Hopkin Gareth, Branson Richard, Campbell Paul, Coole Holly, Cooper Sophie, Edelmann Francesca, Gatera Grace, Morgan Jamie, Salmon Mark
National Institute for Health and Care Excellence, Manchester, UK.
Medicines and Healthcare products Regulatory Agency, London, UK.
Lancet Digit Health. 2025 Jan;7(1):e89-e93. doi: 10.1016/S2589-7500(24)00215-2. Epub 2024 Nov 15.
Demand for mental health services exceeds available resources globally, and access to diagnosis and evidence-based treatment is affected by long delays. Digital mental health technologies present an opportunity to reimagine the delivery of mental health support by providing innovative, effective, and tailored approaches that meet people's individual preferences and goals. These technologies also present new challenges, however, and efforts must be made to ensure they are safe and effective. The UK Medicines and Healthcare products Regulatory Agency and the National Institute for Health and Care Excellence have launched a partnership, funded by Wellcome, that explores regulation and evaluation of digital mental health technologies. This Viewpoint describes a series of key challenges across the regulatory and health technology assessment pathways and aims to facilitate discussions to ensure that approaches to regulation and evaluation are informed by patients, the public, and professionals working within mental health. We invite partners from across the mental health community to engage with, collaborate with, and provide scrutiny of this project to ensure it delivers the best possible outcomes.
全球范围内，心理健康服务的需求超过了现有资源，诊断和循证治疗的可及性受到长期延误的影响。数字心理健康技术提供了创新、有效且量身定制的方法，以满足人们的个人偏好和目标，从而为重新构想心理健康支持的提供方式带来了机遇。然而，这些技术也带来了新的挑战，必须努力确保其安全有效。英国药品和医疗产品监管局以及国家卫生与保健优化研究所发起了一项由惠康基金会资助的合作项目，该项目旨在探索对数字心理健康技术的监管和评估。本观点文章描述了监管和卫生技术评估路径中的一系列关键挑战，旨在推动相关讨论，以确保监管和评估方法能听取患者、公众以及心理健康领域专业人士的意见。我们邀请心理健康领域的各方合作伙伴参与、协作并审视该项目，以确保其能产生尽可能好的成果。
