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

ASSESS-DHT将在欧洲范围内增加可信和有效的数字健康技术（DHT）的采用，使卫生系统和患者能够从欧洲各地访问DHT，并为行业提供欧洲市场。我们将开发一个新的评估框架，超越现有的模型，能够在整个欧洲统一采用HTA，解决数字治疗，人工智能和远程医疗的新评估挑战。我们的联盟包括4个卫生技术评估机构，欧洲卫生系统和政策观察站，5个学术和非营利组织，他们在欧盟法规，DHT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具有专业知识。通过国际糖尿病联合会和欧洲心脏病学会将患者和卫生专业人员包括在内。我们通过产品公司将DHT行业包括在内，以便我们通过模拟实际HTA评估的正式方法进行评估- 3作为合作伙伴，有些通过公开电话和通过DIGITAL EUROPE进行全行业咨询。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，通过一个新的循证类型学指定的不同类别的DHT的专业途径。我们将满足分阶段采用（超越DiGA等快速通道模型），复杂的生命周期，迭代开发的人工智能，在全面的HTA评估手册中进行整合，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存储库，其中包含ASSESS-DHT框架，途径和明确的标准，语义搜索证据库，清单和工具，以支持公司提供证据生成，来自DHT的卫生系统价值证据，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.