ASSESS-DHT: DEVELOPMENT AND HARMONISATION OF METHODOLOGIES FOR ASSESSING DIGITAL HEALTH TECHNOLOGIES IN EUROPE

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 models like DiGA), complex life-cycles, iteratively developed AI, consolidated in a comprehensive HTA assessment manual plus specific 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.