low-risk DMHTs are currently excluded from regulation. The TGA conducted a review of the legislation for software as a medical device and artificial intelligence (Al) as part of the Government's Safe and Responsible Al program and published a report.in July 2025. Stakeholders raised that the DMHT exclusion may no longer be appropriate and should be reviewed. The TGA has commenced a review of the way DMHTs are regulated and is engaging with the Commission on this work. The review will inform any potential changes required to strengthen oversight of DMHTs in Australia. The Government's regulatory approach to Al will continue to build on Australia's existing legal and regulatory frameworks, making sure that established laws remain the foundation for addressing and mitigating Al-related risks. The Government has invested $29.8 million in the Australian Al Safety Institute, which was established on 1 June 2026. The Institute will provide timely, expert-led advice to help regulators and agencies make informed decisions about strengthening or updating Australia's laws to keep pace with Al developments. The Government acknowledges DMHTs play an important role in improving access to care and remains committed to making sure these services are integrated into the broader mental health system in a way that supports safety and quality. Yours sincerely from the Assistant Minister for Mental Health and Suicide Prevention, Ms McBride