ASSESS-DHT: Deveploment and Harmonisation of Methodologies for Assessing Digital Health Technologies un Europe

评估-DHT将在整个欧洲增加对值得信赖和有效的数字健康技术(DHT)的采用，实现一个更连贯的数字单一市场，让来自欧洲各地的医疗系统和患者可以访问DHT，并为行业提供一个欧洲市场。我们将在现有模式的基础上开发一个新的评估框架，能够在整个欧洲统一采用HTA，以应对数字治疗、人工智能和远程医疗领域的新评估挑战。我们的联盟由4个HTA机构、欧洲卫生系统和政策观察站、5个学术和非营利性组织组成，这些组织在欧盟法规、分布式哈希表开发和评估方法、数据保护、数据质量、互操作性和网络安全方面拥有专业知识。通过国际糖尿病联合会和欧洲心脏病学会纳入患者和卫生专业人员。我们通过拥有供我们通过模仿实际HTA评估的正式方法进行评估的公司将DHT行业包括在内-3作为合作伙伴，一些公司通过数字欧洲的公开呼吁和行业咨询进行评估。我们将通过我们的咨询委员会与医疗保健支付者和部委接触。我们将共同创建我们的总体评估框架，通过一种新的基于证据的类型学为不同类别的DHT指定专门的路径。我们将迎合阶段性采用(超越像Diga这样的快速通道模型)、复杂的生命周期、迭代开发的人工智能、整合在全面的HTA评估手册中以及网络安全等主题的特定指南。我们将开发一个可持续的储存库，其中包含评估-分布式哈希表框架、路径和明确的标准，一个语义可搜索的证据库，核对表和工具，以支持公司的证据生成，分布式哈希表健康系统价值的证据，以及在线实践社区。

ASSESS-DHT will increase the adoption of trustworthy and effective Digital Health Technologies (DHT) across Europe, enabling a more coherent digital single market, for health systems and patients to access DHT from all over Europe and giving industry a European market. We will develop a new assessment framework, beyond the existing models, capable of uniform HTA adoption across Europe, addressing new assessment challenges in Digital Therapeutics, AI and telehealth. Our consortium comprises 4 HTA bodies, the European Observatory on Health Systems and Policies, 5 academic and not for profit organisations with expertise in EU Regulation, DHT development and assessment methodologies, data protection, data quality, interoperability and cybersecurity. Patients and health professionals are included through the International Diabetes Federation and European Society of Cardiology. We include the DHT industry through companies with products for us to assess through a formal methodology mimicking actual HTA assessments – 3 as partners, some through an open call and industry-wide consultation via DIGITAL EUROPE. We will engage healthcare payers and ministries through our Advisory Board. We will co-create our overarching assessment framework with specialised pathways for different categories of DHT specified through a novel evidence-based typology. We will cater for phased adoption (going beyond fast track modelslike DiGA), complex life-cycles, iteratively developed AI, consolidated in a comprehensive HTA assessment manual plusspecific guides in topics like cybersecurity. We will develop a sustainable repository containing the ASSESS-DHT framework, pathways and unambiguous criteria, a semantically searchable evidence library, checklists and tools to support companies with evidence generation, evidence of health system value from DHT, and online communities of practice.