Implementation of a new Digi-HTA process for digital health technologies in Finland

Abstract

Objectives There has been a lack of health technology assessment (HTA) methods for novel digital health technologies (DHTs) such as mHealth, artificial intelligence, and robotics in Finland. The Digi-HTA method has been developed for this purpose. The aim of this study is to determine whether it would be possible to use Digi-HTA recommendations to support healthcare decision-makers. Secondly, from the perspective of companies offering different types of DHT products, this study assesses the suitability of using the Digi-HTA framework to perform HTAs for their products. Methods Feedback about Digi-HTA recommendations was collected from healthcare professionals. DHT companies provided input about the Digi-HTA framework. Data were collected via a web-based survey and were analyzed using qualitative methods. Results Of the twenty-four healthcare professional respondents, twenty said that the Digi-HTA recommendations contained all the necessary information, and twenty-one found them useful for their work. Respondents hoped that the Digi-HTA recommendations would be better integrated into the decision-making processes and healthcare professionals would be more informed about this new HTA process. The questions of the Digi-HTA framework were applicable for different DHT products based on the responses from DHT companies (n = 8). Conclusions According to the study participants, although the Digi-HTA recommendations include clear and beneficial information, their integration into healthcare decision-making processes should be improved. Responses from DHT companies indicate that the Digi-HTA framework would be an appropriate tool for performing assessments for their products. To generalize the findings of this study, more comprehensive studies will be needed.

International practices in health technology assessment and public financing of digital health technologies: recommendations for Hungary

“…The implementation of innovative DHTs, − particularly focusing on AI and robotics, that support smart aging and care at home - was fostered by the publication of Hyteairo and KATI frameworks by the Ministry of Social Affairs and Health in Finland between 2018–2019 ( 33 ). Recognizing shortcomings of the KATI framework, a new general-purpose HTA, “Digi-HTA” was developed and implemented in 2019, aimed to cover a broader range of DHTs, by the Finnish Coordinating Center for Health Technology Assessment (FinCCHTA) and University of Oulu ( 7 ).…”

“…Reassessment can be requested by the developer in case of significant product/service changes. According to a survey carried out among health professionals and DHT companies, there is a clear need to further integrate into the reimbursement decision-making processes, as there is currently no formal process for this, contrary to Germany ( 7 ).…”

“…With almost as many approaches to this as health systems in Europe, significant differences can be observed in the types of technologies countries have included, as well as the methods chosen to assess and make solutions available to patients. German DiGAs so far are mostly low-risk health apps and web-based platforms, whereas other countries like France and Finland are also integrating telemedicine, AI solutions, and robotics in their frameworks ( 7 , 10 , 11 ). There are also considerable differences in the assessment domains across the studied countries, with the outcome of the assessment ranging from a multi-level tier system, traffic light system or simple go/no-go decisions.…”

Knowledge management tools and mechanisms for evidence-informed decision-making in the WHO European Region: a scoping review

“…Demand-led evidence briefing service, a resource-intensive service, was not associated with increases in NHS commissioners capacity to acquire, assess, adapt and apply research evidence to support decision-making compared with less intensive and less targeted strategies [ 79 ]. Included studies showed that HTA [ 80 – 83 ], CED schemes [ 84 , 85 ], evidence-based national guidelines [ 86 ] and DECIDE tool [ 87 ] can inform resource allocation and reimbursement decisions to create the most value for money. Data mining and public health triangulation was also identified as tools to support decision-making in public health [ 88 , 89 ].…”

Stakeholder preferences for attributes of digital health technologies to consider in health service funding

“…Our systematic review of DHT evaluation frameworks (2) identified recommendations for DHT-specific issues in all nine domains, particularly safety and ethical analysis. Recently, specific HTA frameworks for DHTs have been developed and used for funding decisions (e.g., UK’s ESF (2) and DTAC (3), Germany’s DiGA, and Finland’s Digi-HTA (4;5)), but none cover issues in all nine domains. In addition, to the best of our knowledge, there have been no studies over a broad cross-section of the general community, patients, carers, and health professionals, to understand the relative importance of the issues included in these DHT frameworks and recommended in the DHT evaluation literature.…”