Digi-HTA, the Finnish health technology assessment model for digital health technologies

Abstract The digitalisation of social and healthcare services is progressing rapidly in Finland. A wide range of digital health technologies (DHTs) are already in use or will be implemented soon, including digital lifestyle interventions, digital therapeutics (DTx), digital home care solutions, and digital service centres for citizens. The use of innovative technologies like artificial intelligence (AI) is expanding, and robotics is already applied in areas such as rehabilitation and medicine dispensing in home care. Assessing the diverse value of DHTs has posed a challenge. To address this, the Finnish Ministry of Social Affairs and Health commissioned the University of Oulu and Finnish Coordinating Center for Health Technology Assessment (FinCCHTA) to develop a new health technology assessment (HTA) model. The result, Digi-HTA, was launched in late 2019 and integrated into FinCCHTA's routine operations since then. It was the first framework to systematically assess a wide range of DHTs-such as health apps, digital home care solutions, AI solutions, and robotics-within a single structure. Digi-HTA is already being used by Finland's wellbeing services counties to support decisions and procurements. Additionally, a reimbursement pilot for digital health applications will be launched during the current government term, requiring approved apps to pass a Digi-HTA assessment. DHTs’ value is highly dependent on their context of use-they are tools that can help reshape care processes and potentially provide benefits for multiple stakeholders simultaneously, such as improving citizens’ health and increasing the efficiency of service delivery. HTA for DHTs demands new considerations beyond traditional HTA domains like effectiveness, cost, and safety. Aspects such as cybersecurity, usability, and accessibility for all intended users are essential. The use of AI in healthcare also introduces new HTA perspectives that have not been considered in previous HTA methodologies