Artificial intelligence in digital mental health technology: Considerations for regulation

Artificial intelligence (AI) is being introduced into all aspects of life with notable adoption seen in health care and systems and growing utility in the domain of digital mental health technology (DMHT). The Medicines and Healthcare products Regulatory Agency and the National Institute for Health and Care Excellence in the UK are together exploring the regulation and evaluation of DMHT through a Wellcome-funded project. As part of this initiative, a symposium was held to bring together experts from across the AI and DMHT sector representing a breadth of disciplines, to share insights and inform the project. This review presents a reflection of the key opportunities and challenges of AI in DMHT with a focus on medical device regulation, distilling the main themes from the symposium. To facilitate responsible and agile regulation enabling access to high quality, safe, and effective medical products, regulators will need to continually adapt and develop, with new processes, guidance, initiatives and forums to fully engage in this innovative, exponentially developing field.