Fassbender Amelie, Donde Shaantanu, Silva Mitchell, Friganovic Adriano, Stievano Alessandro, Costa Elisio, Winders Tonya, van Vugt Joris
Medical Affairs DM, Viatris, Hoeilaart, Belgium.
Medical Affairs, DM&JANZ, Viatris, Hatfield, London, UK.
Ther Clin Risk Manag. 2024 Dec 27;20:939-954. doi: 10.2147/TCRM.S489873. eCollection 2024.
Digital therapeutics (DTx) are an emerging medical therapy comprising evidence-based interventions that are regulatory approved for patient use, or are under development, for a variety of medical conditions, including hypertension, cancer, substance use disorders and mental disorders. DTx have significant potential to reduce the overall burden on healthcare systems and offer potential economic benefits. There is currently no specific legal regulation on DTx in the EU. Although European countries have similar approaches to digital health solutions, the adoption of DTx varies across the continent. The aim of this narrative review is to discuss the levels of adoption of DTx in Europe, and to explore possible strategies to improve adoption, with the goal of higher rates of adoption, and more consistent use of DTx across the continent. The article discusses the regulatory and reimbursement landscape across Europe; validation requirements for DTx, and the importance of co-design and an ecosystem-centric approach in the development of DTx. Also considered are drivers of adoption and prescription practices for DTx, as well as patient perspectives on these therapeutics. The article explores potential factors that may contribute to low rates of DTx adoption in Europe, including lack of harmonisation in regulatory requirements and reimbursement; sociodemographic factors; health status; ethical concerns; challenges surrounding the use and validation of AI; knowledge and awareness among healthcare professionals (HCPs) and patients, and data standards and interoperability. Efforts to improve rates of access to DTx and adoption of these therapeutics across Europe are described. Finally, a framework for improved uptake of DTx in Europe is proposed.
数字疗法（DTx）是一种新兴的医学疗法，包括基于证据的干预措施，这些措施已获得监管部门批准可供患者使用，或正在开发中，用于治疗多种疾病，包括高血压、癌症、物质使用障碍和精神障碍。数字疗法有巨大潜力减轻医疗保健系统的整体负担，并带来潜在的经济效益。目前欧盟对数字疗法没有具体的法律规定。尽管欧洲国家对数字健康解决方案有类似的做法，但数字疗法在欧洲大陆的采用情况各不相同。本叙述性综述的目的是讨论欧洲数字疗法的采用水平，并探索提高采用率的可能策略，目标是在整个欧洲大陆提高数字疗法的采用率，并使其使用更加一致。本文讨论了欧洲各地的监管和报销情况；数字疗法的验证要求，以及共同设计和以生态系统为中心的方法在数字疗法开发中的重要性。还考虑了数字疗法的采用驱动因素和处方实践，以及患者对这些疗法的看法。本文探讨了可能导致欧洲数字疗法采用率低的潜在因素，包括监管要求和报销缺乏协调；社会人口因素；健康状况；伦理问题；围绕人工智能使用和验证的挑战；医疗保健专业人员（HCP）和患者的知识与意识，以及数据标准和互操作性。描述了在整个欧洲提高数字疗法可及性和采用率的努力。最后，提出了一个在欧洲提高数字疗法采用率的框架。
