EDiHTA: The first European Digital Health Technology Assessment framework co-created by all stakeholders along the value chain

数字医疗技术(DHTs)有望改善欧洲社会医疗服务的质量和提供，同时确保欧洲医疗系统的可持续性。DHTs还能够收集与决策者相关的真实世界数据和证据。然而，DHTs的实施对评估标准的标准化提出了新的方法学挑战。现有的卫生技术评估(HTA)无法捕捉到DHTs的真正附加值。EDiHTA将是第一个达到TRL 6-7的灵活、包容、经过验证和随时可用的欧洲HTA框架，允许在不同的TRL、地区级别(国家、地区和地方)和视角(如付款人、社会、医院)对不同的DHTA(例如远程医疗、Mapp、人工智能)进行评估。所有相关利益攸关方都将参与其设计、开发和验证。数字框架将在欧洲5家主要医院的真实医疗环境中进行试点，并通过与欧洲DHT开发商的开放试点计划进行。EDiHTA的原则是1)促进所有利益攸关方参与，以便在国家和欧洲层面建立共识；2)定义一个通用术语，协调和丰富现有的HTA框架，并创建一个开放的储存库，其中包括框架、指南、文章和HTA方法；3)优化DHT生命周期的评估流程；4)遵循多利益攸关方、多领域和模块化的方法；5)共同创建EDiHTA解决方案；以及6)为DHTS提供经过验证和随时可用的数字化HTA框架。除了HTA研究领域的领先学术团体，我们的多学科联盟还包括HTA机构、作为DHT最终用户的诊所、技术提供商和一个患者组织，该组织与更广泛的欧洲医疗保健领域的监管机构、政策制定者和支付者建立了联系。EDiHTA将利用其网络加快新DHTs的市场进入，造福欧洲社会。

Digital health technologies (DHTs) are expected to improve both the quality and delivery of healthcare services for European societies while ensuring the sustainability of Europe`s healthcare systems. DHTs are also able to collect real-world data and evidence relevant for decision makers. However, the implementation of DHTs implies new methodological challenges to the standardisation of assessment criteria. Existing Health Technology Assessments (HTAs) are unable to capture the real added value of DHTs. EDiHTA will be the first flexible, inclusive, validated and ready-for-use European HTA framework reaching TRL 6-7, allowing the assessment of different DHTs (e.g. telemedicine, mApps, AI) at different TRLs, territorial levels (national, regional and local) and perspectives (e.g. payer, society, hospital). All relevant stakeholders will contribute to its design, development and validation. The digital framework will be piloted in real healthcare settings in 5 major European hospitals and through an open piloting scheme with European DHT developers. The principles of EDiHTA are to 1) promote a holistic approach involving all stakeholders for consensus building at national and European levels; 2) define a common terminology, harmonise and enrich existing HTA frameworks and create an open repository with frameworks, guides, articles and HTA methodologies; 3) optimise assessment processes along the DHT life cycle; 4) follow a multi-stakeholder, multi domain and modular approach; 5) co-create EDiHTA solutions; and 6) provide a validated and ready-for-use digital HTA framework for DHTs. Next to leading academic groups in HTA research, our multidisciplinary consortium includes HTA agencies, clinics as DHT end-users, technology providers and a patient organisation with links to the broader European healthcare landscape of regulatory bodies, policymakers and payers. EDiHTA will leverage its network to accelerate the market entry of new DHTs for the benefit of European society.