Details of the application process to the Danish Board for Health Apps

In December 2024, the Danish Board for Health Apps (Nævnet for Sundhedsapps) published information on how to apply for the health app evaluation, including the electronic form for the application to the Board of Health Apps, the assessment criteria, and details of the application process. 

The application form consists of seven topics, including clinical evidence, usability, and price. 

The assessment criteria are divided into four categories: evidence of effect, user-friendliness, price, and societal value. Specific information included in the assessment of the health apps is available in the specific application guidelines (separately for CE-marked and non-CE-marked health apps).

Before submitting an application, it must be ensured that the health app falls within the definition of a medical device. Applications generally will be processed in the order in which the secretariat has received complete applications.

If the health app is recommended, it will appear in the list of recommended health apps on sundhed.dk. The secretariat ensures that the information provided in the application for viewing on sundhed.dk is accurate. In the event that the application is rejected, the reason for the rejection will be provided, including an explanation of the specific requirements that the Board assesses that the health app does not meet.

See the full details in Danish here and here.

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