Seminar series: Quality review of a health app

Today, there are more than 200 000 health applications (health apps) available on the Swedish market. Usage differs between the country’s regions and municipalities. Fragmented requirements contribute to uncertainty and long lead times for development, procurement and implementation. As a result, Sweden is missing out on good solutions, as developing companies look to other markets.

At the same time, regulation of digital technologies is increasing, and the need to establish and coordinate procedures and regulatory frameworks to capitalise on digital opportunities is growing rapidly. A common interpretation of what constitutes quality in a health app would simplify innovation and procurement and help build trust in digital technology. It would also make it easier and safer to implement new technologies – so that good solutions can be utilised.

Four-part seminar series

The health innovation environments DigitalWell Arena and Leap for Life, together with Linnaeus University and SIS – Swedish Institute for Standards – invite you to a seminar series on the theme: To quality analyse a health app.

Over four sessions, starting on 25 September, participants will be guided through quality requirements for evidence, usability, data and information security, technical robustness and interoperability. Lectures will be given by experts in each field and there will be time for questions and joint dialogue.

Please note that separate registration is required for each session! See below for details.
It is also possible to participate in individual seminars. All seminars will also be made available online afterwards.

The aim of the seminar series is to provide a better understanding of the different regulatory areas and standards covered when assessing the quality of a health app. It enables a concrete dialogue on the requirements set, and create the conditions for a common interpretation of health app quality in Sweden.

The seminar series is based on the international technical specification ISO/TS 82304-2:2021, which summarises the relevant quality requirements for health apps and provides a common basis to work from.

For whom?

The series is aimed at employees of municipalities and regions who in various ways formulate requirements for applications and participate in the assessment, procurement, or implementation of health apps.

Background

The seminar series is given within the framework of the ERDF-funded project Capacity for quality assurance of health apps, which is carried out by DigitalWell Arena, Leap for Life, Linnaeus University, Region Värmland, Academic Primary Care Centre in Region Stockholm, Karlstad Municipality, Arvika Municipality, eHealth Agency, KTH and Swedish Medtech. The project will run until June 2027.

Want to learn more now? Download the international technical specification ISO/TS 82304-2:2021

An introduction to quality assurance

Marie Granander, project manager at DigitalWell Arena, gives an introduction to the challenges and opportunities that exist for quality assurance of health apps. The recording was made in May 2025 and is followed by a panel discussion, where representatives from Region Värmland, Karlstad Municipality, the Swedish Medical Products Agency and the eHealth Agency participate.