Health apps insight
Proposed framework for a new health apps board has just been published. New executive order on rules of procedure for this board is going out for consultation.
At the start of the year, the government and all of the parties represented in the Danish parliament agreed to a new strategy for the digitization of Denmark. The parties to this agreement agreed to allocate funding from 2024 to 2027 for a new board to be tasked with assessing whether to recommend and display health apps on sundhed.dk.
According to this agreement, the aim of the board is to provide citizens and healthcare personnel with a better overview and guidance on high-quality healthcare apps.
This is the reason why the new executive order on the rules of procedure for this board is going out for consultation.
The consultation letter states that the board intends to apply a broad definition in relation to health apps in the form of a software programme to be used on mobile phones, tablets, personal computers or wearables.
In this respect, it is important to keep in mind that according to the consultation letter, the board will be assessing apps which either are or are not categorised as a medical device.
Further, the consultation letter states that after the introduction of this board, it is not a requirement that health apps receive board recommendation prior to being used by the healthcare services.
The draft executive order makes it clear that the board will be assessing apps based on applications from companies or other suppliers or developers of health apps upon recommendation from the Danish Medicines Agency. In addition to that, the board will also be able to request applications within specific disease areas.
In relation to recommendation criteria, the draft executive order states that health apps will be recommended based on a number of assessment criteria on, for instance, effect, evidence, user friendliness and reasonable pricing. The board will establish the specific criteria to apply. If an apps has received recommendation, it will be displayed on sundhed.dk.
The draft executive order also outlines rules in relation to members of the board, voting rules, impartiality, confidentiality, etc.
If you have any comments to this draft executive order, please note that you must provide these comments by 5 April 2024, at 12 noon at the latest.
According to the plan, the new statutory order comes into force on 1 July 2024.
We will follow this process closely and an update will be provided when possible.
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If you have any questions, please contact our Life Science team.
