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

数字医疗技术（dht）有望提高欧洲社会医疗服务的质量和交付，同时确保欧洲医疗系统的可持续性。dht还能够收集与决策者相关的真实数据和证据。然而，实施dht意味着对评估标准标准化提出了新的方法挑战。现有的卫生技术评估（hta）无法捕捉到dht的真正附加价值。EDiHTA将是第一个达到TRL 6-7的灵活、包容、经过验证和即用的欧洲HTA框架，允许在不同的TRL、领土层面（国家、区域和地方）和角度（例如付款人、社会、医院）评估不同的dht（例如远程医疗、mApps、人工智能）。所有相关利益相关者都将参与其设计、开发和验证。该数字框架将在欧洲5家主要医院的实际医疗保健环境中进行试点，并通过与欧洲DHT开发人员的开放试点计划进行试点。EDiHTA的原则是1)促进涉及所有利益相关者的整体方法，以在国家和欧洲层面建立共识；2)定义通用术语，协调和丰富现有的HTA框架，并创建一个包含框架、指南、文章和HTA方法的开放存储库；3)沿着DHT生命周期优化评估流程；4)遵循多利益相关者、多领域和模块化方法；5)共同打造EDiHTA解决方案；6)为dht提供一个经过验证的、可用的数字HTA框架。除了HTA研究领域的领先学术团体外，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、政策制定者和支付方有联系的患者组织。EDiHTA将利用其网络加速新dht的市场进入，以造福欧洲社会。

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.