Health apps can now be evaluated and recommended by a Danish Board for Health Apps
How to obtain a recommendation?
To obtain a recommendation, a health app must meet a series of specific criteria. The Board has identified four key evaluation categories:
- Evidence of Effectiveness
- User Friendliness
- Pricing
- Benefit to society
The evidence of effectiveness for a health app must be substantiated through clinical studies. Stricter requirements apply if the app is CE-marked as a medical device, necessitating additional documentation of its efficacy.
If the Danish Board for Health Apps determines that a health app meets the established criteria, the app will be included on a list of recommended health apps available on sundhed.dk, Denmark’s public health portal for citizens and healthcare professionals.
Why apply for a recommendation?
A recommendation by the Danish Board for Health Apps aims to provide transparency for users and healthcare professionals when identifying health apps of high medical quality.
From the economic operator's perspective, the primary benefit of a recommendation is its potential to provide a competitive market advantage to the company whose app receives it.
Applying for a recommendation is voluntary, and any application for the evaluation and presentation of a company’s health app will solely result in a recommendation at the Board’s discretion. The recommendation carries no legal implications for the app provider.
Practicalities: the application process
Applications are now open to companies, organizations, and developers involved in creating health apps. To initiate the evaluation process, applicants must submit a form available on the Danish Medicines Agency's website.
The application is reviewed by the secretariat, which, in consultation with the Board's chairmanship, decides whether the app should be assessed by an external expert.
A case report is drawn up based on (i) the application materials, (ii) any expert assessments, and (iii) the review conducted by the secretariat. This report is then reviewed by the Board, which meets approximately six times a year.
Decisions made by the Board are final and cannot be appealed, as they do not constitute legal rulings under administrative law.
It is currently unclear how long it will take to obtain a recommendation.
An evaluation is provided free of charge.
You can find more information and guidance on applications at the Danish Medicines Agency's website:
Alt er klar til ansøgere, der vil have sundhedsapps vurderet (in Danish)