Considerations for regulation and evaluation of digital mental health technologies
Digital mental health technologies (DMHTs) are becoming well established within mental health services and through direct-to-consumer models. Due to their scalable nature, DMHTs may support services to bridge the gap between demand and the available workforce, particularly where existing pathways ha...
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| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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SAGE Publishing
2024-11-01
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| Series: | Digital Health |
| Online Access: | https://doi.org/10.1177/20552076241293313 |
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| _version_ | 1850176983918444544 |
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| author | Gareth Hopkin Richard Branson Paul Campbell Holly Coole Sophie Cooper Francesca Edelmann Mark Salmon |
| author_facet | Gareth Hopkin Richard Branson Paul Campbell Holly Coole Sophie Cooper Francesca Edelmann Mark Salmon |
| author_sort | Gareth Hopkin |
| collection | DOAJ |
| description | Digital mental health technologies (DMHTs) are becoming well established within mental health services and through direct-to-consumer models. Due to their scalable nature, DMHTs may support services to bridge the gap between demand and the available workforce, particularly where existing pathways have long delays or restricted capacity. Challenges and risks associated with DMHTs also need consideration. Regulatory and health technology assessment (HTA) agencies play a key role in ensuring the potential of DMHTs is achieved and their risks are mitigated. However, the nature of DMHTs and advances in digital technology present challenges for regulation and evaluation. In this paper, we describe eight key considerations across the regulatory and HTA pathway for DMHTs. These relate to 1) intended purpose, 2) qualification and classification, 3) risk management, 4) clinical evidence, 5) resource requirements and economic evidence, 6) post-market surveillance and life cycle assessment, 7) replicability and equity, and 8) wider responsibilities. Ensuring clarity within these considerations and addressing outstanding uncertainties is necessary to ensure that the benefits of DMHTs are unlocked, while also ensuring that people have access to high quality and safe tools. |
| format | Article |
| id | doaj-art-13faa09a853244e690fb40e93cc5b7fe |
| institution | OA Journals |
| issn | 2055-2076 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Digital Health |
| spelling | doaj-art-13faa09a853244e690fb40e93cc5b7fe2025-08-20T02:19:07ZengSAGE PublishingDigital Health2055-20762024-11-011010.1177/20552076241293313Considerations for regulation and evaluation of digital mental health technologiesGareth Hopkin0Richard Branson1Paul Campbell2Holly Coole3Sophie Cooper4Francesca Edelmann5Mark Salmon6 Science Evidence and Analytics Directorate, National Institute for Health and Care Excellence (NICE), Manchester, England, UK Software Team, Healthcare Quality and Access Group, Medicines and Healthcare products Regulatory Agency, London, England, UK Software Team, Healthcare Quality and Access Group, Medicines and Healthcare products Regulatory Agency, London, England, UK Software Team, Healthcare Quality and Access Group, Medicines and Healthcare products Regulatory Agency, London, England, UK Science Evidence and Analytics Directorate, National Institute for Health and Care Excellence (NICE), Manchester, England, UK Software Team, Healthcare Quality and Access Group, Medicines and Healthcare products Regulatory Agency, London, England, UK Science Evidence and Analytics Directorate, National Institute for Health and Care Excellence (NICE), Manchester, England, UKDigital mental health technologies (DMHTs) are becoming well established within mental health services and through direct-to-consumer models. Due to their scalable nature, DMHTs may support services to bridge the gap between demand and the available workforce, particularly where existing pathways have long delays or restricted capacity. Challenges and risks associated with DMHTs also need consideration. Regulatory and health technology assessment (HTA) agencies play a key role in ensuring the potential of DMHTs is achieved and their risks are mitigated. However, the nature of DMHTs and advances in digital technology present challenges for regulation and evaluation. In this paper, we describe eight key considerations across the regulatory and HTA pathway for DMHTs. These relate to 1) intended purpose, 2) qualification and classification, 3) risk management, 4) clinical evidence, 5) resource requirements and economic evidence, 6) post-market surveillance and life cycle assessment, 7) replicability and equity, and 8) wider responsibilities. Ensuring clarity within these considerations and addressing outstanding uncertainties is necessary to ensure that the benefits of DMHTs are unlocked, while also ensuring that people have access to high quality and safe tools.https://doi.org/10.1177/20552076241293313 |
| spellingShingle | Gareth Hopkin Richard Branson Paul Campbell Holly Coole Sophie Cooper Francesca Edelmann Mark Salmon Considerations for regulation and evaluation of digital mental health technologies Digital Health |
| title | Considerations for regulation and evaluation of digital mental health technologies |
| title_full | Considerations for regulation and evaluation of digital mental health technologies |
| title_fullStr | Considerations for regulation and evaluation of digital mental health technologies |
| title_full_unstemmed | Considerations for regulation and evaluation of digital mental health technologies |
| title_short | Considerations for regulation and evaluation of digital mental health technologies |
| title_sort | considerations for regulation and evaluation of digital mental health technologies |
| url | https://doi.org/10.1177/20552076241293313 |
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