With the rapid development of digital health services, the number of health apps on the market has increased significantly. Today, more than 270 000 health apps are available in Sweden, but there is no harmonised national framework for quality assurance. This creates challenges for manufacturers, the public sector and individual users.

Municipalities and regions are faced with the task of independently quality assuring apps, which leads to increased development costs for companies and a slow pace of implementation. At the same time, individuals lack clear information about which apps are safe and effective to use.

The project aims to increase knowledge on quality assurance of health apps, start using existing frameworks and build capacity of the public sector to effectively quality assure and implement digital health services. It is expected to lead to increased trust in health apps and common boundaries for a more effective implementation in the public sector.

Overall objectives of the project

• Increase knowledge about quality assurance of health apps for an equal and common understanding of quality in Sweden.

• Start using and creating demand for common quality assurance frameworks for health apps

Participating organisations

Ten actors are participating as project partners, with Swedish Medtech, the Swedish eHealth Agency and KTH being part of a national reference group to gather knowledge. The project is funded by the Swedish Agency for Economic and Regional Growth and runs from February 2025 to June 2027.

Areas of intervention of the project

Dissemination of knowledge

Targeted communication actions and open seminars on different themes describing and clarifying the quality of digital health services, as well as knowledge sharing communities.

Here you can find the content of the seminar series “Quality review of a health app”. It is mainly aimed at the public sector and all four seminars will be published online. (It is possible to register for the remaining seminars, even if you missed the first ones. Video recordings of all seminars will also be published online).

Implementation and evaluation of quality frameworks

Use of existing quality frameworks in the screening of Swedish health apps. The work is done together with both companies and the public sector to identify common limits and interpretations. Two relevant frameworks to look at are the international technical specification ISO/TS 82304-2:2021, and the Nordic framework NordDEC.

National scale-up

Lead a national reference group with representatives from government, academia and industry associations to promote dialogue and exchange of experience nationally and internationally.