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

ASSESS-DHT：欧洲数字医疗技术评估方法的开发和协调

• 批准号: 10106825
• 金额: $ 72.19万
• 依托单位: NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE
• 依托单位国家: 英国
• 项目类别: EU-Funded
• 财政年份: 2024
• 资助国家: 英国
• 起止时间: 2024 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=10106825
• 关键词: ASSESS; DHT; Deveploment; Harmonisation; Methodologies

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.

ASSESS-DHT 将增加整个欧洲对值得信赖且有效的数字健康技术 (DHT) 的采用，从而建立一个更加连贯的数字单一市场，让整个欧洲的卫生系统和患者能够访问 DHT，并为行业提供一个欧洲市场。超越现有模型的新评估框架，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方面的新​​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 组成。国际糖尿病联盟和欧洲心脏病学会纳入了在欧盟监管、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的学术和非营利组织。通过提供产品的公司，我们通过模仿实际 HTA 评估的正式方法进行评估 - 3 作为合作伙伴，一些通过数字欧洲进行公开征集和全行业咨询，我们将通过我们的咨询委员会与医疗保健支付者和部门进行接触。将共同创建我们的总体评估框架，并通过新颖的基于证据的类型学指定不同类别的 DHT 的专门途径。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，我们将开发一个可持续的存储库，其中包含 ASSESS-DHT 框架、路径和明确的标准、语义可搜索的证据库、清单和工具。通过证据生成、DHT 的卫生系统价值证据和在线实践社区为公司提供支持。