Norwegian evaluation framework and national model for quality assurance of health apps based on CEN-ISO/TS 82304-2


December 14, 2022

In its aim of promoting the adoption of CEN-ISO/TS 82304-2, Label2Enable was happy to learn about the significant progress Norway is making with providing citizens with quality health apps through a national project that has developed an app quality evaluation framework partly based on CEN-ISO/TS 82304-2.

“Safer health apps” is a joint project under the auspices of the Directorate for Health, the Norwegian Health Network and the Directorate for eHealth. The project has developed an evaluation framework, initially designed for apps that are not medical devices.

The framework – and a how-to-guide for public procurements – will be finished before Christmas this year. It may be used by public health authorities when procuring health apps for their audiences.

The evaluation criteria selected in the framework are based, among other, on CEN-ISO/TS 82304-2 and local regulations on universal design. In addition, a systematic review has been performed to understand the requirements of other countries like Belgium, Germany, England (NHS) and the Netherlands.

Three apps – Brain Twin, My Workout go and Lifeness – have already been evaluated and for a limited time period included in the Norwegian digital health services portal The framework is now being tested even in a public procurement process.

Brain Twin is an app-based headache diary that helps to keep track of headaches and related medication use. The app data can be used by citizens during consultations with health professionals, providing a simple and quick overview of headache trends.

Lifeness is a follow-up assistant for healthcare professionals which provides a patient management functionality, including the use of chat and video for interacting with patients remotely in order to provide the right intervention to the right patient at the right time. Patients can also use the app to report their mental and physical health, set goals, answer surveys and establish a dialogue with the treating health professional.

My Workout Go is designed to provide motivation and support between consultations, and enhance compliance with prescribed physical activity/training.

A label similar to the CEN-ISO/TS 82304-2 quality label has been used to display the evaluation results for the apps.

For more information about the “Safer health apps” and the two apps, visit

(only in Norwegian)

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