Danish Board for Health Apps

Applications for a recommendation of a health app by the Danish Board for Health Apps must be submitted through the online 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 recommendation from the Danish Board for Health Apps.

1. After submitting your application through the application form, you will receive an email confirmation from the secretariat.
   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 Danish Board for Health Apps and you subsequently make changes to the app, there are several considerations you should be aware of. Depending on the nature and extent of the changes, you may be required to notify the Board.

A recommendation is based on the version of the health app that was originally submitted for assessment or the version most recently evaluated by the Board. Therefore, the Board must be informed if significant changes are made to the app’s content, design, information published on sundhed.dk, or technical functionality.

This is because such changes may affect the criteria on which the recommendation was based or require updates to the app’s description and presentation on sundhed.dk.

Three types of changes

The Board generally distinguishes between three types of changes. The type of change determines whether and how you must notify the Board.

• Significant changes must be reported as soon as they are implemented.
• Minor changes must be reported as part of the annual review process.
• Insignificant changes do not need to be reported to the Board.

Significant changes

Significant changes to a health app must be reported to the Board when they are implemented. This is because such changes may affect the Board’s recommendation, and the Board must therefore have the opportunity to assess their impact on an ongoing basis.

This applies to the following changes:

• Changes to the general information about the health app, including information that requires updates to the app’s description on sundhed.dk, or changes to its purpose, target group, language, devices, or use of wearables.

• 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 changes to functionality or accessibility.
• Any changes to the price of using the health app, including changes to payment models, subscription models, advertising, or similar features.
• Significant changes to the health app that affect its societal 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.

In September 2024, the then Minister for the Interior and Health appointed the following eight members to the 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 consist of up to 11 members, who are appointed for terms of up to four years.

The Board may, where necessary, appoint alternate members to act on behalf of members and participate in the Board’s work.

Declarations of interests (in Danish)

Erik Jylling (pdf)

Ann Leistiko (pdf)

Rikke Saltoft Andersen (pdf)

Bjarne Skjødt Hjaltalin (pdf)

Niels Ulrich Holm (pdf)

Christine Lønager Boesen (pdf)

Lene Laursen (pdf)

Laura Duus Dahlin (pdf)

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: 30 September 2026 (pdf)

Agenda: 23 June 2026 (pdf)

Agenda: 16 April 2026 (pdf)

Agenda: 3 February 2026 (pdf)

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: 16 April 2026 (pdf)

Minutes: 3 February 2026 (pdf)

Minutes: 25 November 2025 (pdf)

Minutes: 26 June 2025 (pdf)

Minutes: 9 April 2025 (pdf)

Minutes: 19 February 2025 (pdf)

Minutes: 6 November 2024 (pdf)

The Danish Medicines Agency provides secretariat support to the Board for Health Apps. The secretariat provides guidance to applicants, processes submitted applications and assists in planning and coordinating the Board’s work in collaboration with the chairmanship.

If you have any questions regarding the Board for Health Apps, please contact the secretariat at Send an email.

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

In addition to these assessment criteria, the Board has established a set of principles governing its review process, as well as a number of success criteria that guide its work. Together, these principles and success criteria help ensure consistency, transparency, and continued relevance in the Board’s recommendations.

Principles

The Board assesses health apps in their entirety. Applicants cannot seek recommendation for only selected components or features of an app, such as those available free of charge. Consequently, a health app will only be recommended if the complete product meets all relevant assessment criteria.

The Board evaluates only the content and functionality contained within the health app itself. Other products, medicines, or services associated with the app fall outside the scope of the assessment. For example, virtual consultations offered through or alongside an app are not evaluated by the Board, nor does the Board endorse or guarantee the quality of such services.

The Board’s recommendations assume that health apps are used correctly and in accordance with the provider’s instructions. Responsibility for the safe and appropriate use of a recommended health app remains with the provider.

The Danish Board for Health Apps reserves the right to define and refine the framework for its recommendations. The Board may temporarily suspend or permanently withdraw a recommendation if new information significantly alters the basis for the original assessment. Procedures for modifying or withdrawing recommendations are described in the section entitled For Applicants.

Applications are processed in the order in which they are received. However, review times may vary depending on the complexity of the application and the requirements of the expert assessment process. The Board does not guarantee a specific processing time, and applicants cannot require that their application be assessed within a predetermined timeframe.

Success criteria

The Danish Board for Health Apps has adopted five success criteria to guide its work and support its overall mission. Together with the assessment criteria, these success criteria help shape the Board’s recommendations and priorities.

1. Visibility 
   The Board will serve as a visible and trusted supplement to the public’s efforts in health monitoring, self-care, and interaction with the healthcare system. It aims to be widely recognized and used by both citizens and healthcare professionals.
2. Scope
   The Board seeks to contribute to public health by covering a broad range of relevant health conditions and disease areas. It therefore strives to recommend health apps addressing major health challenges, including chronic diseases, cancer, mental health conditions, pregnancy, smoking and nicotine cessation, nutrition, and physical activity. The Board also encourages widely used health apps to apply for recommendations. 
3. Reducing health inequalities
   The Board aims to help reduce health inequalities by recommending health apps that are accessible to the general population and that consider the needs of minority and underserved groups within society. 
4. Coherence 
   The Board seeks to promote consistency and integration across healthcare services. It therefore prioritizes health apps that support coordinated patient pathways and facilitate collaboration across healthcare sectors. 
5. Labour saving healthcare system
   The Board aims to support a more resource-efficient healthcare system by recommending health apps that can reduce the need for in-person consultations and enable care and monitoring to take place in the home environment where appropriate.

The Board regularly reviews its success criteria to ensure that they continue to be relevant and aligned with their objectives. As experience is gained and the field of digital health evolves, the Board may revise its success criteria, assessment criteria, and guiding principles to reflect new knowledge, priorities, and developments in health app assessment.

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)