Danish Board for Health Apps

Applications for a health app recommendation from the Danish Board for Health Apps are submitted using the application form: Application to the Danish Board for Health Apps

To complete the application form correctly, please first:

• read the available guidance documents carefully:Guide to CE-marked Health Apps (word), Guide to Non-CE-marked Health Apps (word) (In Danish only),
• find the information and documents needed to complete the form,
• complete and sign the declaration of truth: Link to the Declaration of truth (word) (in Danish only).

The application form has several steps in which you must answer questions, enter information and upload documents within the following seven topics:

1. General information about the applicant and the health app
2. Clinical evidence
3. Usability
4. Price
5. Social value
6. Security and access 
7. Declaration of truth

The secretariat of the Danish Board for Health Apps is responsible for storing and handling all data entered and the documents attached to the application form. The information provided is shared with the members of the Danish Board for Health Apps; with employees of the Danish Medicines Agency who provide services to the Board; and, where appropriate, with experts.

If you have any questions, please contact the Secretariat of the Danish Board for Health Apps at sundhedsapps@dkma.dk.

Below, we outline the criteria to be fulfilled if a health app is to be recommended by the Danish Board for Health Apps. The assessment criteria have been established by the Danish Board for Health Apps and fall into four categories: evidence of efficacy, usability, price and social value.

Evidence of efficacy

The efficacy of a health app must be based on clinical studies, since the efficacy of the health app must not be called into question once the app is recommended to the public and healthcare professionals.

The evidence to be provided depends on whether or not the health app is a CE-marked medical device.

In the case of health apps that are CE-marked as medical devices, studies must be submitted to demonstrate the app’s efficacy. The assessment of CE-marked health apps is based on whether there is evidence of the app’s efficacy, and whether this evidence is documented at the level required according to the regulation and risk class under which the health app is registered

In the case of health apps that are not CE-marked as medical devices, studies must be submitted to demonstrate the efficacy of the intervention that is used or communicated in the health app concerned. The assessment of a non-CE marked health app is based on whether there is evidence of the efficacy of the intervention that is used or communicated by the health app.

Usability

The health app must support a positive, efficient and intuitive interaction with the user, thus meeting the needs and expectations of the users. You must provide evidence of its usability, for example through a usability test or user survey as well as functionality descriptions and possibly design and accessibility standards. 

Price

The payment method and price must be proportional to the efficacy expected to be delivered by the health app.

Social value

The health app is expected to contribute to solving health and social challenges through prevention and increased accessibility. You must explain how the health app will support the Danish healthcare sector in terms of both direct and indirect social value. Direct social value means a reduction in direct costs, for example through reductions in healthcare needs, including number of consultations and supplied medicine. Indirect social value means a reduction in indirect costs, for example reduced sick leave.

Before submitting an application, you should verify that the health app qualifies as a medical device. For more information on CE marking of medical devices, please refer to the Danish Medicines Agency's introduction here.

The guides below go through the specific data that is included in the assessment of the health app:

Guide to CE-marked Health Apps (word)

Guide to non-CE-marked Health Apps (word)

This section explains what happens after you have applied for a Board-recommendation.

1. Once you have completed your application using the application form, you will receive an email confirmation from the secretariat shortly after.
   The secretariat then reviews your application, ensuring that all questions have been answered adequately and that the required documents have been uploaded. It is also verified that the CE marking has been correctly applied and that the application complies with it.
   If the secretariat has questions or requires further information, they will contact you at the email address you provided in the application.
   
2. When the application file is considered complete, the secretariat decides (possibly in consultation with the Board’s leadership) whether the health app needs to be assessed by an external expert. Among other things, experts will be used to assess health apps related to specific disease areas, and experts might also be used in other areas, such as technology.
   The experts' opinions are included in the Board's assessment of the health app.
   
3. Based on the application documents, any expert opinions and the secretariat’s review, a case report is prepared and subsequently processed at a Board meeting.
   Applications are generally processed in the order in which the secretariat receives complete application documents.
   
4. At the meeting of the Danish Board for Health Apps, the Board assesses whether or not to recommend the health app. It may lay down specific conditions for the recommendation of the health app. The Board may also – in agreement with the Chair – ask you to appear before the Board to present or elaborate on your application.
   
5. If the health app is recommended, it will be featured on the list of recommended health apps on sundhed.dk, the Danish e-Health Portal. The secretariat ensures that the information you have provided in your application for display on sundhed.dk is accurate.
   
6. If your application is rejected, you will also receive an explanation of the decision, which will also outline which specific requirements the Board found the app failed to meet.

If your health app has been recommended by the Board and you subsequently make changes to it, you will need to pay attention to certain aspect – and (depending on the nature and extent of the change), you may also be required to notify the Board.

Board recommendations are based on the version of the health app originally applied for, or the version most recently assessed by the Board. You must therefore inform the Board if you modify, for example, the app’s content, design, information for sundhed.dk or the technology of a recommended health app. This is required because changes like these might impact the criteria for the health app’s recommendation or lead to changes to the information displayed on sundhed.dk.

Three categories of changes

The Board distinguishes between three categories of changes. The category of change determines whether and how you should inform the Board of the change.

• Significant changes must be reported immediately when implemented
• Minor changes must be reported at the annual review
• Insignificant changes should not be reported to the Board

Significant changes

You must report significant changes to the health app when they are implemented, since these may impact the Board’s health app recommendation. The Board must therefore be given the opportunity to review significant changes when implemented. This applies to the following changes:

• Changes to the health app’s general information. This could be changes requiring adjustments to the app description on sundhed.dk as well as changes to the purpose, target group, language, devices, use of wearables etc.
• Significant changes in the efficacy of the health app, including changes affecting the clinical evidence used as documentation in the application
• Significant changes to the documentation of usability, including considerable changes to functionality and availability
• Any changes to the price of using the health app, including changes in payment method, the use of ads and the like
• Significant changes to the health app affecting its social value

You can report significant changes by using this change notification form (in Danish only) and send it to sundhedsapps@dkma.dk.

Minor changes

You are required to report minor changes at the annual health app review. At the annual review you will be asked to fill in a change log detailing all the relevant changes made in the past year.

The secretariat will contact you when it is time for the annual review.

Minor changes include: 

• Minor modifications and enhancement of app functionality with no material effect on the assessment criteria
• Changes to systems for and handling of user errors and incident detection
• Modifications to the design and setup of the health app affecting its overall appearance
• Changes in collaborative relations and/or the organisation behind the health app, including, for example, partnerships or new evaluations of authorities in Denmark or abroad

Insignificant changes

You are not required to report insignificant changes to the Danish Board for Health Apps.

This includes the ongoing updating and adaptation of content, for example, changes that are part of the routine operation of many health apps, provided no significant changes to the assessment criteria are involved. It also includes simple changes to the app’s design, appearance and technical improvements that do not affect the assessment criteria for recommendation of health apps.

If you have any questions about how to handle a change to a Board-recommended health app, please contact the Board secretariat at sundhedsapps@dkma.dk.

The Minister for the Interior and Health appoints members to the Danish Board for Health Apps. The Board comprises up to 11 members, each appointed for a term of up to four years.

The Minister for the Interior and Health has appointed eight members to the Danish Board for Health Apps:

• Erik Jylling, Regional Chief Operations Officer of the Capital Region of Denmark, nominated by Danish Regions (Chair)
• Ann Leistiko, Chief Executive Officer of the Danish Lung Association, nominated by Danish Patients (Vice-Chair)
• Rikke Saltoft, Head of IT at København Kommunes Sundhedsforvaltning (Copenhagen Health Administration), nominated by Local Government Denmark. 
• Bjarne Skjødt Hjaltalin, Clinical Director and member of the Board of Consultants and the Digitisation and IT Committee of the Danish Medical Association
• Niels Ulrich Holm, Physician and Vice-Chair of the Organization of General Practitioners
• Christine Lonager Boesen, Social Analysis Consultant, DaneAge Association
• Lene Laursen, Deputy Director General, Medicoindustrien
• Laura Duus Dahlin, Head of Digital Health and Innovation, Danish Chamber of Commerce

The Board may, as necessary, appoint alternates for the members to take part in the Board's work.

Board meeting dates

2025

• 19 February 2025, from 3pm to 6pm
• 9 April 2025, from 3pm to 6pm
• 26 June 2025, from 3pm to 6pm
• 15 September 2025, from 3pm to 6pm
• 25 November 2025, from 9am to 12pm

2026

• 3 February 2026, from 9am to 12pm
• 16 April 2026, from 9am to 12pm
• 23 June 2026, from 12pm to 3pm
• 30 September 2026, from 3pm to 6pm
• 1 December 2026, from 12pm to 3pm

Agendas (in Danish)

Agenda: 25 november 2025 (pdf)

Agenda: 15 September 2025 (pdf)

Agenda: 26 June 2025 (pdf)

Agenda: 9 April 2025 (pdf)

Agenda: 19 February 2025 (pdf)

Agenda: 6 November 2024 (pdf)

Minutes (in Danish)

Minutes: 26 June 2025 (pdf)

Minutes: 9 April 2025 (pdf)

Minutes: 19 February 2025 (pdf)

Minutes: 6 November 2024 (pdf)

The Danish Medicines Agency serves as secretariat to the Danish Board for Health Apps. The secretariat gives advice to applicants, processes incoming applications and helps organise the Board’s work in collaboration with the Board’s leadership.

If you have any questions to the Danish Board for Health Apps, please contact the Board’s secretariat at sundhedsapps@dkma.dk.

The list of health apps recommended by the Danish Board for Health Apps gives the public and healthcare professionals a better overview of available health apps. It can be a valuable contribution to treatment for those in contact with the healthcare system, but it can also support prevention and the promotion of better health when pursued on the individual’s own initiative.

The Danish Board for Health Apps was established as part of the Danish government’s national digital strategy of November 2023 and the political agreement of February 2024 on an ambitious and responsible strategy for Denmark’s digital development. The Board constitutes one of the key initiatives to advance digital healthcare in Denmark.

The purpose of the Danish Board for Health Apps is to recommend health apps, making it easier for the public and healthcare professionals to navigate the wide range of apps available from various providers. The aim is to ensure a better overview and to provide guidance on high-quality apps. In order for a health app to be recommended by the Board, it must first and foremost meet the assessment criteria laid down by the Board:

• clinical evidence of efficacy
• usability
• price
• social value

The Board has also laid down principles for its review of applications and success criteria for its work. The principles and success criteria serve both to ensure consistency in the Board’s assessments and recommendations of health apps and to keep the overview of recommended health apps relevant.

Principles

The Board assesses the health apps as a whole. This means that applicants cannot apply for recommendation of one or more parts of a health app, for example parts that are free of charge. Consequently, the Board only recommends health apps if the whole app meets the established assessment criteria. 

In addition, the Board assesses only the content contained in the health app, not any other products, medicines or services beyond it. To illustrate, virtual consultations, whether provided as an in-app purchase or selectable through a health app, are not assessed by the Board. Nor does the Board vouch for the quality of any such services.

The Board's recommendations assume that the recommended health apps are used correctly according to the provider's instructions. The provider is responsible for any incidents that occur during use of the recommended health apps.

The Danish Board for Health Apps reserves the right to define the framework for its recommendation in more detail, and to withdraw a health app’s recommendation temporarily or permanently at any time if information comes to light that substantially changes the assessment basis. The process for changing recommended health apps is described in the ‘For applicants’ section.

Applications are processed in the order received. Note, however, that the review time may vary from application to application, one reason being that the expert assessment of health apps may be prolonged. There is no guarantee regarding how quickly the Board will review and decide on a health app recommendation. Applicants therefore cannot demand that their application be processed within a specific time frame.

Success criteria

The Danish Board for Health Apps has adopted five success criteria for its work. The five criteria along with the assessment criteria will serve to guide the Board's work and recommendations. The success criteria are:

1. Visibility 
   We will be a visible supplement to, and support for, the public’s monitoring of their own health, self-care and contact with the healthcare system – known and used by many members of the public and healthcare professionals.
2. Scope
   We will contribute to the public’s health by covering relevant health and disease areas widely. Therefore, we will strive to recommend health apps that embrace the major health and disease areas including the most common chronic diseases, cancer, psychiatry, pregnancy, nicotine cessation, diet and exercise. Likewise, we will help encourage the most widely used health apps to apply for a recommendation from the Danish Board for Health Apps. 
3. Reducing health inequalities
   We will help reduce health inequalities by recommending apps available to the general public, including health apps that embrace society’s minority groups. 
4. Coherence 
   We will contribute to uniformity and coherence in the healthcare system. Therefore, we will strive to recommend health apps that will support patient care across sectors and which
5. Labour saving healthcare system
   We will contribute to being labour saving in the healthcare system. Therefore, we will strive to recommend health apps capable of minimising the need for physical appointments in the healthcare system and supporting the possibility of home care.

The Board will continuously review the success criteria to assess whether they are followed and to ensure their continued relevance. Likewise, the Board may adapt success criteria, assessment criteria and principles as it builds up experience in recommending health apps and as the concept of recommending health apps evolves

Draft bill to amend the Danish Health Act (better digital parental access to children's personal health data, collection and disclosure of personal health data and other confidential information and the establishment of a Board for Health Apps) (retsinformation.dk)

Executive order on the Rules of Procedure of the Danish Board for Health Apps (retsinformation.dk)

Political agreement in place on Denmark's new national digital strategy (regeringen.dk)