Big Health Inc., San Francisco, California, USA.
Big Health Inc., London, UK.
Br J Clin Psychol. 2022 Jan;61 Suppl 1:130-135. doi: 10.1111/bjc.12286. Epub 2021 Mar 1.
With so many promising digital therapeutics for anxiety and obsessive-compulsive (OC) spectrum problems, there is an urgent need to consider how evolving regulatory oversight of digital therapeutics is poised to shift how these tools are developed, evaluated, reimbursed, and delivered. In this commentary, we discuss both opportunities and potential pitfalls associated with emerging government regulations of digital therapeutics for mental health, and we consider how applying the traditional 'prescription-based' medical approval paradigm to digital therapeutics for mental health could ultimately undermine and limit the broad accessibility of these software-based innovations that have been explicitly designed to expand the accessibility of care. For example, the vast majority of behavioural and mental health providers do not have 'prescription privileges' (a term originally rooted in pharmacologic practices), and as a result, under current regulations in the U.S. would not be authorized to make FDA-cleared digital therapeutics available to their patients. This is particularly concerning given that most digital therapeutics for mental health are directly rooted in psychological and behavioural science, yet psychologists would not be authorized to incorporate these innovations into their practice. We consider how synchronizing regulatory standards across countries may prove useful, and we conclude by arguing that multidisciplinary teams making regulatory decisions concerning digital therapeutics for mental health must include representation from the discipline and practice of psychology. PRACTITIONER POINTS: Emerging government regulations of digital therapeutics for mental health present both opportunities and potential pitfalls Applying the traditional 'prescription-based' medical approval paradigm to digital therapeutics for mental health could ultimately undermine the broad accessibility of these software-based innovations. Synchronizing regulatory standards across countries may prove useful. Multidisciplinary teams making regulatory decisions concerning digital therapeutics for mental health must include representation from the field of psychology.
随着针对焦虑和强迫症（OC）谱系问题的有前途的数字疗法越来越多，我们迫切需要考虑数字疗法不断发展的监管监督如何改变这些工具的开发、评估、报销和提供方式。在这篇评论中，我们讨论了与心理健康数字疗法新兴政府法规相关的既有机会，也有潜在的陷阱，我们还考虑了将传统的“基于处方”的医疗批准范式应用于心理健康数字疗法可能最终会产生的影响，以及这种做法会如何限制和阻碍这些专门为扩大护理可及性而设计的基于软件的创新的广泛可及性。例如，绝大多数行为和心理健康提供者没有“处方特权”（这个术语最初源于药理学实践），因此，根据美国目前的规定，他们无权将 FDA 批准的数字疗法提供给他们的患者。鉴于大多数心理健康数字疗法都直接植根于心理和行为科学，而心理学家却无权将这些创新纳入他们的实践，这一点尤其令人担忧。我们考虑了在各国之间协调监管标准可能带来的好处，并得出结论，负责心理健康数字疗法监管决策的多学科团队必须包括来自心理学学科和实践的代表。从业者要点：
心理健康数字疗法的新兴政府法规既带来了机遇，也带来了潜在的陷阱。
将传统的“基于处方”的医疗批准范式应用于心理健康数字疗法可能最终会破坏这些基于软件的创新的广泛可及性。
在各国之间协调监管标准可能会被证明是有用的。
负责心理健康数字疗法监管决策的多学科团队必须包括来自心理学领域的代表。
