A life-cycle approach to digital health technology assessment

The approach of Health Technology Assessment, which developed from the Evidence-Based Medicine movement of the 1990s, has proved its value in appraising the value of pharma products but presents methodological challenges when applied to medical devices and digital technologies, whose importance has increased enormously during the last 30 years. The concept of a single assessment, which can summarize relative effectiveness and cost-effectiveness, has been further challenged by the rapidly rising importance of software-driven devices, and latterly Artificial Intelligence. The need to adopt a broader evaluation approach based on product life cycles has been recognized by both regulators and HTA bodies, but practical frameworks for this have not yet been widely adopted. We describe a Life-Cycle-Based Evaluation (LCBE) approach to the assessment of Digital Health Technologies, developed as part of the ASSESS-DHT Horizon Europe 2020 project, EU project 101137347. The LCBE framework is currently being evaluated in pilot studies and aims to support early, proportionate, and continuous assessment and foster collaboration among developers, regulators, and HTA bodies to ensure timely, rigorous, and adaptive evaluations across the technology life cycle.