Introduction of new and innovative digital health technologies (DHTs), including health apps, should follow the same criteria as other healthcare methods. They must provide evidence-based benefits and be safe to use, and their impacts on patients and organizations need to be clarified. In the case of DHTs, products’ data security and protection must also be ensured in all situations, and special attention should be paid to their usability and accessibility.

The new and innovative DHTs require new health technology assessment (HTA) methods as well. Digi-HTA has been developed in Finland for that purpose, supporting HTA activities for all new DHTs, including health apps, artificial intelligence and robotics solutions. Digi-HTA has been part of daily HTA operations of the Finnish Coordinating Center for Health Technology Assessment (FinCCHTA) since the end of 2019.

Internationally, there are more and more HTA frameworks available that support HTA activities for DHTs. One of the most well-known is the DiGA assessment model, which is also linked to the national reimbursement process in Germany. CEN/ISO TS 82304-2:2021 is an assessment framework that provides requirements for the specification for a health app quality label. The NordDEC assessment method has been developed to support joint Nordic assessment activities for health apps. In order to ensure that Digi-HTA would be as compatible as possible with other recognized assessment methods, FinCCHTA has carried out a comparison work that includes the DiGA and NordDEC assessment models and the CEN/ISO TS 82304-2:2021 technical specification. Based on this comparison work, it can be noted that the assessment models share many similarities. The main differences were related to how comprehensively the cost utility and ethical perspectives were examined in different frameworks. There were also differences in supported DHTs.