Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, an advisor to MedTech suppliers, chair of the Urology Trade Association, and governor of the Anscombe Bioethics Centre, highlights new guidelines for assessing digital mental health apps.
The UK government’s medicines and medical devices regulator, the Medicines and Healthcare products Regulatory Agency [MHRA] has published new guidance to ensure digital mental health tech is effective, reliable and safe.
As take-up of mental health apps, artificial intelligence powered assessments, and virtual reality therapy grows, the Agency wants to remind manufacturers that complex software used to diagnose, prevent or treat conditions must meet medical device standards.
The new guidance sets out how manufacturers should define and communicate the intended purpose of a digital mental health technology, when that technology is considered a medical device under UK law, and how risk classification is determined, ensuring proportionate regulation for different types of technologies.
The review of regulation comes from a three-year Wellcome-funded project, launched in 2023, to explore the regulation of digital mental health products. Developed by the MHRA, with input from the National Institute for Health and Care Excellence, NHS experts, researchers, healthcare professionals, and people with lived experience, it aims to meet both clinical and real-world needs, to address the growing mental health crisis in the UK.
The Author used AI in preparing this article. Comments upon or questions about this article can be addressed to chris.whitehouse@whitehousecomms.com.
